[House Report 117-348]
[From the U.S. Government Publishing Office]
117th Congress } { Report
HOUSE OF REPRESENTATIVES
2d Session } { 117-348
_______________________________________________________________________
.
FOOD AND DRUG AMENDMENTS OF 2022
----------
R E P O R T
of the
COMMITTEE ON ENERGY AND COMMERCE
to accompany
H.R. 7667
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
June 7, 2022.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
FOOD AND DRUG AMENDMENTS OF 2022
117th Congress } { Report
HOUSE OF REPRESENTATIVES
2d Session } { 117-348
_______________________________________________________________________
FOOD AND DRUG AMENDMENTS OF 2022
__________
R E P O R T
of the
COMMITTEE ON ENERGY AND COMMERCE
to accompany
H.R. 7667
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
June 7, 2022.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
__________
U.S. GOVERNMENT PUBLISHING OFFICE
29-006 WASHINGTON : 2022
117th Congress } { Report
HOUSE OF REPRESENTATIVES
2d Session } { 117-348
======================================================================
FOOD AND DRUG AMENDMENTS OF 2022
_______
June 7, 2022.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Pallone, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 7667]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 7667) to amend the Federal Food, Drug, and
Cosmetic Act to revise and extend the user-fee programs for
prescription drugs, medical devices, generic drugs, and
biosimilar biological products, and for other purposes, having
considered the same, reports favorably thereon with an
amendment and recommends that the bill as amended do pass.
CONTENTS
Page
I. Purpose and Summary.............................................49
II. Background and Need for the Legislation.........................49
III. Committee Hearings..............................................67
IV. Committee Consideration.........................................68
V. Committee Votes.................................................68
VI. Oversight Findings..............................................72
VII. New Budget Authority, Entitlement Authority, and Tax Expenditure72
VIII.Federal Mandates Statement......................................72
IX. Statement of General Performance Goals and Objectives...........72
X. Duplication of Federal Programs.................................72
XI. Committee Cost Estimate.........................................72
XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits.....72
XIII.Advisory Committee Statement....................................73
XIV. Applicability to Legislative Branch.............................73
XV. Section-by-Section Analysis of the Legislation..................73
XVI. Changes in Existing Law Made by the Bill, as Reported...........86
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Food and Drug Amendments of 2022''.
SEC. 2. TABLE OF CONTENTS.
The table of contents of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
TITLE I--FEES RELATING TO DRUGS
Sec. 101. Short title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Reauthorization; reporting requirements.
Sec. 105. Sunset dates.
Sec. 106. Effective date.
Sec. 107. Savings clause.
TITLE II--FEES RELATING TO DEVICES
Sec. 201. Short title; finding.
Sec. 202. Definitions.
Sec. 203. Authority to assess and use device fees.
Sec. 204. Reauthorization; reporting requirements.
Sec. 205. Conformity assessment pilot program.
Sec. 206. Reauthorization of third-party review program.
Sec. 207. Sunset dates.
Sec. 208. Effective date.
Sec. 209. Savings clause.
TITLE III--FEES RELATING TO GENERIC DRUGS
Sec. 301. Short title; finding.
Sec. 302. Authority to assess and use human generic drug fees.
Sec. 303. Reauthorization; reporting requirements.
Sec. 304. Sunset dates.
Sec. 305. Effective date.
Sec. 306. Savings clause.
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
Sec. 401. Short title; finding.
Sec. 402. Definitions.
Sec. 403. Authority to assess and use biosimilar fees.
Sec. 404. Reauthorization; reporting requirements.
Sec. 405. Sunset dates.
Sec. 406. Effective date.
Sec. 407. Savings clause.
TITLE V--IMPROVING DIVERSITY IN CLINICAL STUDIES
Sec. 501. Diversity action plans for clinical studies.
Sec. 502. Evaluation of the need for FDA authority to mandate
postapproval studies or postmarket surveillance due to insufficient
demographic subgroup data.
Sec. 503. Public workshops to enhance clinical study diversity.
Sec. 504. Annual summary report on progress to increase diversity in
clinical studies.
Sec. 505. Public meeting on clinical study flexibilities initiated in
response to COVID-19 pandemic.
Sec. 506. Decentralized clinical studies.
TITLE VI--GENERIC DRUG COMPETITION
Sec. 601. Increasing transparency in generic drug applications.
Sec. 602. Enhancing access to affordable medicines.
TITLE VII--RESEARCH, DEVELOPMENT, AND SUPPLY CHAIN IMPROVEMENTS
Subtitle A--In General
Sec. 701. Animal testing alternatives.
Sec. 702. Emerging technology program.
Sec. 703. Improving the treatment of rare diseases and conditions.
Sec. 704. Antifungal research and development.
Sec. 705. Advancing qualified infectious disease product innovation.
Sec. 706. Advanced manufacturing technologies designation pilot
program.
Sec. 707. Public workshop on cell therapies.
Sec. 708. Reauthorization of best pharmaceuticals for children.
Sec. 709. Reauthorization for humanitarian device exemption and
demonstration grants for improving pediatric availability.
Sec. 710. Reauthorization of provision related to exclusivity of
certain drugs containing single enantiomers.
Sec. 711. Reauthorization of the critical path public-private
partnership program.
Sec. 712. Reauthorization of orphan drug grants.
Sec. 713. Research into pediatric uses of drugs; additional authorities
of Food and Drug Administration regarding molecularly targeted cancer
drugs.
Subtitle B--Inspections
Sec. 721. Factory inspection.
Sec. 722. Uses of certain evidence.
Sec. 723. Improving FDA inspections.
Sec. 724. GAO report on inspections of foreign establishments
manufacturing drugs.
Sec. 725. Unannounced foreign facility inspections pilot program.
Sec. 726. Reauthorization of inspection program.
Sec. 727. Enhancing intra-agency coordination and public health
assessment with regard to compliance activities.
Sec. 728. Reporting of mutual recognition agreements for inspections
and review activities.
Sec. 729. Enhancing transparency of drug facility inspection timelines.
TITLE VIII--TRANSPARENCY, PROGRAM INTEGRITY, AND REGULATORY
IMPROVEMENTS
Sec. 801. Prompt reports of marketing status by holders of approved
applications for biological products.
Sec. 802. Encouraging blood donation.
Sec. 803. Regulation of certain products as drugs.
Sec. 804. Postapproval studies and program integrity for accelerated
approval drugs.
Sec. 805. Facilitating the use of real world evidence.
Sec. 806. Dual Submission for Certain Devices.
Sec. 807. Medical Devices Advisory Committee meetings.
Sec. 808. Ensuring cybersecurity of medical devices.
Sec. 809. Public docket on proposed changes to third-party vendors.
Sec. 810. Facilitating exchange of product information prior to
approval.
Sec. 811. Bans of devices for one or more intended uses.
Sec. 812. Clarifying application of exclusive approval, certification,
or licensure for drugs designated for rare diseases or conditions.
Sec. 813. GAO report on third-party review.
Sec. 814. Reporting on pending generic drug applications and priority
review applications.
Sec. 815. FDA Workforce Improvements.
TITLE I--FEES RELATING TO DRUGS
SEC. 101. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Prescription Drug
User Fee Amendments of 2022''.
(b) Finding.--The Congress finds that the fees authorized by the
amendments made by this title will be dedicated toward expediting the
drug development process and the process for the review of human drug
applications, including postmarket drug safety activities, as set forth
in the goals identified for purposes of part 2 of subchapter C of
chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g
et seq.), in the letters from the Secretary of Health and Human
Services to the Chairman of the Committee on Health, Education, Labor,
and Pensions of the Senate and the Chairman of the Committee on Energy
and Commerce of the House of Representatives, as set forth in the
Congressional Record.
SEC. 102. DEFINITIONS.
(a) Human Drug Application.--Section 735(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is amended by striking ``an
allergenic extract product, or'' and inserting ``does not include an
application with respect to an allergenic extract product licensed
before October 1, 2022, does not include an application with respect to
a standardized allergenic extract product submitted pursuant to a
notification to the applicant from the Secretary regarding the
existence of a potency test that measures the allergenic activity of an
allergenic extract product licensed by the applicant before October 1,
2022, does not include an application with respect to''.
(b) Prescription Drug Product.--Section 735(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379g(3)) is amended--
(1) by redesignating subparagraphs (A), (B), and (C) as
clauses (i), (ii), and (iii), respectively;
(2) by striking ``(3) The term'' and inserting ``(3)(A) The
term'';
(3) by striking ``Such term does not include whole blood''
and inserting the following:
``(B) Such term does not include whole blood'';
(4) by striking ``an allergenic extract product,'' and
inserting ``an allergenic extract product licensed before
October 1, 2022, a standardized allergenic extract product
submitted pursuant to a notification to the applicant from the
Secretary regarding the existence of a potency test that
measures the allergenic activity of an allergenic extract
product licensed by the applicant before October 1, 2022,'' ;
and
(5) by adding at the end the following:
``(C)(i) If a written request to place a product in
the discontinued section of either of the lists
referenced in subparagraph (A)(iii) is submitted to the
Secretary on behalf of an applicant, and the request
identifies the date the product is withdrawn from sale,
then for purposes of assessing the prescription drug
program fee under section 736(a)(2), the Secretary
shall consider such product to have been included in
the discontinued section on the later of--
``(I) the date such request was received; or
``(II) if the product will be withdrawn from
sale on a future date, such future date when
the product is withdrawn from sale.
``(ii) For purposes of this subparagraph, a product
shall be considered withdrawn from sale once the
applicant has ceased its own distribution of the
product, whether or not the applicant has ordered
recall of all previously distributed lots of the
product, except that a routine, temporary interruption
in supply shall not render a product withdrawn from
sale.''.
(c) Skin-Test Diagnostic Product.--Section 735 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379g) is amended by adding at the end
the following:
``(12) The term `skin-test diagnostic product'--
``(A) means a product--
``(i) for prick, scratch, intradermal, or
subcutaneous administration;
``(ii) expected to produce a limited, local
reaction at the site of administration (if
positive), rather than a systemic effect;
``(iii) not intended to be a preventive or
therapeutic intervention; and
``(iv) intended to detect an immediate- or
delayed-type skin hypersensitivity reaction to
aid in the diagnosis of--
``(I) an allergy to an antimicrobial
agent;
``(II) an allergy that is not to an
antimicrobial agent, if the diagnostic
product was authorized for marketing
prior to October 1, 2022; or
``(III) infection with fungal or
mycobacterial pathogens; and
``(B) includes positive and negative controls
required to interpret the results of a product
described in subparagraph (A).''.
SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.
(a) Types of Fees.--
(1) Human drug application fee.--Section 736(a) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)) is
amended--
(A) in the matter preceding paragraph (1), by
striking ``fiscal year 2018'' and inserting ``fiscal
year 2023'';
(B) in paragraph (1)(A), by striking ``(c)(5)'' each
place it appears and inserting ``(c)(6)'';
(C) in paragraph (1)(C), by inserting ``prior to
approval'' after ``or was withdrawn''; and
(D) in paragraph (1), by adding at the end the
following:
``(H) Exception for skin-test diagnostic products.--A
human drug application for a skin-test diagnostic
product shall not be subject to a fee under
subparagraph (A).''.
(2) Prescription drug program fee.--Section 736(a)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)(2)) is
amended--
(A) in subparagraph (A)--
(i) by striking ``Except as provided in
subparagraphs (B) and (C)'' and inserting the
following:
``(i) Fee.--Except as provided in
subparagraphs (B) and (C)'';
(ii) by striking ``subsection (c)(5)'' and
inserting ``subsection (c)(6)''; and
(iii) by adding at the end the following:
``(ii) Special rule.--If a drug product that
is identified in a human drug application
approved as of October 1 of a fiscal year is
not a prescription drug product as of that date
because the drug product is in the discontinued
section of a list referenced in section
735(3)(A)(iii), and on any subsequent day
during such fiscal year the drug product is a
prescription drug product, then except as
provided in subparagraphs (B) and (C), each
person who is named as the applicant in a human
drug application with respect to such product,
and who, after September 1, 1992, had pending
before the Secretary a human drug application
or supplement with respect to such product,
shall pay the annual prescription drug program
fee established for a fiscal year under
subsection (c)(6) for such prescription drug
product. Such fee shall be due on the last
business day of such fiscal year and shall be
paid only once for each such product for a
fiscal year in which the fee is payable.''; and
(B) by amending subparagraph (B) to read as follows:
``(B) Exception for certain prescription drug
products.--A prescription drug program fee shall not be
assessed for a prescription drug product under
subparagraph (A) if such product is--
``(i) a large volume parenteral product (a
sterile aqueous drug product packaged in a
single-dose container with a volume greater
than or equal to 100 mL, not including powders
for reconstitution or pharmacy bulk packages)
identified on the list compiled under section
505(j)(7);
``(ii) pharmaceutically equivalent (as
defined in section 314.3 of title 21, Code of
Federal Regulations (or any successor
regulation)) to another product on the list of
products compiled under section 505(j)(7) (not
including the discontinued section of such
list); or
``(iii) a skin-test diagnostic product.''.
(b) Fee Revenue Amounts.--
(1) In general.--Paragraph (1) of section 736(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is
amended to read as follows:
``(1) In general.--For each of the fiscal years 2023 through
2027, fees under subsection (a) shall, except as provided in
subsections (c), (d), (f), and (g), be established to generate
a total revenue amount under such subsection that is equal to
the sum of--
``(A) the annual base revenue for the fiscal year (as
determined under paragraph (3));
``(B) the dollar amount equal to the inflation
adjustment for the fiscal year (as determined under
subsection (c)(1));
``(C) the dollar amount equal to the strategic hiring
and retention adjustment for the fiscal year (as
determined under subsection (c)(2));
``(D) the dollar amount equal to the capacity
planning adjustment for the fiscal year (as determined
under subsection (c)(3));
``(E) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if applicable
(as determined under subsection (c)(4));
``(F) the dollar amount equal to the additional
direct cost adjustment for the fiscal year (as
determined under subsection (c)(5)); and
``(G) additional dollar amounts for each fiscal year
as follows:
``(i) $65,773,693 for fiscal year 2023.
``(ii) $25,097,671 for fiscal year 2024.
``(iii) $14,154,169 for fiscal year 2025.
``(iv) $4,864,860 for fiscal year 2026.
``(v) $1,314,620 for fiscal year 2027.''.
(2) Annual base revenue.--Paragraph (3) of section 736(b) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is
amended to read as follows:
``(3) Annual base revenue.--For purposes of paragraph (1),
the dollar amount of the annual base revenue for a fiscal year
shall be--
``(A) for fiscal year 2023, $1,151,522,958; and
``(B) for fiscal years 2024 through 2027, the dollar
amount of the total revenue amount established under
paragraph (1) for the previous fiscal year, not
including any adjustments made under subsection (c)(4)
or (c)(5).''.
(c) Adjustments; Annual Fee Setting.--
(1) Inflation adjustment.--Section 736(c)(1)(B)(ii) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h(c)(1)(B)(ii)) is amended by striking ``Washington-
Baltimore, DC-MD-VA-WV'' and inserting ``Washington-Arlington-
Alexandria, DC-VA-MD-WV''.
(2) Strategic hiring and retention adjustment.--Section
736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h(c)) is amended--
(A) by redesignating paragraphs (2) through (6) as
paragraphs (3) through (7), respectively; and
(B) by inserting after paragraph (1) the following:
``(2) Strategic hiring and retention adjustment.--For each
fiscal year, after the annual base revenue established in
subsection (b)(1)(A) is adjusted for inflation in accordance
with paragraph (1), the Secretary shall further increase the
fee revenue and fees by the following amounts:
``(A) For fiscal year 2023, $9,000,000.
``(B) For each of fiscal years 2024 through 2027,
$4,000,000.''.
(3) Capacity planning adjustment.--Paragraph (3), as
redesignated, of section 736(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as follows:
``(3) Capacity planning adjustment.--
``(A) In general.--For each fiscal year, after the
annual base revenue established in subsection (b)(1)(A)
is adjusted in accordance with paragraphs (1) and (2),
such revenue shall be adjusted further for such fiscal
year, in accordance with this paragraph, to reflect
changes in the resource capacity needs of the Secretary
for the process for the review of human drug
applications.
``(B) Methodology.--For purposes of this paragraph,
the Secretary shall employ the capacity planning
methodology utilized by the Secretary in setting fees
for fiscal year 2021, as described in the notice titled
`Prescription Drug User Fee Rates for Fiscal Year 2021'
published in the Federal Register on August 3, 2020 (85
Fed. Reg. 46651). The workload categories used in
applying such methodology in forecasting shall include
only the activities described in that notice and, as
feasible, additional activities that are also directly
related to the direct review of applications and
supplements, including additional formal meeting types,
the direct review of postmarketing commitments and
requirements, the direct review of risk evaluation and
mitigation strategies, and the direct review of annual
reports for approved prescription drug products.
Subject to the exceptions in the preceding sentence,
the Secretary shall not include as workload categories
in applying such methodology in forecasting any non-
core review activities, including those activities that
the Secretary referenced for potential future use in
such notice but did not utilize in setting fees for
fiscal year 2021.
``(C) Limitation.--Under no circumstances shall an
adjustment under this paragraph result in fee revenue
for a fiscal year that is less than the sum of the
amounts under subsections (b)(1)(A) (the annual base
revenue for the fiscal year), (b)(1)(B) (the dollar
amount of the inflation adjustment for the fiscal
year), and (b)(1)(C) (the dollar amount of the
strategic hiring and retention adjustment for the
fiscal year).
``(D) Publication in federal register.--The Secretary
shall publish in the Federal Register notice under
paragraph (6) of the fee revenue and fees resulting
from the adjustment and the methodologies under this
paragraph.''.
(4) Operating reserve adjustment.--Paragraph (4), as
redesignated, of section 736(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(c)) is amended--
(A) by amending subparagraph (A) to read as follows:
``(A) Increase.--For fiscal year 2023 and subsequent
fiscal years, the Secretary shall, in addition to
adjustments under paragraphs (1), (2), and (3), further
increase the fee revenue and fees if such an adjustment
is necessary to provide for operating reserves of
carryover user fees for the process for the review of
human drug applications for each fiscal year in at
least the following amounts:
``(i) For fiscal year 2023, at least 8 weeks
of operating reserves.
``(ii) For fiscal year 2024, at least 9 weeks
of operating reserves.
``(iii) For fiscal year 2025 and subsequent
fiscal years, at least 10 weeks of operating
reserves.''; and
(B) in subparagraph (C), by striking ``paragraph
(5)'' and inserting ``paragraph (6)''.
(5) Additional direct cost adjustment.--Paragraph (5), as
redesignated, of section 736(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as follows:
``(5) Additional direct cost adjustment.--
``(A) Increase.--The Secretary shall, in addition to
adjustments under paragraphs (1), (2), (3), and (4),
further increase the fee revenue and fees--
``(i) for fiscal year 2023, by $44,386,150;
and
``(ii) for each of fiscal years 2024 through
2027, by the amount set forth in clauses (i)
through (iv) of subparagraph (B), as
applicable, multiplied by the Consumer Price
Index for urban consumers (Washington-
Arlington-Alexandria, DC-VA-MD-WV; Not
Seasonally Adjusted; All Items; Annual Index)
for the most recent year of available data,
divided by such Index for 2021.
``(B) Applicable amounts.--The amounts referred to in
subparagraph (A)(ii) are the following:
``(i) For fiscal year 2024, $60,967,993.
``(ii) For fiscal year 2025, $35,799,314.
``(iii) For fiscal year 2026, $35,799, 314.
``(iv) For fiscal year 2027, $35,799,314.''.
(6) Annual fee setting.--Paragraph (6), as redesignated, of
section 736(c) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379h(c)) is amended by striking ``September 30, 2017''
and inserting ``September 30, 2022''.
(d) Crediting and Availability of Fees.--Section 736(g)(3) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(3)) is amended
by striking ``fiscal years 2018 through 2022'' and inserting ``fiscal
years 2023 through 2027''.
(e) Written Requests for Waivers, Reductions, Exemptions, and
Returns; Disputes Concerning Fees.--Section 736(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h(i)) is amended to read as
follows:
``(i) Written Requests for Waivers, Reductions, Exemptions, and
Returns; Disputes Concerning Fees.--To qualify for consideration for a
waiver or reduction under subsection (d), an exemption under subsection
(k), or the return of any fee paid under this section, including if the
fee is claimed to have been paid in error, a person shall--
``(1) not later than 180 days after such fee is due, submit
to the Secretary a written request justifying such waiver,
reduction, exemption, or return; and
``(2) include in the request any legal authorities under
which the request is made.''.
(f) Orphan Drugs.--Section 736(k) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(k)) is amended--
(1) in paragraph (1)(B), by striking ``during the previous
year'' and inserting ``as determined under paragraph (2)''; and
(2) by amending paragraph (2) to read as follows:
``(2) Evidence of qualification.--An exemption under
paragraph (1) applies with respect to a drug only if the
applicant involved submits a certification that the applicant's
gross annual revenues did not exceed $50,000,000 for the last
calendar year ending prior to the fiscal year for which the
exemption is requested. Such certification shall be supported
by--
``(A) tax returns submitted to the United States
Internal Revenue Service; or
``(B) as necessary, other appropriate financial
information.''.
SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h-2) is amended--
(1) in subsection (a)(1), by striking ``Beginning with fiscal
year 2018, not'' and inserting ``Not'';
(2) by striking ``Prescription Drug User Fee Amendments of
2017'' each place it appears and inserting ``Prescription Drug
User Fee Amendments of 2022'';
(3) in subsection (a)(3)(A), by striking ``Not later than 30
calendar days after the end of the second quarter of fiscal
year 2018, and not later than 30 calendar days after the end of
each quarter of each fiscal year thereafter'' and inserting
``Not later than 30 calendar days after the end of each quarter
of each fiscal year for which fees are collected under this
part'';
(4) in subsection (a)(3)(B), by adding at the end the
following:
``(v) For fiscal years 2023 and 2024, of the
meeting requests from sponsors for which the
Secretary has determined that a face-to-face
meeting is appropriate, the number of face-to-
face meetings requested by sponsors to be
conducted in person (in such manner as the
Secretary shall prescribe on the internet
website of the Food and Drug Administration),
and the number of such in-person meetings
granted by the Secretary.'';
(5) in subsection (a)(4), by striking ``Beginning with fiscal
year 2020, the'' and inserting ``The'';
(6) in subsection (b), by striking ``Beginning with fiscal
year 2018, not'' and inserting ``Not'';
(7) in subsection (c), by striking ``Beginning with fiscal
year 2018, for'' and inserting ``For''; and
(8) in subsection (f)--
(A) in paragraph (1), in the matter preceding
subparagraph (A), by striking ``fiscal year 2022'' and
inserting ``fiscal year 2027''; and
(B) in paragraph (5), by striking ``January 15,
2022'' and inserting ``January 15, 2027''.
SEC. 105. SUNSET DATES.
(a) Authorization.--Sections 735 and 736 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to be effective
October 1, 2027.
(b) Reporting Requirements.--Section 736B of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379h-2) shall cease to be effective January
31, 2028.
(c) Previous Sunset Provision.--Effective October 1, 2022,
subsections (a) and (b) of section 104 of the FDA Reauthorization Act
of 2017 (Public Law 115-52) are repealed.
SEC. 106. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2022, or the date of the enactment of this Act, whichever is later,
except that fees under part 2 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.) shall be
assessed for all human drug applications received on or after October
1, 2022, regardless of the date of the enactment of this Act.
SEC. 107. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 2 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379g et seq.), as in effect on the day before the date of
the enactment of this title, shall continue to be in effect with
respect to human drug applications and supplements (as defined in such
part as of such day) that on or after October 1, 2017, but before
October 1, 2022, were accepted by the Food and Drug Administration for
filing with respect to assessing and collecting any fee required by
such part for a fiscal year prior to fiscal year 2023.
TITLE II--FEES RELATING TO DEVICES
SEC. 201. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Medical Device
User Fee Amendments of 2022''.
(b) Finding.--The Congress finds that the fees authorized under the
amendments made by this title will be dedicated toward expediting the
process for the review of device applications and for assuring the
safety and effectiveness of devices, as set forth in the goals
identified for purposes of part 3 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), in the
letters from the Secretary of Health and Human Services to the Chairman
of the Committee on Health, Education, Labor, and Pensions of the
Senate and the Chairman of the Committee on Energy and Commerce of the
House of Representatives, as set forth in the Congressional Record.
SEC. 202. DEFINITIONS.
Section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379i) is amended--
(1) in paragraph (9)--
(A) in the matter preceding subparagraph (A), by
striking ``and premarket notification submissions'' and
inserting ``premarket notification submissions, and de
novo classification requests'';
(B) in subparagraph (D), by striking ``and
submissions'' and inserting ``submissions, and
requests'';
(C) in subparagraph (F), by striking ``and premarket
notification submissions'' and inserting ``premarket
notification submissions, and de novo classification
requests'';
(D) in each of subparagraphs (G) and (H), by striking
``or submissions'' and inserting ``submissions, or
requests''; and
(E) in subparagraph (K), by striking ``or premarket
notification submissions'' and inserting ``premarket
notification submissions, or de novo classification
requests''; and
(2) in paragraph (11), by striking ``2016'' and inserting
``2021''.
SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.
(a) Types of Fees.--Section 738(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(a)) is amended--
(1) in paragraph (1), by striking ``fiscal year 2018'' and
inserting ``fiscal year 2023''; and
(2) in paragraph (2)--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i), by
striking ``October 1, 2017'' and inserting
``October 1, 2022'';
(ii) in clause (iii), by striking ``75
percent'' and inserting ``80 percent''; and
(iii) in clause (viii), by striking ``3.4
percent'' and inserting ``4.5 percent'';
(B) in subparagraph (B)(iii), by striking ``or
premarket notification submission'' and inserting
``premarket notification submission, or de novo
classification request''; and
(C) in subparagraph (C), by striking ``or periodic
reporting concerning a class III device'' and inserting
``periodic reporting concerning a class III device, or
de novo classification request''.
(b) Fee Amounts.--Section 738(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(b)) is amended--
(1) in paragraph (1), by striking ``2018 through 2022'' and
inserting ``2023 through 2027'';
(2) by amending paragraph (2) to read as follows:
``(2) Base fee amounts specified.--For purposes of paragraph
(1), the base fee amounts specified in this paragraph are as
follows:
----------------------------------------------------------------------------------------------------------------
Fiscal Fiscal Fiscal Fiscal Fiscal
``Fee Type Year 2023 Year 2024 Year 2025 Year 2026 Year 2027
----------------------------------------------------------------------------------------------------------------
Premarket Application.................................... $425,000 $435,000 $445,000 $455,000 $470,000
Establishment Registration............................... $6,250 $6,875 $7,100 $7,575 $8,465'';
and
----------------------------------------------------------------------------------------------------------------
''; and (3) by amending paragraph (3) to read as follows:
``(3) Total revenue amounts specified.--For purposes of
paragraph (1), the total revenue amounts specified in this
paragraph are as follows:
``(A) $312,606,000 for fiscal year 2023.
``(B) $335,750,000 for fiscal year 2024.
``(C) $350,746,400 for fiscal year 2025.
``(D) $366,486,300 for fiscal year 2026.
``(E) $418,343,000 for fiscal year 2027.''.
(c) Annual Fee Setting; Adjustments.--Section 738(c) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is amended--
(1) in paragraph (1), by striking ``2017'' and inserting
``2022'';
(2) in paragraph (2)--
(A) in subparagraph (A), by striking ``2018'' and
inserting ``2023'';
(B) in subparagraph (B)--
(i) in the matter preceding clause (i), by
striking ``fiscal year 2018'' and inserting
``fiscal year 2023''; and
(ii) in clause (ii), by striking ``fiscal
year 2016'' and inserting ``fiscal year 2022'';
(C) in subparagraph (C), by striking ``Washington-
Baltimore, DC-MD-VA-WV'' and inserting ``Washington-
Arlington-Alexandria, DC-VA-MD-WV''; and
(D) in subparagraph (D), in the matter preceding
clause (i), by striking ``fiscal years 2018 through
2022'' and inserting ``fiscal years 2023 through
2027'';
(3) in paragraph (3), by striking ``2018 through 2022'' and
inserting ``2023 through 2027'';
(4) by redesignating paragraphs (4) and (5) as paragraphs (7)
and (8), respectively; and
(5) by inserting after paragraph (3) the following:
``(4) Performance improvement adjustment.--
``(A) In general.--For each of fiscal years 2025
through 2027, after the adjustments under paragraphs
(2) and (3), the base establishment registration fee
amounts for such fiscal year shall be increased to
reflect changes in the resource needs of the Secretary
due to improved review performance goals for the
process for the review of device applications
identified in the letters described in section 201(b)
of the Medical Device User Fee Amendments of 2022, as
the Secretary determines necessary to achieve an
increase in total fee collections for such fiscal year
equal to the following amounts:
``(i) For fiscal year 2025, the product of--
``(I) the amount determined under
subparagraph (B)(i)(I); and
``(II) the applicable inflation
adjustment under paragraph (2)(B) for
such fiscal year.
``(ii) For fiscal year 2026, the product of--
``(I) the sum of the amounts
determined under subparagraphs
(B)(i)(II), (B)(ii)(I), and
(B)(iii)(I); and
``(II) the applicable inflation
adjustment under paragraph (2)(B) for
such fiscal year.
``(iii) For fiscal year 2027, the product
of--
``(I) the sum of the amounts
determined under subparagraphs
(B)(i)(III), (B)(ii)(II), and
(B)(iii)(II); and
``(II) the applicable inflation
adjustment under paragraph (2)(B) for
such fiscal year.
``(B) Amounts.--
``(i) Pre-submission amount.--For purposes of
subparagraph (A), with respect to the pre-
submission written feedback goal, the amounts
determined under this subparagraph are as
follows:
``(I) For fiscal year 2025,
$15,396,600 if such goal for fiscal
year 2023 is met.
``(II) For fiscal year 2026:
``(aa) $15,396,600 if such
goal for fiscal year 2023 is
met and such goal for fiscal
year 2024 is not met.
``(bb) $36,792,200 if such
goal for fiscal year 2024 is
met.
``(III) For fiscal year 2027:
``(aa) $15,396,600 if such
goal for fiscal year 2023 is
met and such goal for each of
fiscal years 2024 and 2025 is
not met.
``(bb) $36,792,200 if such
goal for fiscal year 2024 is
met and such goal for fiscal
year 2025 is not met.
``(cc) $40,572,600 if such
goal for fiscal year 2025 is
met.
``(ii) De novo classification amount.--For
purposes of subparagraph (A), with respect to
the de novo decision goal, the amounts
determined under this subparagraph are as
follows:
``(I) For fiscal year 2026,
$6,323,500 if such goal for fiscal year
2023 is met.
``(II) For fiscal year 2027:
``(aa) $6,323,500 if such
goal for fiscal year 2023 is
met and such goal for fiscal
year 2024 is not met.
``(bb) $11,765,400 if such
goal for fiscal year 2024 is
met.
``(iii) Premarket notification and premarket
approval amount.--For purposes of subparagraph
(A), with respect to the 510(k) decision goal,
510(k) shared outcome total time to decision
goal, PMA decision goal, and PMA shared outcome
total time to decision goal, the amounts
determined under this subparagraph are as
follows:
``(I) For fiscal year 2026,
$1,020,000 if the four goals for fiscal
year 2023 are met.
``(II) For fiscal year 2027:
``(aa) $1,020,000 if the four
goals for fiscal year 2023 are
met and one or more of the four
goals for fiscal year 2024 are
not met.
``(bb) $3,906,000 if the four
goals for fiscal year 2024 are
met.
``(C) Performance calculation.--For purposes of this
paragraph, performance of the goals listed in
subparagraph (D) shall be determined as specified in
the letters described in section 201(b) of the Medical
Device User Fee Amendments of 2022 and based on data
available as of the following dates:
``(i) The performance of the pre-submission
written feedback goal shall be based on data
available as of--
``(I) for fiscal year 2023, March 31,
2024;
``(II) for fiscal year 2024, March
31, 2025; and
``(III) for fiscal year 2025, March
31, 2026.
``(ii) The performance of the de novo
decision goal, 510(k) decision goal, 510(k)
shared outcome total time to decision goal, PMA
decision goal, and PMA shared outcome total
time to decision goal shall be based on data
available as of--
``(I) for fiscal year 2023, March 31,
2025; and
``(II) for fiscal year 2024, March
31, 2026.
``(D) Goals defined.--For purposes of this paragraph,
the terms `pre-submission written feedback goal', `de
novo decision goal', `510(k) decision goal', `510(k)
shared outcome total time to decision goal', `PMA
decision goal', and `PMA shared outcome total time to
decision goal' refer to the goals identified by the
same names in the letters described in section 201(b)
of the Medical Device User Fee Amendments of 2022.
``(5) Hiring adjustment.--
``(A) In general.--For each of fiscal years 2025
through 2027, after the adjustments under paragraphs
(2), (3), and (4), if applicable, if the number of
hires to support the process for the review of device
applications falls below the thresholds specified in
subparagraph (B) for the applicable fiscal years, the
base establishment registration fee amounts shall be
decreased as the Secretary determines necessary to
achieve a reduction in total fee collections equal to
the hiring adjustment amount under subparagraph (C).
``(B) Thresholds.--The thresholds specified in this
subparagraph are as follows:
``(i) For fiscal year 2025, the threshold is
123 hires for fiscal year 2023.
``(ii) For fiscal year 2026, the threshold is
38 hires for fiscal year 2024.
``(iii) For fiscal year 2027, the threshold
is--
``(I) 22 hires for fiscal year 2025
if the base establishment registration
fees are not increased by the amount
determined under paragraph (4)(A)(i);
or
``(II) 75 hires for fiscal year 2025
if such fees are so increased.
``(C) Hiring adjustment amount.--The hiring
adjustment amount for fiscal year 2025 and each
subsequent fiscal year is the product of--
``(i) the number of hires by which the hiring
goal specified in subparagraph (D) for the
fiscal year before the prior fiscal year was
not met;
``(ii) $72,877; and
``(iii) the applicable inflation adjustment
under paragraph (2)(B) for the fiscal year for
which the hiring goal was not met.
``(D) Hiring goals.--The hiring goals for each of
fiscal years 2023 through 2025 are as follows:
``(i) For fiscal year 2023, 144 hires.
``(ii) For fiscal year 2024, 42 hires.
``(iii) For fiscal year 2025:
``(I) 24 hires if the base
establishment registration fees are not
increased by the amount determined
under paragraph (4)(A)(i).
``(II) 83 hires if the base
establishment registration fees are
increased by the amount determined
under paragraph (4)(A)(i).
``(E) Number of hires.--For purposes of this
paragraph, the number of hires shall be determined by
the Secretary as set forth in the letters described in
section 201(b) of the Medical Device User Fee
Amendments of 2022.
``(6) Operating reserve adjustment.--
``(A) In general.--For each of fiscal years 2023
through 2027, after the adjustments under paragraphs
(2), (3), (4), and (5), if applicable, if the Secretary
has operating reserves of carryover user fees for the
process for the review of device applications in excess
of the designated amount in subparagraph (B), the
Secretary shall decrease the base establishment
registration fee amounts to provide for not more than
such designated amount of operating reserves.
``(B) Designated amount.--Subject to subparagraph
(C), for each fiscal year, the designated amount in
this subparagraph is equal to the sum of--
``(i) 13 weeks of operating reserves of
carryover user fees; and
``(ii) 1 month of operating reserves
maintained pursuant to paragraph (8).
``(C) Excluded amount.--For the period of fiscal
years 2023 through 2026, a total amount equal to
$118,000,000 shall not be considered part of the
designated amount under subparagraph (B) and shall not
be subject to the decrease under subparagraph (A).''.
(d) Small Businesses.--Section 738 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j) is amended in each of subsections
(d)(2)(B)(iii) and (e)(2)(B)(iii) by inserting ``, if extant,'' after
``national taxing authority''.
(e) Conditions.--Section 738(g) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(g)) is amended--
(1) in paragraph (1)(A), by striking ``$320,825,000'' and
inserting ``$398,566,000''; and
(2) in paragraph (2), by inserting ``de novo classification
requests,'' after ``class III device,''.
(f) Crediting and Availability of Fees.--Section 738(h)(3) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(h)(3)) is amended
to read as follows:
``(3) Authorization of appropriations.--
``(A) In general.--For each of fiscal years 2023
through 2027, there is authorized to be appropriated
for fees under this section an amount equal to the
revenue amount determined under subparagraph (B), less
the amount of reductions determined under subparagraph
(C).
``(B) Revenue amount.--For purposes of this
paragraph, the revenue amount for each fiscal year is
the sum of--
``(i) the total revenue amount under
subsection (b)(3) for the fiscal year, as
adjusted under paragraphs (2) and (3) of
subsection (c); and
``(ii) the performance improvement adjustment
amount for the fiscal year under subsection
(c)(4), if applicable.
``(C) Reductions.--For purposes of this paragraph,
the amount of reductions for each fiscal year is the
sum of--
``(i) the hiring adjustment amount for the
fiscal year under subsection (c)(5), if
applicable; and
``(ii) the operating reserve adjustment
amount for the fiscal year under subsection
(c)(6), if applicable.''.
SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Performance Reports.--Section 738A(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-1(a)) is amended--
(1) by striking ``fiscal year 2018'' each place it appears
and inserting ``fiscal year 2023'';
(2) by striking ``Medical Device User Fee Amendments of
2017'' each place it appears and inserting ``Medical Device
User Fee Amendments of 2022'';
(3) in paragraph (1)--
(A) in subparagraph (A), by redesignating the second
clause (iv) (relating to analysis) as clause (v); and
(B) in subparagraph (A)(iv), by striking ``fiscal
year 2020'' and inserting ``fiscal year 2023''; and
(4) in paragraph (4), by striking ``2018 through 2022'' and
inserting ``2023 through 2027''.
(b) Reauthorization.--Section 738A(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-1(b)) is amended--
(1) in paragraph (1), by striking ``2022'' and inserting
``2027''; and
(2) in paragraph (5), by striking ``2022'' and inserting
``2027''.
SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM.
Section 514(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360d(d)) is amended to read as follows:
``(d) Accreditation Scheme for Conformity Assessment.--
``(1) In general.--The Secretary shall establish a program
under which--
``(A) testing laboratories meeting criteria specified
in guidance by the Secretary may be accredited by
accreditation bodies meeting criteria specified in
guidance by the Secretary, to conduct testing to
support the assessment of the conformity of a device to
certain standards recognized under this section; and
``(B) subject to paragraph (2), results from tests
conducted to support the assessment of conformity of
devices as described in subparagraph (A) conducted by
testing laboratories accredited pursuant to this
subsection shall be accepted by the Secretary for
purposes of demonstrating such conformity unless the
Secretary finds that certain results of such tests
should not be so accepted.
``(2) Secretarial review of accredited laboratory results.--
The Secretary may--
``(A) review the results of tests conducted by
testing laboratories accredited pursuant to this
subsection, including by conducting periodic audits of
such results or of the processes of accredited bodies
or testing laboratories;
``(B) following such review, take additional measures
under this Act, as the Secretary determines
appropriate, such as--
``(i) suspension or withdrawal of
accreditation of a testing laboratory or
recognition of an accreditation body under
paragraph (1)(A); or
``(ii) requesting additional information with
respect to a device; and
``(C) if the Secretary becomes aware of information
materially bearing on the safety or effectiveness of a
device for which an assessment of conformity was
supported by testing conducted by a testing laboratory
accredited under this subsection, take such additional
measures under this Act, as the Secretary determines
appropriate, such as--
``(i) suspension or withdrawal of
accreditation of a testing laboratory or
recognition of an accreditation body under
paragraph (1)(A); or
``(ii) requesting additional information with
regard to such device.
``(3) Implementation and reporting.--
``(A) Pilot program transition.--After September 30,
2023, the pilot program previously initiated under this
subsection, as in effect prior to the date of enactment
of the Medical Device User Fee Amendments of 2022,
shall be considered to be completed, and the Secretary
may continue operating a program consistent with this
subsection.
``(B) Report.--The Secretary shall make available on
the internet website of the Food and Drug
Administration an annual report on the progress of the
pilot program under this subsection.''.
SEC. 206. REAUTHORIZATION OF THIRD-PARTY REVIEW PROGRAM.
Section 523(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360m(c)) is amended by striking ``2022'' and inserting ``2027''.
SEC. 207. SUNSET DATES.
(a) Authorization.--Sections 737 and 738 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379i; 379j) shall cease to be effective
October 1, 2027.
(b) Reporting Requirements.--Section 738A (21 U.S.C. 379j- 1) of the
Federal Food, Drug, and Cosmetic Act (regarding reauthorization and
reporting requirements) shall cease to be effective January 31, 2028.
(c) Previous Sunset Provisions.--Effective October 1, 2022,
subsections (a) and (b) of section 210 of the FDA Reauthorization Act
of 2017 (Public Law 115-52) are repealed.
SEC. 208. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2022, or the date of the enactment of this Act, whichever is later,
except that fees under part 3 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.) shall be
assessed for all submissions listed in section 738(a)(2)(A) of such Act
received on or after October 1, 2022, regardless of the date of the
enactment of this Act.
SEC. 209. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 3 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379i et seq.), as in effect on the day before the date of
the enactment of this title, shall continue to be in effect with
respect to the submissions listed in section 738(a)(2)(A) of such Act
(as defined in such part as of such day) that on or after October 1,
2017, but before October 1, 2022, were received by the Food and Drug
Administration with respect to assessing and collecting any fee
required by such part for a fiscal year prior to fiscal year 2023.
TITLE III--FEES RELATING TO GENERIC DRUGS
SEC. 301. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Generic Drug User
Fee Amendments of 2022''.
(b) Finding.--The Congress finds that the fees authorized by the
amendments made by this title will be dedicated to human generic drug
activities, as set forth in the goals identified for purposes of part 7
of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j-41 et seq.), in the letters from the Secretary of
Health and Human Services to the Chairman of the Committee on Health,
Education, Labor, and Pensions of the Senate and the Chairman of the
Committee on Energy and Commerce of the House of Representatives, as
set forth in the Congressional Record.
SEC. 302. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES.
(a) Types of Fees.--Section 744B(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-42(a)) is amended--
(1) in the matter preceding paragraph (1), by striking
``fiscal year 2018'' and inserting ``fiscal year 2023'';
(2) in paragraph (2)(C), by striking ``2018 through 2022''
and inserting ``2023 through 2027'';
(3) in paragraph (3)(B), by striking ``2018 through 2022''
and inserting ``2023 through 2027'';
(4) in paragraph (4)(D), by striking ``2018 through 2022''
and inserting ``2023 through 2027''; and
(5) in paragraph (5)(D), by striking ``2018 through 2022''
and inserting ``2023 through 2027''.
(b) Fee Revenue Amounts.--Section 744B(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-42(b)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A)--
(i) in the heading, by striking ``2018'' and
inserting ``2023'';
(ii) by striking ``2018'' and inserting
``2023''; and
(iii) by striking ``$493,600,000'' and
inserting ``$582,500,000''; and
(B) by amending subparagraph (B) to read as follows:
``(B) Fiscal years 2024 through 2027.--
``(i) In general.--For each of the fiscal
years 2024 through 2027, fees under paragraphs
(2) through (5) of subsection (a) shall be
established to generate a total estimated
revenue amount under such subsection that is
equal to the base revenue amount for the fiscal
year under clause (ii), as adjusted pursuant to
subsection (c).
``(ii) Base revenue amount.--The base revenue
amount for a fiscal year referred to in clause
(i) is equal to the total revenue amount
established under this paragraph for the
previous fiscal year, not including any
adjustments made for such previous fiscal year
under subsection (c)(3).''; and
(2) in paragraph (2)--
(A) in subparagraph (C), by striking ``one-third the
amount'' and inserting ``twenty-four percent'';
(B) in subparagraph (D), by striking ``Seven
percent'' and inserting ``Six percent''; and
(C) in subparagraph (E)(i), by striking ``Thirty-five
percent'' and inserting ``Thirty-six percent''.
(c) Adjustments.--Section 744B(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-42(c)) is amended--
(1) in paragraph (1)--
(A) in the matter preceding subparagraph (A)--
(i) by striking ``2019'' and inserting
``2024''; and
(ii) by striking ``to equal the product of
the total revenues established in such notice
for the prior fiscal year multiplied'' and
inserting ``to equal the base revenue amount
for the fiscal year (as specified in subsection
(b)(1)(B)) multiplied''; and
(B) in subparagraph (C), by striking ``Washington-
Baltimore, DC-MD-VA-WV'' and inserting ``Washington-
Arlington-Alexandria, DC-VA-MD-WV''; and
(2) by striking paragraph (2) and inserting the following:
``(2) Capacity planning adjustment.--
``(A) In general.--Beginning with fiscal year 2024,
the Secretary shall, in addition to the adjustment
under paragraph (1), further increase the fee revenue
and fees under this section for a fiscal year, in
accordance with this paragraph, to reflect changes in
the resource capacity needs of the Secretary for human
generic drug activities.
``(B) Capacity planning methodology.--The Secretary
shall establish a capacity planning methodology for
purposes of this paragraph, which shall--
``(i) be derived from the methodology and
recommendations made in the report titled
`Independent Evaluation of the GDUFA Resource
Capacity Planning Adjustment Methodology:
Evaluation and Recommendations' announced in
the Federal Register on August 3, 2020;
``(ii) incorporate approaches and attributes
determined appropriate by the Secretary,
including approaches and attributes made in
such report, except that in incorporating such
approaches and attributes the workload
categories used in forecasting resources shall
only be the workload categories specified in
section VIII.B.2.e. of the letters described in
section 301(b) of the Generic Drug User Fee
Amendments of 2022; and
``(iii) be effective beginning with fiscal
year 2024.
``(C) Limitations.--
``(i) In general.--Under no circumstances
shall an adjustment under this paragraph result
in fee revenue for a fiscal year that is less
than the sum of the amounts under subsection
(b)(1)(B)(ii) (the base revenue amount for the
fiscal year) and paragraph (1) (the dollar
amount of the inflation adjustment for the
fiscal year).
``(ii) Percentage limitation.--An adjustment
under this paragraph shall not exceed three
percent of the sum described in clause (i) for
the fiscal year, except that such limitation
shall be four percent if--
``(I) for purposes of a fiscal year
2024 adjustment, the Secretary
determines that during the period from
April 1, 2021, through March 31, 2023--
``(aa) the total number of
abbreviated new drug
applications submitted was
greater than or equal to 2,000;
or
``(bb) thirty-five percent or
more of abbreviated new drug
applications submitted related
to complex products (as that
term is defined in section XI
of the letters described in
section 301(b) of the Generic
Drug User Fee Amendments of
2022);
``(II) for purposes of a fiscal year
2025 adjustment, the Secretary
determines that during the period from
April 1, 2022, through March 31, 2024--
``(aa) the total number of
abbreviated new drug
applications submitted was
greater than or equal to 2,300;
or
``(bb) thirty-five percent or
more of abbreviated new drug
applications submitted related
to complex products (as so
defined);
``(III) for purposes of a fiscal year
2026 adjustment, the Secretary
determines that during the period from
April 1, 2023, through March 31, 2025--
``(aa) the total number of
abbreviated new drug
applications submitted was
greater than or equal to 2,300;
or
``(bb) thirty-five percent or
more of abbreviated new drug
applications submitted related
to complex products (as so
defined); and
``(IV) for purposes of a fiscal year
2027 adjustment, the Secretary
determines that during the period from
April 1, 2024, through March 31, 2026--
``(aa) the total number of
abbreviated new drug
applications submitted was
greater than or equal to 2,300;
or
``(bb) thirty-five percent or
more of abbreviated new drug
applications submitted related
to complex products (as so
defined).
``(D) Publication in federal register.--The Secretary
shall publish in the Federal Register notice referred
to in subsection (a) the fee revenue and fees resulting
from the adjustment and the methodology under this
paragraph.
``(3) Operating reserve adjustment.--
``(A) In general.--For fiscal year 2024 and each
subsequent fiscal year, the Secretary may, in addition
to adjustments under paragraphs (1) and (2), further
increase the fee revenue and fees under this section
for such fiscal year if such an adjustment is necessary
to provide operating reserves of carryover user fees
for human generic drug activities for not more than the
number of weeks specified in subparagraph (B) with
respect to that fiscal year.
``(B) Number of weeks.--The number of weeks specified
in this subparagraph is--
``(i) 8 weeks for fiscal year 2024;
``(ii) 9 weeks for fiscal year 2025; and
``(iii) 10 weeks for each of fiscal year 2026
and 2027.
``(C) Decrease.--If the Secretary has carryover
balances for human generic drug activities in excess of
12 weeks of the operating reserves referred to in
subparagraph (A), the Secretary shall decrease the fee
revenue and fees referred to in such subparagraph to
provide for not more than 12 weeks of such operating
reserves.
``(D) Rationale for adjustment.--If an adjustment
under this paragraph is made, the rationale for the
amount of the increase or decrease (as applicable) in
fee revenue and fees shall be contained in the annual
Federal Register notice under subsection (a) publishing
the fee revenue and fees for the fiscal year
involved.''.
(d) Annual Fee Setting.--Section 744B(d)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-42(d)(1)) is amended--
(1) in the paragraph heading, by striking ``2018 through
2022'' and inserting ``2023 through 2027''; and
(2) by striking ``more than 60 days before the first day of
each of fiscal years 2018 through 2022'' and inserting ``later
than 60 days before the first day of each of fiscal years 2023
through 2027''.
(e) Crediting and Availability of Fees.--Section 744B(i)(3) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(i)(3)) is
amended by striking ``fiscal years 2018 through 2022'' and inserting
``fiscal years 2023 through 2027''.
(f) Effect of Failure to Pay Fees.--The heading of paragraph (3) of
section 744B(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-42(g)) is amended by striking ``and prior approval supplement
fee''.
SEC. 303. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-43) is amended--
(1) in subsection (a)(1), by striking ``Beginning with fiscal
year 2018, not'' and inserting ``Not'';
(2) by striking ``Generic Drug User Fee Amendments of 2017''
each place it appears and inserting ``Generic Drug User Fee
Amendments of 2022'';
(3) in subsection (a)(2), by striking ``Not later than 30
calendar days after the end of the second quarter of fiscal
year 2018, and not later than 30 calendar days after the end of
each quarter of each fiscal year thereafter'' and inserting
``Not later than 30 calendar days after the end of each quarter
of each fiscal year for which fees are collected under this
part'';
(4) in subsection (a)(3), by striking ``Beginning with fiscal
year 2020, the'' and inserting ``The'';
(5) in subsection (b), by striking ``Beginning with fiscal
year 2018, not'' and inserting ``Not'';
(6) in subsection (c), by striking ``Beginning with fiscal
year 2018, for'' and inserting ``For''; and
(7) in subsection (f)--
(A) in paragraph (1), in the matter preceding
subparagraph (A), by striking ``fiscal year 2022'' and
inserting ``fiscal year 2027''; and
(B) in paragraph (5), by striking ``January 15,
2022'' and inserting ``January 15, 2027''.
SEC. 304. SUNSET DATES.
(a) Authorization.--Sections 744A and 744B of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-41; 379j-42) shall cease to be
effective October 1, 2027.
(b) Reporting Requirements.--Section 744C of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-43) shall cease to be effective
January 31, 2028.
(c) Previous Sunset Provision.--Effective October 1, 2022,
subsections (a) and (b) of section 305 of the FDA Reauthorization Act
of 2017 (Public Law 115-52) are repealed.
SEC. 305. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2022, or the date of the enactment of this Act, whichever is later,
except that fees under part 7 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-41 et seq.) shall
be assessed for all abbreviated new drug applications received on or
after October 1, 2022, regardless of the date of the enactment of this
Act.
SEC. 306. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 7 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-41 et seq.), as in effect on the day before the date of
the enactment of this title, shall continue to be in effect with
respect to abbreviated new drug applications (as defined in such part
as of such day) that were received by the Food and Drug Administration
within the meaning of section 505(j)(5)(A) of such Act (21 U.S.C.
355(j)(5)(A)), prior approval supplements that were submitted, and drug
master files for Type II active pharmaceutical ingredients that were
first referenced on or after October 1, 2017, but before October 1,
2022, with respect to assessing and collecting any fee required by such
part for a fiscal year prior to fiscal year 2023.
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
SEC. 401. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Biosimilar User
Fee Amendments of 2022''.
(b) Finding.--The Congress finds that the fees authorized by the
amendments made by this title will be dedicated to expediting the
process for the review of biosimilar biological product applications,
including postmarket safety activities, as set forth in the goals
identified for purposes of part 8 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51 et seq.), in
the letters from the Secretary of Health and Human Services to the
Chairman of the Committee on Health, Education, Labor, and Pensions of
the Senate and the Chairman of the Committee on Energy and Commerce of
the House of Representatives, as set forth in the Congressional Record.
SEC. 402. DEFINITIONS.
(a) Adjustment Factor.--Section 744G(1) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-51(1)) is amended to read as follows:
``(1) The term `adjustment factor' applicable to a fiscal
year is the Consumer Price Index for urban consumers
(Washington-Arlington-Alexandria, DC-VA-MD-WV; Not Seasonally
Adjusted; All items; Annual Index) for September of the
preceding fiscal year divided by such Index for September
2011.''.
(b) Biosimilar Biological Product Application.--Section
744G(4)(B)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-51(4)(B)(iii)) is amended--
(1) by striking subclause (II) (relating to an allergenic
extract product); and
(2) by redesignating subclauses (III) and (IV) as subclauses
(II) and (III), respectively.
SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR FEES.
(a) Types of Fees.--
(1) In general.--The matter preceding paragraph (1) in
section 744H(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-52(a)) is amended by striking ``fiscal year 2018''
and inserting ``fiscal year 2023''.
(2) Initial biosimilar biological product development fee.--
Clauses (iv)(I) and (v)(II) of section 744H(a)(1)(A) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
52(a)(1)(A)) are each amended by striking ``5 days'' and
inserting ``7 days''.
(3) Annual biosimilar biological product development fee.--
Section 744H(a)(1)(B) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j-52(a)(1)(B)) is amended--
(A) in clause (i), by inserting before the period at
the end the following: ``, except where such product
(including, where applicable, ownership of the relevant
investigational new drug application) is transferred to
a licensee, assignee, or successor of such person, and
written notice of such transfer is provided to the
Secretary, in which case such licensee, assignee, or
successor shall pay the annual biosimilar biological
product development fee'';
(B) in clause (iii)--
(i) in subclause (I), by striking ``or'' at
the end;
(ii) in subclause (II), by striking the
period at the end and inserting ``; or''; and
(iii) by adding at the end the following:
``(III) been administratively removed
from the biosimilar biological product
development program for the product
under subparagraph (E)(v).''; and
(C) in clause (iv), by striking ``is accepted for
filing on or after October 1 of such fiscal year'' and
inserting ``is subsequently accepted for filing''.
(4) Reactivation fee.--Section 744H(a)(1)(D) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52(a)(1)(D)) is
amended to read as follows:
``(D) Reactivation fee.--
``(i) In general.--A person that has
discontinued participation in the biosimilar
biological product development program for a
product under subparagraph (C), or who has been
administratively removed from the biosimilar
biological product development program for a
product under subparagraph (E)(v), shall, if
the person seeks to resume participation in
such program, pay all annual biosimilar
biological product development fees previously
assessed for such product and still owed and a
fee (referred to in this section as
`reactivation fee') by the earlier of the
following:
``(I) Not later than 7 days after the
Secretary grants a request by such
person for a biosimilar biological
product development meeting for the
product (after the date on which such
participation was discontinued or the
date of administrative removal, as
applicable).
``(II) Upon the date of submission
(after the date on which such
participation was discontinued or the
date of administrative removal, as
applicable) by such person of an
investigational new drug application
describing an investigation that the
Secretary determines is intended to
support a biosimilar biological product
application for that product.
``(ii) Application of annual fee.--A person
that pays a reactivation fee for a product
shall pay for such product, beginning in the
next fiscal year, the annual biosimilar
biological product development fee under
subparagraph (B), except where such product
(including, where applicable, ownership of the
relevant investigational new drug application)
is transferred to a licensee, assignee, or
successor of such person, and written notice of
such transfer is provided to the Secretary, in
which case such licensee, assignee, or
successor shall pay the annual biosimilar
biological product development fee.''.
(5) Effect of failure to pay fees.--Section 744H(a)(1)(E) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
52(a)(1)(E)) is amended by adding at the end the following:
``(v) Administrative removal from the
biosimilar biological product development
program.--If a person has failed to pay an
annual biosimilar biological product
development fee for a product as required under
subparagraph (B) for a period of two
consecutive fiscal years, the Secretary may
administratively remove such person from the
biosimilar biological product development
program for the product. At least 30 days prior
to administratively removing a person from the
biosimilar biological product development
program for a product under this clause, the
Secretary shall provide written notice to such
person of the intended administrative
removal.''.
(6) Biosimilar biological product application fee.--Section
744H(a)(2)(D) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-52(a)(2)(D)) is amended by inserting after ``or was
withdrawn'' the following: ``prior to approval''.
(7) Biosimilar biological product program fee.--Section
744H(a)(3) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-52(a)(3)) is amended--
(A) in subparagraph (A)--
(i) in clause (i), by striking ``and'' at the
end;
(ii) by redesignating clause (ii) as clause
(iii); and
(iii) by inserting after clause (i) the
following:
``(ii) may be dispensed only under
prescription pursuant to section 503(b); and'';
and
(B) by adding at the end the following:
``(E) Movement to discontinued list.--
``(i) Date of inclusion.--If a written
request to place a product on the list
referenced in subparagraph (A) of discontinued
biosimilar biological products is submitted to
the Secretary on behalf of an applicant, and
the request identifies the date the product is
withdrawn from sale, then for purposes of
assessing the biosimilar biological product
program fee, the Secretary shall consider such
product to have been included on such list on
the later of--
``(I) the date such request was
received; or
``(II) if the product will be
withdrawn from sale on a future date,
such future date when the product is
withdrawn from sale.
``(ii) Treatment as withdrawn from sale.--For
purposes of clause (i), a product shall be
considered withdrawn from sale once the
applicant has ceased its own distribution of
the product, whether or not the applicant has
ordered recall of all previously distributed
lots of the product, except that a routine,
temporary interruption in supply shall not
render a product withdrawn from sale.
``(iii) Special rule.--If a biosimilar
biological product that is identified in a
biosimilar biological product application
approved as of October 1 of a fiscal year
appears, as of October 1 of such fiscal year,
on the list referenced in subparagraph (A) of
discontinued biosimilar biological products,
and on any subsequent day during such fiscal
year the biosimilar biological product does not
appear on such list, then except as provided in
subparagraph (D), each person who is named as
the applicant in a biosimilar biological
product application with respect to such
product shall pay the annual biosimilar
biological product program fee established for
a fiscal year under subsection (c)(5) for such
biosimilar biological product. Notwithstanding
subparagraph (B), such fee shall be due on the
last business day of such fiscal year and shall
be paid only once for each such product for
each fiscal year.''.
(8) Biosimilar biological product fee.--Section 744H(a) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52(a))
is amended by striking paragraph (4).
(c) Fee Revenue Amounts.--Subsection (b) of section 744H of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended--
(1) by striking paragraph (1);
(2) by redesignating paragraphs (2) through (4) as paragraphs
(1) through (3), respectively;
(3) by amending paragraph (1) (as so redesignated) to read as
follows:
``(1) In general.--For each of the fiscal years 2023 through
2027, fees under subsection (a) shall, except as provided in
subsection (c), be established to generate a total revenue
amount equal to the sum of--
``(A) the annual base revenue for the fiscal year (as
determined under paragraph (3));
``(B) the dollar amount equal to the inflation
adjustment for the fiscal year (as determined under
subsection (c)(1));
``(C) the dollar amount equal to the strategic hiring
and retention adjustment (as determined under
subsection (c)(2));
``(D) the dollar amount equal to the capacity
planning adjustment for the fiscal year (as determined
under subsection (c)(3));
``(E) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if applicable
(as determined under subsection (c)(4));
``(F) for fiscal year 2023 an additional amount of
$4,428,886; and
``(G) for fiscal year 2024 an additional amount of
$320,569.'';
(4) in paragraph (2) (as so redesignated)--
(A) in the paragraph heading, by striking ``;
limitations on fee amounts'';
(B) by striking subparagraph (B); and
(C) by redesignating subparagraphs (C) and (D) as
subparagraphs (B) and (C), respectively; and
(5) by amending paragraph (3) (as so redesignated) to read as
follows:
``(3) Annual base revenue.--For purposes of paragraph (1),
the dollar amount of the annual base revenue for a fiscal year
shall be--
``(A) for fiscal year 2023, $43,376,922; and
``(B) for fiscal years 2024 through 2027, the dollar
amount of the total revenue amount established under
paragraph (1) for the previous fiscal year, excluding
any adjustments to such revenue amount under subsection
(c)(4).''.
(d) Adjustments; Annual Fee Setting.--Section 744H(c) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52(c)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i), by
striking ``subsection (b)(2)(B)'' and inserting
``subsection (b)(1)(B)''; and
(ii) in clause (i), by striking ``subsection
(b)'' and inserting ``subsection (b)(1)(A)'';
and
(B) in subparagraph (B)(ii), by striking
``Washington-Baltimore, DC-MD-VA-WV'' and inserting
``Washington-Arlington-Alexandria, DC-VA-MD-WV'';
(2) by striking paragraphs (2) through (4) and inserting the
following:
``(2) Strategic hiring and retention adjustment.--For each
fiscal year, after the annual base revenue under subsection
(b)(1)(A) is adjusted for inflation in accordance with
paragraph (1), the Secretary shall further increase the fee
revenue and fees by $150,000.
``(3) Capacity planning adjustment.--
``(A) In general.--For each fiscal year, the
Secretary shall, in addition to the adjustments under
paragraphs (1) and (2), further adjust the fee revenue
and fees under this section for a fiscal year to
reflect changes in the resource capacity needs of the
Secretary for the process for the review of biosimilar
biological product applications.
``(B) Methodology.--For purposes of this paragraph,
the Secretary shall employ the capacity planning
methodology utilized by the Secretary in setting fees
for fiscal year 2021, as described in the notice titled
`Biosimilar User Fee Rates for Fiscal Year 2021'
published in the Federal Register on August 4, 2020 (85
Fed. Reg. 47220). The workload categories used in
applying such methodology in forecasting shall include
only the activities described in that notice and, as
feasible, additional activities that are also directly
related to the direct review of biosimilar biological
product applications and supplements, including
additional formal meeting types, the direct review of
postmarketing commitments and requirements, the direct
review of risk evaluation and mitigation strategies,
and the direct review of annual reports for approved
biosimilar biological products. Subject to the
exceptions in the preceding sentence, the Secretary
shall not include as workload categories in applying
such methodology in forecasting any non-core review
activities, including those activities that the
Secretary referenced for potential future use in such
notice but did not utilize in setting fees for fiscal
year 2021.
``(C) Limitations.--Under no circumstances shall an
adjustment under this paragraph result in fee revenue
for a fiscal year that is less than the sum of the
amounts under subsections (b)(1)(A) (the annual base
revenue for the fiscal year), (b)(1)(B) (the dollar
amount of the inflation adjustment for the fiscal
year), and (b)(1)(C) (the dollar amount of the
strategic hiring and retention adjustment).
``(D) Publication in federal register.--The Secretary
shall publish in the Federal Register notice under
paragraph (5) the fee revenue and fees resulting from
the adjustment and the methodologies under this
paragraph.
``(4) Operating reserve adjustment.--
``(A) Increase.--For fiscal year 2023 and subsequent
fiscal years, the Secretary shall, in addition to
adjustments under paragraphs (1), (2), and (3), further
increase the fee revenue and fees if such an adjustment
is necessary to provide for at least 10 weeks of
operating reserves of carryover user fees for the
process for the review of biosimilar biological product
applications.
``(B) Decrease.--
``(i) Fiscal year 2023.--For fiscal year
2023, if the Secretary has carryover balances
for such process in excess of 33 weeks of such
operating reserves, the Secretary shall
decrease such fee revenue and fees to provide
for not more than 33 weeks of such operating
reserves.
``(ii) Fiscal year 2024.--For fiscal year
2024, if the Secretary has carryover balances
for such process in excess of 27 weeks of such
operating reserves, the Secretary shall
decrease such fee revenue and fees to provide
for not more than 27 weeks of such operating
reserves.
``(iii) Fiscal year 2025 and subsequent
fiscal years.--For fiscal year 2025 and
subsequent fiscal years, if the Secretary has
carryover balances for such process in excess
of 21 weeks of such operating reserves, the
Secretary shall decrease such fee revenue and
fees to provide for not more than 21 weeks of
such operating reserves.
``(C) Federal register notice.--If an adjustment
under subparagraph (A) or (B) is made, the rationale
for the amount of the increase or decrease in fee
revenue and fees shall be contained in the annual
Federal Register notice under paragraph (5)(B)
establishing fee revenue and fees for the fiscal year
involved.''; and
(3) in paragraph (5), in the matter preceding subparagraph
(A), by striking ``2018'' and inserting ``2023''.
(e) Crediting and Availability of Fees.--Subsection (f)(3) of section
744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
52(f)(3)) is amended by striking ``2018 through 2022'' and inserting
``2023 through 2027''.
(f) Written Requests for Waivers and Returns; Disputes Concerning
Fees.--Section 744H(h) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-52(h)) is amended to read as follows:
``(h) Written Requests for Waivers and Returns; Disputes Concerning
Fees.--To qualify for consideration for a waiver under subsection (d),
or for the return of any fee paid under this section, including if the
fee is claimed to have been paid in error, a person shall submit to the
Secretary a written request justifying such waiver or return and,
except as otherwise specified in this section, such written request
shall be submitted to the Secretary not later than 180 days after such
fee is due. A request submitted under this paragraph shall include any
legal authorities under which the request is made.''.
SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 744I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-53) is amended--
(1) in subsection (a)(1), by striking ``Beginning with fiscal
year 2018, not'' and inserting ``Not'';
(2) by striking ``Biosimilar User Fee Amendments of 2017''
each place it appears and inserting ``Biosimilar User Fee
Amendments of 2022'';
(3) in subsection (a)(2), by striking ``Beginning with fiscal
year 2018, the'' and inserting ``The'';
(4) in subsection (a)(3)(A), by striking ``Not later than 30
calendar days after the end of the second quarter of fiscal
year 2018, and not later than 30 calendar days after the end of
each quarter of each fiscal year thereafter'' and inserting
``Not later than 30 calendar days after the end of each quarter
of each fiscal year for which fees are collected under this
part'';
(5) in subsection (b), by striking ``Not later than 120 days
after the end of fiscal year 2018 and each subsequent fiscal
year for which fees are collected under this part'' and
inserting ``Not later than 120 days after the end of each
fiscal year for which fees are collected under this part'';
(6) in subsection (c), by striking ``Beginning with fiscal
year 2018, and for'' and inserting ``For''; and
(7) in subsection (f)--
(A) in paragraph (1), in the matter preceding
subparagraph (A), by striking ``fiscal year 2022'' and
inserting ``fiscal year 2027''; and
(B) in paragraph (3), by striking ``January 15,
2022'' and inserting ``January 15, 2027''.
SEC. 405. SUNSET DATES.
(a) Authorization.--Sections 744G and 744H of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-51, 379j-52) shall cease to be
effective October 1, 2027.
(b) Reporting Requirements.--Section 744I of the Federal Food, Drug,
and Cosmetic Act shall cease to be effective January 31, 2028.
(c) Previous Sunset Provision.--Effective October 1, 2022,
subsections (a) and (b) of section 405 of the FDA Reauthorization Act
of 2017 (Public Law 115-52) are repealed.
SEC. 406. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2022, or the date of the enactment of this Act, whichever is later,
except that fees under part 8 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51 et seq.) shall
be assessed for all biosimilar biological product applications received
on or after October 1, 2022, regardless of the date of the enactment of
this Act.
SEC. 407. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 8 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-51 et seq.), as in effect on the day before the date of
the enactment of this title, shall continue to be in effect with
respect to biosimilar biological product applications and supplements
(as defined in such part as of such day) that were accepted by the Food
and Drug Administration for filing on or after October 1, 2017, but
before October 1, 2022, with respect to assessing and collecting any
fee required by such part for a fiscal year prior to fiscal year 2023.
TITLE V--IMPROVING DIVERSITY IN CLINICAL STUDIES
SEC. 501. DIVERSITY ACTION PLANS FOR CLINICAL STUDIES.
(a) Drugs.--Section 505(i) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(i)) is amended by adding at the end the following:
``(5)(A) In order for a new drug that is being studied in a phase 3
study, as defined in section 312.21(c) of title 21, Code of Federal
Regulations (or successor regulations), or other pivotal study (other
than bioavailability or bioequivalence studies), to be exempt pursuant
to this subsection, the sponsor of a clinical investigation of such new
drug shall submit to the Secretary a diversity action plan.
``(B) Such diversity action plan shall include--
``(i) the sponsor's goals for enrollment in such clinical
study;
``(ii) the sponsor's rationale for such goals; and
``(iii) an explanation of how the sponsor intends to meet
such goals.
``(C) The sponsor shall submit such diversity action plan in the form
and manner specified in the guidance required by section 524B as soon
as practicable but no later than when the sponsor seeks feedback
regarding such a phase 3 study or other pivotal study of the drug.
``(D) The Secretary may waive the requirement in subparagraph (A) if
the Secretary determines that a waiver is necessary based on what is
known about the prevalence of the disease in terms of the patient
population that may use the new drug.
``(E) No diversity action plan shall be required for a submission
described in section 561.''.
(b) Devices.--Section 520(g) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360j(g)) is amended by adding at the end the following:
``(9)(A)(i) In order for a device in a clinical study for which
submission of an application for an investigational device exemption is
required to be exempt under this subsection, the sponsor of such study
shall submit to the Secretary in such application a diversity action
plan in the form and manner specified in the guidance required by
section 524B.
``(ii) In order for a device in a clinical study for which submission
of an application for an investigational device exemption is not
required, except for a device being studied as described in section
812.2(c) of title 21, Code of Federal Regulations (or successor
regulations), to be exempt under this subsection, the sponsor of such
study shall develop and implement a diversity action plan. Such
diversity action plan shall be submitted to the Secretary in any
premarket notification under section 510(k), request for classification
under section 513(f)(2), or application for premarket approval under
section 515 for such device.
``(B) A diversity action plan under clause (i) or (ii) of
subparagraph (A) shall include--
``(i) the sponsor's goals for enrollment in the clinical
study;
``(ii) the sponsor's rationale for such goals; and
``(iii) an explanation of how the sponsor intends to meet
such goals.
``(C) The Secretary may waive the requirement in subparagraph (A) or
(B) if the Secretary determines that a waiver is necessary based on
what is known about the prevalence of the disease in terms of the
patient population that may use the device.
``(D) No diversity action plan shall be required for a submission
described in section 561.''.
(c) Guidance.--Subchapter A of chapter V of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at the
end the following:
``SEC. 524B. GUIDANCE ON DIVERSITY ACTION PLANS FOR CLINICAL STUDIES.
``(a) In General.--The Secretary shall issue guidance relating to--
``(1) the format and content of the diversity action plans
required by sections 505(i)(5) and 520(g)(9) pertaining to the
sponsor's goals for clinical study enrollment, disaggregated by
age group, sex, race, geographic location, socioeconomic
status, and ethnicity, including with respect to--
``(A) the rationale for the sponsor's enrollment
goals, which may include--
``(i) the estimated prevalence or incidence
in the United States of the disease or
condition for which the drug or device is being
developed or investigated, if such estimated
prevalence or incidence is known or can be
determined based on available data;
``(ii) what is known about the disease or
condition for which the drug or device is being
developed or investigated;
``(iii) any relevant pharmacokinetic or
pharmacogenomic data;
``(iv) what is known about the patient
population for such disease or condition,
including, to the extent data is available--
``(I) demographic information,
including age group, sex, race,
geographic location, socioeconomic
status, and ethnicity;
``(II) non-demographic factors,
including co-morbidities affecting the
patient population; and
``(III) potential barriers to
enrolling diverse participants, such as
patient population size, geographic
location, and socioeconomic status; and
``(v) any other data or information relevant
to selecting appropriate enrollment goals,
disaggregated by demographic subgroup, such as
the inclusion of pregnant and lactating women;
``(B) an explanation for how the sponsor intends to
meet such goals, including demographic-specific
outreach and enrollment strategies, study-site
selection, clinical study inclusion and exclusion
practices, and any diversity training for study
personnel; and
``(C) procedures for the public posting of key
information from the diversity action plan that would
be useful to patients and providers on the sponsor's
website, as appropriate; and
``(2) how sponsors should include in regular reports to the
Secretary--
``(A) the sponsor's progress in meeting the goals
referred to in paragraph (1)(A); and
``(B) if the sponsor does not expect to meet such
goals--
``(i) any updates needed to be made to a
diversity action plan referred to in paragraph
(1) to help meet such goals; and
``(ii) the sponsor's reasons for why the
sponsor does not expect to meet such goals.
``(b) Issuance.--The Secretary shall--
``(1) not later than 12 months after the date of enactment of
this section, issue new draft guidance or update existing draft
guidance described in subsection (a); and
``(2) not later than 9 months after closing the comment
period on such draft guidance, finalize such guidance.''.
(d) Applicability.--Sections 505(i)(5) and 520(g)(9) of the Federal
Food, Drug, and Cosmetic Act, as added by subsections (a) and (b) of
this section, apply only with respect to clinical investigations with
respect to which enrollment commences after the date that is 180 days
after the publication of final guidance under section 524B(b)(2) of the
Federal Food, Drug, and Cosmetic Act, as added by subsection (c).
SEC. 502. EVALUATION OF THE NEED FOR FDA AUTHORITY TO MANDATE
POSTAPPROVAL STUDIES OR POSTMARKET SURVEILLANCE DUE
TO INSUFFICIENT DEMOGRAPHIC SUBGROUP DATA.
(a) In General.--Not later than 2 years after the date of publication
of final guidance pursuant to section 524B(b)(2) of the Federal Food,
Drug, and Cosmetic Act, as added by section 501(c) of this Act, the
Secretary of Health and Human Services shall commence an evaluation to
assess whether additions or changes to statutes or regulations are
warranted to ensure that sponsors conduct post-approval studies or
postmarket surveillance where--
(1) premarket studies collected insufficient data for
underrepresented subgroups according to the goals specified in
the diversity action plans of such sponsors; and
(2) the Secretary has requested additional studies be
conducted.
(b) Determination and Reporting.--Not later than 180 days after the
commencement of the evaluation under subsection (a), the Secretary of
Health and Human Services shall submit a report to the Congress on the
outcome of such evaluation, including any recommendations related to
additional needed authorities.
SEC. 503. PUBLIC WORKSHOPS TO ENHANCE CLINICAL STUDY DIVERSITY.
(a) In General.--Not later than one year after the date of enactment
of this Act, the Secretary of Health and Human Services, in
consultation with drug sponsors, medical device manufacturers,
patients, and other stakeholders, shall convene one or more public
workshops to solicit input from stakeholders on increasing the
enrollment of historically underrepresented populations in clinical
studies and encouraging clinical study participation that reflects the
prevalence of the disease or condition among demographic subgroups,
where appropriate, and other topics, including--
(1) how and when to collect and present the prevalence or
incidence data on a disease or condition by demographic
subgroup, including possible sources for such data and
methodologies for assessing such data;
(2) considerations for the dissemination, after approval, of
information to the public on clinical study enrollment
demographic data;
(3) the establishment of goals for enrollment in clinical
trials, including the relevance of the estimated prevalence or
incidence, as applicable, in the United States of the disease
or condition for which the drug or device is being developed;
and
(4) approaches to support inclusion of underrepresented
populations and to encourage clinical study participation that
reflects the population expected to use the drug or device
under study, including with respect to--
(A) the establishment of inclusion and exclusion
criteria for certain subgroups, such as pregnant and
lactating women and individuals with disabilities,
including intellectual or developmental disabilities or
mental illness;
(B) considerations regarding informed consent with
respect to individuals with intellectual or
developmental disabilities or mental illness, including
ethical and scientific considerations;
(C) the appropriate use of decentralized trials or
digital health tools;
(D) clinical endpoints;
(E) biomarker selection; and
(F) studying analysis.
(b) Public Docket.--The Secretary of Health and Human Services shall
establish a public comment period to receive written comments related
to the topics addressed during each public workshop convened under this
section. The public comment period shall remain open for 60 days
following the date on which each public workshop is convened.
(c) Report.--Not later than 180 days after the close of the public
comment period for each public workshop convened under this section,
the Secretary of Health and Human Services shall make available on the
public website of the Food and Drug Administration a report on the
topics discussed at such workshop. The report shall include a summary
of, and response to, recommendations raised in such workshop.
SEC. 504. ANNUAL SUMMARY REPORT ON PROGRESS TO INCREASE DIVERSITY IN
CLINICAL STUDIES.
(a) In General.--Beginning not later than 2 years after the date of
enactment of this Act, and each year thereafter, the Secretary of
Health and Human Services shall submit to the Congress, and publish on
the public website of the Food and Drug Administration, a report that--
(1) summarizes, in aggregate, the diversity action plans
received pursuant to section 505(i)(5) or 520(g)(9) of the
Federal Food, Drug, and Cosmetic Act, as added by subsection
(a) or (b) of section 501 of this Act; and
(2) contains information on--
(A) for drugs, biological products, and devices
approved, licensed, cleared, or classified under
section 505, 515, 510(k), or 513(f)(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355; 360e;
360(k); and 360(f)(2)), or section 351(a) of the Public
Health Service Act (42 U.S.C. 262(a)), whether the
clinical studies conducted with respect to such
applications met the demographic subgroup enrollment
goals from the diversity action plan submitted for such
applications;
(B) the reasons provided for why enrollment goals
from submitted diversity action plans were not met; and
(C) any postmarket studies of a drug or device in a
demographic subgroup or subgroups required or
recommended by the Secretary based on inadequate
premarket clinical study diversity or based on other
reasons where a premarket study lacked adequate
diversity, including the status and completion date of
any such study.
(b) Confidentiality.--Nothing in this section shall be construed as
authorizing the Secretary of Health and Human Services to disclose any
information that is a trade secret or confidential information subject
to section 552(b)(4) of title 5, United States Code, or section 1905 of
title 18, United States Code.
SEC. 505. PUBLIC MEETING ON CLINICAL STUDY FLEXIBILITIES INITIATED IN
RESPONSE TO COVID-19 PANDEMIC.
(a) In General.--Not later than 180 days after the date on which the
COVID-19 emergency period ends, the Secretary of Health and Human
Services shall convene a public meeting to discuss the recommendations
provided by the Food and Drug Administration during the COVID-19
emergency period to mitigate disruption of clinical studies, including
recommendations detailed in the guidance entitled ``Conduct of Clinical
Trials of Medical Products During the COVID-19 Public Health Emergency,
Guidance for Industry, Investigators, and Institutional Review
Boards'', as updated on August 8, 2021, and by any subsequent updates
to such guidance. The Secretary of Health and Human Services shall
invite to such meeting representatives from the pharmaceutical and
medical device industries who sponsored clinical studies during the
COVID-19 emergency period and organizations representing patients.
(b) Topics.--Not later than 90 days after the date on which the
public meeting under subsection (a) is convened, the Secretary of
Health and Human Services shall make available on the public website of
the Food and Drug Administration a report on the topics discussed at
such meeting. Such topics shall include discussion of--
(1) the actions drug sponsors took to utilize such
recommendations and the frequency at which such recommendations
were employed;
(2) the characteristics of the sponsors, studies, and patient
populations impacted by such recommendations;
(3) a consideration of how recommendations intended to
mitigate disruption of clinical studies during the COVID-19
emergency period, including any recommendations to consider
decentralized clinical studies when appropriate, may have
affected access to clinical studies for certain patient
populations, especially unrepresented racial and ethnic
minorities; and
(4) recommendations for incorporating certain clinical study
disruption mitigation recommendations into current or
additional guidance to improve clinical study access and
enrollment of diverse patient populations.
(c) COVID-19 Emergency Period Defined.--In this section, the term
``COVID-19 emergency period'' has the meaning given the term
``emergency period'' in section 1135(g)(1)(B) of the Social Security
Act (42 U.S.C. 1320b-5(g)(1)(B)).
SEC. 506. DECENTRALIZED CLINICAL STUDIES.
(a) Guidance.--The Secretary of Health and Human Services shall--
(1) not later than 12 months after the date of enactment of
this Act, issue draft guidance that addresses considerations
for decentralized clinical studies, including considerations
regarding the engagement, enrollment, and retention of a
meaningfully diverse clinical population, with respect to race,
ethnicity, age, sex, and geographic location, when appropriate;
and
(2) not later than 1 year after closing the comment period on
such draft guidance, finalize such guidance.
(b) Content of Guidance.--The guidance under subsection (a) shall
address the following:
(1) Recommendations for how digital health technology or
other remote assessment options, such as telehealth, could
support decentralized clinical studies, including guidance on
considerations for selecting technological platforms and
mediums, data collection and use, data integrity and security,
and communication to study participants through digital
technology.
(2) Recommendations for subject recruitment and retention,
including considerations for sponsors to minimize or reduce
burdens for clinical study participants through the use of
digital health technology, telehealth, local health care
providers and laboratories, or other means.
(3) Recommendations with respect to the evaluation of data
collected within a decentralized clinical study setting.
(c) Definition.--In this section, the term ``decentralized clinical
study'' means a clinical study in which some or all of the study-
related activities occur at a location separate from the investigator's
location.
TITLE VI--GENERIC DRUG COMPETITION
SEC. 601. INCREASING TRANSPARENCY IN GENERIC DRUG APPLICATIONS.
(a) In General.--Section 505(j)(3) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(3)) is amended by adding at the end the
following:
``(H)(i) Upon request (in controlled correspondence or otherwise) by
a person that has submitted or intends to submit an abbreviated
application for a new drug under this subsection for which the
Secretary has specified in regulation, including under section
314.94(a)(9), title 21, Code of Federal Regulations (or a successor
regulation), or recommended in applicable guidance, certain qualitative
or quantitative criteria with respect to an inactive ingredient, or on
the Secretary's own initiative during the review of such abbreviated
application, the Secretary shall inform the person whether such new
drug is qualitatively and quantitatively the same as the listed drug.
``(ii) Notwithstanding section 301(j), if the Secretary determines
that such new drug is not qualitatively or quantitatively the same as
the listed drug, the Secretary shall identify and disclose to the
person--
``(I) the ingredient or ingredients that cause the new drug
not to be qualitatively or quantitatively the same as the
listed drug; and
``(II) for any ingredient for which there is an identified
quantitative deviation, the amount of such deviation.
``(iii) If the Secretary determines that such new drug is
qualitatively and quantitatively the same as the listed drug, the
Secretary shall not change or rescind such determination after the
submission of an abbreviated application for such new drug under this
subsection unless--
``(I) the formulation of the listed drug has been changed and
the Secretary has determined that the prior listed drug
formulation was withdrawn for reasons of safety or
effectiveness; or
``(II) the Secretary makes a written determination that the
prior determination must be changed because an error has been
identified.
``(iv) If the Secretary makes a written determination described in
clause (iii)(II), the Secretary shall provide notice and a copy of the
written determination to the person making the request under clause
(i).
``(v) The disclosures required by this subparagraph are disclosures
authorized by law including for purposes of section 1905 of title 18,
United States Code.''.
(b) Guidance.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services shall issue draft guidance, or update guidance,
describing how the Secretary will determine whether a new drug
is qualitatively and quantitatively the same as the listed drug
(as such terms are used in section 505(j)(3)(H) of the Federal
Food, Drug, and Cosmetic Act, as added by subsection (a)),
including with respect to assessing pH adjusters.
(2) Process.--In issuing guidance as required by paragraph
(1), the Secretary of Health and Human Services shall--
(A) publish draft guidance;
(B) provide a period of at least 60 days for comment
on the draft guidance; and
(C) after considering any comments received, and not
later than one year after the close of the comment
period on the draft guidance, publish final guidance.
(c) Applicability.--Section 505(j)(3)(H) of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a), applies beginning on the
date of enactment of this Act, irrespective of the date on which the
guidance required by subsection (b) is finalized.
SEC. 602. ENHANCING ACCESS TO AFFORDABLE MEDICINES.
Section 505(j)(10)(A) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)(10)(A)) is amended by striking clauses (i) through (iii)
and inserting the following:
``(i) a revision to the labeling of the listed drug has been
approved by the Secretary within 90 days of when the
application is otherwise eligible for approval under this
subsection;
``(ii) the sponsor of the application agrees to submit
revised labeling for the drug that is the subject of the
application not later than 60 days after approval under this
subsection of the application;
``(iii) the labeling revision described under clause (i) does
not include a change to the `Warnings' section of the labeling;
and''.
TITLE VII--RESEARCH, DEVELOPMENT, AND SUPPLY CHAIN IMPROVEMENTS
Subtitle A--In General
SEC. 701. ANIMAL TESTING ALTERNATIVES.
Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355) is amended--
(1) in subsection (b)(5)(B)(i)(II), by striking ``animal''
and inserting ``nonclinical tests'';
(2) in subsection (i)--
(A) in paragraph (1)(A), by striking ``preclinical
tests (including tests on animals)'' and inserting
``nonclinical tests''; and
(B) in paragraph (2)(B), by striking ``animal'' and
inserting ``nonclinical tests''; and
(3) after subsection (y), by inserting the following:
``(z) Nonclinical Test Defined.--For purposes of this section, the
term `nonclinical test' means a test conducted in vitro, in silico, or
in chemico, or a nonhuman in vivo test, that occurs before or during
the clinical trial phase of the investigation of the safety and
effectiveness of a drug. Such test may include the following:
``(1) Cell-based assays.
``(2) Organ chips and microphysiological systems.
``(3) Computer modeling.
``(4) Other nonhuman or human biology-based test methods.
``(5) Animal tests.''.
SEC. 702. EMERGING TECHNOLOGY PROGRAM.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 201
et seq.) is amended by inserting after section 566 of such Act (21
U.S.C. 360bbb-5) the following:
``SEC. 566A. EMERGING TECHNOLOGY PROGRAM.
``(a) Program Establishment.--
``(1) In general.--The Secretary shall establish a program to
support the adoption of, and improve the development of,
innovative approaches to drug product design and manufacturing.
``(2) Actions.--In carrying out the program under paragraph
(1), the Secretary may--
``(A) facilitate and increase communication between
public and private entities, consortia, and individuals
with respect to innovative drug product design and
manufacturing;
``(B) solicit information regarding, and conduct or
support research on, innovative approaches to drug
product design and manufacturing;
``(C) convene meetings with representatives of
industry, academia, other Federal agencies,
international agencies, and other interested persons,
as appropriate;
``(D) convene working groups to support drug product
design and manufacturing research and development;
``(E) support education and training for regulatory
staff and scientists related to innovative approaches
to drug product design and manufacturing;
``(F) advance regulatory science related to the
development and review of innovative approaches to drug
product design and manufacturing;
``(G) convene or participate in working groups to
support the harmonization of international regulatory
requirements related to innovative approaches to drug
product design and manufacturing; and
``(H) award grants or contracts to carry out or
support the program under paragraph (1).
``(3) Grants and contracts.--To seek a grant or contract
under this section, an entity shall submit an application--
``(A) in such form and manner as the Secretary may
require; and
``(B) containing such information as the Secretary
may require, including a description of--
``(i) how the entity will conduct the
activities to be supported through the grant or
contract; and
``(ii) how such activities will further
research and development related to, or
adoption of, innovative approaches to drug
product design and manufacturing.
``(b) Guidance.--The Secretary shall--
``(1) issue or update guidance to help facilitate the
adoption of, and advance the development of, innovative
approaches to drug product design and manufacturing; and
``(2) include in such guidance descriptions of--
``(A) any regulatory requirements related to the
development or review of technologies related to
innovative approaches to drug product design and
manufacturing, including updates and improvements to
such technologies after product approval; and
``(B) data that can be used to demonstrate the
identity, safety, purity, and potency of drugs
manufactured using such technologies.
``(c) Report to Congress.--Not later than 4 years after the date of
enactment of this section, the Secretary shall submit to the Committee
on Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the Senate a
report containing--
``(1) an annual accounting of the allocation of funds made
available to carry out this section;
``(2) a description of how Food and Drug Administration staff
were utilized to carry out this section and, as applicable, any
challenges or limitations related to staffing;
``(3) the number of public meetings held or participated in
by the Food and Drug Administration pursuant to this section,
including meetings convened as part of a working group
described in subparagraph (D) or (G) of subsection (a)(2), and
the topics of each such meeting; and
``(4) the number of drug products approved or licensed, after
the date of enactment of this section, using an innovative
approach to drug product design and manufacturing.
``(d) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $20,000,000 for each fiscal year
2023 through 2027.''.
SEC. 703. IMPROVING THE TREATMENT OF RARE DISEASES AND CONDITIONS.
(a) Report on Orphan Drug Program.--
(1) In general.--Not later than September 30, 2026, the
Secretary shall submit to the Committee on Energy and Commerce
of the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report
summarizing the activities of the Food and Drug Administration
related to designating drugs under section 526 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) for a rare
disease or condition and approving such drugs under section 505
of such Act (21 U.S.C. 355) or licensing such drugs under
section 351 of the Public Health Service Act (42 U.S.C. 262),
including--
(A) the number of applications for such drugs under
section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) or section 351 of the Public Health
Service Act (42 U.S.C. 262) received by the Food and
Drug Administration, the number of such applications
accepted and rejected for filing, and the number of
such applications pending, approved, and disapproved by
the Food and Drug Administration;
(B) a description of trends in drug approvals for
rare diseases and conditions across review divisions at
the Food and Drug Administration;
(C) the extent to which the Food and Drug
Administration is consulting with external experts
pursuant to section 569(a)(2) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360bbb-8(a)(2)) on
topics pertaining to drugs for a rare disease or
condition, including how and when any such consultation
is occurring; and
(D) the Food and Drug Administration's efforts to
promote best practices in the development of novel
treatments for rare diseases, including--
(i) reviewer training on rare disease-related
policies, methods, and tools; and
(ii) new regulatory science and coordinated
support for patient and stakeholder engagement.
(2) Public availability.--The Secretary shall make the report
under paragraph (1) available to the public, including by
posting the report on the website of the Food and Drug
Administration.
(3) Information disclosure.--Nothing in this subsection shall
be construed to authorize the disclosure of information that is
prohibited from disclosure under section 1905 of title 18,
United States Code, or subject to withholding under paragraph
(4) of section 552(b) of title 5, United States Code (commonly
referred to as the ``Freedom of Information Act'').
(b) Study on European Union Safety and Efficacy Reviews of Drugs for
Rare Diseases and Conditions.--
(1) In general.--The Secretary of Health and Human Services
shall enter into a contract with an appropriate entity to
conduct a study on processes for evaluating the safety and
efficacy of drugs for rare diseases or conditions in the United
States and the European Union, including--
(A) flexibilities, authorities, or mechanisms
available to regulators in the United States and the
European Union specific to rare diseases or conditions;
(B) the consideration and use of supplemental data
submitted during review processes in the United States
and the European Union, including data associated with
open label extension studies and expanded access
programs specific to rare diseases or conditions;
(C) an assessment of collaborative efforts between
United States and European Union regulators related
to--
(i) product development programs under
review;
(ii) policies under development recently
issued; and
(iii) scientific information related to
product development or regulation; and
(D) recommendations for how Congress can support
collaborative efforts described in subparagraph (C).
(2) Consultation.--The contract under paragraph (1) shall
provide for consultation with relevant stakeholders,
including--
(A) representatives from the Food and Drug
Administration and the European Medicines Agency;
(B) rare disease or condition patients; and
(C) patient groups that--
(i) represent rare disease or condition
patients; and
(ii) have international patient outreach.
(3) Report.--The contract under paragraph (1) shall provide
for, not later than 2 years after the date of entering into
such contract--
(A) the completion of the study under paragraph (1);
and
(B) the submission of a report on the results of such
study to the Committee on Energy and Commerce of the
House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate.
(4) Public availability.--The contract under paragraph (1)
shall provide for the appropriate entity referred to in
paragraph (1) to make the report under paragraph (3) available
to the public, including by posting the report on the website
of the appropriate entity.
(c) Public Meeting.--
(1) In general.--Not later than December 31, 2023, the
Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, shall convene one or more
public meetings to solicit input from stakeholders regarding
the approaches described in paragraph (2).
(2) Approaches.--The public meeting or meetings under
paragraph (1) shall address approaches to increasing and
improving engagement with rare disease or condition patients,
groups representing such patients, rare disease or condition
experts, and experts on small population studies, in order to
improve the understanding with respect to rare diseases or
conditions of--
(A) patient burden;
(B) treatment options; and
(C) side effects of treatments, including--
(i) comparing the side effects of treatments;
and
(ii) understanding the risks of side effects
relative to the health status of the patient
and the progression of the disease or
condition.
(3) Public docket.--The Secretary of Health and Human
Services shall establish a public docket to receive written
comments related to the approaches addressed during each public
meeting under paragraph (1). Such public docket shall remain
open for 60 days following the date of each such public
meeting.
(4) Reports.--Not later than 180 days after each public
meeting under paragraph (1), the Commissioner of Food and Drugs
shall develop and publish on the website of the Food and Drug
Administration a report on--
(A) the approaches discussed at the public meeting;
and
(B) any related recommendations.
(d) Consultation on the Science of Small Population Studies.--Section
569(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-8(a)(2)) is amended by adding at the end the following:
``(C) Small population studies.--The external experts
on the list maintained pursuant to subparagraph (A) may
include experts on the science of small population
studies.''.
(e) Study on Sufficiency and Use of FDA Mechanisms for Incorporating
the Patient and Clinician Perspective in FDA Processes Related to
Applications Concerning Drugs for Rare Diseases or Conditions.--
(1) In general.--The Comptroller General of the United States
shall conduct a study on the use of Food and Drug
Administration mechanisms and tools to ensure that patient and
physician perspectives are considered and incorporated
throughout the processes of the Food and Drug Administration--
(A) for approving or licensing under section 505 of
the Federal Food, Drug, or Cosmetic Act (21 U.S.C. 355)
or section 351 of the Public Health Service Act (42
U.S.C. 262) a drug designated as a drug for a rare
disease or condition under section 526 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360bb); and
(B) in making any determination related to such a
drug's approval, including assessment of the drug's--
(i) safety or effectiveness; or
(ii) postapproval safety monitoring.
(2) Topics.--The study under paragraph (1) shall--
(A) identify and compare the processes that the Food
and Drug Administration has formally put in place and
utilized to gather external expertise (including
patients, patient groups, and physicians) related to
applications for rare diseases or conditions;
(B) examine tools or mechanisms to improve efforts
and initiatives of the Food and Drug Administration to
collect and consider such external expertise with
respect to applications for rare diseases or conditions
throughout the application review and approval or
licensure processes, including within internal benefit-
risk assessments, advisory committee processes, and
postapproval safety monitoring; and
(C) examine processes or alternatives to address or
resolve conflicts of interest that impede the Food and
Drug Administration in gaining external expert input on
rare diseases or conditions with a limited set of
clinical and research experts.
(3) Report.--Not later than 2 years after the date of
enactment of this Act, the Comptroller General of the United
States shall--
(A) complete the study under paragraph (1);
(B) submit a report on the results of such study to
the Congress; and
(C) include in such report recommendations, if
appropriate, for changes to the processes and
authorities of the Food and Drug Administration to
improve the collection and consideration of external
expert opinions of patients, patient groups, and
physicians with expertise in rare diseases or
conditions.
(f) Definition.--In this section, the term ``rare disease or
condition'' has the meaning given such term in section 526(a)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb(a)(2)).
SEC. 704. ANTIFUNGAL RESEARCH AND DEVELOPMENT.
(a) Draft Guidance.--Not later than 3 years after the date of the
enactment of this Act, the Secretary of Health and Human Services,
acting through the Commissioner of Food and Drugs, shall issue draft
guidance for industry for the purposes of assisting entities seeking
approval under section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) or licensure under section 351 of the Public Health
Service Act (42 U.S.C. 262) of antifungal therapies designed to treat
coccidioidomycosis (commonly known as Valley Fever).
(b) Final Guidance.--Not later than 18 months after the close of the
public comment period on the draft guidance issued pursuant to
subsection (a), the Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, shall finalize the draft
guidance.
(c) Workshop.--To assist entities developing preventive vaccines for
fungal infections and coccidioidomycosis, the Secretary of Health and
Human Services shall hold a public workshop.
SEC. 705. ADVANCING QUALIFIED INFECTIOUS DISEASE PRODUCT INNOVATION.
(a) In General.--Section 505E of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355f) is amended--
(1) in subsection (c)--
(A) in paragraph (2), by striking ``or'' at the end;
(B) in paragraph (3), by striking the period at the
end and inserting ``; or''; and
(C) by adding at the end the following:
``(4) an application pursuant to section 351(a) of the Public
Health Service Act.'';
(2) in subsection (d)(1), by inserting ``of this Act or
section 351(a) of the Public Health Service Act'' after
``section 505(b)''; and
(3) by amending subsection (g) to read as follows:
``(g) Qualified Infectious Disease Product.--The term `qualified
infectious disease product' means a drug, including an antibacterial or
antifungal drug or a biological product, for human use that--
``(1) acts directly on bacteria or fungi or on substances
produced by such bacteria or fungi; and
``(2) is intended to treat a serious or life-threatening
infection, including such an infection caused by--
``(A) an antibacterial or antifungal resistant
pathogen, including novel or emerging infectious
pathogens; or
``(B) qualifying pathogens listed by the Secretary
under subsection (f).''.
(b) Priority Review.--Section 524A(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360n-1(a)) is amended by inserting ``of this
Act or section 351(a) of the Public Health Service Act that requires
clinical data (other than bioavailability studies) to demonstrate
safety or effectiveness'' before the period at the end.
SEC. 706. ADVANCED MANUFACTURING TECHNOLOGIES DESIGNATION PILOT
PROGRAM.
Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 351 et seq.) is amended by inserting after section 506J (21
U.S.C. 356j) the following:
``SEC. 506K. ADVANCED MANUFACTURING TECHNOLOGIES DESIGNATION PILOT
PROGRAM.
``(a) In General.--Not later than 1 year after the date of enactment
of this section, the Secretary shall initiate a pilot program under
which persons may request designation of an advanced manufacturing
technology as described in subsection (b).
``(b) Designation Process.--The Secretary shall establish a process
for the designation under this section of methods of manufacturing
drugs, including biological products, and active pharmaceutical
ingredients of such drugs, as advanced manufacturing technologies. A
method of manufacturing, or a combination of manufacturing methods, is
eligible for designation as an advanced manufacturing technology if
such method or combination of methods incorporates a novel technology,
or uses an established technique or technology in a novel way, that
will substantially improve the manufacturing process for a drug and
maintain equivalent or provide superior drug quality, including by--
``(1) reducing development time for a drug using the
designated manufacturing method; or
``(2) increasing or maintaining the supply of--
``(A) a drug that is described in section 506C(a) and
is intended to treat a serious or life-threatening
condition; or
``(B) a drug that is on the drug shortage list under
section 506E.
``(c) Evaluation and Designation of an Advanced Manufacturing
Technology.--
``(1) Submission.--A person who requests designation of a
method of manufacturing as an advanced manufacturing technology
under this section shall submit to the Secretary data or
information demonstrating that the method of manufacturing
meets the criteria described in subsection (b) in a particular
context of use. The Secretary may facilitate the development
and review of such data or information by--
``(A) providing timely advice to, and interactive
communication with, such person regarding the
development of the method of manufacturing; and
``(B) involving senior managers and experienced staff
of the Food and Drug Administration, as appropriate, in
a collaborative, cross-disciplinary review of the
method of manufacturing, as applicable.
``(2) Evaluation and designation.--Not later than 180
calendar days after the receipt of a request under paragraph
(1), the Secretary shall determine whether to designate such
method of manufacturing as an advanced manufacturing
technology, in a particular context of use, based on the data
and information submitted under paragraph (1) and the criteria
described in subsection (b).
``(d) Review of Advanced Manufacturing Technologies.--If the
Secretary designates a method of manufacturing as an advanced
manufacturing technology, the Secretary shall--
``(1) expedite the development and review of an application
submitted under section 505 of this Act or section 351 of the
Public Health Service Act, including supplemental applications,
for drugs that are manufactured using a designated advanced
manufacturing technology and could help mitigate or prevent a
shortage or substantially improve manufacturing processes for a
drug and maintain equivalent or provide superior drug quality,
as described in subsection (b); and
``(2) allow the holder of an advanced technology designation,
or a person authorized by the advanced manufacturing technology
designation holder, to reference or rely upon, in an
application submitted under section 505 of this Act or section
351 of the Public Health Service Act, including a supplemental
application, data and information about the designated advanced
manufacturing technology for use in manufacturing drugs in the
same context of use for which the designation was granted.
``(e) Implementation and Evaluation of Advanced Manufacturing
Technologies Pilot.--
``(1) Public meeting.--The Secretary shall publish in the
Federal Register a notice of a public meeting, to be held not
later than 180 days after the date of enactment of this
section, to discuss and obtain input and recommendations from
relevant stakeholders regarding--
``(A) the goals and scope of the pilot program, and a
suitable framework, procedures, and requirements for
such program; and
``(B) ways in which the Food and Drug Administration
will support the use of advanced manufacturing
technologies and other innovative manufacturing
approaches for drugs.
``(2) Pilot program guidance.--
``(A) In general.--The Secretary shall--
``(i) not later than 180 days after the
public meeting under paragraph (1), issue draft
guidance regarding the goals and implementation
of the pilot program under this section; and
``(ii) not later than 2 years after the date
of enactment of this section, issue final
guidance regarding the implementation of such
program.
``(B) Content.--The guidance described in
subparagraph (A) shall address--
``(i) the process by which a person may
request a designation under subsection (b);
``(ii) the data and information that a person
requesting such a designation is required to
submit under subsection (c), and how the
Secretary intends to evaluate such submissions;
``(iii) the process to expedite the
development and review of applications under
subsection (d); and
``(iv) the criteria described in subsection
(b) for eligibility for such a designation.
``(3) Report.--Not later than 3 years after the date of
enactment of this section and annually thereafter, the
Secretary shall publish on the website of the Food and Drug
Administration and submit to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives a report
containing a description and evaluation of the pilot program
being conducted under this section, including the types of
innovative manufacturing approaches supported under the
program. Such report shall include the following:
``(A) The number of persons that have requested
designations and that have been granted designations.
``(B) The number of methods of manufacturing that
have been the subject of designation requests and that
have been granted designations.
``(C) The average number of calendar days for
completion of evaluations under subsection (c)(2).
``(D) An analysis of the factors in data submissions
that are relevant to determinations to designate and
not to designate after evaluation under subsection
(c)(2).
``(E) The number of applications received under
section 505 of this Act or section 351 of the Public
Health Service Act, including supplemental
applications, that have included an advanced
manufacturing technology designated under this section,
and the number of such applications approved.
``(f) Sunset.--The Secretary--
``(1) may not consider any requests for designation submitted
under subsection (c) after October 1, 2029; and
``(2) may continue all activities under this section with
respect to advanced manufacturing technologies that were
designated pursuant to subsection (d) prior to such date, if
the Secretary determines such activities are in the interest of
the public health.''.
SEC. 707. PUBLIC WORKSHOP ON CELL THERAPIES.
Not later than 3 years after the date of the enactment of this Act,
the Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, shall convene a public workshop with
relevant stakeholders to discuss best practices on generating
scientific data necessary to further facilitate the development of
certain human cell-, tissue-, and cellular-based medical products (and
the latest scientific information about such products) that are
regulated as drugs under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) and biological products under section 351 of the
Public Health Service Act (42 U.S.C. 262), namely, stem-cell and other
cellular therapies.
SEC. 708. REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHILDREN.
Section 409I(d)(1) of the Public Health Service Act (42 U.S.C.
284m(d)(1)) is amended by striking ``2018 through 2022'' and inserting
``2023 through 2027''.
SEC. 709. REAUTHORIZATION FOR HUMANITARIAN DEVICE EXEMPTION AND
DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC
AVAILABILITY.
(a) Humanitarian Device Exemption.--Section 520(m)(6)(A)(iv) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is
amended by striking ``2022'' and inserting ``2027''.
(b) Pediatric Medical Device Safety and Improvement Act.--Section
305(e) of the Pediatric Medical Device Safety and Improvement Act of
2007 (Public Law 110-85) is amended by striking ``2018 through 2022''
and inserting ``2023 through 2027''.
SEC. 710. REAUTHORIZATION OF PROVISION RELATED TO EXCLUSIVITY OF
CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.
Section 505(u)(4) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(u)(4)) is amended by striking ``2022'' and inserting
``2027''.
SEC. 711. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE
PARTNERSHIP PROGRAM.
Section 566(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-5(f)) is amended by striking ``$6,000,000 for each of fiscal
years 2018 through 2022'' and inserting ``$10,000,000 for each of
fiscal years 2023 through 2027''.
SEC. 712. REAUTHORIZATION OF ORPHAN DRUG GRANTS.
Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) is amended--
(1) in subsection (a)--
(A) by striking ``and (3)'' and inserting ``(3)'';
and
(B) by inserting before the period at the end the
following: ``, and (4) developing regulatory science
pertaining to the chemistry, manufacturing, and
controls of individualized medical products to treat
individuals with rare diseases or conditions''; and
(2) in subsection (c), by striking ``2018 through 2022'' and
inserting ``2023 through 2027''.
SEC. 713. RESEARCH INTO PEDIATRIC USES OF DRUGS; ADDITIONAL AUTHORITIES
OF FOOD AND DRUG ADMINISTRATION REGARDING
MOLECULARLY TARGETED CANCER DRUGS.
(a) In General.--
(1) Additional active ingredient for application drug;
limitation regarding novel-combination application drug.--
Section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355c(a)(3)) is amended--
(A) by redesignating subparagraphs (B) and (C) as
subparagraphs (C) and (D), respectively; and
(B) by striking subparagraph (A) and inserting the
following:
``(A) In general.--For purposes of paragraph (1)(B),
the investigation described in this paragraph is (as
determined by the Secretary) a molecularly targeted
pediatric cancer investigation of--
``(i) the drug or biological product for
which the application referred to in such
paragraph is submitted; or
``(ii) such drug or biological product in
combination with--
``(I) an active ingredient of a drug
or biological product--
``(aa) for which an approved
application under section
505(j) under this Act or under
section 351(k) of the Public
Health Service Act is in
effect; and
``(bb) that is determined by
the Secretary to be the
standard of care for treating a
pediatric cancer; or
``(II) an active ingredient of a drug
or biological product--
``(aa) for which an approved
application under section
505(b) of this Act or section
351(a) of the Public Health
Service Act to treat an adult
cancer is in effect and is held
by the same person submitting
the application under paragraph
(1)(B); and
``(bb) that is directed at a
molecular target that the
Secretary determines to be
substantially relevant to the
growth or progression of a
pediatric cancer.
``(B) Additional requirements.--
``(i) Design of investigation.--A molecularly
targeted pediatric cancer investigation
referred to in subparagraph (A) shall be
designed to yield clinically meaningful
pediatric study data that is gathered using
appropriate formulations for each age group for
which the study is required, regarding dosing,
safety, and preliminary efficacy to inform
potential pediatric labeling.
``(ii) Limitation.--An investigation
described in subparagraph (A)(ii) may be
required only if the drug or biological product
for which the application referred to in
paragraph (1)(B) contains either--
``(I) a single new active ingredient;
or
``(II) more than one active
ingredient, if an application for the
combination of active ingredients has
not previously been approved but each
active ingredient has been previously
approved to treat an adult cancer.
``(iii) Results of already-completed
preclinical studies of application drug.--The
Secretary may require that reports on an
investigation required pursuant to paragraph
(1)(B) include the results of all preclinical
studies on which the decision to conduct such
investigation was based.
``(iv) Rule of construction regarding
inactive ingredients.--With respect to a
combination of active ingredients referred to
in subparagraph (A)(ii), such subparagraph
shall not be construed as addressing the use of
inactive ingredients with such combination.''.
(2) Determination of applicable requirements.--Section
505B(e)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355c(e)(1)) is amended by adding at the end the
following: ``The Secretary shall determine whether subparagraph
(A) or (B) of subsection (a)(1) shall apply with respect to an
application before the date on which the applicant is required
to submit the initial pediatric study plan under paragraph
(2)(A).''.
(3) Clarifying applicability.--Section 505B(a)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)(1)) is
amended by adding at the end the following:
``(C) Rule of construction.--No application that is
subject to the requirements of subparagraph (B) shall
be subject to the requirements of subparagraph (A), and
no application (or supplement to an application) that
is subject to the requirements of subparagraph (A)
shall be subject to the requirements of subparagraph
(B).''.
(4) Conforming amendments.--Section 505B(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)) is amended--
(A) in paragraph (3)(C), as redesignated by paragraph
(1)(A) of this subsection, by striking ``investigations
described in this paragraph'' and inserting
``investigations referred to in subparagraph (A)''; and
(B) in paragraph (3)(D), as redesignated by paragraph
(1)(A) of this subsection, by striking ``the
assessments under paragraph (2)(B)'' and inserting
``the assessments required under paragraph (1)(A)''.
(b) Guidance.--The Secretary shall--
(1) not later than 6 months after the date of enactment of
this Act, issue draft guidance on the implementation of the
requirements in subsection (a); and
(2) not later than 12 months after closing the comment period
on such draft guidance, finalize such guidance.
(c) Applicability.--The amendments made by this section apply with
respect to any application under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) and any application under
section 351(a) of the Public Health Service Act (42 U.S.C. 262), that
is submitted on or after the date that is 3 years after the date of
enactment of this Act.
(d) Reports to Congress.--
(1) Secretary of health and human services.--Not later than 2
years after the date of enactment of this Act, the Secretary of
Health and Human Services shall submit to the Committee on
Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the
Senate a report on the Secretary's efforts, in coordination
with industry, to ensure implementation of the amendments made
by subsection (a).
(2) GAO study and report.--
(A) Study.--Not later than 2 years after the date of
enactment of this Act, the Comptroller General of the
United States shall conduct a study of the
effectiveness of requiring assessments and
investigations described in section 505B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.355c), as
amended by subsection (a), in the development of drugs
and biological products for pediatric cancer
indications.
(B) Findings.--Not later than 4 years after the date
of enactment of this Act, the Comptroller General shall
submit to the Committee on Energy and Commerce of the
House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report
containing the findings of the study conducted under
subparagraph (A).
Subtitle B--Inspections
SEC. 721. FACTORY INSPECTION.
(a) In General.--Section 704(a)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 374(a)(1)) is amended by striking ``restricted
devices'' each place it appears and inserting ``devices''.
(b) Records or Other Information.--
(1) Establishments.--Section 704(a)(4)(A) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(4)(A)) is
amended--
(A) by striking ``an establishment that is engaged in
the manufacture, preparation, propagation, compounding,
or processing of a drug'' and inserting ``an
establishment that is engaged in the manufacture,
preparation, propagation, compounding, or processing of
a drug or device, or that is subject to inspection
under paragraph (5)(C),''; and
(B) by inserting after ``a sufficient description of
the records requested'' the following: ``and a
rationale for requesting such records or other
information in advance of, or in lieu of, an
inspection''.
(2) Guidance.--
(A) In general.--The Secretary of Health and Human
Services shall issue or update guidance describing--
(i) circumstances in which the Secretary
intends to issue requests for records or other
information in advance of, or in lieu of, an
inspection under section 704(a)(4) of the
Federal Food, Drug, and Cosmetic Act, as
amended by paragraph (1);
(ii) processes for responding to such
requests electronically or in physical form;
and
(iii) factors the Secretary intends to
consider in evaluating whether such records and
other information are provided within a
reasonable timeframe, within reasonable limits,
and in a reasonable manner, accounting for
resource and other limitations that may exist,
including for small businesses.
(B) Timing.--The Secretary of Health and Human
Services shall--
(i) not later than 1 year after the date of
enactment of this Act, issue draft guidance
under subparagraph (A); and
(ii) not later than 1 year after the close of
the comment period for such draft guidance,
issue final guidance under subparagraph (A).
(c) Bioresearch Monitoring Inspections.--
(1) In general.--Section 704(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 374(a)) is amended by adding at the
end the following:
``(5) Bioresearch monitoring inspections.--
``(A) In general.--The Secretary may, to ensure the
accuracy and reliability of studies and records or
other information described in subparagraph (B) and to
assess compliance with applicable requirements under
this Act or the Public Health Service Act, enter sites
and facilities specified in subparagraph (C) in order
to inspect such records or other information.
``(B) Information subject to inspection.--An
inspection under this paragraph shall extend to all
records and other information related to the studies
and submissions described in subparagraph (E),
including records and information related to the
conduct, results, and analyses of, and the protection
of human and animal trial participants participating
in, such studies.
``(C) Sites and facilities subject to inspection.--
``(i) Sites and facilities described.--The
sites and facilities subject to inspection by
the Secretary under this paragraph are those
owned or operated by a person described in
clause (ii) and which are (or were) utilized by
such person in connection with--
``(I) developing an application or
other submission to the Secretary under
this Act or the Public Health Service
Act related to marketing authorization
for a product described in paragraph
(1);
``(II) preparing, conducting, or
analyzing the results of a study
described in subparagraph (E); or
``(III) holding any records or other
information described in subparagraph
(B).
``(ii) Persons described.--A person described
in this clause is--
``(I) the sponsor of an application
or submission specified in subparagraph
(E);
``(II) a person engaged in any
activity described in clause (i) on
behalf of such a sponsor, through a
contract, grant, or other business
arrangement with such sponsor;
``(III) an institutional review
board, or other individual or entity,
engaged by contract, grant, or other
business arrangement with a nonsponsor
in preparing, collecting, or analyzing
records or other information described
in subparagraph (B); or
``(IV) any person not otherwise
described in this clause that conducts,
or has conducted, a study described in
subparagraph (E) yielding records or
other information described in
subparagraph (B).
``(D) Conditions of inspection.--
``(i) Access to information subject to
inspection.--Subject to clause (ii), an entity
that owns or operates any site or facility
subject to inspection under this paragraph
shall provide the Secretary with access to
records and other information described in
subparagraph (B) that is held by or under the
control of such entity, including--
``(I) permitting the Secretary to
record or copy such information for
purposes of this paragraph;
``(II) providing the Secretary with
access to any electronic information
system utilized by such entity to hold,
process, analyze, or transfer any
records or other information described
in subparagraph (B); and
``(III) permitting the Secretary to
inspect the facilities, equipment,
written procedures, processes, and
conditions through which records or
other information described in
subparagraph (B) is or was generated,
held, processed, analyzed, or
transferred.
``(ii) No effect on applicability of
provisions for protection of proprietary
information or trade secrets.--Nothing in
clause (i) shall negate, supersede, or
otherwise affect the applicability of
provisions, under this or any other Act,
preventing or limiting the disclosure of
confidential commercial information or other
information considered proprietary or trade
secret.
``(iii) Reasonableness of inspections.--An
inspection under this paragraph shall be
conducted at reasonable times and within
reasonable limits and in a reasonable manner.
``(E) Studies and submissions described.--The studies
and submissions described in this subparagraph are each
of the following:
``(i) Clinical and nonclinical studies
submitted to the Secretary in support of, or
otherwise related to, applications and other
submissions to the Secretary under this Act or
the Public Health Service Act for marketing
authorization of a product described in
paragraph (1).
``(ii) Postmarket safety activities conducted
under this Act or the Public Health Service
Act.
``(iii) Any other clinical investigation of--
``(I) a drug subject to section 505
or 512 of this Act or section 351 of
the Public Health Service Act; or
``(II) a device subject to section
520(g).
``(iv) Any other submissions made under this
Act or the Public Health Service Act with
respect to which the Secretary determines an
inspection under this paragraph is warranted in
the interest of public health.
``(F) Clarification.--This paragraph clarifies the
authority of the Secretary to conduct inspections of
the type described in this paragraph and shall not be
construed as a basis for inferring that, prior to the
date of enactment of this paragraph, the Secretary
lacked the authority to conduct such inspections,
including under this Act or the Public Health Service
Act.''.
(2) Review of processes and practices; guidance for
industry.--
(A) In general.--The Secretary of Health and Human
Services shall--
(i) review processes and practices in effect
as of the date of enactment of this Act
applicable to inspections of foreign and
domestic sites and facilities described in
subparagraph (C)(i) of section 704(a)(5) of the
Federal Food, Drug, and Cosmetic Act, as added
by paragraph (1); and
(ii) evaluate whether any updates are needed
to facilitate the consistency of such processes
and practices.
(B) Guidance.--
(i) In general.--The Secretary of Health and
Human Services shall issue guidance describing
the processes and practices applicable to
inspections of sites and facilities described
in subparagraph (C)(i) of section 704(a)(5) of
the Federal Food, Drug, and Cosmetic Act, as
added by paragraph (1), including with respect
to the types of records and information
required to be provided, best practices for
communication between the Food and Drug
Administration and industry in advance of or
during an inspection or request for records or
other information, and other inspections-
related conduct, to the extent not specified in
existing publicly available Food and Drug
Administration guides and manuals for such
inspections.
(ii) Timing.--The Secretary of Health and
Human Services shall--
(I) not later than 18 months after
the date of enactment of this Act,
issue draft guidance under clause (i);
and
(II) not later than 1 year after the
close of the public comment period for
such draft guidance, issue final
guidance under clause (i).
SEC. 722. USES OF CERTAIN EVIDENCE.
Section 703 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
373) is amended by adding at the end the following:
``(c) Applicability.--The limitations on the Secretary's use of
evidence obtained under this section, or any evidence which is directly
or indirectly derived from such evidence, in a criminal prosecution of
the person from whom such evidence was obtained shall not apply to
evidence, including records or other information, obtained under
authorities other than this section, unless such limitations are
specifically incorporated by reference in such other authorities.''.
SEC. 723. IMPROVING FDA INSPECTIONS.
(a) Risk Factors for Establishments.--Section 510(h)(4) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(h)(4)) is amended--
(1) by redesignating subparagraph (F) as subparagraph (G);
and
(2) by inserting after subparagraph (E) the following:
``(F) The compliance history of establishments in the
country or region in which the establishment is located
that are subject to regulation under this Act,
including the history of violations related to products
exported from such country or region that are subject
to such regulation.''.
(b) Use of Records.--Section 704(a)(4) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 374(a)(4)) is amended--
(1) by redesignating subparagraph (C) as subparagraph (D);
and
(2) by inserting after subparagraph (B) the following:
``(C) The Secretary may rely on any records or other information that
the Secretary may inspect under this section to satisfy requirements
that may pertain to a preapproval or risk-based surveillance
inspection, or to resolve deficiencies identified during such
inspections, if applicable and appropriate.''.
(c) Recognition of Foreign Government Inspections.--Section 809 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384e) is amended--
(1) in subsection (a)(1), by inserting ``preapproval or''
before ``risk-based inspections''; and
(2) by adding at the end the following:
``(c) Periodic Review.--
``(1) In general.--Beginning not later than 1 year after the
date of the enactment of the Food and Drug Amendments of 2022,
the Secretary shall periodically assess whether additional
arrangements and agreements with a foreign government or an
agency of a foreign government, as allowed under this section,
are appropriate.
``(2) Reports to congress.--Beginning not later than 4 years
after the date of the enactment of the Food and Drug Amendments
of 2022, and every 4 years thereafter, the Secretary shall
submit to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate a report describing the findings and
conclusions of each review conducted under paragraph (1).''.
SEC. 724. GAO REPORT ON INSPECTIONS OF FOREIGN ESTABLISHMENTS
MANUFACTURING DRUGS.
(a) In General.--Not later than 18 months after the date of the
enactment of this Act, the Comptroller General of the United States
shall submit to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor, and
Pensions of the Senate a report on inspections conducted by--
(1) the Secretary of Health and Human Services (in this
section referred to as the ``Secretary'') of foreign
establishments pursuant to subsections (h) and (i) of section
510 and section 704 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360; 374); or
(2) a foreign government or an agency of a foreign government
pursuant to section 809 of such Act (21 U.S.C. 384e).
(b) Contents.--The report conducted under subsection (a) shall
include--
(1) what alternative tools, including remote inspections or
remote evaluations, other countries are utilizing to facilitate
inspections of foreign establishments;
(2) how frequently trusted foreign regulators conduct
inspections of foreign facilities that could be useful to the
Food and Drug Administration to review in lieu of its own
inspections;
(3) how frequently and under what circumstances, including
for what types of inspections, the Secretary utilizes existing
agreements or arrangements under section 809 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 384e) and whether the
use of such agreements could be appropriately expanded;
(4) whether the Secretary has accepted reports of inspections
of facilities in China and India conducted by entities with
which they have entered into such an agreement or arrangement;
(5) what additional foreign governments or agencies of
foreign governments the Secretary has considered entering into
a mutual recognition agreement with and, if applicable, reasons
why the Secretary declined to enter into a mutual recognition
agreement with such foreign governments or agencies;
(6) what tools, if any, the Secretary used to facilitate
inspections of domestic facilities that could also be
effectively utilized to appropriately inspect foreign
facilities;
(7) what steps the Secretary has taken to identify and
evaluate tools and strategies the Secretary may use to continue
oversight with respect to inspections when in-person
inspections are disrupted;
(8) how the Secretary is considering incorporating
alternative tools into the inspection activities conducted
pursuant to the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.); and
(9) what steps the Secretary has taken to identify and
evaluate how the Secretary may use alternative tools to address
workforce shortages to carry out such inspection activities.
SEC. 725. UNANNOUNCED FOREIGN FACILITY INSPECTIONS PILOT PROGRAM.
(a) In General.--The Secretary of Health and Human Services (referred
to in this section as the ``Secretary'') shall conduct a pilot program
under which the Secretary increases the conduct of unannounced
surveillance inspections of foreign human drug establishments and
evaluates the differences between such inspections of domestic and
foreign human drug establishments, including the impact of announcing
inspections to persons who own or operate foreign human drug
establishments in advance of an inspection. Such pilot program shall
evaluate--
(1) differences in the number and type of violations of
section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351(a)(2)(B)) identified as a result of
unannounced and announced inspections of foreign human drug
establishments and any other significant differences between
each type of inspection;
(2) costs and benefits associated with conducting announced
and unannounced inspections of foreign human drug
establishments;
(3) barriers to conducting unannounced inspections of foreign
human drug establishments and any challenges to achieving
parity between domestic and foreign human drug establishment
inspections; and
(4) approaches for mitigating any negative effects of
conducting announced inspections of foreign human drug
establishments.
(b) Pilot Program Scope.--The inspections evaluated under the pilot
program under this section shall be routine surveillance inspections
and shall not include inspections conducted as part of the Secretary's
evaluation of a request for approval to market a drug submitted under
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the
Public Health Service Act (42 U.S.C. 201 et seq.).
(c) Pilot Program Initiation.--The Secretary shall initiate the pilot
program under this section not later than 180 days after the date of
enactment of this Act.
(d) Report.--The Secretary shall, not later than 180 days following
the completion of the pilot program under this section, make available
on the website of the Food and Drug Administration a final report on
the pilot program under this section, including--
(1) findings and any associated recommendations with respect
to the evaluation under subsection (a), including any
recommendations to address identified barriers to conducting
unannounced inspections of foreign human drug establishments;
(2) findings and any associated recommendations regarding how
the Secretary may achieve parity between domestic and foreign
human drug inspections; and
(3) the number of unannounced inspections during the pilot
program that would not be unannounced under existing practices.
SEC. 726. REAUTHORIZATION OF INSPECTION PROGRAM.
Section 704(g)(11) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 374(g)(11)) is amended by striking ``2022'' and inserting
``2027''.
SEC. 727. ENHANCING INTRA-AGENCY COORDINATION AND PUBLIC HEALTH
ASSESSMENT WITH REGARD TO COMPLIANCE ACTIVITIES.
(a) Coordination.--Section 506D of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356d) is amended by adding at the end the
following:
``(g) Coordination.--The Secretary shall ensure timely and effective
internal coordination and alignment among the field investigators of
the Food and Drug Administration and the staff of the Center for Drug
Evaluation and Research's Office of Compliance and Drug Shortage
Program regarding--
``(1) the reviews of reports shared pursuant to section
704(b)(2); and
``(2) any feedback or corrective or preventive actions in
response to such reports.''.
(b) Reporting.--
(1) In general.--Section 506C-1(a)(2) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 356c-1(a)(2)) is amended to
read as follows:
``(2)(A) describes the communication between the field
investigators of the Food and Drug Administration and the staff
of the Center for Drug Evaluation and Research's Office of
Compliance and Drug Shortage Program, including the Food and
Drug Administration's procedures for enabling and ensuring such
communication;
``(B) provides the number of reports described in section
704(b)(2) that were required to be sent to the appropriate
offices of the Food and Drug Administration and the number of
such reports that were sent; and
``(C) describes the coordination and alignment activities
undertaken pursuant to section 506D(g);''.
(2) Applicability.--The amendment made by paragraph (1) shall
apply with respect to reports submitted on or after March 31,
2023.
SEC. 728. REPORTING OF MUTUAL RECOGNITION AGREEMENTS FOR INSPECTIONS
AND REVIEW ACTIVITIES.
(a) In General.--Not later than December 31, 2022, and annually
thereafter, the Secretary of Health and Human Services (referred to in
this section as the ``Secretary'') shall publish a report on the public
website of the Food and Drug Administration on the utilization of
agreements entered into pursuant to section 809 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 384e) or otherwise entered into by
the Secretary in the previous fiscal year to recognize inspections
between drug regulatory authorities across countries and international
regions with analogous review criteria to the Food and Drug
Administration, such as the Pharmaceutical Inspection Co-Operation
Scheme, the Mutual Recognition Agreement with the European Union, and
the Australia-Canada-Singapore-Switzerland-United Kingdom Consortium.
(b) Content.--The report under subsection (a) shall include each of
the following:
(1) The total number of establishments that are registered
under section 510(i) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360(i)), and the number of such establishments
in each region of interest.
(2) The total number of inspections conducted at
establishments described in paragraph (1), disaggregated by
inspections conducted--
(A) pursuant to an agreement or other recognition
described in subsection (a); and
(B) by employees or contractors of the Food and Drug
Administration.
(3) Of the inspections described in paragraph (2), the total
number of inspections in each region of interest.
(4) Of the inspections in each region of interest reported
pursuant to paragraph (3), the number of inspections in each
FDA inspection category.
(5) Of the number of inspections reported under each of
paragraphs (3) and (4)--
(A) the number of inspections which have been
conducted pursuant to an agreement or other recognition
described in subsection (a); and
(B) the number of inspections which have been
conducted by employees or contractors of the Food and
Drug Administration.
(c) Definitions.--In this section:
(1) FDA inspection category.--The term ``FDA inspection
category'' means the following inspection categories:
(A) Inspections to support approvals of changes to
the manufacturing process of drugs approved under
section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) or section 351 of the Public Health
Service Act (42 U.S.C. 262).
(B) Surveillance inspections.
(C) For-cause inspections.
(2) Region of interest.--The term ``region of interest''
means China, India, the European Union, and any other
geographic region as the Secretary determines appropriate.
SEC. 729. ENHANCING TRANSPARENCY OF DRUG FACILITY INSPECTION TIMELINES.
Section 902 of the FDA Reauthorization Act of 2017 (21 U.S.C. 355
note) is amended to read as follows:
``SEC. 902. ANNUAL REPORT ON INSPECTIONS.
``Not later than 120 days after the end of each fiscal year, the
Secretary of Health and Human Services shall post on the public website
of the Food and Drug Administration information related to inspections
of facilities necessary for approval of a drug under subsection (c) or
(j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355), approval of a device under section 515 of such Act (21
U.S.C. 360e), or clearance of a device under section 510(k) of such Act
(21 U.S.C. 360(k)) that were conducted during the previous fiscal year.
Such information shall include the following:
``(1) The median time following a request from staff of the
Food and Drug Administration reviewing an application or report
to the beginning of the inspection, including--
``(A) the median time for drugs described in section
505(j)(11)(A)(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(11)(A)(i));
``(B) the median time for drugs described in section
506C(a) of such Act (21 U.S.C. 356c(a)) only; and
``(C) the median time for drugs on the drug shortage
list in effect under section 506E of such Act (21
U.S.C. 356e).
``(2) The median time from the issuance of a report pursuant
to section 704(b) of such Act (21 U.S.C. 374(b)) to the sending
of a warning letter, issuance of an import alert, or holding of
a regulatory meeting for inspections for which the Secretary
concluded that regulatory or enforcement action was indicated,
including the median time for each category of drugs listed in
subparagraphs (A) through (C) of paragraph (1).
``(3) The median time from the sending of a warning letter,
issuance of an import alert, or holding of a regulatory meeting
to resolution of the actions indicated to address the
conditions or practices observed during an inspection.
``(4) The number of facilities that failed to implement
adequate corrective or preventive actions following a report
pursuant to such section 704(b), resulting in a withhold
recommendation, including the number of such times for each
category of drugs listed in subparagraphs (A) through (C) of
paragraph (1).''.
TITLE VIII--TRANSPARENCY, PROGRAM INTEGRITY, AND REGULATORY
IMPROVEMENTS
SEC. 801. PROMPT REPORTS OF MARKETING STATUS BY HOLDERS OF APPROVED
APPLICATIONS FOR BIOLOGICAL PRODUCTS.
(a) In General.--Section 506I of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 356i) is amended--
(1) in subsection (a)--
(A) in the matter preceding paragraph (1), by
striking ``The holder of an application approved under
subsection (c) or (j) of section 505'' and inserting
``The holder of an application approved under
subsection (c) or (j) of section 505 of this Act or
subsection (a) or (k) of section 351 of the Public
Health Service Act'';
(B) in paragraph (2), by striking ``established
name'' and inserting ``established name (for biological
products, by proper name)''; and
(C) in paragraph (3), by striking ``or abbreviated
application number'' and inserting ``, abbreviated
application number, or biologics license application
number''; and
(2) in subsection (b)--
(A) in the matter preceding paragraph (1), by
striking ``The holder of an application approved under
subsection (c) or (j)'' and inserting ``The holder of
an application approved under subsection (c) or (j) of
section 505 of this Act or subsection (a) or (k) of
section 351 of the Public Health Service Act'';
(B) in paragraph (1), by striking ``established
name'' and inserting ``established name (for biological
products, by proper name)''; and
(C) in paragraph (2), by striking ``or abbreviated
application number'' and inserting ``, abbreviated
application number, or biologics license application
number''.
(b) Additional One-Time Report.--Subsection (c) of section 506I of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356i) is amended to
read as follows:
``(c) Additional One-Time Report.--Within 180 days of the date of
enactment of the Food and Drug Amendments of 2022, all holders of
applications approved under subsection (a) or (k) of section 351 of the
Public Health Service Act shall review the information in the list
published under section 351(k)(9)(A) and shall submit a written notice
to the Secretary--
``(1) stating that all of the application holder's biological
products in the list published under section 351(k)(9)(A) that
are not listed as discontinued are available for sale; or
``(2) including the information required pursuant to
subsection (a) or (b), as applicable, for each of the
application holder's biological products that are in the list
published under section 351(k)(9)(A) and not listed as
discontinued, but have been discontinued from sale or never
have been available for sale.''.
(c) Purple Book.--Section 506I of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356i) is amended--
(1) by striking subsection (d) and inserting the following:
``(d) Failure To Meet Requirements.--If a holder of an approved
application fails to submit the information required under subsection
(a), (b), or (c), the Secretary may--
``(1) move the application holder's drugs from the active
section of the list published under section 505(j)(7)(A) to the
discontinued section of the list, except that the Secretary
shall remove from the list in accordance with section
505(j)(7)(C) drugs the Secretary determines have been withdrawn
from sale for reasons of safety or effectiveness; and
``(2) identify the application holder's biological products
as discontinued in the list published under section
351(k)(9)(A) of the Public Health Service Act, except that the
Secretary shall remove from the list in accordance with section
351(k)(9)(B) of such Act biological products for which the
license has been revoked or suspended for reasons of safety,
purity, or potency.''; and
(2) in subsection (e)--
(A) by inserting after the first sentence the
following: ``The Secretary shall update the list
published under section 351(k)(9)(A) of the Public
Health Service Act based on information provided under
subsections (a), (b), and (c) by identifying as
discontinued biological products that are not available
for sale, except that biological products for which the
license has been revoked or suspended for safety,
purity, or potency reasons shall be removed from the
list in accordance with section 351(k)(9)(B) of the
Public Health Service Act.'';
(B) by striking ``monthly updates to the list'' and
inserting ``monthly updates to the lists referred to in
the preceding sentences''; and
(C) by striking ``and shall update the list based
on'' and inserting ``and shall update such lists based
on''.
(d) Technical Corrections.--Section 506I(e) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 356i(e)) is amended--
(1) by striking ``subsection 505(j)(7)(A)'' and inserting
``section 505(j)(7)(A)''; and
(2) by striking ``subsection 505(j)(7)(C)'' and inserting
``section 505(j)(7)(C)''.
SEC. 802. ENCOURAGING BLOOD DONATION.
(a) Streamlining Patient and Blood Donor Input.--Section 3003 of the
21st Century Cures Act (21 U.S.C. 360bbb-8c note) is amended to read as
follows:
``SEC. 3003. STREAMLINING PATIENT AND BLOOD DONOR INPUT.
``Chapter 35 of title 44, United States Code, shall not apply to the
collection of information to which a response is voluntary, to
solicit--
``(1) the views and perspectives of patients under section
569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-8c) (as amended by section 3001) or section 3002; or
``(2) information from blood donors or potential blood donors
to support the development of recommendations by the Secretary
of Health and Human Services acting through the Commissioner of
Food and Drugs concerning blood donation.''.
(b) Clerical Amendment.--The table of contents in section 1(b) of the
21st Century Cures Act is amended by striking the item relating to
section 3003 and inserting the following:
``Sec. 3003. Streamlining patient and blood donor input.''.
SEC. 803. REGULATION OF CERTAIN PRODUCTS AS DRUGS.
Section 503 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
353) is amended by adding at the end the following:
``(h)(1) Any contrast agent, radioactive drug, or OTC monograph drug
shall be deemed to be a drug under section 201(g) and not a device
under section 201(h).
``(2) For purposes of this subsection:
``(A) The term `contrast agent' means an article that is
intended for use in conjunction with a medical imaging device,
and--
``(i) is a diagnostic radiopharmaceutical, as defined
in sections 315.2 and 601.31 of title 21, Code of
Federal Regulations (or any successor regulations); or
``(ii) is a diagnostic agent that improves the
visualization of structure or function within the body
by increasing the relative difference in signal
intensity within the target tissue, structure, or
fluid.
``(B) The term `radioactive drug' has the meaning given such
term in section 310.3(n) of title 21, Code of Federal
Regulations (or any successor regulations), except that such
term does not include--
``(i) an implant or article similar to an implant;
``(ii) an article that applies radiation from outside
of the body; or
``(iii) the radiation source of an article described
in clause (i) or (ii).
``(C) The term `OTC monograph drug' has the meaning given
such term in section 744L.
``(3) Nothing in this subsection shall be construed as allowing for
the classification of a product as a drug (as defined in section
201(g)) if such product--
``(A) is not described in paragraph (1); and
``(B) meets the definition of a device under section 201(h),
unless another provision of this Act otherwise indicates a different
classification.''.
SEC. 804. POSTAPPROVAL STUDIES AND PROGRAM INTEGRITY FOR ACCELERATED
APPROVAL DRUGS.
(a) In General.--Section 506(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356(c)) is amended--
(1) by striking paragraph (2) and inserting the following:
``(2) Limitation.--
``(A) In general.--Approval of a product under this
subsection may be subject to 1 or both of the following
requirements:
``(i) That the sponsor conduct an appropriate
postapproval study or studies (which may be
augmented or supported by real world evidence)
to verify and describe the predicted effect on
irreversible morbidity or mortality or other
clinical benefit.
``(ii) That the sponsor submit copies of all
promotional materials related to the product
during the preapproval review period and,
following approval and for such period
thereafter as the Secretary determines to be
appropriate, at least 30 days prior to
dissemination of the materials.
``(B) Studies not required.--If the Secretary does
not require that the sponsor of a product approved
under accelerated approval conduct a postapproval study
under this paragraph, the Secretary shall publish on
the website of the Food and Drug Administration the
rationale for why such study is not appropriate or
necessary.
``(C) Postapproval study conditions.--Not later than
the time of approval of a product under accelerated
approval, the Secretary shall specify the conditions
for a postapproval study or studies required to be
conducted under this paragraph with respect to such
product, which may include enrollment targets, the
study protocol, and milestones, including the target
date of study completion.
``(D) Studies begun before approval.--The Secretary
may require such study or studies to be underway prior
to approval.''; and
(2) by striking paragraph (3) and inserting the following:
``(3) Expedited withdrawal of approval.--
``(A) In general.--The Secretary may withdraw
approval of a product approved under accelerated
approval using expedited procedures described in
subparagraph (B), if--
``(i) the sponsor fails to conduct any
required postapproval study of the product with
due diligence, including with respect to
conditions specified by the Secretary under
paragraph (2)(C);
``(ii) a study required to verify and
describe the predicted effect on irreversible
morbidity or mortality or other clinical
benefit of the product fails to verify and
describe such effect or benefit;
``(iii) other evidence demonstrates that the
product is not shown to be safe or effective
under the conditions of use; or
``(iv) the sponsor disseminates false or
misleading promotional materials with respect
to the product.
``(B) Expedited procedures described.--Expedited
procedures described in this subparagraph shall consist
of, prior to the withdrawal of accelerated approval--
``(i) providing the sponsor with--
``(I) due notice;
``(II) an explanation for the
proposed withdrawal;
``(III) an opportunity for a meeting
with the Commissioner of Food and Drugs
or the Commissioner's designee; and
``(IV) an opportunity for written
appeal to--
``(aa) the Commissioner of
Food and Drugs; or
``(bb) a designee of the
Commissioner who has not
participated in the proposed
withdrawal of approval (other
than a meeting pursuant to
subclause (III)) and is not a
subordinate of an individual
(other than the Commissioner)
who participated in such
proposed withdrawal;
``(ii) providing an opportunity for public
comment on the notice proposing to withdraw
approval;
``(iii) the publication of a summary of the
public comments received, and the Secretary's
response to such comments, on the website of
the Food and Drug Administration; and
``(iv) convening and consulting an advisory
committee on issues related to the proposed
withdrawal, if requested by the sponsor and if
no such advisory committee has previously
advised the Secretary on such issues with
respect to the withdrawal of the product prior
to the sponsor's request.
``(4) Labeling.--
``(A) In general.--Subject to subparagraph (B), the
labeling for a product approved under accelerated
approval shall include--
``(i) a statement indicating that the product
was approved under accelerated approval;
``(ii) a statement indicating that continued
approval of the product is subject to
postmarketing studies to verify clinical
benefit;
``(iii) identification of the surrogate or
intermediate endpoint or endpoints that
supported approval and any known limitations of
such surrogate or intermediate endpoint or
endpoints in determining clinical benefit; and
``(iv) a succinct description of the product
and any uncertainty about anticipated clinical
benefit and a discussion of available evidence
with respect to such clinical benefit.
``(B) Applicability.--The labeling requirements of
subparagraph (A) shall apply only to products approved
under accelerated approval for which the predicted
effect on irreversible morbidity or mortality or other
clinical benefit has not been verified.
``(C) Rule of construction.--With respect to any
application pending before the Secretary on the date of
enactment of the Food and Drug Amendments of 2022, the
Secretary shall allow any applicable changes to the
product labeling required to comply with subparagraph
(A) to be made by supplement after the approval of such
application.
``(5) Reporting.--Not later than September 30, 2025, the
Secretary shall submit to the Committee on Energy and Commerce
of the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report
describing circumstances in which the Secretary considered real
world evidence submitted to support postapproval studies
required under this subsection that were completed after the
date of enactment of the Food and Drug Amendments of 2022.''.
(b) Reports of Postmarketing Studies.--Section 506B(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 356b(a)) is amended--
(1) by redesignating paragraph (2) as paragraph (3); and
(2) by inserting after paragraph (1) the following:
``(2) Accelerated approval.--Notwithstanding paragraph (1), a
sponsor of a drug approved under accelerated approval shall
submit to the Secretary a report of the progress of any study
required under section 506(c), including progress toward
enrollment targets, milestones, and other information as
required by the Secretary, not later than 180 days after the
approval of such drug and not less frequently than every 180
days thereafter, until the study is completed or terminated.''.
(c) Guidance.--
(1) In general.--The Secretary of Health and Human Services
shall issue guidance describing--
(A) how sponsor questions related to the
identification of novel surrogate or intermediate
clinical endpoints may be addressed in early-stage
development meetings with the Food and Drug
Administration;
(B) the use of novel clinical trial designs that may
be used to conduct appropriate postapproval studies as
may be required under section 506(c)(2)(A) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356(c)(2)(A)), as amended by subsection (a); and
(C) the expedited procedures described in section
506(c)(3)(B) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 356(c)(3)(B)).
(2) Final guidance.--The Secretary shall issue--
(A) draft guidance under paragraph (1) not later than
18 months after the date of enactment of this Act; and
(B) final guidance not later than 1 year after the
close of the public comment period on such draft
guidance.
(d) Rare Disease Endpoint Advancement Pilot.--
(1) In general.--The Secretary of Health and Human Services
shall establish a pilot program under which the Secretary will
establish procedures to provide increased interaction with
sponsors of rare disease drug development programs for purposes
of advancing the development of efficacy endpoints, including
surrogate and intermediate endpoints, for drugs intended to
treat rare diseases, including through--
(A) determining eligibility of participants for such
a program; and
(B) developing and implementing a process for
applying to, and participating in, such a program.
(2) Public workshops.--The Secretary shall conduct up to 3
public workshops, which shall be completed not later than
September 30, 2026, to discuss topics relevant to the
development of endpoints for rare diseases, which may include
discussions about--
(A) novel endpoints developed through the pilot
program established under this subsection; and
(B) as appropriate, the use of real world evidence
and real world data to support the validation of
efficacy endpoints, including surrogate and
intermediate endpoints, for rare diseases.
(3) Report.--Not later than September 30, 2027, the Secretary
shall submit to the Committee on Energy and Commerce of the
House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report
describing the outcomes of the pilot program established under
this subsection.
(4) Guidance.--Not later than September 30, 2027, the
Secretary shall issue guidance describing best practices and
strategies for development of efficacy endpoints, including
surrogate and intermediate endpoints, for rare diseases.
(5) Sunset.--The Secretary may not accept any new application
or request to participate in the program established by this
subsection on or after October 1, 2027.
SEC. 805. FACILITATING THE USE OF REAL WORLD EVIDENCE.
(a) Guidance.--Not later than 1 year after the date of the enactment
of this Act, the Secretary of Health and Human Services shall issue, or
revise existing, guidance on considerations for the use of real world
data and real world evidence to support regulatory decisionmaking, as
follows:
(1) With respect to drugs, such guidance shall address--
(A) the use of such data and evidence to support the
approval of a drug application under section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or
a biological product application under section 351 of
the Public Health Service Act (42 U.S.C. 262), or to
support an investigational use exemption under section
505(i) of the Federal Food, Drug, and Cosmetic Act or
section 351(a)(3) of the Public Health Service Act; and
(B) the use of such data and evidence obtained as a
result of the use of drugs authorized for emergency use
under section 564 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-3) in such applications,
submissions, or requests; and
(C) standards and methodologies which may be used for
collection and analysis of real world evidence included
in such applications, submissions, or requests, as
appropriate.
(2) With respect to devices, such guidance shall address--
(A) the use of such data and evidence to support the
approval, clearance, or classification of a device
pursuant to an application or submission submitted
under section 510(k), 513(f)(2), or 515 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360(k),
360c(f)(2), 360e), or to support an investigational use
exemption under section 520(g) of such Act (21 U.S.C.
360j(g));
(B) the use of such data and evidence obtained as a
result of the use of devices authorized for emergency
use under section 564 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-3), in such
applications, submissions, or requests; and
(C) standards and methodologies which may be used for
collection and analysis of real world evidence included
in such applications, submissions, or requests, as
appropriate.
(b) Report to Congress.--Not later than 2 years after the termination
of the public health emergency determination by the Secretary of Health
and Human Services under section 564 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-3) on February 4, 2020, with respect to
the Coronavirus Disease 2019 (COVID-19), the Secretary shall submit a
report to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor, and
Pensions of the Senate on--
(1) the number of applications, submissions, or requests
submitted for clearance or approval under section 505, 510(k),
513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355, 360(k), 360c(f)(2), 360e) or section 351 of the
Public Health Service Act, for which an authorization under
section 564 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-3) was previously granted;
(2) of the number of applications so submitted, the number of
such applications--
(A) for which real world evidence was submitted and
used to support a regulatory decision; and
(B) for which real world evidence was submitted and
determined to be insufficient to support a regulatory
decision; and
(3) a summary explanation of why, in the case of applications
described in paragraph (2)(B), real world evidence could not be
used to support regulatory decisions.
(c) Information Disclosure.--Nothing in this section shall be
construed to authorize the disclosure of information that is prohibited
from disclosure under section 1905 of title 18, United States Code, or
subject to withholding under subsection (b)(4) of section 552 of title
5, United States Code (commonly referred to as the ``Freedom of
Information Act'').
SEC. 806. DUAL SUBMISSION FOR CERTAIN DEVICES.
Section 513 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360c) is amended by adding at the end the following:
``(k) For a device authorized for emergency use under section 564 for
which, in accordance with section 564(m), the Secretary has deemed a
laboratory examination or procedure associated with such device to be
in the category of examinations and procedures described in section
353(d)(3) of the Public Health Service Act, the sponsor of such device
may, when submitting a request for classification under section
513(f)(2), submit a single submission containing--
``(1) the information needed for such a request; and
``(2) sufficient information to enable the Secretary to
determine whether such laboratory examination or procedure
satisfies the criteria to be categorized under section
353(d)(3) of the Public Health Service Act.''.
SEC. 807. MEDICAL DEVICES ADVISORY COMMITTEE MEETINGS.
(a) In General.--The Secretary shall convene one or more panels of
the Medical Devices Advisory Committee not less than once per year for
the purpose of providing advice to the Secretary on topics related to
medical devices used in pandemic preparedness and response, including
topics related to in vitro diagnostics.
(b) Required Panel Member.--A panel convened under subsection (a)
shall include at least 1 population health-specific representative.
(c) Sunset.--This section shall cease to be effective on October 1,
2027.
SEC. 808. ENSURING CYBERSECURITY OF MEDICAL DEVICES.
(a) In General.--Subchapter A of chapter V of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 351 et seq.), as amended by section 501, is
further amended by adding at the end the following:
``SEC. 524C. ENSURING CYBERSECURITY OF DEVICES.
``(a) In General.--For purposes of ensuring cybersecurity throughout
the lifecycle of a cyber device, any person who submits a premarket
submission for the cyber device shall include such information as the
Secretary may require to ensure that the cyber device meets such
cybersecurity requirements as the Secretary determines to be
appropriate to demonstrate a reasonable assurance of safety and
effectiveness, including at a minimum the cybersecurity requirements
under subsection (b).
``(b) Cybersecurity Requirements.--At a minimum, the manufacturer of
a cyber device shall meet the following cybersecurity requirements:
``(1) The manufacturer shall have a plan to appropriately
monitor, identify, and address in a reasonable time postmarket
cybersecurity vulnerabilities and exploits, including
coordinated vulnerability disclosure and procedures.
``(2) The manufacturer shall design, develop, and maintain
processes and procedures to ensure the device and related
systems are cybersecure, and shall make available updates and
patches to the cyber device and related systems throughout the
lifecycle of the cyber device to address--
``(A) on a reasonably justified regular cycle, known
unacceptable vulnerabilities; and
``(B) as soon as possible out of cycle, critical
vulnerabilities that could cause uncontrolled risks.
``(3) The manufacturer shall provide in the labeling of the
cyber device a software bill of materials, including
commercial, open-source, and off-the-shelf software components.
``(4) The manufacturer shall comply with such other
requirements as the Secretary may require to demonstrate
reasonable assurance of the safety and effectiveness of the
device for purposes of cybersecurity, which the Secretary may
require by an order published in the Federal Register.
``(c) Substantial Equivalence.--In making a determination of
substantial equivalence under section 513(i) for a cyber device, the
Secretary may--
``(1) find that cybersecurity information for the cyber
device described in the relevant premarket submission in the
cyber device's use environment is inadequate; and
``(2) issue a nonsubstantial equivalence determination based
on this finding.
``(d) Definition.--In this section:
``(1) Cyber device.--The term `cyber device' means a device
that--
``(A) includes software, including software as or in
a device;
``(B) has the ability to connect to the internet; or
``(C) contains any such technological characteristics
that could be vulnerable to cybersecurity threats.
``(2) Lifecycle of the cyber device.--The term `lifecycle of
the cyber device' includes the postmarket lifecycle of the
cyber device.
``(3) Premarket submission.--The term `premarket submission'
means any submission under section 510(k), 513, 515(c), 515(f),
or 520(m).
``(e) Exemption.--The Secretary may identify devices or types of
devices that are exempt from meeting the cybersecurity requirements
established by this section and regulations promulgated pursuant to
this section. The Secretary shall publish in the Federal Register, and
update, as appropriate, a list of the devices and types of devices so
identified by the Secretary.''.
(b) Prohibited Act.--Section 301(q) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(q)) is amended by adding at the end the
following:
``(3) The failure to comply with any requirement under section 524C
(relating to ensuring device cybersecurity).''.
(c) Adulteration.--Section 501 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351) is amended by inserting after paragraph
(j) the following:
``(k) If it is a device subject to the requirements set forth in
section 524C (relating to ensuring device cybersecurity) and fails to
comply with any requirement under that section.''.
(d) Misbranding.--Section 502(t) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 352(t)) is amended--
(1) by striking ``or (3)'' and inserting ``(3)''; and
(2) by inserting before the period at the end the following:
``, or (4) to furnish a software bill of materials as required
under section 524C (relating to ensuring device
cybersecurity)''.
SEC. 809. PUBLIC DOCKET ON PROPOSED CHANGES TO THIRD-PARTY VENDORS.
(a) In General.--
(1) Opening public docket.--Not later than 90 days after the
date of enactment of this Act, the Secretary of Health and
Human Services shall open a single public docket to solicit
comments on factors that generally should be considered by the
Secretary when reviewing requests from sponsors of drugs
subject to risk evaluation and mitigation strategies to change
third-party vendors engaged by sponsors to aid in
implementation and management of the strategies.
(2) Factors.--Such factors include the potential effects of
changes in third-party vendors on--
(A) patient access; and
(B) prescribing and administration of the drugs by
health care providers.
(3) Closing public docket.--The Secretary of Health and Human
Services may close such public docket not earlier than 90 days
after such docket is opened.
(4) No delay.--Nothing in this section shall delay agency
action on any modification to a risk evaluation and mitigation
strategy.
(b) GAO Report.--Not later than December 31, 2026, the Comptroller
General of the United States shall submit to the Committee on Energy
and Commerce of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate a report on--
(1) the number of changes in third-party vendors (engaged by
sponsors to aid implementation and management of risk
evaluation and mitigation strategies) for an approved risk
evaluation and mitigation strategy the Secretary of Health and
Human Services has approved under section 505-1(h) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(h));
(2) any issues affecting patient access to the drug that is
subject to the strategy or considerations with respect to the
administration or prescribing of such drug by health care
providers that arose as a result of such modifications; and
(3) how such issues were resolved, as applicable.
SEC. 810. FACILITATING EXCHANGE OF PRODUCT INFORMATION PRIOR TO
APPROVAL.
(a) In General.--Section 502 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 352) is amended--
(1) in paragraph (a)--
(A) by striking ``drugs for coverage'' and inserting
``drugs or devices for coverage''; and
(B) by striking ``drug'' each place it appears and
inserting ``drug or device'', respectively;
(2) in paragraphs (a)(1) and (a)(2)(B), by striking ``under
section 505 or under section 351 of the Public Health Service
Act'' and inserting ``under section 505, 510(k), 513(f)(2), or
515 of this Act or section 351 of the Public Health Service
Act'';
(3) in paragraph (a)(1)--
(A) by striking ``under section 505 or under section
351(a) of the Public Health Service Act'' and inserting
``under section 505, 510(k), 513(f)(2), or 515 of this
Act or section 351 of the Public Health Service Act'';
and
(B) by striking ``in section 505(a) or in subsections
(a) and (k) of section 351 of the Public Health Service
Act'' and inserting ``in section 505, 510(k),
513(f)(2), or 515 of this Act or section 351 of the
Public Health Service Act''; and
(4) by adding at the end the following:
``(gg)(1) Unless its labeling bears adequate directions for use in
accordance with paragraph (f), except that (in addition to drugs or
devices that conform with exemptions pursuant to such paragraph) no
drug or device shall be deemed to be misbranded under such paragraph
through the provision of product information to a payor, formulary
committee, or other similar entity with knowledge and expertise in the
area of health care economic analysis carrying out its responsibilities
for the selection of drugs or devices for coverage or reimbursement if
the product information relates to an investigational drug or device or
investigational use of a drug or device that is approved, cleared,
granted marketing authorization, or licensed under section 505, 510(k),
513(f)(2), or 515 of this Act or section 351 of the Public Health
Service Act (as applicable), provided--
``(A) the product information includes--
``(i) a clear statement that the investigational drug
or device or investigational use of a drug or device
has not been approved, cleared, granted marketing
authorization, or licensed under section 505, 510(k),
513(f)(2), or 515 of this Act or section 351 of the
Public Health Service Act (as applicable) and that the
safety and effectiveness of the drug or device or use
has not been established;
``(ii) information related to the stage of
development of the drug or device involved, such as--
``(I) the status of any study or studies in
which the investigational drug or device or
investigational use is being investigated;
``(II) how the study or studies relate to the
overall plan for the development of the drug or
device; and
``(III) whether an application, premarket
notification, or request for classification for
the investigational drug or device or
investigational use has been submitted to the
Secretary and when such a submission is
planned;
``(iii) in the case of information that includes
factual presentations of results from studies, which
shall not be selectively presented, a description of--
``(I) all material aspects of study design,
methodology, and results; and
``(II) all material limitations related to
the study design, methodology, and results;
``(iv) where applicable, a prominent statement
disclosing the indication or indications for which the
Secretary has approved, granted marketing
authorization, cleared, or licensed the product
pursuant to section 505, 510(k), 513(f)(2), or 515 of
this Act or section 351 of the Public Health Service
Act, and a copy of the most current required labeling;
and
``(v) updated information, if previously communicated
information becomes materially outdated as a result of
significant changes or as a result of new information
regarding the product or its review status; and
``(B) the product information does not include--
``(i) information that represents that an unapproved
product--
``(I) has been approved, cleared, granted
marketing authorization, or licensed under
section 505, 510(k), 513(f)(2), or 515 of this
Act or section 351 of the Public Health Service
Act (as applicable); or
``(II) has otherwise been determined to be
safe or effective for the purpose or purposes
for which the drug or device is being studied;
or
``(ii) information that represents that an unapproved
use of a drug or device that has been so approved,
granted marketing authorization, cleared, or licensed--
``(I) is so approved, granted marketing
authorization, cleared, or licensed; or
``(II) that the product is safe or effective
for the use or uses for which the drug or
device is being studied.
``(2) For purposes of this paragraph, the term `product information'
includes--
``(A) information describing the drug or device (such as drug
class, device description, and features);
``(B) information about the indication or indications being
investigated;
``(C) the anticipated timeline for a possible approval,
clearance, marketing authorization, or licensure pursuant to
section 505, 510(k), 513, or 515 of this Act or section 351 of
the Public Health Service Act;
``(D) drug or device pricing information;
``(E) patient utilization projections;
``(F) product-related programs or services; and
``(G) factual presentations of results from studies that do
not characterize or make conclusions regarding safety or
efficacy.''.
(b) GAO Study and Report.--Beginning on the date that is 5 years and
6 months after the date of enactment of this Act, the Comptroller
General of the United States shall conduct a study on the provision and
use of information pursuant to section 502(gg) of the Federal Food,
Drug, and Cosmetic Act, as added by this subsection (a), between
manufacturers of drugs and devices (as defined in section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)) and entities
described in such section 502(gg). Such study shall include an analysis
of the following:
(1) The types of information communicated between such
manufacturers and payors.
(2) The manner of communication between such manufacturers
and payors.
(3)(A) Whether such manufacturers file an application for
approval, marketing authorization, clearance, or licensing of a
new drug or device or the new use of a drug or device that is
the subject of communication between such manufacturers and
payors under section 502(gg) of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a).
(B) How frequently the Food and Drug Administration approves,
grants marketing authorization, clears, or licenses the new
drug or device or new use.
(C) The timeframe between the initial communications
permitted under section 502(gg) of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), regarding an
investigational drug or device or investigational use, and the
initial marketing of such drug or device.
SEC. 811. BANS OF DEVICES FOR ONE OR MORE INTENDED USES.
(a) In General.--Section 516(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360f(a)) is amended--
(1) in paragraph (1), by inserting ``for one or more intended
use'' before the semicolon at the end; and
(2) in the matter following paragraph (2), by inserting ``for
any such intended use or uses. A device that is banned for one
or more intended uses is not a legally marketed device under
section 1006 when intended for such use or uses'' after
``banned device''.
(b) Specific Devices Deemed Banned.--Section 516 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360f) is further amended by adding at
the end the following:
``(c) Specific Device Banned.--Electrical stimulation devices that
apply a noxious electrical stimulus to a person's skin intended to
reduce or cease self-injurious behavior or aggressive behavior are
deemed to be banned devices, as described in subsection (a).
``(d) Reversal by Regulation.--Devices banned under this section are
banned devices unless or until the Secretary promulgates a regulation
to make such devices or use of such devices no longer banned based on a
finding that such devices or use of such devices does not present
substantial deception or an unreasonable and substantial risk of
illness or injury, or that such risk can be corrected or eliminated by
labeling.''.
SEC. 812. CLARIFYING APPLICATION OF EXCLUSIVE APPROVAL, CERTIFICATION,
OR LICENSURE FOR DRUGS DESIGNATED FOR RARE DISEASES
OR CONDITIONS.
(a) Application of Exclusive Approval, Certification, or Licensure
for Drugs Designated for Rare Diseases or Conditions.--Section 527 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended--
(1) in subsection (a), in the matter following paragraph (2),
by striking ``same disease or condition'' and inserting ``same
approved indication or use within such rare disease or
condition'';
(2) in subsection (b)--
(A) in the matter preceding paragraph (1), by
striking ``same rare disease or condition'' and
inserting ``same indication or use for which the
Secretary has approved or licensed such drug''; and
(B) in paragraph (1), by striking ``with the disease
or condition for which the drug was designated'' and
inserting ``for whom the drug is indicated''; and
(3) in subsection (c), by striking ``same rare disease or
condition'' and inserting ``same indication or use''.
(b) Application of Amendments.--The amendments made by subsection (a)
shall apply with respect to any drug designated under section 526 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), regardless
of the date on which the drug was so designated, and regardless of the
date on which the drug was approved under section 505 of such Act (21
U.S.C. 355) or licensed under section 351 of the Public Health Service
Act (42 U.S.C. 262).
SEC. 813. GAO REPORT ON THIRD-PARTY REVIEW.
Not later than September 30, 2026, the Comptroller General of the
United States shall submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate a report on the third-party review
program described in section 523 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360m). Such report shall include--
(1) a description of the financial and staffing resources
used to carry out such program;
(2) a description of actions taken by the Secretary pursuant
section 523(b)(2)(C) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360m(b)(2)(C)); and
(3) the results of an audit of the performance of select
persons accredited under such program.
SEC. 814. REPORTING ON PENDING GENERIC DRUG APPLICATIONS AND PRIORITY
REVIEW APPLICATIONS.
Section 807 of the FDA Reauthorization Act of 2017 (Public Law 115-
52) is amended, in the matter preceding paragraph (1), by striking
``2022'' and inserting ``2027''.
SEC. 815. FDA WORKFORCE IMPROVEMENTS.
Section 714A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379d-3a) is amended--
(1) in subsection (a), by striking ``medical products'' and
inserting ``products regulated by the Food and Drug
Administration''; and
(2) by striking subsection (d) and inserting the following:
``(d) Agency-wide Strategic Workforce Plan.--
``(1) In general.--Not later than 1 year after the date of
enactment of the Food and Drug Amendments of 2022, the
Commissioner of Food and Drugs shall develop and begin
implementation of an agency-wide strategic workforce plan at
the Food and Drug Administration, which shall include--
``(A) agency-wide human capital goals and strategies;
``(B) performance measures, benchmarks, or other
elements to facilitate the monitoring and evaluation of
the progress made toward such goals and the
effectiveness of such strategies; and
``(C) a process for updating such plan based on
timely and relevant information on an ongoing basis.
``(2) Report to congress.--Not later than 18 months after the
date of enactment of the Food and Drug Amendments of 2022, the
Secretary shall submit to the Committee on Energy and Commerce
of the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report
describing the plan under paragraph (1) and the status of its
implementation.''.
I. Purpose and Summary
H.R. 7667, the ``Food and Drug Amendments of 2022,''
enables Food and Drug Administration (FDA) to continue to
collect user fees from regulated industry to supplement
Congressional appropriations for the premarket review and
regulation of medical products. Specifically, the bill revises
and reauthorizes provisions of the Prescription Drug User Fee
Act (PDUFA), the Medical Device User Fee Amendments (MDUFA),
the Generic Drug User Fee Amendments (GDUFA), and the
Biosimilars User Fee Act (BsUFA) through 2027. The legislation
also includes various provisions that will promote clinical
trial diversity, encourage increased generic drug competition,
preserve existing incentives for orphan drug development,
facilitate a more resilient supply chain, and improve the
review and regulation of medical products and the inspections
of facilities that manufacture them.
II. Background and Need for Legislation
A. User Fees
Since 1992, pursuant to PDUFA, Congress has authorized FDA
to collect fees from regulated industry to supplement
Congressional appropriations. Revenues generated from these
fees have been used on specific activities related to the
review and regulation of medical products. FDA also commits to
meeting certain performance goals, such as completing product
reviews within specified timeframes. FDA's ability to collect
such fees must be reauthorized every five years following a
process laid out in statute that involves negotiations between
the agency and regulated industry and recommendations provided
to Congress. The reauthorization process allows for input by
other interested stakeholders, including patient and consumer
groups, and provides opportunity for broader public comment.
Based in large part on the positive impact PDUFA had on
expediting new drug product review times and improving related
regulatory activities at FDA, Congress authorized FDA to
collect medical device user fees in 2002 as part of the Medical
Device User Fee and Modernization Act.\1\ MDUFA user fees were
reauthorized in 2007, 2012, and 2017, along with PDUFA.
---------------------------------------------------------------------------
\1\Pub. L. No. 107-250 (2002).
---------------------------------------------------------------------------
Due to growing concerns from a wide range of stakeholders
about the time it was taking FDA to review generic drug
applications and the backlog of such applications pending at
the agency, Congress passed the Generic Drug User Fee
Amendments (GDUFA) in 2012 as part of the Food and Drug
Administration Safety and Innovation Act (FDASIA).\2\ Congress
reauthorized GDUFA user fees in 2017.
---------------------------------------------------------------------------
\2\Pub. L. No. 112-114 (2012).
---------------------------------------------------------------------------
As part of FDASIA, Congress also passed BsUFA in 2012 to
authorize FDA to collect user fees from biosimilar product
manufacturers. Congress reauthorized BsUFA in 2017.
Each of these four user fee programs is due to expire at
the end of this fiscal year and must be reauthorized if FDA is
to continue collecting fees to support review programs and
other functions of the agency. H.R. 7667 would reauthorize all
four user fee programs through 2027. The Committee also
considered additional policies that would improve the
regulation of certain medical products, a number of which are
also included in the bill.
B. Improvements Across Product Areas
1. Clinical Study Diversity
Clinical studies--studies in human subjects--are
fundamental to assessing whether medical products are safe and
effective for a particular use and patient population.\3\ FDA
relies on these studies to assess whether medical products meet
applicable premarket review standards, which determines whether
they may be marketed, as well as what uses and patient
populations they may be approved for, what labeling, including
warnings and contraindications is required, and whether
additional post-market studies are warranted, among other
considerations. These studies also inform physician decisions
regarding diagnosis and treatment, and providers and patients
rely on FDA's premarket review and labeling determinations in
their medical decision-making.
---------------------------------------------------------------------------
\3\U.S. Food and Drug Administration, Step 3: Clinical Research
(www.fda.gov/patients/drug-development-process/step-3-clinical-
research) (Jan. 4, 2018).
---------------------------------------------------------------------------
Neither diseases nor medical products affect everyone the
same way. Certain demographic groups are at higher risk of
developing certain illnesses or conditions than others; a
product that poses little risk or is highly effective in some
demographic groups may pose serious risks or provide little
benefit to others.\4\ Non-demographic factors such as co-
morbidities can also affect outcomes. Inclusion of diverse,
representative populations in clinical studies can enable
identification of these differences in risk and benefit across
subgroups before a product comes to market,\5\ which in turn
can improve both regulatory and medical decision-making. It is
thus critical that the participants that sponsors and
investigators enroll in a clinical study are reflective of the
patient population expected to use the medical product, both as
a matter of health equity and as a matter of good science and
medicine.\6\
---------------------------------------------------------------------------
\4\House Committee on Energy and Commerce, Subcommittee on Health,
Testimony of Dr. Ruben Mesa, Executive Director, Mays Cancer Center at
UT Health San Antonio MD Anderson, Hearing on The Future of Medicine:
Legislation to Encourage Innovation and Improve Oversight, 117th Cong.
(Mar. 17, 2022) (energycommerce.house.gov/sites/
democrats.energycommerce
.house.gov/files/documents/Witness%20Testimony_Mesa_HE_2022.03.17.pdf).
\5\Food and Drug Administration, Draft Guidance, Diversity Plans to
Improve Enrollment of Participants from Underrepresented Racial and
Ethnic Populations in Clinical Trials (April 2022) (www.fda.gov/
regulatory-information/search-fda-guidance-documents/diversity-plans-
improve-enrollment-participants-underrepresented-racial-and-ethnic-
populations).
\6\See note 4; National Academies of Sciences, Engineering, and
Medicine, Improving Representation in Clinical Trials and Research:
Building Research Equity for Women and Underrepresented Groups (2022)
(nap.nationalacademies.org/download/26479).
---------------------------------------------------------------------------
At present, clinical studies often lack adequate diversity.
Individuals from Black or African American, Hispanic/Latino,
Indigenous and Native American, Asian, Native Hawaiian and
other Pacific Islander populations and other persons of color
``are frequently underrepresented in biomedical research
despite having a disproportionate disease burden for certain
diseases relative to their proportional representation in the
general population.''\7\ For example, in an FDA analysis of
nearly 300,000 people who participated in clinical studies
between 2015 and 2019, only seven percent identified as African
American and only 13 percent identified as Hispanic or
Latino,\8\ despite these groups making up 13.4 percent and 18.5
percent of the United States population, respectively.\9\ There
are various reasons for this lack of adequate representation.
On the sponsor side, there may be challenges to including
subpopulations where expanding enrollment may require
additional time or resources.\10\ On the participant side,
barriers include lack of awareness of open studies, mistrust of
research, financial and language barriers, and lack of
diversity among those conducting the studies.\11\
---------------------------------------------------------------------------
\7\See note 4.
\8\Food and Drug Administration, 2015-2019 Drug Trials Snapshots
Summary Report (www.fda.gov/media/143592/download).
\9\Census Bureau, QuickFacts (www.census.gov/quickfacts/fact/table/
US/PST045221) (accessed May 24, 2022).
\10\See note 6 at 134-35.
\11\See note 4.
---------------------------------------------------------------------------
Title V of H.R. 7667 addresses both sides of this problem.
Under section 501, the legislation requires sponsors of phase 3
or other pivotal studies of drugs and biological products, and
sponsors of clinical studies of devices, to develop, implement,
and submit to FDA diversity action plans that include the
sponsor's goals for study enrollment, a rationale for such
goals, and an explanation of how these goals will be met.
Section 501 also requires FDA to update its guidance to address
sponsor diversity goals, disaggregated by age group, sex, race,
geographic location, socioeconomic status, and ethnicity, and
how sponsors will publicly post key information from their
plans on their website. Building on some of the experience
gained during the current coronavirus disease 2019 (COVID-19)
pandemic, the legislation also requires guidance addressing
decentralized study enrollment, including the engagement,
enrollment, and retention of a meaningfully diverse study
population and recommendations for sponsors to reduce burdens
for participants through digital health technology, telehealth,
local providers and laboratories, or other means.
To further advance the goal of robust diverse
participation, the legislation requires FDA to further study
and discuss these issues. Section 502 requires FDA to evaluate
whether there is a need for additional authorities to assure
that sponsors conduct post-approval studies or postmarket
surveillance in certain circumstances where premarket studies
collect insufficient data for underrepresented subgroups.
Section 503 requires public workshops to discuss how study
enrollment of historically underrepresented populations may be
increased and how participation reflective of the prevalence of
a disease among subgroups may be encouraged, the creation of a
docket for public comment regarding such information, and the
publication of an FDA report on such workshops on its website.
Section 504 requires an annual report from FDA to Congress
summarizing the diversity action plans received, whether goals
were met, and the reasons given why any goals were not met. The
report also must include any postmarket studies required or
recommended by FDA based on its existing authority and the
premarket study lacked adequate diversity. Section 505 requires
a public meeting regarding the clinical study flexibilities
initiated in response to the COVID-19 pandemic, including how
such flexibilities, such as those relating to study
decentralization, may have affected access to studies by
unrepresented or underrepresented populations, including racial
and ethnic minorities, and how they may help improve clinical
study access and diverse enrollment in the future. Finally,
Section 506 requires FDA to issue guidance recommending how
digital health technology or other remote assessment options
could support decentralized clinical studies, as well as
considerations for sponsors to minimize or reduce burdens for
clinical study participants, thus encouraging the retention of
a meaningfully diverse clinical population.
2. Inspections
The COVID-19 pandemic and an increasing reliance on drugs
manufactured overseas has illustrated the need for updates and
clarification with respect to FDA's inspectional authorities
for medical products, in particular with respect to certain
aspects of foreign inspections, bioresearch monitoring
inspections, and inspections of records both in-person and
remotely.
Concerns have been raised in recent years regarding FDA's
inspections of foreign medical product facilities, including
with respect to its practice of preannouncing most of these
inspections. For example, in 2019 the Government Accountability
Office (GAO) reported:
FDA investigators identified persistent challenges
conducting foreign inspections, raising questions about
the equivalence of foreign to domestic inspections. For
example, while domestic inspections are almost always
unannounced, FDA's practice of preannouncing foreign
inspections up to 12 weeks in advance may give
manufacturers the opportunity to fix problems [before
the investigator arrives]. Investigators from FDA's
China and India offices do conduct some unannounced
inspections, but they are involved in a small
percentage of inspections in these countries (27
percent and 10 percent, respectively).\12\
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\12\House Committee on Energy and Commerce, Subcommittee on
Oversight and Investigations, Testimony of Mary Denigan-Macauley,
Director, U.S. Government Accountability Office, Hearing on Securing
the U.S. Drug Supply Chain: Oversight of FDA's Foreign Inspection
Program, Preliminary Findings Indicate Persistent Challenges with FDA
Foreign Inspections, 116th Cong. (Dec. 10, 2019) (www.gao.gov/assets/
gao-20-262t.pdf).
On the other hand, FDA investigators reported some benefits
to preannouncing foreign inspections, including avoiding
wasting agency resources, better preparation of establishment
records and staff, and ensuring the safety of investigators in
the foreign country,\13\ which has become more of a concern
during the COVID-19 public health emergency. FDA also reported
a lack of data that would enable it to assess the relative
merits of unannounced and preannounced inspections.\14\ GAO
more recently reported that FDA plans to implement two pilot
programs to help address challenges related to preannounced
inspections and language barriers, which will include gathering
data that can be used to evaluate differences between announced
and unannounced inspections.\15\ However, FDA has not yet
finalized the design of these pilots due to the COVID-19
pandemic.\16\
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\13\Id.
\14\Id.
\15\Government Accountability Office, GAO-22-103611, Drug Safety:
FDA Should Take Additional Steps to Improve its Foreign Inspection
Program (Jan. 2022) (www.gao.gov/assets/gao-22-103611.pdf).
\16\Id.
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H.R. 7667 addresses these issues in several ways. Section
725 requires FDA to initiate a pilot program within 180 days of
enactment in which FDA increases the conduct of unannounced
surveillance inspections of foreign drug establishments,
evaluates the differences between such inspections of domestic
and foreign establishments, including the impact of announcing
inspections, and posts a report of its findings and
recommendations on the FDA website. Section 721 requires FDA to
review its processes and practices applicable to bioresearch
monitoring inspections in the United States and in foreign
countries, evaluate whether updates are needed to facilitate
consistency, and issue guidance describing the conduct of such
inspections. Section 723 provides for FDA consideration of the
compliance history of other FDA-regulated establishments in the
country or region in which an establishment is located as a
factor in establishing a schedule for risk-based inspections
and requires a periodic assessment of whether additional
arrangements with foreign governments pertaining to recognition
of foreign government inspections of foreign establishments are
appropriate. Currently, FDA has these arrangements in place
with the European Union and the United Kingdom; however, the
agency's inspection capabilities may benefit from assessing
whether additional arrangements with countries with robust
regulatory systems and drug safety protocols, such as Israel,
Japan, or others, are appropriate, taking into account public
health and safety, and any differences with regard to how these
systems operate. Section 728 requires FDA to annually publish
on its website a report on the utilization of these and other
agreements entered into with foreign governments with review
criteria analogous to those of FDA.
Building on the lessons learned during the COVID-19
pandemic, which has made in-person inspections more difficult,
section 721 clarifies that FDA's authority to inspect records,
among other things, applies not only to restricted devices but
to all devices, and that FDA's authority to require records in
advance or in lieu of an inspection applies not only to drugs
but devices as well. Section 721 also codifies and clarifies
FDA authority to inspect clinical study sites, also known as
bioresearch monitoring inspections, including with respect to
records. Section 723 clarifies that FDA may rely on any records
or other information inspected to satisfy requirements that may
pertain to a preapproval or risk-based surveillance inspection,
or to resolve deficiencies found in such inspections, if
applicable and appropriate. Finally, section 727 requires FDA
to ensure timely and effective internal coordination and
alignment among field investigators and staff regarding the
reviews of inspection reports and any feedback or corrective
actions in response to such reports and requires FDA reporting
to Congress regarding such coordination and feedback and
regarding certain drug shortage reports.
3. Appropriate and Consistent Regulation of Certain
Products as Drugs
FDA has consistently regulated contrast agents as drugs for
decades. However, a 2021 decision by the Court of Appeals for
the District of Columbia Circuit created uncertainty as to
whether these products, as well as certain therapeutic
radioactive products and certain products that have been
regulated under over-the-counter drug monographs, could be
regulated by FDA as drugs or medical devices.\17\ Devices have
different standards for premarket review and different
regulatory requirements from drugs. Without a legislative
remedy, sponsors of contrast agents and certain other products
who went through the drug approval process may be unnecessarily
subject to new regulatory regimes.
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\17\Genus Med. Techs., LLC v. FDA, 994 F.3d 631 (D.C. Cir. 2021).
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This court-mandated change raises concerns about fairness
and potential negative consequences for patients. The
uncertainty and determinations regarding which products may
transition, the timing and process by which they would
transition, and how they would be regulated as devices would
impose additional costs on sponsors and the agency. Section 803
of H.R. 7667 addresses these concerns by preserving the
longstanding status quo of regulation of these products as
drugs, as they have been regulated for decades.
4. Real World Evidence
Real-world evidence (RWE) has been playing an increasing
role in health care and regulatory decision-making in recent
years, for example with respect to clinical practice
guidelines, improving clinical study designs, and postmarket
safety monitoring.\18\ While RWE holds great promise for
further advancing the study, regulation, and use of medical
products, further understanding and development of RWE and RWE
generation practices is needed. At least one example in which
RWE played a significant role in premarket drug review, for a
product used in combination with other immunosuppressant drugs
to prevent organ rejection in lung transplant recipients,
illustrates this point.\19\ First, while FDA relied on RWE in
its approval of a new indication for Prograf (tacrolimus), it
has not yet approved a new molecular entity primarily relying
on RWE; second, the observed clinical benefit was so large that
it was highly unlikely that the outcomes could be explained by
bias; and third, in addition to RWE, the approval was also
supported by randomized controlled trials of the drug in other
settings, which provided confirmatory evidence of
effectiveness, and additional clinical trial evidence from
research publications, which supported the independent
contribution of the drug as part of a multidrug regimen.\20\
---------------------------------------------------------------------------
\18\Food and Drug Administration, Real-World Evidence (www.fda.gov/
science-research/science-and-research-special-topics/real-world-
evidence) (accessed May 24, 2022).
\19\Food and Drug Administration, FDA Approval Demonstrates the
Role of Real-World Evidence in Regulatory Decision-Making on Drug
Effectiveness (Aug. 4, 2021) (www.fda.gov/drugs/news-events-human-
drugs/fda-approval-demonstrates-role-real-world-evidence-regulatory-
decision-making-drug-effectiveness).
\20\Id.
---------------------------------------------------------------------------
There is hope that RWE will not only reduce medical product
development costs, speed patient access, and lower prices, but
also provide greater confidence in their safety and
effectiveness. Thus, it is important to advance the
development, study, and regulatory application of RWE, while
being careful to recognize that at the present time
``randomized and other types of clinical trials are still
generally the most reliable way to assess the potential
effectiveness of a drug and these trials will remain a critical
part of the drug development process.''\21\
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\21\Id.
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Section 805 of H.R. 7667 aims to improve the understanding
of the potential uses and limitations of RWE in the premarket
review of medical products by requiring FDA to issue guidance
addressing the use of RWE, including that obtained through
COVID-19 emergency use authorizations, to support drug and
device approvals and clearances. This section also advances
this goal by requiring FDA to report to Congress regarding the
number of applications including RWE submitted for products for
which an emergency use authorization was granted and whether
such evidence was sufficient to support a regulatory decision.
Additionally, section 804 clarifies that RWE may augment or
support appropriate postapproval studies required by FDA,
including such conditions as the Secretary may require, to
verify clinical benefit for drugs approved through accelerated
approval.
5. Pre-Approval Information Exchange
Information about a drug or device being studied in
clinical investigations can be used to inform payors, formulary
committees, and other entities responsible for the selection of
drugs or devices for coverage or reimbursement as they plan for
and make coverage and reimbursement decisions. In its guidance
on these communications, FDA has explained that the important
impact these decisions have for many patients renders it
critical that the information drug and device sponsors provide
to payors about their products be truthful and not misleading,
and that appropriate background and context be provided so that
this sophisticated audience will understand its limitations and
be able to make informed decisions.\22\
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\22\Food and Drug Administration, Drug and Device Manufacturer
Communications with Payors, Formulary Committees, and Similar Entities,
Questions and Answers (final guidance) (June 2018) (www.fda.gov/media/
133620/download).
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In the interest of facilitating the provision of this
information to these specific audiences and ensuring its
accuracy and comprehensiveness, section 810 of H.R. 7667
essentially codifies FDA's guidance on preapproval information
exchange.\23\ Section 810 of H.R. 7667 amends section 502 of
the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C.
Sec. 352) to clarify that no drug or device shall be misbranded
as a result of providing information regarding investigational
drugs or devices or uses to payors, formulary committees, or
other similar entities under specified conditions. It requires
the information to include a clear statement that the drug or
device discussed has not been approved, and that the safety and
efficacy of the drug or device has not been established.
Additional required disclosures to help ensure the information
is not misleading include information about the studies the
product is undergoing, whether an application for the drug or
device has been submitted to FDA, and if not, when such
submission is planned.
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\23\Id.
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6. Hiring
FDA needs to be able to hire and retain a highly-skilled
workforce with various types of specialized expertise in order
to successfully carry out its mission to promote the public
health by promptly and efficiently reviewing clinical research
and taking appropriate action on the marketing of regulated
products in a timely manner; and to protect the public health
by ensuring that foods are safe, wholesome, sanitary, and
properly labeled; human and veterinary drugs are safe and
effective; there is reasonable assurance of the safety and
effectiveness of devices intended for human use; cosmetics are
safe and properly labeled; and public health and safety are
protected from electronic product radiation.\24\ As the science
behind the products FDA regulates becomes more complex and
specialized, so too must the skills and expertise of its
staff.\25\
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\24\Section 1003(b) of the FFDCA (21 U.S.C. Sec. 393(b)).
\25\Food and Drug Administration, 21st Century Cures Workforce
Planning Report to Congress (June 2018) (www.fda.gov/media/114163/
download).
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To advance this end with respect to the development,
review, and regulation of medical products, in 2016 Congress
provided FDA specific hiring authority in the 21st Century
Cures Act, which added section 714A to the FFDCA (21 U.S.C.
Sec. 379d-3a).\26\ This authority has enabled FDA to simplify
and expedite the hiring process for certain scientific,
technical, and professional positions and set higher rates of
pay for these positions to enable it to better compete with the
private sector in the recruitment and retention of outstanding,
highly qualified candidates.\27\
---------------------------------------------------------------------------
\26\Pub. L. No. 114-255 (2016).
\27\See note 25.
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FDA's need for highly skilled employees with specialized
expertise is not limited to its regulation of human drugs,
biological products, and devices. The successful regulation of
food, veterinary medicine, tobacco, cosmetics, and electronic
products also demands the hiring and retention of such highly
qualified and trained individuals. Section 815 of H.R. 7667
accomplishes this goal by extending the hiring and pay
authority Congress granted to FDA in 2016 to the hiring of
outstanding candidates for scientific, technical, or
professional positions across the entire agency. This section
also provides accountability by requiring FDA to develop and
implement a strategic workforce plan, as recommended by GAO,
and report to Congress regarding such implementation.
C. Improvements to Drug Regulation
1. Accelerated Approval Integrity
Initiated by FDA through regulation in 1992 in response to
the HIV/AIDS crisis and codified in section 506(c) of the FFDCA
(21 U.S.C. Sec. 356(c)) by Congress in 2012, the accelerated
approval premarket review pathway for new drugs has expedited
the approvals of hundreds of drugs and biologics in several
disease areas, most of which have been for oncology and
hematology indications; as a result, patients with no
alternative options have had access to life-extending
treatments for cancer and other serious diseases years earlier
than they would have had without accelerated approval.\28\
Drugs approved via accelerated approval must meet the same
``safe and effective'' review standard as other drugs,
including substantial evidence of effectiveness, but rather
than having to prove clinical benefit in the same way as drugs
reviewed under the traditional pathway, sponsors of drugs
reviewed under accelerated approval can demonstrate effect on a
surrogate or intermediate endpoint reasonably likely to predict
clinical benefit. This enables shorter studies and earlier
approvals, but this greater uncertainty regarding benefit to
patients requires postapproval studies to confirm such benefit.
If a sponsor fails to conduct such a required study with due
diligence, such a study fails to verify benefit, or if the drug
is otherwise not shown to be safe and effective, FDA may
withdraw approval. If a sponsor fails to complete such a
postapproval study, this violates section 505(p) of the FFDCA
(21 U.S.C. Sec. 355(p)) and distribution of the drug in
interstate commerce is prohibited.
---------------------------------------------------------------------------
\28\Julia A. Beaver, et al., A 25-Year Experience of US Food and
Drug Administration Accelerated Approval of Malignant Hematology and
Oncology Drugs and Biologics: A Review, JAMA Oncology (June 1, 2018);
Food and Drug Administration, Project Confirm, Promoting the
transparency of Accelerated Approval for oncology indications
(www.fda.gov/about-fda/oncology-center-excellence/project-confirm).
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While many in the patient community, among others, have
touted the success of this program,\29\ others, including some
patient and provider groups, have criticized various aspects of
it, such as the uncertainty of clinical benefit; delays in
postapproval study initiation, conduct, and completion;
inadequacy of postapproval study design; inadequacy of
postapproval study reporting and transparency; inadequacy of
labeling information for providers and patients; and the fact
that FDA has not withdrawn approvals for a number of drugs
where confirmatory studies failed to verify benefit, which some
argue is due to a cumbersome and time-consuming process.\30\
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\29\House Committee on Energy and Commerce, Subcommittee on Health,
Testimony of Jeff Allen, Ph.D., President and CEO, Friends of Cancer
Research, Hearing on The Future of Medicine: Legislation to Encourage
Innovation and Improve Oversight, 117th Cong. (March 17, 2022)
(energycommerce.house.gov/sites/democrats.energycommerce.house.gov/
files/documents/Witness%20Testimony_Allen_HE_2022.03.17.pdf).
\30\See Bishal Gyawali, M.D., Ph.D., et al., Assessment of the
Clinical Benefit of Cancer Drugs Receiving Accelerated Approval, JAMA
Internal Medicine (May 28, 2019) (jamanetwork.com/journals/
jamainternalmedicine/fullarticle/2733561); House Committee on Energy
and Commerce, Subcommittee on Health, Testimony of Reshma Ramachandran,
M.D., M.P.P., Yale School of Medicine, Hearing on The Future of
Medicine: Legislation to Encourage Innovation and Improve Oversight,
117th Cong. (March 17, 2022) (energycommerce.house.gov/sites/
democrats.energycommerce.house.gov/files/documents/
Witness%20Testimony_Ramachandran_HE_2022.03.17.pdf); National
Organization for Rare Diseases, FDA's Accelerated Approval Pathway: A
Rare Disease Perspective (2021) (rarediseases.org/wp-content/uploads/
2021/06/NRD-2182-Policy-Report_Accelerated-Approval_FNL.pdf).
---------------------------------------------------------------------------
Section 804 of H.R. 7667 aims to improve the integrity and
performance of this valuable pathway by addressing some of
these concerns. In the interest of enhancing the quality and
timeliness of postapproval studies, it requires FDA to specify
the conditions for such studies, which may include enrollment
targets and the target date for study completion as well as
other milestones, by the time the drug is approved, requires
more frequent reporting of postapproval study progress, and
makes clear that FDA may require postapproval studies to be
underway at the time of approval and may withdraw approval
where the conditions it specified at the time of approval are
not satisfied. It also clarifies that postapproval studies,
which FDA regulation requires to be adequate, well controlled,
and carried out with due diligence, may be supported or
augmented by real world evidence.\31\ To promote accurate
provider and patient understanding of the limitations of
accelerated approvals, section 804 requires the labeling of
drugs approved under this pathway to include certain
information, such as the uncertainty regarding benefit, the
endpoints used in premarket studies, and the fact that
continued approval depends on the ability of a postapproval
study to verify benefit.
---------------------------------------------------------------------------
\31\See 21 C.F.R. Sec. 314.510.
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H.R. 7667 also ensures FDA can expeditiously withdraw
approval where a postapproval study fails to verify patient
benefit or if any of the other grounds for withdrawal apply,
while still providing the sponsor due process by which to
challenge a proposed withdrawal. The informal hearing required
by the current process can be cumbersome and time-consuming,
requires a meeting of an advisory committee even if the same
committee previously met to discuss the same issues regarding
withdrawal of the drug's approval, and enables a drug sponsor
to continue marketing a drug long after a postapproval study
fails to verify any benefit to patients.\32\ Section 804
replaces the requirement for an informal hearing with an
opportunity for written appeal to the Commissioner of Food and
Drugs, which should significantly streamline the withdrawal
process, while allowing sponsors to present the same case
against withdrawal they may currently present to the
Commissioner. In the interest of fairness and transparency,
section 804 also requires FDA to provide an explanation for the
withdrawal, an opportunity for a meeting with the Commissioner,
a public comment period and responses to public comments, and
an advisory committee meeting, if one was not held previously,
to discuss the issues that have led to the determination that
the product should be withdrawn.
---------------------------------------------------------------------------
\32\House Committee on Energy and Commerce, Subcommittee on Health,
Testimony of Patrizia Cavazzoni, Director, Center for Drug Evaluation
and Research, U.S. Food and Drug Administration, Hearing on FDA User
Fee Reauthorization: Ensuring Safe and Effective Drugs and Biologics
(Feb. 3, 2022).
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2. Drugs for Rare Diseases, Pediatric Populations, and
Certain Infectious Diseases
Significant progress has been made in recent decades with
respect to the treatment of rare diseases, also known as orphan
products, thanks in part to the Orphan Drug Act of 1983. Before
the enactment of this law, only 38 orphan products existed;
between 1983 and 2020, FDA approved 599 orphan products to
treat rare diseases.\33\ However, there is still a long way to
go; together rare diseases affect more than 25 million
Americans, 90 percent of these diseases continue not to have an
FDA-approved treatment, and numerous obstacles to the
investment in research and development of these drugs
remain.\34\
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\33\National Organization for Rare Disorders, Orphan Drugs in the
United States: An Examination of Patents and Orphan Drug Exclusivity
(March 25, 2021) (https://rarediseases.org/wp-content/uploads/2021/03/
NORD-Avalere-Report-2021_FNL-1.pdf).
\34\Id.; Food and Drug Administration, Remarks by Acting
Commissioner Woodcock to the 2021 NORD Breakthrough Summit (Oct. 19,
2021) (www.fda.gov/news-events/speeches-fda-officials/remarks-acting-
commissioner-woodcock-2021-nord-breakthrough-summit-10192021).
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A recent decision of the 11th Circuit Court of Appeals
upended FDA's longstanding interpretation of seven-year orphan
drug exclusivity under section 527 of the FFDCA (21 U.S.C.
Sec. 360cc).\35\ Under FDA's implementation of section 527,
orphan drug exclusivity blocks approval of the same drug only
for the same use or indication that FDA previously approved,
which may be in a small subgroup affected by the disease. This
incentivizes companies to continue to study and obtain approval
for other uses within the designated disease, such as a
pediatric indication for a drug approved for adults.\36\
---------------------------------------------------------------------------
\35\Catalyst Pharms., Inc. v. Becerra, 14 F.4th 1299 (11th Cir.
2021).
\36\Food and Drug Administration, Overview of Catalyst Pharms.,
Inc. v. Becerra (www.fda.gov/industry/developing-products-rare-
diseases-conditions/fdas-overview-catalyst-pharms-inc-v-becerra)
(accessed May 24, 2022).
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As a result of the court's decision, which held that
exclusivity applies to the entire designated disease regardless
of the specific indications for which a drug is actually
approved, sponsors would have incentive to obtain approval for
the smallest, easiest-to-study subpopulation and block approval
for any other populations or indications within the rare
disease for seven years.\37\ Were this interpretation to stand,
there could be a chilling effect on investment in studying and
obtaining approval for these drugs in different subpopulations,
which could be especially harmful to populations that tend to
be studied later in drug development, such as children, the
elderly, and patients with co-morbidities. The ruling also
creates uncertainty regarding existing approvals for a number
of brand-name and generic drugs and could block approval of
drugs in late-stage development or for which premarket review
is pending. This problem will grow over time for the hundreds
of existing terms of orphan exclusivity that would be subject
to the broad scope resulting from the Catalyst decision.\38\
---------------------------------------------------------------------------
\37\Id.
\38\Id.
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Section 812 of H.R. 7667 will prevent the potential
negative consequences of this decision from occurring by
amending section 527 of the FFDCA (21 U.S.C. Sec. 360cc) to
clearly provide that orphan exclusivity applies only to the
specific indication or use approved by FDA under this section,
not the entire rare disease or condition for which a drug is
designated, consistent with FDA's long-held interpretation of
the law.\39\
---------------------------------------------------------------------------
\39\21 CFR 316.
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Section 703 of H.R. 7667 further seeks to advance the
development of drugs for rare diseases by requiring FDA to
study processes for evaluating drugs for rare diseases in the
United States and the European Union, convene a public meeting
to solicit input from stakeholders regarding approaches to
improving engagement with patients, patient groups, and
experts, and submit a report to Congress summarizing its
activities relating to designating, approving, and licensing
drugs used to treat rare diseases. Section 703 also requires
GAO to conduct a study on the use of FDA tools to ensure that
patient and physician perspectives are incorporated throughout
FDA processes for approving and licensing drugs and making
determinations related to a drug's approval.
Section 804 addresses the need for further rare disease
development by requiring FDA to establish a rare disease
endpoint advancement pilot program and issue guidance on novel
surrogate endpoints and trial designs, and section 712 does so
by reauthorizing orphan drug grants and allowing such grants to
be used to develop regulatory science pertaining to the
chemistry, manufacturing, and controls of rare disease drugs.
Although there has been progress in the treatment of
pediatric cancer in recent years, particularly with respect to
the most common malignancy, little improvement has been made in
the treatment of certain other types of childhood cancer. High
development costs and the relatively smaller number of
pediatric patients limit investment in treatments for this
population; as a result, few cancer drugs have obtained FDA
approval for pediatric indications and the need for more
clinical studies in children persists.\40\
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\40\Theodore W. Laetsch, et al., Opportunities and Challenges in
Drug Development for Pediatric Cancers, Cancer Discovery (Mar. 2, 2021)
(aacrjournals.org/cancerdiscovery/article/11/3/545/3017/Opportunities-
and-Challenges-in-Drug-Development).
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The FDA Reauthorization Act of 2017 sought to facilitate
development of appropriate new therapies for pediatric cancer
patients by requiring pediatric investigations of certain adult
cancer drugs with new active ingredients directed at a
molecular target FDA determines to be substantially relevant to
the growth or progression of a pediatric cancer, unless FDA
waives or defers the requirement.\41\ Section 713 of H.R. 7667
takes this mandate a step further, clarifying that the required
pediatric investigations may be of the new drug for which
approval is sought or such drug used in combination with a
previously-approved drug or biological product that meets
certain conditions. This section also requires FDA to issue
guidance and report to Congress on its implementation of this
section, and a GAO report on its success.
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\41\Pub. L. No. 115-52 (2017).
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As antibiotic resistance continues to rise throughout the
world and remains one of the biggest threats to public health,
there continues to be a critical need for new antibiotic and
antifungal treatments.\42\ The Generating Antibiotic Incentives
Now (GAIN) provisions of the FDA Safety and Innovation Act of
2012 promoted the development and approval of such treatments
for serious or life-threatening infections by allowing a drug
designated by FDA as a Qualified Infectious Disease Product
(QIDP) to be eligible for market exclusivity, priority review
for the first application submitted for approval, and fast-
track designation upon request. Section 705 of H.R. 7667
broadens QIDP designation to antibiotic and antifungal
biological products, which renders them eligible for fast-track
designation and provides for priority review for the first
application for an innovative biological antifungal or
antibiotic QIDP that requires clinical data to demonstrate
safety or effectiveness. This section does not extend QIDP
exclusivity to biological products.
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\42\World Health Organization, Antibiotic Resistance (www.who.int/
news-room/fact-sheets/detail/antibiotic-resistance) (accessed May 24,
2002).
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H.R. 7667 also addresses the specific need for antifungal
treatments for coccidioidomycosis, commonly known as Valley
Fever, which is a serious fungal lung infection that afflicts
about 15,000 patients in the United States each year, mostly in
Arizona and California.\43\ Section 704 attempts to advance the
development of antifungal therapies for this illness by
requiring FDA to issue guidance assisting entities seeking
approval for such treatments and to hold a public workshop to
assist entities developing vaccines for fungal infections,
including Valley Fever.
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\43\Centers for Disease Control and Prevention, Valley Fever
Awareness (www.cdc.gov/fungal/features/valley-fever.html) (accessed May
24, 2022).
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3. Generic Drug and Biosimilar Competition
For a generic drug to be approved by FDA, it generally must
have the same inactive ingredients in the same concentration
(within a certain range) as the listed drug.\44\ Currently,
generic drug sponsors often have to engage in trial and error
before they successfully match the same inactive ingredients in
the same proportions as the listed drug in order to obtain
approval.\45\ This is a costly, burdensome, and inefficient
process for both the agency and these sponsors, and more
importantly, can delay patient access to cost-saving generic
drugs.\46\ Section 601 of H.R. 7667 fixes this problem by
requiring FDA to provide this information to generic sponsors
of certain drugs upon request, which will avoid this
unnecessary back-and-forth and enable patients to have access
to more affordable drugs sooner, which will reduce costs for
patients and the health system. This section makes clear this
information is not protected under the Trade Secrets Act.
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\44\21 C.F.R. Sec. 314.94(a)(9).
\45\House Committee on Energy and Commerce, Subcommittee on Health,
Testimony of David R. Gaugh, RPh, Senior Vice President, Sciences &
Regulatory Affairs, Association for Accessible Medicines, Hearing on
The Future of Medicine: Legislation to Encourage Innovation and Improve
Oversight, 117th Cong. (Mar. 17, 2022) (energycommerce.house.gov/sites/
democrats.energycommerce.house.gov/files/documents/
Witness%20Testimony_Gaugh_HE_2022.03.17.pdf).
\46\Id.
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An NDA holder for a listed drug can also attempt to block
competition from generics by changing the labeling of its drug
shortly before a generic is approved and prepared to enter the
market. Because generic drug labeling must generally match that
of the listed drug, any change in a listed drug's labeling can
temporarily block a generic drug market entry. Section
505(j)(10)(A) of the FFDCA (21 U.S.C. Sec. 355(j)(10)(A))
addresses this issue by enabling FDA to approve a generic drug
despite differences between its proposed labeling and that of
the listed drug, other than differences in the ``Warnings''
section, resulting from revisions made to the labeling of the
listed drug approved by FDA within 60 days of when the generic
could be approved. Section 602 of H.R. 7667 extends this
protection to 90 days, which will help cost-saving generic
drugs get to market sooner in certain circumstances, saving
patients money.
Timely, accurate information regarding which drugs are on
the market, and which are not, can help generic drug
manufacturers and policymakers identify circumstances where
generic competition is lacking, which can help spur competition
and help identify any policy changes that may be appropriate to
address these circumstances.\47\ This information can also be
useful to providers, payors, pharmacies, and patients. Congress
addressed this issue in the FDA Reauthorization Act of 2017,
which added section 506I to the FFDCA (21 U.S.C. Sec. 356i),
requiring all drug application holders to report to FDA certain
information regarding the marketing status of approved drug
products. Section 801 of H.R. 7667 extends these requirements
and benefits to biological products, including biosimilars.
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\47\Food and Drug Administration, Statement from FDA Commissioner
Scott Gottlieb, M.D., on the agency's efforts to enhance the utility of
the Orange Book to foster drug competition (Jan. 30, 2019)
(www.fda.gov/news-events/press-announcements/statement-fda-
commissioner-scott-gottlieb-md-agencys-efforts-enhance-utility-orange-
book-foster-drug).
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4. Advanced and Innovative Manufacturing for Drugs
The COVID-19 public health emergency has exposed gaps in
the United States manufacturing supply chain and has reinforced
the need to develop and implement manufacturing technologies
that improve drug supply chain resilience, reduce time to
market, or increase manufacturing capacity.\48\ Advanced
manufacturing, which is a collective term for new medical
product manufacturing technologies and approaches that can
improve drug quality, address shortages of medicines, and speed
time-to-market, is a key component of the overall United States
strategy to strengthen domestic drug manufacturing and increase
the domestic supply of quality medical products for
consumers.\49\ Patients with diseases including cystic
fibrosis, HIV, breast cancer, leukemia, and asthma are already
benefitting from medications manufactured in newer, more
expedient, and more flexible ways.\50\ Innovations in this area
promise to rapidly scale manufacturing capabilities for
vaccines and other medical countermeasures to enable faster
responses in public health emergencies, shorten supply chains
and increase manufacturing resilience to disruption by creating
reserve capacity in network of small manufacturing sites,
accelerate therapy development for rare diseases by improving
the cost-efficiency of small-scale manufacturing processes,
speed availability of emerging therapies, and provide new tools
to address drug shortages and other challenges, including
pharmaceutical quality.\51\
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\48\Manufacturing x Digital (MxD) and the International Academy of
Automation Engineering (IAAE), Analysis of the Advantages of and
Barriers to Adoption of Smart Manufacturing for Medical Products--Focus
on Response to Emerging and Pandemic Threats such as SARS-CoV-2, FDA-
funded study (June 30, 2021) (www.fda.gov/media/152569/download).
\49\Food and Drug Administration, Advanced Manufacturing
(www.fda.gov/emergency-preparedness-and-response/mcm-issues/advanced-
manufacturing) (accessed May 24, 2022).
\50\Id.
\51\Id.; Food and Drug Administration, FDA's Advanced Manufacturing
Initiatives Helping to Provide Quality Human Drugs for Patients
(www.fda.gov/news-events/fda-voices/fdas-advanced-manufacturing-
initiatives-helping-provide-quality-human-drugs-patients) (accessed May
24, 2022).
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Section 706 of H.R. 7667 fosters expanded creation and use
of these methods by requiring FDA to initiate a pilot program
for the designation of advanced manufacturing technologies. A
method of manufacturing is eligible for designation if such
method incorporates a novel technology or novel use of
technology, will at least maintain equivalent drug quality, and
will substantially improve the manufacturing process, for
example by reducing development time or increasing or
maintaining the supply of certain drugs on the shortage list or
drugs for serious diseases the manufacture of which has been
interrupted or discontinued. Designated technologies qualify
for expedited application development and review and allow the
holder or their designee to reference or rely upon data and
information about the designated technology for use in
manufacturing drugs in the same context of use as the
designation. This section also encourages advanced
manufacturing utilization by requiring FDA to hold a public
meeting, issue guidance, and report to Congress regarding this
pilot.
These goals are further advanced through section 702 of
H.R. 7667, which codifies FDA's Emerging Technologies Program.
This is a collaborative program wherein industry
representatives, academics, and others can meet with FDA
officials to support the adoption and improve the development
of innovative approaches to drug design and manufacturing. This
section also authorizes FDA to make grants, provides FDA $20
million annually to carry out the program, and requires FDA to
issue guidance regarding such innovative approaches. It also
requires a report to Congress detailing the effectiveness of
the program.
5. Animal Testing
Animal studies have long been critical to the development
of safe and effective medical products. For example, scientists
have relied heavily on animal studies to determine whether a
drug is toxic before testing it in humans; such studies have
shown great accuracy in predicting safe doses and determining
appropriate monitoring for adverse effects.\52\ Conversely,
although animal testing is still necessary in many situations,
it is expensive and time-consuming, and does not always predict
toxic effects in humans.\53\ Some have also raised ethical
concerns.\54\ Advances in recent years, for example in the use
of stem cells, engineered tissues, and mathematical modeling,
have led to the development of alternative testing models that
promise to improve the predictive ability of pre-clinical
testing in conjunction with more traditional approaches.\55\
While most current alternative methods cannot yet predict
effects in highly complex interacting systems, they hold the
potential to reduce and refine animal testing, and potentially
someday replace it.\56\
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\52\Food and Drug Administration, Advancing New Alternative
Methodologies at FDA (Jan. 2021) (www.fda.gov/media/144891/download).
\53\Id.
\54\Stephanie Liou, The Ethics of Animal Experimentation,
Huntington's Outreach Project for Education at Stanford (July 6, 2010)
(hopes.stanford.edu/animal-research/).
\55\See note 52.
\56\Food and Drug Administration, Advancing Alternative Methods at
FDA (www.fda.gov/science-research/about-science-research-fda/advancing-
alternative-methods-fda) (accessed May 24, 2022).
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Recognizing these advances and this potential for expanded
use of non-animal testing, section 701 of H.R. 7667 amends
certain provisions of the FFDCA pertaining to drug studies to
allow for the possible use of non-animal nonclinical testing in
certain circumstances as appropriate. It broadens the purpose
of a certain type of FDA-sponsor meeting in situations where
human efficacy studies are not ethical or feasible to include
reaching agreement on the design of ``nonclinical tests''
intended to support effectiveness, so that non-animal
nonclinical studies may be included in these meetings. This
section also broadens references to animal testing in section
505(i) regarding investigational new drug exemptions to
``nonclinical tests,'' defined to include cell-based assays,
organ chips and microphysiological systems, computer modeling,
other nonhuman or human biology-based test methods, and animal
tests.
6. Addressing Third-Party Vendor Issues
In the wake of recent FDA-approved changes to the risk
evaluation and mitigation strategies (REMS) programs for
clozapine and isotretinoin, users have experienced problems
such as long wait times and difficulties obtaining certain
authorizations. To attempt to avoid such problems in the
future, section 809 of H.R. 7667 requires FDA to provide a
single public comment period regarding patient access and
provider administration when a proposed modification to an
approved REMS is reviewed under section 505-1(h) of the FFDCA
(21 U.S.C. Sec. 355-1). This section makes clear that it shall
not delay any agency action on any modification to a REMS. It
also requires a GAO study on how any third-party vendor changes
have impacted patient access to drugs subject to the modified
REMS and how those access issues were resolved.
7. Encouraging Blood Donation
To facilitate FDA collection of certain information
pertaining to blood donation and ultimately encourage broad
donation of blood to assure adequate supply, section 802
exempts from Paperwork Reduction Act requirements FDA
information gathering regarding patient perspectives during
medical product development and solicitation of information
from blood donors and potential blood donors to inform
recommendations regarding blood donation.
8. Cell and Gene Therapy Workshop
In the interest of advancing the understanding of certain
human cell-, tissue-, and cellular-based medical products and
the latest scientific information about such products and
providing a public forum for discussion of related issues,
section 707 requires FDA to convene a public workshop on
generating the scientific data necessary to further facilitate
development of these products.
D. Improvements for Device Regulation
1. Cybersecurity
As cyberattacks generally, and on the health care sector in
particular, have become more widespread and more sophisticated
in recent years, medical device cybersecurity is more important
than ever.\57\ Connected, networked systems that leverage
wireless technologies provide many advantages in health care
delivery, but also leave systems more vulnerable to
cyberattacks. For example, recent ransomware attacks on
hospitals have rendered medical devices and hospital networks
inoperable, necessitated moving patients to other hospitals,
and prevented access to patient records, putting patients at
risk and imposing substantial financial costs on the health
care system.\58\ Without adequate cybersecurity across all
components of larger medical device systems, which can include
health care facility networks, various individual devices, and
software update servers, a cybersecurity threat can compromise
the safety or effectiveness of a device by compromising any
component in the system.\59\
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\57\Cybersecurity and Infrastructure Security Agency, Stop
Ransomware Resources, Sector Risk Management Agencies, Healthcare and
the Public Sector (www.cisa.gov/stopransomware/healthcare-and-public-
health-sector) (accessed May 24, 2022); Cybersecurity and
Infrastructure Security Agency, Federal Bureau of Investigation, and
Department of Health and Human Services, Alert AA20-302A, Ransomware
Activity Targeting the Healthcare and Public Health Sector (Oct. 28,
2020) (www.cisa.gov/uscert/ncas/alerts/aa20-302a).
\58\Id.; Food and Drug Administration, Cybersecurity in Medical
Devices: Quality System Considerations and Content of Premarket
Submissions (draft guidance) (April 8, 2022) (www.fda.gov/media/119933/
download).
\59\Id.
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Section 808 of H.R. 7667 imposes crucial requirements that
will improve the cybersecurity of medical devices and thereby
improve the cybersecurity of our entire health care system. It
requires manufacturers of all cyber devices, defined as any
device that includes software, can connect to the internet, or
otherwise could be vulnerable to cybersecurity threats, to
develop processes to ensure their devices are secure, have
plans to identify and address cybersecurity vulnerabilities,
and provide a software bill of materials in their labeling so
that users can more easily identify threats and
vulnerabilities. This section also provides that this
information, as well as any other information pertaining to
cybersecurity that FDA determines to be appropriate to
demonstrate a reasonable assurance of safety and effectiveness,
must be submitted in any premarket submissions and authorizes
FDA to deny 510(k) clearance if cybersecurity information is
inadequate. To enable enforcement of these requirements, it
makes failure to comply a prohibited act.
2. Bans of Devices for Specific Intended Use(s)
In 2020, FDA, pursuant to section 516 of the FFDCA (21
U.S.C. Sec. 360f), issued a final rule banning electric shock
devices intended to aversively condition patients against self-
injurious and aggressive behavior.\60\ In 2021, the Court of
Appeals for the District of Columbia Circuit, without weighing
in on the reasons for FDA's decision to ban such devices,
overturned the ban, finding that banning a device for a
particular use interferes with the practice of medicine in
contravention of section 1006 of the FFDCA (21 U.S.C.
Sec. 396).\61\ This section makes two legislative changes to
address this court decision: one to clarify FDA's authority to
ban a device, in appropriate circumstances where the
longstanding banning standard is met, regardless of whether it
includes other devices that are technologically similar but
have different intended uses within the scope of the ban, and
another to effectuate FDA's ban of this particular device,
including its particular intended use.
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\60\ Food and Drug Administration, Banned Devices: Electrical
Stimulation Devices for Self-Injurious or Aggressive Behavior, 85 Fed.
Reg. 13312 (Mar. 6, 2020).
\61\Judge Rotenberg Educ. Ctr., Inc. v. FDA, 3 F.4th 390 (D.C. Cir.
2021).
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Since the Medical Device Amendments of 1976, FDA has had
the authority under section 516 of the FFDCA (21 U.S.C.
Sec. 360f) to ban medical devices that present an unreasonable
and substantial risk of illness or injury. For an even longer
time--since Congress first gave FDA authority over devices in
the FFDCA of 1938--the regulatory status of a product as a
``device'' under section 201(h) of the FFDCA (21 U.S.C.
Sec. 321(h)) has been dependent on its intended use; whereas a
technology for one use may not be FDA-regulated, the same
technology for a different use may be a ``device.'' How a
device is classified, its premarket pathway, labeling, and
other requirements very much depend on its intended use; a
device that is safe and effective for one use may be unsafe and
ineffective for a different use or different population.\62\
Section 811 of H.R. 7667 makes clear that the same principle
applies to FDA's banning authority, so that FDA may ban a
device intended for one particular use. Without this change,
FDA would either have to ban a technology for all uses, which
could prevent patient access to safe and effective devices, or
not ban a device that presents a substantial and unreasonable
risk of illness or injury for a certain use or population,
depriving those individuals of the protection Congress intended
the banning authority to provide for over 45 years.
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\62\Sections 513(a)(1), 513(a)(2) and 513(i) of the FFDCA (21
U.S.C. Sec. Sec. 360c(a)(1), 360c(a)(2), 360c(i)).
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FDA's ban applied to shock devices intended for use on a
particularly vulnerable patient population--individuals who
engage in self-injurious and aggressive behavior, conditions
that present in individuals with intellectual and developmental
disabilities, such as Autism spectrum disorder, Down syndrome,
and Tourette's syndrome.\63\ FDA determined that these devices
intended for this use present an unreasonable and substantial
risk of illness or injury based on the serious risks they pose,
the inadequacy of data to show effectiveness, and the positive
benefit-risk profiles of behavioral and pharmacological
alternatives developed in recent decades to treat patients with
these conditions.\64\
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\63\See note 60.
\64\Id.
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Specifically, in its final rule imposing the ban, FDA cited
medical literature that found that the use of these devices
included risks of physical harms, including pain, skin burns,
and tissue damage, as well as serious psychological harms,
including depression, posttraumatic stress disorder (PTSD),
suicidality, chronic stress, anxiety, fear, panic, and
substitution of other negative behaviors.\65\ FDA issued the
final rule after an extensive process spanning nearly a decade
over two administrations, with multiple opportunities for
stakeholder input, including an outside expert advisory
committee meeting in 2014, a proposed rule in 2016, meetings
with the affected company and other stakeholders, consideration
of tens of thousands of pages of scientific literature, state
court proceedings, and over 1,500 comments, which were
overwhelmingly supportive of the ban.\66\ Section 811 of H.R.
7667 would reinstitute this ban without the need for additional
time-consuming and resource-intensive proceedings.
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\65\Id.
\66\Id.
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3. Public Health Emergency Diagnostic Testing
One of the lessons learned from the COVID-19 public health
emergency regards the value that external expertise and
experience can provide to FDA regarding medical devices that
are essential during such an emergency, such as personal
protective equipment and diagnostic tests, including with
respect to the use of such tests in the detection of an
emerging threat and its spread across the nation and globe. It
can be difficult to obtain such expertise in the middle of an
emergency, given the focus of public health resources on other
aspects of emergency response. Section 807 of H.R. 7667 aims to
address this issue by requiring at least one panel of FDA's
Medical Device Advisory Committee, which shall include at least
one population-health representative, to meet at least once per
year to discuss topics related to device use in pandemic
preparedness and response, including with respect to in vitro
diagnostics.
Looking ahead to a post-pandemic world, section 806 of H.R.
7667 will streamline FDA premarket review and categorization
under the Clinical Laboratory Improvement Amendments (CLIA) for
certain diagnostic tests that were granted an emergency use
authorization during the COVID-19 emergency. More specifically,
sponsors of such tests that were deemed to be CLIA-waived under
section 564(m) of the FFDCA (21 U.S.C. Sec. 360bbb-3) as part
of such authorization that submit requests for de novo
classification of their test under section 513(f)(2) (21 U.S.C.
Sec. 360c(f)(2)) of the FFDCA may submit a request for CLIA
categorization together with their de novo request in a single
submission.
III. Committee Hearings
For the purposes of section 3(c) of rule XIII of the Rules
of the House of Representatives, the following hearings were
used to develop and consider H.R. 7667:
The Subcommittee on Health held a legislative hearing on
February 3, 2022, entitled ``FDA User Fee Reauthorization:
Ensuring Safe and Effective Drugs and Biologics.'' The
Subcommittee received testimony from the following witnesses:
Panel I:
Patrizia Cavazzoni, M.D., Director, Center
for Drug Evaluation and Research, Food and Drug
Administration; and
Peter Marks, M.D., Ph.D., Director, Center
for Biologics Evaluation and Research, Food and Drug
Administration.
Panel II:
Cartier Esham, Ph.D., Chief Scientific
Officer, Executive Vice President, Emerging Companies,
Biotechnology Innovation Organization;
David Gaugh, Senior Vice President, Sciences
and Regulatory Affairs, Association for Accessible
Medicines;
Reshma Ramachandran, M.D., Chair, Doctors
for America FDA Task Force, Physician-Fellow, Yale
National Clinician Scholars Program, Yale School of
Medicine;
Juliana M. Reed, Executive Director,
Biosimilars Forum; and
Lucy Vereshchagina, Ph.D., Vice President,
Science and Regulatory Advocacy. Pharmaceutical
Research and Manufacturers of America.
The Subcommittee on Health held a hearing on March 17,
2022, entitled ``The Future of Medicine: Legislation to
Encourage Innovation and Improve Oversight.'' The Subcommittee
received testimony from the following witnesses:
Jeff Allen, Ph.D., President and CEO,
Friends of Cancer Research;
Cartier Esham, Ph.D., Chief Scientific
Officer, Executive Vice President, Emerging Companies,
Biotechnology Innovation Organization;
David Gaugh, Senior Vice President, Sciences
and Regulatory Affairs, Association for Accessible
Medicines;
Ruben Mesa, M.D., Executive Director, Mays
Cancer Center, UT Health San Antonio MD Anderson;
Reshma Ramachandran, M.D., Chair, Doctors
for America FDA Task Force, Physician-Fellow, Yale
National Clinician Scholars Program, Yale School of
Medicine; and
Lucy Vereshchagina, Ph.D., Vice President,
Science and Regulatory Advocacy. Pharmaceutical
Research and Manufacturers of America.
The Subcommittee on Health held a legislative hearing on
March 30, 2022, entitled ``FDA User Fee Reauthorization:
Ensuring Safe and Effective Medical Devices.'' The Subcommittee
received testimony from the following witnesses:
Panel I:
Jeff Shuren, M.D., Director, Center for
Devices and Radiological Health, Food and Drug
Administration.
Panel II:
Richard J. Kovacs, M.D., Q.E. and Sally
Russell Professor of Medicine, Indiana University
School of Medicine, Chief Medical Officer, American
College of Cardiology;
Mark Leahey, President & CEO, Medical Device
Manufacturers Association;
Janet Trunzo, Senior Executive Vice
President, Technology and Regulatory Affairs, Advanced
Medical Technology Association (AdvaMed); and
Diane Wurzburger, Executive of Regulatory
Affairs, GE Healthcare.
IV. Committee Consideration
H.R. 7667, the ``Food and Drug Amendments of 2022,'' was
introduced on May 6, 2022, by Representatives Eshoo (D-CA),
Guthrie (R-KY), Pallone (D-NJ), and Rodgers (R-WA) and referred
to the Committee on Energy and Commerce. Subsequently, on May
9, 2022, the bill was referred to the Subcommittee on Health.
On May 11, 2022, the Subcommittee on Health met in open
markup session, pursuant to notice, to consider H.R. 7667 and
five other bills. During consideration of the bill, an
amendment in the nature of a substitute (AINS) offered by
Representative Eshoo was agreed to by a voice vote. Upon
conclusion of consideration of the bill, the Subcommittee on
Health agreed to report the bill favorably to the full
Committee, amended, by a roll call vote of 30 yeas to zero
nays.
On May 18, 2022, the full Committee met in open markup
session, pursuant to notice, to consider H.R. 7667 and five
other bills. An AINS offered by Representative Guthrie was
agreed to by a voice vote. An amendment to the AINS offered by
Representative Butterfield (D-NC) was agreed to by a voice
vote. Upon conclusion of consideration of the bill, the full
Committee agreed to a motion on final passage offered by
Representative Pallone, Chairman of the Committee, to order
H.R. 7667 reported favorably to the House, amended, by a roll
call vote of 55 yeas to zero nays.
V. Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list each record vote
on the motion to report legislation and amendments thereto. The
Committee advises that there were two record votes taken on
H.R. 7667, including a motion by Mr. Pallone ordering H.R. 7667
favorably reported to the House, amended. The motion on final
passage of the bill was approved by a record vote of 55 yeas to
zero nays. The following are the record votes taken during
Committee consideration, including the names of those members
voting for and against:
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
VI. Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1)
of rule X of the Rules of the House of Representatives, the
oversight findings and recommendations of the Committee are
reflected in the descriptive portion of the report.
VII. New Budget Authority, Entitlement Authority, and Tax Expenditures
Pursuant to 3(c)(2) of rule XIII of the Rules of the House
of Representatives, the Committee adopts as its own the
estimate of new budget authority, entitlement authority, or tax
expenditures or revenues contained in the cost estimate
prepared by the Director of the Congressional Budget Office
pursuant to section 402 of the Congressional Budget Act of
1974.
The Committee has requested but not received from the
Director of the Congressional Budget Office a statement as to
whether this bill contains any new budget authority, spending
authority, credit authority, or an increase or decrease in
revenues or tax expenditures.
VIII. Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
IX. Statement of General Performance Goals and Objectives
Pursuant to clause 3(c)(4) of rule XIII, the general
performance goal or objective of this legislation is to
reauthorize important FDA user fee programs and to improve the
review and regulation of products regulated by FDA.
X. Duplication of Federal Programs
Pursuant to clause 3(c)(5) of rule XIII, no provision of
H.R. 7667 is known to be duplicative of another Federal
program, including any program that was included in a report to
Congress pursuant to section 21 of Public Law 111-139 or the
most recent Catalog of Federal Domestic Assistance.
XI. Committee Cost Estimate
Pursuant to clause 3(d)(1) of rule XIII, the Committee
adopts as its own the cost estimate prepared by the Director of
the Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974.
XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits
Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the
Committee finds that H.R. 7667 contains no earmarks, limited
tax benefits, or limited tariff benefits.
XIII. Advisory Committee Statement
No advisory committee within the meaning of section 5(b) of
the Federal Advisory Committee Act was created by this
legislation.
XIV. Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
XV. Section-by-Section Analysis of the Legislation
TITLE I--FEES RELATING TO DRUGS
Section 101. Short title; finding
Section 101 establishes a short title for Title I--the
``Prescription Drug User Fee Amendments of 2022''--and provides
that the fees authorized in the title will be dedicated to
expediting the drug development and review processes, including
postmarket drug safety activities, as set forth in the
commitment letter submitted to the Congressional Record.
Sec. 102. Definitions
Section 102 adds to the definition of human drug
application certain applications with respect to allergenic
extract products, adds to the definition of prescription drug
product certain allergenic extract products, details how
product withdrawn from sale may be considered discontinued for
purposes of the prescription drug program fee, and adds a
definition for skin-test diagnostic products.
Sec. 103. Authority to assess and use drug fees
Section 103 reauthorizes FDA's prescription drug user fee
program through 2027, maintains the existing fee structure, and
increases and adjusts fees, including a new strategic hiring
and a reserve adjustment. This section also excepts skin-test
diagnostic products from human drug application fees, provides
a special rule for products that are no longer discontinued,
and provides program fee exceptions for certain large volume
parenteral products, products that are pharmaceutically
equivalent to certain other products, and skin-test diagnostic
products.
Sec. 104. Reauthorization; reporting requirements
Section 104 reauthorizes and updates requirements for FDA
reporting to Congress and requires reporting regarding certain
requests for in-person face-to-face meetings in fiscal years
2023 and 2024.
Sec 105. Sunset dates
Section 105 sunsets the authority to collect prescription
drug user fees on October 1, 2027, and sunsets reporting
requirements on January 31, 2028.
Sec 106. Effective date
Section 106 clarifies that the effective date of this title
is October 1, 2022, or the date of enactment, whichever is
later, except that the fees in FFDCA apply to applications
received on or after October 1, 2022, regardless of the date of
enactment.
Sec. 107. Savings clause
Section 107 clarifies that the prescription drug user fees
in effect before enactment continue to apply to human drug
applications and supplements accepted by FDA for filing before
October 1, 2022.
TITLE II--FEES RELATING TO DEVICES
Sec. 201. Short title; finding
Section 201 establishes a short title for Title II--the
``Medical Device User Fee Amendments of 2022''--and provides
that the fees authorized in the title will be dedicated to
expediting the process for device review and assuring device
safety and effectiveness, as set forth in the commitment letter
submitted to the Congressional Record.
Sec. 202. Definitions
Section 202 amends the definition of ``process for the
review of device applications'' to include de novo
classification requests.
Sec. 203. Authority to assess and use device fees
Section 203 reauthorizes FDA's medical device user fee
program through 2027, maintains the existing fee structure, and
increases and adjusts fees, including a new strategic hiring
adjustment, operating reserve adjustment, and performance
improvement adjustment that provides for increased fees in
later years if FDA meets review goal timelines.
Sec. 204. Reauthorization; reporting requirements
Section 204 reauthorizes and updates requirements for FDA
reporting to Congress.
Sec. 205. Conformity assessment pilot program
Section 205 reauthorizes a pilot program for accreditation
of testing laboratories to assess conformance of a device with
certain recognized standards and continuation of program after
completion of pilot.
Sec. 206. Reauthorization of third-party review program
Section 206 reauthorizes third party 510(k) review of
certain devices.
Sec. 207. Sunset dates
Section 209 sunsets the authority to collect medical device
user fees on October 1, 2027, and sunsets reporting
requirements on January 31, 2028.
Sec. 208. Effective date
Section 208 clarifies that the effective date of this title
is October 1, 2022, or the date of enactment, whichever is
later, except that the fees in FFDCA apply to submissions
received on or after October 1, 2022, regardless of the date of
enactment.
Sec. 209. Savings clause
Section 207 clarifies that the medical device user fees in
effect before enactment continue to apply to device submissions
received by FDA before October 1, 2022.
TITLE III--FEES RELATING TO GENERIC DRUGS
Sec. 301. Short title; finding
Section 301 establishes a short title for Title III--the
``Generic Drug User Fee Amendments of 2022''--and provides that
the fees authorized in the title will be dedicated to human
generic drug activities, as set forth in the commitment letter
submitted to the Congressional Record.
Sec. 302. Authority to assess and use human generic drug fees
Section 302 reauthorizes FDA's generic drug user fee
program through 2027, maintains existing fee structure, and
increases and adjusts fees, including capacity planning and
operating reserve adjustments.
Sec. 303. Reauthorization; reporting requirements
Section 303 reauthorizes and updates requirements for FDA
reporting to Congress.
Sec. 304. Sunset dates
Section 304 sunsets the authority to collect generic drug
user fees on October 1, 2027, and sunsets reporting
requirements on January 31, 2028.
Sec. 305. Effective date
Section 305 clarifies that the effective date of this title
is October 1, 2022, or the date of enactment, whichever is
later, except that the fees in FFDCA apply to applications
received on or after October 1, 2022, regardless of the date of
enactment.
Sec. 306. Savings clause
Section 306 clarifies that the generic drug user fees in
effect before enactment continue to apply to new drug
applications and prior approval supplements received by FDA
before October 1, 2022, and drug master files for Type II
active pharmaceutical ingredients first referenced before
October 1, 2022.
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
Sec. 401. Short title; finding
Section 401 establishes a short title for Title IV--the
``Biosimilar User Fee Amendments of 2022''--and provides that
the fees authorized in the title will be dedicated to
expediting the review of biosimilar biological product
applications, including postmarket drug safety activities, as
set forth in the commitment letter submitted to the
Congressional Record.
Sec. 402. Definitions
Section 402 defines adjustment factor and removes the
exclusion of allergenic extract product applications from the
definition of biosimilar biological product application.
Sec. 403. Authority to assess and use biosimilar fees
Section 403 reauthorizes the biosimilar user fee program
through 2027, maintains the existing fee structure, and
increases and adjusts fees, including a strategic hiring and
retention adjustment. Section 403 also adds provisions
regarding removal from the biosimilar development program for
failure to pay fees under certain circumstances, requests for
movement to the list of discontinued biosimilar biological
products, and a special rule for products that are no longer
discontinued.
Sec. 404. Reauthorization; reporting requirements
Section 404 reauthorizes and updates requirements for FDA
reporting to Congress.
Sec. 405. Sunset dates
Section 405 sunsets the authority to collect biosimilar
user fees on October 1, 2027, and sunsets reporting
requirements on January 31, 2028.
Sec. 406. Effective date
Section 406 clarifies that the effective date of this title
is October 1, 2022, or the date of enactment, whichever is
later, except that the fees in FFDCA apply to applications
received on or after October 1, 2022, regardless of the date of
enactment.
Sec. 407. Savings clause
Section 407 clarifies that the biosimilar user fees in
effect before enactment continue to apply to biosimilar
biological product applications and supplements accepted by FDA
for filing before October 1, 2022.
TITLE V--IMPROVING DIVERSITY IN CLINICAL STUDIES
Sec. 501. Diversity action plans for clinical studies
Section 501 requires sponsors of phase 3 and other pivotal
studies of new drugs (and biological products that are also
drugs) and sponsors of studies of devices (including biological
products that are also devices) except those excepted under 21
C.F.R. Sec. 812.3(c), to develop and implement a diversity
action plan. Such plan must include the sponsor's goals for
enrollment in the clinical studies, the sponsor's rationale for
such goals, and an explanation for how the sponsor intends to
meet such goals. FDA may waive this requirement for certain
drugs and devices based on a determination that submission of a
diversity action plan is not necessary based on what is known
about the prevalence of the disease in terms of the patient
population that may use the drug. Submissions under section 561
of the FFDCA (21 U.S.C. Sec. 360bbb) are exempt from this
requirement. This section requires drug sponsors to submit
their plans to FDA in the form and manner specified in the
guidance required by this section as soon as practicable but no
later than when the sponsor seeks feedback from FDA regarding a
phase 3 study or other pivotal study of the drug.
The timing and manner of diversity action plan submission
to FDA for device studies is dependent upon whether submission
of an application for investigational device exemption (IDE) to
FDA is required under FDA regulations. FDA regulations, 21
C.F.R. Sec. 812.20(a), require submission of an IDE application
for studies of significant risk devices, studies involving
exceptions from informed consent, and studies for which FDA
notifies the sponsor an application is required. Under 21
C.F.R. Sec. 812.2(b), non-significant risk studies are
considered to have approved IDE applications, without sponsor
submission of such, as long as the sponsor complies with
certain abbreviated requirements and FDA does not notify the
sponsor that IDE application submission is required. Section
501 of H.R. 7667 provides that device sponsors must submit
their diversity action plan in their IDE application, if one is
required; if one is not required, sponsors must submit their
plans in any premarket notification, application for premarket
approval, or request for de novo classification the sponsor may
submit to FDA. Diversity action plans would also be subject to
inspection by FDA.
The requirement to submit diversity action plans becomes
effective six months after publication of the final guidance
required by this section; sponsors of studies for which
enrollment has begun after such date must comply. Failure to
comply prevents a drug or device to which this requirement is
applicable from being exempt under section 505(i) or 520(g) of
the FFDCA (21 U.S.C. Sec. Sec. 355(i), 360j(g)) from other
applicable requirements. For non-significant risk devices, at
the time the study is being conducted, failure to develop or
implement a plan as required by this section would prevent the
device from being exempt under section 520(g) of the FFDCA; at
the time of any submission for premarket review to FDA, failure
to submit the diversity action plan to FDA would render the
device adulterated under section 501(i) of the FFDCA.
This section also requires FDA to issue new draft guidance
or update existing draft guidance within 12 months of
enactment, and to finalize such guidance no later than nine
months after the close of the comment period. The guidance must
specify the form and content of diversity action plans
regarding the sponsor's goals for study enrollment,
disaggregated into certain demographic categories, including
with respect to the rationale for enrollment goals, an
explanation for how the sponsor will meet such goals, and how
the sponsor will publicly post key information from the plan
that would be useful to patients and providers on its website.
Sec. 502. Evaluation of the need for FDA authority to mandate
postapproval studies or postmarket surveillance due to
insufficient demographic subgroup data
Section 502 requires FDA to evaluate, not later than two
years after the publication of the final guidance required by
section 501, whether regulations or additional authorities are
warranted to ensure that sponsors conduct post-approval studies
or postmarket surveillance where premarket studies collected
insufficient data for underrepresented subgroups according to
the sponsor's goals and FDA has requested additional studies to
be conducted.
Sec. 503. Public workshops to enhance clinical study diversity
Section 503 requires FDA, in consultation with drug
sponsors, medical device manufacturers, patients, and other
stakeholders, not later than one year after enactment, to
convene one or more public workshops to solicit input from
stakeholders on increasing the enrollment of historically
underrepresented populations in clinical studies.
Sec. 504. Annual summary report on progress to increase diversity in
clinical studies
Section 504 requires FDA, not later than two years after
the enactment of the Food and Drug Amendments of 2022, and
annually thereafter, to submit to Congress, and publish on the
public website of FDA, a report that summarizes the diversity
action plans received pursuant to section 501 and contains
information on whether studies for approved and cleared drugs
and devices met diversity action plan goals, the reasons given
whenever sponsors failed to meet their goals, and any
postmarket studies requested or required by FDA where there was
inadequate premarket study diversity.
Sec. 505. Public meeting on clinical study flexibilities initiated in
response to COVID-19 pandemic
Section 505 requires FDA, not later than 180 days after the
date on which the COVID-19 public health emergency period ends,
to convene a public meeting to discuss recommendations provided
during the COVID-19 public health emergency to mitigate
disruption of clinical studies. Such meeting shall discuss
incorporating certain clinical study disruption mitigation
recommendations into current or additional guidance to improve
clinical study access and enrollment of diverse patient
populations.
Sec. 506. Decentralized clinical studies
Section 506 requires FDA, not later than 12 months after
the enactment of the Food and Drug Amendments of 2022, to issue
draft guidance that addresses considerations for decentralized
clinical studies, including regarding the engagement,
enrollment, and retention of a meaningfully diverse clinical
population with respect to race, ethnicity, age, sex, and
geographic location, when appropriate. FDA is required to
finalize this guidance no later than one year after the public
comment period for the draft guidance ends.
TITLE VI--GENERIC DRUG COMPETITION
Sec. 601. Increasing transparency in generic drug applications
Section 601 requires FDA to provide generic drug sponsors,
upon request, information regarding any qualitative or
quantitative differences in ingredients between their generic
drug and the reference listed drug to which they are compared,
to facilitate generic drug development and review. This section
makes clear these disclosures are authorized by law, including
under section 1905 of title 18, United States Code. This
section also requires FDA to issue guidance explaining how it
determines whether a generic drug is qualitatively and
quantitatively the same as the listed drug.
Sec. 602. Enhancing access to affordable medicines
Section 602 provides that a generic drug is eligible for
approval notwithstanding differences between its proposed
labeling and that of the listed drug due to revisions made to
the labeling of the listed drug approved by FDA within 90 days
of when the generic application is otherwise eligible for
approval. This section preserves the provisions requiring that
the revisions not be to the ``Warnings'' section of the
labeling, the generic sponsor must submit revised labeling
within 60 days of approval, and the applicable otherwise meet
applicable requirements for approval.
TITLE VII--RESEARCH, DEVELOPMENT, AND SUPPLY CHAIN IMPROVEMENTS
SUBTITLE A--IN GENERAL
Sec. 701. Animal testing alternatives
Section 701 clarifies one of the purposes of a certain type
of meeting FDA is required to have with sponsors of drug
studies and applicants for drug approval, upon reasonable
written request, in situations where human efficacy studies are
not ethical or feasible. Section 701 broadens the purpose from
reaching agreement on the design and size of ``animal and any
associated clinical trials'' intended to support effectiveness
to reaching agreement on the design and size of ``nonclinical
tests and any associated clinical trials'' intended to support
effectiveness, so that non-animal nonclinical studies would be
included in these meetings in the event that such studies may
be sufficient to provide substantial evidence of effectiveness
in these situations. This section also broadens references to
animal testing in section 505(i) regarding investigational new
drug exemptions to ``nonclinical tests.'' Section 701 also
defines ``nonclinical test'' and clarifies that it includes
cell-based assays, organ chips and microphysiological systems,
computer modeling, other nonhuman or human biology-based test
methods, and animal tests.
Sec. 702. Emerging technology program
Section 702 authorizes the Emerging Technologies Program at
FDA, a collaborative program wherein industry representatives,
academics, and others can meet with FDA officials to support
the adoption and improve the development of innovative
approaches to drug design and manufacturing. This section
requires FDA to issue guidance regarding requirements related
to such approaches and report to Congress regarding allocation
of funds and staff utilization in this program. It authorizes
FDA to make grants and authorizes $20 million each year for
fiscal years 2023 through 2027 to carry out the program.
Sec. 703. Improving the treatment of rare diseases and conditions
Section 703 requires FDA to submit a report summarizing its
activities relating to designating, approving, and licensing
drugs used to treat rare diseases no later than September 30,
2026. This section also requires FDA to study processes for
evaluating drugs for rare diseases in the United States and the
European Union and to convene one or more public meetings to
solicit input from stakeholders regarding approaches to
improving engagement with rare disease condition patients,
patient groups, and experts. Section 703 also requires the
Government Accountability Office (GAO) to conduct a study on
the use of FDA tools and mechanisms to ensure that patient and
physician perspectives are considered and incorporated
throughout FDA processes for approving and licensing drugs and
making determinations related to a drug's approval.
Sec. 704. Antifungal research and development
Section 704 requires the Secretary to issue guidance for
industry to assist entities seeking approval or licensure for
antifungal therapies intended to treat coccidioidomycosis,
commonly known as Valley Fever, and to hold a public workshop
to assist entities developing preventative vaccines for fungal
infections and Valley Fever.
Sec. 705. Advancing qualified infectious disease product innovation
Section 705 allows a biological product to qualify as a
Qualified Infectious Disease Product (QIDP) under Section 505E
of the FFDCA (21 U.S.C. Sec. 355f), which renders it eligible
for fast track designation, and provides for priority review
for the first application for an innovative biological
antifungal or antibiotic QIDP that requires clinical data to
demonstrate safety or effectiveness. This section does not
extend QIDP exclusivity to biological products.
Sec. 706. Advanced manufacturing technologies designation pilot program
Section 706 requires FDA to initiate a pilot program for
designating methods of manufacturing as advanced manufacturing
technologies. A method of manufacturing is eligible for
designation if such method both: incorporates a novel
technology or uses an established technology in a novel way and
will substantially improve the manufacturing process and
maintain equivalent or superior drug quality. Designated
technologies qualify for expedited application development and
review and allow the holder of such designation, or a person
authorized by the designation holder, to reference or rely
upon, in a drug or biologic application, data and information
about the designated technology for use in manufacturing drugs
in the same context of use for which FDA granted the
designation. This section also requires FDA to hold a public
meeting, issue guidance, and report to Congress regarding this
pilot, which sunsets on October 1, 2029.
Sec. 707. Public workshop on cell therapies
Section 707 requires FDA to convene a public workshop on
best practices on generating scientific data necessary to
further facilitate development of certain human cell-, tissue-,
and cellular-based medical products, and the latest scientific
information about such products.
Sec. 708. Reauthorization of best pharmaceuticals for children
Section 708 reauthorizes the Best Pharmaceuticals for
Children Act through 2027, which allows the National Institutes
of Health to fund studies of off-patent drugs in children.
Sec. 709. Reauthorization for humanitarian device exemption and
demonstration grants for improving pediatric availability
Section 709 reauthorizes through 2027 the exemption,
subject to certain conditions, from the profit limitation on
devices granted a humanitarian device exemption under section
520(m) of the FFDCA (21 U.S.C. Sec. 360j(m)). Such devices,
which are designed to treat or diagnose a disease or condition
that affects 8,000 or fewer individuals in the United States,
are exempt from certain requirements if they meet certain
criteria. Section 709 also reauthorizes demonstration grants
for improving development of pediatric medical devices through
2027.
Sec. 710. Reauthorization of provision related to exclusivity of
certain drugs containing single enantiomers
Section 710 reauthorizes the provision allowing for
exclusivity for certain single enantiomer drugs under certain
conditions through 2027.
Sec. 711. Reauthorization of the critical path public-private
partnership program
Section 711 reauthorizes the Critical Path Public-Private
Partnership at $10 million annually through 2027.
Sec. 712. Reauthorization of orphan drug grants
Section 712 reauthorizes orphan drug grants through 2027
and expands uses of such grants to include the development of
regulatory science pertaining to manufacturing and controls
related to individualized medical products to treat those with
rare diseases or conditions.
Sec. 713. Research into pediatric uses of drugs; additional authorities
of Food and Drug Administration regarding molecularly targeted
cancer drugs
This section builds on the requirement included in Section
504 of the FDA Reauthorization Act of 2017 for pediatric
studies by sponsors of certain adult cancer drugs with new
active ingredients directed at a molecular target FDA
determines to be substantially relevant to the growth or
progression of a pediatric cancer. Such required pediatric
studies shall be designed to yield clinically meaningful data
regarding dosing, safety, and preliminary efficacy to inform
potential pediatric labeling. The section also clarifies that
the required pediatric study may be of the new drug for which
approval is sought or such drug used in combination with a
previously approved drug or biological product that meets
certain conditions. Additionally, Section 713 requires FDA to
issue guidance and report to Congress on its implementation of
this section not later than two years after enactment, and a
GAO report on its success in the development of drugs and
biological products for pediatric cancer indications.
SUBTITLE B--INSPECTIONS
Sec. 721. Factory inspection
Section 721 clarifies that the scope of FDA inspectional
authority extending to all things in a factory, warehouse,
establishment, or consulting laboratory applies to such places
that manufacture, process, pack, or hold non-restricted devices
as well as ones that do so with respect to restricted devices.
This section also extends the requirement for the provision, to
FDA, of records requested in advance or in lieu of an
inspection to persons that own or operate establishments
engaged in the manufacture, preparation, propagation,
compounding, or processing of devices. FDA will have to provide
a rationale for requesting such records and issue guidance
regarding such requests.
Section 721 also codifies and clarifies FDA authority to
inspect clinical study sites, also known as bioresearch
monitoring inspections. It requires FDA to review its processes
and practices applicable to such inspections in the United
States and in foreign countries, evaluate whether updates are
needed to facilitate consistency, and issue guidance describing
the conduct of such inspections.
Sec. 722. Uses of certain evidence
Section 722 clarifies that the limitation on FDA's use of
certain evidence regarding product movement in interstate
commerce obtained from carriers and receivers does not apply to
information obtained under other authorities such as those
authorizing inspections unless such limitations are
specifically incorporated.
Sec. 723. Improving FDA inspections
Section 723 provides for FDA consideration of the
compliance history of other FDA-regulated establishments in the
country or region in which an establishment is located as a
factor in establishing a schedule for risk-based inspections.
It clarifies that FDA may rely on any records or other
information inspected to satisfy requirements that may pertain
to a preapproval or risk-based surveillance inspection, or to
resolve deficiencies found in such inspections, if applicable
and appropriate. It provides that FDA may enter into agreements
with foreign governments to recognize inspections of foreign
establishments to facilitate preapproval inspections and
requires a periodic assessment of whether additional
arrangements with foreign governments are appropriate.
Sec. 724. GAO report on inspections of foreign establishments
manufacturing drugs
Section 724 requires GAO to report on FDA and recognized
foreign government inspections of foreign establishments
manufacturing drugs.
Sec. 725. Unannounced foreign facility inspections pilot program
Section 725 requires FDA to conduct a pilot program in
which FDA increases the conduct of unannounced surveillance
inspections of foreign drug establishments, evaluates the
differences between such inspections of domestic and foreign
establishments, including the impact of announcing inspections,
and post a report of its findings and recommendations on the
FDA website.
Sec. 726. Reauthorization of inspection program
Section 726 reauthorizes the third-party inspection program
until October 1, 2027.
Sec. 727. Enhancing intra-agency coordination and public health
assessment with regard to compliance activities
Section 727 amends section 506D of the FFDCA (21 U.S.C.
Sec. 356d) to require FDA to ensure timely and effective
internal coordination and alignment among field investigators
and staff of CDER's Office of Compliance and Drug Shortage
Program regarding the reviews of inspection reports and any
feedback or corrective actions in response to such reports. It
also requires FDA reporting to Congress regarding certain drug
shortage reports and the internal coordination and alignment
required by this section.
Sec. 728. Reporting of mutual recognition agreements for inspections
and review activities
Section 728 requires FDA to publish on its website a
report, no later than the end of calendar year 2022 and
annually thereafter, on the utilization of agreements entered
into pursuant to section 809 of the FFDCA (21 U.S.C. Sec. 384e)
or otherwise entered into to recognize inspections across
countries and international regions by drug regulatory
authorities with analogous review criteria to the FDA.
Sec. 729. Enhancing transparency of drug facility inspection timelines
Section 729 amends the information FDA must annually report
regarding inspections on its website pursuant to section 902 of
the FDA Reauthorization Act of 2017, including by adding to
this information the time between a request from FDA and the
beginning of an inspection for certain generic drugs, drugs
subject to discontinuance reporting, and drugs on the shortage
list.
TITLE VIII--TRANSPARENCY, PROGRAM INTEGRITY, AND REGULATORY
IMPROVEMENTS
Sec. 801. Prompt reports of marketing status by holders of approved
applications for biological products
Section 801 requires all holders of approved Biologics
License Applications to submit a one-time notification to FDA
indicating whether their products listed in the Purple Book are
still available for sale and to report to FDA on an ongoing
basis when withdrawing a product from the market.
Sec. 802. Encouraging blood donation
Section 802 exempts from Paperwork Reduction Act
requirements FDA information collections to solicit patient
perspectives during medical product development and to solicit
information from blood donors and potential blood donors to
inform recommendations regarding blood donation.
Sec. 803. Regulation of certain products as drugs
Section 803 deems all contrast agents and products under
over-the-counter drug monographs, and certain radioactive
products, to be drugs and not medical devices.
Sec. 804. Postapproval studies and program integrity for accelerated
approval drugs
Section 804 requires FDA to specify conditions for required
postapproval studies for drugs approved under accelerated
approval, which may include enrollment targets and milestones,
including the target date for study completion, by the time the
drug is approved. This section also authorizes FDA to require
postapproval studies to be underway at the time of approval for
such drugs, requires FDA to explain any instances where it does
not require such studies, and provides that postapproval
studies may be augmented or supported by real world evidence.
This section clarifies that existing authority to withdraw
approvals where sponsors fail to conduct studies with due
diligence applies with respect to the approval conditions and
streamlines the procedures for withdrawal of approval. To
withdraw an accelerated approval, it requires FDA to provide an
explanation for the withdrawal, an opportunity for written
appeal, a meeting with the Commissioner or their designee,
responses to public comment, and, upon request, an advisory
committee meeting if there was not previously one on the
withdrawal. Section 804 codifies labeling requirements for
accelerated approval and requires more frequent reports on
postapproval study progress. It also requires FDA to report to
Congress on the use of real world evidence to support
postapproval studies, issue guidance on novel surrogate
endpoints and trial designs, and establish a rare disease
endpoint advancement pilot program.
Sec. 805. Facilitating the use of real world evidence
Section 805 requires FDA to issue guidance addressing the
use of real world evidence and real world data, including that
obtained for drugs and devices authorized for emergency use
during the COVID-19 public health emergency, to support drug
and device approvals and clearances. It requires FDA to report
to Congress regarding the number of applications submitted for
products for which an emergency use authorization was
previously granted and, of such applications, how many included
real world evidence and whether such evidence was sufficient to
support a regulatory decision.
Sec. 806. Dual submission for certain devices
Section 806 provides that sponsors of diagnostic tests that
have been deemed to be CLIA-waived under section 564(m) of the
FFDCA (21 U.S.C. Sec. 360j(m)) as part of a COVID-19 emergency
use authorization that submit requests for de novo
classification of their test under section 513(f)(2) of the
FFDCA (21 U.S.C. Sec. 360c(f)(2)) may submit such request
together with sufficient information to enable FDA to determine
whether the test satisfies the criteria for CLIA categorization
under section 353(d)(3) of the Public Health Service Act (42
U.S.C. Sec. 263a(d)(3)) in a single submission.
Sec. 807. Medical devices advisory committee meetings
Section 807 requires the Medical Device Advisory Committee
to meet at least once a year through 2027 to provide FDA advice
on topics related to medical devices in pandemic preparedness
and response, including issues related to in vitro diagnostics.
Sec. 808. Ensuring cybersecurity of medical devices
Section 808 requires manufacturers of cyber devices to
develop processes to ensure their devices are secure, have
plans to identify and address cybersecurity vulnerabilities,
provide a software bill of materials in their labeling, and
submit this information to FDA in any premarket submissions. It
defines cyber devices as devices that have software, connect to
the internet, or otherwise could be vulnerable to cybersecurity
threats. Section 808 authorizes FDA to deny 510(k) clearance if
cyber security information is inadequate and to exempt types of
devices from these requirements. It makes failure to comply
with these requirements a prohibited act.
Sec. 809. Public docket on proposed changes to third-party vendors
Section 809 requires FDA to provide a public comment period
regarding patient access and provider administration when a
proposed modification to an approved risk evaluation and
mitigation strategy (REMS) is reviewed under section 505-1(h)
of the FFDCA (21 U.S.C. Sec. 355 1(h)). This section makes
clear that it shall not delay any agency action on any
modification to a REMS.
Sec. 810. Facilitating exchange of product information prior to
approval
Section 810 provides that no drug or device shall be
considered misbranded as a result of the provision of
information regarding investigational drugs or devices or uses
to payors, formulary committees, or other similar entities
under specified conditions. It requires the information to
include a clear statement that the drug or device it discusses
has not been approved and that the safety and efficacy of the
drug or device has not been established. Additional required
disclosures include information about studies the drug or
device is undergoing, how the studies relate to the overall
plan for the development of the drug or device, whether an
application for the drug or device has been submitted to FDA,
and if not, when such submission is planned.
Sec. 811. Bans of devices for one or more intended uses
Section 811 amends section 516 of the FFDCA (21 U.S.C.
Sec. 360f) to make clear that FDA is authorized to ban a
medical device intended for a particular use. A ban may apply
to devices intended for more than one use, but in a situation
where there are devices with the same or similar technological
characteristics and different intended uses, FDA may ban one
and not the other. Section 811 also bans electrical stimulation
devices intended for self-injurious and aggressive behavior,
which renders such devices adulterated under section 501(g) of
the FFDCA (21 U.S.C. Sec. 351(g)).
Sec. 812. Clarifying application of exclusive approval, certification,
or licensure for drugs designated for rare disease or
conditions
Section 812 amends section 527 of the FFDCA (21 U.S.C.
Sec. 360cc) regarding orphan drugs to provide clarity that
orphan exclusivity applies only to the specific indication or
use approved by FDA under this section, not the entire rare
disease or condition for which the drug was designated,
consistent with FDA's long-held interpretation of the law.
Sec. 813. GAO report on third-party review
Section 813 requires GAO to report on the program for
accredited third-party review of 510(k) premarket notifications
for medical devices.
Sec. 814. Reporting on pending generic drug applications and priority
review applications
Section 814 reauthorizes reporting on certain pending
generic drug applications and priority review applications
through 2027.
Sec. 815. FDA workforce improvements
Section 815 extends the authority Congress granted to FDA
in the 21st Century Cures Act of 2016 to facilitate the hiring
and retention of outstanding candidates for scientific,
technical, or professional positions that support the
development and regulation of medical products to the hiring of
candidates for such positions to support the regulation of
products across the entire agency. This section also requires
FDA to develop and begin implementation of a strategic
workforce plan and report to Congress regarding such plan.
XVI. Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italics, and existing law in which no
change is proposed is shown in roman):
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
CHAPTER III--PROHIBITED ACTS AND PENALTIES
prohibited acts
Sec. 301. The following acts and the causing thereof are
hereby prohibited:
(a) The introduction or delivery for introduction into
interstate commerce of any food, drug, device, tobacco product,
or cosmetic that is adulterated or misbranded.
(b) The adulteration or misbranding of any food, drug,
device, tobacco product, or cosmetic in interstate commerce.
(c) The receipt in interstate commerce of any food, drug,
device, tobacco product, or cosmetic that is adulterated or
misbranded, and the delivery or proffered delivery thereof for
pay or otherwise.
(d) The introduction or delivery for introduction into
interstate commerce of any article in violation of section 404,
415, 505, or 564.
(e) The refusal to permit access to or copying of any record
as required by section 412, 414, 417(j), 416, 504, 564, 703,
704(a), 760, or 761; or the failure to establish or maintain
any record, or make any report, required under section 412,
414(b), 417, 416, 504, 505 (i) or (k), 512(a)(4)(C), 512 (j),
(l) or (m), 572(i), 515(f), 519, 564, 760, 761, 909, or 920 or
the refusal to permit access to or verification or copying of
any such required record; or the violation of any recordkeeping
requirement under section 204 of the FDA Food Safety
Modernization Act (except when such violation is committed by a
farm).
(f) The refusal to permit entry or inspection as authorized
by section 704.
(g) The manufacture within any Territory of any food, drug,
device, tobacco product, or cosmetic that is adulterated or
misbranded.
(h) The giving of a guaranty or undertaking referred to in
section 303(c)(2), which guaranty or undertaking is false,
except by a person who relied upon a guaranty or undertaking to
the same effect signed by, and containing the name and address
of, the person residing in the United States from whom he
received in good faith the food, drug, device, tobacco product,
or cosmetic; or the giving of a guaranty or undertaking
referred to in section 303(c)(3), which guaranty or undertaking
is false.
(i)(1) Forging, counterfeiting, simulating, or falsely
representing, or without proper authority using any mark,
stamp, tag, label, or other identification device authorized or
required by regulations promulgated under the provisions of
section 404 or 721.
(2) Making, selling, disposing of, or keeping in possession,
control, or custody, or concealing any punch, die, plate,
stone, or other thing designed to print, imprint, or reproduce
the trademark, trade name, or other identifying mark, imprint,
or device of another or any likeness of any of the foregoing
upon any drug or container or labeling thereof so as to render
such drugs a counterfeit drug.
(3) The doing of any act which causes a drug to be a
counterfeit drug, or the sale or dispensing, or the holding for
sale or dispensing, of a counterfeit drug.
(j) The using by any person to his own advantage, or
revealing, other than to the Secretary or officers or employees
of the Department, or to the courts when relevant in any
judicial proceeding under this Act, any information acquired
under authority of section 404, 409, 412, 414, 505, 510, 512,
513, 514, 515, 516, 518, 519, 520, 571, 572, 573, 704, 708,
721, 904, 905, 906, 907, 908, 909, or 920(b) concerning any
method or process which as a trade secret is entitled to
protection; or the violating of section 408(i)(2) or any
regulation issued under that section.. This paragraph does not
authorize the withholding of information from either House of
Congress or from, to the extent of matter within its
jurisdiction, any committee or subcommittee of such committee
or any joint committee of Congress or any subcommittee of such
joint committee.
(k) The alteration, mutilation, destruction, obliteration, or
removal of the whole or any part of the labeling of, or the
doing of any other act with respect to, a food, drug, device,
tobacco product, or cosmetic, if such act is done while such
article is held for sale (whether or not the first sale) after
shipment in interstate commerce and results in such article
being adulterated or misbranded.
(m) The sale or offering for sale of colored oleomargarine or
colored margarine, or the possession or serving of colored
oleomargarine or colored margarine in violation of section
407(b) or 407(c).
(n) The using, in labeling, advertising or other sales
promotion of any reference to any report or analysis furnished
in compliance with section 704.
(o) In the case of a prescription drug distributed or offered
for sale in interstate commerce, the failure of the
manufacturer, packer, or distributor thereof to maintain for
transmittal, or to transmit, to any practitioner licensed by
applicable State law to administer such drug who makes written
request for information as to such drug, true and correct
copies of all printed matter which is required to be included
in any package in which that drug is distributed or sold, or
such other printed matter as is approved by the Secretary.
Nothing in this paragraph shall be construed to exempt any
person from any labeling requirement imposed by or under other
provisions of this Act.
(p) The failure to register in accordance with section 510 or
905, the failure to provide any information required by section
510(j), 510(k), 905(i), or 905(j), or the failure to provide a
notice required by section 510(j)(2) or 905(i)(3).
(q)(1) The failure or refusal--
(A) to comply with any requirement prescribed under
section 518, 520(g), 903(b), 907, 908, or 915;
(B) to furnish any notification or other material or
information required by or under section 519, 520(g),
904, 909, or 920; or
(C) to comply with a requirement under section 522 or
913.
(2) With respect to any device or tobacco product, the
submission of any report that is required by or under this Act
that is false or misleading in any material respect.
(3) The failure to comply with any requirement under section
524C (relating to ensuring device cybersecurity).
(r) The movement of a device, drug, or tobacco product in
violation of an order under section 304(g) or the removal or
alteration of any mark or label required by the order to
identify the device, drug, or tobacco product as detained.
(s) The failure to provide the notice required by section
412(c) or 412(e), the failure to make the reports required by
section 412(f)(1)(B), the failure to retain the records
required by section 412(b)(4), or the failure to meet the
requirements prescribed under section 412(f)(3).
(t) The importation of a drug in violation of section
801(d)(1), the sale, purchase, or trade of a drug or drug
sample or the offer to sell, purchase, or trade a drug or drug
sample in violation of section 503(c), the sale, purchase, or
trade of a coupon, the offer to sell, purchase, or trade such a
coupon, or the counterfeiting of such a coupon in violation of
section 503(c)(2), the distribution of a drug sample in
violation of section 503(d) or the failure to otherwise comply
with the requirements of section 503(d), the distribution of
drugs in violation of section 503(e), failure to comply with
the requirements under section 582, the failure to comply with
the requirements under section 584, as applicable, or the
failure to otherwise comply with the requirements of section
503(e).
(u) The failure to comply with any requirements of the
provisions of, or any regulations or orders of the Secretary,
under section 512(a)(4)(A), 512(a)(4)(D), or 512(a)(5).
(v) The introduction or delivery for introduction into
interstate commerce of a dietary supplement that is unsafe
under section 413.
(w) The making of a knowingly false statement in any
statement, certificate of analysis, record, or report required
or requested under section 801(d)(3); the failure to submit a
certificate of analysis as required under such section; the
failure to maintain records or to submit records or reports as
required by such section; the release into interstate commerce
of any article or portion thereof imported into the United
States under such section or any finished product made from
such article or portion, except for export in accordance with
section 801(e) or 802, or with section 351(h) of the Public
Health Service Act; or the failure to so export or to destroy
such an article or portions thereof, or such a finished
product.
(x) The falsification of a declaration of conformity
submitted under section 514(c) or the failure or refusal to
provide data or information requested by the Secretary under
paragraph (3) of such section.
(y) In the case of a drug, device, or food--
(1) the submission of a report or recommendation by a
person accredited under section 523 that is false or
misleading in any material respect;
(2) the disclosure by a person accredited under
section 523 of confidential commercial information or
any trade secret without the express written consent of
the person who submitted such information or secret to
such person; or
(3) the receipt by a person accredited under section
523 of a bribe in any form or the doing of any corrupt
act by such person associated with a responsibility
delegated to such person under this Act.
(z) The dissemination of information in violation of section
551.
(aa) The importation of a prescription drug in violation of
section 804, the falsification of any record required to be
maintained or provided to the Secretary under such section, or
any other violation of regulations under such section.
(bb) The transfer of an article of food in violation of an
order under section 304(h), or the removal or alteration of any
mark or label required by the order to identify the article as
detained.
(cc) The importing or offering for import into the United
States of an article of food or a drug by, with the assistance
of, or at the direction of, a person debarred from such
activity under section 306(b)(3).
(dd) The failure to register in accordance with section 415.
(ee) The importing or offering for import into the United
States of an article of food in violation of the requirements
under section 801(m).
(ff) The importing or offering for import into the United
States of a drug or device with respect to which there is a
failure to comply with a request of the Secretary to submit to
the Secretary a statement under section 801(o).
(gg) The knowing failure to comply with paragraph (7)(E) of
section 704(g); the knowing inclusion by a person accredited
under paragraph (2) of such section of false information in an
inspection report under paragraph (7)(A) of such section; or
the knowing failure of such a person to include material facts
in such a report.
(hh) The failure by a shipper, carrier by motor vehicle or
rail vehicle, receiver, or any other person engaged in the
transportation of food to comply with the sanitary
transportation practices prescribed by the Secretary under
section 416.
(ii) The falsification of a report of a serious adverse event
submitted to a responsible person (as defined under section 760
or 761) or the falsification of a serious adverse event report
(as defined under section 760 or 761) submitted to the
Secretary.
(jj)(1) The failure to submit the certification required by
section 402(j)(5)(B) of the Public Health Service Act, or
knowingly submitting a false certification under such section.
(2) The failure to submit clinical trial information required
under subsection (j) of section 402 of the Public Health
Service Act.
(3) The submission of clinical trial information under
subsection (j) of section 402 of the Public Health Service Act
that is false or misleading in any particular under paragraph
(5)(D) of such subsection (j).
(kk) The dissemination of a television advertisement without
complying with section 503B.
(ll) The introduction or delivery for introduction into
interstate commerce of any food to which has been added a drug
approved under section 505, a biological product licensed under
section 351 of the Public Health Service Act, or a drug or a
biological product for which substantial clinical
investigations have been instituted and for which the existence
of such investigations has been made public, unless--
(1) such drug or such biological product was marketed
in food before any approval of the drug under section
505, before licensure of the biological product under
such section 351, and before any substantial clinical
investigations involving the drug or the biological
product have been instituted;
(2) the Secretary, in the Secretary's discretion, has
issued a regulation, after notice and comment,
approving the use of such drug or such biological
product in the food;
(3) the use of the drug or the biological product in
the food is to enhance the safety of the food to which
the drug or the biological product is added or applied
and not to have independent biological or therapeutic
effects on humans, and the use is in conformity with--
(A) a regulation issued under section 409
prescribing conditions of safe use in food;
(B) a regulation listing or affirming
conditions under which the use of the drug or
the biological product in food is generally
recognized as safe;
(C) the conditions of use identified in a
notification to the Secretary of a claim of
exemption from the premarket approval
requirements for food additives based on the
notifier's determination that the use of the
drug or the biological product in food is
generally recognized as safe, provided that the
Secretary has not questioned the general
recognition of safety determination in a letter
to the notifier;
(D) a food contact substance notification
that is effective under section 409(h); or
(E) such drug or biological product had been
marketed for smoking cessation prior to the
date of the enactment of the Food and Drug
Administration Amendments Act of 2007; or
(4) the drug is a new animal drug whose use is not
unsafe under section 512.
(mm) The failure to submit a report or provide a notification
required under section 417(d).
(nn) The falsification of a report or notification required
under section 417(d).
(oo) The sale of tobacco products in violation of a no-
tobacco-sale order issued under section 303(f).
(pp) The introduction or delivery for introduction into
interstate commerce of a tobacco product in violation of
section 911.
(qq)(1) Forging, counterfeiting, simulating, or falsely
representing, or without proper authority using any mark, stamp
(including tax stamp), tag, label, or other identification
device upon any tobacco product or container or labeling
thereof so as to render such tobacco product a counterfeit
tobacco product.
(2) Making, selling, disposing of, or keeping in possession,
control, or custody, or concealing any punch, die, plate,
stone, or other item that is designed to print, imprint, or
reproduce the trademark, trade name, or other identifying mark,
imprint, or device of another or any likeness of any of the
foregoing upon any tobacco product or container or labeling
thereof so as to render such tobacco product a counterfeit
tobacco product.
(3) The doing of any act that causes a tobacco product to be
a counterfeit tobacco product, or the sale or dispensing, or
the holding for sale or dispensing, of a counterfeit tobacco
product.
(rr) The charitable distribution of tobacco products.
(ss) The failure of a manufacturer or distributor to notify
the Attorney General and the Secretary of the Treasury of their
knowledge of tobacco products used in illicit trade.
(tt) Making any express or implied statement or
representation directed to consumers with respect to a tobacco
product, in a label or labeling or through the media or
advertising, that either conveys, or misleads or would mislead
consumers into believing, that--
(1) the product is approved by the Food and Drug
Administration;
(2) the Food and Drug Administration deems the
product to be safe for use by consumers;
(3) the product is endorsed by the Food and Drug
Administration for use by consumers; or
(4) the product is safe or less harmful by virtue
of--
(A) its regulation or inspection by the Food
and Drug Administration; or
(B) its compliance with regulatory
requirements set by the Food and Drug
Administration;
including any such statement or representation
rendering the product misbranded under section 903.
(uu) The operation of a facility that manufactures,
processes, packs, or holds food for sale in the United States
if the owner, operator, or agent in charge of such facility is
not in compliance with section 418.
(vv) The failure to comply with the requirements under
section 419.
(ww) The failure to comply with section 420.
(xx) The refusal or failure to follow an order under section
423.
(yy) The knowing and willful failure to comply with the
notification requirement under section 417(h).
(zz) The importation or offering for importation of a food if
the importer (as defined in section 805) does not have in place
a foreign supplier verification program in compliance with such
section 805.
(aaa) The failure to register in accordance with section
801(s).
(bbb) The failure to notify the Secretary in violation of
section 568.
(ccc)(1) The resale of a compounded drug that is labeled
``not for resale'' in accordance with section 503B.
(2) With respect to a drug to be compounded pursuant to
section 503A or 503B, the intentional falsification of a
prescription, as applicable.
(3) The failure to report drugs or adverse events by an
entity that is registered in accordance with subsection (b) of
section 503B.
(ddd)(1) The manufacture or the introduction or delivery for
introduction into interstate commerce of a rinse-off cosmetic
that contains intentionally-added plastic microbeads.
(2) In this paragraph--
(A) the term ``plastic microbead'' means any solid
plastic particle that is less than five millimeters in
size and is intended to be used to exfoliate or cleanse
the human body or any part thereof; and
(B) the term ``rinse-off cosmetic'' includes
toothpaste.
(eee) The failure to comply with any order issued under
section 569D.
* * * * * * *
CHAPTER V--DRUGS AND DEVICES
Subchapter A--Drugs and Devices
adulterated drugs and devices
Sec. 501. A drug or device shall be deemed to be
adulterated--
(a)(1) If it consists in whole or in part of any filthy,
putrid, or decomposed substance; or (2)(A) if it has been
prepared, packed, or held under insanitary conditions whereby
it may have been contaminated with filth, or whereby it may
have been rendered injurious to health; or (B) if it is a drug
and the methods used in, or the facilities or controls used
for, its manufacture, processing, packing, or holding do not
conform to or are not operated or administered in conformity
with current good manufacturing practice to assure that such
drug meets the requirements of this Act as to safety and has
the identity and strength, and meets the quality and purity
characteristics, which it purports or is represented to
possess; or (C) if it is a compounded positron emission
tomography drug and the methods used in, or the facilities and
controls used for, its compounding, processing, packing, or
holding do not conform to or are not operated or administered
in conformity with the positron emission tomography compounding
standards and the official monographs of the United States
Pharmacopoeia to assure that such drug meets the requirements
of this Act as to safety and has the identity and strength, and
meets the quality and purity characteristics, that it purports
or is represented to possess; or (3) if its container is
composed, in whole or in part, of any poisonous or deleterious
substance which may render the contents injurious to health; or
(4) if (A) it bears or contains, for purposes of coloring only,
a color additive which is unsafe within the meaning of section
721(a), or (B) it is a color additive the intended use of which
in or on drugs or devices is for purposes of coloring only and
is unsafe within the meaning of section 721(a); or (5) if it is
a new animal drug which is unsafe within the meaning of section
512; or (6) if it is an animal feed bearing or containing a new
animal drug, and such animal feed is unsafe within the meaning
of section 512.
(b) If it purports to be or is represented as a drug the name
of which is recognized in an official compendium, and its
strength differs from, or its quality or purity falls below,
the standards set forth in such compendium. Such determination
as to strength, quality, or purity shall be made in accordance
with the tests or methods of assay set forth in such
compendium, except that whenever tests or methods of assay have
not been prescribed in such compendium, or such tests or
methods of assay as are prescribed are, in the judgment of the
Secretary, insufficient for the making of such determination,
the Secretary shall bring such fact to the attention of the
appropriate body charged with the revision of such compendium,
and if such body fails within a reasonable time to prescribe
tests or methods of assay which, in the judgment of the
Secretary, are sufficient for purposes of this paragraph, then
the Secretary shall promulgate regulations prescribing
appropriate tests or methods of assay in accordance with which
such determination as to strength, quality, or purity shall be
made. No drug defined in an official compendium shall be deemed
to be adulterated under this paragraph because it differs from
the standard of strength, quality, or purity therefor set forth
in such compendium, if its difference in strength, quality, or
purity from such standards is plainly stated on its label.
Whenever a drug is recognized in both the United States
Pharmacopeia and the Homeopathic Pharmacopeia of the United
States it shall be subject to the requirements of the United
States Pharmacopeia unless it is labeled and offered for sale
as a homeopathic drug, in which case it shall be subject to the
provisions of the Homeopathic Pharmacopeia of the United States
and not to those of the United States Pharmacopeia.
(c) If it is not subject to the provisions of paragraph (b)
of this section and its strength differs from, or its purity or
quality falls below, that which it purports or is represented
to possess.
(d) If it is a drug and any substance has been (1) mixed or
packed therewith so as to reduce its quality or strength or (2)
substituted wholly or in part therefor.
(e)(1) If it is, or purports to be or is represented as, a
device which is subject to a performance standard established
under section 514, unless such device is in all respects in
conformity with such standard.
(2) If it is declared to be, purports to be, or is
represented as, a device that is in conformity with any
standard recognized under section 514(c) unless such device is
in all respects in conformity with such standard.
(f)(1) If it is a class III device--
(A)(i) which is required by an order issued under
subsection (b) of section 515 to have an approval under
such section of an application for premarket approval
and which is not exempt from section 515 under section
520(g), and
(ii)(I) for which an application for premarket
approval or a notice of completion of a product
development protocol was not filed with the Secretary
within the ninety-day period beginning on the date of
the issuance of such order, or
(II) for which such an application was filed and
approval of the application has been denied, suspended,
or withdrawn, or such a notice was filed and has been
declared not completed or the approval of the device
under the protocol has been withdrawn;
(B)(i) which was classified under section 513(f) into
class III, which under section 515(a) is required to
have in effect an approved application for premarket
approval, and which is not exempt from section 515
under section 520(g), and
(ii) which has an application which has been
suspended or is otherwise not in effect; or
(C) which was classified under section 520(l) into
class III, which under such section is required to have
in effect an approved application under section 515,
and which has an application which has been suspended
or is otherwise not in effect.
(2)(A) In the case of a device classified under section
513(f) into class III and intended solely for investigational
use, paragraph (1)(B) shall not apply with respect to such
device during the period ending on the ninetieth day after the
date of the promulgation of the regulations prescribing the
procedures and conditions required by section 520(g)(2).
(B) In the case of a device subject to an order issued under
subsection (b) of section 515, paragraph (1) shall not apply
with respect to such device during the period ending--
(i) on the last day of the thirtieth calendar month
beginning after the month in which the classification
of the device in class III became effective under
section 513, or
(ii) on the ninetieth day after the date of the
issuance of such order,
whichever occurs later.
(3) In the case of a device with respect to which a
regulation was promulgated under section 515(b) prior to the
date of enactment of the Food and Drug Administration Safety
and Innovation Act, a reference in this subsection to an order
issued under section 515(b) shall be deemed to include such
regulation.
(g) If it is a banned device.
(h) If it is a device and the methods used in, or the
facilities or controls used for, its manufacture, packing,
storage, or installation are not in conformity with applicable
requirements under section 520(f)(1) or an applicable condition
prescribed by an order under section 520(f)(2).
(i) If it is a device for which an exemption has been granted
under section 520(g) for investigational use and the person who
was granted such exemption or any investigator who uses such
device under such exemption fails to comply with a requirement
prescribed by or under such section.
(j) If it is a drug or device and it has been manufactured,
processed, packed, or held in any factory, warehouse, or
establishment and the owner, operator, or agent of such
factory, warehouse, or establishment delays, denies, or limits
an inspection, or refuses to permit entry or inspection.
For purposes of paragraph (a)(2)(B), the term ``current good
manufacturing practice'' includes the implementation of
oversight and controls over the manufacture of drugs to ensure
quality, including managing the risk of and establishing the
safety of raw materials, materials used in the manufacturing of
drugs, and finished drug products.
(k) If it is a device subject to the requirements set forth
in section 524C (relating to ensuring device cybersecurity) and
fails to comply with any requirement under that section.
misbranded drugs and devices
Sec. 502. A drug or device shall be deemed to be misbranded--
(a)(1) If its labeling is false or misleading in any
particular. Health care economic information provided to a
payor, formulary committee, or other similar entity with
knowledge and expertise in the area of health care economic
analysis, carrying out its responsibilities for the selection
of [drugs for coverage] drugs or devices for coverage or
reimbursement, shall not be considered to be false or
misleading under this paragraph if the health care economic
information relates to an indication approved [under section
505 or under section 351(a) of the Public Health Service Act]
under section 505, 510(k), 513(f)(2), or 515 of this Act or
section 351 of the Public Health Service Act for such [drug]
drug or device, is based on competent and reliable scientific
evidence, and includes, where applicable, a conspicuous and
prominent statement describing any material differences between
the health care economic information and the labeling approved
for the [drug] drug or device [under section 505 or under
section 351 of the Public Health Service Act] under section
505, 510(k), 513(f)(2), or 515 of this Act or section 351 of
the Public Health Service Act. The requirements set forth [in
section 505(a) or in subsections (a) and (k) of section 351 of
the Public Health Service Act] in section 505, 510(k),
513(f)(2), or 515 of this Act or section 351 of the Public
Health Service Act shall not apply to health care economic
information provided to such a payor, committee, or entity in
accordance with this paragraph. Information that is relevant to
the substantiation of the health care economic information
presented pursuant to this paragraph shall be made available to
the Secretary upon request.
(2)(A) For purposes of this paragraph, the term ``health care
economic information'' means any analysis (including the
clinical data, inputs, clinical or other assumptions, methods,
results, and other components underlying or comprising the
analysis) that identifies, measures, or describes the economic
consequences, which may be based on the separate or aggregated
clinical consequences of the represented health outcomes, of
the use of a [drug] drug or device. Such analysis may be
comparative to the use of another [drug] drug or device, to
another health care intervention, or to no intervention.
(B) Such term does not include any analysis that relates only
to an indication that is not approved [under section 505 or
under section 351 of the Public Health Service Act] under
section 505, 510(k), 513(f)(2), or 515 of this Act or section
351 of the Public Health Service Act for such [drug] drug or
device.
(b) If in a package form unless it bears a label containing
(1) the name and place of business of the manufacturer, packer,
or distributor; and (2) an accurate statement of the quantity
of the contents in terms of weight, measure, or numerical
count: Provided, That under clause (2) of this paragraph
reasonable variations shall be permitted, and exemptions as to
small packages shall be established, by regulations prescribed
by the Secretary.
(c) If any word, statement, or other information required by
or under authority of this Act to appear on the label or
labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements,
designs, or devices, in the labeling) and in such terms as to
render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use.
(e)(1)(A) If it is a drug, unless its label bears, to the
exclusion of any other nonproprietary name (except the
applicable systematic chemical name or the chemical formula)--
(i) the established name (as defined in subparagraph
(3)) of the drug, if there is such a name;
(ii) the established name and quantity or, if
determined to be appropriate by the Secretary, the
proportion of each active ingredient, including the
quantity, kind, and proportion of any alcohol, and also
including whether active or not the established name
and quantity or if determined to be appropriate by the
Secretary, the proportion of any bromides, ether,
chloroform, acetanilide, acetophenetidin, amidopyrine,
antipyrine, atropine, hyoscine, hyoscyamine, arsenic,
digitalis, digitalis glucosides, mercury, ouabain,
strophanthin, strychnine, thyroid, or any derivative or
preparation of any such substances, contained therein,
except that the requirement for stating the quantity of
the active ingredients, other than the quantity of
those specifically named in this subclause, shall not
apply to nonprescription drugs not intended for human
use; and
(iii) the established name of each inactive
ingredient listed in alphabetical order on the outside
container of the retail package and, if determined to
be appropriate by the Secretary, on the immediate
container, as prescribed in regulation promulgated by
the Secretary, except that nothing in this subclause
shall be deemed to require that any trade secret be
divulged, and except that the requirements of this
subclause with respect to alphabetical order shall
apply only to nonprescription drugs that are not also
cosmetics and that this subclause shall not apply to
nonprescription drugs not intended for human use.
(B) For any prescription drug the established name of such
drug or ingredient, as the case may be, on such label (and on
any labeling on which a name for such drug or ingredient is
used) shall be printed prominently and in type at least half as
large as that used thereon for any proprietary name or
designation for such drug or ingredient, except that to the
extent that compliance with the requirements of subclause (ii)
or (iii) of clause (A) or this clause is impracticable,
exemptions shall be established by regulations promulgated by
the Secretary.
(2) If it is a device and it has an established name, unless
its label bears, to the exclusion of any other nonproprietary
name, its established name (as defined in subparagraph (4))
prominently printed in type at least half as large as that used
thereon for any proprietary name or designation for such
device, except that to the extent compliance with the
requirements of this subparagraph is impracticable, exemptions
shall be established by regulations promulgated by the
Secretary.
(3) As used in subparagraph (1), the term ``established
name'', with respect to a drug or ingredient thereof, means (A)
the applicable official name designated pursuant to section
508, or (B) if there is no such name and such drug, or such
ingredient, is an article recognized in an official compendium,
then the official title thereof in such compendium, or (C) if
neither clause (A) nor clause (B) of this subparagraph applies,
then the common or usual name, if any, of such drug or of such
ingredient, except that where clause (B) of this subparagraph
applies to an article recognized in the United States
Pharmacopeia and in the Homeopathic Pharmacopeia under
different official titles, the official title used in the
United States Pharmacopeia shall apply unless it is labeled and
offered for sale as a homeopathic drug, in which case the
official title used in the Homeopathic Pharmacopeia shall
apply.
(4) As used in subparagraph (2), the term ``established
name'' with respect to a device means (A) the applicable
official name of the device designated pursuant to section 508,
(B) if there is no such name and such device is an article
recognized in an official compendium, then the official title
thereof in such compendium, or (C) if neither clause (A) nor
clause (B) of this subparagraph applies, then any common or
usual name of such device.
(f) Unless its labeling bears (1) adequate directions for
use; and (2) such adequate warnings against use in those
pathological conditions or by children where its use may be
dangerous to health, or against unsafe dosage or methods or
duration of administration or application, in such manner and
form, as are necessary for the protection of users, except that
where any requirement of clause (1) of this paragraph, as
applied to any drug or device, is not necessary for the
protection of the public health, the Secretary shall promulgate
regulations exempting such drug or device from such
requirement. Required labeling for prescription devices
intended for use in health care facilities or by a health care
professional and required labeling for in vitro diagnostic
devices intended for use by health care professionals or in
blood establishments may be made available solely by electronic
means, provided that the labeling complies with all applicable
requirements of law, and that the manufacturer affords such
users the opportunity to request the labeling in paper form,
and after such request, promptly provides the requested
information without additional cost.
(g) If it purports to be a drug the name of which is
recognized in an official compendium, unless it is packaged and
labeled as prescribed therein. The method of packing may be
modified with the consent of the Secretary. Whenever a drug is
recognized in both the United States Pharmacopeia and the
Homeopathic Pharmacopeia of the United States, it shall be
subject to the requirements of the United States Pharmacopeia
with respect to packaging, and labeling unless it is labeled
and offered for sale as a homeopathic drug, in which case it
shall be subject to the provisions of the Homeopathic
Pharmacopeia of the United States, and not to those of the
United States Pharmacopeia, except that in the event of
inconsistency between the requirements of this paragraph and
those of paragraph (e) as to the name by which the drug or its
ingredients shall be designated, the requirements of paragraph
(e) shall prevail.
(h) If it has been found by the Secretary to be a drug liable
to deterioration, unless it is packaged in such form and
manner, and its label bears a statement of such precautions, as
the Secretary shall by regulations require as necessary for the
protection of the public health. No such regulation shall be
established for any drug recognized in an official compendium
until the Secretary shall have informed the appropriate body
charged with the revision of such compendium of the need for
such packaging or labeling requirements and such body shall
have failed within a reasonable time to prescribe such
requirements.
(i)(1) If it is a drug and its container is so made, formed,
or filled as to be misleading; or (2) if it is an imitation of
another drug; or (3) if it is offered for sale under the name
of another drug.
(j) If it is dangerous to health when used in the dosage or
manner; or with the frequency or duration prescribed,
recommended, or suggested in the labeling thereof.
(m) If it is a color additive the intended use of which is
for the purpose of coloring only, unless its packaging and
labeling are in conformity with such packaging and labeling
requirements applicable to such color additive, as may be
contained in regulations issued under section 721.
(n) In the case of any prescription drug distributed or
offered for sale in any State, unless the manufacturer, packer,
or distributor thereof includes in all advertisements and other
descriptive printed matter issued or caused to be issued by the
manufacturer, packer, or distributor with respect to that drug
a true statement of (1) the established name as defined in
section 502(e), printed prominently and in type at least half
as large as that used for any trade or brand name thereof, (2)
the formula showing quantitatively each ingredient of such drug
to the extent required for labels under section 502(e), and (3)
such other information in brief summary relating to side
effects, contraindications, and effectiveness as shall be
required in regulations which shall be issued by the Secretary
in accordance with section 701(a), and in the case of published
direct-to-consumer advertisements the following statement
printed in conspicuous text: ``You are encouraged to report
negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.'', except that
(A) except in extraordinary circumstances, no regulation issued
under this paragraph shall require prior approval by the
Secretary of the content of any advertisement, and (B) no
advertisement of a prescription drug, published after the
effective date of regulations issued under this paragraph
applicable to advertisements of prescription drugs, shall, with
respect to the matters specified in this paragraph or covered
by such regulations, be subject to the provisions of sections
12 through 17 of the Federal Trade Commission Act, as amended
(15 U.S.C. 52-57). This paragraph (n) shall not be applicable
to any printed matter which the Secretary determines to be
labeling as defined in section 201(m) of this Act. Nothing in
the Convention on Psychotropic Substances, signed at Vienna,
Austria, on February 21, 1971, shall be construed to prevent
drug price communications to consumers. In the case of an
advertisement for a drug subject to section 503(b)(1) presented
directly to consumers in television or radio format and stating
the name of the drug and its conditions of use, the major
statement relating to side effects and contraindications shall
be presented in a clear, conspicuous, and neutral manner.
(o) If it was manufactured, prepared, propagated, compounded,
or processed in an establishment not duly registered under
section 510, if it is a drug and was imported or offered for
import by a commercial importer of drugs not duly registered
under section 801(s), if it was not included in a list required
by section 510(j), if a notice or other information respecting
it was not provided as required by such section or section
510(k), or if it does not bear such symbols from the uniform
system for identification of devices prescribed under section
510(e) as the Secretary by regulation requires.
(p) If it is a drug and its packaging or labeling is in
violation of an applicable regulation issued pursuant to
section 3 or 4 of the Poison Prevention Packaging Act of 1970.
(q) In the case of any restricted device distributed or
offered for sale in any State, if (1) its advertising is false
or misleading in any particular, or (2) it is sold,
distributed, or used in violation of regulations prescribed
under section 520(e).
(r) In the case of any restricted device distributed or
offered for sale in any State, unless the manufacturer, packer,
or distributor thereof includes in all advertisements and other
descriptive printed matter issued or caused to be issued by the
manufacturer, packer, or distributor with respect to that
device (1) a true statement of the device's established name as
defined in section 502(e), printed prominently and in type at
least half as large as that used for any trade or brand name
thereof, and (2) a brief statement of the intended uses of the
device and relevant warnings, precautions, side effects, and
contraindications and, in the case of specific devices made
subject to a finding by the Secretary after notice and
opportunity for comment that such action is necessary to
protect the public health, a full description of the components
of such device or the formula showing quantitatively each
ingredient of such device to the extent required in regulations
which shall be issued by the Secretary after an opportunity for
a hearing. Except in extraordinary circumstances, no regulation
issued under this paragraph shall require prior approval by the
Secretary of the content of any advertisement and no
advertisement of a restricted device, published after the
effective date of this paragraph shall, with respect to the
matters specified in this paragraph or covered by regulations
issued hereunder, be subject to the provisions of sections 12
through 15 of the Federal Trade Commission Act (15 U.S.C. 52-
55). This paragraph shall not be applicable to any printed
matter which the Secretary determines to be labeling as defined
in section 201(m).
(s) If it is a device subject to a performance standard
established under section 514, unless it bears such labeling as
may be prescribed in such performance standard.
(t) If it is a device and there was a failure or refusal (1)
to comply with any requirement prescribed under section 518
respecting the device, (2) to furnish any material or
information required by or under section 519 respecting the
device, [or (3)] (3) to comply with a requirement under section
522, or (4) to furnish a software bill of materials as required
under section 524C (relating to ensuring device cybersecurity).
(u)(1) Subject to paragraph (2), if it is a reprocessed
single-use device, unless it, or an attachment thereto,
prominently and conspicuously bears the name of the
manufacturer of the reprocessed device, a generally recognized
abbreviation of such name, or a unique and generally recognized
symbol identifying such manufacturer.
(2) If the original device or an attachment thereto does not
prominently and conspicuously bear the name of the manufacturer
of the original device, a generally recognized abbreviation of
such name, or a unique and generally recognized symbol
identifying such manufacturer, a reprocessed device may satisfy
the requirements of paragraph (1) through the use of a
detachable label on the packaging that identifies the
manufacturer and is intended to be affixed to the medical
record of a patient.
(v) If it is a reprocessed single-use device, unless all
labeling of the device prominently and conspicuously bears the
statement ``Reprocessed device for single use. Reprocessed by
__.'' The name of the manufacturer of the reprocessed device
shall be placed in the space identifying the person responsible
for reprocessing.
(w) If it is a new animal drug--
(1) that is conditionally approved under section 571
and its labeling does not conform with the approved
application or section 571(f), or that is not
conditionally approved under section 571 and its label
bears the statement set forth in section 571(f)(1)(A);
(2) that is indexed under section 572 and its
labeling does not conform with the index listing under
section 572(e) or 572(h), or that has not been indexed
under section 572 and its label bears the statement set
forth in section 572(h); or
(3) for which an application has been approved under
section 512 and the labeling of such drug does not
include the application number in the format:
``Approved by FDA under (A)NADA # xxx-xxx'', except
that this subparagraph shall not apply to
representative labeling required under section
514.1(b)(3)(v)(b) of title 21, Code of Federal
Regulations (or any successor regulation) for animal
feed bearing or containing a new animal drug.
(x) If it is a nonprescription drug (as defined in section
760) that is marketed in the United States, unless the label of
such drug includes a domestic address or domestic phone number
through which the responsible person (as described in section
760) may receive a report of a serious adverse event (as
defined in section 760) with such drug.
(y) If it is a drug subject to an approved risk evaluation
and mitigation strategy pursuant to section 505(p) and the
responsible person (as such term is used in section 505-1)
fails to comply with a requirement of such strategy provided
for under subsection (d), (e), or (f) of section 505-1.
(z) If it is a drug, and the responsible person (as such term
is used in section 505(o)) is in violation of a requirement
established under paragraph (3) (relating to postmarket studies
and clinical trials) or paragraph (4) (relating to labeling) of
section 505(o) with respect to such drug.
(aa) If it is a drug, or an active pharmaceutical ingredient,
and it was manufactured, prepared, propagated, compounded, or
processed in a facility for which fees have not been paid as
required by section 744B(a)(4) or for which identifying
information required by section 744B(f) has not been submitted,
or it contains an active pharmaceutical ingredient that was
manufactured, prepared, propagated, compounded, or processed in
such a facility.
(bb) If the advertising or promotion of a compounded drug is
false or misleading in any particular.
(cc) If it is a drug and it fails to bear the product
identifier as required by section 582.
(dd) If it is an antimicrobial drug, as defined in section
511A(f), and its labeling fails to conform with the
requirements under section 511A(d).
(ee) If it is a nonprescription drug that is subject to
section 505G, is not the subject of an application approved
under section 505, and does not comply with the requirements
under section 505G.
(ff) If it is a drug and it was manufactured, prepared,
propagated, compounded, or processed in a facility for which
fees have not been paid as required by section 744M.
(gg)(1) Unless its labeling bears adequate directions for use
in accordance with paragraph (f), except that (in addition to
drugs or devices that conform with exemptions pursuant to such
paragraph) no drug or device shall be deemed to be misbranded
under such paragraph through the provision of product
information to a payor, formulary committee, or other similar
entity with knowledge and expertise in the area of health care
economic analysis carrying out its responsibilities for the
selection of drugs or devices for coverage or reimbursement if
the product information relates to an investigational drug or
device or investigational use of a drug or device that is
approved, cleared, granted marketing authorization, or licensed
under section 505, 510(k), 513(f)(2), or 515 of this Act or
section 351 of the Public Health Service Act (as applicable),
provided--
(A) the product information includes--
(i) a clear statement that the
investigational drug or device or
investigational use of a drug or device has not
been approved, cleared, granted marketing
authorization, or licensed under section 505,
510(k), 513(f)(2), or 515 of this Act or
section 351 of the Public Health Service Act
(as applicable) and that the safety and
effectiveness of the drug or device or use has
not been established;
(ii) information related to the stage of
development of the drug or device involved,
such as--
(I) the status of any study or
studies in which the investigational
drug or device or investigational use
is being investigated;
(II) how the study or studies relate
to the overall plan for the development
of the drug or device; and
(III) whether an application,
premarket notification, or request for
classification for the investigational
drug or device or investigational use
has been submitted to the Secretary and
when such a submission is planned;
(iii) in the case of information that
includes factual presentations of results from
studies, which shall not be selectively
presented, a description of--
(I) all material aspects of study
design, methodology, and results; and
(II) all material limitations related
to the study design, methodology, and
results;
(iv) where applicable, a prominent statement
disclosing the indication or indications for
which the Secretary has approved, granted
marketing authorization, cleared, or licensed
the product pursuant to section 505, 510(k),
513(f)(2), or 515 of this Act or section 351 of
the Public Health Service Act, and a copy of
the most current required labeling; and
(v) updated information, if previously
communicated information becomes materially
outdated as a result of significant changes or
as a result of new information regarding the
product or its review status; and
(B) the product information does not include--
(i) information that represents that an
unapproved product--
(I) has been approved, cleared,
granted marketing authorization, or
licensed under section 505, 510(k),
513(f)(2), or 515 of this Act or
section 351 of the Public Health
Service Act (as applicable); or
(II) has otherwise been determined to
be safe or effective for the purpose or
purposes for which the drug or device
is being studied; or
(ii) information that represents that an
unapproved use of a drug or device that has
been so approved, granted marketing
authorization, cleared, or licensed--
(I) is so approved, granted marketing
authorization, cleared, or licensed; or
(II) that the product is safe or
effective for the use or uses for which
the drug or device is being studied.
(2) For purposes of this paragraph, the term ``product
information'' includes--
(A) information describing the drug or device (such
as drug class, device description, and features);
(B) information about the indication or indications
being investigated;
(C) the anticipated timeline for a possible approval,
clearance, marketing authorization, or licensure
pursuant to section 505, 510(k), 513, or 515 of this
Act or section 351 of the Public Health Service Act;
(D) drug or device pricing information;
(E) patient utilization projections;
(F) product-related programs or services; and
(G) factual presentations of results from studies
that do not characterize or make conclusions regarding
safety or efficacy.
exemptions and consideration for certain drugs, devices, and biological
products
Sec. 503. (a) The Secretary is hereby directed to promulgate
regulations exempting from any labeling or packaging
requirement of this Act drugs and devices which are, in
accordance with the practice of the trade, to be processed,
labeled, or repacked in substantial quantities at
establishments other than those where originally processed or
packed, on condition that such drugs and devices are not
adulterated or misbranded, under the provisions of this Act
upon removal from such processing, labeling, or repacking
establishment.
(b)(1) A drug intended for use by man which--
(A) because of its toxicity or other potentiality for
harmful effect, or the method of its use, or the
collateral measures necessary to its use, is not safe
for use except under the supervision of a practitioner
licensed by law to administer such drug; or
(B) is limited by an approved application under
section 505 to use under the professional supervision
of a practitioner licensed by law to administer such
drug;
shall be dispensed only (i) upon a written prescription of a
practitioner licensed by law to administer such drug, or (ii)
upon an oral prescription of such practitioner which is reduced
promptly to writing and filed by the pharmacist, or (iii) by
refilling any such written or oral prescription if such
refilling is authorized by the prescriber either in the
original prescription or by oral order which is reduced
promptly to writing and filed by the pharmacist. The act of
dispensing a drug contrary to the provisions of this paragraph
shall be deemed to be an act which results in the drug being
misbranded while held for sale.
(2) Any drug dispensed by filling or refilling a written or
oral prescription of a practitioner licensed by law to
administer such drug shall be exempt from the requirements of
section 502, except paragraphs (a), (i) (2) and (3), (k), and
(l), and the packaging requirements of paragraphs (g), (h), and
(p), if the drug bears a label containing the name and address
of the dispenser, the serial number and date of the
prescription or of its filling, the name of the prescriber,
and, if stated in the prescription, the name of the patient,
and the directions for use and cautionary statements, if any,
contained in such prescription. This exemption shall not apply
to any drug dispensed in the course of the conduct of a
business of dispensing drugs pursuant to diagnosis by mail, or
to a drug dispensed in violation of paragraph (1) of this
subsection.
(3) The Secretary may by regulation remove drugs subject to
section 505 from the requirements of paragraph (1) of this
subsection when such requirements are not necessary for the
protection of the public health.
(4)(A) A drug that is subject to paragraph (1) shall be
deemed to be misbranded if at any time prior to dispensing the
label of the drug fails to bear, at a minimum, the symbol ``Rx
only''.
(B) A drug to which paragraph (1) does not apply shall be
deemed to be misbranded if at any time prior to dispensing the
label of the drug bears the symbol described in subparagraph
(A).
(5) Nothing in this subsection shall be construed to relieve
any person from any requirement prescribed by or under
authority of law with respect to drugs now included or which
may hereafter be included within the classifications stated in
section 3220 of the Internal Revenue Code (26 U.S.C. 3220), or
to marihuana as defined in section 3238(b) of the Internal
Revenue Code (26 U.S.C. 3238(b)).
(c)(1) No person may sell, purchase, or trade or offer to
sell, purchase, or trade any drug sample. For purposes of this
paragraph and subsection (d), the term ``drug sample'' means a
unit of a drug, subject to subsection (b), which is not
intended to be sold and is intended to promote the sale of the
drug. Nothing in this paragraph shall subject an officer or
executive of a drug manufacturer or distributor to criminal
liability solely because of a sale, purchase, trade, or offer
to sell, purchase, or trade in violation of this paragraph by
other employees of the manufacturer or distributor.
(2) No person may sell, purchase, or trade, offer to sell,
purchase, or trade, or counterfeit any coupon. For purposes of
this paragraph, the term ``coupon'' means a form which may be
redeemed, at no cost or at a reduced cost, for a drug which is
prescribed in accordance with subsection (b).
(3)(A) No person may sell, purchase, or trade, or offer to
sell, purchase, or trade, any drug--
(i) which is subject to subsection (b), and
(ii)(I) which was purchased by a public or private
hospital or other health care entity, or
(II) which was donated or supplied at a reduced price
to a charitable organization described in section
501(c)(3) of the Internal Revenue Code of 1954.
(B) Subparagraph (A) does not apply to--
(i) the purchase or other acquisition by a hospital
or other health care entity which is a member of a
group purchasing organization of a drug for its own use
from the group purchasing organization or from other
hospitals or health care entities which are members of
such organization,
(ii) the sale, purchase, or trade of a drug or an
offer to sell, purchase, or trade a drug by an
organization described in subparagraph (A)(ii)(II) to a
nonprofit affiliate of the organization to the extent
otherwise permitted by law,
(iii) a sale, purchase, or trade of a drug or an
offer to sell, purchase, or trade a drug among
hospitals or other health care entities which are under
common control,
(iv) a sale, purchase, or trade of a drug or an offer
to sell, purchase, or trade a drug for emergency
medical reasons, or
(v) a sale, purchase, or trade of a drug, an offer to
sell, purchase, or trade a drug, or the dispensing of a
drug pursuant to a prescription executed in accordance
with subsection (b).
For purposes of this paragraph, the term ``entity'' does not
include a wholesale distributor of drugs or a retail pharmacy
licensed under State law and the term ``emergency medical
reasons'' includes transfers of a drug between health care
entities or from a health care entity to a retail pharmacy
undertaken to alleviate temporary shortages of the drug arising
from delays in or interruptions of regular distribution
schedules.
(d)(1) Except as provided in paragraphs (2) and (3), no
person may distribute any drug sample. For purposes of this
subsection, the term ``distribute'' does not include the
providing of a drug sample to a patient by a--
(A) practitioner licensed to prescribe such drug,
(B) health care professional acting at the direction
and under the supervision of such a practitioner, or
(C) pharmacy of a hospital or of another health care
entity that is acting at the direction of such a
practitioner and that received such sample pursuant to
paragraph (2) or (3).
(2)(A) The manufacturer or authorized distributor of record
of a drug subject to subsection (b) may, in accordance with
this paragraph, distribute drug samples by mail or common
carrier to practitioners licensed to prescribe such drugs or,
at the request of a licensed practitioner, to pharmacies of
hospitals or other health care entities. Such a distribution of
drug samples may only be made--
(i) in response to a written request for drug samples
made on a form which meets the requirements of
subparagraph (B), and
(ii) under a system which requires the recipient of
the drug sample to execute a written receipt for the
drug sample upon its delivery and the return of the
receipt to the manufacturer or authorized distributor
of record.
(B) A written request for a drug sample required by
subparagraph (A)(i) shall contain--
(i) the name, address, professional designation, and
signature of the practitioner making the request,
(ii) the identity of the drug sample requested and
the quantity requested,
(iii) the name of the manufacturer of the drug sample
requested, and
(iv) the date of the request.
(C) Each drug manufacturer or authorized distributor of
record which makes distributions by mail or common carrier
under this paragraph shall maintain, for a period of 3 years,
the request forms submitted for such distributions and the
receipts submitted for such distributions and shall maintain a
record of distributions of drug samples which identifies the
drugs distributed and the recipients of the distributions.
Forms, receipts, and records required to be maintained under
this subparagraph shall be made available by the drug
manufacturer or authorized distributor of record to Federal and
State officials engaged in the regulation of drugs and in the
enforcement of laws applicable to drugs.
(3) The manufacturer or authorized distributor of record of a
drug subject to subsection (b) may, by means other than mail or
common carrier, distribute drug samples only if the
manufacturer or authorized distributor of record makes the
distributions in accordance with subparagraph (A) and carries
out the activities described in subparagraphs (B) through (F)
as follows:
(A) Drug samples may only be distributed--
(i) to practitioners licensed to prescribe
such drugs if they make a written request for
the drug samples, or
(ii) at the written request of such a
licensed practitioner, to pharmacies of
hospitals or other health care entities.
A written request for drug samples shall be made on a
form which contains the practitioner's name, address,
and professional designation, the identity of the drug
sample requested, the quantity of drug samples
requested, the name of the manufacturer or authorized
distributor of record of the drug sample, the date of
the request and signature of the practitioner making
the request.
(B) Drug manufacturers or authorized distributors of
record shall store drug samples under conditions that
will maintain their stability, integrity, and
effectiveness and will assure that the drug samples
will be free of contamination, deterioration, and
adulteration.
(C) Drug manufacturers or authorized distributors of
record shall conduct, at least annually, a complete and
accurate inventory of all drug samples in the
possession of representatives of the manufacturer or
authorized distributor of record. Drug manufacturers or
authorized distributors of record shall maintain lists
of the names and address of each of their
representatives who distribute drug samples and of the
sites where drug samples are stored. Drug manufacturers
or authorized distributors of record shall maintain
records for at least 3 years of all drug samples
distributed, destroyed, or returned to the manufacturer
or authorized distributor of record, of all inventories
maintained under this subparagraph, of all thefts or
significant losses of drug samples, and of all requests
made under subparagraph (A) for drug samples. Records
and lists maintained under this subparagraph shall be
made available by the drug manufacturer or authorized
distributor of record to the Secretary upon request.
(D) Drug manufacturers or authorized distributors of
record shall notify the Secretary of any significant
loss of drug samples and any known theft of drug
samples.
(E) Drug manufacturers or authorized distributors of
record shall report to the Secretary any conviction of
their representatives for violations of subsection
(c)(1) or a State law because of the sale, purchase, or
trade of a drug sample or the offer to sell, purchase,
or trade a drug sample.
(F) Drug manufacturers or authorized distributors of
record shall provide to the Secretary the name and
telephone number of the individual responsible for
responding to a request for information respecting drug
samples.
(4) In this subsection, the term ``authorized
distributors of record'' means those distributors with
whom a manufacturer has established an ongoing
relationship to distribute such manufacturer's
products.
(e)
(1) Requirement.--Subject to section 583:
(A) In general.--No person may engage in
wholesale distribution of a drug subject to
subsection (b)(1) in any State unless such
person--
(i)(I) is licensed by the State from
which the drug is distributed; or
(II) if the State from which the drug
is distributed has not established a
licensure requirement, is licensed by
the Secretary; and
(ii) if the drug is distributed
interstate, is licensed by the State
into which the drug is distributed if
the State into which the drug is
distributed requires the licensure of a
person that distributes drugs into the
State.
(B) Standards.--Each Federal and State
license described in subparagraph (A) shall
meet the standards, terms, and conditions
established by the Secretary under section 583.
(2) Reporting and database.--
(A) Reporting.--Beginning January 1, 2015,
any person who owns or operates an
establishment that engages in wholesale
distribution shall--
(i) report to the Secretary, on an
annual basis pursuant to a schedule
determined by the Secretary--
(I) each State by which the
person is licensed and the
appropriate identification
number of each such license;
and
(II) the name, address, and
contact information of each
facility at which, and all
trade names under which, the
person conducts business; and
(ii) report to the Secretary within a
reasonable period of time and in a
reasonable manner, as determined by the
Secretary, any significant disciplinary
actions, such as the revocation or
suspension of a wholesale distributor
license, taken by a State or the
Federal Government during the reporting
period against the wholesale
distributor.
(B) Database.--Not later than January 1,
2015, the Secretary shall establish a database
of authorized wholesale distributors. Such
database shall--
(i) identify each authorized
wholesale distributor by name, contact
information, and each State where such
wholesale distributor is appropriately
licensed to engage in wholesale
distribution;
(ii) be available to the public on
the Internet Web site of the Food and
Drug Administration; and
(iii) be regularly updated on a
schedule determined by the Secretary.
(C) Coordination.--The Secretary shall
establish a format and procedure for
appropriate State officials to access the
information provided pursuant to subparagraph
(A) in a prompt and secure manner.
(D) Confidentiality.--Nothing in this
paragraph shall be construed as authorizing the
Secretary to disclose any information that is a
trade secret or confidential information
subject to section 552(b)(4) of title 5, United
States Code, or section 1905 of title 18,
United States Code.
(3) Costs.--
(A) Authorized fees of secretary.--If a State
does not establish a licensing program for
persons engaged in the wholesale distribution
of a drug subject to subsection (b), the
Secretary shall license a person engaged in
wholesale distribution located in such State
and may collect a reasonable fee in such amount
necessary to reimburse the Secretary for costs
associated with establishing and administering
the licensure program and conducting periodic
inspections under this section. The Secretary
shall adjust fee rates as needed on an annual
basis to generate only the amount of revenue
needed to perform this service. Fees authorized
under this paragraph shall be collected and
available for obligation only to the extent and
in the amount provided in advance in
appropriations Acts. Such fees are authorized
to remain available until expended. Such sums
as may be necessary may be transferred from the
Food and Drug Administration salaries and
expenses appropriation account without fiscal
year limitation to such appropriation account
for salaries and expenses with such fiscal year
limitation.
(B) State licensing fees.--Nothing in this
Act shall prohibit States from collecting fees
from wholesale distributors in connection with
State licensing of such distributors.
(4) For the purposes of this subsection and
subsection (d), the term ``wholesale distribution''
means the distribution of a drug subject to subsection
(b) to a person other than a consumer or patient, or
receipt of a drug subject to subsection (b) by a person
other than the consumer or patient, but does not
include--
(A) intracompany distribution of any drug
between members of an affiliate or within a
manufacturer;
(B) the distribution of a drug, or an offer
to distribute a drug among hospitals or other
health care entities which are under common
control;
(C) the distribution of a drug or an offer to
distribute a drug for emergency medical
reasons, including a public health emergency
declaration pursuant to section 319 of the
Public Health Service Act, except that, for
purposes of this paragraph, a drug shortage not
caused by a public health emergency shall not
constitute an emergency medical reason;
(D) the dispensing of a drug pursuant to a
prescription executed in accordance with
subsection (b)(1);
(E) the distribution of minimal quantities of
drug by a licensed retail pharmacy to a
licensed practitioner for office use;
(F) the distribution of a drug or an offer to
distribute a drug by a charitable organization
to a nonprofit affiliate of the organization to
the extent otherwise permitted by law;
(G) the purchase or other acquisition by a
dispenser, hospital, or other health care
entity of a drug for use by such dispenser,
hospital, or other health care entity;
(H) the distribution of a drug by the
manufacturer of such drug;
(I) the receipt or transfer of a drug by an
authorized third-party logistics provider
provided that such third-party logistics
provider does not take ownership of the drug;
(J) a common carrier that transports a drug,
provided that the common carrier does not take
ownership of the drug;
(K) the distribution of a drug, or an offer
to distribute a drug by an authorized
repackager that has taken ownership or
possession of the drug and repacks it in
accordance with section 582(e);
(L) salable drug returns when conducted by a
dispenser;
(M) the distribution of a collection of
finished medical devices, which may include a
product or biological product, assembled in kit
form strictly for the convenience of the
purchaser or user (referred to in this
subparagraph as a ``medical convenience kit'')
if--
(i) the medical convenience kit is
assembled in an establishment that is
registered with the Food and Drug
Administration as a device manufacturer
in accordance with section 510(b)(2);
(ii) the medical convenience kit does
not contain a controlled substance that
appears in a schedule contained in the
Comprehensive Drug Abuse Prevention and
Control Act of 1970;
(iii) in the case of a medical
convenience kit that includes a
product, the person that manufacturers
the kit--
(I) purchased such product
directly from the
pharmaceutical manufacturer or
from a wholesale distributor
that purchased the product
directly from the
pharmaceutical manufacturer;
and
(II) does not alter the
primary container or label of
the product as purchased from
the manufacturer or wholesale
distributor; and
(iv) in the case of a medical
convenience kit that includes a
product, the product is--
(I) an intravenous solution
intended for the replenishment
of fluids and electrolytes;
(II) a product intended to
maintain the equilibrium of
water and minerals in the body;
(III) a product intended for
irrigation or reconstitution;
(IV) an anesthetic;
(V) an anticoagulant;
(VI) a vasopressor; or
(VII) a sympathomimetic;
(N) the distribution of an intravenous drug
that, by its formulation, is intended for the
replenishment of fluids and electrolytes (such
as sodium, chloride, and potassium) or calories
(such as dextrose and amino acids);
(O) the distribution of an intravenous drug
used to maintain the equilibrium of water and
minerals in the body, such as dialysis
solutions;
(P) the distribution of a drug that is
intended for irrigation, or sterile water,
whether intended for such purposes or for
injection;
(Q) the distribution of medical gas, as
defined in section 575;
(R) facilitating the distribution of a
product by providing solely administrative
services, including processing of orders and
payments; or
(S) the transfer of a product by a hospital
or other health care entity, or by a wholesale
distributor or manufacturer operating at the
direction of the hospital or other health care
entity, to a repackager described in section
581(16)(B) and registered under section 510 for
the purpose of repackaging the drug for use by
that hospital, or other health care entity and
other health care entities that are under
common control, if ownership of the drug
remains with the hospital or other health care
entity at all times.
(5) Third-party logistics providers.--Notwithstanding
paragraphs (1) through (4), each entity that meets the
definition of a third-party logistics provider under
section 581(22) shall obtain a license as a third-party
logistics provider as described in section 584(a) and
is not required to obtain a license as a wholesale
distributor if the entity never assumes an ownership
interest in the product it handles.
(6) Affiliate.--For purposes of this subsection, the
term ``affiliate'' means a business entity that has a
relationship with a second business entity if, directly
or indirectly--
(A) one business entity controls, or has the
power to control, the other business entity; or
(B) a third party controls, or has the power
to control, both of the business entities.
(f)(1)(A) A drug intended for use by animals other than man,
other than a veterinary feed directive drug intended for use in
animal feed or an animal feed bearing or containing a
veterinary feed directive drug, which--
(i) because of its toxicity or other potentiality for
harmful effect, or the method of its use, or the
collateral measures necessary for its use, is not safe
for animal use except under the professional
supervision of a licensed veterinarian, or
(ii) is limited by an approved application under
subsection (b) of section 512, a conditionally-approved
application under section 571, or an index listing
under section 572 to use under the professional
supervision of a licensed veterinarian,
shall be dispensed only by or upon the lawful written or oral
order of a licensed veterinarian in the course of the
veterinarian's professional practice.
(B) For purposes of subparagraph (A), an order is lawful if
the order--
(i) is a prescription or other order authorized by
law,
(ii) is, if an oral order, promptly reduced to
writing by the person lawfully filling the order, and
filed by that person, and
(iii) is refilled only if authorized in the original
order or in a subsequent oral order promptly reduced to
writing by the person lawfully filling the order, and
filed by that person.
(C) The act of dispensing a drug contrary to the provisions
of this paragraph shall be deemed to be an act which results in
the drug being misbranded while held for sale.
(2) Any drug when dispensed in accordance with paragraph (1)
of this subsection--
(A) Shall be exempt from the requirements of section
502, except subsections (a), (g), (h), (i)(2), (i)(3),
and (p) of such section, and
(B) shall be exempt from the packaging requirements
of subsections (g), (h), and (p) of such section, if--
(i) when dispensed by a licensed
veterinarian, the drug bears a label containing
the name and address of the practitioner and
any directions for use and cautionary
statements specified by the practitioner, or
(ii) when dispensed by filling the lawful
order of a licensed veterinarian, the drug
bears a label containing the name and address
of the dispenser, the serial number and date of
the order or of its filing, the name of the
licensed veterinarian, and the directions for
use and cautionary statements, if any,
contained in such order.
The preceding sentence shall not apply to any drug dispensed in
the course of the conduct of a business of dispensing drugs
pursuant to diagnosis by mail.
(3) The Secretary may by regulation exempt drugs for animals
other than man subject to section 512, 571, or 572 from the
requirements of paragraph (1) when such requirements are not
necessary for the protection of the public health.
(4) A drug which is subject to paragraph (1) shall be deemed
to be misbranded if at any time prior to dispensing its label
fails to bear the statement ``Caution: Federal law restricts
this drug to use by or on the order of a licensed
veterinarian.''. A drug to which paragraph (1) does not apply
shall be deemed to be misbranded if at any time prior to
dispensing its label bears the statement specified in the
preceding sentence.
(g)(1)(A) The Secretary shall, in accordance with this
subsection, assign a primary agency center to regulate products
that constitute a combination of a drug, device, or biological
product.
(B) The Secretary shall conduct the premarket review of any
combination product under a single application, whenever
appropriate.
(C) For purposes of this subsection, the term ``primary mode
of action'' means the single mode of action of a combination
product expected to make the greatest contribution to the
overall intended therapeutic effects of the combination
product.
(D) The Secretary shall determine the primary mode of action
of the combination product. If the Secretary determines that
the primary mode of action is that of--
(i) a drug (other than a biological product), the
agency center charged with premarket review of drugs
shall have primary jurisdiction;
(ii) a device, the agency center charged with
premarket review of devices shall have primary
jurisdiction; or
(iii) a biological product, the agency center charged
with premarket review of biological products shall have
primary jurisdiction.
(E) In determining the primary mode of action of a
combination product, the Secretary shall not determine that the
primary mode of action is that of a drug or biological product
solely because the combination product has any chemical action
within or on the human body.
(F) If a sponsor of a combination product disagrees with the
determination under subparagraph (D)--
(i) such sponsor may request, and the Secretary shall
provide, a substantive rationale to such sponsor that
references scientific evidence provided by the sponsor
and any other scientific evidence relied upon by the
Secretary to support such determination; and
(ii)(I) the sponsor of the combination product may
propose one or more studies (which may be nonclinical,
clinical, or both) to establish the relevance, if any,
of the chemical action in achieving the primary mode of
action of such product;
(II) if the sponsor proposes any such studies, the
Secretary and the sponsor of such product shall
collaborate and seek to reach agreement, within a
reasonable time of such proposal, not to exceed 90
calendar days, on the design of such studies; and
(III) if an agreement is reached under subclause (II)
and the sponsor conducts one or more of such studies,
the Secretary shall consider the data resulting from
any such study when reevaluating the determination of
the primary mode of action of such product, and unless
and until such reevaluation has occurred and the
Secretary issues a new determination, the determination
of the Secretary under subparagraph (D) shall remain in
effect.
(2)(A)(i) To establish clarity and certainty for the sponsor,
the sponsor of a combination product may request a meeting on
such combination product. If the Secretary concludes that a
determination of the primary mode of action pursuant to
paragraph (1)(D) is necessary, the sponsor may request such
meeting only after the Secretary makes such determination. If
the sponsor submits a written meeting request, the Secretary
shall, not later than 75 calendar days after receiving such
request, meet with the sponsor of such combination product.
(ii) A meeting under clause (i) may--
(I) address the standards and requirements for market
approval or clearance of the combination product;
(II) address other issues relevant to such
combination product, such as requirements related to
postmarket modification of such combination product and
good manufacturing practices applicable to such
combination product; and
(III) identify elements under subclauses (I) and (II)
that may be more appropriate for discussion and
agreement with the Secretary at a later date given that
scientific or other information is not available, or
agreement is otherwise not feasible regarding such
elements, at the time a request for such meeting is
made.
(iii) Any agreement under this subparagraph shall be in
writing and made part of the administrative record by the
Secretary.
(iv) Any such agreement shall remain in effect, except--
(I) upon the written agreement of the Secretary and
the sponsor or applicant; or
(II) pursuant to a decision by the director of the
reviewing division of the primary agency center, or a
person more senior than such director, in consultation
with consulting centers and the Office, as appropriate,
that an issue essential to determining whether the
standard for market clearance or other applicable
standard under this Act or the Public Health Service
Act applicable to the combination product has been
identified since the agreement was reached, or that
deviating from the agreement is otherwise justifiable
based on scientific evidence, for public health
reasons.
(3) For purposes of conducting the premarket review of a
combination product that contains an approved constituent part
described in paragraph (4), the Secretary may require that the
sponsor of such combination product submit to the Secretary
only data or information that the Secretary determines is
necessary to meet the standard for clearance or approval, as
applicable, under this Act or the Public Health Service Act,
including any incremental risks and benefits posed by such
combination product, using a risk-based approach and taking
into account any prior finding of safety and effectiveness or
substantial equivalence for the approved constituent part
relied upon by the applicant in accordance with paragraph (5).
(4) For purposes of paragraph (3), an approved constituent
part is--
(A) a drug constituent part of a combination product
being reviewed in a single application or request under
section 515, 510(k), or 513(f)(2) (submitted in
accordance with paragraph (5)), that is an approved
drug, provided such application or request complies
with paragraph (5);
(B) a device constituent part approved under section
515 that is referenced by the sponsor and that is
available for use by the Secretary under section
520(h)(4); or
(C) any constituent part that was previously
approved, cleared, or classified under section 505,
510(k), 513(f)(2), or 515 of this Act for which the
sponsor has a right of reference or any constituent
part that is a nonprescription drug, as defined in
section 760(a)(2).
(5)(A) If an application is submitted under section 515 or
510(k) or a request is submitted under section 513(f)(2),
consistent with any determination made under paragraph (1)(D),
for a combination product containing as a constituent part an
approved drug--
(i) the application or request shall include the
certification or statement described in section
505(b)(2); and
(ii) the applicant or requester shall provide notice
as described in section 505(b)(3).
(B) For purposes of this paragraph and paragraph (4), the
term ``approved drug'' means an active ingredient--
(i) that was in an application previously approved
under section 505(c);
(ii) where such application is relied upon by the
applicant submitting the application or request
described in subparagraph (A);
(iii) for which full reports of investigations that
have been made to show whether such drug is safe for
use and whether such drug is effective in use were not
conducted by or for the applicant submitting the
application or request described in subparagraph (A);
and
(iv) for which the applicant submitting the
application or request described in subparagraph (A)
has not obtained a right of reference or use from the
person by or for whom the investigations described in
clause (iii) were conducted.
(C) The following provisions shall apply with respect to an
application or request described in subparagraph (A) to the
same extent and in the same manner as if such application or
request were an application described in section 505(b)(2) that
referenced the approved drug:
(i) Subparagraphs (A), (B), (C), and (D) of section
505(c)(3).
(ii) Clauses (ii), (iii), and (iv) of section
505(c)(3)(E).
(iii) Subsections (b) and (c) of section 505A.
(iv) Section 505E(a).
(v) Section 527(a).
(D) Notwithstanding any other provision of this subsection,
an application or request for classification for a combination
product described in subparagraph (A) shall be considered an
application submitted under section 505(b)(2) for purposes of
section 271(e)(2)(A) of title 35, United States Code.
(6) Nothing in this subsection shall be construed as
prohibiting a sponsor from submitting separate applications for
the constituent parts of a combination product, unless the
Secretary determines that a single application is necessary.
(7) Nothing in this subsection shall prevent the Secretary
from using any agency resources of the Food and Drug
Administration necessary to ensure adequate review of the
safety, effectiveness, or substantial equivalence of an
article.
(8)(A) Not later than 60 days after the date of the enactment
of this paragraph, the Secretary shall establish within the
Office of the Commissioner of Food and Drugs an office to
ensure the prompt assignment of combination products to agency
centers, the timely and effective premarket review of such
products, and consistent and appropriate postmarket regulation
of like products subject to the same statutory requirements to
the extent permitted by law. Additionally, the office shall, in
determining whether a product is to be designated a combination
product, consult with the component within the Office of the
Commissioner of Food and Drugs that is responsible for such
determinations. Such office (referred to in this paragraph as
the ``Office'') shall have appropriate scientific and medical
expertise, and shall be headed by a director.
(B) In carrying out this subsection, the Office shall, for
each combination product, promptly assign an agency center with
primary jurisdiction in accordance with paragraph (1) for the
premarket review of such product.
(C)(i) In carrying out this subsection, the Office shall help
to ensure timely and effective premarket review that involves
more than one agency center by coordinating such reviews,
overseeing the timeliness of such reviews, and overseeing the
alignment of feedback regarding such reviews.
(ii) In order to ensure the timeliness and alignment of the
premarket review of a combination product, the agency center
with primary jurisdiction for the product, and the consulting
agency center, shall be responsible to the Office with respect
to the timeliness and alignment of the premarket review.
(iii) The Office shall ensure that, with respect to a
combination product, a designated person or persons in the
primary agency center is the primary point or points of contact
for the sponsor of such combination product. The Office shall
also coordinate communications to and from any consulting
center involved in such premarket review, if requested by such
primary agency center or any such consulting center. Agency
communications and commitments, to the extent consistent with
other provisions of law and the requirements of all affected
agency centers, from the primary agency center shall be
considered as communication from the Secretary on behalf of all
agency centers involved in the review.
(iv) The Office shall, with respect to the premarket review
of a combination product--
(I) ensure that any meeting between the Secretary and
the sponsor of such product is attended by each agency
center involved in the review, as appropriate;
(II) ensure that each consulting agency center has
completed its premarket review and provided the results
of such review to the primary agency center in a timely
manner; and
(III) ensure that each consulting center follows the
guidance described in clause (vi) and advises, as
appropriate, on other relevant regulations, guidances,
and policies.
(v) In seeking agency action with respect to a combination
product, the sponsor of such product--
(I) shall identify the product as a combination
product; and
(II) may request in writing the participation of
representatives of the Office in meetings related to
such combination product, or to have the Office
otherwise engage on such regulatory matters concerning
the combination product.
(vi) Not later than 4 years after the date of enactment of
the 21st Century Cures Act, and after a public comment period
of not less than 60 calendar days, the Secretary shall issue a
final guidance that describes--
(I) the structured process for managing pre-
submission interactions with sponsors developing
combination products;
(II) the best practices for ensuring that the
feedback in such pre-submission interactions represents
the Agency's best advice based on the information
provided during such pre-submission interactions;
(III) the information that is required to be
submitted with a meeting request under paragraph (2),
how such meetings relate to other types of meetings in
the Food and Drug Administration, and the form and
content of any agreement reached through a meeting
under such paragraph (2);
(D) In carrying out this subsection, the Office shall ensure
the consistency and appropriateness of postmarket regulation of
like products subject to the same statutory requirements to the
extent permitted by law.
(E)(i) Any dispute regarding the timeliness of the premarket
review of a combination product may be presented to the Office
for resolution, unless the dispute is clearly premature.
(ii) During the review process, any dispute regarding the
substance of the premarket review may be presented to the
Commissioner of Food and Drugs after first being considered by
the agency center with primary jurisdiction of the premarket
review, under the scientific dispute resolution procedures for
such center. The Commissioner of Food and Drugs shall consult
with the Director of the Office in resolving the substantive
dispute.
(F) The Secretary, acting through the Office, shall review
each agreement, guidance, or practice of the Secretary that is
specific to the assignment of combination products to agency
centers and shall determine whether the agreement, guidance, or
practice is consistent with the requirements of this
subsection. In carrying out such review, the Secretary shall
consult with stakeholders and the directors of the agency
centers. After such consultation, the Secretary shall determine
whether to continue in effect, modify, revise, or eliminate
such agreement, guidance, or practice, and shall publish in the
Federal Register a notice of the availability of such modified
or revised agreement, guidance or practice. Nothing in this
paragraph shall be construed as preventing the Secretary from
following each agreement, guidance, or practice until
continued, modified, revised, or eliminated.
(G) Not later than one year after the date of the enactment
of this paragraph (except with respect to clause (iv),
beginning not later than one year after the date of the
enactment of the 21st Century Cures Act) and annually
thereafter, the Secretary shall report to the appropriate
committees of Congress on the activities and impact of the
Office. The report shall include provisions--
(i) describing the numbers and types of combination
products under review and the timeliness in days of
such assignments, reviews, and dispute resolutions;
(ii) identifying the number of premarket reviews of
such products that involved a consulting agency center;
(iii) describing improvements in the consistency of
postmarket regulation of combination products; and
(iv) identifying the percentage of combination
products for which a dispute resolution, with respect
to premarket review, was requested by the combination
product's sponsor.
(H) Nothing in this paragraph shall be construed to limit the
regulatory authority of any agency center.
(9) As used in this subsection:
(A) The term ``agency center'' means a center or
alternative organizational component of the Food and
Drug Administration.
(B) The term ``biological product'' has the meaning
given the term in section 351(i) of the Public Health
Service Act (42 U.S.C. 262(i)).
(C) The term ``market clearance'' includes--
(i) approval of an application under section
505, 507, 515, or 520(g);
(ii) a finding of substantial equivalence
under this subchapter;
(iii) approval of a biologics license
application under subsection (a) of section 351
of the Public Health Service Act (42 U.S.C.
262); and
(iv) de novo classification under section
513(a)(1).
(D) The terms ``premarket review'' and ``reviews''
include all activities of the Food and Drug
Administration conducted prior to approval or clearance
of an application, notification, or request for
classification submitted under section 505, 510(k),
513(f)(2), 515, or 520 of this Act or under section 351
of the Public Health Service Act, including with
respect to investigational use of the product.
(h)(1) Any contrast agent, radioactive drug, or OTC monograph
drug shall be deemed to be a drug under section 201(g) and not
a device under section 201(h).
(2) For purposes of this subsection:
(A) The term ``contrast agent'' means an article that
is intended for use in conjunction with a medical
imaging device, and--
(i) is a diagnostic radiopharmaceutical, as
defined in sections 315.2 and 601.31 of title
21, Code of Federal Regulations (or any
successor regulations); or
(ii) is a diagnostic agent that improves the
visualization of structure or function within
the body by increasing the relative difference
in signal intensity within the target tissue,
structure, or fluid.
(B) The term `radioactive drug' has the meaning given
such term in section 310.3(n) of title 21, Code of
Federal Regulations (or any successor regulations),
except that such term does not include--
(i) an implant or article similar to an
implant;
(ii) an article that applies radiation from
outside of the body; or
(iii) the radiation source of an article
described in clause (i) or (ii).
(C) The term `OTC monograph drug' has the meaning
given such term in section 744L.
(3) Nothing in this subsection shall be construed as allowing
for the classification of a product as a drug (as defined in
section 201(g)) if such product--
(A) is not described in paragraph (1); and
(B) meets the definition of a device under section
201(h),
unless another provision of this Act otherwise indicates a
different classification.
* * * * * * *
new drugs
Sec. 505. (a) No person shall introduce or deliver for
introduction into interstate commerce any new drug, unless an
approval of an application filed pursuant to subsection (b) or
(j) is effective with respect to such drug.
(b)
(b)(1)(A) Any person may file with the Secretary an
application with respect to any drug subject to the provisions
of subsection (a). Such persons shall submit to the Secretary
as part of the application--
(i) full reports of investigations which have been
made to show whether such drug is safe for use and
whether such drug is effective in use;
(ii) a full list of the articles used as components
of such drug;
(iii) a full statement of the composition of such
drug;
(iv) a full description of the methods used in, and
the facilities and controls used for, the manufacture,
processing, and packing of such drug;
(v) such samples of such drug and of the articles
used as components thereof as the Secretary may
require;
(vi) specimens of the labeling proposed to be used
for such drug;
(vii) any assessments required under section 505B;
and
(viii) the patent number and expiration date of each
patent for which a claim of patent infringement could
reasonably be asserted if a person not licensed by the
owner of the patent engaged in the manufacture, use, or
sale of the drug, and that--
(I) claims the drug for which the applicant
submitted the application and is a drug
substance (active ingredient) patent or a drug
product (formulation or composition) patent; or
(II) claims a method of using such drug for
which approval is sought or has been granted in
the application.
(B) If an application is filed under this subsection for a
drug, and a patent of the type described in subparagraph
(A)(viii) is issued after the filing date but before approval
of the application, the applicant shall amend the application
to include the patent number and expiration date.
(2) An application submitted under paragraph (1) for a drug
for which the investigations described in clause (A) of such
paragraph and relied upon by the applicant for approval of the
application were not conducted by or for the applicant and for
which the applicant has not obtained a right of reference or
use from the person by or for whom the investigations were
conducted shall also include--
(A) a certification, in the opinion of the applicant
and to the best of his knowledge, with respect to each
patent which claims the drug for which such
investigations were conducted or which claims a use for
such drug for which the applicant is seeking approval
under this subsection and for which information is
required to be filed under paragraph (1) or subsection
(c)--
(i) that such patent information has not been
filed,
(ii) that such patent has expired,
(iii) of the date on which such patent will
expire, or
(iv) that such patent is invalid or will not
be infringed by the manufacture, use, or sale
of the new drug for which the application is
submitted; and
(B) if with respect to the drug for which
investigations described in paragraph (1)(A) were
conducted information was filed under paragraph (1) or
subsection (c) for a method of use patent which does
not claim a use for which the applicant is seeking
approval under this subsection, a statement that the
method of use patent does not claim such a use.
(3) Notice of opinion that patent is invalid or will not be
infringed.--
(A) Agreement to give notice.--An applicant that
makes a certification described in paragraph (2)(A)(iv)
shall include in the application a statement that the
applicant will give notice as required by this
paragraph.
(B) Timing of notice.--An applicant that makes a
certification described in paragraph (2)(A)(iv) shall
give notice as required under this paragraph--
(i) if the certification is in the
application, not later than 20 days after the
date of the postmark on the notice with which
the Secretary informs the applicant that the
application has been filed; or
(ii) if the certification is in an amendment
or supplement to the application, at the time
at which the applicant submits the amendment or
supplement, regardless of whether the applicant
has already given notice with respect to
another such certification contained in the
application or in an amendment or supplement to
the application.
(C) Recipients of notice.--An applicant required
under this paragraph to give notice shall give notice
to--
(i) each owner of the patent that is the
subject of the certification (or a
representative of the owner designated to
receive such a notice); and
(ii) the holder of the approved application
under this subsection for the drug that is
claimed by the patent or a use of which is
claimed by the patent (or a representative of
the holder designated to receive such a
notice).
(D) Contents of notice.--A notice required under this
paragraph shall--
(i) state that an application that contains
data from bioavailability or bioequivalence
studies has been submitted under this
subsection for the drug with respect to which
the certification is made to obtain approval to
engage in the commercial manufacture, use, or
sale of the drug before the expiration of the
patent referred to in the certification; and
(ii) include a detailed statement of the
factual and legal basis of the opinion of the
applicant that the patent is invalid or will
not be infringed.
(4)(A) An applicant may not amend or supplement an
application referred to in paragraph (2) to seek approval of a
drug that is a different drug than the drug identified in the
application as submitted to the Secretary.
(B) With respect to the drug for which such an application is
submitted, nothing in this subsection or subsection (c)(3)
prohibits an applicant from amending or supplementing the
application to seek approval of a different strength.
(5)(A) The Secretary shall issue guidance for the individuals
who review applications submitted under paragraph (1) or under
section 351 of the Public Health Service Act, which shall
relate to promptness in conducting the review, technical
excellence, lack of bias and conflict of interest, and
knowledge of regulatory and scientific standards, and which
shall apply equally to all individuals who review such
applications.
(B) The Secretary shall meet with a sponsor of an
investigation or an applicant for approval for a drug under
this subsection or section 351 of the Public Health Service Act
if the sponsor or applicant makes a reasonable written request
for a meeting for the purpose of reaching agreement on the
design and size--
(i)(I) of clinical trials intended to form the
primary basis of an effectiveness claim; or
(II) in the case where human efficacy studies are not
ethical or feasible, of [animal] nonclinical tests and
any associated clinical trials which, in combination,
are intended to form the primary basis of an
effectiveness claim; or
(ii) with respect to an application for approval of a
biological product under section 351(k) of the Public
Health Service Act, of any necessary clinical study or
studies.
The sponsor or applicant shall provide information necessary
for discussion and agreement on the design and size of the
clinical trials. Minutes of any such meeting shall be prepared
by the Secretary and made available to the sponsor or applicant
upon request.
(C) Any agreement regarding the parameters of the design and
size of clinical trials of a new drug under this paragraph that
is reached between the Secretary and a sponsor or applicant
shall be reduced to writing and made part of the administrative
record by the Secretary. Such agreement shall not be changed
after the testing begins, except--
(i) with the written agreement of the sponsor or
applicant; or
(ii) pursuant to a decision, made in accordance with
subparagraph (D) by the director of the reviewing
division, that a substantial scientific issue essential
to determining the safety or effectiveness of the drug
has been identified after the testing has begun.
(D) A decision under subparagraph (C)(ii) by the director
shall be in writing and the Secretary shall provide to the
sponsor or applicant an opportunity for a meeting at which the
director and the sponsor or applicant will be present and at
which the director will document the scientific issue involved.
(E) The written decisions of the reviewing division shall be
binding upon, and may not directly or indirectly be changed by,
the field or compliance division personnel unless such field or
compliance division personnel demonstrate to the reviewing
division why such decision should be modified.
(F) No action by the reviewing division may be delayed
because of the unavailability of information from or action by
field personnel unless the reviewing division determines that a
delay is necessary to assure the marketing of a safe and
effective drug.
(G) For purposes of this paragraph, the reviewing division is
the division responsible for the review of an application for
approval of a drug under this subsection or section 351 of the
Public Health Service Act (including all scientific and medical
matters, chemistry, manufacturing, and controls).
(6) An application submitted under this subsection
shall be accompanied by the certification required
under section 402(j)(5)(B) of the Public Health Service
Act. Such certification shall not be considered an
element of such application.
(c)(1) Within one hundred and eighty days after the filing of
an application under subsection (b), or such additional period
as may be agreed upon by the Secretary and the applicant, the
Secretary shall either--
(A) approve the application if he then finds that
none of the grounds for denying approval specified in
subsection (d) applies, or
(B) give the applicant notice of an opportunity for a
hearing before the Secretary under subsection (d) on
the question whether such application is approvable. If
the applicant elects to accept the opportunity for
hearing by written request within thirty days after
such notice, such hearing shall commence not more than
ninety days after the expiration of such thirty days
unless the Secretary and the applicant otherwise agree.
Any such hearing shall thereafter be conducted on an
expedited basis and the Secretary's order thereon shall
be issued within ninety days after the date fixed by
the Secretary for filing final briefs.
(2) Not later than 30 days after the date of approval of an
application submitted under subsection (b), the holder of the
approved application shall file with the Secretary the patent
number and the expiration date of any patent described in
subsection (b)(1)(A)(viii), except that a patent that is
identified as claiming a method of using such drug shall be
filed only if the patent claims a method of use approved in the
application. If a patent described in subsection
(b)(1)(A)(viii) is issued after the date of approval of an
application submitted under subsection (b), the holder of the
approved application shall, not later than 30 days after the
date of issuance of the patent, file the patent number and the
expiration date of the patent, except that a patent that claims
a method of using such drug shall be filed only if approval for
such use has been granted in the application. If the patent
information described in subsection (b) could not be filed with
the submission of an application under subsection (b) because
the application was filed before the patent information was
required under subsection (b) or a patent was issued after the
application was approved under such subsection, the holder of
an approved application shall file with the Secretary, the
patent number and the expiration date of any patent described
in subsection (b)(1)(A)(viii). If the holder of an approved
application could not file patent information under subsection
(b) because it was not required at the time the application was
approved, the holder shall file such information under this
subsection not later than thirty days after the date of the
enactment of this sentence, and if the holder of an approved
application could not file patent information under subsection
(b) because no patent of the type for which information is
required to be submitted in subsection (b)(1)(A)(viii) had been
issued when an application was filed or approved, the holder
shall file such information under this subsection not later
than thirty days after the date the patent involved is issued.
Upon the submission of patent information under this
subsection, the Secretary shall publish it. Patent
informationthat is not the type of patent information
requiredby subsection (b)(1)(A)(viii) shall not be submitted
underthis paragraph.
(3) The approval of an application filed under subsection (b)
which contains a certification required by paragraph (2) of
such subsection shall be made effective on the last applicable
date determined by applying the following to each certification
made under subsection (b)(2)(A):
(A) If the applicant only made a certification
described in clause (i) or (ii) of subsection (b)(2)(A)
or in both such clauses, the approval may be made
effective immediately.
(B) If the applicant made a certification described
in clause (iii) of subsection (b)(2)(A), the approval
may be made effective on the date certified under
clause (iii).
(C) If the applicant made a certification described
in clause (iv) of subsection (b)(2)(A), the approval
shall be made effective immediately unless, before the
expiration of 45 days after the date on which the
notice described in subsection (b)(3) is received, an
action is brought for infringement of the patent that
is the subject of the certification and for which
information was submitted to the Secretary under
paragraph (2) or subsection (b)(1) before the date on
which the application (excluding an amendment or
supplement to the application) was submitted. If such
an action is brought before the expiration of such
days, the approval may be made effective upon the
expiration of the thirty-month period beginning on the
date of the receipt of the notice provided under
subsection (b)(3) or such shorter or longer period as
the court may order because either party to the action
failed to reasonably cooperate in expediting the
action, except that--
(i) if before the expiration of such period
the district court decides that the patent is
invalid or not infringed (including any
substantive determination that there is no
cause of action for patent infringement or
invalidity), the approval shall be made
effective on--
(I) the date on which the court
enters judgment reflecting the
decision; or
(II) the date of a settlement order
or consent decree signed and entered by
the court stating that the patent that
is the subject of the certification is
invalid or not infringed;
(ii) if before the expiration of such period
the district court decides that the patent has
been infringed--
(I) if the judgment of the district
court is appealed, the approval shall
be made effective on--
(aa) the date on which the
court of appeals decides that
the patent is invalid or not
infringed (including any
substantive determination that
there is no cause of action for
patent infringement or
invalidity); or
(bb) the date of a settlement
order or consent decree signed
and entered by the court of
appeals stating that the patent
that is the subject of the
certification is invalid or not
infringed; or
(II) if the judgment of the district
court is not appealed or is affirmed,
the approval shall be made effective on
the date specified by the district
court in a court order under section
271(e)(4)(A) of title 35, United States
Code;
(iii) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent is invalid or not
infringed, the approval shall be made effective
as provided in clause (i); or
(iv) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent has been infringed,
the approval shall be made effective as
provided in clause (ii).
In such an action, each of the parties shall reasonably
cooperate in expediting the action.
(D) Civil action to obtain patent certainty.--
(i) Declaratory judgment absent infringement
action.--
(I) In general.--No action may be
brought under section 2201 of title 28,
United States Code, by an applicant
referred to in subsection (b)(2) for a
declaratory judgment with respect to a
patent which is the subject of the
certification referred to in
subparagraph (C) unless--
(aa) the 45-day period
referred to in such
subparagraph has expired;
(bb) neither the owner of
such patent nor the holder of
the approved application under
subsection (b) for the drug
that is claimed by the patent
or a use of which is claimed by
the patent brought a civil
action against the applicant
for infringement of the patent
before the expiration of such
period; and
(cc) in any case in which the
notice provided under paragraph
(2)(B) relates to
noninfringement, the notice was
accompanied by a document
described in subclause (III).
(II) Filing of civil action.--If the
conditions described in items (aa),
(bb), and as applicable, (cc) of
subclause (I) have been met, the
applicant referred to in such subclause
may, in accordance with section 2201 of
title 28, United States Code, bring a
civil action under such section against
the owner or holder referred to in such
subclause (but not against any owner or
holder that has brought such a civil
action against the applicant, unless
that civil action was dismissed without
prejudice) for a declaratory judgment
that the patent is invalid or will not
be infringed by the drug for which the
applicant seeks approval, except that
such civil action may be brought for a
declaratory judgment that the patent
will not be infringed only in a case in
which the condition described in
subclause (I)(cc) is applicable. A
civil action referred to in this
subclause shall be brought in the
judicial district where the defendant
has its principal place of business or
a regular and established place of
business.
(III) Offer of confidential access to
application.--For purposes of subclause
(I)(cc), the document described in this
subclause is a document providing an
offer of confidential access to the
application that is in the custody of
the applicant referred to in subsection
(b)(2) for the purpose of determining
whether an action referred to in
subparagraph (C) should be brought. The
document providing the offer of
confidential access shall contain such
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, as would
apply had a protective order been
entered for the purpose of protecting
trade secrets and other confidential
business information. A request for
access to an application under an offer
of confidential access shall be
considered acceptance of the offer of
confidential access with the
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, contained
in the offer of confidential access,
and those restrictions and other terms
of the offer of confidential access
shall be considered terms of an
enforceable contract. Any person
provided an offer of confidential
access shall review the application for
the sole and limited purpose of
evaluating possible infringement of the
patent that is the subject of the
certification under subsection
(b)(2)(A)(iv) and for no other purpose,
and may not disclose information of no
relevance to any issue of patent
infringement to any person other than a
person provided an offer of
confidential access. Further, the
application may be redacted by the
applicant to remove any information of
no relevance to any issue of patent
infringement.
(ii) Counterclaim to infringement action.--
(I) In general.--If an owner of the
patent or the holder of the approved
application under subsection (b) for
the drug that is claimed by the patent
or a use of which is claimed by the
patent brings a patent infringement
action against the applicant, the
applicant may assert a counterclaim
seeking an order requiring the holder
to correct or delete the patent
information submitted by the holder
under subsection (b) or this subsection
on the ground that the patent does not
claim either--
(aa) the drug for which the
application was approved; or
(bb) an approved method of
using the drug.
(II) No independent cause of
action.--Subclause (I) does not
authorize the assertion of a claim
described in subclause (I) in any civil
action or proceeding other than a
counterclaim described in subclause
(I).
(iii) No damages.--An applicant shall not be
entitled to damages in a civil action under
clause (i) or a counterclaim under clause (ii).
(E)
(ii) If an application submitted under subsection (b)
for a drug, no active moiety (as defined by the
Secretary in section 314.3 of title 21, Code of Federal
Regulations (or any successor regulations)) of which
has been approved in any other application under
subsection (b), is approved after the date of the
enactment of this clause, no application which refers
to the drug for which the subsection (b) application
was submitted and for which the investigations
described in subsection (b)(1)(A)(i) and relied upon by
the applicant for approval of the application were not
conducted by or for the applicant and for which the
applicant has not obtained a right of reference or use
from the person by or for whom the investigations were
conducted may be submitted under subsection (b) before
the expiration of five years from the date of the
approval of the application under subsection (b),
except that such an application may be submitted under
subsection (b) after the expiration of four years from
the date of the approval of the subsection (b)
application if it contains a certification of patent
invalidity or noninfringement described in clause (iv)
of subsection (b)(2)(A). The approval of such an
application shall be made effective in accordance with
this paragraph except that, if an action for patent
infringement is commenced during the one-year period
beginning forty-eight months after the date of the
approval of the subsection (b) application, the thirty-
month period referred to in subparagraph (C) shall be
extended by such amount of time (if any) which is
required for seven and one-half years to have elapsed
from the date of approval of the subsection (b)
application.
(iii) If an application submitted under subsection
(b) for a drug, which includes an active moiety (as
defined by the Secretary in section 314.3 of title 21,
Code of Federal Regulations (or any successor
regulations)) that has been approved in another
application approved under subsection (b), is approved
after the date of the enactment of this clause and if
such application contains reports of new clinical
investigations (other than bioavailability studies)
essential to the approval of the application and
conducted or sponsored by the applicant, the Secretary
may not make the approval of an application submitted
under subsection (b) for the conditions of approval of
such drug in the approved subsection (b) application
effective before the expiration of three years from the
date of the approval of the application under
subsection (b) if the investigations described in
subsection (b)(1)(A)(i) and relied upon by the
applicant for approval of the application were not
conducted by or for the applicant and if the applicant
has not obtained a right of reference or use from the
person by or for whom the investigations were
conducted.
(iv) If a supplement to an application approved under
subsection (b) is approved after the date of enactment
of this clause and the supplement contains reports of
new clinical investigations (other than bioavailabilty
studies) essential to the approval of the supplement
and conducted or sponsored by the person submitting the
supplement, the Secretary may not make the approval of
an application submitted under subsection (b) for a
change approved in the supplement effective before the
expiration of three years from the date of the approval
of the supplement under subsection (b) if the
investigations described in subsection (b)(1)(A)(i) and
relied upon by the applicant for approval of the
application were not conducted by or for the applicant
and if the applicant has not obtained a right of
reference or use from the person by or for whom the
investigations were conducted.
(v) If an application (or supplement to an
application) submitted under subsection (b) for a drug,
which includes anactive moiety (as defined by the
Secretary in section 314.3 of title 21, Code of Federal
Regulations (or any successor regulations)) that has
been approved in another application under subsection
(b), was approved during the period beginning January
1, 1982, and ending on the date of the enactment of
this clause, the Secretary may not make the approval of
an application submitted under this subsection and for
which the investigations described in subsection
(b)(1)(A)(i) and relied upon by the applicant for
approval of the application were not conducted by or
for the applicant and for which the applicant has not
obtained a right of reference or use from the person by
or for whom the investigations were conducted and which
refers to the drug for which the subsection (b)
application was submitted effective before the
expiration of two years from the date of enactment of
this clause.
(4) A drug manufactured in a pilot or other small facility
may be used to demonstrate the safety and effectiveness of the
drug and to obtain approval for the drug prior to manufacture
of the drug in a larger facility, unless the Secretary makes a
determination that a full scale production facility is
necessary to ensure the safety or effectiveness of the drug.
(5)(A) The Secretary may rely upon qualified data summaries
to support the approval of a supplemental application, with
respect to a qualified indication for a drug, submitted under
subsection (b), if such supplemental application complies with
subparagraph (B).
(B) A supplemental application is eligible for review as
described in subparagraph (A) only if--
(i) there is existing data available and acceptable
to the Secretary demonstrating the safety of the drug;
and
(ii) all data used to develop the qualified data
summaries are submitted to the Secretary as part of the
supplemental application.
(C) The Secretary shall post on the Internet website of the
Food and Drug Administration and update annually--
(i) the number of applications reviewed solely under
subparagraph (A) or section 351(a)(2)(E) of the Public
Health Service Act;
(ii) the average time for completion of review under
subparagraph (A) or section 351(a)(2)(E) of the Public
Health Service Act;
(iii) the average time for review of supplemental
applications where the Secretary did not use review
flexibility under subparagraph (A) or section
351(a)(2)(E) of the Public Health Service Act; and
(iv) the number of applications reviewed under
subparagraph (A) or section 351(a)(2)(E) of the Public
Health Service Act for which the Secretary made use of
full data sets in addition to the qualified data
summary.
(D) In this paragraph--
(i) the term ``qualified indication'' means an
indication for a drug that the Secretary determines to
be appropriate for summary level review under this
paragraph; and
(ii) the term ``qualified data summary'' means a
summary of clinical data that demonstrates the safety
and effectiveness of a drug with respect to a qualified
indication.
(d) If the Secretary finds, after due notice to the applicant
in accordance with subsection (c) and giving him an opportunity
for a hearing, in accordance with said subsection, that (1) the
investigations, reports of which are required to be submitted
to the Secretary pursuant to subsection (b), do not include
adequate tests by all methods reasonably applicable to show
whether or not such drug is safe for use under the conditions
prescribed, recommended, or suggested in the proposed labeling
thereof; (2) the results of such tests show that such drug is
unsafe for use under such conditions or do not show that such
drug is safe for use under such conditions; (3) the methods
used in, and the facilities and controls used for, the
manufacture, processing, and packing of such drug are
inadequate to preserve its identity, strength, quality, and
purity; (4) upon the basis of the information submitted to him
as part of the application, or upon the basis of any other
information before him with respect to such drug, he has
insufficient information to determine whether such drug is safe
for use under such conditions; or (5) evaluated on the basis of
the information submitted to him as part of the application and
any other information before him with respect to such drug,
there is a lack of substantial evidence that the drug will have
the effect it purports or is represented to have under the
conditions of use prescribed, recommended, or suggested in the
proposed labeling thereof; or (6) the application failed to
contain the patent information prescribed by subsection (b); or
(7) based on a fair evaluation of all material facts, such
labeling is false or misleading in any particular; he shall
issue an order refusing to approve the application. If, after
such notice and opportunity for hearing, the Secretary finds
that clauses (1) through (6) do not apply, he shall issue an
order approving the application. As used in this subsection and
subsection (e), the term ``substantial evidence'' means
evidence consisting of adequate and well-controlled
investigations, including clinical investigations, by experts
qualified by scientific training and experience to evaluate the
effectiveness of the drug involved, on the basis of which it
could fairly and responsibly be concluded by such experts that
the drug will have the effect it purports or is represented to
have under the conditions of use prescribed, recommended, or
suggested in the labeling or proposed labeling thereof. If the
Secretary determines, based on relevant science, that data from
one adequate and well-controlled clinical investigation and
confirmatory evidence (obtained prior to or after such
investigation) are sufficient to establish effectiveness, the
Secretary may consider such data and evidence to constitute
substantial evidence for purposes of the preceding sentence.
The Secretary shall implement a structured risk-benefit
assessment framework in the new drug approval process to
facilitate the balanced consideration of benefits and risks, a
consistent and systematic approach to the discussion and
regulatory decisionmaking, and the communication of the
benefits and risks of new drugs. Nothing in the preceding
sentence shall alter the criteria for evaluating an application
for marketing approval of a drug.
(e) The Secretary shall, after due notice and opportunity for
hearing to the applicant, withdraw approval of an application
with respect to any drug under this section if the Secretary
finds (1) that clinical or other experience, tests, or other
scientific data show that such drug is unsafe for use under the
conditions of use upon the basis of which the application was
approved; (2) that new evidence of clinical experience, not
contained in such application or not available to the Secretary
until after such application was approved, or tests by new
methods, or tests by methods not deemed reasonably applicable
when such application was approved, evaluated together with the
evidence available to the Secretary when the application was
approved, shows that such drug is not shown to be safe for use
under the conditions of use upon the basis of which the
application was approved; or (3) on the basis of new
information before him with respect to such drug, evaluated
together with the evidence available to him when the
application was approved, that there is a lack of substantial
evidence that the drug will have the effect it purports or is
represented to have under the conditions of use prescribed,
recommended, or suggested in the labeling thereof; or (4) the
patent information prescribed by subsection (c) was not filed
within thirty days after the receipt of written notice from the
Secretary specifying the failure to file such information; or
(5) that the application contains any untrue statement of a
material fact: Provided, That if the Secretary (or in his
absence the officer acting as Secretary) finds that there is an
imminent hazard to the public health, he may suspend the
approval of such application immediately, and give the
applicant prompt notice of his action and afford the applicant
the opportunity for an expedited hearing under this subsection;
but the authority conferred by this proviso to suspend the
approval of an application shall not be delegated. The
Secretary may also, after due notice and opportunity for
hearing to the applicant, withdraw the approval of an
application submitted under subsection (b) or (j) with respect
to any drug under this section if the Secretary finds (1) that
the applicant has failed to establish a system for maintaining
required records, or has repeatedly or deliberately failed to
maintain such records or to make required reports, in
accordance with a regulation or order under subsection (k) or
to comply with the notice requirements of section 510(k)(2), or
the applicant has refused to permit access to, or copying or
verification of, such records as required by paragraph (2) of
such subsection; or (2) that on the basis of new information
before him, evaluated together with the evidence before him
when the application was approved, the methods used in, or the
facilities and controls used for, the manufacture, processing,
and packing of such drug are inadequate to assure and preserve
its identity, strength, quality, and purity and were not made
adequate within a reasonable time after receipt of written
notice from the Secretary specifying the matter complained of;
or (3) that on the basis of new information before him,
evaluated together with the evidence before him when the
application was approved, the labeling of such drug, based on a
fair evaluation of all material facts, is false or misleading
in any particular and was not corrected within a reasonable
time after receipt of written notice from the Secretary
specifying the matter complained of. Any order under this
subsection shall state the findings upon which it is based. The
Secretary may withdraw the approval of an application submitted
under this section, or suspend the approval of such an
application, as provided under this subsection, without first
ordering the applicant to submit an assessment of the approved
risk evaluation and mitigation strategy for the drug under
section 505-1(g)(2)(D).
(f) Whenever the Secretary finds that the facts so require,
he shall revoke any previous order under subsection (d) or (e)
refusing, withdrawing, or suspending approval of an application
and shall approve such application or reinstate such approval,
as may be appropriate.
(g) Orders of the Secretary issued under this section shall
be served (1) in person by any officer or employee of the
Department designated by the Secretary or (2) by mailing the
order by registered mail or by certified mail addressed to the
applicant or respondent at his last-known address in the
records of the Secretary.
(h) An appeal may be taken by the applicant from an order of
the Secretary refusing or withdrawing approval of an
application under this section. Such appeal shall be taken by
filing in the United States court of appeals for the circuit
wherein such applicant resides or has his principal place of
business, or in the United States Court of Appeals for the
District of Columbia Circuit, within sixty days after the entry
of such order, a written petition praying that the order of the
Secretary be set aside. A copy of such petition shall be
forthwith transmitted by the clerk of the court to the
Secretary, or any officer designated by him for that purpose,
and thereupon the Secretary shall certify and file in the court
the record upon which the order complained of was entered, as
provided in section 2112 of title 28, United States Code. Upon
the filing of such petition such court shall have exclusive
jurisdiction to affirm or set aside such order, except that
until the filing of the record the Secretary may modify or set
aside his order. No objection to the order of the Secretary
shall be considered by the court unless such objection shall
have been urged before the Secretary or unless there were
reasonable grounds for failure so to do. The finding of the
Secretary as to the facts, if supported by substantial
evidence, shall be conclusive. If any person shall apply to the
court for leave to adduce additional evidence, and shall show
to the satisfaction of the court that such additional evidence
is material and that there were reasonable grounds for failure
to adduce such evidence in the proceeding before the Secretary,
the court may order such additional evidence to be taken before
the Secretary and to be adduced upon the hearing in such manner
and upon such terms and conditions as to the court may seem
proper. The Secretary may modify his findings as to the facts
by reason of the additional evidence so taken, and he shall
file with the court such modified findings which, if supported
by substantial evidence, shall be conclusive, and his
recommendation, if any, for the setting aside of the original
order. The judgment of the court affirming or setting aside any
such order of the Secretary shall be final, subject to review
by the Supreme Court of the United States upon certiorari or
certification as provided in section 1254 of title 28 of the
United States Code. The commencement of proceedings under this
subsection shall not, unless specifically ordered by the court
to the contrary, operate as a stay of the Secretary's order.
(i)(1) The Secretary shall promulgate regulations for
exempting from the operation of the foregoing subsections of
this section drugs intended solely for investigational use by
experts qualified by scientific training and experience to
investigate the safety and effectiveness of drugs. Such
regulations may, within the discretion of the Secretary, among
other conditions relating to the protection of the public
health, provide for conditioning such exemption upon--
(A) the submission to the Secretary, before any
clinical testing of a new drug is undertaken, of
reports, by the manufacturer or the sponsor of the
investigation of such drug, or [preclinical tests
(including tests on animals)] nonclinical tests of such
drug adequate to justify the proposed clinical testing;
(B) the manufacturer or the sponsor of the
investigation of a new drug proposed to be distributed
to investigators for clinical testing obtaining a
signed agreement from each of such investigators that
patients to whom the drug is administered will be under
his personal supervision, or under the supervision of
investigators responsible to him, and that he will not
supply such drug to any other investigator, or to
clinics, for administration to human beings;
(C) the establishment and maintenance of such
records, and the making of such reports to the
Secretary, by the manufacturer or the sponsor of the
investigation of such drug, of data (including but not
limited to analytical reports by investigators)
obtained as the result of such investigational use of
such drug, as the Secretary finds will enable him to
evaluate the safety and effectiveness of such drug in
the event of the filing of an application pursuant to
subsection (b); and
(D) the submission to the Secretary by the
manufacturer or the sponsor of the
investigation of a new drug of a statement of
intent regarding whether the manufacturer or
sponsor has plans for assessing pediatric
safety and efficacy.
(2) Subject to paragraph (3), a clinical investigation of a
new drug may begin 30 days after the Secretary has received
from the manufacturer or sponsor of the investigation a
submission containing such information about the drug and the
clinical investigation, including--
(A) information on design of the investigation and
adequate reports of basic information, certified by the
applicant to be accurate reports, necessary to assess
the safety of the drug for use in clinical
investigation; and
(B) adequate information on the chemistry and
manufacturing of the drug, controls available for the
drug, and primary data tabulations from [animal]
nonclinical tests or human studies.
(3)(A) At any time, the Secretary may prohibit the sponsor of
an investigation from conducting the investigation (referred to
in this paragraph as a ``clinical hold'') if the Secretary
makes a determination described in subparagraph (B). The
Secretary shall specify the basis for the clinical hold,
including the specific information available to the Secretary
which served as the basis for such clinical hold, and confirm
such determination in writing.
(B) For purposes of subparagraph (A), a determination
described in this subparagraph with respect to a clinical hold
is that--
(i) the drug involved represents an unreasonable risk
to the safety of the persons who are the subjects of
the clinical investigation, taking into account the
qualifications of the clinical investigators,
information about the drug, the design of the clinical
investigation, the condition for which the drug is to
be investigated, and the health status of the subjects
involved; or
(ii) the clinical hold should be issued for such
other reasons as the Secretary may by regulation
establish (including reasons established by regulation
before the date of the enactment of the Food and Drug
Administration Modernization Act of 1997).
(C) Any written request to the Secretary from the sponsor of
an investigation that a clinical hold be removed shall receive
a decision, in writing and specifying the reasons therefor,
within 30 days after receipt of such request. Any such request
shall include sufficient information to support the removal of
such clinical hold.
(4) Regulations under paragraph (1) shall provide that such
exemption shall be conditioned upon the manufacturer, or the
sponsor of the investigation, requiring that experts using such
drugs for investigational purposes certify to such manufacturer
or sponsor that they will inform any human beings to whom such
drugs, or any controls used in connection therewith, are being
administered, or their representatives, that such drugs are
being used for investigational purposes and will obtain the
consent of such human beings or their representatives, except
where it is not feasible, it is contrary to the best interests
of such human beings, or the proposed clinical testing poses no
more than minimal risk to such human beings and includes
appropriate safeguards as prescribed to protect the rights,
safety, and welfare of such human beings. Nothing in this
subsection shall be construed to require any clinical
investigator to submit directly to the Secretary reports on the
investigational use of drugs. The Secretary shall update such
regulations to require inclusion in the informed consent
documents and process a statement that clinical trial
information for such clinical investigation has been or will be
submitted for inclusion in the registry data bank pursuant to
subsection (j) of section 402 of the Public Health Service Act.
(5)(A) In order for a new drug that is being studied in a
phase 3 study, as defined in section 312.21(c) of title 21,
Code of Federal Regulations (or successor regulations), or
other pivotal study (other than bioavailability or
bioequivalence studies), to be exempt pursuant to this
subsection, the sponsor of a clinical investigation of such new
drug shall submit to the Secretary a diversity action plan.
(B) Such diversity action plan shall include--
(i) the sponsor's goals for enrollment in such
clinical study;
(ii) the sponsor's rationale for such goals; and
(iii) an explanation of how the sponsor intends to
meet such goals.
(C) The sponsor shall submit such diversity action plan in
the form and manner specified in the guidance required by
section 524B as soon as practicable but no later than when the
sponsor seeks feedback regarding such a phase 3 study or other
pivotal study of the drug.
(D) The Secretary may waive the requirement in subparagraph
(A) if the Secretary determines that a waiver is necessary
based on what is known about the prevalence of the disease in
terms of the patient population that may use the new drug.
(E) No diversity action plan shall be required for a
submission described in section 561.
(j)(1) Any person may file with the Secretary an abbreviated
application for the approval of a new drug.
(2)(A) An abbreviated application for a new drug shall
contain--
(i) information to show that the conditions of use
prescribed, recommended, or suggested in the labeling
proposed for the new drug have been previously approved
for a drug listed under paragraph (7) (hereinafter in
this subsection referred to as a ``listed drug'');
(ii)(I) if the listed drug referred to in clause (i)
has only one active ingredient, information to show
that the active ingredient of the new drug is the same
as that of the listed drug;
(II) if the listed drug referred to in clause (i) has
more than one active ingredient, information to show
that the active ingredients of the new drug are the
same as those of the listed drug, or
(III) if the listed drug referred to in clause (i)
has more than one active ingredient and if one of the
active ingredients of the new drug is different and the
application is filed pursuant to the approval of a
petition filed under subparagraph (C), information to
show that the other active ingredients of the new drug
are the same as the active ingredients of the listed
drug, information to show that the different active
ingredient is an active ingredient of a listed drug or
of a drug which does not meet the requirements of
section 201(p), and such other information respecting
the different active ingredient with respect to which
the petition was filed as the Secretary may require;
(iii) information to show that the route of
administration, the dosage form, and the strength of
the new drug are the same as those of the listed drug
referred to in clause (i) or, if the route of
administration, the dosage form, or the strength of the
new drug is different and the application is filed
pursuant to the approval of a petition filed under
subparagraph (C), such information respecting the route
of administration, dosage form, or strength with
respect to which the petition was filed as the
Secretary may require;
(iv) information to show that the new drug is
bioequivalent to the listed drug referred to in clause
(i), except that if the application is filed pursuant
to the approval of a petition filed under subparagraph
(C), information to show that the active ingredients of
the new drug are of the same pharmacological or
therapeutic class as those of the listed drug referred
to in clause (i) and the new drug can be expected to
have the same therapeutic effect as the listed drug
when administered to patients for a condition of use
referred to in clause (i);
(v) information to show that the labeling proposed
for the new drug is the same as the labeling approved
for the listed drug referred to in clause (i) except
for changes required because of differences approved
under a petition filed under subparagraph (C) or
because the new drug and the listed drug are produced
or distributed by different manufacturers;
(vi) the items specified in clauses (ii) through (vi)
of subsection (b)(1)(A);
(vii) a certification, in the opinion of the
applicant and to the best of his knowledge, with
respect to each patent which claims the listed drug
referred to in clause (i) or which claims a use for
such listed drug for which the applicant is seeking
approval under this subsection and for which
information is required to be filed under subsection
(b) or (c)--
(I) that such patent information has not been
filed,
(II) that such patent has expired,
(III) of the date on which such patent will
expire, or
(IV) that such patent is invalid or will not
be infringed by the manufacture, use, or sale
of the new drug for which the application is
submitted; and
(viii) if with respect to the listed drug referred to
in clause (i) information was filed under subsection
(b) or (c) for a method of use patent which does not
claim a use for which the applicant is seeking approval
under this subsection, a statement that the method of
use patent does not claim such a use.
The Secretary may not require that an abbreviated application
contain information in addition to that required by clauses (i)
through (viii).
(B) Notice of opinion that patent is invalid or will not be
infringed.--
(i) Agreement to give notice.--An applicant that
makes a certification described in subparagraph
(A)(vii)(IV) shall include in the application a
statement that the applicant will give notice as
required by this subparagraph.
(ii) Timing of notice.--An applicant that makes a
certification described in subparagraph (A)(vii)(IV)
shall give notice as required under this subparagraph--
(I) if the certification is in the
application, not later than 20 days after the
date of the postmark on the notice with which
the Secretary informs the applicant that the
application has been filed; or
(II) if the certification is in an amendment
or supplement to the application, at the time
at which the applicant submits the amendment or
supplement, regardless of whether the applicant
has already given notice with respect to
another such certification contained in the
application or in an amendment or supplement to
the application.
(iii) Recipients of notice.--An applicant required
under this subparagraph to give notice shall give
notice to--
(I) each owner of the patent that is the
subject of the certification (or a
representative of the owner designated to
receive such a notice); and
(II) the holder of the approved application
under subsection (b) for the drug that is
claimed by the patent or a use of which is
claimed by the patent (or a representative of
the holder designated to receive such a
notice).
(iv) Contents of notice.--A notice required under
this subparagraph shall--
(I) state that an application that contains
data from bioavailability or bioequivalence
studies has been submitted under this
subsection for the drug with respect to which
the certification is made to obtain approval to
engage in the commercial manufacture, use, or
sale of the drug before the expiration of the
patent referred to in the certification; and
(II) include a detailed statement of the
factual and legal basis of the opinion of the
applicant that the patent is invalid or will
not be infringed.
(C) If a person wants to submit an abbreviated application
for a new drug which has a different active ingredient or whose
route of administration, dosage form, or strength differ from
that of a listed drug, such person shall submit a petition to
the Secretary seeking permission to file such an application.
The Secretary shall approve or disapprove a petition submitted
under this subparagraph within ninety days of the date the
petition is submitted. The Secretary shall approve such a
petition unless the Secretary finds--
(i) that investigations must be conducted to show the
safety and effectiveness of the drug or of any of its
active ingredients, the route of administration, the
dosage form, or strength which differ from the listed
drug; or
(ii) that any drug with a different active ingredient
may not be adequately evaluated for approval as safe
and effective on the basis of the information required
to be submitted in an abbreviated application.
(D)(i) An applicant may not amend or supplement an
application to seek approval of a drug referring to a different
listed drug from the listed drug identified in the application
as submitted to the Secretary.
(ii) With respect to the drug for which an application is
submitted, nothing in this subsection prohibits an applicant
from amending or supplementing the application to seek approval
of a different strength.
(iii) Within 60 days after the date of the enactment of the
Medicare Prescription Drug, Improvement, and Modernization Act
of 2003, the Secretary shall issue guidance defining the term
``listed drug'' for purposes of this subparagraph.
(3)(A) The Secretary shall issue guidance for the individuals
who review applications submitted under paragraph (1), which
shall relate to promptness in conducting the review, technical
excellence, lack of bias and conflict of interest, and
knowledge of regulatory and scientific standards, and which
shall apply equally to all individuals who review such
applications.
(B) The Secretary shall meet with a sponsor of an
investigation or an applicant for approval for a drug under
this subsection if the sponsor or applicant makes a reasonable
written request for a meeting for the purpose of reaching
agreement on the design and size of bioavailability and
bioequivalence studies needed for approval of such application.
The sponsor or applicant shall provide information necessary
for discussion and agreement on the design and size of such
studies. Minutes of any such meeting shall be prepared by the
Secretary and made available to the sponsor or applicant.
(C) Any agreement regarding the parameters of design and size
of bioavailability and bioequivalence studies of a drug under
this paragraph that is reached between the Secretary and a
sponsor or applicant shall be reduced to writing and made part
of the administrative record by the Secretary. Such agreement
shall not be changed after the testing begins, except--
(i) with the written agreement of the sponsor or
applicant; or
(ii) pursuant to a decision, made in accordance with
subparagraph (D) by the director of the reviewing
division, that a substantial scientific issue essential
to determining the safety or effectiveness of the drug
has been identified after the testing has begun.
(D) A decision under subparagraph (C)(ii) by the director
shall be in writing and the Secretary shall provide to the
sponsor or applicant an opportunity for a meeting at which the
director and the sponsor or applicant will be present and at
which the director will document the scientific issue involved.
(E) The written decisions of the reviewing division shall be
binding upon, and may not directly or indirectly be changed by,
the field or compliance office personnel unless such field or
compliance office personnel demonstrate to the reviewing
division why such decision should be modified.
(F) No action by the reviewing division may be delayed
because of the unavailability of information from or action by
field personnel unless the reviewing division determines that a
delay is necessary to assure the marketing of a safe and
effective drug.
(G) For purposes of this paragraph, the reviewing division is
the division responsible for the review of an application for
approval of a drug under this subsection (including scientific
matters, chemistry, manufacturing, and controls).
(H)(i) Upon request (in controlled correspondence or
otherwise) by a person that has submitted or intends to submit
an abbreviated application for a new drug under this subsection
for which the Secretary has specified in regulation, including
under section 314.94(a)(9), title 21, Code of Federal
Regulations (or a successor regulation), or recommended in
applicable guidance, certain qualitative or quantitative
criteria with respect to an inactive ingredient, or on the
Secretary's own initiative during the review of such
abbreviated application, the Secretary shall inform the person
whether such new drug is qualitatively and quantitatively the
same as the listed drug.
(ii) Notwithstanding section 301(j), if the Secretary
determines that such new drug is not qualitatively or
quantitatively the same as the listed drug, the Secretary shall
identify and disclose to the person--
(I) the ingredient or ingredients that cause the new
drug not to be qualitatively or quantitatively the same
as the listed drug; and
(II) for any ingredient for which there is an
identified quantitative deviation, the amount of such
deviation.
(iii) If the Secretary determines that such new drug is
qualitatively and quantitatively the same as the listed drug,
the Secretary shall not change or rescind such determination
after the submission of an abbreviated application for such new
drug under this subsection unless--
(I) the formulation of the listed drug has been
changed and the Secretary has determined that the prior
listed drug formulation was withdrawn for reasons of
safety or effectiveness; or
(II) the Secretary makes a written determination that
the prior determination must be changed because an
error has been identified.
(iv) If the Secretary makes a written determination described
in clause (iii)(II), the Secretary shall provide notice and a
copy of the written determination to the person making the
request under clause (i).
(v) The disclosures required by this subparagraph are
disclosures authorized by law including for purposes of section
1905 of title 18, United States Code.
(4) Subject to paragraph (5), the Secretary shall approve an
application for a drug unless the Secretary finds--
(A) the methods used in, or the facilities and
controls used for, the manufacture, processing, and
packing of the drug are inadequate to assure and
preserve its identity, strength, quality, and purity;
(B) information submitted with the application is
insufficient show that each of the proposed conditions
of use have been previously approved for the listed
drug referred to in the application;
(C)(i) if the listed drug has only one active
ingredient, information submitted with the application
is insufficient to show that the active ingredient is
the same as that of the listed drug;
(ii) if the listed drug has more than one active
ingredient, information submitted with the application
is insufficient to show that the active ingredients are
the same as the active ingredients of the listed drug,
or
(iii) if the listed drug has more than one active
ingredient and if the application is for a drug which
has an active ingredient different from the listed
drug, information submitted with the application is
insufficient to show--
(I) that the other active ingredients are the
same as the active ingredients of the listed
drug, or
(II) that the different active ingredient is
an active ingredient of a listed drug or a drug
which does not meet the requirements of section
201(p),
or no petition to file an application for the drug with
the different ingredient was approved under paragraph
(2)(C);
(D)(i) if the application is for a drug whose route
of administration, dosage form, or strength of the drug
is the same as the route of administration, dosage
form, or strength of the listed drug referred to in the
application, information submitted in the application
is insufficient to show that the route of
administration, dosage form, or strength is the same as
that of the listed drug, or
(ii) if the application is for a drug whose route of
administration, dosage form, or strength of the drug is
different from that of the listed drug referred to in
the application, no petition to file an application for
the drug with the different route of administration,
dosage form, or strength was approved under paragraph
(2)(C);
(E) if the application was filed pursuant to the
approval of a petition under paragraph (2)(C), the
application did not contain the information required by
the Secretary respecting the active ingredient, route
of administration, dosage form, or strength which is
not the same;
(F) information submitted in the application is
insufficient to show that the drug is bioequivalent to
the listed drug referred to in the application or, if
the application was filed pursuant to a petition
approved under paragraph (2)(C), information submitted
in the application is insufficient to show that the
active ingredients of the new drug are of the same
pharmacological or therapeutic class as those of the
listed drug referred to in paragraph (2)(A)(i) and that
the new drug can be expected to have the same
therapeutic effect as the listed drug when administered
to patients for a condition of use referred to in such
paragraph;
(G) information submitted in the application is
insufficient to show that the labeling proposed for the
drug is the same as the labeling approved for the
listed drug referred to in the application except for
changes required because of differences approved under
a petition filed under paragraph (2)(C) or because the
drug and the listed drug are produced or distributed by
different manufacturers;
(H) information submitted in the application or any
other information available to the Secretary shows that
(i) the inactive ingredients of the drug are unsafe for
use under the conditions prescribed, recommended, or
suggested in the labeling proposed for the drug, or
(ii) the composition of the drug is unsafe under such
conditions because of the type or quantity of inactive
ingredients included or the manner in which the
inactive ingredients are included;
(I) the approval under subsection (c) of the listed
drug referred to in the application under this
subsection has been withdrawn or suspended for grounds
described in the first sentence of subsection (e), the
Secretary has published a notice of opportunity for
hearing to withdraw approval of the listed drug under
subsection (c) for grounds described in the first
sentence of subsection (e), the approval under this
subsection of the listed drug referred to in the
application under this subsection has been withdrawn or
suspended under paragraph (6), or the Secretary has
determined that the listed drug has been withdrawn from
sale for safety or effectiveness reasons;
(J) the application does not meet any other
requirement of paragraph (2)(A); or
(K) the application contains an untrue statement of
material fact.
(5)(A) Within one hundred and eighty days of the initial
receipt of an application under paragraph (2) or within such
additional period as may be agreed upon by the Secretary and
the applicant, the Secretary shall approve or disapprove the
application.
(B) The approval of an application submitted under paragraph
(2) shall be made effective on the last applicable date
determined by applying the following to each certification made
under paragraph (2)(A)(vii):
(i) If the applicant only made a certification
described in subclause (I) or (II) of paragraph
(2)(A)(vii) or in both such subclauses, the approval
may be made effective immediately.
(ii) If the applicant made a certification described
in subclause (III) of paragraph (2)(A)(vii), the
approval may be made effective on the date certified
under subclause (III).
(iii) If the applicant made a certification described
in subclause (IV) of paragraph (2)(A)(vii), the
approval shall be made effective immediately unless,
before the expiration of 45 days after the date on
which the notice described in paragraph (2)(B) is
received, an action is brought for infringement of the
patent that is the subject of the certification and for
which information was submitted to the Secretary under
subsection (b)(1) or (c)(2) before the date on which
the application (excluding an amendment or supplement
to the application), which the Secretary later
determines to be substantially complete, was submitted.
If such an action is brought before the expiration of
such days, the approval shall be made effective upon
the expiration of the thirty-month period beginning on
the date of the receipt of the notice provided under
paragraph (2)(B)(i) or such shorter or longer period as
the court may order because either party to the action
failed to reasonably cooperate in expediting the
action, except that--
(I) if before the expiration of such period
the district court decides that the patent is
invalid or not infringed (including any
substantive determination that there is no
cause of action for patent infringement or
invalidity), the approval shall be made
effective on--
(aa) the date on which the court
enters judgment reflecting the
decision; or
(bb) the date of a settlement order
or consent decree signed and entered by
the court stating that the patent that
is the subject of the certification is
invalid or not infringed;
(II) if before the expiration of such period
the district court decides that the patent has
been infringed--
(aa) if the judgment of the district
court is appealed, the approval shall
be made effective on--
(AA) the date on which the
court of appeals decides that
the patent is invalid or not
infringed (including any
substantive determination that
there is no cause of action for
patent infringement or
invalidity); or
(BB) the date of a settlement
order or consent decree signed
and entered by the court of
appeals stating that the patent
that is the subject of the
certification is invalid or not
infringed; or
(bb) if the judgment of the district
court is not appealed or is affirmed,
the approval shall be made effective on
the date specified by the district
court in a court order under section
271(e)(4)(A) of title 35, United States
Code;
(III) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent is invalid or not
infringed, the approval shall be made effective
as provided in subclause (I); or
(IV) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent has been infringed,
the approval shall be made effective as
provided in subclause (II).
In such an action, each of the parties shall reasonably
cooperate in expediting the action.
(iv) 180-day exclusivity period.--
(I) Effectiveness of application.--Subject to
subparagraph (D), if the application contains a
certification described in paragraph
(2)(A)(vii)(IV) and is for a drug for which a
first applicant has submitted an application
containing such a certification, the
application shall be made effective on the date
that is 180 days after the date of the first
commercial marketing of the drug (including the
commercial marketing of the listed drug) by any
first applicant.
(II) Definitions.--In this paragraph:
(aa) 180-day exclusivity period.--
The term ``180-day exclusivity period''
means the 180-day period ending on the
day before the date on which an
application submitted by an applicant
other than a first applicant could
become effective under this clause.
(bb) First applicant.--As used in
this subsection, the term ``first
applicant'' means an applicant that, on
the first day on which a substantially
complete application containing a
certification described in paragraph
(2)(A)(vii)(IV) is submitted for
approval of a drug, submits a
substantially complete application that
contains and lawfully maintains a
certification described in paragraph
(2)(A)(vii)(IV) for the drug.
(cc) Substantially complete
application.--As used in this
subsection, the term ``substantially
complete application'' means an
application under this subsection that
on its face is sufficiently complete to
permit a substantive review and
contains all the information required
by paragraph (2)(A).
(dd) Tentative approval.--
(AA) In general.--The term
``tentative approval'' means
notification to an applicant by
the Secretary that an
application under this
subsection meets the
requirements of paragraph
(2)(A), but cannot receive
effective approval because the
application does not meet the
requirements of this
subparagraph, there is a period
of exclusivity for the listed
drug under subparagraph (F) or
section 505A, or there is a 7-
year period of exclusivity for
the listed drug under section
527.
(BB) Limitation.--A drug that
is granted tentative approval
by the Secretary is not an
approved drug and shall not
have an effective approval
until the Secretary issues an
approval after any necessary
additional review of the
application.
(v) 180-day exclusivity period for competitive
generic therapies.--
(I) Effectiveness of application.--Subject to
subparagraph (D)(iv), if the application is for
a drug that is the same as a competitive
generic therapy for which any first approved
applicant has commenced commercial marketing,
the application shall be made effective on the
date that is 180 days after the date of the
first commercial marketing of the competitive
generic therapy (including the commercial
marketing of the listed drug) by any first
approved applicant.
(II) Limitation.--The exclusivity period
under subclause (I) shall not apply with
respect to a competitive generic therapy that
has previously received an exclusivity period
under subclause (I).
(III) Definitions.--In this clause and
subparagraph (D)(iv):
(aa) The term ``competitive generic
therapy'' means a drug--
(AA) that is designated as a
competitive generic therapy
under section 506H; and
(BB) for which there are no
unexpired patents or
exclusivities on the list of
products described in section
505(j)(7)(A) at the time of
submission.
(bb) The term ``first approved
applicant'' means any applicant that
has submitted an application that--
(AA) is for a competitive
generic therapy that is
approved on the first day on
which any application for such
competitive generic therapy is
approved;
(BB) is not eligible for a
180-day exclusivity period
under clause (iv) for the drug
that is the subject of the
application for the competitive
generic therapy; and
(CC) is not for a drug for
which all drug versions have
forfeited eligibility for a
180-day exclusivity period
under clause (iv) pursuant to
subparagraph (D).
(C) Civil action to obtain patent certainty.--
(i) Declaratory judgment absent infringement
action.--
(I) In general.--No action may be
brought under section 2201 of title 28,
United States Code, by an applicant
under paragraph (2) for a declaratory
judgment with respect to a patent which
is the subject of the certification
referred to in subparagraph (B)(iii)
unless--
(aa) the 45-day period
referred to in such
subparagraph has expired;
(bb) neither the owner of
such patent nor the holder of
the approved application under
subsection (b) for the drug
that is claimed by the patent
or a use of which is claimed by
the patent brought a civil
action against the applicant
for infringement of the patent
before the expiration of such
period; and
(cc) in any case in which the
notice provided under paragraph
(2)(B) relates to
noninfringement, the notice was
accompanied by a document
described in subclause (III).
(II) Filing of civil action.--If the
conditions described in items (aa),
(bb), and as applicable, (cc) of
subclause (I) have been met, the
applicant referred to in such subclause
may, in accordance with section 2201 of
title 28, United States Code, bring a
civil action under such section against
the owner or holder referred to in such
subclause (but not against any owner or
holder that has brought such a civil
action against the applicant, unless
that civil action was dismissed without
prejudice) for a declaratory judgment
that the patent is invalid or will not
be infringed by the drug for which the
applicant seeks approval, except that
such civil action may be brought for a
declaratory judgment that the patent
will not be infringed only in a case in
which the condition described in
subclause (I)(cc) is applicable. A
civil action referred to in this
subclause shall be brought in the
judicial district where the defendant
has its principal place of business or
a regular and established place of
business.
(III) Offer of confidential access to
application.--For purposes of subclause
(I)(cc), the document described in this
subclause is a document providing an
offer of confidential access to the
application that is in the custody of
the applicant under paragraph (2) for
the purpose of determining whether an
action referred to in subparagraph
(B)(iii) should be brought. The
document providing the offer of
confidential access shall contain such
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, as would
apply had a protective order been
entered for the purpose of protecting
trade secrets and other confidential
business information. A request for
access to an application under an offer
of confidential access shall be
considered acceptance of the offer of
confidential access with the
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, contained
in the offer of confidential access,
and those restrictions and other terms
of the offer of confidential access
shall be considered terms of an
enforceable contract. Any person
provided an offer of confidential
access shall review the application for
the sole and limited purpose of
evaluating possible infringement of the
patent that is the subject of the
certification under paragraph
(2)(A)(vii)(IV) and for no other
purpose, and may not disclose
information of no relevance to any
issue of patent infringement to any
person other than a person provided an
offer of confidential access. Further,
the application may be redacted by the
applicant to remove any information of
no relevance to any issue of patent
infringement.
(ii) Counterclaim to infringement action.--
(I) In general.--If an owner of the
patent or the holder of the approved
application under subsection (b) for
the drug that is claimed by the patent
or a use of which is claimed by the
patent brings a patent infringement
action against the applicant, the
applicant may assert a counterclaim
seeking an order requiring the holder
to correct or delete the patent
information submitted by the holder
under subsection (b) or (c) on the
ground that the patent does not claim
either--
(aa) the drug for which the
application was approved; or
(bb) an approved method of
using the drug.
(II) No independent cause of
action.--Subclause (I) does not
authorize the assertion of a claim
described in subclause (I) in any civil
action or proceeding other than a
counterclaim described in subclause
(I).
(iii) No damages.--An applicant shall not be
entitled to damages in a civil action under
clause (i) or a counterclaim under clause (ii).
(D) Forfeiture of 180-day exclusivity period.--
(i) Definition of forfeiture event.--In this
subparagraph, the term ``forfeiture event'',
with respect to an application under this
subsection, means the occurrence of any of the
following:
(I) Failure to market.--The first
applicant fails to market the drug by
the later of--
(aa) the earlier of the date
that is--
(AA) 75 days after
the date on which the
approval of the
application of the
first applicant is made
effective under
subparagraph (B)(iii);
or
(BB) 30 months after
the date of submission
of the application of
the first applicant; or
(bb) with respect to the
first applicant or any other
applicant (which other
applicant has received
tentative approval), the date
that is 75 days after the date
as of which, as to each of the
patents with respect to which
the first applicant submitted
and lawfully maintained a
certification qualifying the
first applicant for the 180-day
exclusivity period under
subparagraph (B)(iv), at least
1 of the following has
occurred:
(AA) In an
infringement action
brought against that
applicant with respect
to the patent or in a
declaratory judgment
action brought by that
applicant with respect
to the patent, a court
enters a final decision
from which no appeal
(other than a petition
to the Supreme Court
for a writ of
certiorari) has been or
can be taken that the
patent is invalid or
not infringed.
(BB) In an
infringement action or
a declaratory judgment
action described in
subitem (AA), a court
signs a settlement
order or consent decree
that enters a final
judgment that includes
a finding that the
patent is invalid or
not infringed.
(CC) The patent
information submitted
under subsection (b) or
(c) is withdrawn by the
holder of the
application approved
under subsection (b).
(II) Withdrawal of application.--The
first applicant withdraws the
application or the Secretary considers
the application to have been withdrawn
as a result of a determination by the
Secretary that the application does not
meet the requirements for approval
under paragraph (4).
(III) Amendment of certification.--
The first applicant amends or withdraws
the certification for all of the
patents with respect to which that
applicant submitted a certification
qualifying the applicant for the 180-
day exclusivity period.
(IV) Failure to obtain tentative
approval.--The first applicant fails to
obtain tentative approval of the
application within 30 months after the
date on which the application is filed,
unless the failure is caused by a
change in or a review of the
requirements for approval of the
application imposed after the date on
which the application is filed.
(V) Agreement with another applicant,
the listed drug application holder, or
a patent owner.--The first applicant
enters into an agreement with another
applicant under this subsection for the
drug, the holder of the application for
the listed drug, or an owner of the
patent that is the subject of the
certification under paragraph
(2)(A)(vii)(IV), the Federal Trade
Commission or the Attorney General
files a complaint, and there is a final
decision of the Federal Trade
Commission or the court with regard to
the complaint from which no appeal
(other than a petition to the Supreme
Court for a writ of certiorari) has
been or can be taken that the agreement
has violated the antitrust laws (as
defined in section 1 of the Clayton Act
(15 U.S.C. 12), except that the term
includes section 5 of the Federal Trade
Commission Act (15 U.S.C. 45) to the
extent that that section applies to
unfair methods of competition).
(VI) Expiration of all patents.--All
of the patents as to which the
applicant submitted a certification
qualifying it for the 180-day
exclusivity period have expired.
(ii) Forfeiture.--The 180-day exclusivity
period described in subparagraph (B)(iv) shall
be forfeited by a first applicant if a
forfeiture event occurs with respect to that
first applicant.
(iii) Subsequent applicant.--If all first
applicants forfeit the 180-day exclusivity
period under clause (ii)--
(I) approval of any application
containing a certification described in
paragraph (2)(A)(vii)(IV) shall be made
effective in accordance with
subparagraph (B)(iii); and
(II) no applicant shall be eligible
for a 180-day exclusivity period.
(iv) Special forfeiture rule for competitive
generic therapy.--The 180-day exclusivity
period described in subparagraph (B)(v) shall
be forfeited by a first approved applicant if
the applicant fails to market the competitive
generic therapy within 75 days after the date
on which the approval of the first approved
applicant's application for the competitive
generic therapy is made effective.
(E) If the Secretary decides to disapprove an application,
the Secretary shall give the applicant notice of an opportunity
for a hearing before the Secretary on the question of whether
such application is approvable. If the applicant elects to
accept the opportunity for hearing by written request within
thirty days after such notice, such hearing shall commence not
more than ninety days after the expiration of such thirty days
unless the Secretary and the applicant otherwise agree. Any
such hearing shall thereafter be conducted on an expedited
basis and the Secretary's order thereon shall be issued within
ninety days after the date fixed by the Secretary for filing
final briefs.
(F)
(ii) If an application submitted under subsection (b) for a
drug, no active moiety (as defined by the Secretary in section
314.3 of title 21, Code of Federal Regulations (or any
successor regulations)) of which has been approved in any other
application under subsection (b), is approved after the date of
the enactment of this subsection, no application may be
submitted under this subsection which refers to the drug for
which the subsection (b) application was submitted before the
expiration of five years from the date of the approval of the
application under subsection (b), except that such an
application may be submitted under this subsection after the
expiration of four years from the date of the approval of the
subsection (b) application if it contains a certification of
patent invalidity or noninfringement described in subclause
(IV) of paragraph (2)(A)(vii). The approval of such an
application shall be made effective in accordance with
subparagraph (B) except that, if an action for patent
infringement is commenced during the one-year period beginning
forty-eight months after the date of the approval of the
subsection (b) application, the thirty-month period referred to
in subparagraph (B)(iii) shall be extended by such amount of
time (if any) which is required for seven and one-half years to
have elapsed from the date of approval of the subsection (b)
application.
(iii) If an application submitted under subsection (b) for a
drug, which includes an active moiety (as defined by the
Secretary in section 314.3 of title 21, Code of Federal
Regulations (or any successor regulations)) that has been
approved in another application approved under subsection (b),
is approved after the date of enactment of this subsection and
if such application contains reports of new clinical
investigations (other than bioavailability studies) essential
to the approval of the application and conducted or sponsored
by the applicant, the Secretary may not make the approval of an
application submitted under this subsection for the conditions
of approval of such drug in the subsection (b) application
effective before the expiration of three years from the date of
the approval of the application under subsection (b) for such
drug.
(iv) If a supplement to an application approved under
subsection (b) is approved after the date of enactment of this
subsection and the supplement contains reports of new clinical
investigations (other than bioavailability studies) essential
to the approval of the supplement and conducted or sponsored by
the person submitting the supplement, the Secretary may not
make the approval of an application submitted under this
subsection for a change approved in the supplement effective
before the expiration of three years from the date of the
approval of the supplement under subsection (b).
(v) If an application (or supplement to an application)
submitted under subsection (b) for a drug, which includes an
active moiety (as defined by the Secretary in section 314.3 of
title 21, Code of Federal Regulations (or any successor
regulations)) that has been approved in another application
under subsection (b), was approved during the period beginning
January 1, 1982, and ending on the date of the enactment of
this subsection, the Secretary may not make the approval of an
application submitted under this subsection which refers to the
drug for which the subsection (b) application was submitted or
which refers to a change approved in a supplement to the
subsection (b) application effective before the expiration of
two years from the date of enactment of this subsection.
(6) If a drug approved under this subsection refers in its
approved application to a drug the approval of which was
withdrawn or suspended for grounds described in the first
sentence of subsection (e) or was withdrawn or suspended under
this paragraph or which, as determined by the Secretary, has
been withdrawn from sale for safety or effectiveness reasons,
the approval of the drug under this subsection shall be
withdrawn or suspended--
(A) for the same period as the withdrawal or
suspension under subsection (e) or this paragraph, or
(B) if the listed drug has been withdrawn from sale,
for the period of withdrawal from sale or, if earlier,
the period ending on the date the Secretary determines
that the withdrawal from sale is not for safety or
effectiveness reasons.
(7)(A)(i) Within sixty days of the date of the enactment of
this subsection, the Secretary shall publish and make available
to the public--
(I) a list in alphabetical order of the official and
proprietary name of each drug which has been approved
for safety and effectiveness under subsection (c)
before the date of the enactment of this subsection;
(II) the date of approval if the drug is approved
after 1981 and the number of the application which was
approved; and
(III) whether in vitro or in vivo bioequivalence
studies, or both such studies, are required for
applications filed under this subsection which will
refer to the drug published.
(ii) Every thirty days after the publication of the first
list under clause (i) the Secretary shall revise the list to
include each drug which has been approved for safety and
effectiveness under subsection (c) or approved under this
subsection during the thirty-day period.
(iii) When patent information submitted under subsection (c)
respecting a drug included on the list is to be published by
the Secretary, the Secretary shall, in revisions made under
clause (ii), include such information for such drug.
(iv) For each drug included on the list, the Secretary shall
specify any exclusivity period that is applicable, for which
the Secretary has determined the expiration date, and for which
such period has not yet expired, under--
(I) clause (ii), (iii), or (iv) of subsection
(c)(3)(E);
(II) clause (iv) or (v) of paragraph (5)(B);
(III) clause (ii), (iii), or (iv) of paragraph
(5)(F);
(IV) section 505A;
(V) section 505E;
(VI) section 527(a); or
(VII) subsection (u).
(B) A drug approved for safety and effectiveness under
subsection (c) or approved under this subsection shall, for
purposes of this subsection, be considered to have been
published under subparagraph (A) on the date of its approval or
the date of enactment, whichever is later.
(C) If the approval of a drug was withdrawn or suspended for
grounds described in the first sentence of subsection (e) or
was withdrawn or suspended under paragraph (6) or if the
Secretary determines that a drug has been withdrawn from sale
for safety or effectiveness reasons, it may not be published in
the list under subparagraph (A) or, if the withdrawal or
suspension occurred after its publication in such list, it
shall be immediately removed from such list--
(i) for the same period as the withdrawal or
suspension under subsection (e) or paragraph (6), or
(ii) if the listed drug has been withdrawn from sale,
for the period of withdrawal from sale or, if earlier,
the period ending on the date the Secretary determines
that the withdrawal from sale is not for safety or
effectiveness reasons.
A notice of the removal shall be published in the Federal
Register.
(D) In the case of a listed drug for which the list under
subparagraph (A)(i) includes a patent for such drug, and any
claim of the patent has been cancelled or invalidated pursuant
to a final decision issued by the Patent Trial and Appeal Board
of the United States Patent and Trademark Office or by a court,
from which no appeal has been, or can be, taken, if the holder
of the applicable application approved under subsection (c)
determines that a patent for such drug, or any patent
information for such drug, no longer meets the listing
requirements under this section--
(i) the holder of such approved application shall
notify the Secretary, in writing, within 14 days of
such decision of such cancellation or invalidation and
request that such patent or patent information, as
applicable, be amended or withdrawn in accordance with
the decision issued by the Patent Trial and Appeal
Board or a court;
(ii) the holder of such approved application shall
include in any notification under clause (i)
information related to such patent cancellation or
invalidation decision and submit such information,
including a copy of such decision, to the Secretary;
and
(iii) the Secretary shall, in response to a
notification under clause (i), amend or remove patent
or patent information in accordance with the relevant
decision from the Patent Trial and Appeals Board or
court, as applicable, except that the Secretary shall
not remove from the list any patent or patent
information before the expiration of any 180-day
exclusivity period under paragraph (5)(B)(iv) that
relies on a certification described in paragraph
(2)(A)(vii)(IV).
(8) For purposes of this subsection:
(A)(i) The term ``bioavailability'' means the rate
and extent to which the active ingredient or
therapeutic ingredient is absorbed from a drug and
becomes available at the site of drug action.
(ii) For a drug that is not intended to be absorbed
into the bloodstream, the Secretary may assess
bioavailability by scientifically valid measurements
intended to reflect the rate and extent to which the
active ingredient or therapeutic ingredient becomes
available at the site of drug action.
(B) A drug shall be considered to be bioequivalent to
a listed drug if--
(i) the rate and extent of absorption of the
drug do not show a significant difference from
the rate and extent of absorption of the listed
drug when administered at the same molar dose
of the therapeutic ingredient under similar
experimental conditions in either a single dose
or multiple doses; or
(ii) the extent of absorption of the drug
does not show a significant difference from the
extent of absorption of the listed drug when
administered at the same molar dose of the
therapeutic ingredient under similar
experimental conditions in either a single dose
or multiple doses and the difference from the
listed drug in the rate of absorption of the
drug is intentional, is reflected in its
proposed labeling, is not essential to the
attainment of effective body drug
concentrations on chronic use, and is
considered medically insignificant for the
drug.
(C) For a drug that is not intended to be absorbed
into the bloodstream, the Secretary may establish
alternative, scientifically valid methods to show
bioequivalence if the alternative methods are expected
to detect a significant difference between the drug and
the listed drug in safety and therapeutic effect.
(9) The Secretary shall, with respect to each application
submitted under this subsection, maintain a record of--
(A) the name of the applicant,
(B) the name of the drug covered by the application,
(C) the name of each person to whom the review of the
chemistry of the application was assigned and the date
of such assignment, and
(D) the name of each person to whom the
bioequivalence review for such application was assigned
and the date of such assignment.
The information the Secretary is required to maintain under
this paragraph with respect to an application submitted under
this subsection shall be made available to the public after the
approval of such application.
(10)(A) If the proposed labeling of a drug that is the
subject of an application under this subsection differs from
the listed drug due to a labeling revision described under
clause (i), the drug that is the subject of such application
shall, notwithstanding any other provision of this Act, be
eligible for approval and shall not be considered misbranded
under section 502 if--
[(i) the application is otherwise eligible for
approval under this subsection but for expiration of
patent, an exclusivity period, or of a delay in
approval described in paragraph (5)(B)(iii), and a
revision to the labeling of the listed drug has been
approved by the Secretary within 60 days of such
expiration;
[(ii) the labeling revision described under clause
(i) does not include a change to the ``Warnings''
section of the labeling;
[(iii) the sponsor of the application under this
subsection agrees to submit revised labeling of the
drug that is the subject of such application not later
than 60 days after the notification of any changes to
such labeling required by the Secretary; and]
(i) a revision to the labeling of the listed drug has
been approved by the Secretary within 90 days of when
the application is otherwise eligible for approval
under this subsection;
(ii) the sponsor of the application agrees to submit
revised labeling for the drug that is the subject of
the application not later than 60 days after approval
under this subsection of the application;
(iii) the labeling revision described under clause
(i) does not include a change to the ``Warnings''
section of the labeling; and
(iv) such application otherwise meets the applicable
requirements for approval under this subsection.
(B) If, after a labeling revision described in subparagraph
(A)(i), the Secretary determines that the continued presence in
interstate commerce of the labeling of the listed drug (as in
effect before the revision described in subparagraph (A)(i))
adversely impacts the safe use of the drug, no application
under this subsection shall be eligible for approval with such
labeling.
(11)(A) Subject to subparagraph (B), the Secretary shall
prioritize the review of, and act within 8 months of the date
of the submission of, an original abbreviated new drug
application submitted for review under this subsection that is
for a drug--
(i) for which there are not more than 3 approved drug
products listed under paragraph (7) and for which there
are no blocking patents and exclusivities; or
(ii) that has been included on the list under section
506E.
(B) To qualify for priority review under this paragraph, not
later than 60 days prior to the submission of an application
described in subparagraph (A) or that the Secretary may
prioritize pursuant to subparagraph (D), the applicant shall
provide complete, accurate information regarding facilities
involved in manufacturing processes and testing of the drug
that is the subject of the application, including facilities in
corresponding Type II active pharmaceutical ingredients drug
master files referenced in an application and sites or
organizations involved in bioequivalence and clinical studies
used to support the application, to enable the Secretary to
make a determination regarding whether an inspection of a
facility is necessary. Such information shall include the
relevant (as determined by the Secretary) sections of such
application, which shall be unchanged relative to the date of
the submission of such application, except to the extent that a
change is made to such information to exclude a facility that
was not used to generate data to meet any application
requirements for such submission and that is not the only
facility intended to conduct one or more unit operations in
commercial production. Information provided by an applicant
under this subparagraph shall not be considered the submission
of an application under this subsection.
(C) The Secretary may expedite an inspection or reinspection
under section 704 of an establishment that proposes to
manufacture a drug described in subparagraph (A).
(D) Nothing in this paragraph shall prevent the Secretary
from prioritizing the review of other applications as the
Secretary determines appropriate.
(12) The Secretary shall publish on the internet website of
the Food and Drug Administration, and update at least once
every 6 months, a list of all drugs approved under subsection
(c) for which all patents and periods of exclusivity under this
Act have expired and for which no application has been approved
under this subsection.
(13) Upon the request of an applicant regarding one or more
specified pending applications under this subsection, the
Secretary shall, as appropriate, provide review status updates
indicating the categorical status of the applications by each
relevant review discipline.
(k)(1) In the case of any drug for which an approval of an
application filed under subsection (b) or (j) is in effect, the
applicant shall establish and maintain such records, and make
such reports to the Secretary, of data relating to clinical
experience and other data or information, received or otherwise
obtained by such applicant with respect to such drug, as the
Secretary may by general regulation, or by order with respect
to such application, prescribe on the basis of a finding that
such records and reports are necessary in order to enable the
Secretary to determine, or facilitate a determination, whether
there is or may be ground for invoking subsection (e) of this
section. Regulations and orders issued under this subsection
and under subsection (i) shall have due regard for the
professional ethics of the medical profession and the interests
of patients and shall provide, where the Secretary deems it to
be appropriate, for the examination, upon request, by the
persons to whom such regulations or orders are applicable, of
similar information received or otherwise obtained by the
Secretary.
(2) Every person required under this section to maintain
records, and every person in charge or custody thereof, shall,
upon request of an officer or employee designated by the
Secretary, permit such officer or employee at all reasonable
times to have access to and copy and verify such records.
(3) Active postmarket risk identification.--
(A) Definition.--In this paragraph, the term
``data'' refers to information with respect to
a drug approved under this section or under
section 351 of the Public Health Service Act,
including claims data, patient survey data,
standardized analytic files that allow for the
pooling and analysis of data from disparate
data environments, and any other data deemed
appropriate by the Secretary.
(B) Development of postmarket risk
identification and analysis methods.--The
Secretary shall, not later than 2 years after
the date of the enactment of the Food and Drug
Administration Amendments Act of 2007, in
collaboration with public, academic, and
private entities--
(i) develop methods to obtain access
to disparate data sources including the
data sources specified in subparagraph
(C);
(ii) develop validated methods for
the establishment of a postmarket risk
identification and analysis system to
link and analyze safety data from
multiple sources, with the goals of
including, in aggregate--
(I) at least 25,000,000
patients by July 1, 2010; and
(II) at least 100,000,000
patients by July 1, 2012; and
(iii) convene a committee of experts,
including individuals who are
recognized in the field of protecting
data privacy and security, to make
recommendations to the Secretary on the
development of tools and methods for
the ethical and scientific uses for,
and communication of, postmarketing
data specified under subparagraph (C),
including recommendations on the
development of effective research
methods for the study of drug safety
questions.
(C) Establishment of the postmarket risk
identification and analysis system.--
(i) In general.--The Secretary shall,
not later than 1 year after the
development of the risk identification
and analysis methods under subparagraph
(B), establish and maintain
procedures--
(I) for risk identification
and analysis based on
electronic health data, in
compliance with the regulations
promulgated under section
264(c) of the Health Insurance
Portability and Accountability
Act of 1996, and in a manner
that does not disclose
individually identifiable
health information in violation
of paragraph (4)(B);
(II) for the reporting (in a
standardized form) of data on
all serious adverse drug
experiences (as defined in
section 505-1(b)) submitted to
the Secretary under paragraph
(1), and those adverse events
submitted by patients,
providers, and drug sponsors,
when appropriate;
(III) to provide for active
adverse event surveillance
using the following data
sources, as available:
(aa) Federal health-
related electronic data
(such as data from the
Medicare program and
the health systems of
the Department of
Veterans Affairs);
(bb) private sector
health-related
electronic data (such
as pharmaceutical
purchase data and
health insurance claims
data); and
(cc) other data as
the Secretary deems
necessary to create a
robust system to
identify adverse events
and potential drug
safety signals;
(IV) to identify certain
trends and patterns with
respect to data accessed by the
system;
(V) to provide regular
reports to the Secretary
concerning adverse event
trends, adverse event patterns,
incidence and prevalence of
adverse events, and other
information the Secretary
determines appropriate, which
may include data on comparative
national adverse event trends;
and
(VI) to enable the program to
export data in a form
appropriate for further
aggregation, statistical
analysis, and reporting.
(ii) Timeliness of reporting.--The
procedures established under clause (i)
shall ensure that such data are
accessed, analyzed, and reported in a
timely, routine, and systematic manner,
taking into consideration the need for
data completeness, coding, cleansing,
and standardized analysis and
transmission.
(iii) Private sector resources.--To
ensure the establishment of the active
postmarket risk identification and
analysis system under this subsection
not later than 1 year after the
development of the risk identification
and analysis methods under subparagraph
(B), as required under clause (i), the
Secretary may, on a temporary or
permanent basis, implement systems or
products developed by private entities.
(iv) Complementary approaches.--To
the extent the active postmarket risk
identification and analysis system
under this subsection is not sufficient
to gather data and information relevant
to a priority drug safety question, the
Secretary shall develop, support, and
participate in complementary approaches
to gather and analyze such data and
information, including--
(I) approaches that are
complementary with respect to
assessing the safety of use of
a drug in domestic populations
not included, or
underrepresented, in the trials
used to approve the drug (such
as older people, people with
comorbidities, pregnant women,
or children); and
(II) existing approaches such
as the Vaccine Adverse Event
Reporting System and the
Vaccine Safety Datalink or
successor databases.
(v) Authority for contracts.--The
Secretary may enter into contracts with
public and private entities to fulfill
the requirements of this subparagraph.
(4) Advanced analysis of drug safety data.--
(A) Purpose.--The Secretary shall establish
collaborations with public, academic, and
private entities, which may include the Centers
for Education and Research on Therapeutics
under section 912 of the Public Health Service
Act, to provide for advanced analysis of drug
safety data described in paragraph (3)(C) and
other information that is publicly available or
is provided by the Secretary, in order to--
(i) improve the quality and
efficiency of postmarket drug safety
risk-benefit analysis;
(ii) provide the Secretary with
routine access to outside expertise to
study advanced drug safety questions;
and
(iii) enhance the ability of the
Secretary to make timely assessments
based on drug safety data.
(B) Privacy.--Such analysis shall not
disclose individually identifiable health
information when presenting such drug safety
signals and trends or when responding to
inquiries regarding such drug safety signals
and trends.
(C) Public process for priority questions.--
At least biannually, the Secretary shall seek
recommendations from the Drug Safety and Risk
Management Advisory Committee (or any successor
committee) and from other advisory committees,
as appropriate, to the Food and Drug
Administration on--
(i) priority drug safety questions;
and
(ii) mechanisms for answering such
questions, including through--
(I) active risk
identification under paragraph
(3); and
(II) when such risk
identification is not
sufficient, postapproval
studies and clinical trials
under subsection (o)(3).
(D) Procedures for the development of drug
safety collaborations.--
(i) In general.--Not later than 180
days after the date of the
establishment of the active postmarket
risk identification and analysis system
under this subsection, the Secretary
shall establish and implement
procedures under which the Secretary
may routinely contract with one or more
qualified entities to--
(I) classify, analyze, or
aggregate data described in
paragraph (3)(C) and
information that is publicly
available or is provided by the
Secretary;
(II) allow for prompt
investigation of priority drug
safety questions, including--
(aa) unresolved
safety questions for
drugs or classes of
drugs; and
(bb) for a newly-
approved drugs, safety
signals from clinical
trials used to approve
the drug and other
preapproval trials;
rare, serious drug side
effects; and the safety
of use in domestic
populations not
included, or
underrepresented, in
the trials used to
approve the drug (such
as older people, people
with comorbidities,
pregnant women, or
children);
(III) perform advanced
research and analysis on
identified drug safety risks;
(IV) focus postapproval
studies and clinical trials
under subsection (o)(3) more
effectively on cases for which
reports under paragraph (1) and
other safety signal detection
is not sufficient to resolve
whether there is an elevated
risk of a serious adverse event
associated with the use of a
drug; and
(V) carry out other
activities as the Secretary
deems necessary to carry out
the purposes of this paragraph.
(ii) Request for specific
methodology.--The procedures described
in clause (i) shall permit the
Secretary to request that a specific
methodology be used by the qualified
entity. The qualified entity shall work
with the Secretary to finalize the
methodology to be used.
(E) Use of analyses.--The Secretary shall
provide the analyses described in this
paragraph, including the methods and results of
such analyses, about a drug to the sponsor or
sponsors of such drug.
(F) Qualified entities.--
(i) In general.--The Secretary shall
enter into contracts with a sufficient
number of qualified entities to develop
and provide information to the
Secretary in a timely manner.
(ii) Qualification.--The Secretary
shall enter into a contract with an
entity under clause (i) only if the
Secretary determines that the entity
has a significant presence in the
United States and has one or more of
the following qualifications:
(I) The research,
statistical, epidemiologic, or
clinical capability and
expertise to conduct and
complete the activities under
this paragraph, including the
capability and expertise to
provide the Secretary de-
identified data consistent with
the requirements of this
subsection.
(II) An information
technology infrastructure in
place to support electronic
data and operational standards
to provide security for such
data.
(III) Experience with, and
expertise on, the development
of drug safety and
effectiveness research using
electronic population data.
(IV) An understanding of drug
development or risk/benefit
balancing in a clinical
setting.
(V) Other expertise which the
Secretary deems necessary to
fulfill the activities under
this paragraph.
(G) Contract requirements.--Each contract
with a qualified entity under subparagraph
(F)(i) shall contain the following
requirements:
(i) Ensuring privacy.--The qualified
entity shall ensure that the entity
will not use data under this subsection
in a manner that--
(I) violates the regulations
promulgated under section
264(c) of the Health Insurance
Portability and Accountability
Act of 1996;
(II) violates sections 552 or
552a of title 5, United States
Code, with regard to the
privacy of individually-
identifiable beneficiary health
information; or
(III) discloses individually
identifiable health information
when presenting drug safety
signals and trends or when
responding to inquiries
regarding drug safety signals
and trends.
Nothing in this clause prohibits lawful
disclosure for other purposes.
(ii) Component of another
organization.--If a qualified entity is
a component of another organization--
(I) the qualified entity
shall establish appropriate
security measures to maintain
the confidentiality and privacy
of such data; and
(II) the entity shall not
make an unauthorized disclosure
of such data to the other
components of the organization
in breach of such
confidentiality and privacy
requirement.
(iii) Termination or nonrenewal.--If
a contract with a qualified entity
under this subparagraph is terminated
or not renewed, the following
requirements shall apply:
(I) Confidentiality and
privacy protections.--The
entity shall continue to comply
with the confidentiality and
privacy requirements under this
paragraph with respect to all
data disclosed to the entity.
(II) Disposition of data.--
The entity shall return any
data disclosed to such entity
under this subsection to which
it would not otherwise have
access or, if returning the
data is not practicable,
destroy the data.
(H) Competitive procedures.--The Secretary
shall use competitive procedures (as defined in
section 4(5) of the Federal Procurement Policy
Act) to enter into contracts under subparagraph
(G).
(I) Review of contract in the event of a
merger or acquisition.--The Secretary shall
review the contract with a qualified entity
under this paragraph in the event of a merger
or acquisition of the entity in order to ensure
that the requirements under this paragraph will
continue to be met.
(J) Coordination.--In carrying out this
paragraph, the Secretary shall provide for
appropriate communications to the public,
scientific, public health, and medical
communities, and other key stakeholders, and to
the extent practicable shall coordinate with
the activities of private entities,
professional associations, or other entities
that may have sources of drug safety data.
(5) The Secretary shall--
(A) conduct regular screenings of the Adverse
Event Reporting System database and post a
quarterly report on the Adverse Event Reporting
System Web site of any new safety information
or potential signal of a serious risk
identified by Adverse Event Reporting System
within the last quarter; and
(B) on an annual basis, review the entire
backlog of postmarket safety commitments to
determine which commitments require revision or
should be eliminated, report to the Congress on
these determinations, and assign start dates
and estimated completion dates for such
commitments; and
(C) make available on the Internet website of the
Food and Drug Administration--
(i) guidelines, developed with input from
experts qualified by scientific training and
experience to evaluate the safety and
effectiveness of drugs, that detail best
practices for drug safety surveillance using
the Adverse Event Reporting System; and
(ii) criteria for public posting of adverse
event signals.
(l)(1) Safety and effectiveness data and information which
has been submitted in an application under subsection (b) for a
drug and which has not previously been disclosed to the public
shall be made available to the public, upon request, unless
extraordinary circumstances are shown--
(A) if no work is being or will be undertaken to have
the application approved,
(B) if the Secretary has determined that the
application is not approvable and all legal appeals
have been exhausted,
(C) if approval of the application under subsection
(c) is withdrawn and all legal appeals have been
exhausted,
(D) if the Secretary has determined that such drug is
not a new drug, or
(E) upon the effective date of the approval of the
first application under subsection (j) which refers to
such drug or upon the date upon which the approval of
an application under subsection (j) which refers to
such drug could be made effective if such an
application had been submitted.
(2) Action Package for Approval.--
(A) Action package.--The Secretary shall publish the
action package for approval of an application under
subsection (b) or section 351 of the Public Health
Service Act on the Internet Web site of the Food and
Drug Administration--
(i) not later than 30 days after the date of
approval of such applications--
(I) for a drug, no active moiety (as
defined by the Secretary in section
314.3 of title 21, Code of Federal
Regulations (or any successor
regulations)) of which has been
approved in any other application under
this section; or
(II) for a biological product, no
active ingredient of which has been
approved in any other application under
section 351 of the Public Health
Service Act; and
(ii) not later than 30 days after the third
request for such action package for approval
received under section 552 of title 5, United
States Code, for any other drug or biological
product.
(B) Immediate publication of summary review.--
Notwithstanding subparagraph (A), the Secretary shall
publish, on the Internet Web site of the Food and Drug
Administration, the materials described in subparagraph
(C)(iv) not later than 48 hours after the date of
approval of the drug, except where such materials
require redaction by the Secretary.
(C) Contents.--An action package for approval of an
application under subparagraph (A) shall be dated and
shall include the following:
(i) Documents generated by the Food and Drug
Administration related to review of the
application.
(ii) Documents pertaining to the format and
content of the application generated during
drug development.
(iii) Labeling submitted by the applicant.
(iv) A summary review that documents
conclusions from all reviewing disciplines
about the drug, noting any critical issues and
disagreements with the applicant and within the
review team and how they were resolved,
recommendations for action, and an explanation
of any nonconcurrence with review conclusions.
(v) The Division Director and Office
Director's decision document which includes--
(I) a brief statement of concurrence
with the summary review;
(II) a separate review or addendum to
the review if disagreeing with the
summary review; and
(III) a separate review or addendum
to the review to add further analysis.
(vi) Identification by name of each officer
or employee of the Food and Drug Administration
who--
(I) participated in the decision to
approve the application; and
(II) consents to have his or her name
included in the package.
(D) Review.--A scientific review of an application is
considered the work of the reviewer and shall not be
altered by management or the reviewer once final.
(E) Confidential information.--This paragraph does
not authorize the disclosure of any trade secret,
confidential commercial or financial information, or
other matter listed in section 552(b) of title 5,
United States Code.
(m) For purposes of this section, the term ``patent'' means a
patent issued by the United States Patent and Trademark Office.
(n)(1) For the purpose of providing expert scientific advice
and recommendations to the Secretary regarding a clinical
investigation of a drug or the approval for marketing of a drug
under section 505 or section 351 of the Public Health Service
Act, the Secretary shall establish panels of experts or use
panels of experts established before the date of enactment of
the Food and Drug Administration Modernization Act of 1997, or
both.
(2) The Secretary may delegate the appointment and oversight
authority granted under section 1004 to a director of a center
or successor entity within the Food and Drug Administration.
(3) The Secretary shall make appointments to each panel
established under paragraph (1) so that each panel shall
consist of--
(A) members who are qualified by training and
experience to evaluate the safety and effectiveness of
the drugs to be referred to the panel and who, to the
extent feasible, possess skill and experience in the
development, manufacture, or utilization of such drugs;
(B) members with diverse expertise in such fields as
clinical and administrative medicine, pharmacy,
pharmacology, pharmacoeconomics, biological and
physical sciences, and other related professions;
(C) a representative of consumer interests, and a
representative of interests of the drug manufacturing
industry not directly affected by the matter to be
brought before the panel; and
(D) two or more members who are specialists or have
other expertise in the particular disease or condition
for which the drug under review is proposed to be
indicated.
Scientific, trade, and consumer organizations shall be afforded
an opportunity to nominate individuals for appointment to the
panels. No individual who is in the regular full-time employ of
the United States and engaged in the administration of this Act
may be a voting member of any panel. The Secretary shall
designate one of the members of each panel to serve as chairman
thereof.
(4) The Secretary shall, as appropriate, provide education
and training to each new panel member before such member
participates in a panel's activities, including education
regarding requirements under this Act and related regulations
of the Secretary, and the administrative processes and
procedures related to panel meetings.
(5) Panel members (other than officers or employees of the
United States), while attending meetings or conferences of a
panel or otherwise engaged in its business, shall be entitled
to receive compensation for each day so engaged, including
traveltime, at rates to be fixed by the Secretary, but not to
exceed the daily equivalent of the rate in effect for positions
classified above grade GS-15 of the General Schedule. While
serving away from their homes or regular places of business,
panel members may be allowed travel expenses (including per
diem in lieu of subsistence) as authorized by section 5703 of
title 5, United States Code, for persons in the Government
service employed intermittently.
(6) The Secretary shall ensure that scientific advisory
panels meet regularly and at appropriate intervals so that any
matter to be reviewed by such a panel can be presented to the
panel not more than 60 days after the matter is ready for such
review. Meetings of the panel may be held using electronic
communication to convene the meetings.
(7) Within 90 days after a scientific advisory panel makes
recommendations on any matter under its review, the Food and
Drug Administration official responsible for the matter shall
review the conclusions and recommendations of the panel, and
notify the affected persons of the final decision on the
matter, or of the reasons that no such decision has been
reached. Each such final decision shall be documented including
the rationale for the decision.
(o) Postmarket Studies and Clinical Trials; Labeling.--
(1) In general.--A responsible person may not
introduce or deliver for introduction into interstate
commerce the new drug involved if the person is in
violation of a requirement established under paragraph
(3) or (4) with respect to the drug.
(2) Definitions.--For purposes of this subsection:
(A) Responsible person.--The term
``responsible person'' means a person who--
(i) has submitted to the Secretary a
covered application that is pending; or
(ii) is the holder of an approved
covered application.
(B) Covered application.--The term ``covered
application'' means--
(i) an application under subsection
(b) for a drug that is subject to
section 503(b); and
(ii) an application under section 351
of the Public Health Service Act.
(C) New safety information; serious risk.--
The terms ``new safety information'', ``serious
risk'', and ``signal of a serious risk'' have
the meanings given such terms in section 505-
1(b).
(3) Studies and clinical trials.--
(A) In general.--For any or all of the
purposes specified in subparagraph (B), the
Secretary may, subject to subparagraph (D),
require a responsible person for a drug to
conduct a postapproval study or studies of the
drug, or a postapproval clinical trial or
trials of the drug, on the basis of scientific
data deemed appropriate by the Secretary,
including information regarding chemically-
related or pharmacologically-related drugs.
(B) Purposes of study or clinical trial.--The
purposes referred to in this subparagraph with
respect to a postapproval study or postapproval
clinical trial are the following:
(i) To assess a known serious risk
related to the use of the drug
involved.
(ii) To assess signals of serious
risk related to the use of the drug.
(iii) To identify an unexpected
serious risk when available data
indicates the potential for a serious
risk.
(C) Establishment of requirement after
approval of covered application.--The Secretary
may require a postapproval study or studies or
postapproval clinical trial or trials for a
drug for which an approved covered application
is in effect as of the date on which the
Secretary seeks to establish such requirement
only if the Secretary becomes aware of new
safety information.
(D) Determination by secretary.--
(i) Postapproval studies.--The
Secretary may not require the
responsible person to conduct a study
under this paragraph, unless the
Secretary makes a determination that
the reports under subsection (k)(1) and
the active postmarket risk
identification and analysis system as
available under subsection (k)(3) will
not be sufficient to meet the purposes
set forth in subparagraph (B).
(ii) Postapproval clinical trials.--
The Secretary may not require the
responsible person to conduct a
clinical trial under this paragraph,
unless the Secretary makes a
determination that a postapproval study
or studies will not be sufficient to
meet the purposes set forth in
subparagraph (B).
(E) Notification; timetables; periodic
reports.--
(i) Notification.--The Secretary
shall notify the responsible person
regarding a requirement under this
paragraph to conduct a postapproval
study or clinical trial by the target
dates for communication of feedback
from the review team to the responsible
person regarding proposed labeling and
postmarketing study commitments as set
forth in the letters described in
section 101(c) of the Food and Drug
Administration Amendments Act of 2007.
(ii) Timetable; periodic reports.--
For each study or clinical trial
required to be conducted under this
paragraph, the Secretary shall require
that the responsible person submit a
timetable for completion of the study
or clinical trial. With respect to each
study required to be conducted under
this paragraph or otherwise undertaken
by the responsible person to
investigate a safety issue, the
Secretary shall require the responsible
person to periodically report to the
Secretary on the status of such study
including whether any difficulties in
completing the study have been
encountered. With respect to each
clinical trial required to be conducted
under this paragraph or otherwise
undertaken by the responsible person to
investigate a safety issue, the
Secretary shall require the responsible
person to periodically report to the
Secretary on the status of such
clinical trial including whether
enrollment has begun, the number of
participants enrolled, the expected
completion date, whether any
difficulties completing the clinical
trial have been encountered, and
registration information with respect
to the requirements under section
402(j) of the Public Health Service
Act. If the responsible person fails to
comply with such timetable or violates
any other requirement of this
subparagraph, the responsible person
shall be considered in violation of
this subsection, unless the responsible
person demonstrates good cause for such
noncompliance or such other violation.
The Secretary shall determine what
constitutes good cause under the
preceding sentence.
(F) Dispute resolution.--The responsible
person may appeal a requirement to conduct a
study or clinical trial under this paragraph
using dispute resolution procedures established
by the Secretary in regulation and guidance.
(4) Safety labeling changes requested by secretary.--
(A) New safety or new effectiveness
information.--If the Secretary becomes aware of
new information, including any new safety
information or information related to reduced
effectiveness, that the Secretary determines
should be included in the labeling of the drug,
the Secretary shall promptly notify the
responsible person or, if the same drug
approved under section 505(b) is not currently
marketed, the holder of an approved application
under 505(j).
(B) Response to notification.--Following
notification pursuant to subparagraph (A), the
responsible person or the holder of the
approved application under section 505(j) shall
within 30 days--
(i) submit a supplement proposing
changes to the approved labeling to
reflect the new safety information,
including changes to boxed warnings,
contraindications, warnings,
precautions, or adverse reactions, or
new effectiveness information; or
(ii) notify the Secretary that the
responsible person or the holder of the
approved application under section
505(j) does not believe a labeling
change is warranted and submit a
statement detailing the reasons why
such a change is not warranted.
(C) Review.--Upon receipt of such supplement,
the Secretary shall promptly review and act
upon such supplement. If the Secretary
disagrees with the proposed changes in the
supplement or with the statement setting forth
the reasons why no labeling change is
necessary, the Secretary shall initiate
discussions to reach agreement on whether the
labeling for the drug should be modified to
reflect the new safety or new effectiveness
information, and if so, the contents of such
labeling changes.
(D) Discussions.--Such discussions shall not
extend for more than 30 days after the response
to the notification under subparagraph (B),
unless the Secretary determines an extension of
such discussion period is warranted.
(E) Order.--Within 15 days of the conclusion
of the discussions under subparagraph (D), the
Secretary may issue an order directing the
responsible person or the holder of the
approved application under section 505(j) to
make such a labeling change as the Secretary
deems appropriate to address the new safety or
new effectiveness information. Within 15 days
of such an order, the responsible person or the
holder of the approved application under
section 505(j) shall submit a supplement
containing the labeling change.
(F) Dispute resolution.--Within 5 days of
receiving an order under subparagraph (E), the
responsible person or the holder of the
approved application under section 505(j) may
appeal using dispute resolution procedures
established by the Secretary in regulation and
guidance.
(G) Violation.--If the responsible person or
the holder of the approved application under
section 505(j) has not submitted a supplement
within 15 days of the date of such order under
subparagraph (E), and there is no appeal or
dispute resolution proceeding pending, the
responsible person or holder shall be
considered to be in violation of this
subsection. If at the conclusion of any dispute
resolution procedures the Secretary determines
that a supplement must be submitted and such a
supplement is not submitted within 15 days of
the date of that determination, the responsible
person or holder shall be in violation of this
subsection.
(H) Public health threat.--Notwithstanding
subparagraphs (A) through (F), if the Secretary
concludes that such a labeling change is
necessary to protect the public health, the
Secretary may accelerate the timelines in such
subparagraphs.
(I) Rule of construction.--This paragraph
shall not be construed to affect the
responsibility of the responsible person or the
holder of the approved application under
section 505(j) to maintain its label in
accordance with existing requirements,
including subpart B of part 201 and sections
314.70 and 601.12 of title 21, Code of Federal
Regulations (or any successor regulations).
(5) Non-delegation.--Determinations by the Secretary
under this subsection for a drug shall be made by
individuals at or above the level of individuals
empowered to approve a drug (such as division directors
within the Center for Drug Evaluation and Research).
(p) Risk Evaluation and Mitigation Strategy.--
(1) In general.--A person may not introduce or
deliver for introduction into interstate commerce a new
drug if--
(A)(i) the application for such drug is
approved under subsection (b) or (j) and is
subject to section 503(b); or
(ii) the application for such drug is
approved under section 351 of the Public Health
Service Act; and
(B) a risk evaluation and mitigation strategy
is required under section 505-1 with respect to
the drug and the person fails to maintain
compliance with the requirements of the
approved strategy or with other requirements
under section 505-1, including requirements
regarding assessments of approved strategies.
(2) Certain postmarket studies.--The failure to
conduct a postmarket study under section 506, subpart H
of part 314, or subpart E of part 601 of title 21, Code
of Federal Regulations (or any successor regulations),
is deemed to be a violation of paragraph (1).
(q) Petitions and Civil Actions Regarding Approval of Certain
Applications.--
(1) In general.--
(A) Determination.--The Secretary shall not
delay approval of a pending application
submitted under subsection (b)(2) or (j) of
this section or section 351(k) of the Public
Health Service Act because of any request to
take any form of action relating to the
application, either before or during
consideration of the request, unless--
(i) the request is in writing and is
a petition submitted to the Secretary
pursuant to section 10.30 or 10.35 of
title 21, Code of Federal Regulations
(or any successor regulations); and
(ii) the Secretary determines, upon
reviewing the petition, that a delay is
necessary to protect the public health.
Consideration of the petition shall be separate
and apart from review and approval of any
application.
(B) Notification.--If the Secretary
determines under subparagraph (A) that a delay
is necessary with respect to an application,
the Secretary shall provide to the applicant,
not later than 30 days after making such
determination, the following information:
(i) Notification of the fact that a
determination under subparagraph (A)
has been made.
(ii) If applicable, any clarification
or additional data that the applicant
should submit to the docket on the
petition to allow the Secretary to
review the petition promptly.
(iii) A brief summary of the specific
substantive issues raised in the
petition which form the basis of the
determination.
(C) Format.--The information described in
subparagraph (B) shall be conveyed via either,
at the discretion of the Secretary--
(i) a document; or
(ii) a meeting with the applicant
involved.
(D) Public disclosure.--Any information
conveyed by the Secretary under subparagraph
(C) shall be considered part of the application
and shall be subject to the disclosure
requirements applicable to information in such
application.
(E) Denial based on intent to delay.--If the
Secretary determines that a petition or a
supplement to the petition was submitted with
the primary purpose of delaying the approval of
an application and the petition does not on its
face raise valid scientific or regulatory
issues, the Secretary may deny the petition at
any point based on such determination. The
Secretary may issue guidance to describe the
factors that will be used to determine under
this subparagraph whether a petition is
submitted with the primary purpose of delaying
the approval of an application.
(F) Final agency action.--The Secretary shall
take final agency action on a petition not
later than 150 days after the date on which the
petition is submitted. The Secretary shall not
extend such period for any reason, including--
(i) any determination made under
subparagraph (A);
(ii) the submission of comments
relating to the petition or
supplemental information supplied by
the petitioner; or
(iii) the consent of the petitioner.
(G) Extension of 30-month period.--If the
filing of an application resulted in first-
applicant status under subsection
(j)(5)(D)(i)(IV) and approval of the
application was delayed because of a petition,
the 30-month period under such subsection is
deemed to be extended by a period of time equal
to the period beginning on the date on which
the Secretary received the petition and ending
on the date of final agency action on the
petition (inclusive of such beginning and
ending dates), without regard to whether the
Secretary grants, in whole or in part, or
denies, in whole or in part, the petition.
(H) Certification.--The Secretary shall not
consider a petition for review unless the party
submitting such petition does so in written
form and the subject document is signed and
contains the following certification: ``I
certify that, to my best knowledge and belief:
(a) this petition includes all information and
views upon which the petition relies; (b) this
petition includes representative data and/or
information known to the petitioner which are
unfavorable to the petition; and (c) I have
taken reasonable steps to ensure that any
representative data and/or information which
are unfavorable to the petition were disclosed
to me. I further certify that the information
upon which I have based the action requested
herein first became known to the party on whose
behalf this petition is submitted on or about
the following date: __________. If I received
or expect to receive payments, including cash
and other forms of consideration, to file this
information or its contents, I received or
expect to receive those payments from the
following persons or organizations:
_____________. I verify under penalty of
perjury that the foregoing is true and correct
as of the date of the submission of this
petition.'', with the date on which such
information first became known to such party
and the names of such persons or organizations
inserted in the first and second blank space,
respectively.
(I) Verification.--The Secretary shall not
accept for review any supplemental information
or comments on a petition unless the party
submitting such information or comments does so
in written form and the subject document is
signed and contains the following verification:
``I certify that, to my best knowledge and
belief: (a) I have not intentionally delayed
submission of this document or its contents;
and (b) the information upon which I have based
the action requested herein first became known
to me on or about __________. If I received or
expect to receive payments, including cash and
other forms of consideration, to file this
information or its contents, I received or
expect to receive those payments from the
following persons or organizations: _____. I
verify under penalty of perjury that the
foregoing is true and correct as of the date of
the submission of this petition.'', with the
date on which such information first became
known to the party and the names of such
persons or organizations inserted in the first
and second blank space, respectively.
(2) Exhaustion of administrative remedies.--
(A) Final agency action within 150 days.--The
Secretary shall be considered to have taken
final agency action on a petition if--
(i) during the 150-day period
referred to in paragraph (1)(F), the
Secretary makes a final decision within
the meaning of section 10.45(d) of
title 21, Code of Federal Regulations
(or any successor regulation); or
(ii) such period expires without the
Secretary having made such a final
decision.
(B) Dismissal of certain civil actions.--If a
civil action is filed against the Secretary
with respect to any issue raised in the
petition before the Secretary has taken final
agency action on the petition within the
meaning of subparagraph (A), the court shall
dismiss without prejudice the action for
failure to exhaust administrative remedies.
(C) Administrative record.--For purposes of
judicial review related to the approval of an
application for which a petition under
paragraph (1) was submitted, the administrative
record regarding any issue raised by the
petition shall include--
(i) the petition filed under
paragraph (1) and any supplements and
comments thereto;
(ii) the Secretary's response to such
petition, if issued; and
(iii) other information, as
designated by the Secretary, related to
the Secretary's determinations
regarding the issues raised in such
petition, as long as the information
was considered by the agency no later
than the date of final agency action as
defined under subparagraph (2)(A), and
regardless of whether the Secretary
responded to the petition at or before
the approval of the application at
issue in the petition.
(3) Annual report on delays in approvals per
petitions.--The Secretary shall annually submit to the
Congress a report that specifies--
(A) the number of applications that were
approved during the preceding 12-month period;
(B) the number of such applications whose
effective dates were delayed by petitions
referred to in paragraph (1) during such
period;
(C) the number of days by which such
applications were so delayed; and
(D) the number of such petitions that were
submitted during such period.
(4) Exceptions.--
(A) This subsection does not apply to--
(i) a petition that relates solely to
the timing of the approval of an
application pursuant to subsection
(j)(5)(B)(iv); or
(ii) a petition that is made by the
sponsor of an application and that
seeks only to have the Secretary take
or refrain from taking any form of
action with respect to that
application.
(B) Paragraph (2) does not apply to a
petition addressing issues concerning an
application submitted pursuant to section
351(k) of the Public Health Service Act.
(5) Definitions.--
(A) Application.--For purposes of this
subsection, the term ``application'' means an
application submitted under subsection (b)(2)
or (j) of this section or section 351(k) of the
Public Health Service Act.
(B) Petition.--For purposes of this
subsection, other than paragraph (1)(A)(i), the
term ``petition'' means a request described in
paragraph (1)(A)(i).
(r) Postmarket Drug Safety Information for Patients and
Providers.--
(1) Establishment.--Not later than 1 year after the
date of the enactment of the Food and Drug
Administration Amendments Act of 2007, the Secretary
shall improve the transparency of information about
drugs and allow patients and health care providers
better access to information about drugs by developing
and maintaining an Internet Web site that--
(A) provides links to drug safety information
listed in paragraph (2) for prescription drugs
that are approved under this section or
licensed under section 351 of the Public Health
Service Act; and
(B) improves communication of drug safety
information to patients and providers.
(2) Internet web site.--The Secretary shall carry out
paragraph (1) by--
(A) developing and maintaining an accessible,
consolidated Internet Web site with easily
searchable drug safety information, including
the information found on United States
Government Internet Web sites, such as the
United States National Library of Medicine's
Daily Med and Medline Plus Web sites, in
addition to other such Web sites maintained by
the Secretary;
(B) ensuring that the information provided on
the Internet Web site is comprehensive and
includes, when available and appropriate--
(i) patient labeling and patient
packaging inserts;
(ii) a link to a list of each drug,
whether approved under this section or
licensed under such section 351, for
which a Medication Guide, as provided
for under part 208 of title 21, Code of
Federal Regulations (or any successor
regulations), is required;
(iii) a link to the registry and
results data bank provided for under
subsections (i) and (j) of section 402
of the Public Health Service Act;
(iv) the most recent safety
information and alerts issued by the
Food and Drug Administration for drugs
approved by the Secretary under this
section, such as product recalls,
warning letters, and import alerts;
(v) publicly available information
about implemented RiskMAPs and risk
evaluation and mitigation strategies
under subsection (o);
(vi) guidance documents and
regulations related to drug safety; and
(vii) other material determined
appropriate by the Secretary;
(C) providing access to summaries of the
assessed and aggregated data collected from the
active surveillance infrastructure under
subsection (k)(3) to provide information of
known and serious side-effects for drugs
approved under this section or licensed under
such section 351;
(D) preparing and making publicly available
on the Internet website established under
paragraph (1) best practices for drug safety
surveillance activities for drugs approved
under this section or section 351 of the Public
Health Service Act;
(E) enabling patients, providers, and drug
sponsors to submit adverse event reports
through the Internet Web site;
(F) providing educational materials for
patients and providers about the appropriate
means of disposing of expired, damaged, or
unusable medications; and
(G) supporting initiatives that the Secretary
determines to be useful to fulfill the purposes
of the Internet Web site.
(3) Posting of drug labeling.--The Secretary shall
post on the Internet Web site established under
paragraph (1) the approved professional labeling and
any required patient labeling of a drug approved under
this section or licensed under such section 351 not
later than 21 days after the date the drug is approved
or licensed, including in a supplemental application
with respect to a labeling change.
(4) Private sector resources.--To ensure development
of the Internet Web site by the date described in
paragraph (1), the Secretary may, on a temporary or
permanent basis, implement systems or products
developed by private entities.
(5) Authority for contracts.--The Secretary may enter
into contracts with public and private entities to
fulfill the requirements of this subsection.
(6) Review.--The Advisory Committee on Risk
Communication under section 567 shall, on a regular
basis, perform a comprehensive review and evaluation of
the types of risk communication information provided on
the Internet Web site established under paragraph (1)
and, through other means, shall identify, clarify, and
define the purposes and types of information available
to facilitate the efficient flow of information to
patients and providers, and shall recommend ways for
the Food and Drug Administration to work with outside
entities to help facilitate the dispensing of risk
communication information to patients and providers.
(s) Referral to Advisory Committee.--The Secretary shall--
(1) refer a drug or biological product to a Food and
Drug Administration advisory committee for review at a
meeting of such advisory committee prior to the
approval of such drug or biological if it is--
(A) a drug, no active moiety (as defined by
the Secretary in section 314.3 of title 21,
Code of Federal Regulations (or any successor
regulations)) of which has been approved in any
other application under this section; or
(B) a biological product, no active
ingredient of which has been approved in any
other application under section 351 of the
Public Health Service Act; or
(2) if the Secretary does not refer a drug or
biological product described in paragraph (1) to a Food
and Drug Administration advisory committee prior to
such approval, provide in the action letter on the
application for the drug or biological product a
summary of the reasons why the Secretary did not refer
the drug or biological product to an advisory committee
prior to approval.
(t) Database for Authorized Generic Drugs.--
(1) In general.--
(A) Publication.--The Commissioner shall--
(i) not later than 9 months after the
date of the enactment of the Food and
Drug Administration Amendments Act of
2007, publish a complete list on the
Internet Web site of the Food and Drug
Administration of all authorized
generic drugs (including drug trade
name, brand company manufacturer, and
the date the authorized generic drug
entered the market); and
(ii) update the list quarterly to
include each authorized generic drug
included in an annual report submitted
to the Secretary by the sponsor of a
listed drug during the preceding 3-
month period.
(B) Notification.--The Commissioner shall
notify relevant Federal agencies, including the
Centers for Medicare & Medicaid Services and
the Federal Trade Commission, when the
Commissioner first publishes the information
described in subparagraph (A) that the
information has been published and that the
information will be updated quarterly.
(2) Inclusion.--The Commissioner shall include in the
list described in paragraph (1) each authorized generic
drug included in an annual report submitted to the
Secretary by the sponsor of a listed drug after January
1, 1999.
(3) Authorized generic drug.--In this section, the
term ``authorized generic drug'' means a listed drug
(as that term is used in subsection (j)) that--
(A) has been approved under subsection (c);
and
(B) is marketed, sold, or distributed
directly or indirectly to retail class of trade
under a different labeling, packaging (other
than repackaging as the listed drug in blister
packs, unit doses, or similar packaging for use
in institutions), product code, labeler code,
trade name, or trade mark than the listed drug.
(u) Certain Drugs Containing Single Enantiomers.--
(1) In general.--For purposes of subsections
(c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is
submitted under subsection (b) for a non-racemic drug
containing as an active moiety (as defined by the
Secretary in section 314.3 of title 21, Code of Federal
Regulations (or any successor regulations)) a single
enantiomer that is contained in a racemic drug approved
in another application under subsection (b), the
applicant may, in the application for such non-racemic
drug, elect to have the single enantiomer not be
considered the same active moiety as that contained in
the approved racemic drug, if--
(A)(i) the single enantiomer has not been
previously approved except in the approved
racemic drug; and
(ii) the application submitted under
subsection (b) for such non-racemic drug--
(I) includes full reports of new
clinical investigations (other than
bioavailability studies)--
(aa) necessary for the
approval of the application
under subsections (c) and (d);
and
(bb) conducted or sponsored
by the applicant; and
(II) does not rely on any clinical
investigations that are part of an
application submitted under subsection
(b) for approval of the approved
racemic drug; and
(B) the application submitted under
subsection (b) for such non-racemic drug is not
submitted for approval of a condition of use--
(i) in a therapeutic category in
which the approved racemic drug has
been approved; or
(ii) for which any other enantiomer
of the racemic drug has been approved.
(2) Limitation.--
(A) No approval in certain therapeutic
categories.--Until the date that is 10 years
after the date of approval of a non-racemic
drug described in paragraph (1) and with
respect to which the applicant has made the
election provided for by such paragraph, the
Secretary shall not approve such non-racemic
drug for any condition of use in the
therapeutic category in which the racemic drug
has been approved.
(B) Labeling.--If applicable, the labeling of
a non-racemic drug described in paragraph (1)
and with respect to which the applicant has
made the election provided for by such
paragraph shall include a statement that the
non-racemic drug is not approved, and has not
been shown to be safe and effective, for any
condition of use of the racemic drug.
(3) Definition.--
(A) In general.--For purposes of this
subsection, the term ``therapeutic category''
means a therapeutic category identified in the
list developed by the United States
Pharmacopeia pursuant to section 1860D-
4(b)(3)(C)(ii) of the Social Security Act and
as in effect on the date of the enactment of
this subsection.
(B) Publication by secretary.--The Secretary
shall publish the list described in
subparagraph (A) and may amend such list by
regulation.
(4) Availability.--The election referred to in
paragraph (1) may be made only in an application that
is submitted to the Secretary after the date of the
enactment of this subsection and before October 1,
[2022] 2027.
(v) Antibiotic Drugs Submitted Before November 21, 1997.--
(1) Antibiotic drugs approved before november 21,
1997.--
(A) In general.--Notwithstanding any
provision of the Food and Drug Administration
Modernization Act of 1997 or any other
provision of law, a sponsor of a drug that is
the subject of an application described in
subparagraph (B)(i) shall be eligible for, with
respect to the drug, the 3-year exclusivity
period referred to under clauses (iii) and (iv)
of subsection (c)(3)(E) and under clauses (iii)
and (iv) of subsection (j)(5)(F), subject to
the requirements of such clauses, as
applicable.
(B) Application; antibiotic drug described.--
(i) Application.--An application
described in this clause is an
application for marketing submitted
under this section after the date of
the enactment of this subsection in
which the drug that is the subject of
the application contains an antibiotic
drug described in clause (ii).
(ii) Antibiotic drug.--An antibiotic
drug described in this clause is an
antibiotic drug that was the subject of
an application approved by the
Secretary under section 507 of this Act
(as in effect before November 21,
1997).
(2) Antibiotic drugs submitted before november 21,
1997, but not approved.--
(A) In general.--Notwithstanding any
provision of the Food and Drug Administration
Modernization Act of 1997 or any other
provision of law, a sponsor of a drug that is
the subject of an application described in
subparagraph (B)(i) may elect to be eligible
for, with respect to the drug--
(i)(I) the 3-year exclusivity period
referred to under clauses (iii) and
(iv) of subsection (c)(3)(E) and under
clauses (iii) and (iv) of subsection
(j)(5)(F), subject to the requirements
of such clauses, as applicable; and
(II) the 5-year exclusivity period
referred to under clause (ii) of
subsection (c)(3)(E) and under clause
(ii) of subsection (j)(5)(F), subject
to the requirements of such clauses, as
applicable; or
(ii) a patent term extension under
section 156 of title 35, United States
Code, subject to the requirements of
such section.
(B) Application; antibiotic drug described.--
(i) Application.--An application
described in this clause is an
application for marketing submitted
under this section after the date of
the enactment of this subsection in
which the drug that is the subject of
the application contains an antibiotic
drug described in clause (ii).
(ii) Antibiotic drug.--An antibiotic
drug described in this clause is an
antibiotic drug that was the subject of
1 or more applications received by the
Secretary under section 507 of this Act
(as in effect before November 21,
1997), none of which was approved by
the Secretary under such section.
(3) Limitations.--
(A) Exclusivities and extensions.--Paragraphs
(1)(A) and (2)(A) shall not be construed to
entitle a drug that is the subject of an
approved application described in subparagraphs
(1)(B)(i) or (2)(B)(i), as applicable, to any
market exclusivities or patent extensions other
than those exclusivities or extensions
described in paragraph (1)(A) or (2)(A).
(B) Conditions of use.--Paragraphs (1)(A) and
(2)(A)(i) shall not apply to any condition of
use for which the drug referred to in
subparagraph (1)(B)(i) or (2)(B)(i), as
applicable, was approved before the date of the
enactment of this subsection.
(4) Application of certain provisions.--
Notwithstanding section 125, or any other provision, of
the Food and Drug Administration Modernization Act of
1997, or any other provision of law, and subject to the
limitations in paragraphs (1), (2), and (3), the
provisions of the Drug Price Competition and Patent
Term Restoration Act of 1984 shall apply to any drug
subject to paragraph (1) or any drug with respect to
which an election is made under paragraph (2)(A).
(w) Deadline for Determination on Certain Petitions.--The
Secretary shall issue a final, substantive determination on a
petition submitted pursuant to subsection (b) of section
314.161 of title 21, Code of Federal Regulations (or any
successor regulations), no later than 270 days after the date
the petition is submitted.
(x) Date of Approval in the Case of Recommended Controls
Under the CSA.--
(1) In general.--In the case of an application under
subsection (b) with respect to a drug for which the
Secretary provides notice to the sponsor that the
Secretary intends to issue a scientific and medical
evaluation and recommend controls under the Controlled
Substances Act, approval of such application shall not
take effect until the interim final rule controlling
the drug is issued in accordance with section 201(j) of
the Controlled Substances Act.
(2) Date of approval.--For purposes of this section,
with respect to an application described in paragraph
(1), the term ``date of approval'' shall mean the later
of--
(A) the date an application under subsection
(b) is approved under subsection (c); or
(B) the date of issuance of the interim final
rule controlling the drug.
(y) Contrast Agents Intended for Use With Applicable Medical
Imaging Devices.--
(1) In general.--The sponsor of a contrast agent for
which an application has been approved under this
section may submit a supplement to the application
seeking approval for a new use following the
authorization of a premarket submission for an
applicable medical imaging device for that use with the
contrast agent pursuant to section 520(p)(1).
(2) Review of supplement.--In reviewing a supplement
submitted under this subsection, the agency center
charged with the premarket review of drugs may--
(A) consult with the center charged with the
premarket review of devices; and
(B) review information and data submitted to
the Secretary by the sponsor of an applicable
medical imaging device pursuant to section 515,
510(k), or 513(f)(2) so long as the sponsor of
such applicable medical imaging device has
provided to the sponsor of the contrast agent a
right of reference.
(3) Definitions.--For purposes of this subsection--
(A) the term ``new use'' means a use of a
contrast agent that is described in the
approved labeling of an applicable medical
imaging device described in section 520(p), but
that is not described in the approved labeling
of the contrast agent; and
(B) the terms ``applicable medical imaging
device'' and ``contrast agent'' have the
meanings given such terms in section 520(p).
(z) Nonclinical Test Defined.--For purposes of this section,
the term ``nonclinical test'' means a test conducted in vitro,
in silico, or in chemico, or a nonhuman in vivo test, that
occurs before or during the clinical trial phase of the
investigation of the safety and effectiveness of a drug. Such
test may include the following:
(1) Cell-based assays.
(2) Organ chips and microphysiological systems.
(3) Computer modeling.
(4) Other nonhuman or human biology-based test
methods.
(5) Animal tests.
* * * * * * *
SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND BIOLOGICAL
PRODUCTS.
(a) New Drugs and Biological Products.--
(1) In general.--
(A) General requirements.--Except with
respect to an application for which
subparagraph (B) applies, a person that
submits, on or after the date of the enactment
of the Pediatric Research Equity Act of 2007,
an application (or supplement to an
application) for a drug--
(i) under section 505 for a new
active ingredient, new indication, new
dosage form, new dosing regimen, or new
route of administration; or
(ii) under section 351 of the Public
Health Service Act (42 U.S.C. 262) for
a new active ingredient, new
indication, new dosage form, new dosing
regimen, or new route of
administration,
shall submit with the application the
assessments described in paragraph (2).
(B) Certain molecularly targeted cancer
indications.--A person that submits, on or
after the date that is 3 years after the date
of enactment of the FDA Reauthorization Act of
2017, an original application for a new active
ingredient under section 505 of this Act or
section 351 of the Public Health Service Act,
shall submit with the application reports on
the investigation described in paragraph (3) if
the drug or biological product that is the
subject of the application is--
(i) intended for the treatment of an
adult cancer; and
(ii) directed at a molecular target
that the Secretary determines to be
substantially relevant to the growth or
progression of a pediatric cancer.
(C) Rule of construction.--No application
that is subject to the requirements of
subparagraph (B) shall be subject to the
requirements of subparagraph (A), and no
application (or supplement to an application)
that is subject to the requirements of
subparagraph (A) shall be subject to the
requirements of subparagraph (B).
(2) Assessments.--
(A) In general.--The assessments referred to
in paragraph (1)(A) shall contain data,
gathered using appropriate formulations for
each age group for which the assessment is
required, that are adequate--
(i) to assess the safety and
effectiveness of the drug or the
biological product for the claimed
indications in all relevant pediatric
subpopulations; and
(ii) to support dosing and
administration for each pediatric
subpopulation for which the drug or the
biological product is safe and
effective.
(B) Similar course of disease or similar
effect of drug or biological product.--
(i) In general.--If the course of the
disease and the effects of the drug are
sufficiently similar in adults and
pediatric patients, the Secretary may
conclude that pediatric effectiveness
can be extrapolated from adequate and
well-controlled studies in adults,
usually supplemented with other
information obtained in pediatric
patients, such as pharmacokinetic
studies.
(ii) Extrapolation between age
groups.--A study may not be needed in
each pediatric age group if data from
one age group can be extrapolated to
another age group.
(iii) Information on extrapolation.--
A brief documentation of the scientific
data supporting the conclusion under
clauses (i) and (ii) shall be included
in any pertinent reviews for the
application under section 505 of this
Act or section 351 of the Public Health
Service Act (42 U.S.C. 262).
(3) Molecularly targeted pediatric cancer
investigation.--
[(A) In general.--With respect to a drug or
biological product described in paragraph
(1)(B), the investigation described in this
paragraph is a molecularly targeted pediatric
cancer investigation, which shall be designed
to yield clinically meaningful pediatric study
data, gathered using appropriate formulations
for each age group for which the study is
required, regarding dosing, safety, and
preliminary efficacy to inform potential
pediatric labeling.]
(A) In general.--For purposes of paragraph
(1)(B), the investigation described in this
paragraph is (as determined by the Secretary) a
molecularly targeted pediatric cancer
investigation of--
(i) the drug or biological product
for which the application referred to
in such paragraph is submitted; or
(ii) such drug or biological product
in combination with--
(I) an active ingredient of a
drug or biological product--
(aa) for which an
approved application
under section 505(j)
under this Act or under
section 351(k) of the
Public Health Service
Act is in effect; and
(bb) that is
determined by the
Secretary to be the
standard of care for
treating a pediatric
cancer; or
(II) an active ingredient of
a drug or biological product--
(aa) for which an
approved application
under section 505(b) of
this Act or section
351(a) of the Public
Health Service Act to
treat an adult cancer
is in effect and is
held by the same person
submitting the
application under
paragraph (1)(B); and
(bb) that is directed
at a molecular target
that the Secretary
determines to be
substantially relevant
to the growth or
progression of a
pediatric cancer.
(B) Additional requirements.--
(i) Design of investigation.--A
molecularly targeted pediatric cancer
investigation referred to in
subparagraph (A) shall be designed to
yield clinically meaningful pediatric
study data that is gathered using
appropriate formulations for each age
group for which the study is required,
regarding dosing, safety, and
preliminary efficacy to inform
potential pediatric labeling.
(ii) Limitation.--An investigation
described in subparagraph (A)(ii) may
be required only if the drug or
biological product for which the
application referred to in paragraph
(1)(B) contains either--
(I) a single new active
ingredient; or
(II) more than one active
ingredient, if an application
for the combination of active
ingredients has not previously
been approved but each active
ingredient has been previously
approved to treat an adult
cancer.
(iii) Results of already-completed
preclinical studies of application
drug.--The Secretary may require that
reports on an investigation required
pursuant to paragraph (1)(B) include
the results of all preclinical studies
on which the decision to conduct such
investigation was based.
(iv) Rule of construction regarding
inactive ingredients.--With respect to
a combination of active ingredients
referred to in subparagraph (A)(ii),
such subparagraph shall not be
construed as addressing the use of
inactive ingredients with such
combination.
[(B)] (C) Extrapolation of data.--Paragraph
(2)(B) shall apply to [investigations described
in this paragraph] investigations referred to
in subparagraph (A) to the same extent and in
the same manner as paragraph (2)(B) applies
with respect to the assessments required under
paragraph (1)(A).
[(C)] (D) Deferrals and waivers.--Deferrals
and waivers under paragraphs (4) and (5) shall
apply to investigations described in this
paragraph to the same extent and in the same
manner as such deferrals and waivers apply with
respect to [the assessments under paragraph
(2)(B)] the assessments required under
paragraph (1)(A).
(4) Deferral.--
(A) In general.--On the initiative of the
Secretary or at the request of the applicant,
the Secretary may defer submission of some or
all assessments required under paragraph (1)(A)
or reports on the investigation required under
paragraph (1)(B) until a specified date after
approval of the drug or issuance of the license
for a biological product if--
(i) the Secretary finds that--
(I) the drug or biological
product is ready for approval
for use in adults before
pediatric studies are complete;
(II) pediatric studies should
be delayed until additional
safety or effectiveness data
have been collected; or
(III) there is another
appropriate reason for
deferral; and
(ii) the applicant submits to the
Secretary--
(I) certification of the
grounds for deferring the
assessments or reports on the
investigation;
(II) a pediatric study plan
as described in subsection (e);
(III) evidence that the
studies are being conducted or
will be conducted with due
diligence and at the earliest
possible time; and
(IV) a timeline for the
completion of such studies.
(B) Deferral extension.--
(i) In general.--On the initiative of
the Secretary or at the request of the
applicant, the Secretary may grant an
extension of a deferral approved under
subparagraph (A) for submission of some
or all assessments required under
paragraph (1)(A) or reports on the
investigation required under paragraph
(1)(B) if--
(I) the Secretary determines
that the conditions described
in subclause (II) or (III) of
subparagraph (A)(i) continue to
be met; and
(II) the applicant submits a
new timeline under subparagraph
(A)(ii)(IV) and any significant
updates to the information
required under subparagraph
(A)(ii).
(ii) Timing and information.--If the
deferral extension under this
subparagraph is requested by the
applicant, the applicant shall submit
the deferral extension request
containing the information described in
this subparagraph not less than 90 days
prior to the date that the deferral
would expire. The Secretary shall
respond to such request not later than
45 days after the receipt of such
letter. If the Secretary grants such an
extension, the specified date shall be
the extended date. The sponsor of the
required assessment under paragraph
(1)(A) or reports on the investigation
under paragraph (1)(B) shall not be
issued a letter described in subsection
(d) unless the specified or extended
date of submission for such required
studies has passed or if the request
for an extension is pending. For a
deferral that has expired prior to the
date of enactment of the Food and Drug
Administration Safety and Innovation
Act or that will expire prior to 270
days after the date of enactment of
such Act, a deferral extension shall be
requested by an applicant not later
than 180 days after the date of
enactment of such Act. The Secretary
shall respond to any such request as
soon as practicable, but not later than
1 year after the date of enactment of
such Act. Nothing in this clause shall
prevent the Secretary from updating the
status of a study or studies publicly
if components of such study or studies
are late or delayed.
(C) Annual review.--
(i) In general.--On an annual basis
following the approval of a deferral
under subparagraph (A), the applicant
shall submit to the Secretary the
following information:
(I) Information detailing the
progress made in conducting
pediatric studies.
(II) If no progress has been
made in conducting such
studies, evidence and
documentation that such studies
will be conducted with due
diligence and at the earliest
possible time.
(III) Projected completion
date for pediatric studies.
(IV) The reason or reasons
why a deferral or deferral
extension continues to be
necessary.
(ii) Public availability.--Not later
than 90 days after the submission to
the Secretary of the information
submitted through the annual review
under clause (i), the Secretary shall
make available to the public in an
easily accessible manner, including
through the Internet Web site of the
Food and Drug Administration--
(I) such information;
(II) the name of the
applicant for the product
subject to the assessment or
investigation;
(III) the date on which the
product was approved; and
(IV) the date of each
deferral or deferral extension
under this paragraph for the
product.
(5) Waivers.--
(A) Full waiver.--On the initiative of the
Secretary or at the request of an applicant,
the Secretary shall grant a full waiver, as
appropriate, of the requirement to submit
assessments or reports on the investigation for
a drug or biological product under this
subsection if the applicant certifies and the
Secretary finds that--
(i) necessary studies are impossible
or highly impracticable (because, for
example, the number of patients is so
small or the patients are
geographically dispersed);
(ii) there is evidence strongly
suggesting that the drug or biological
product would be ineffective or unsafe
in all pediatric age groups; or
(iii) the drug or biological
product--
(I) does not represent a
meaningful therapeutic benefit
over existing therapies for
pediatric patients; and
(II) is not likely to be used
in a substantial number of
pediatric patients.
(B) Partial waiver.--On the initiative of the
Secretary or at the request of an applicant,
the Secretary shall grant a partial waiver, as
appropriate, of the requirement to submit
assessments or reports on the investigation for
a drug or biological product under this
subsection with respect to a specific pediatric
age group if the applicant certifies and the
Secretary finds that--
(i) necessary studies are impossible
or highly impracticable (because, for
example, the number of patients in that
age group is so small or patients in
that age group are geographically
dispersed);
(ii) there is evidence strongly
suggesting that the drug or biological
product would be ineffective or unsafe
in that age group;
(iii) the drug or biological
product--
(I) does not represent a
meaningful therapeutic benefit
over existing therapies for
pediatric patients in that age
group; and
(II) is not likely to be used
by a substantial number of
pediatric patients in that age
group; or
(iv) the applicant can demonstrate
that reasonable attempts to produce a
pediatric formulation necessary for
that age group have failed.
(C) Pediatric formulation not possible.--If a
partial waiver is granted on the ground that it
is not possible to develop a pediatric
formulation, the waiver shall cover only the
pediatric groups requiring that formulation. An
applicant seeking such a partial waiver shall
submit to the Secretary documentation detailing
why a pediatric formulation cannot be developed
and, if the waiver is granted, the applicant's
submission shall promptly be made available to
the public in an easily accessible manner,
including through posting on the Web site of
the Food and Drug Administration.
(D) Labeling requirement.--If the Secretary
grants a full or partial waiver because there
is evidence that a drug or biological product
would be ineffective or unsafe in pediatric
populations, the information shall be included
in the labeling for the drug or biological
product.
(b) Marketed Drugs and Biological Products.--
(1) In general.--The Secretary may (by order in the
form of a letter) require the sponsor or holder of an
approved application for a drug under section 505 or
the holder of a license for a biological product under
section 351 of the Public Health Service Act to submit
by a specified date the assessments described in
subsection (a)(2), if the Secretary finds that--
(A)(i) the drug or biological product is used
for a substantial number of pediatric patients
for the labeled indications; and
(ii) adequate pediatric labeling could confer
a benefit on pediatric patients;
(B) there is reason to believe that the drug
or biological product would represent a
meaningful therapeutic benefit over existing
therapies for pediatric patients for 1 or more
of the claimed indications; or
(C) the absence of adequate pediatric
labeling could pose a risk to pediatric
patients.
(2) Waivers.--
(A) Full waiver.--At the request of an
applicant, the Secretary shall grant a full
waiver, as appropriate, of the requirement to
submit assessments under this subsection if the
applicant certifies and the Secretary finds
that--
(i) necessary studies are impossible
or highly impracticable (because, for
example, the number of patients in that
age group is so small or patients in
that age group are geographically
dispersed); or
(ii) there is evidence strongly
suggesting that the drug or biological
product would be ineffective or unsafe
in all pediatric age groups.
(B) Partial waiver.--At the request of an
applicant, the Secretary shall grant a partial
waiver, as appropriate, of the requirement to
submit assessments under this subsection with
respect to a specific pediatric age group if
the applicant certifies and the Secretary finds
that--
(i) necessary studies are impossible
or highly impracticable (because, for
example, the number of patients in that
age group is so small or patients in
that age group are geographically
dispersed);
(ii) there is evidence strongly
suggesting that the drug or biological
product would be ineffective or unsafe
in that age group;
(iii)(I) the drug or biological
product--
(aa) does not represent a
meaningful therapeutic benefit
over existing therapies for
pediatric patients in that age
group; and
(bb) is not likely to be used
in a substantial number of
pediatric patients in that age
group; and
(II) the absence of adequate labeling
could not pose significant risks to
pediatric patients; or
(iv) the applicant can demonstrate
that reasonable attempts to produce a
pediatric formulation necessary for
that age group have failed.
(C) Pediatric formulation not possible.--If a
waiver is granted on the ground that it is not
possible to develop a pediatric formulation,
the waiver shall cover only the pediatric
groups requiring that formulation. An applicant
seeking either a full or partial waiver shall
submit to the Secretary documentation detailing
why a pediatric formulation cannot be developed
and, if the waiver is granted, the applicant's
submission shall promptly be made available to
the public in an easily accessible manner,
including through posting on the Web site of
the Food and Drug Administration.
(D) Labeling requirement.--If the Secretary
grants a full or partial waiver because there
is evidence that a drug or biological product
would be ineffective or unsafe in pediatric
populations, the information shall be included
in the labeling for the drug or biological
product.
(3) Effect of subsection.--Nothing in this subsection
alters or amends section 301(j) of this Act or section
552 of title 5 or section 1905 of title 18, United
States Code.
(c) Meaningful Therapeutic Benefit.--For the purposes of
paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) of subsection (a)
and paragraphs (1)(B) and (2)(B)(iii)(I)(aa) of subsection (b),
a drug or biological product shall be considered to represent a
meaningful therapeutic benefit over existing therapies if the
Secretary determines that--
(1) if approved, the drug or biological product could
represent an improvement in the treatment, diagnosis,
or prevention of a disease, compared with marketed
products adequately labeled for that use in the
relevant pediatric population; or
(2) the drug or biological product is in a class of
products or for an indication for which there is a need
for additional options.
(d) Submission of Assessments And Reports on the
Investigation.--If a person fails to submit a required
assessment described in subsection (a)(2) or the investigation
described in subsection (a)(3), fails to meet the applicable
requirements in subsection (a)(4), or fails to submit a request
for approval of a pediatric formulation described in subsection
(a) or (b), in accordance with applicable provisions of
subsections (a) and (b), the following shall apply:
(1) Beginning 270 days after the date of enactment of
the Food and Drug Administration Safety and Innovation
Act, the Secretary shall issue a non-compliance letter
to such person informing them of such failure to submit
or meet the requirements of the applicable subsection.
Such letter shall require the person to respond in
writing within 45 calendar days of issuance of such
letter. Such response may include the person's request
for a deferral extension if applicable. Such letter and
the person's written response to such letter shall be
made publicly available on the Internet Web site of the
Food and Drug Administration 60 calendar days after
issuance, with redactions for any trade secrets and
confidential commercial information. If the Secretary
determines that the letter was issued in error, the
requirements of this paragraph shall not apply. The
Secretary shall inform the Pediatric Advisory Committee
of letters issued under this paragraph and responses to
such letters.
(2) The drug or biological product that is the
subject of an assessment described in subsection (a)(2)
or the investigation described in subsection (a)(3),
applicable requirements in subsection (a)(4), or
request for approval of a pediatric formulation, may be
considered misbranded solely because of that failure
and subject to relevant enforcement action (except that
the drug or biological product shall not be subject to
action under section 303), but such failure shall not
be the basis for a proceeding--
(A) to withdraw approval for a drug under
section 505(e); or
(B) to revoke the license for a biological
product under section 351 of the Public Health
Service Act.
(e) Pediatric Study Plans.--
(1) In general.--An applicant subject to subsection
(a) shall submit to the Secretary an initial pediatric
study plan prior to the submission of the assessments
described under subsection (a)(2) or the investigation
described in subsection (a)(3). The Secretary shall
determine whether subparagraph (A) or (B) of subsection
(a)(1) shall apply with respect to an application
before the date on which the applicant is required to
submit the initial pediatric study plan under paragraph
(2)(A).
(2) Timing; content; meetings.--
(A) Timing.--An applicant shall submit the
initial pediatric study plan under paragraph
(1)--
(i) before the date on which the
applicant submits the assessments under
subsection (a)(2) or the investigation
described in subsection (a)(3); and
(ii) not later than--
(I) 60 calendar days after
the date of the end-of-Phase 2
meeting (as such term is used
in section 312.47 of title 21,
Code of Federal Regulations, or
successor regulations); or
(II) such other time as may
be agreed upon between the
Secretary and the applicant.
Nothing in this section shall preclude the
Secretary from accepting the submission of an
initial pediatric study plan earlier than the
date otherwise applicable under this
subparagraph.
(B) Content of initial pediatric study
plan.--The initial pediatric study plan shall
include--
(i) an outline of the pediatric study
or studies that the applicant plans to
conduct (including, to the extent
practicable study objectives and
design, age groups, relevant endpoints,
and statistical approach);
(ii) any request for a deferral,
partial waiver, or waiver under this
section, if applicable, along with any
supporting information; and
(iii) other information specified in
the regulations promulgated under
paragraph (7).
(C) Meetings.--The Secretary--
(i) shall meet with the applicant--
(I) if requested by the
applicant with respect to a
drug or biological product that
is intended to treat a serious
or life-threatening disease or
condition, to discuss
preparation of the initial
pediatric study plan, not later
than the end-of-Phase 1 meeting
(as such term is used in
section 312.82(b) of title 21,
Code of Federal Regulations, or
successor regulations) or
within 30 calendar days of
receipt of such request,
whichever is later;
(II) to discuss the initial
pediatric study plan as soon as
practicable, but not later than
90 calendar days after the
receipt of such plan under
subparagraph (A); and
(III) to discuss the bases
for the deferral under
subsection (a)(4) or a full or
partial waiver under subsection
(a)(5);
(ii) may determine that a written
response to the initial pediatric study
plan is sufficient to communicate
comments on the initial pediatric study
plan, and that no meeting under clause
(i)(II) is necessary; and
(iii) if the Secretary determines
that no meeting under clause (i)(II) is
necessary, shall so notify the
applicant and provide written comments
of the Secretary as soon as
practicable, but not later than 90
calendar days after the receipt of the
initial pediatric study plan.
(3) Agreed initial pediatric study plan.--Not later
than 90 calendar days following the meeting under
paragraph (2)(C)(i)(II) or the receipt of a written
response from the Secretary under paragraph
(2)(C)(iii), the applicant shall document agreement on
the initial pediatric study plan in a submission to the
Secretary marked ``Agreed Initial Pediatric Study
Plan'', and the Secretary shall confirm such agreement
to the applicant in writing not later than 30 calendar
days of receipt of such agreed initial pediatric study
plan.
(4) Deferral and waiver.--If the agreed initial
pediatric study plan contains a request from the
applicant for a deferral, partial waiver, or waiver
under this section, the written confirmation under
paragraph (3) shall include a recommendation from the
Secretary as to whether such request meets the
standards under paragraphs (3) or (4) of subsection
(a).
(5) Amendments to the agreed initial pediatric study
plan.--At the initiative of the Secretary or the
applicant, the agreed initial pediatric study plan may
be amended at any time. The requirements of paragraph
(2)(C) shall apply to any such proposed amendment in
the same manner and to the same extent as such
requirements apply to an initial pediatric study plan
under paragraph (1). The requirements of paragraphs (3)
and (4) shall apply to any agreement resulting from
such proposed amendment in the same manner and to the
same extent as such requirements apply to an agreed
initial pediatric study plan.
(6) Internal committee.--The Secretary shall consult
the internal committee under section 505C on the review
of the initial pediatric study plan, agreed initial
pediatric study plan, and any significant amendments to
such plans.
(7) Required rulemaking.--Not later than 1 year after
the date of enactment of the Food and Drug
Administration Safety and Innovation Act, the Secretary
shall promulgate proposed regulations and issue
guidance to implement the provisions of this
subsection.
(f) Review of Pediatric Study Plans,Assessments, Deferrals,
Deferral Extensions, and Waivers.--
(1) Review.--Beginning not later than 30 days after
the date of the enactment of the Pediatric Research
Equity Act of 2007, the Secretary shall utilize the
internal committee established under section 505C to
provide consultation to reviewing divisions on initial
pediatric study plans, agreed initial pediatric study
plans, and any significant amendments to such plans,
and assessments prior to approval of an application or
supplement for which a pediatric assessment is required
under this section and all deferral, deferral
extension, and waiver requests granted pursuant to this
section.
(2) Activity by committee.--The committee referred to
in paragraph (1) may operate using appropriate members
of such committee and need not convene all members of
the committee.
(3) Documentation of committee action.--For each drug
or biological product, the committee referred to in
paragraph (1) shall document, for each activity
described in paragraph (4) or (5), which members of the
committee participated in such activity.
(4) Review of pediatric study plans, assessments,
deferrals, deferral extensions, and waivers.--
Consultation on initial pediatric study plans, agreed
initial pediatric study plans, and assessments by the
committee referred to in paragraph (1) pursuant to this
section shall occur prior to approval of an application
or supplement for which a pediatric assessment is
required under this section. The committee shall review
all requests for deferrals, deferral extensions, and
waivers from the requirement to submit a pediatric
assessment granted under this section and shall provide
recommendations as needed to reviewing divisions,
including with respect to whether such a supplement,
when submitted, shall be considered for priority
review.
(5) Retrospective review of pediatric assessments,
deferrals, and waivers.--Not later than 1 year after
the date of the enactment of the Pediatric Research
Equity Act of 2007, the committee referred to in
paragraph (1) shall conduct a retrospective review and
analysis of a representative sample of assessments
submitted and deferrals and waivers approved under this
section since the enactment of the Pediatric Research
Equity Act of 2003. Such review shall include an
analysis of the quality and consistency of pediatric
information in pediatric assessments and the
appropriateness of waivers and deferrals granted. Based
on such review, the Secretary shall issue
recommendations to the review divisions for
improvements and initiate guidance to industry related
to the scope of pediatric studies required under this
section.
(6) Tracking of assessments and labeling changes.--
The Secretary, in consultation with the committee
referred to in paragraph (1), shall track and make
available to the public in an easily accessible manner,
including through posting on the Web site of the Food
and Drug Administration--
(A) the number of assessments conducted under
this section;
(B) the specific drugs and biological
products and their uses assessed under this
section;
(C) the types of assessments conducted under
this section, including trial design, the
number of pediatric patients studied, and the
number of centers and countries involved;
(D) aggregated on an annual basis--
(i) the total number of deferrals and
deferral extensions requested and
granted under this section and, if
granted, the reasons for each such
deferral or deferral extension;
(ii) the timeline for completion of
the assessments;
(iii) the number of assessments
completed and pending; and
(iv) the number of postmarket non-
compliance letters issued pursuant to
subsection (d), and the recipients of
such letters;
(E) the number of waivers requested and
granted under this section and, if granted, the
reasons for the waivers;
(F) the number of pediatric formulations
developed and the number of pediatric
formulations not developed and the reasons any
such formulation was not developed;
(G) the labeling changes made as a result of
assessments conducted under this section;
(H) an annual summary of labeling changes
made as a result of assessments conducted under
this section for distribution pursuant to
subsection (h)(2);
(I) an annual summary of information
submitted pursuant to subsection (a)(3)(B); and
(J) the number of times the committee
referred to in paragraph (1) made a
recommendation to the Secretary under paragraph
(4) regarding priority review, the number of
times the Secretary followed or did not follow
such a recommendation, and, if not followed,
the reasons why such a recommendation was not
followed.
(g) Labeling Changes.--
(1) Dispute resolution.--
(A) Request for labeling change and failure
to agree.--If, on or after the date of the
enactment of the Pediatric Research Equity Act
of 2007, the Commissioner determines that a
sponsor and the Commissioner have been unable
to reach agreement on appropriate changes to
the labeling for the drug that is the subject
of the application or supplement, not later
than 180 days after the date of the submission
of the application or supplement that receives
a priority review or 330 days after the date of
the submission of an application or supplement
that receives a standard review--
(i) the Commissioner shall request
that the sponsor of the application
make any labeling change that the
Commissioner determines to be
appropriate; and
(ii) if the sponsor does not agree
within 30 days after the Commissioner's
request to make a labeling change
requested by the Commissioner, the
Commissioner shall refer the matter to
the Pediatric Advisory Committee.
(B) Action by the pediatric advisory
committee.--Not later than 90 days after
receiving a referral under subparagraph
(A)(ii), the Pediatric Advisory Committee
shall--
(i) review the pediatric study
reports; and
(ii) make a recommendation to the
Commissioner concerning appropriate
labeling changes, if any.
(C) Consideration of recommendations.--The
Commissioner shall consider the recommendations
of the Pediatric Advisory Committee and, if
appropriate, not later than 30 days after
receiving the recommendation, make a request to
the sponsor of the application or supplement to
make any labeling changes that the Commissioner
determines to be appropriate.
(D) Misbranding.--If the sponsor of the
application or supplement, within 30 days after
receiving a request under subparagraph (C),
does not agree to make a labeling change
requested by the Commissioner, the Commissioner
may deem the drug that is the subject of the
application or supplement to be misbranded.
(E) No effect on authority.--Nothing in this
subsection limits the authority of the United
States to bring an enforcement action under
this Act when a drug lacks appropriate
pediatric labeling. Neither course of action
(the Pediatric Advisory Committee process or an
enforcement action referred to in the preceding
sentence) shall preclude, delay, or serve as
the basis to stay the other course of action.
(2) Other labeling changes.--If, on or after the date
of the enactment of the Pediatric Research Equity Act
of 2007, the Secretary makes a determination that a
pediatric assessment conducted under this section does
or does not demonstrate that the drug that is the
subject of such assessment is safe and effective in
pediatric populations or subpopulations, including
whether such assessment results are inconclusive, the
Secretary shall order the labeling of such product to
include information about the results of the assessment
and a statement of the Secretary's determination.
(h) Dissemination of Pediatric Information.--
(1) In general.--Not later than 210 days after the
date of submission of an application (or supplement to
an application) that contains a pediatric assessment
under this section, if the application (or supplement)
receives a priority review, or not later than 330 days
after the date of submission of an application (or
supplement to an application) that contains a pediatric
assessment under this section, if the application (or
supplement) receives a standard review, the Secretary
shall make available to the public in an easily
accessible manner the medical, statistical, and
clinical pharmacology reviews of such pediatric
assessments, and shall post such assessments on the Web
site of the Food and Drug Administration.
(2) Dissemination of information regarding labeling
changes.--Beginning on the date of the enactment of the
Pediatric Research Equity Act of 2007, the Secretary
shall require that the sponsors of the assessments that
result in labeling changes that are reflected in the
annual summary developed pursuant to subsection
(f)(6)(H) distribute such information to physicians and
other health care providers.
(3) Effect of subsection.--Nothing in this subsection
shall alter or amend section 301(j) of this Act or
section 552 of title 5 or section 1905 of title 18,
United States Code.
(i) Adverse Event Reporting.--
(1) Reporting in first 18-month period.--Beginning on
the date of the enactment of the Pediatric Research
Equity Act of 2007, during the 18-month period
beginning on the date a labeling change is made
pursuant to subsection (g), the Secretary shall ensure
that all adverse event reports that have been received
for such drug (regardless of when such report was
received) are referred to the Office of Pediatric
Therapeutics. In considering such reports, the Director
of such Office shall provide for the review of such
reports by the Pediatric Advisory Committee, including
obtaining any recommendations of such committee
regarding whether the Secretary should take action
under this Act in response to such reports.
(2) Reporting in subsequent periods.--Following the
18-month period described in paragraph (1), the
Secretary shall, as appropriate, refer to the Office of
Pediatric Therapeutics all pediatric adverse event
reports for a drug for which a pediatric study was
conducted under this section. In considering such
reports, the Director of such Office may provide for
the review of such reports by the Pediatric Advisory
Committee, including obtaining any recommendation of
such Committee regarding whether the Secretary should
take action in response to such reports.
(3) Preservation of authority.--Nothing in this
subsection shall prohibit the Office of Pediatric
Therapeutics from providing for the review of adverse
event reports by the Pediatric Advisory Committee prior
to the 18-month period referred to in paragraph (1), if
such review is necessary to ensure safe use of a drug
in a pediatric population.
(4) Effect.--The requirements of this subsection
shall supplement, not supplant, other review of such
adverse event reports by the Secretary.
(j) Scope of Authority.--Nothing in this section provides to
the Secretary any authority to require a pediatric assessment
of any drug or biological product, or any assessment regarding
other populations or uses of a drug or biological product,
other than the pediatric assessments described in this section.
(k) Relation to Orphan Drugs.--
(1) In general; exemption for orphan indications.--
Unless the Secretary requires otherwise by regulation
and except as provided in paragraph (2), this section
does not apply to any drug or biological product for an
indication for which orphan designation has been
granted under section 526.
(2) Applicability despite orphan designation of
certain indications.--This section shall apply with
respect to a drug or biological product for which an
indication has been granted orphan designation under
526 if the investigation described in subsection (a)(3)
applies to the drug or biological product as described
in subsection (a)(1)(B).
(l) New Active Ingredient.--
(1) Non-interchangeable biosimilar biological
product.--A biological product that is biosimilar to a
reference product under section 351 of the Public
Health Service Act, and that the Secretary has not
determined to meet the standards described in
subsection (k)(4) of such section for
interchangeability with the reference product, shall be
considered to have a new active ingredient under this
section.
(2) Interchangeable biosimilar biological product.--A
biological product that is interchangeable with a
reference product under section 351 of the Public
Health Service Act shall not be considered to have a
new active ingredient under this section.
(m) List of Primary Molecular Targets.--
(1) In general.--Within one year of the date of
enactment of the FDA Reauthorization Act of 2017, the
Secretary shall establish and update regularly, and
shall publish on the internet website of the Food and
Drug Administration--
(A) a list of molecular targets considered,
on the basis of data the Secretary determines
to be adequate, to be substantially relevant to
the growth and progression of a pediatric
cancer, and that may trigger the requirements
under this section; and
(B) a list of molecular targets of new cancer
drugs and biological products in development
for which pediatric cancer study requirements
under this section will be automatically
waived.
(2) Consultation.--In establishing the lists
described in paragraph (1), the Secretary shall consult
the National Cancer Institute, members of the internal
committee under section 505C, and the Pediatric
Oncology Subcommittee of the Oncologic Drugs Advisory
Committee, and shall take into account comments from
the meeting under subsection (c).
(3) Rule of construction.--Nothing in paragraph (1)
shall be construed--
(A) to require the inclusion of a molecular
target on the list published under such
paragraph as a condition for triggering the
requirements under subsection (a)(1)(B) with
respect to a drug or biological product
directed at such molecular target; or
(B) to authorize the disclosure of
confidential commercial information, as
prohibited under section 301(j) of this Act or
section 1905 of title 18, United States Code.
* * * * * * *
SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW QUALIFIED INFECTIOUS
DISEASE PRODUCTS.
(a) Extension.--If the Secretary approves an application
pursuant to section 505 for a drug that has been designated as
a qualified infectious disease product under subsection (d),
the 4- and 5-year periods described in subsections
(c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the 3-year
periods described in clauses (iii) and (iv) of subsection
(c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) of
section 505, or the 7-year period described in section 527, as
applicable, shall be extended by 5 years.
(b) Relation to Pediatric Exclusivity.--Any extension under
subsection (a) of a period shall be in addition to any
extension of the period under section 505A with respect to the
drug.
(c) Limitations.--Subsection (a) does not apply to the
approval of--
(1) a supplement to an application under section
505(b) for any qualified infectious disease product for
which an extension described in subsection (a) is in
effect or has expired;
(2) a subsequent application filed with respect to a
product approved under section 505 for a change that
results in a new indication, route of administration,
dosing schedule, dosage form, delivery system, delivery
device, or strength; [or]
(3) a product that does not meet the definition of a
qualified infectious disease product under subsection
(g) based upon its approved uses[.]; or
(4) an application pursuant to section 351(a) of the
Public Health Service Act.
(d) Designation.--
(1) In general.--The manufacturer or sponsor of a
drug may request the Secretary to designate a drug as a
qualified infectious disease product at any time before
the submission of an application under section 505(b)
of this Act or section 351(a) of the Public Health
Service Act for such drug. The Secretary shall, not
later than 60 days after the submission of such a
request, determine whether the drug is a qualified
infectious disease product.
(2) Limitation.--Except as provided in paragraph (3),
a designation under this subsection shall not be
withdrawn for any reason, including modifications to
the list of qualifying pathogens under subsection
(f)(2)(C).
(3) Revocation of designation.--The Secretary may
revoke a designation of a drug as a qualified
infectious disease product if the Secretary finds that
the request for such designation contained an untrue
statement of material fact.
(e) Regulations.--
(1) In general.--Not later than 2 years after the
date of enactment of the Food and Drug Administration
Safety and Innovation Act, the Secretary shall adopt
final regulations implementing this section, including
developing the list of qualifying pathogens described
in subsection (f).
(2) Procedure.--In promulgating a regulation
implementing this section, the Secretary shall--
(A) issue a notice of proposed rulemaking
that includes the proposed regulation;
(B) provide a period of not less than 60 days
for comments on the proposed regulation; and
(C) publish the final regulation not less
than 30 days before the effective date of the
regulation.
(3) Restrictions.--Notwithstanding any other
provision of law, the Secretary shall promulgate
regulations implementing this section only as described
in paragraph (2), except that the Secretary may issue
interim guidance for sponsors seeking designation under
subsection (d) prior to the promulgation of such
regulations.
(4) Designation prior to regulations.--The Secretary
shall designate drugs as qualified infectious disease
products under subsection (d) prior to the promulgation
of regulations under this subsection, if such drugs
meet the definition of a qualified infectious disease
product described in subsection (g).
(f) Qualifying Pathogen.--
(1) Definition.--In this section, the term
``qualifying pathogen'' means a pathogen identified and
listed by the Secretary under paragraph (2) that has
the potential to pose a serious threat to public
health, such as--
(A) resistant gram positive pathogens,
including methicillin-resistant Staphylococcus
aureus, vancomycin-resistant Staphylococcus
aureus, and vancomycin-resistant enterococcus;
(B) multi-drug resistant gram negative
bacteria, including Acinetobacter, Klebsiella,
Pseudomonas, and E. coli species;
(C) multi-drug resistant tuberculosis; and
(D) Clostridium difficile.
(2) List of qualifying pathogens.--
(A) In general.--The Secretary shall
establish and maintain a list of qualifying
pathogens, and shall make public the
methodology for developing such list.
(B) Considerations.--In establishing and
maintaining the list of pathogens described
under this section, the Secretary shall--
(i) consider--
(I) the impact on the public
health due to drug-resistant
organisms in humans;
(II) the rate of growth of
drug-resistant organisms in
humans;
(III) the increase in
resistance rates in humans; and
(IV) the morbidity and
mortality in humans; and
(ii) consult with experts in
infectious diseases and antibiotic
resistance, including the Centers for
Disease Control and Prevention, the
Food and Drug Administration, medical
professionals, and the clinical
research community.
(C) Review.--Every 5 years, or more often as
needed, the Secretary shall review, provide
modifications to, and publish the list of
qualifying pathogens under subparagraph (A) and
shall by regulation revise the list as
necessary, in accordance with subsection (e).
[(g) Qualified Infectious Disease Product.--The term
``qualified infectious disease product'' means an antibacterial
or antifungal drug for human use intended to treat serious or
life-threatening infections, including those caused by--
[(1) an antibacterial or antifungal resistant
pathogen, including novel or emerging infectious
pathogens; or
[(2) qualifying pathogens listed by the Secretary
under subsection (f).]
(g) Qualified Infectious Disease Product.--The term
``qualified infectious disease product'' means a drug,
including an antibacterial or antifungal drug or a biological
product, for human use that--
(1) acts directly on bacteria or fungi or on
substances produced by such bacteria or fungi; and
(2) is intended to treat a serious or life-
threatening infection, including such an infection
caused by--
(A) an antibacterial or antifungal resistant
pathogen, including novel or emerging
infectious pathogens; or
(B) qualifying pathogens listed by the
Secretary under subsection (f).
* * * * * * *
SEC. 506. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS OR LIFE-THREATENING
DISEASES OR CONDITIONS.
(a) Designation of a Drug as a Breakthrough Therapy.--
(1) In general.--The Secretary shall, at the request
of the sponsor of a drug, expedite the development and
review of such drug if the drug is intended, alone or
in combination with 1 or more other drugs, to treat a
serious or life-threatening disease or condition and
preliminary clinical evidence indicates that the drug
may demonstrate substantial improvement over existing
therapies on 1 or more clinically significant
endpoints, such as substantial treatment effects
observed early in clinical development. (In this
section, such a drug is referred to as a ``breakthrough
therapy''.)
(2) Request for designation.--The sponsor of a drug
may request the Secretary to designate the drug as a
breakthrough therapy. A request for the designation may
be made concurrently with, or at any time after, the
submission of an application for the investigation of
the drug under section 505(i) or section 351(a)(3) of
the Public Health Service Act.
(3) Designation.--
(A) In general.--Not later than 60 calendar
days after the receipt of a request under
paragraph (2), the Secretary shall determine
whether the drug that is the subject of the
request meets the criteria described in
paragraph (1). If the Secretary finds that the
drug meets the criteria, the Secretary shall
designate the drug as a breakthrough therapy
and shall take such actions as are appropriate
to expedite the development and review of the
application for approval of such drug.
(B) Actions.--The actions to expedite the
development and review of an application under
subparagraph (A) may include, as appropriate--
(i) holding meetings with the sponsor
and the review team throughout the
development of the drug;
(ii) providing timely advice to, and
interactive communication with, the
sponsor regarding the development of
the drug to ensure that the development
program to gather the nonclinical and
clinical data necessary for approval is
as efficient as practicable;
(iii) involving senior managers and
experienced review staff, as
appropriate, in a collaborative, cross-
disciplinary review;
(iv) assigning a cross-disciplinary
project lead for the Food and Drug
Administration review team to
facilitate an efficient review of the
development program and to serve as a
scientific liaison between the review
team and the sponsor; and
(v) taking steps to ensure that the
design of the clinical trials is as
efficient as practicable, when
scientifically appropriate, such as by
minimizing the number of patients
exposed to a potentially less
efficacious treatment.
(b) Designation of Drug as Fast Track Product.--
(1) In general.--The Secretary shall, at the request
of the sponsor of a new drug, facilitate the
development and expedite the review of such drug if it
is intended, whether alone or in combination with one
or more other drugs, for the treatment of a serious or
life-threatening disease or condition, and it
demonstrates the potential to address unmet medical
needs for such a disease or condition, or if the
Secretary designates the drug as a qualified infectious
disease product under section 505E(d). (In this
section, such a drug is referred to as a ``fast track
product''.)
(2) Request for designation.--The sponsor of a new
drug may request the Secretary to designate the drug as
a fast track product. A request for the designation may
be made concurrently with, or at any time after,
submission of an application for the investigation of
the drug under section 505(i) or section 351(a)(3) of
the Public Health Service Act.
(3) Designation.--Within 60 calendar days after the
receipt of a request under paragraph (2), the Secretary
shall determine whether the drug that is the subject of
the request meets the criteria described in paragraph
(1). If the Secretary finds that the drug meets the
criteria, the Secretary shall designate the drug as a
fast track product and shall take such actions as are
appropriate to expedite the development and review of
the application for approval of such product.
(c) Accelerated Approval of a Drug for a Serious or Life-
Threatening Disease or Condition, Including a Fast Track
Product.--
(1) In general.--
(A) Accelerated approval.--The Secretary may
approve an application for approval of a
product for a serious or life-threatening
disease or condition, including a fast track
product, under section 505(c) or section 351(a)
of the Public Health Service Act upon a
determination that the product has an effect on
a surrogate endpoint that is reasonably likely
to predict clinical benefit, or on a clinical
endpoint that can be measured earlier than
irreversible morbidity or mortality, that is
reasonably likely to predict an effect on
irreversible morbidity or mortality or other
clinical benefit, taking into account the
severity, rarity, or prevalence of the
condition and the availability or lack of
alternative treatments. The approval described
in the preceding sentence is referred to in
this section as ``accelerated approval''.
(B) Evidence.--The evidence to support that
an endpoint is reasonably likely to predict
clinical benefit under subparagraph (A) may
include epidemiological, pathophysiological,
therapeutic, pharmacologic, or other evidence
developed using biomarkers, for example, or
other scientific methods or tools.
[(2) Limitation.--Approval of a product under this
subsection may be subject to 1 or both of the following
requirements:
[(A) That the sponsor conduct appropriate
postapproval studies to verify and describe the
predicted effect on irreversible morbidity or
mortality or other clinical benefit.
[(B) That the sponsor submit copies of all
promotional materials related to the product
during the preapproval review period and,
following approval and for such period
thereafter as the Secretary determines to be
appropriate, at least 30 days prior to
dissemination of the materials.
[(3) Expedited withdrawal of approval.--The Secretary
may withdraw approval of a product approved under
accelerated approval using expedited procedures (as
prescribed by the Secretary in regulations which shall
include an opportunity for an informal hearing) if--
[(A) the sponsor fails to conduct any
required postapproval study of the drug with
due diligence;
[(B) a study required to verify and describe
the predicted effect on irreversible morbidity
or mortality or other clinical benefit of the
product fails to verify and describe such
effect or benefit;
[(C) other evidence demonstrates that the
product is not safe or effective under the
conditions of use; or
[(D) the sponsor disseminates false or
misleading promotional materials with respect
to the product.]
(2) Limitation.--
(A) In general.--Approval of a product under
this subsection may be subject to 1 or both of
the following requirements:
(i) That the sponsor conduct an
appropriate postapproval study or
studies (which may be augmented or
supported by real world evidence) to
verify and describe the predicted
effect on irreversible morbidity or
mortality or other clinical benefit.
(ii) That the sponsor submit copies
of all promotional materials related to
the product during the preapproval
review period and, following approval
and for such period thereafter as the
Secretary determines to be appropriate,
at least 30 days prior to dissemination
of the materials.
(B) Studies not required.--If the Secretary
does not require that the sponsor of a product
approved under accelerated approval conduct a
postapproval study under this paragraph, the
Secretary shall publish on the website of the
Food and Drug Administration the rationale for
why such study is not appropriate or necessary.
(C) Postapproval study conditions.--Not later
than the time of approval of a product under
accelerated approval, the Secretary shall
specify the conditions for a postapproval study
or studies required to be conducted under this
paragraph with respect to such product, which
may include enrollment targets, the study
protocol, and milestones, including the target
date of study completion.
(D) Studies begun before approval.--The
Secretary may require such study or studies to
be underway prior to approval.
(3) Expedited withdrawal of approval.--
(A) In general.--The Secretary may withdraw
approval of a product approved under
accelerated approval using expedited procedures
described in subparagraph (B), if--
(i) the sponsor fails to conduct any
required postapproval study of the
product with due diligence, including
with respect to conditions specified by
the Secretary under paragraph (2)(C);
(ii) a study required to verify and
describe the predicted effect on
irreversible morbidity or mortality or
other clinical benefit of the product
fails to verify and describe such
effect or benefit;
(iii) other evidence demonstrates
that the product is not shown to be
safe or effective under the conditions
of use; or
(iv) the sponsor disseminates false
or misleading promotional materials
with respect to the product.
(B) Expedited procedures described.--
Expedited procedures described in this
subparagraph shall consist of, prior to the
withdrawal of accelerated approval--
(i) providing the sponsor with--
(I) due notice;
(II) an explanation for the
proposed withdrawal;
(III) an opportunity for a
meeting with the Commissioner
of Food and Drugs or the
Commissioner's designee; and
(IV) an opportunity for
written appeal to--
(aa) the Commissioner
of Food and Drugs; or
(bb) a designee of
the Commissioner who
has not participated in
the proposed withdrawal
of approval (other than
a meeting pursuant to
subclause (III)) and is
not a subordinate of an
individual (other than
the Commissioner) who
participated in such
proposed withdrawal;
(ii) providing an opportunity for
public comment on the notice proposing
to withdraw approval;
(iii) the publication of a summary of
the public comments received, and the
Secretary's response to such comments,
on the website of the Food and Drug
Administration; and
(iv) convening and consulting an
advisory committee on issues related to
the proposed withdrawal, if requested
by the sponsor and if no such advisory
committee has previously advised the
Secretary on such issues with respect
to the withdrawal of the product prior
to the sponsor's request.
(4) Labeling.--
(A) In general.--Subject to subparagraph (B),
the labeling for a product approved under
accelerated approval shall include--
(i) a statement indicating that the
product was approved under accelerated
approval;
(ii) a statement indicating that
continued approval of the product is
subject to postmarketing studies to
verify clinical benefit;
(iii) identification of the surrogate
or intermediate endpoint or endpoints
that supported approval and any known
limitations of such surrogate or
intermediate endpoint or endpoints in
determining clinical benefit; and
(iv) a succinct description of the
product and any uncertainty about
anticipated clinical benefit and a
discussion of available evidence with
respect to such clinical benefit.
(B) Applicability.--The labeling requirements
of subparagraph (A) shall apply only to
products approved under accelerated approval
for which the predicted effect on irreversible
morbidity or mortality or other clinical
benefit has not been verified.
(C) Rule of construction.--With respect to
any application pending before the Secretary on
the date of enactment of the Food and Drug
Amendments of 2022, the Secretary shall allow
any applicable changes to the product labeling
required to comply with subparagraph (A) to be
made by supplement after the approval of such
application.
(5) Reporting.--Not later than September 30, 2025,
the Secretary shall submit to the Committee on Energy
and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of
the Senate a report describing circumstances in which
the Secretary considered real world evidence submitted
to support postapproval studies required under this
subsection that were completed after the date of
enactment of the Food and Drug Amendments of 2022.
(d) Review of Incomplete Applications for Approval of a Fast
Track Product.--
(1) In general.--If the Secretary determines, after
preliminary evaluation of clinical data submitted by
the sponsor, that a fast track product may be
effective, the Secretary shall evaluate for filing, and
may commence review of portions of, an application for
the approval of the product before the sponsor submits
a complete application. The Secretary shall commence
such review only if the applicant--
(A) provides a schedule for submission of
information necessary to make the application
complete; and
(B) pays any fee that may be required under
section 736.
(2) Exception.--Any time period for review of human
drug applications that has been agreed to by the
Secretary and that has been set forth in goals
identified in letters of the Secretary (relating to the
use of fees collected under section 736 to expedite the
drug development process and the review of human drug
applications) shall not apply to an application
submitted under paragraph (1) until the date on which
the application is complete.
(e) Construction.--
(1) Purpose.--The amendments made by the Food and
Drug Administration Safety and Innovation Act and the
21st Century Cures Act to this section are intended to
encourage the Secretary to utilize innovative and
flexible approaches to the assessment of products under
accelerated approval for treatments for patients with
serious or life-threatening diseases or conditions and
unmet medical needs.
(2) Construction.--Nothing in this section shall be
construed to alter the standards of evidence under
subsection (c) or (d) of section 505 (including the
substantial evidence standard in section 505(d)) of
this Act or under section 351(a) of the Public Health
Service Act. Such sections and standards of evidence
apply to the review and approval of products under this
section, including whether a product is safe and
effective. Nothing in this section alters the ability
of the Secretary to rely on evidence that does not come
from adequate and well-controlled investigations for
the purpose of determining whether an endpoint is
reasonably likely to predict clinical benefit as
described in subsection (b)(1)(B).
(f) Awareness Efforts.--The Secretary shall--
(1) develop and disseminate to physicians, patient
organizations, pharmaceutical and biotechnology
companies, and other appropriate persons a description
of the provisions of this section applicable to
breakthrough therapies, accelerated approval, and and
fast track products; and
(2) establish a program to encourage the development
of surrogate and clinical endpoints, including
biomarkers, and other scientific methods and tools that
can assist the Secretary in determining whether the
evidence submitted in an application is reasonably
likely to predict clinical benefit for serious or life-
threatening conditions for which significant unmet
medical needs exist.
(g) Regenerative Advanced Therapy.--
(1) In general.--The Secretary, at the request of the
sponsor of a drug, shall facilitate an efficient
development program for, and expedite review of, such
drug if the drug qualifies as a regenerative advanced
therapy under the criteria described in paragraph (2).
(2) Criteria.--A drug is eligible for designation as
a regenerative advanced therapy under this subsection
if--
(A) the drug is a regenerative medicine
therapy (as defined in paragraph (8));
(B) the drug is intended to treat, modify,
reverse, or cure a serious or life-threatening
disease or condition; and
(C) preliminary clinical evidence indicates
that the drug has the potential to address
unmet medical needs for such a disease or
condition.
(3) Request for designation.--The sponsor of a drug
may request the Secretary to designate the drug as a
regenerative advanced therapy concurrently with, or at
any time after, submission of an application for the
investigation of the drug under section 505(i) of this
Act or section 351(a)(3) of the Public Health Service
Act.
(4) Designation.--Not later than 60 calendar days
after the receipt of a request under paragraph (3), the
Secretary shall determine whether the drug that is the
subject of the request meets the criteria described in
paragraph (2). If the Secretary determines that the
drug meets the criteria, the Secretary shall designate
the drug as a regenerative advanced therapy and shall
take such actions as are appropriate under paragraph
(1). If the Secretary determines that a drug does not
meet the criteria for such designation, the Secretary
shall include with the determination a written
description of the rationale for such determination.
(5) Actions.--The sponsor of a regenerative advanced
therapy shall be eligible for the actions to expedite
development and review of such therapy under subsection
(a)(3)(B), including early interactions to discuss any
potential surrogate or intermediate endpoint to be used
to support the accelerated approval of an application
for the product under subsection (c).
(6) Access to expedited approval pathways.--An
application for a regenerative advanced therapy under
section 505(b)(1) of this Act or section 351(a) of the
Public Health Service Act may be--
(A) eligible for priority review, as
described in the Manual of Policies and
Procedures of the Food and Drug Administration
and goals identified in the letters described
in section 101(b) of the Prescription Drug User
Fee Amendments of 2012; and
(B) eligible for accelerated approval under
subsection (c), as agreed upon pursuant to
subsection (a)(3)(B), through, as appropriate--
(i) surrogate or intermediate
endpoints reasonably likely to predict
long-term clinical benefit; or
(ii) reliance upon data obtained from
a meaningful number of sites, including
through expansion to additional sites,
as appropriate.
(7) Postapproval requirements.--The sponsor of a
regenerative advanced therapy that is granted
accelerated approval and is subject to the postapproval
requirements under subsection (c) may, as appropriate,
fulfill such requirements, as the Secretary may
require, through--
(A) the submission of clinical evidence,
clinical studies, patient registries, or other
sources of real world evidence, such as
electronic health records;
(B) the collection of larger confirmatory
data sets, as agreed upon pursuant to
subsection (a)(3)(B); or
(C) postapproval monitoring of all patients
treated with such therapy prior to approval of
the therapy.
(8) Definition.--For purposes of this section, the
term ``regenerative medicine therapy'' includes cell
therapy, therapeutic tissue engineering products, human
cell and tissue products, and combination products
using any such therapies or products, except for those
regulated solely under section 361 of the Public Health
Service Act and part 1271 of title 21, Code of Federal
Regulations.
(h) Limited Population Pathway for Antibacterial and
Antifungal Drugs.--
(1) In general.--The Secretary may approve an
antibacterial or antifungal drug, alone or in
combination with one or more other drugs, as a limited
population drug pursuant to this subsection only if--
(A) the drug is intended to treat a serious
or life-threatening infection in a limited
population of patients with unmet needs;
(B) the standards for approval under section
505(c) and (d), or the standards for licensure
under section 351 of the Public Health Service
Act, as applicable, are met; and
(C) the Secretary receives a written request
from the sponsor to approve the drug as a
limited population drug pursuant to this
subsection.
(2) Benefit-risk consideration.--The Secretary's
determination of safety and effectiveness of an
antibacterial or antifungal drug shall reflect the
benefit-risk profile of such drug in the intended
limited population, taking into account the severity,
rarity, or prevalence of the infection the drug is
intended to treat and the availability or lack of
alternative treatment in such limited population. Such
drug may be approved under this subsection
notwithstanding a lack of evidence to fully establish a
favorable benefit-risk profile in a population that is
broader than the intended limited population.
(3) Additional requirements.--A drug approved under
this subsection shall be subject to the following
requirements, in addition to any other applicable
requirements of this Act:
(A) Labeling.--To indicate that the safety
and effectiveness of a drug approved under this
subsection has been demonstrated only with
respect to a limited population--
(i) all labeling and advertising of
an antibacterial or antifungal drug
approved under this subsection shall
contain the statement ``Limited
Population'' in a prominent manner and
adjacent to, and not more prominent
than--
(I) the proprietary name of
such drug, if any; or
(II) if there is no
proprietary name, the
established name of the drug,
if any, as defined in section
503(e)(3), or, in the case of a
drug that is a biological
product, the proper name, as
defined by regulation; and
(ii) the prescribing information for
the drug required by section 201.57 of
title 21, Code of Federal Regulations
(or any successor regulation) shall
also include the following statement:
``This drug is indicated for use in a
limited and specific population of
patients.''.
(B) Promotional material.--The sponsor of an
antibacterial or antifungal drug subject to
this subsection shall submit to the Secretary
copies of all promotional materials related to
such drug at least 30 calendar days prior to
dissemination of the materials.
(4) Other programs.--A sponsor of a drug that seeks
approval of a drug under this subsection may also seek
designation or approval, as applicable, of such drug
under other applicable sections or subsections of this
Act or the Public Health Service Act.
(5) Guidance.--Not later than 18 months after the
date of enactment of the 21st Century Cures Act, the
Secretary shall issue draft guidance describing
criteria, processes, and other general considerations
for demonstrating the safety and effectiveness of
limited population antibacterial and antifungal drugs.
The Secretary shall publish final guidance within 18
months of the close of the public comment period on
such draft guidance. The Secretary may approve
antibacterial and antifungal drugs under this
subsection prior to issuing guidance under this
paragraph.
(6) Advice.--The Secretary shall provide prompt
advice to the sponsor of a drug for which the sponsor
seeks approval under this subsection to enable the
sponsor to plan a development program to obtain the
necessary data for such approval, and to conduct any
additional studies that would be required to gain
approval of such drug for use in a broader population.
(7) Termination of limitations.--If, after approval
of a drug under this subsection, the Secretary approves
a broader indication for such drug under section 505(b)
or section 351(a) of the Public Health Service Act, the
Secretary may remove any postmarketing conditions,
including requirements with respect to labeling and
review of promotional materials under paragraph (3),
applicable to the approval of the drug under this
subsection.
(8) Rules of construction.--Nothing in this
subsection shall be construed to alter the authority of
the Secretary to approve drugs pursuant to this Act or
section 351 of the Public Health Service Act, including
the standards of evidence and applicable conditions for
approval under such Acts, the standards of approval of
a drug under such Acts, or to alter the authority of
the Secretary to monitor drugs pursuant to such Acts.
(9) Reporting and accountability.--
(A) Biennial reporting.--The Secretary shall
report to Congress not less often than once
every 2 years on the number of requests for
approval, and the number of approvals, of an
antibacterial or antifungal drug under this
subsection.
(B) GAO report.--Not later than December
2021, the Comptroller General of the United
States shall submit to the Committee on Energy
and Commerce of the House of Representatives
and the Committee on Health, Education, Labor
and Pensions of the Senate a report on the
coordination of activities required under
section 319E of the Public Health Service Act.
Such report shall include a review of such
activities, and the extent to which the use of
the pathway established under this subsection
has streamlined premarket approval for
antibacterial or antifungal drugs for limited
populations, if such pathway has functioned as
intended, if such pathway has helped provide
for safe and effective treatment for patients,
if such premarket approval would be appropriate
for other categories of drugs, and if the
authorities under this subsection have affected
antibacterial or antifungal resistance.
* * * * * * *
SEC. 506B. REPORTS OF POSTMARKETING STUDIES.
(a) Submission.--
(1) In general.--A sponsor of a drug that has entered
into an agreement with the Secretary to conduct a
postmarketing study of a drug shall submit to the
Secretary, within 1 year after the approval of such
drug and annually thereafter until the study is
completed or terminated, a report of the progress of
the study or the reasons for the failure of the sponsor
to conduct the study. The report shall be submitted in
such form as is prescribed by the Secretary in
regulations issued by the Secretary.
(2) Accelerated approval.--Notwithstanding paragraph
(1), a sponsor of a drug approved under accelerated
approval shall submit to the Secretary a report of the
progress of any study required under section 506(c),
including progress toward enrollment targets,
milestones, and other information as required by the
Secretary, not later than 180 days after the approval
of such drug and not less frequently than every 180
days thereafter, until the study is completed or
terminated.
[(2)] (3) Agreements prior to effective date.--Any
agreement entered into between the Secretary and a
sponsor of a drug, prior to the date of enactment of
the Food and Drug Administration Modernization Act of
1997, to conduct a postmarketing study of a drug shall
be subject to the requirements of paragraph (1). An
initial report for such an agreement shall be submitted
within 6 months after the date of the issuance of the
regulations under paragraph (1).
(b) Consideration of Information as Public Information.--Any
information pertaining to a report described in subsection (a)
shall be considered to be public information to the extent that
the information is necessary--
(1) to identify the sponsor; and
(2) to establish the status of a study described in
subsection (a) and the reasons, if any, for any failure
to carry out the study.
(c) Status of Studies and Reports.--The Secretary shall
annually develop and publish in the Federal Register a report
that provides information on the status of the postmarketing
studies--
(1) that sponsors have entered into agreements to
conduct; and
(2) for which reports have been submitted under
subsection (a)(1).
(d) Disclosure.--If a sponsor fails to complete an agreed
upon study required by this section by its original or
otherwise negotiated deadline, the Secretary shall publish a
statement on the Internet site of the Food and Drug
Administration stating that the study was not completed and, if
the reasons for such failure to complete the study were not
satisfactory to the Secretary, a statement that such reasons
were not satisfactory to the Secretary.
(e) Notification.--With respect to studies of the type
required under section 506(c)(2)(A) or under section 314.510 or
601.41 of title 21, Code of Federal Regulations, as each of
such sections was in effect on the day before the effective
date of this subsection, the Secretary may require that a
sponsor who, for reasons not satisfactory to the Secretary,
fails to complete by its deadline a study under any of such
sections of such type for a drug or biological product
(including such a study conducted after such effective date)
notify practitioners who prescribe such drug or biological
product of the failure to complete such study and the questions
of clinical benefit, and, where appropriate, questions of
safety, that remain unanswered as a result of the failure to
complete such study. Nothing in this subsection shall be
construed as altering the requirements of the types of studies
required under section 506(c)(2)(A) or under section 314.510 or
601.41 of title 21, Code of Federal Regulations, as so in
effect, or as prohibiting the Secretary from modifying such
sections of title 21 of such Code to provide for studies in
addition to those of such type.
* * * * * * *
SEC. 506C-1. ANNUAL REPORTING ON DRUG SHORTAGES.
(a) Annual Reports to Congress.--Not later than March 31 of
each calendar year, the Secretary shall submit to the Committee
on Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the
Senate a report, with respect to the preceding calendar year,
on drug shortages that--
(1) specifies the number of manufacturers that
submitted a notification to the Secretary under section
506C(a) during such calendar year;
[(2) describes the communication between the field
investigators of the Food and Drug Administration and
the staff of the Center for Drug Evaluation and
Research's Office of Compliance and Drug Shortage
Program, including the Food and Drug Administration's
procedures for enabling and ensuring such
communication;]
(2)(A) describes the communication between the field
investigators of the Food and Drug Administration and
the staff of the Center for Drug Evaluation and
Research's Office of Compliance and Drug Shortage
Program, including the Food and Drug Administration's
procedures for enabling and ensuring such
communication;
(B) provides the number of reports described in
section 704(b)(2) that were required to be sent to the
appropriate offices of the Food and Drug Administration
and the number of such reports that were sent; and
(C) describes the coordination and alignment
activities undertaken pursuant to section 506D(g);
(3)(A) lists the major actions taken by the Secretary
to prevent or mitigate the drug shortages described in
paragraph (7);
(B) in the list under subparagraph (A), includes--
(i) the number of applications and
supplements for which the Secretary expedited
review under section 506C(g)(1) during such
calendar year; and
(ii) the number of establishment inspections
or reinspections that the Secretary expedited
under section 506C(g)(2) during such calendar
year;
(4) describes the coordination between the Food and
Drug Administration and the Drug Enforcement
Administration on efforts to prevent or alleviate drug
shortages;
(5) identifies the number of and describes the
instances in which the Food and Drug Administration
exercised regulatory flexibility and discretion to
prevent or alleviate a drug shortage;
(6) lists the names of manufacturers that were issued
letters under section 506C(f); and
(7) specifies the number of drug shortages occurring
during such calendar year, as identified by the
Secretary.
(b) Trend Analysis.--The Secretary is authorized to retain a
third party to conduct a study, if the Secretary believes such
a study would help clarify the causes, trends, or solutions
related to drug shortages.
(c) Definition.--In this section, the term ``drug shortage''
or ``shortage'' has the meaning given such term in section
506C.
SEC. 506D. COORDINATION; TASK FORCE AND STRATEGIC PLAN.
(a) Task Force and Strategic Plan.--
(1) In general.--
(A) Task force.--As soon as practicable after
the date of enactment of the Food and Drug
Administration Safety and Innovation Act, the
Secretary shall establish a task force to
develop and implement a strategic plan for
enhancing the Secretary's response to
preventing and mitigating drug shortages.
(B) Strategic plan.--The strategic plan
described in subparagraph (A) shall include--
(i) plans for enhanced interagency
and intra-agency coordination,
communication, and decisionmaking;
(ii) plans for ensuring that drug
shortages are considered when the
Secretary initiates a regulatory action
that could precipitate a drug shortage
or exacerbate an existing drug
shortage;
(iii) plans for effective
communication with outside
stakeholders, including who the
Secretary should alert about potential
or actual drug shortages, how the
communication should occur, and what
types of information should be shared;
(iv) plans for considering the impact
of drug shortages on research and
clinical trials; and
(v) an examination of whether to
establish a ``qualified manufacturing
partner program'', as described in
subparagraph (C).
(C) Description of program.--In conducting
the examination of a ``qualified manufacturing
partner program'' under subparagraph (B)(v),
the Secretary--
(i) shall take into account that--
(I) a ``qualified
manufacturer'', for purposes of
such program, would need to
have the capability and
capacity to supply products
determined or anticipated to be
in shortage; and
(II) in examining the
capability and capacity to
supply products in shortage,
the ``qualified manufacturer''
could have a site that
manufactures a drug listed
under section 506E or have the
capacity to produce drugs in
response to a shortage within a
rapid timeframe; and
(ii) shall examine whether incentives
are necessary to encourage the
participation of ``qualified
manufacturers'' in such a program.
(D) Consultation.--In carrying out this
paragraph, the task force shall ensure
consultation with the appropriate offices
within the Food and Drug Administration,
including the Office of the Commissioner, the
Center for Drug Evaluation and Research, the
Office of Regulatory Affairs, and employees
within the Department of Health and Human
Services with expertise regarding drug
shortages. The Secretary shall engage external
stakeholders and experts as appropriate.
(2) Timing.--Not later than 1 year after the date of
enactment of the Food and Drug Administration Safety
and Innovation Act, the task force shall--
(A) publish the strategic plan described in
paragraph (1); and
(B) submit such plan to Congress.
(b) Communication.--The Secretary shall ensure that, prior to
any enforcement action or issuance of a warning letter that the
Secretary determines could reasonably be anticipated to lead to
a meaningful disruption in the supply in the United States of a
drug described under section 506C(a), there is communication
with the appropriate office of the Food and Drug Administration
with expertise regarding drug shortages regarding whether the
action or letter could cause, or exacerbate, a shortage of the
drug.
(c) Action.--If the Secretary determines, after the
communication described in subsection (b), that an enforcement
action or a warning letter could reasonably cause or exacerbate
a shortage of a drug described under section 506C(a), then the
Secretary shall evaluate the risks associated with the impact
of such shortage upon patients and those risks associated with
the violation involved before taking such action or issuing
such letter, unless there is imminent risk of serious adverse
health consequences or death to humans.
(d) Reporting by Other Entities.--The Secretary shall
identify or establish a mechanism by which health care
providers and other third-party organizations may report to the
Secretary evidence of a drug shortage.
(e) Review and Construction.--No determination, finding,
action, or omission of the Secretary under this section shall--
(1) be subject to judicial review; or
(2) be construed to establish a defense to an
enforcement action by the Secretary.
(f) Sunset.--Subsections (a), (b), (c), and (e) shall cease
to be effective on the date that is 5 years after the date of
enactment of the Food and Drug Administration Safety and
Innovation Act.
(g) Coordination.--The Secretary shall ensure timely and
effective internal coordination and alignment among the field
investigators of the Food and Drug Administration and the staff
of the Center for Drug Evaluation and Research's Office of
Compliance and Drug Shortage Program regarding--
(1) the reviews of reports shared pursuant to section
704(b)(2); and
(2) any feedback or corrective or preventive actions
in response to such reports.
* * * * * * *
SEC. 506I. PROMPT REPORTS OF MARKETING STATUS.
(a) Notification of Withdrawal.--[The holder of an
application approved under subsection (c) or (j) of section
505] The holder of an application approved under subsection (c)
or (j) of section 505 of this Act or subsection (a) or (k) of
section 351 of the Public Health Service Act shall notify the
Secretary in writing 180 days prior to withdrawing the approved
drug from sale, or if 180 days is not practicable as soon as
practicable but not later than the date of withdrawal. The
holder shall include with such notice the--
(1) National Drug Code;
(2) identity of the drug by [established name]
established name (for biological products, by proper
name) and by proprietary name, if any;
(3) new drug application number [or abbreviated
application number], abbreviated application number, or
biologics license application number;
(4) strength of the drug;
(5) date on which the drug is expected to no longer
be available for sale; and
(6) reason for withdrawal of the drug.
(b) Notification of Drug Not Available for Sale.--[The holder
of an application approved under subsection (c) or (j)] The
holder of an application approved under subsection (c) or (j)
of section 505 of this Act or subsection (a) or (k) of section
351 of the Public Health Service Act shall notify the Secretary
in writing within 180 calendar days of the date of approval of
the drug if the drug will not be available for sale within 180
calendar days of such date of approval. The holder shall
include with such notice the--
(1) identity of the drug by [established name]
established name (for biological products, by proper
name) and by proprietary name, if any;
(2) new drug application number [or abbreviated
application number], abbreviated application number, or
biologics license application number;
(3) strength of the drug;
(4) date on which the drug will be available for
sale, if known; and
(5) reason for not marketing the drug after approval.
[(c) Additional One-time Report.--Within 180 days of the date
of enactment of this section, all holders of applications
approved under subsection (c) or (j) of section 505 shall
review the information in the list published under subsection
505(j)(7)(A) and shall notify the Secretary in writing that--
[(1) all of the application holder's drugs in the
active section of the list published under subsection
505(j)(7)(A) are available for sale; or
[(2) one or more of the application holder's drugs in
the active section of the list published under
subsection 505(j)(7)(A) have been withdrawn from sale
or have never been available for sale, and include with
such notice the information required pursuant to
subsection (a) or (b), as applicable.
[(d) Failure to Meet Requirements.--If a holder of an
approved application fails to submit the information required
under subsection (a), (b), or (c), the Secretary may move the
application holder's drugs from the active section of the list
published under subsection 505(j)(7)(A) to the discontinued
section of the list, except that the Secretary shall remove
from the list in accordance with subsection 505(j)(7)(C) drugs
the Secretary determines have been withdrawn from sale for
reasons of safety of effectiveness.]
(c) Additional One-Time Report.--Within 180 days of the date
of enactment of the Food and Drug Amendments of 2022, all
holders of applications approved under subsection (a) or (k) of
section 351 of the Public Health Service Act shall review the
information in the list published under section 351(k)(9)(A)
and shall submit a written notice to the Secretary--
(1) stating that all of the application holder's
biological products in the list published under section
351(k)(9)(A) that are not listed as discontinued are
available for sale; or
(2) including the information required pursuant to
subsection (a) or (b), as applicable, for each of the
application holder's biological products that are in
the list published under section 351(k)(9)(A) and not
listed as discontinued, but have been discontinued from
sale or never have been available for sale.
(d) Failure To Meet Requirements.--If a holder of an approved
application fails to submit the information required under
subsection (a), (b), or (c), the Secretary may--
(1) move the application holder's drugs from the
active section of the list published under section
505(j)(7)(A) to the discontinued section of the list,
except that the Secretary shall remove from the list in
accordance with section 505(j)(7)(C) drugs the
Secretary determines have been withdrawn from sale for
reasons of safety or effectiveness; and
(2) identify the application holder's biological
products as discontinued in the list published under
section 351(k)(9)(A) of the Public Health Service Act,
except that the Secretary shall remove from the list in
accordance with section 351(k)(9)(B) of such Act
biological products for which the license has been
revoked or suspended for reasons of safety, purity, or
potency.
(e) Updates.--The Secretary shall update the list published
under [subsection 505(j)(7)(A)] section 505(j)(7)(A) based on
the information provided under subsections (a), (b), and (c) by
moving drugs that are not available for sale from the active
section to the discontinued section of the list, except that
drugs the Secretary determines have been withdrawn from sale
for reasons of safety or effectiveness shall be removed from
the list in accordance with [subsection 505(j)(7)(C)] section
505(j)(7)(C). The Secretary shall update the list published
under section 351(k)(9)(A) of the Public Health Service Act
based on information provided under subsections (a), (b), and
(c) by identifying as discontinued biological products that are
not available for sale, except that biological products for
which the license has been revoked or suspended for safety,
purity, or potency reasons shall be removed from the list in
accordance with section 351(k)(9)(B) of the Public Health
Service Act. The Secretary shall make [monthly updates to the
list] monthly updates to the lists referred to in the preceding
sentences based on the information provided pursuant to
subsections (a) and (b), [and shall update the list based on]
and shall update such lists based on the information provided
under subsection (c) as soon as practicable.
(f) Limitation on Use of Notices.--Any notice submitted under
this section shall not be made public by the Secretary and
shall be used solely for the purpose of the updates described
in subsection (e).
* * * * * * *
SEC. 506K. ADVANCED MANUFACTURING TECHNOLOGIES DESIGNATION PILOT
PROGRAM.
(a) In General.--Not later than 1 year after the date of
enactment of this section, the Secretary shall initiate a pilot
program under which persons may request designation of an
advanced manufacturing technology as described in subsection
(b).
(b) Designation Process.--The Secretary shall establish a
process for the designation under this section of methods of
manufacturing drugs, including biological products, and active
pharmaceutical ingredients of such drugs, as advanced
manufacturing technologies. A method of manufacturing, or a
combination of manufacturing methods, is eligible for
designation as an advanced manufacturing technology if such
method or combination of methods incorporates a novel
technology, or uses an established technique or technology in a
novel way, that will substantially improve the manufacturing
process for a drug and maintain equivalent or provide superior
drug quality, including by--
(1) reducing development time for a drug using the
designated manufacturing method; or
(2) increasing or maintaining the supply of--
(A) a drug that is described in section
506C(a) and is intended to treat a serious or
life-threatening condition; or
(B) a drug that is on the drug shortage list
under section 506E.
(c) Evaluation and Designation of an Advanced Manufacturing
Technology.--
(1) Submission.--A person who requests designation of
a method of manufacturing as an advanced manufacturing
technology under this section shall submit to the
Secretary data or information demonstrating that the
method of manufacturing meets the criteria described in
subsection (b) in a particular context of use. The
Secretary may facilitate the development and review of
such data or information by--
(A) providing timely advice to, and
interactive communication with, such person
regarding the development of the method of
manufacturing; and
(B) involving senior managers and experienced
staff of the Food and Drug Administration, as
appropriate, in a collaborative, cross-
disciplinary review of the method of
manufacturing, as applicable.
(2) Evaluation and designation.--Not later than 180
calendar days after the receipt of a request under
paragraph (1), the Secretary shall determine whether to
designate such method of manufacturing as an advanced
manufacturing technology, in a particular context of
use, based on the data and information submitted under
paragraph (1) and the criteria described in subsection
(b).
(d) Review of Advanced Manufacturing Technologies.--If the
Secretary designates a method of manufacturing as an advanced
manufacturing technology, the Secretary shall--
(1) expedite the development and review of an
application submitted under section 505 of this Act or
section 351 of the Public Health Service Act, including
supplemental applications, for drugs that are
manufactured using a designated advanced manufacturing
technology and could help mitigate or prevent a
shortage or substantially improve manufacturing
processes for a drug and maintain equivalent or provide
superior drug quality, as described in subsection (b);
and
(2) allow the holder of an advanced technology
designation, or a person authorized by the advanced
manufacturing technology designation holder, to
reference or rely upon, in an application submitted
under section 505 of this Act or section 351 of the
Public Health Service Act, including a supplemental
application, data and information about the designated
advanced manufacturing technology for use in
manufacturing drugs in the same context of use for
which the designation was granted.
(e) Implementation and Evaluation of Advanced Manufacturing
Technologies Pilot.--
(1) Public meeting.--The Secretary shall publish in
the Federal Register a notice of a public meeting, to
be held not later than 180 days after the date of
enactment of this section, to discuss and obtain input
and recommendations from relevant stakeholders
regarding--
(A) the goals and scope of the pilot program,
and a suitable framework, procedures, and
requirements for such program; and
(B) ways in which the Food and Drug
Administration will support the use of advanced
manufacturing technologies and other innovative
manufacturing approaches for drugs.
(2) Pilot program guidance.--
(A) In general.--The Secretary shall--
(i) not later than 180 days after the
public meeting under paragraph (1),
issue draft guidance regarding the
goals and implementation of the pilot
program under this section; and
(ii) not later than 2 years after the
date of enactment of this section,
issue final guidance regarding the
implementation of such program.
(B) Content.--The guidance described in
subparagraph (A) shall address--
(i) the process by which a person may
request a designation under subsection
(b);
(ii) the data and information that a
person requesting such a designation is
required to submit under subsection
(c), and how the Secretary intends to
evaluate such submissions;
(iii) the process to expedite the
development and review of applications
under subsection (d); and
(iv) the criteria described in
subsection (b) for eligibility for such
a designation.
(3) Report.--Not later than 3 years after the date of
enactment of this section and annually thereafter, the
Secretary shall publish on the website of the Food and
Drug Administration and submit to the Committee on
Health, Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the House
of Representatives a report containing a description
and evaluation of the pilot program being conducted
under this section, including the types of innovative
manufacturing approaches supported under the program.
Such report shall include the following:
(A) The number of persons that have requested
designations and that have been granted
designations.
(B) The number of methods of manufacturing
that have been the subject of designation
requests and that have been granted
designations.
(C) The average number of calendar days for
completion of evaluations under subsection
(c)(2).
(D) An analysis of the factors in data
submissions that are relevant to determinations
to designate and not to designate after
evaluation under subsection (c)(2).
(E) The number of applications received under
section 505 of this Act or section 351 of the
Public Health Service Act, including
supplemental applications, that have included
an advanced manufacturing technology designated
under this section, and the number of such
applications approved.
(f) Sunset.--The Secretary--
(1) may not consider any requests for designation
submitted under subsection (c) after October 1, 2029;
and
(2) may continue all activities under this section
with respect to advanced manufacturing technologies
that were designated pursuant to subsection (d) prior
to such date, if the Secretary determines such
activities are in the interest of the public health.
* * * * * * *
Sec. 510. (a) As used in this section--
(1) the term ``manufacture, preparation, propagation,
compounding, or processing'' shall include repackaging
or otherwise changing the container, wrapper, or
labeling of any drug package or device package in
furtherance of the distribution of the drug or device
from the original place of manufacture to the person
who makes final delivery or sale to the ultimate
consumer or user; and
(2) the term ``name'' shall include in the case of a
partnership the name of each partner and, in the case
of a corporation, the name of each corporate officer
and director, and the State of incorporation.
(b)(1) During the period beginning on October 1 and ending on
December 31 of each year, every person who owns or operates any
establishment in any State engaged in the manufacture,
preparation, propagation, compounding, or processing of a drug
or drugs shall register with the Secretary the name of such
person, places of business of such person, all such
establishments, the unique facility identifier of each such
establishment, and a point of contact e-mail address.
(2) During the period beginning on October 1 and ending on
December 31 of each year, every person who owns or operates any
establishment in any State engaged in the manufacture,
preparation, propagation, compounding, or processing of a
device or devices shall register with the Secretary his name,
places of business, and all such establishments.
(3) The Secretary shall specify the unique facility
identifier system that shall be used by registrants under
paragraph (1). The requirement to include a unique facility
identifier in a registration under paragraph (1) shall not
apply until the date that the identifier system is specified by
the Secretary under the preceding sentence.
(c) Every person upon first engaging in the manufacture,
preparation, propagation, compounding, or processing of a drug
or drugs or a device or devices in any establishment which he
owns or operates in any State shall immediately register with
the Secretary--
(1) with respect to drugs, the information described
under subsection (b)(1); and
(2) with respect to devices, the information
described under subsection (b)(2)..
(d) Every person duly registered in accordance with the
foregoing subsections of this section shall immediately
register with the Secretary any additional establishment which
he owns or operates in any State and in which he begins the
manufacture, preparation, propagation, compounding, or
processing of a drug or drugs or a device or devices.
(e) The Secretary may assign a registration number to any
person or any establishment registered in accordance with this
section. The Secretary may also assign a listing number to each
drug or class of drugs listed under subsection (j). Any number
assigned pursuant to the preceding sentence shall be the same
as that assigned pursuant to the National Drug Code. The
Secretary may by regulation prescribe a uniform system for the
identification of devices intended for human use and may
require that persons who are required to list such devices
pursuant to subsection (j) shall list such devices in
accordance with such system.
(f) The Secretary shall make available for inspection, to any
person so requesting, any registration filed pursuant to this
section; except that any list submitted pursuant to paragraph
(3) of subsection (j) and the information accompanying any list
or notice filed under paragraph (1) or (2) of that subsection
shall be exempt from such inspection unless the Secretary finds
that such an exemption would be inconsistent with protection of
the public health.
(g) The foregoing subsections of this section shall not apply
to--
(1) pharmacies which maintain establishments in
conformance with any applicable local laws regulating
the practice of pharmacy and medicine and which are
regularly engaged in dispensing prescription drugs or
devices, upon prescriptions of practitioners licensed
to administer such drugs or devices to patients under
the care of such practitioners in the course of their
professional practice, and which do not manufacture,
prepare, propagate, compound, or process drugs or
devices for sale other than in the regular course of
their business of dispensing or selling drugs or
devices at retail;
(2) practitioners licensed by law to prescribe or
administer drugs or devices and who manufacture,
prepare, propagate, compound, or process drugs or
devices solely for use in the course of their
professional practice;
(3) persons who manufacture, prepare, propagate,
compound, or process drugs or devices solely for use in
research, teaching, or chemical analysis and not for
sale;
(4) any distributor who acts as a wholesale
distributor of devices, and who does not manufacture,
repackage, process, or relabel a device; or
(5) such other classes of persons as the Secretary
may by regulation exempt from the application of this
section upon a finding that registration by such
classes of persons in accordance with this section is
not necessary for the protection of the public health.
In this subsection, the term ``wholesale distributor'' means
any person (other than the manufacturer or the initial
importer) who distributes a device from the original place of
manufacture to the person who makes the final delivery or sale
of the device to the ultimate consumer or user.
(h) Inspections.--
(1) In general.--Every establishment that is required
to be registered with the Secretary under this section
shall be subject to inspection pursuant to section 704.
(2) Risk-based schedule for devices.--
(A) In general.--The Secretary, acting
through one or more officers or employees duly
designated by the Secretary, shall inspect
establishments described in paragraph (1) that
are engaged in the manufacture, propagation,
compounding, or processing of a device or
devices (referred to in this subsection as
``device establishments'') in accordance with a
risk-based schedule established by the
Secretary.
(B) Factors and considerations.--In
establishing the risk-based schedule under
subparagraph (A), the Secretary shall--
(i) apply, to the extent applicable
for device establishments, the factors
identified in paragraph (4); and
(ii) consider the participation of
the device establishment, as
applicable, in international device
audit programs in which the United
States participates or the United
States recognizes for purposes of
inspecting device establishments.
(3) Risk-based schedule for drugs.--The Secretary,
acting through one or more officers or employees duly
designated by the Secretary, shall inspect
establishments described in paragraph (1) that are
engaged in the manufacture, preparation, propagation,
compounding, or processing of a drug or drugs (referred
to in this subsection as ``drug establishments'') in
accordance with a risk-based schedule established by
the Secretary.
(4) Risk factors.--In establishing a risk-based
schedule under paragraph (2) or (3), the Secretary
shall inspect establishments according to the known
safety risks of such establishments, which shall be
based on the following factors:
(A) The compliance history of the
establishment.
(B) The record, history, and nature of
recalls linked to the establishment.
(C) The inherent risk of the drug or device
manufactured, prepared, propagated, compounded,
or processed at the establishment.
(D) The inspection frequency and history of
the establishment, including whether the
establishment has been inspected pursuant to
section 704 within the last 4 years.
(E) Whether the establishment has been
inspected by a foreign government or an agency
of a foreign government recognized under
section 809.
(F) The compliance history of establishments
in the country or region in which the
establishment is located that are subject to
regulation under this Act, including the
history of violations related to products
exported from such country or region that are
subject to such regulation.
[(F)] (G) Any other criteria deemed necessary
and appropriate by the Secretary for purposes
of allocating inspection resources.
(5) Effect of status.--In determining the risk
associated with an establishment for purposes of
establishing a risk-based schedule under paragraph (3),
the Secretary shall not consider whether the drugs
manufactured, prepared, propagated, compounded, or
processed by such establishment are drugs described in
section 503(b).
(6) Annual report on inspections of establishments.--
Beginning in 2014, not later than May 1 of each year,
the Secretary shall make available on the Internet Web
site of the Food and Drug Administration a report
regarding--
(A)(i) the number of domestic and foreign
establishments registered pursuant to this
section in the previous calendar year; and
(ii) the number of such domestic
establishments and the number of such foreign
establishments that the Secretary inspected in
the previous calendar year;
(B) with respect to establishments that
manufacture, prepare, propagate, compound, or
process an active ingredient of a drug or a
finished drug product, the number of each such
type of establishment; and
(C) the percentage of the budget of the Food
and Drug Administration used to fund the
inspections described under subparagraph (A).
(i)(1) Every person who owns or operates any establishment
within any foreign country engaged in the manufacture,
preparation, propagation, compounding, or processing of a drug
or device that is imported or offered for import into the
United States shall, through electronic means in accordance
with the criteria of the Secretary--
(A) upon first engaging in any such activity,
immediately submit a registration to the Secretary that
includes--
(i) with respect to drugs, the name and place
of business of such person, all such
establishments, the unique facility identifier
of each such establishment, a point of contact
e-mail address, the name of the United States
agent of each such establishment, the name of
each importer of such drug in the United States
that is known to the establishment, and the
name of each person who imports or offers for
import such drug to the United States for
purposes of importation; and
(ii) with respect to devices, the name and
place of business of the establishment, the
name of the United States agent for the
establishment, the name of each importer of
such device in the United States that is known
to the establishment, and the name of each
person who imports or offers for import such
device to the United States for purposes of
importation; and
(B) each establishment subject to the requirements of
subparagraph (A) shall thereafter register with the
Secretary during the period beginning on October 1 and
ending on December 31 of each year.
(2) The establishment shall also provide the information
required by subsection (j).
(3) The Secretary is authorized to enter into cooperative
arrangements with officials of foreign countries to ensure that
adequate and effective means are available for purposes of
determining, from time to time, whether drugs or devices
manufactured, prepared, propagated, compounded, or processed by
an establishment described in paragraph (1), if imported or
offered for import into the United States, shall be refused
admission on any of the grounds set forth in section 801(a).
(4) The Secretary shall specify the unique facility
identifier system that shall be used by registrants under
paragraph (1) with respect to drugs. The requirement to include
a unique facility identifier in a registration under paragraph
(1) with respect to drugs shall not apply until the date that
the identifier system is specified by the Secretary under the
preceding sentence.
(j)(1) Every person who registers with the Secretary under
subsection (b), (c), (d), or (i) shall, at the time of
registration under any such subsection, file with the Secretary
a list of all drugs and a list of all devices and a brief
statement of the basis for believing that each device included
in the list is a device rather than a drug (with each drug and
device in each list listed by its established name (as defined
in section 502(e)) and by any proprietary name) which are being
manufactured, prepared, propagated, compounded, or processed by
him for commercial distribution and which he has not included
in any list of drugs or devices filed by him with the Secretary
under this paragraph or paragraph (2) before such time of
registration. Such list shall be prepared in such form and
manner as the Secretary may prescribe and shall be accompanied
by--
(A) in the case of a drug contained in the applicable
list and subject to section 505 or 512, or a device
intended for human use contained in the applicable list
with respect to which a performance standard has been
established under section 514 or which is subject to
section 515, a reference to the authority for the
marketing of such drug or device and a copy of all
labeling for such drug or device;
(B) in the case of any other drug or device contained
in an applicable list--
(i) which drug is subject to section
503(b)(1), or which device is a restricted
device, a copy of all labeling for such drug or
device, a representative sampling of
advertisements for such drug or device, and,
upon request made by the Secretary for good
cause, a copy of all advertisements for a
particular drug product or device, or
(ii) which drug is not subject to section
503(b)(1) or which device is not a restricted
device, the label and package insert for such
drug or device and a representative sampling of
any other labeling for such drug or device;
(C) in the case of any drug contained in an
applicable list which is described in subparagraph (B),
a quantitative listing of its active ingredient or
ingredients, except that with respect to a particular
drug product the Secretary may require the submission
of a quantitative listing of all ingredients if he
finds that such submission is necessary to carry out
the purposes of this Act;
(D) if the registrant filing a list has determined
that a particular drug product or device contained in
such list is not subject to section 505 or 512, or the
particular device contained in such list is not subject
to a performance standard established under section 514
or to section 515 or is not a restricted device, a
brief statement of the basis upon which the registrant
made such determination if the Secretary requests such
a statement with respect to that particular drug
product or device; and
(E) in the case of a drug contained in the applicable
list, the name and place of business of each
manufacturer of an excipient of the listed drug with
which the person listing the drug conducts business,
including all establishments used in the production of
such excipient, the unique facility identifier of each
such establishment, and a point of contact e-mail
address for each such excipient manufacturer.
(2) Each person who registers with the Secretary under this
section shall report to the Secretary, with regard to drugs
once during the month of June of each year and once during the
month of December of each year, and with regard to devices once
each year during the period beginning on October 1 and ending
on December 31, the following information:
(A) A list of each drug or device introduced by the
registrant for commercial distribution which has not
been included in any list previously filed by him with
the Secretary under this subparagraph or paragraph (1)
of this subsection. A list under this subparagraph
shall list a drug or device by its established name (as
defined in section 502(e)) and by any proprietary name
it may have and shall be accompanied by the other
information required by paragraph (1).
(B) If since the date the registrant last made a
report under this paragraph (or if he has not made a
report under this paragraph, since the effective date
of this subsection) he has discontinued the
manufacture, preparation, propagation, compounding, or
processing for commercial distribution of a drug or
device included in a list filed by him under
subparagraph (A) or paragraph (1); notice of such
discontinuance, the date of such discontinuance, and
the identity (by established name (as defined in
section 502(e)) and by any proprietary name) of such
drug or device.
(C) If since the date the registrant reported
pursuant to subparagraph (B) a notice of discontinuance
he has resumed the manufacture, preparation,
propagation, compounding, or processing for commercial
distribution of the drug or device with respect to
which such notice of discontinuance was reported;
notice of such resumption, the date of such resumption,
the identity of such drug or device (by established
name (as defined in section 502(e)) and by any
proprietary name), and the other information required
by paragraph (1), unless the registrant has previously
reported such resumption to the Secretary pursuant to
this subparagraph.
(D) Any material change in any information previously
submitted pursuant to this paragraph or paragraph (1).
(3)(A) Each person who registers with the Secretary
under this section with regard to a drug shall report
annually to the Secretary on the amount of each drug
listed under paragraph (1) that was manufactured,
prepared, propagated, compounded, or processed by such
person for commercial distribution. Such information
may be required to be submitted in an electronic format
as determined by the Secretary. The Secretary may
require that information required to be reported under
this paragraph be submitted at the time a public health
emergency is declared by the Secretary under section
319 of the Public Health Service Act.
(B) By order of the Secretary, certain biological
products or categories of biological products regulated
under section 351 of the Public Health Service Act may
be exempt from some or all of the reporting
requirements under subparagraph (A), if the Secretary
determines that applying such reporting requirements to
such biological products or categories of biological
products is not necessary to protect the public health.
(4) The Secretary may also require each registrant under this
section to submit a list of each drug product which (A) the
registrant is manufacturing, preparing, propagating,
compounding, or processing for commercial distribution, and (B)
contains a particular ingredient. The Secretary may not require
the submission of such a list unless he has made a finding that
the submission of such a list is necessary to carry out the
purposes of this Act.
(5) The Secretary shall require persons subject to this
subsection to use, for purposes of this subsection, the unique
facility identifier systems specified under subsections (b)(3)
and (i)(4) with respect to drugs. Such requirement shall not
apply until the date that the identifier system under
subsection (b)(3) or (i)(4), as applicable, is specified by the
Secretary.
(k) Each person who is required to register under this
section and who proposes to begin the introduction or delivery
for introduction into interstate commerce for commercial
distribution of a device intended for human use shall, at least
ninety days before making such introduction or delivery, report
to the Secretary or person who is accredited under section
523(a) (in such form and manner as the Secretary shall by
regulation prescribe)--
(1) the class in which the device is classified under
section 513 or if such person determines that the
device is not classified under such section, a
statement of that determination and the basis for such
person's determination that the device is or is not so
classified, and
(2) action taken by such person to comply with
requirements under section 514 or 515 which are
applicable to the device.
A notification submitted under this subsection that contains
clinical trial data for an applicable device clinical trial (as
defined in section 402(j)(1) of the Public Health Service Act)
shall be accompanied by the certification required under
section 402(j)(5)(B) of such Act. Such certification shall not
be considered an element of such notification.
(l)(1) A report under subsection (k) is not required for a
device intended for human use that is exempted from the
requirements of this subsection under subsection (m) or is
within a type that has been classified into class I under
section 513. The exception established in the preceding
sentence does not apply to any class I device that is intended
for a use which is of substantial importance in preventing
impairment of human health, or to any class I device that
presents a potential unreasonable risk of illness or injury.
(2) Not later than 120 calendar days after the date of
enactment of the 21st Century Cures Act and at least once every
5 years thereafter, as the Secretary determines appropriate,
the Secretary shall identify, through publication in the
Federal Register, any type of class I device that the Secretary
determines no longer requires a report under subsection (k) to
provide reasonable assurance of safety and effectiveness. Upon
such publication--
(A) each type of class I device so identified shall
be exempt from the requirement for a report under
subsection (k); and
(B) the classification regulation applicable to each
such type of device shall be deemed amended to
incorporate such exemption.
(m)(1) The Secretary shall--
(A) not later than 90 days after the date of
enactment of the 21st Century Cures Act and at least
once every 5 years thereafter, as the Secretary
determines appropriate--
(i) publish in the Federal Register a notice
that contains a list of each type of class II
device that the Secretary determines no longer
requires a report under subsection (k) to
provide reasonable assurance of safety and
effectiveness; and
(ii) provide for a period of not less than 60
calendar days for public comment beginning on
the date of the publication of such notice; and
(B) not later than 210 calendar days after the date
of enactment of the 21st Century Cures Act, publish in
the Federal Register a list representing the
Secretary's final determination with respect to the
devices contained in the list published under
subparagraph (A).
(2) Beginning on the date that is 1 calendar day after the
date of publication of the final list under paragraph (1)(B),
the Secretary may exempt a class II device from the requirement
to submit a report under subsection (k), upon the Secretary's
own initiative or a petition of an interested person, if the
Secretary determines that such report is not necessary to
assure the safety and effectiveness of the device. The
Secretary shall publish in the Federal Register notice of the
intent of the Secretary to exempt the device, or of the
petition, and provide a 60-calendar-day period for public
comment. Within 120 days after the issuance of the notice in
the Federal Register, the Secretary shall publish an order in
the Federal Register that sets forth the final determination of
the Secretary regarding the exemption of the device that was
the subject of the notice. If the Secretary fails to respond to
a petition within 180 days of receiving it, the petition shall
be deemed to be granted.
(3) Upon the publication of the final list under paragraph
(1)(B)--
(A) each type of class II device so listed shall be
exempt from the requirement for a report under
subsection (k); and
(B) the classification regulation applicable to each
such type of device shall be deemed amended to
incorporate such exemption.
(n)(1) The Secretary shall review the report required in
subsection (k) and make a determination under section 513(f)(1)
not later than 90 days after receiving the report.
(2)(A) Not later than 18 months after the date of
enactment of this paragraph, the Secretary shall submit
to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate a report regarding
when a premarket notification under subsection (k)
should be submitted for a modification or change to a
legally marketed device. The report shall include the
Secretary's interpretation of the following terms:
``could significantly affect the safety or
effectiveness of the device'', ``a significant change
or modification in design, material, chemical
composition, energy source, or manufacturing process'',
and ``major change or modification in the intended use
of the device''. The report also shall discuss possible
processes for industry to use to determine whether a
new submission under subsection (k) is required and
shall analyze how to leverage existing quality system
requirements to reduce premarket burden, facilitate
continual device improvement, and provide reasonable
assurance of safety and effectiveness of modified
devices. In developing such report, the Secretary shall
consider the input of interested stakeholders.
(B) The Secretary shall withdraw the Food and Drug
Administration draft guidance entitled ``Guidance for
Industry and FDA Staff--510(k) Device Modifications:
Deciding When to Submit a 510(k) for a Change to an
Existing Device'', dated July 27, 2011, and shall not
use this draft guidance as part of, or for the basis
of, any premarket review or any compliance or
enforcement decisions or actions. The Secretary shall
not issue--
(i) any draft guidance or proposed regulation
that addresses when to submit a premarket
notification submission for changes and
modifications made to a manufacturer's
previously cleared device before the receipt by
the Committee on Energy and Commerce of the
House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the
Senate of the report required in subparagraph
(A); and
(ii) any final guidance or regulation on that
topic for one year after date of receipt of
such report by the Committee on Energy and
Commerce of the House of Representatives and
the Committee on Health, Education, Labor, and
Pensions of the Senate.
(C) The Food and Drug Administration guidance
entitled ``Deciding When to Submit a 510(k) for a
Change to an Existing Device'', dated January 10, 1997,
shall be in effect until the subsequent issuance of
guidance or promulgation, if appropriate, of a
regulation described in subparagraph (B), and the
Secretary shall interpret such guidance in a manner
that is consistent with the manner in which the
Secretary has interpreted such guidance since 1997.
(o)(1) With respect to reprocessed single-use devices for
which reports are required under subsection (k):
(A) The Secretary shall identify such devices or
types of devices for which reports under such
subsection must, in order to ensure that the device is
substantially equivalent to a predicate device, include
validation data, the types of which shall be specified
by the Secretary, regarding cleaning and sterilization,
and functional performance demonstrating that the
single-use device will remain substantially equivalent
to its predicate device after the maximum number of
times the device is reprocessed as intended by the
person submitting the premarket notification. Within
six months after enactment of this subsection, the
Secretary shall publish in the Federal Register a list
of the types so identified, and shall revise the list
as appropriate. Reports under subsection (k) for
devices or types of devices within a type included on
the list are, upon publication of the list, required to
include such validation data.
(B) In the case of each report under subsection (k)
that was submitted to the Secretary before the
publication of the initial list under subparagraph (A),
or any revision thereof, and was for a device or type
of device included on such list, the person who
submitted the report under subsection (k) shall submit
validation data as described in subparagraph (A) to the
Secretary not later than nine months after the
publication of the list. During such nine-month period,
the Secretary may not take any action under this Act
against such device solely on the basis that the
validation data for the device have not been submitted
to the Secretary. After the submission of the
validation data to the Secretary, the Secretary may not
determine that the device is misbranded under section
502(o) or adulterated under section 501(f)(1)(B), or
take action against the device under section 301(p) for
failure to provide any information required by
subsection (k) until (i) the review is terminated by
withdrawal of the submission of the report under
subsection (k); (ii) the Secretary finds the data to be
acceptable and issues a letter; or (iii) the Secretary
determines that the device is not substantially
equivalent to a predicate device. Upon a determination
that a device is not substantially equivalent to a
predicate device, or if such submission is withdrawn,
the device can no longer be legally marketed.
(C) In the case of a report under subsection (k) for
a device identified under subparagraph (A) that is of a
type for which the Secretary has not previously
received a report under such subsection, the Secretary
may, in advance of revising the list under subparagraph
(A) to include such type, require that the report
include the validation data specified in subparagraph
(A).
(D) Section 502(o) applies with respect to the
failure of a report under subsection (k) to include
validation data required under subparagraph (A).
(2) With respect to critical or semi-critical reprocessed
single-use devices that, under subsection (l) or (m), are
exempt from the requirement of submitting reports under
subsection (k):
(A) The Secretary shall identify such devices or
types of devices for which such exemptions should be
terminated in order to provide a reasonable assurance
of the safety and effectiveness of the devices. The
Secretary shall publish in the Federal Register a list
of the devices or types of devices so identified, and
shall revise the list as appropriate. The exemption for
each device or type included on the list is terminated
upon the publication of the list. For each report under
subsection (k) submitted pursuant to this subparagraph
the Secretary shall require the validation data
described in paragraph (1)(A).
(B) For each device or type of device included on the
list under subparagraph (A), a report under subsection
(k) shall be submitted to the Secretary not later than
15 months after the publication of the initial list, or
a revision of the list, whichever terminates the
exemption for the device. During such 15-month period,
the Secretary may not take any action under this Act
against such device solely on the basis that such
report has not been submitted to the Secretary. After
the submission of the report to the Secretary the
Secretary may not determine that the device is
misbranded under section 502(o) or adulterated under
section 501(f)(1)(B), or take action against the device
under section 301(p) for failure to provide any
information required by subsection (k) until (i) the
review is terminated by withdrawal of the submission;
(ii) the Secretary determines by order that the device
is substantially equivalent to a predicate device; or
(iii) the Secretary determines by order that the device
is not substantially equivalent to a predicate device.
Upon a determination that a device is not substantially
equivalent to a predicate device, the device can no
longer be legally marketed.
(C) In the case of semi-critical devices, the initial
list under subparagraph (A) shall be published not
later than 18 months after the effective date of this
subsection. In the case of critical devices, the
initial list under such subparagraph shall be published
not later than six months after such effective date.
(D) Section 502(o) applies with respect to the
failure to submit a report under subsection (k) that is
required pursuant to subparagraph (A), including a
failure of the report to include validation data
required in such subparagraph.
(E) The termination under subparagraph (A) of an
exemption under subsection (l) or (m) for a critical or
semi-critical reprocessed single-use device does not
terminate the exemption under subsection (l) or (m) for
the original device.
(p) Electronic Registration and Listing.--
(1) In general.--Registrations and listings under
this section (including the submission of updated
information) shall be submitted to the Secretary by
electronic means unless the Secretary grants a request
for waiver of such requirement because use of
electronic means is not reasonable for the person
requesting such waiver.
(2) Electronic database.--Not later than 2 years
after the Secretary specifies a unique facility
identifier system under subsections (b) and (i), the
Secretary shall maintain an electronic database, which
shall not be subject to inspection under subsection
(f), populated with the information submitted as
described under paragraph (1) that--
(A) enables personnel of the Food and Drug
Administration to search the database by any
field of information submitted in a
registration described under paragraph (1), or
combination of such fields; and
(B) uses the unique facility identifier
system to link with other relevant databases
within the Food and Drug Administration,
including the database for submission of
information under section 801(r).
(3) Risk-based information and coordination.--The
Secretary shall ensure the accuracy and coordination of
relevant Food and Drug Administration databases in
order to identify and inform risk-based inspections
under section 510(h).
(q) Reusable Medical Devices.--
(1) In general.--Not later than 180 days after the
date of enactment of the 21st Century Cures Act, the
Secretary shall identify and publish a list of reusable
device types for which reports under subsection (k) are
required to include--
(A) instructions for use, which have been
validated in a manner specified by the
Secretary; and
(B) validation data, the types of which shall
be specified by the Secretary;
regarding cleaning, disinfection, and sterilization,
and for which a substantial equivalence determination
may be based.
(2) Revision of list.--The Secretary shall revise the
list under paragraph (2), as the Secretary determines
appropriate, with notice in the Federal Register.
(3) Content of reports.--Reports under subsection (k)
that are submitted after the publication of the list
described in paragraph (1), for devices or types of
devices included on such list, shall include such
instructions for use and validation data.
* * * * * * *
classification of devices intended for human use
Device Classes
Sec. 513. (a)(1) There are established the following classes
of devices intended for human use:
(A) Class I, General Controls.--
(i) A device for which the controls
authorized by or under section 501, 502, 510,
516, 518, 519, or 520 or any combination of
such sections are sufficient to provide
reasonable assurance of the safety and
effectiveness of the device.
(ii) A device for which insufficient
information exists to determine that the
controls referred to in clause (i) are
sufficient to provide reasonable assurance of
the safety and effectiveness of the device or
to establish special controls to provide such
assurance, but because it--
(I) is not purported or represented
to be for a use in supporting or
sustaining human life or for a use
which is of substantial importance in
preventing impairment of human health,
and
(II) does not present a potential
unreasonable risk of illness or injury,
is to be regulated by the controls referred to
in clause (i).
(B) Class ii, special controls.--A device which
cannot be classified as a class I device because the
general controls by themselves are insufficient to
provide reasonable assurance of the safety and
effectiveness of the device, and for which there is
sufficient information to establish special controls to
provide such assurance, including the promulgation of
performance standards, postmarket surveillance, patient
registries, development and dissemination of guidelines
(including guidelines for the submission of clinical
data in premarket notification submissions in
accordance with section 510(k)), recommendations, and
other appropriate actions as the Secretary deems
necessary to provide such assurance. For a device that
is purported or represented to be for a use in
supporting or sustaining human life, the Secretary
shall examine and identify the special controls, if
any, that are necessary to provide adequate assurance
of safety and effectiveness and describe how such
controls provide such assurance.
(C) Class III, Premarket Approval.--A device which
because--
(i) it (I) cannot be classified as a class I
device because insufficient information exists
to determine that the application of general
controls are sufficient to provide reasonable
assurance of the safety and effectiveness of
the device, and (II) cannot be classified as a
class II device because insufficient
information exists to determine that the
special controls described in subparagraph (B)
would provide reasonable assurance of its
safety and effectiveness, and
(ii)(I) is purported or represented to be for
a use in supporting or sustaining human life or
for a use which is of substantial importance in
preventing impairment of human health, or
(II) presents a potential unreasonable risk
of illness or injury,
is to be subject, in accordance with section 515, to
premarket approval to provide reasonable assurance of
its safety and effectiveness.
If there is not sufficient information to establish a
performance standard for a device to provide reasonable
assurance of its safety and effectiveness, the Secretary may
conduct such activities as may be necessary to develop or
obtain such information.
(2) For purposes of this section and sections 514 and 515,
the safety and effectiveness of a device are to be determined--
(A) with respect to the persons for whose use the
device is represented or intended,
(B) with respect to the conditions of use prescribed,
recommended, or suggested in the labeling of the
device, and
(C) weighing any probable benefit to health from the
use of the device against any probable risk of injury
or illness from such use.
(3)(A) Except as authorized by subparagraph (B), the
effectiveness of a device is, for purposes of this section and
sections 514 and 515, to be determined, in accordance with
regulations promulgated by the Secretary, on the basis of well-
controlled investigations, including 1 or more clinical
investigations where appropriate, by experts qualified by
training and experience to evaluate the effectiveness of the
device, from which investigations it can fairly and responsibly
be concluded by qualified experts that the device will have the
effect it purports or is represented to have under the
conditions of use prescribed, recommended, or suggested in the
labeling of the device.
(B) If the Secretary determines that there exists valid
scientific evidence (other than evidence derived from
investigations described in subparagraph (A))--
(i) which is sufficient to determine the
effectiveness of a device, and
(ii) from which it can fairly and responsibly be
concluded by qualified experts that the device will
have the effect it purports or is represented to have
under the conditions of use prescribed, recommended, or
suggested in the labeling of the device,
then, for purposes of this section and sections 514 and 515,
the Secretary may authorize the effectiveness of the device to
be determined on the basis of such evidence.
(C) In making a determination of a reasonable assurance of
the effectiveness of a device for which an application under
section 515 has been submitted, the Secretary shall consider
whether the extent of data that otherwise would be required for
approval of the application with respect to effectiveness can
be reduced through reliance on postmarket controls.
(D)(i) The Secretary, upon the written request of any person
intending to submit an application under section 515, shall
meet with such person to determine the type of valid scientific
evidence (within the meaning of subparagraphs (A) and (B)) that
will be necessary to demonstrate for purposes of approval of an
application the effectiveness of a device for the conditions of
use proposed by such person. The written request shall include
a detailed description of the device, a detailed description of
the proposed conditions of use of the device, a proposed plan
for determining whether there is a reasonable assurance of
effectiveness, and, if available, information regarding the
expected performance from the device. Within 30 days after such
meeting, the Secretary shall specify in writing the type of
valid scientific evidence that will provide a reasonable
assurance that a device is effective under the conditions of
use proposed by such person.
(ii) Any clinical data, including one or more well-controlled
investigations, specified in writing by the Secretary for
demonstrating a reasonable assurance of device effectiveness
shall be specified as result of a determination by the
Secretary that such data are necessary to establish device
effectiveness. The Secretary shall consider, in consultation
with the applicant, the least burdensome appropriate means of
evaluating device effectiveness that would have a reasonable
likelihood of resulting in approval.
(iii) For purposes of clause (ii), the term ``necessary''
means the minimum required information that would support a
determination by the Secretary that an application provides
reasonable assurance of the effectiveness of the device.
(iv) Nothing in this subparagraph shall alter the criteria
for evaluating an application for premarket approval of a
device.
(v) The determination of the Secretary with respect to the
specification of valid scientific evidence under clauses (i)
and (ii) shall be binding upon the Secretary, unless such
determination by the Secretary could be contrary to the public
health.
Classification; Classification Panels
(b)(1) For purposes of--
(A) determining which devices intended for human use
should be subject to the requirements of general
controls, performance standards, or premarket approval,
and
(B) providing notice to the manufacturers and
importers of such devices to enable them to prepare for
the application of such requirements to devices
manufactured or imported by them,
the Secretary shall classify all such devices (other than
devices classified by subsection (f)) into the classes
established by subsection (a). For the purpose of securing
recommendations with respect to the classification of devices,
the Secretary shall establish panels of experts or use panels
of experts established before the date of the enactment of this
section, or both. Section 14 of the Federal Advisory Committee
Act shall not apply to the duration of a panel established
under this paragraph.
(2) The Secretary shall appoint to each panel established
under paragraph (1) persons who are qualified by training and
experience to evaluate the safety and effectiveness of the
devices to be referred to the panel and who, to the extent
feasible, possess skill in the use of, or experience in the
development, manufacture, or utilization of, such devices. The
Secretary shall make appointments to each panel so that each
panel shall consist of members with adequately diversified
expertise in such fields as clinical and administrative
medicine, engineering, biological and physical sciences, and
other related professions. In addition, each panel shall
include as nonvoting members a representative of consumer
interests and a representative of interests of the device
manufacturing industry. Scientific, trade, and consumer
organizations shall be afforded an opportunity to nominate
individuals for appointment to the panels. No individual who is
in the regular full-time employ of the United States and
engaged in the administration of this Act may be a member of
any panel. The Secretary shall designate one of the members of
each panel to serve as chairman thereof.
(3) Panel members (other than officers or employees of the
United States), while attending meetings or conferences of a
panel or otherwise engaged in its business, shall be entitled
to receive compensation at rates to be fixed by the Secretary,
but not at rates exceeding the daily equivalent of the rate in
effect for grade GS-18 of the General Schedule, for each day so
engaged, including traveltime; and while so serving away from
their homes or regular places of business each member may be
allowed travel expenses (including per diem in lieu of
subsistence) as authorized by section 5703 of title 5, United
States Code, for persons in the Government service employed
intermittently.
(4) The Secretary shall furnish each panel with adequate
clerical and other necessary assistance.
(5)(A) Classification panels covering each type of device
shall be scheduled to meet at such times as may be appropriate
for the Secretary to meet applicable statutory deadlines.
(B) When a device is specifically the subject of review by a
classification panel, the Secretary shall--
(i) ensure that adequate expertise is represented on
the classification panel to assess--
(I) the disease or condition which the device
is intended to cure, treat, mitigate, prevent,
or diagnose; and
(II) the technology of the device; and
(ii) provide an opportunity for the person whose
device is specifically the subject of panel review to
provide recommendations on the expertise needed among
the voting members of the panel.
(C) For purposes of subparagraph (B)(i), the term ``adequate
expertise'' means that the membership of the classification
panel includes--
(i) two or more voting members, with a specialty or
other expertise clinically relevant to the device under
review; and
(ii) at least one voting member who is knowledgeable
about the technology of the device.
(D) The Secretary shall provide an annual opportunity for
patients, representatives of patients, and sponsors of medical
devices that may be specifically the subject of a review by a
classification panel to provide recommendations for individuals
with appropriate expertise to fill voting member positions on
classification panels.
(6)(A) Any person whose device is specifically the subject of
review by a classification panel shall have--
(i) the same access to data and information submitted
to a classification panel (except for data and
information that are not available for public
disclosure under section 552 of title 5, United States
Code) as the Secretary;
(ii) the opportunity to submit, for review by a
classification panel, information that is based on the
data or information provided in the application
submitted under section 515 by the person, which
information shall be submitted to the Secretary for
prompt transmittal to the classification panel; and
(iii) the same opportunity as the Secretary to
participate in meetings of the panel, including,
subject to the discretion of the panel chairperson, by
designating a representative who will be provided a
time during the panel meeting to address the panel for
the purpose of correcting misstatements of fact or
providing clarifying information, and permitting the
person or representative to call on experts within the
person's organization to address such specific issues
in the time provided.
(B)(i) Any meeting of a classification panel with respect to
the review of a device shall--
(I) provide adequate time for initial presentations
by the person whose device is specifically the subject
of such review and by the Secretary; and
(II) encourage free and open participation by all
interested persons.
(ii) Following the initial presentations described in clause
(i), the panel may--
(I) pose questions to a designated representative
described in subparagraph (A)(iii); and
(II) consider the responses to such questions in the
panel's review of the device.
(7) After receiving from a classification panel the
conclusions and recommendations of the panel on a matter that
the panel has reviewed, the Secretary shall review the
conclusions and recommendations, shall make a final decision on
the matter in accordance with section 515(d)(2), and shall
notify the affected persons of the decision in writing and, if
the decision differs from the conclusions and recommendations
of the panel, shall include the reasons for the difference.
(8) A classification panel under this subsection shall not be
subject to the annual chartering and annual report requirements
of the Federal Advisory Committee Act.
Classification Panel Organization and Operation
(c)(1) The Secretary shall organize the panels according to
the various fields of clinical medicine and fundamental
sciences in which devices intended for human use are used. The
Secretary shall refer a device to be classified under this
section to an appropriate panel established or authorized to be
used under subsection (b) for its review and for its
recommendation respecting the classification of the device. The
Secretary shall by regulation prescribe the procedure to be
followed by the panels in making their reviews and
recommendations. In making their reviews of devices, the
panels, to the maximum extent practicable, shall provide an
opportunity for interested persons to submit data and views on
the classification of the devices.
(2)(A) Upon completion of a panel's review of a device
referred to it under paragraph (1), the panel shall, subject to
subparagraphs (B) and (C), submit to the Secretary its
recommendation for the classification of the device. Any such
recommendation shall (i) contain (I) a summary of the reasons
for the recommendation, (II) a summary of the data upon which
the recommendation is based, and (III) an identification of the
risks to health (if any) presented by the device with respect
to which the recommendation is made, and (ii) to the extent
practicable, include a recommendation for the assignment of a
priority for the application of the requirements of section 514
or 515 to a device recommended to be classified in class II or
class III.
(B) A recommendation of a panel for the classification of a
device in class I shall include a recommendation as to whether
the device should be exempted from the requirements of section
510, 519, or 520(f).
(C) In the case of a device which has been referred under
paragraph (1) to a panel, and which--
(i) is intended to be implanted in the human body or
is purported or represented to be for a use in
supporting or sustaining human life, and
(ii)(I) has been introduced or delivered for
introduction into interstate commerce for commercial
distribution before the date of enactment of this
section, or
(II) is within a type of device which was so
introduced or delivered before such date and is
substantially equivalent to another device within that
type,
such panel shall recommend to the Secretary that the device be
classified in class III unless the panel determines that
classification of the device in such class is not necessary to
provide reasonable assurance of its safety and effectiveness.
If a panel does not recommend that such a device be classified
in class III, it shall in its recommendation to the Secretary
for the classification of the device set forth the reasons for
not recommending classification of the device in such class.
(3) The panels shall submit to the Secretary within one year
of the date funds are first appropriated for the implementation
of this section their recommendations respecting all devices of
a type introduced or delivered for introduction into interstate
commerce for commercial distribution before the date of the
enactment of this section.
Classification
(d)(1) Upon receipt of a recommendation from a panel
respecting a device, the Secretary shall publish in the Federal
Register the panel's recommendation and a proposed regulation
classifying such device and shall provide interested persons an
opportunity to submit comments on such recommendation and the
proposed regulation. After reviewing such comments, the
Secretary shall, subject to paragraph (2), by regulation
classify such device.
(2)(A) A regulation under paragraph (1) classifying a device
in class I shall prescribe which, if any, of the requirements
of section 510, 519 or 520(f) shall not apply to the device. A
regulation which makes a requirement of section 510, 519, or
520(f) inapplicable to a device shall be accompanied by a
statement of the reasons of the Secretary for making such
requirement inapplicable.
(B) A device described in subsection (c)(2)(C) shall be
classified in class III unless the Secretary determines that
classification of the device in such class is not necessary to
provide reasonable assurance of its safety and effectiveness. A
proposed regulation under paragraph (1) classifying such a
device in a class other than class III shall be accompanied by
a full statement of the reasons of the Secretary (and
supporting documentation and data) for not classifying such
device in such class and an identification of the risks to
health (if any) presented by such device.
(3) In the case of devices classified in class II and devices
classified under this subsection in class III and described in
section 515(b)(1) the Secretary may establish priorities which,
in his discretion, shall be used in applying sections 514 and
515, as appropriate, to such devices.
Classification Changes
(e)(1)(A)(i) Based on new information respecting a device,
the Secretary may, upon the initiative of the Secretary or upon
petition of an interested person, change the classification of
such device, and revoke, on account of the change in
classification, any regulation or requirement in effect under
section 514 or 515 with respect to such device, by
administrative order published in the Federal Register
following publication of a proposed reclassification order in
the Federal Register, a meeting of a device classification
panel described in subsection (b), and consideration of
comments to a public docket, notwithstanding subchapter II of
chapter 5 of title 5, United States Code. The proposed
reclassification order published in the Federal Register shall
set forth the proposed reclassification, and a substantive
summary of the valid scientific evidence concerning the
proposed reclassification, including--
(I) the public health benefit of the use of the
device, and the nature and, if known, incidence of the
risk of the device;
(II) in the case of a reclassification from class II
to class III, why general controls pursuant to
subsection (a)(1)(A) and special controls pursuant to
subsection (a)(1)(B) together are not sufficient to
provide a reasonable assurance of safety and
effectiveness for such device; and
(III) in the case of reclassification from class III
to class II, why general controls pursuant to
subsection (a)(1)(A) and special controls pursuant to
subsection (a)(1)(B) together are sufficient to provide
a reasonable assurance of safety and effectiveness for
such device.
(ii) An order under this subsection changing the
classification of a device from class III to class II may
provide that such classification shall not take effect until
the effective date of a performance standard established under
section 514 for such device.
(B) Authority to issue such administrative order shall not be
delegated below the Director of the Center for Devices and
Radiological Health, acting in consultation with the
Commissioner.
(2) By an order issued under paragraph (1), the Secretary may
change the classification of a device from class III--
(A) to class II if the Secretary determines that
special controls would provide reasonable assurance of
the safety and effectiveness of the device and that
general controls would not provide reasonable assurance
of the safety and effectiveness of the device, or
(B) to class I if the Secretary determines that
general controls would provide reasonable assurance of
the safety and effectiveness of the device.
Initial Classification and Reclassification of Certain Devices
(f)(1) Any device intended for human use which was not
introduced or delivered for introduction into interstate
commerce for commercial distribution before the date of the
enactment of this section is classified in class III unless--
(A) the device--
(i) is within a type of device (I) which was
introduced or delivered for introduction into
interstate commerce for commercial distribution
before such date and which is to be classified
pursuant to subsection (b), or (II) which was
not so introduced or delivered before such date
and has been classified in class I or II, and
(ii) is substantially equivalent to another
device within such type;
(B) the Secretary in response to a petition submitted
under paragraph (3) has classified such device in class
I or II; or
(C) the device is classified pursuant to a request
submitted under paragraph (2).
A device classified in class III under this paragraph shall be
classified in that class until the effective date of an order
of the Secretary under paragraph (2) or (3) classifying the
device in class I or II.
(2)(A)(i) Any person who submits a report under section
510(k) for a type of device that has not been previously
classified under this Act, and that is classified into class
III under paragraph (1), may request, after receiving written
notice of such a classification, the Secretary to classify the
device.
(ii) In lieu of submitting a report under section 510(k) and
submitting a request for classification under clause (i) for a
device, if a person determines there is no legally marketed
device upon which to base a determination of substantial
equivalence (as defined in subsection (i)), a person may submit
a request under this clause for the Secretary to classify the
device.
(iii) Upon receipt of a request under clause (i) or (ii), the
Secretary shall classify the device subject to the request
under the criteria set forth in subparagraphs (A) through (C)
of subsection (a)(1) within 120 days.
(iv) Notwithstanding clause (iii), the Secretary may decline
to undertake a classification request submitted under clause
(ii) if the Secretary identifies a legally marketed device that
could provide a reasonable basis for review of substantial
equivalence under paragraph (1), or when the Secretary
determines that the device submitted is not of low to moderate
risk or that general controls would be inadequate to control
the risks and special controls to mitigate the risks cannot be
developed.
(v) The person submitting the request for classification
under this subparagraph may recommend to the Secretary a
classification for the device and shall, if recommending
classification in class II, include in the request an initial
draft proposal for applicable special controls, as described in
subsection (a)(1)(B), that are necessary, in conjunction with
general controls, to provide reasonable assurance of safety and
effectiveness and a description of how the special controls
provide such assurance. Any such request shall describe the
device and provide detailed information and reasons for the
recommended classification.
(B)(i) The Secretary shall by written order classify the
device involved. Such classification shall be the initial
classification of the device for purposes of paragraph (1) and
any device classified under this paragraph shall be a predicate
device for determining substantial equivalence under paragraph
(1).
(ii) A device that remains in class III under this
subparagraph shall be deemed to be adulterated within the
meaning of section 501(f)(1)(B) until approved under section
515 or exempted from such approval under section 520(g).
(C) Within 30 days after the issuance of an order classifying
a device under this paragraph, the Secretary shall publish a
notice in the Federal Register announcing such classification.
(3)(A) The Secretary may initiate the reclassification of a
device classified into class III under paragraph (1) of this
subsection or the manufacturer or importer of a device
classified under paragraph (1) may petition the Secretary (in
such form and manner as he shall prescribe) for the issuance of
an order classifying the device in class I or class II. Within
thirty days of the filing of such a petition, the Secretary
shall notify the petitioner of any deficiencies in the petition
which prevent the Secretary from making a decision on the
petition.
(B)(i) Upon determining that a petition does not contain any
deficiency which prevents the Secretary from making a decision
on the petition, the Secretary may for good cause shown refer
the petition to an appropriate panel established or authorized
to be used under subsection (b). A panel to which such a
petition has been referred shall not later than ninety days
after the referral of the petition make a recommendation to the
Secretary respecting approval or denial of the petition. Any
such recommendation shall contain (I) a summary of the reasons
for the recommendation, (II) a summary of the data upon which
the recommendation is based, and (III) an identification of the
risks to health (if any) presented by the device with respect
to which the petition was filed. In the case of a petition for
a device which is intended to be implanted in the human body or
which is purported or represented to be for a use in supporting
or sustaining human life, the panel shall recommend that the
petition be denied unless the panel determines that the
classification in class III of the device is not necessary to
provide reasonable assurance of its safety and effectiveness.
If the panel recommends that such petition be approved, it
shall in its recommendation to the Secretary set forth its
reasons for such recommendation.
(ii) The requirements of paragraphs (1) and (2) of subsection
(c) (relating to opportunities for submission of data and views
and recommendations respecting priorities and exemptions from
sections 510, 519, and 520(f)) shall apply with respect to
consideration by panels of petitions submitted under
subparagraph (A).
(C)(i) Within ninety days from the date the Secretary
receives the recommendation of a panel respecting a petition
(but not later than 210 days after the filing of such petition)
the Secretary shall by order deny or approve the petition. If
the Secretary approves the petition, the Secretary shall order
the classification of the device into class I or class II in
accordance with the criteria prescribed by subsection (a)(1)(A)
or (a)(1)(B). In the case of a petition for a device which is
intended to be implanted in the human body or which is
purported or represented to be for a use in supporting or
sustaining human life, the Secretary shall deny the petition
unless the Secretary determines that the classification in
class III of the device is not necessary to provide reasonable
assurance of its safety and effectiveness. An order approving
such petition shall be accompanied by a full statement of the
reasons of the Secretary (and supporting documentation and
data) for approving the petition and an identification of the
risks to health (if any) presented by the device to which such
order applies.
(ii) The requirements of paragraphs (1) and (2)(A) of
subsection (d) (relating to publication of recommendations,
opportunity for submission of comments, and exemption from
sections 510, 519, and 520(f)) shall apply with respect to
action by the Secretary on petitions submitted under
subparagraph (A).
(4) If a manufacturer reports to the Secretary under section
510(k) that a device is substantially equivalent to another
device--
(A) which the Secretary has classified as a class III
device under subsection (b),
(B) which was introduced or delivered for
introduction into interstate commerce for commercial
distribution before December 1, 1990, and
(C) for which no final regulation requiring premarket
approval has been promulgated under section 515(b),
the manufacturer shall certify to the Secretary that the
manufacturer has conducted a reasonable search of all
information known or otherwise available to the manufacturer
respecting such other device and has included in the report
under section 510(k) a summary of and a citation to all adverse
safety and effectiveness data respecting such other device and
respecting the device for which the section 510(k) report is
being made and which has not been submitted to the Secretary
under section 519. The Secretary may require the manufacturer
to submit the adverse safety and effectiveness data described
in the report.
(5) The Secretary may not withhold a determination of the
initial classification of a device under paragraph (1) because
of a failure to comply with any provision of this Act unrelated
to a substantial equivalence decision, including a finding that
the facility in which the device is manufactured is not in
compliance with good manufacturing requirements as set forth in
regulations of the Secretary under section 520(f) (other than a
finding that there is a substantial likelihood that the failure
to comply with such regulations will potentially present a
serious risk to human health).
(6)(A) Subject to the succeeding subparagraphs of this
paragraph, the Secretary shall, by written order, classify an
accessory under this section based on the risks of the
accessory when used as intended and the level of regulatory
controls necessary to provide a reasonable assurance of safety
and effectiveness of the accessory, notwithstanding the
classification of any other device with which such accessory is
intended to be used.
(B) The classification of any accessory distinct from another
device by regulation or written order issued prior to December
13, 2016, shall continue to apply unless and until the
accessory is reclassified by the Secretary, notwithstanding the
classification of any other device with which such accessory is
intended to be used. Nothing in this paragraph shall preclude
the Secretary's authority to initiate the classification of an
accessory through regulation or written order, as appropriate.
(C)(i) In the case of a device intended to be used with an
accessory, where the accessory has been included in an
application for premarket approval of such device under section
515 or a report under section 510(k) for clearance of such
device and the Secretary has not classified such accessory
distinctly from another device in accordance with subparagraph
(A), the person filing the application or report (as
applicable) at the time such application or report is filed--
(I) may include a written request for the proper
classification of the accessory pursuant to
subparagraph (A);
(II) shall include in any such request such
information as may be necessary for the Secretary to
evaluate, based on the least burdensome approach, the
appropriate class for the accessory under subsection
(a); and
(III) shall, if the request under subclause (I) is
requesting classification of the accessory in class II,
include in the application an initial draft proposal
for special controls, if special controls would be
required pursuant to subsection (a)(1)(B).
(ii) The Secretary's response under section 515(d) or section
510(n) (as applicable) to an application or report described in
clause (i) shall also contain the Secretary's granting or
denial of the request for classification of the accessory
involved.
(iii) The Secretary's evaluation of an accessory under clause
(i) shall constitute an order establishing a new classification
for such accessory for the specified intended use or uses of
such accessory and for any accessory with the same intended use
or uses as such accessory.
(D) For accessories that have been granted marketing
authorization as part of a submission for another device with
which the accessory involved is intended to be used, through an
application for such other device under section 515(c), a
report under section 510(k), or a request for classification
under paragraph (2) of this subsection, the following shall
apply:
(i) Not later than the date that is one year after
the date of enactment of the FDA Reauthorization Act of
2017 and at least once every 5 years thereafter, and as
the Secretary otherwise determines appropriate,
pursuant to this paragraph, the Secretary shall publish
in the Federal Register a notice proposing a list of
such accessories that the Secretary determines may be
suitable for a distinct classification in class I and
the proposed regulations for such classifications. In
developing such list, the Secretary shall consider
recommendations from sponsors of device submissions and
other stakeholders for accessories to be included on
such list. The notices shall provide for a period of
not less than 60 calendar days for public comment.
Within 180 days after the end of the comment period,
the Secretary shall publish in the Federal Register a
final action classifying such suitable accessories into
class I.
(ii) A manufacturer or importer of an accessory that
has been granted such marketing authorization may
submit to the Secretary a written request for the
appropriate classification of the accessory based on
the risks and appropriate level of regulatory controls
as described in subparagraph (A), and shall, if the
request is requesting classification of the accessory
in class II, include in the submission an initial draft
proposal for special controls, if special controls
would be required pursuant to subsection (a)(1)(B).
Such request shall include such information as may be
necessary for the Secretary to evaluate, based on the
least burdensome approach, the appropriate class for
the accessory under subsection (a). The Secretary shall
provide an opportunity for a manufacturer or importer
to meet with appropriate personnel of the Food and Drug
Administration to discuss the appropriate
classification of such accessory prior to submitting a
written request under this clause for classification of
the accessory.
(iii) The Secretary shall respond to a request made
under clause (ii) not later than 85 calendar days after
receiving such request by issuing a written order
classifying the accessory or denying the request. If
the Secretary does not agree with the recommendation
for classification submitted by the manufacturer or
importer, the response shall include a detailed
description and justification for such determination.
Within 30 calendar days after granting such a request,
the Secretary shall publish a notice in the Federal
Register announcing such response.
(E) Nothing in this paragraph may be construed as precluding
a manufacturer of an accessory of a new type from using the
classification process described in subsection (f)(2) to obtain
classification of such accessory in accordance with the
criteria and requirements set forth in that subsection.
Information
(g) Within sixty days of the receipt of a written request of
any person for information respecting the class in which a
device has been classified or the requirements applicable to a
device under this Act, the Secretary shall provide such person
a written statement of the classification (if any) of such
device and the requirements of this Act applicable to the
device.
Definitions
(h) For purposes of this section and sections 501, 510, 514,
515, 516, 519, and 520--
(1) a reference to ``general controls'' is a
reference to the controls authorized by or under
sections 501, 502, 510, 516, 518, 519, and 520,
(2) a reference to ``class I,''``class II,'' or
``class III'' is a reference to a class of medical
devices described in subparagraph (A), (B), or (C) of
subsection (a)(1), and
(3) a reference to a ``panel under section 513'' is a
reference to a panel established or authorized to be
used under this section.
Substantial Equivalence
(i)(1)(A) For purposes of determinations of substantial
equivalence under subsection (f) and section 520(l), the term
``substantially equivalent'' or ``substantial equivalence''
means, with respect to a device being compared to a predicate
device, that the device has the same intended use as the
predicate device and that the Secretary by order has found that
the device--
(i) has the same technological characteristics as the
predicate device, or
(ii)(I) has different technological characteristics
and the information submitted that the device is
substantially equivalent to the predicate device
contains information, including appropriate clinical or
scientific data if deemed necessary by the Secretary or
a person accredited under section 523, that
demonstrates that the device is as safe and effective
as a legally marketed device, and (II) does not raise
different questions of safety and effectiveness than
the predicate device.
(B) For purposes of subparagraph (A), the term ``different
technological characteristics'' means, with respect to a device
being compared to a predicate device, that there is a
significant change in the materials, design, energy source, or
other features of the device from those of the predicate
device.
(C) To facilitate reviews of reports submitted to the
Secretary under section 510(k), the Secretary shall consider
the extent to which reliance on postmarket controls may
expedite the classification of devices under subsection (f)(1)
of this section.
(D)(i) Whenever the Secretary requests information to
demonstrate that devices with differing technological
characteristics are substantially equivalent, the Secretary
shall only request information that is necessary to making
substantial equivalence determinations. In making such request,
the Secretary shall consider the least burdensome means of
demonstrating substantial equivalence and request information
accordingly.
(ii) For purposes of clause (i), the term ``necessary'' means
the minimum required information that would support a
determination of substantial equivalence between a new device
and a predicate device.
(iii) Nothing in this subparagraph shall alter the standard
for determining substantial equivalence between a new device
and a predicate device.
(E)(i) Any determination by the Secretary of the intended use
of a device shall be based upon the proposed labeling submitted
in a report for the device under section 510(k). However, when
determining that a device can be found substantially equivalent
to a legally marketed device, the director of the
organizational unit responsible for regulating devices (in this
subparagraph referred to as the ``Director'') may require a
statement in labeling that provides appropriate information
regarding a use of the device not identified in the proposed
labeling if, after providing an opportunity for consultation
with the person who submitted such report, the Director
determines and states in writing--
(I) that there is a reasonable likelihood that the
device will be used for an intended use not identified
in the proposed labeling for the device; and
(II) that such use could cause harm.
(ii) Such determination shall--
(I) be provided to the person who submitted the
report within 10 days from the date of the notification
of the Director's concerns regarding the proposed
labeling;
(II) specify the limitations on the use of the device
not included in the proposed labeling; and
(III) find the device substantially equivalent if the
requirements of subparagraph (A) are met and if the
labeling for such device conforms to the limitations
specified in subclause (II).
(iii) The responsibilities of the Director under this
subparagraph may not be delegated.
(F) Not later than 270 days after the date of the enactment
of the Food and Drug Administration Modernization Act of 1997,
the Secretary shall issue guidance specifying the general
principles that the Secretary will consider in determining when
a specific intended use of a device is not reasonably included
within a general use of such device for purposes of a
determination of substantial equivalence under subsection (f)
or section 520(l).
(2) A device may not be found to be substantially equivalent
to a predicate device that has been removed from the market at
the initiative of the Secretary or that has been determined to
be misbranded or adulterated by a judicial order.
(3)(A) As part of a submission under section 510(k)
respecting a device, the person required to file a premarket
notification under such section shall provide an adequate
summary of any information respecting safety and effectiveness
or state that such information will be made available upon
request by any person.
(B) Any summary under subparagraph (A) respecting a device
shall contain detailed information regarding data concerning
adverse health effects and shall be made available to the
public by the Secretary within 30 days of the issuance of a
determination that such device is substantially equivalent to
another device.
(j) Training and Oversight of Least Burdensome
Requirements.--
(1) The Secretary shall--
(A) ensure that each employee of the Food and
Drug Administration who is involved in the
review of premarket submissions, including
supervisors, receives training regarding the
meaning and implementation of the least
burdensome requirements under subsections
(a)(3)(D) and (i)(1)(D) of this section and
section 515(c)(5); and
(B) periodically assess the implementation of
the least burdensome requirements, including
the employee training under subparagraph (A),
to ensure that the least burdensome
requirements are fully and consistently
applied.
(2) Not later than 18 months after the date of
enactment of the 21st Century Cures Act, the ombudsman
for any organizational unit of the Food and Drug
Administration responsible for the premarket review of
devices shall--
(A) conduct an audit of the training
described in paragraph (1)(A), including the
effectiveness of such training in implementing
the least burdensome requirements;
(B) include in such audit interviews of
persons who are representatives of the device
industry regarding their experiences in the
device premarket review process, including with
respect to the application of least burdensome
concepts to premarket review and
decisionmaking;
(C) include in such audit a list of the
measurement tools the Secretary uses to assess
the implementation of the least burdensome
requirements, including under paragraph (1)(B)
and section 517A(a)(3), and may also provide
feedback on the effectiveness of such tools in
the implementation of the least burdensome
requirements;
(D) summarize the findings of such audit in a
final audit report; and
(E) within 30 calendar days of completion of
such final audit report, make such final audit
report available--
(i) to the Committee on Health,
Education, Labor, and Pensions of the
Senate and the Committee on Energy and
Commerce of the House of
Representatives; and
(ii) on the Internet website of the
Food and Drug Administration.
(k) For a device authorized for emergency use under section
564 for which, in accordance with section 564(m), the Secretary
has deemed a laboratory examination or procedure associated
with such device to be in the category of examinations and
procedures described in section 353(d)(3) of the Public Health
Service Act, the sponsor of such device may, when submitting a
request for classification under section 513(f)(2), submit a
single submission containing--
(1) the information needed for such a request; and
(2) sufficient information to enable the Secretary to
determine whether such laboratory examination or
procedure satisfies the criteria to be categorized
under section 353(d)(3) of the Public Health Service
Act.
performance standards
Provisions of Standards
Sec. 514. (a)(1) The special controls required by section
513(a)(1)(B) shall include performance standards for a class II
device if the Secretary determines that a performance standard
is necessary to provide reasonable assurance of the safety and
effectiveness of the device. A class III device may also be
considered a class II device for purposes of establishing a
standard for the device under subsection (b) if the device has
been reclassified as a class II device under an administrative
order under section 513(e) (or a regulation promulgated under
such section prior to the date of enactment of the Food and
Drug Administration Safety and Innovation Act) but such order
(or regulation) provides that the reclassification is not to
take effect until the effective date of such a standard for the
device.
(2) A performance standard established under subsection (b)
for a device--
(A) shall include provisions to provide reasonable
assurance of its safe and effective performance;
(B) shall, where necessary to provide reasonable
assurance of its safe and effective performance,
include--
(i) provisions respecting the construction,
components, ingredients, and properties of the
device and its compatibility with power systems
and connections to such systems,
(ii) provisions for the testing (on a sample
basis or, if necessary, on an individual basis)
of the device or, if it is determined that no
other more practicable means are available to
the Secretary to assure the conformity of the
device to the standard, provisions for the
testing (on a sample basis or, if necessary, on
an individual basis) by the Secretary or by
another person at the direction of the
Secretary,
(iii) provisions for the measurement of the
performance characteristics of the device,
(iv) provisions requiring that the results of
each or of certain of the tests of the device
required to be made under clause (ii) show that
the device is in conformity with the portions
of the standard for which the test or tests
were required, and
(v) a provision requiring that the sale and
distribution of the device be restricted but
only to the extent that the sale and
distribution of a device may be restricted
under a regulation under section 520(e); and
(C) shall, where appropriate, require the use and
prescribe the form and content of labeling for the
proper installation, maintenance, operation, and use of
the device.
(3) The Secretary shall provide for periodic evaluation of
performance standards established under subsection (b) to
determine if such standards should be changed to reflect new
medical, scientific, or other technological data.
(4) In carrying out his duties under this subsection and
subsection (b), the Secretary shall, to the maximum extent
practicable--
(A) use personnel, facilities, and other technical
support available in other Federal agencies,
(B) consult with other Federal agencies concerned
with standard-setting and other nationally or
internationally recognized standard-setting entities,
and
(C) invite appropriate participation, through joint
or other conferences, workshops, or other means, by
informed persons representative of scientific,
professional, industry, or consumer organizations who
in his judgment can make a significant contribution.
Establishment of a Standard
(b)(1)(A) The Secretary shall publish in the Federal Register
a notice of proposed rulemaking for the establishment,
amendment, or revocation of any performance standard for a
device.
(B) A notice of proposed rulemaking for the establishment or
amendment of a performance standard for a device shall--
(i) set forth a finding with supporting justification
that the performance standard is appropriate and
necessary to provide reasonable assurance of the safety
and effectiveness of the device,
(ii) set forth proposed findings with respect to the
risk of illness or injury that the performance standard
is intended to reduce or eliminate,
(iii) invite interested persons to submit to the
Secretary, within 30 days of the publication of the
notice, requests for changes in the classification of
the device pursuant to section 513(e) based on new
information relevant to the classification, and
(iv) invite interested persons to submit an existing
performance standard for the device, including a draft
or proposed performance standard, for consideration by
the Secretary.
(C) A notice of proposed rulemaking for the revocation of a
performance standard shall set forth a finding with supporting
justification that the performance standard is no longer
necessary to provide reasonable assurance of the safety and
effectiveness of a device.
(D) The Secretary shall provide for a comment period of not
less than 60 days.
(2) If, after publication of a notice in accordance with
paragraph (1), the Secretary receives a request for a change in
the classification of the device, the Secretary shall, within
60 days of the publication of the notice, after consultation
with the appropriate panel under section 513, either deny the
request or give notice of an intent to initiate such change
under section 513(e).
(3)(A) After the expiration of the period for comment on a
notice of proposed rulemaking published under paragraph (1)
respecting a performance standard and after consideration of
such comments and any report from an advisory committee under
paragraph (5), the Secretary shall (i) promulgate a regulation
establishing a performance standard and publish in the Federal
Register findings on the matters referred to in paragraph (1),
or (ii) publish a notice terminating the proceeding for the
development of the standard together with the reasons for such
termination. If a notice of termination is published, the
Secretary shall (unless such notice is issued because the
device is a banned device under section 516) initiate a
proceeding under section 513(e) to reclassify the device
subject to the proceeding terminated by such notice.
(B) A regulation establishing a performance standard shall
set forth the date or dates upon which the standard shall take
effect, but no such regulation may take effect before one year
after the date of its publication unless (i) the Secretary
determines that an earlier effective date is necessary for the
protection of the public health and safety, or (ii) such
standard has been established for a device which, effective
upon the effective date of the standard, has been reclassified
from class III to class II. Such date or dates shall be
established so as to minimize, consistent with the public
health and safety, economic loss to, and disruption or
dislocation of, domestic and international trade.
(4)(A) The Secretary, upon his own initiative or upon
petition of an interested person may by regulation, promulgated
in accordance with the requirements of paragraphs (1), (2), and
(3)(B) of this subsection, amend or revoke a performance
standard.
(B) The Secretary may declare a proposed amendment of a
performance standard to be effective on and after its
publication in the Federal Register and until the effective
date of any final action taken on such amendment if he
determines that making it so effective is in the public
interest. A proposed amendment of a performance standard made
so effective under the preceding sentence may not prohibit,
during the period in which it is so effective, the introduction
or delivery for introduction into interstate commerce of a
device which conforms to such standard without the change or
changes provided by such proposed amendment.
(5)(A) The Secretary--
(i) may on his own initiative refer a proposed
regulation for the establishment, amendment, or
revocation of a performance standard, or
(ii) shall, upon the request of an interested person
which demonstrates good cause for referral and which is
made before the expiration of the period for submission
of comments on such proposed regulation refer such
proposed regulation,
to an advisory committee of experts, established pursuant to
subparagraph (B) for a report and recommendation with respect
to any matter involved in the proposed regulation which
requires the exercise of scientific judgment. If a proposed
regulation is referred under this subparagraph to an advisory
committee, the Secretary shall provide the advisory committee
with the data and information on which such proposed regulation
is based. The advisory committee shall, within sixty days of
the referral of a proposed regulation and after independent
study of the data and information furnished to it by the
Secretary and other data and information before it, submit to
the Secretary a report and recommendation respecting such
regulation, together with all underlying data and information
and a statement of the reason or basis for the recommendation.
A copy of such report and recommendation shall be made public
by the Secretary.
(B) The Secretary shall establish advisory committees (which
may not be panels under section 513) to receive referrals under
subparagraph (A). The Secretary shall appoint as members of any
such advisory committee persons qualified in the subject matter
to be referred to the committee and of appropriately
diversified professional background, except that the Secretary
may not appoint to such a committee any individual who is in
the regular full-time employ of the United States and engaged
in the administration of this Act. Each such committee shall
include as nonvoting members a representative of consumer
interests and a representative of interests of the device
manufacturing industry. Members of an advisory committee who
are not officers or employees of the United States, while
attending conferences or meetings of their committee or
otherwise serving at the request of the Secretary, shall be
entitled to receive compensation at rates to be fixed by the
Secretary, which rates may not exceed the daily equivalent of
the rate in effect for grade GS-18 of the General Schedule, for
each day (including traveltime) they are so engaged; and while
so serving away from their homes or regular places of business
each member may be allowed travel expenses, including per diem
in lieu of subsistence, as authorized by section 5703 of title
5 of the United States Code for persons in the Government
service employed intermittently. The Secretary shall designate
one of the members of each advisory committee to serve as
chairman thereof. The Secretary shall furnish each advisory
committee with clerical and other assistance, and shall by
regulation prescribe the procedures to be followed by each such
committee in acting on referrals made under subparagraph (A).
Recognition of a Standard
(c)(1)(A) In addition to establishing a performance standard
under this section, the Secretary shall, by publication in the
Federal Register (or, with respect to a susceptibility test
interpretive criteria standard under section 511A, by posting
on the Interpretive Criteria Website in accordance with such
section), recognize all or part of an appropriate standard
established by a nationally or internationally recognized
standard development organization for which a person may submit
a declaration of conformity in order to meet a premarket
submission requirement or other requirement under this Act to
which such standard is applicable.
(B) If a person elects to use a standard recognized by the
Secretary under subparagraph (A) to meet the requirements
described in such subparagraph, the person shall provide a
declaration of conformity to the Secretary that certifies that
the device is in conformity with such standard. A person may
elect to use data, or information, other than data required by
a standard recognized under subparagraph (A) to meet any
requirement regarding devices under this Act.
(C)(i) Any person may submit a request for recognition under
subparagraph (A) of all or part of an appropriate standard
established by a nationally or internationally recognized
standard organization.
(ii) Not later than 60 calendar days after the Secretary
receives such a request, the Secretary shall--
(I) make a determination to recognize all, part, or
none of the standard that is the subject of the
request; and
(II) issue to the person who submitted such request a
response in writing that states the Secretary's
rationale for that determination, including the
scientific, technical, regulatory, or other basis for
such determination.
(iii) The Secretary shall make a response issued under clause
(ii)(II) publicly available, in such a manner as the Secretary
determines appropriate.
(iv) The Secretary shall take such actions as may be
necessary to implement all or part of a standard recognized
under clause (ii)(I), in accordance with subparagraph (A).
(D) The Secretary shall make publicly available, in such
manner as the Secretary determines appropriate, the rationale
for recognition under subparagraph (A) of all, part, or none of
a standard, including the scientific, technical, regulatory, or
other basis for the decision regarding such recognition.
(2) The Secretary may withdraw such recognition of a standard
through publication of a notice in the Federal Register if the
Secretary determines that the standard is no longer appropriate
for meeting a requirement regarding devices under this Act.
(3)(A) Subject to subparagraph (B), the Secretary shall
accept a declaration of conformity that a device is in
conformity with a standard recognized under paragraph (1)
unless the Secretary finds--
(i) that the data or information submitted to support
such declaration does not demonstrate that the device
is in conformity with the standard identified in the
declaration of conformity; or
(ii) that the standard identified in the declaration
of conformity is not applicable to the particular
device under review.
(B) The Secretary may request, at any time, the data or
information relied on by the person to make a declaration of
conformity with respect to a standard recognized under
paragraph (1).
(C) A person making a declaration of conformity with respect
to a standard recognized under paragraph (1) shall maintain the
data and information demonstrating conformity of the device to
the standard for a period of two years after the date of the
classification or approval of the device by the Secretary or a
period equal to the expected design life of the device,
whichever is longer.
(4) The Secretary shall provide to all employees of the Food
and Drug Administration who review premarket submissions for
devices periodic training on the concept and use of recognized
standards for purposes of meeting a premarket submission
requirement or other applicable requirement under this Act,
including standards relevant to an employee's area of device
review.
[(d) Pilot Accreditation Scheme for Conformity Assessment.--
[(1) In general.--The Secretary shall establish a
pilot program under which--
[(A) testing laboratories may be accredited,
by accreditation bodies meeting criteria
specified by the Secretary, to assess the
conformance of a device with certain standards
recognized under this section; and
[(B) subject to paragraph (2), determinations
by testing laboratories so accredited that a
device conforms with such standard or standards
shall be accepted by the Secretary for purposes
of demonstrating such conformity under this
section unless the Secretary finds that a
particular such determination shall not be so
accepted.
[(2) Secretarial review of accredited laboratory
determinations.--The Secretary may--
[(A) review determinations by testing
laboratories accredited pursuant to this
subsection, including by conducting periodic
audits of such determinations or processes of
accredited bodies or testing laboratories and,
following such review, taking additional
measures under this Act, such as suspension or
withdrawal of accreditation of such testing
laboratory under paragraph (1)(A) or requesting
additional information with respect to such
device, as the Secretary determines
appropriate; and
[(B) if the Secretary becomes aware of
information materially bearing on safety or
effectiveness of a device assessed for
conformity by a testing laboratory so
accredited, take such additional measures under
this Act as the Secretary determines
appropriate, such as suspension or withdrawal
of accreditation of such testing laboratory
under paragraph (1)(A), or requesting
additional information with regard to such
device.
[(3) Implementation and reporting.--
[(A) Public meeting.--The Secretary shall
publish in the Federal Register a notice of a
public meeting to be held no later than
September 30, 2018, to discuss and obtain input
and recommendations from stakeholders regarding
the goals and scope of, and a suitable
framework and procedures and requirements for,
the pilot program under this subsection.
[(B) Pilot program guidance.--The Secretary
shall--
[(i) not later than September 30,
2019, issue draft guidance regarding
the goals and implementation of the
pilot program under this subsection;
and
[(ii) not later than September 30,
2021, issue final guidance with respect
to the implementation of such program.
[(C) Pilot program initiation.--Not later
than September 30, 2020, the Secretary shall
initiate the pilot program under this
subsection.
[(D) Report.--The Secretary shall make
available on the internet website of the Food
and Drug Administration an annual report on the
progress of the pilot program under this
subsection.
[(4) Sunset.--As of October 1, 2022--
[(A) the authority for accreditation bodies
to accredit testing laboratories pursuant to
paragraph (1)(A) shall cease to have force or
effect;
[(B) the Secretary--
[(i) may not accept a determination
pursuant to paragraph (1)(B) made by a
testing laboratory after such date; and
[(ii) may accept such a determination
made prior to such date;
[(C) except for purposes of accepting a
determination described in subparagraph
(B)(ii), the Secretary shall not continue to
recognize the accreditation of testing
laboratories accredited under paragraph (1)(A);
and
[(D) the Secretary may take actions in
accordance with paragraph (2) with respect to
the determinations made prior to such date and
recognition of the accreditation of testing
laboratories pursuant to determinations made
prior to such date.]
(d) Accreditation Scheme for Conformity Assessment.--
(1) In general.--The Secretary shall establish a
program under which--
(A) testing laboratories meeting criteria
specified in guidance by the Secretary may be
accredited by accreditation bodies meeting
criteria specified in guidance by the
Secretary, to conduct testing to support the
assessment of the conformity of a device to
certain standards recognized under this
section; and
(B) subject to paragraph (2), results from
tests conducted to support the assessment of
conformity of devices as described in
subparagraph (A) conducted by testing
laboratories accredited pursuant to this
subsection shall be accepted by the Secretary
for purposes of demonstrating such conformity
unless the Secretary finds that certain results
of such tests should not be so accepted.
(2) Secretarial review of accredited laboratory
results.--The Secretary may--
(A) review the results of tests conducted by
testing laboratories accredited pursuant to
this subsection, including by conducting
periodic audits of such results or of the
processes of accredited bodies or testing
laboratories;
(B) following such review, take additional
measures under this Act, as the Secretary
determines appropriate, such as--
(i) suspension or withdrawal of
accreditation of a testing laboratory
or recognition of an accreditation body
under paragraph (1)(A); or
(ii) requesting additional
information with respect to a device;
and
(C) if the Secretary becomes aware of
information materially bearing on the safety or
effectiveness of a device for which an
assessment of conformity was supported by
testing conducted by a testing laboratory
accredited under this subsection, take such
additional measures under this Act, as the
Secretary determines appropriate, such as--
(i) suspension or withdrawal of
accreditation of a testing laboratory
or recognition of an accreditation body
under paragraph (1)(A); or
(ii) requesting additional
information with regard to such device.
(3) Implementation and reporting.--
(A) Pilot program transition.--After
September 30, 2023, the pilot program
previously initiated under this subsection, as
in effect prior to the date of enactment of the
Medical Device User Fee Amendments of 2022,
shall be considered to be completed, and the
Secretary may continue operating a program
consistent with this subsection.
(B) Report.--The Secretary shall make
available on the internet website of the Food
and Drug Administration an annual report on the
progress of the pilot program under this
subsection.
* * * * * * *
banned devices
General Rule
Sec. 516. (a) Whenever the Secretary finds, on the basis of
all available data and information, that--
(1) a device intended for human use presents
substantial deception or an unreasonable and
substantial risk of illness or injury for one or more
intended use; and
(2) in the case of substantial deception or an
unreasonable and substantial risk of illness or injury
which the Secretary determined could be corrected or
eliminated by labeling or change in labeling and with
respect to which the Secretary provided written notice
to the manufacturer specifying the deception or risk of
illness or injury, the labeling or change in labeling
to correct the deception or eliminate or reduce such
risk, and the period within which such labeling or
change in labeling was to be done, such labeling or
change in labeling was not done within such period;
he may initiate a proceeding to promulgate a regulation to make
such device a banned device for any such intended use or uses.
A device that is banned for one or more intended uses is not a
legally marketed device under section 1006 when intended for
such use or uses.
Special Effective Date
(b) The Secretary may declare a proposed regulation under
subsection (a) to be effective upon its publication in the
Federal Register and until the effective date of any final
action taken respecting such regulation if (1) he determines,
on the basis of all available data and information, that the
deception or risk of illness or injury associated with the use
of the device which is subject to the regulation presents an
unreasonable, direct, and substantial danger to the health of
individuals, and (2) before the date of the publication of such
regulation, the Secretary notifies the manufacturer of such
device that such regulation is to be made so effective. If the
Secretary makes a proposed regulation so effective, he shall,
as expeditiously as possible, give interested persons prompt
notice of his action under this subsection, provide reasonable
opportunity for an informal hearing on the proposed regulation,
and either affirm, modify, or revoke such proposed regulation.
(c) Specific Device Banned.--Electrical stimulation devices
that apply a noxious electrical stimulus to a person's skin
intended to reduce or cease self-injurious behavior or
aggressive behavior are deemed to be banned devices, as
described in subsection (a).
(d) Reversal by Regulation.--Devices banned under this
section are banned devices unless or until the Secretary
promulgates a regulation to make such devices or use of such
devices no longer banned based on a finding that such devices
or use of such devices does not present substantial deception
or an unreasonable and substantial risk of illness or injury,
or that such risk can be corrected or eliminated by labeling.
* * * * * * *
general provisions respecting control of devices intended for human use
General Rule
Sec. 520. (a) Any requirement authorized by or under section
501, 502, 510, or 519 applicable to a device intended for human
use shall apply to such device until the applicability of the
requirement to the device has been changed by action taken
under section 513, 514, or 515 or under subsection (g) of this
section, and any requirement established by or under section
501, 502, 510, or 519 which is inconsistent with a requirement
imposed on such device under section 514 or 515 or under
subsection (g) of this section shall not apply to such device.
(b) Custom Devices.--
(1) In general.--The requirements of sections 514 and
515 shall not apply to a device that--
(A) is created or modified in order to comply
with the order of an individual physician or
dentist (or any other specially qualified
person designated under regulations promulgated
by the Secretary after an opportunity for an
oral hearing);
(B) in order to comply with an order
described in subparagraph (A), necessarily
deviates from an otherwise applicable
performance standard under section 514 or
requirement under section 515;
(C) is not generally available in the United
States in finished form through labeling or
advertising by the manufacturer, importer, or
distributor for commercial distribution;
(D) is designed to treat a unique pathology
or physiological condition that no other device
is domestically available to treat;
(E)(i) is intended to meet the special needs
of such physician or dentist (or other
specially qualified person so designated) in
the course of the professional practice of such
physician or dentist (or other specially
qualified person so designated); or
(ii) is intended for use by an individual
patient named in such order of such physician
or dentist (or other specially qualified person
so designated);
(F) is assembled from components or
manufactured and finished on a case-by-case
basis to accommodate the unique needs of
individuals described in clause (i) or (ii) of
subparagraph (E); and
(G) may have common, standardized design
characteristics, chemical and material
compositions, and manufacturing processes as
commercially distributed devices.
(2) Limitations.--Paragraph (1) shall apply to a
device only if--
(A) such device is for the purpose of
treating a sufficiently rare condition, such
that conducting clinical investigations on such
device would be impractical;
(B) production of such device under paragraph
(1) is limited to no more than 5 units per year
of a particular device type, provided that such
replication otherwise complies with this
section; and
(C) the manufacturer of such device notifies
the Secretary on an annual basis, in a manner
prescribed by the Secretary, of the manufacture
of such device.
(3) Guidance.--Not later than 2 years after the date
of enactment of this section, the Secretary shall issue
final guidance on replication of multiple devices
described in paragraph (2)(B).
Trade Secrets
(c) Any information reported to or otherwise obtained by the
Secretary or his representative under section 513, 514, 515,
516, 518, 519, or 704 or under subsection (f) or (g) of this
section which is exempt from disclosure pursuant to subsection
(a) of section 552 of title 5, United States Code, by reason of
subsection (b)(4) of such section shall be considered
confidential and shall not be disclosed and may not be used by
the Secretary as the basis for the reclassification of a device
from class III to class II or class I or as the basis for the
establishment or amendment of a performance standard under
section 514 for a device reclassified from class III to class
II, except (1) in accordance with subsection (h), and (2) that
such information may be disclosed to other officers or
employees concerned with carrying out this Act or when relevant
in any proceeding under this Act (other than section 513 or 514
thereof).
Notices and Findings
(d) Each notice of proposed rulemaking under section 513,
514, 515, 516, 518, or 519, or under this section, any other
notice which is published in the Federal Register with respect
to any other action taken under any such section and which
states the reasons for such action, and each publication of
findings required to be made in connection with rulemaking
under any such section shall set forth--
(1) the manner in which interested persons may
examine data and other information on which the notice
or findings is based, and
(2) the period within which interested persons may
present their comments on the notice or findings
(including the need therefor) orally or in writing,
which period shall be at least sixty days but may not
exceed ninety days unless the time is extended by the
Secretary by a notice published in the Federal Register
stating good cause therefor.
Restricted Devices
(e)(1) The Secretary may by regulation require that a device
be restricted to sale, distribution, or use--
(A) only upon the written or oral authorization of a
practitioner licensed by law to administer or use such
device, or
(B) upon such other conditions as the Secretary may
prescribe in such regulation,
if, because of its potentiality for harmful effect or the
collateral measures necessary to its use, the Secretary
determines that there cannot otherwise be reasonable assurance
of its safety and effectiveness. No condition prescribed under
subparagraph (B) may restrict the use of a device to persons
with specific training or experience in its use or to persons
for use in certain facilities unless the Secretary determines
that such a restriction is required for the safe and effective
use of the device. No such condition may exclude a person from
using a device solely because the person does not have the
training or experience to make him eligible for certification
by a certifying board recognized by the American Board of
Medical Specialties or has not been certified by such a Board.
A device subject to a regulation under this subsection is a
restricted device.
(2) The label of a restricted device shall bear such
appropriate statements of the restrictions required by a
regulation under paragraph (1) as the Secretary may in such
regulation prescribe.
Good Manufacturing Practice Requirements
(f)(1)(A) The Secretary may, in accordance with subparagraph
(B), prescribe regulations requiring that the methods used in,
and the facilities and controls used for, the manufacture, pre-
production design validation (including a process to assess the
performance of a device but not including an evaluation of the
safety or effectiveness of a device), packing, storage, and
installation of a device conform to current good manufacturing
practice, as prescribed in such regulations, to assure that the
device will be safe and effective and otherwise in compliance
with this Act.
(B) Before the Secretary may promulgate any regulation under
subparagraph (A) he shall--
(i) afford the advisory committee established under
paragraph (3) an opportunity to submit recommendations
to him with respect to the regulation proposed to be
promulgated;
(ii) afford opportunity for an oral hearing; and
(iii) ensure that such regulation conforms, to the
extent practicable, with internationally recognized
standards defining quality systems, or parts of the
standards, for medical devices.
The Secretary shall provide the advisory committee a reasonable
time to make its recommendation with respect to proposed
regulations under subparagraph (A).
(2)(A) Any person subject to any requirement prescribed by
regulations under paragraph (1) may petition the Secretary for
an exemption or variance from such requirement. Such a petition
shall be submitted to the Secretary in such form and manner as
he shall prescribe and shall--
(i) in the case of a petition for an exemption from a
requirement, set forth the basis for the petitioner's
determination that compliance with the requirement is
not required to assure that the device will be safe and
effective and otherwise in compliance with this Act,
(ii) in the case of a petition for a variance from a
requirement, set forth the methods proposed to be used
in, and the facilities and controls proposed to be used
for, the manufacture, packing, storage, and
installation of the device in lieu of the methods,
facilities, and controls prescribed by the requirement,
and
(iii) contain such other information as the Secretary
shall prescribe.
(B) The Secretary may refer to the advisory committee
established under paragraph (3) any petition submitted under
subparagraph (A). The advisory committee shall report its
recommendations to the Secretary with respect to a petition
referred to it within sixty days of the date of the petition's
referral. Within sixty days after--
(i) the date the petition was submitted to the
Secretary under subparagraph (A), or
(ii) if the petition was referred to an advisory
committee, the expiration of the sixty-day period
beginning on the date the petition was referred to the
advisory committee,
whichever occurs later, the Secretary shall by order either
deny the petition or approve it.
(C) The Secretary may approve--
(i) a petition for an exemption for a device from a
requirement if he determines that compliance with such
requirement is not required to assure that the device
will be safe and effective and otherwise in compliance
with this Act, and
(ii) a petition for a variance for a device from a
requirement if he determines that the methods to be
used in, and the facilities and controls to be used
for, the manufacture, packing, storage, and
installation of the device in lieu of the methods,
controls, and facilities prescribed by the requirement
are sufficient to assure that the device will be safe
and effective and otherwise in compliance with this
Act.
An order of the Secretary approving a petition for a variance
shall prescribe such conditions respecting the methods used in,
and the facilities and controls used for, the manufacture,
packing, storage, and installation of the device to be granted
the variance under the petition as may be necessary to assure
that the device will be safe and effective and otherwise in
compliance with this Act.
(D) After the issuance of an order under subparagraph (B)
respecting a petition, the petitioner shall have an opportunity
for an informal hearing on such order.
(3) The Secretary shall establish an advisory committee for
the purpose of advising and making recommendations to him with
respect to regulations proposed to be promulgated under
paragraph (1)(A) and the approval or disapproval of petitions
submitted under paragraph (2). The advisory committee shall be
composed of nine members as follows:
(A) Three of the members shall be appointed from
persons who are officers or employees of any State or
local government or of the Federal Government.
(B) Two of the members shall be appointed from
persons who are representative of interests of the
device manufacturing industry; two of the members shall
be appointed from persons who are representative of the
interests of physicians and other health professionals;
and two of the members shall be representative of the
interests of the general public.
Members of the advisory committee who are not officers or
employees of the United States, while attending conferences or
meetings of the committee or otherwise engaged in its business,
shall be entitled to receive compensation at rates to be fixed
by the Secretary, which rates may not exceed the daily
equivalent of the rate in effect for grade GS-18 of the General
Schedule, for each day (including traveltime) they are so
engaged; and while so serving away from their homes or regular
places of business each member may be allowed travel expenses,
including per diem in lieu of subsistence, as authorized by
section 5703 of title 5 of the United States Code for persons
in the Government service employed intermittently. The
Secretary shall designate one of the members of the advisory
committee to serve as its chairman. The Secretary shall furnish
the advisory committee with clerical and other assistance.
Section 14 of the Federal Advisory Committee Act shall not
apply with respect to the duration of the advisory committee
established under this paragraph.
Exemption for Devices for Investigational Use
(g)(1) It is the purpose of this subsection to encourage to
the extent consistent with the protection of the public health
and safety and with ethical standards, the discovery and
development of useful devices intended for human use and to
that end to maintain optimum freedom for scientific
investigators in their pursuit of that purpose.
(2)(A) The Secretary shall, within the one hundred and
twenty-day period beginning on the date of the enactment of
this section, by regulation prescribe procedures and conditions
under which devices intended for human use may upon application
be granted an exemption from the requirements of section 502,
510, 514, 515, 516, 519, or 721 or subsection (e) or (f) of
this section or from any combination of such requirements to
permit the investigational use of such devices by experts
qualified by scientific training and experience to investigate
the safety and effectiveness of such devices.
(B) The conditions prescribed pursuant to subparagraph (A)
shall include the following:
(i) A requirement that an application be submitted to
the Secretary before an exemption may be granted and
that the application be submitted in such form and
manner as the Secretary shall specify.
(ii) A requirement that the person applying for an
exemption for a device assure the establishment and
maintenance of such records, and the making of such
reports to the Secretary of safety or effectiveness
data obtained as a result of the investigational use of
the device during the exemption, as the Secretary
determines will enable him to assure compliance with
such conditions, review the progress of the
investigation, and evaluate the safety and
effectiveness of the device.
(iii) Such other requirements as the Secretary may
determine to be necessary for the protection of the
public health and safety.
(C) Procedures and conditions prescribed pursuant to
subparagraph (A) for an exemption may appropriately vary
depending on (i) the scope and duration of clinical testing to
be conducted under such exemption, (ii) the number of human
subjects that are to be involved in such testing, (iii) the
need to permit changes to be made in the device subject to the
exemption during testing conducted in accordance with a
clinical testing plan required under paragraph (3)(A), and (iv)
whether the clinical testing of such device is for the purpose
of developing data to obtain approval for the commercial
distribution of such device.
(3) Procedures and conditions prescribed pursuant to
paragraph (2)(A) shall require, as a condition to the exemption
of any device to be the subject of testing involving human
subjects, that the person applying for the exemption--
(A) submit a plan for any proposed clinical testing
of the device and a report of prior investigations of
the device (including, where appropriate, tests on
animals) adequate to justify the proposed clinical
testing--
(i) to the institutional review committee
established in accordance with regulations of
the Secretary to supervise clinical testing of
devices in the facilities where the proposed
clinical testing is to be conducted, or
(ii) to the Secretary, if--
(I) no such committee exists, or
(II) the Secretary finds that the
process of review by such committee is
inadequate (whether or not the plan for
such testing has been approved by such
committee),
for review for adequacy to justify the commencement of
such testing; and, unless the plan and report are
submitted to the Secretary, submit to the Secretary a
summary of the plan and a report of prior
investigations of the device (including, where
appropriate, tests on animals);
(B) promptly notify the Secretary (under such
circumstances and in such manner as the Secretary
prescribes) of approval by an institutional review
committee of any clinical testing plan submitted to it
in accordance with subparagraph (A);
(C) in the case of a device to be distributed to
investigators for testing, obtain signed agreements
from each of such investigators that any testing of the
device involving human subjects will be under such
investigator's supervision and in accordance with
subparagraph (D) and submit such agreements to the
Secretary; and
(D) assure that informed consent will be obtained
from each human subject (or his representative) of
proposed clinical testing involving such device, except
where, subject to such conditions as the Secretary may
prescribe--
(i) the proposed clinical testing poses no
more than minimal risk to the human subject and
includes appropriate safeguards to protect the
rights, safety, and welfare of the human
subject; or
(ii) the investigator conducting or
supervising the proposed clinical testing of
the device determines in writing that there
exists a life threatening situation involving
the human subject of such testing which
necessitates the use of such device and it is
not feasible to obtain informed consent from
the subject and there is not sufficient time to
obtain such consent from his representative.
The determination required by subparagraph (D)(ii) shall be
concurred in by a licensed physician who is not involved in the
testing of the human subject with respect to which such
determination is made unless immediate use of the device is
required to save the life of the human subject of such testing
and there is not sufficient time to obtain such concurrence.
(4)(A) An application, submitted in accordance with the
procedures prescribed by regulations under paragraph (2), for
an exemption for a device (other than an exemption from section
516) shall be deemed approved on the thirtieth day after the
submission of the application to the Secretary unless on or
before such day the Secretary by order disapproves the
application and notifies the applicant of the disapproval of
the application.
(B) The Secretary may disapprove an application only if he
finds that the investigation with respect to which the
application is submitted does not conform to procedures and
conditions prescribed under regulations under paragraph (2).
Such a notification shall contain the order of disapproval and
a complete statement of the reasons for the Secretary's
disapproval of the application and afford the applicant
opportunity for an informal hearing on the disapproval order.
(C) Consistent with paragraph (1), the Secretary shall not
disapprove an application under this subsection because the
Secretary determines that--
(i) the investigation may not support a substantial
equivalence or de novo classification determination or
approval of the device;
(ii) the investigation may not meet a requirement,
including a data requirement, relating to the approval
or clearance of a device; or
(iii) an additional or different investigation may be
necessary to support clearance or approval of the
device.
(5) The Secretary may by order withdraw an exemption granted
under this subsection for a device if the Secretary determines
that the conditions applicable to the device under this
subsection for such exemption are not met. Such an order may be
issued only after opportunity for an informal hearing, except
that such an order may be issued before the provision of an
opportunity for an informal hearing if the Secretary determines
that the continuation of testing under the exemption with
respect to which the order is to be issued will result in an
unreasonable risk to the public health.
(6)(A) Not later than 1 year after the date of the enactment
of the Food and Drug Administration Modernization Act of 1997,
the Secretary shall by regulation establish, with respect to a
device for which an exemption under this subsection is in
effect, procedures and conditions that, without requiring an
additional approval of an application for an exemption or the
approval of a supplement to such an application, permit--
(i) developmental changes in the device (including
manufacturing changes) that do not constitute a
significant change in design or in basic principles of
operation and that are made in response to information
gathered during the course of an investigation; and
(ii) changes or modifications to clinical protocols
that do not affect--
(I) the validity of data or information
resulting from the completion of an approved
protocol, or the relationship of likely patient
risk to benefit relied upon to approve a
protocol;
(II) the scientific soundness of an
investigational plan submitted under paragraph
(3)(A); or
(III) the rights, safety, or welfare of the
human subjects involved in the investigation.
(B) Regulations under subparagraph (A) shall provide that a
change or modification described in such subparagraph may be
made if--
(i) the sponsor of the investigation determines, on
the basis of credible information (as defined by the
Secretary) that the applicable conditions under
subparagraph (A) are met; and
(ii) the sponsor submits to the Secretary, not later
than 5 days after making the change or modification, a
notice of the change or modification.
(7)(A) In the case of a person intending to investigate the
safety or effectiveness of a class III device or any
implantable device, the Secretary shall ensure that the person
has an opportunity, prior to submitting an application to the
Secretary or to an institutional review committee, to submit to
the Secretary, for review, an investigational plan (including a
clinical protocol). If the applicant submits a written request
for a meeting with the Secretary regarding such review, the
Secretary shall, not later than 30 days after receiving the
request, meet with the applicant for the purpose of reaching
agreement regarding the investigational plan (including a
clinical protocol). The written request shall include a
detailed description of the device, a detailed description of
the proposed conditions of use of the device, a proposed plan
(including a clinical protocol) for determining whether there
is a reasonable assurance of effectiveness, and, if available,
information regarding the expected performance from the device.
(B) Any agreement regarding the parameters of an
investigational plan (including a clinical protocol) that is
reached between the Secretary and a sponsor or applicant shall
be reduced to writing and made part of the administrative
record by the Secretary. Any such agreement shall not be
changed, except--
(i) with the written agreement of the sponsor or
applicant; or
(ii) pursuant to a decision, made in accordance with
subparagraph (C) by the director of the office in which
the device involved is reviewed, that a substantial
scientific issue essential to determining the safety or
effectiveness of the device involved has been
identified.
(C) A decision under subparagraph (B)(ii) by the director
shall be in writing, and may be made only after the Secretary
has provided to the sponsor or applicant an opportunity for a
meeting at which the director and the sponsor or applicant are
present and at which the director documents the scientific
issue involved.
(8)(A) At any time, the Secretary may prohibit the sponsor of
an investigation from conducting the investigation (referred to
in this paragraph as a ``clinical hold'') if the Secretary
makes a determination described in subparagraph (B). The
Secretary shall specify the basis for the clinical hold,
including the specific information available to the Secretary
which served as the basis for such clinical hold, and confirm
such determination in writing.
(B) For purposes of subparagraph (A), a determination
described in this subparagraph with respect to a clinical hold
is a determination that--
(i) the device involved represents an unreasonable
risk to the safety of the persons who are the subjects
of the clinical investigation, taking into account the
qualifications of the clinical investigators,
information about the device, the design of the
clinical investigation, the condition for which the
device is to be investigated, and the health status of
the subjects involved; or
(ii) the clinical hold should be issued for such
other reasons as the Secretary may by regulation
establish.
(C) Any written request to the Secretary from the sponsor of
an investigation that a clinical hold be removed shall receive
a decision, in writing and specifying the reasons therefor,
within 30 days after receipt of such request. Any such request
shall include sufficient information to support the removal of
such clinical hold.
(9)(A)(i) In order for a device in a clinical study for which
submission of an application for an investigational device
exemption is required to be exempt under this subsection, the
sponsor of such study shall submit to the Secretary in such
application a diversity action plan in the form and manner
specified in the guidance required by section 524B.
(ii) In order for a device in a clinical study for which
submission of an application for an investigational device
exemption is not required, except for a device being studied as
described in section 812.2(c) of title 21, Code of Federal
Regulations (or successor regulations), to be exempt under this
subsection, the sponsor of such study shall develop and
implement a diversity action plan. Such diversity action plan
shall be submitted to the Secretary in any premarket
notification under section 510(k), request for classification
under section 513(f)(2), or application for premarket approval
under section 515 for such device.
(B) A diversity action plan under clause (i) or (ii) of
subparagraph (A) shall include--
(i) the sponsor's goals for enrollment in the
clinical study;
(ii) the sponsor's rationale for such goals; and
(iii) an explanation of how the sponsor intends to
meet such goals.
(C) The Secretary may waive the requirement in subparagraph
(A) or (B) if the Secretary determines that a waiver is
necessary based on what is known about the prevalence of the
disease in terms of the patient population that may use the
device.
(D) No diversity action plan shall be required for a
submission described in section 561.
Release of Safety and Effectiveness Information
(h)(1) The Secretary shall promulgate regulations under which
a detailed summary of information respecting the safety and
effectiveness of a device which information was submitted to
the Secretary and which was the basis for--
(A) an order under section 515(d)(1)(A) approving an
application for premarket approval for the device or
denying approval of such an application or an order
under section 515(e) withdrawing approval of such an
application for the device,
(B) an order under section 515(f)(6)(A) revoking an
approved protocol for the device, an order under
section 515(f)(6)(B) declaring a protocol for the
device completed or not completed, or an order under
section 515(f)(7) revoking the approval of the device,
or
(C) an order approving an application under
subsection (g) for an exemption for the device from
section 516 or an order disapproving, or withdrawing
approval of, an application for an exemption under such
subsection for the device,
shall be made available to the public upon issuance of the
order. Summaries of information made available pursuant to this
paragraph respecting a device shall include information
respecting any adverse effects on health of the device.
(2) The Secretary shall promulgate regulations under which
each advisory committee established under section 515(g)(2)(B)
shall make available to the public a detailed summary of
information respecting the safety and effectiveness of a device
which information was submitted to the advisory committee and
which was the basis for its recommendation to the Secretary
made pursuant to section 515(g)(2)(A). A summary of information
upon which such a recommendation is based shall be made
available pursuant to this paragraph only after the issuance of
the order with respect to which the recommendation was made and
each summary shall include information respecting any adverse
effect on health of the device subject to such order.
(3) Except as provided in paragraph (4), any information
respecting a device which is made available pursuant to
paragraph (1) or (2) of this subsection (A) may not be used to
establish the safety or effectiveness of another device for
purposes of this Act by any person other than the person who
submitted the information so made available, and (B) shall be
made available subject to subsection (c) of this section.
(4)(A) Subject to subparagraph (C), any information contained
in an application for premarket approval filed with the
Secretary pursuant to section 515(c) (including information
from clinical and preclinical tests or studies that demonstrate
the safety and effectiveness of a device, but excluding
descriptions of methods of manufacture and product composition
and other trade secrets) shall be available, 6 years after the
application has been approved by the Secretary, for use by the
Secretary in--
(i) approving another device;
(ii) determining whether a product development
protocol has been completed, under section 515 for
another device;
(iii) establishing a performance standard or special
control under this Act; or
(iv) classifying or reclassifying another device
under section 513 and subsection (l)(2).
(B) The publicly available detailed summaries of information
respecting the safety and effectiveness of devices required by
paragraph (1)(A) shall be available for use by the Secretary as
the evidentiary basis for the agency actions described in
subparagraph (A).
(C) No information contained in an application for premarket
approval filed with the Secretary pursuant to section 515(c)
may be used to approve or clear any application submitted under
section 515 or 510(k) or to classify a product under section
513(f)(2) for a combination product containing as a constituent
part an approved drug (as defined in section 503(g)(5)(B))
unless--
(i) the application includes the certification or
statement referenced in section 503(g)(5)(A);
(ii) the applicant provides notice as described in
section 503(g)(5)(A); and
(iii) the Secretary's approval of such application is
subject to the provisions in section 503(g)(5)(C).
Proceedings of Advisory Panels and Committees
(i) Each panel under section 513 and each advisory committee
established under section 514(b)(5)(B) or 515(g) or under
subsection (f) of this section shall make and maintain a
transcript of any proceeding of the panel or committee. Each
such panel and committee shall delete from any transcript made
pursuant to this subsection information which under subsection
(c) of this section is to be considered confidential.
Traceability Requirements
(j) Except as provided in section 519(e), no regulation under
this Act may impose on a type or class of device requirements
for the traceability of such type or class of device unless
such requirements are necessary to assure the protection of the
public health.
Research and Development
(k) The Secretary may enter into contracts for research,
testing, and demonstrations respecting devices and may obtain
devices for research, testing, and demonstration purposes
without regard to sections 3648 and 3709 of the Revised
Statutes (31 U.S.C. 529, 41 U.S.C. 5).
Transitional Provisions for Devices Considered as New Drugs
(l)(1) Any device intended for human use--
(A) for which on the date of enactment of the Medical
Device Amendments of 1976 (hereinafter in this
subsection referred to as the ``enactment date'') an
approval of an application submitted under section
505(b) was in effect;
(B) for which such an application was filed on or
before the enactment date and with respect to which
application no order of approval or refusing to approve
had been issued on such date under subsection (c) or
(d) of such section;
(C) for which on the enactment date an exemption
under subsection (i) of such section was in effect;
(D) which is within a type of device described in
subparagraph (A), (B), or (C) and is substantially
equivalent to another device within that type;
(E) which the Secretary in a notice published in the
Federal Register before the enactment date has declared
to be a new drug subject to section 505; or
(F) with respect to which on the enactment date an
action is pending in a United States court under
section 302, 303, or 304 for an alleged violation of a
provision of section 301 which enforces a requirement
of section 505 or for an alleged violation of section
505(a),
is classified in class III unless the Secretary in response to
a petition submitted under paragraph (2) has classified such
device in class I or II.
(2) The Secretary may initiate the reclassification of a
device classified into class III under paragraph (1) of this
subsection or the manufacturer or importer of a device
classified under paragraph (1) may petition the Secretary (in
such form and manner as he shall prescribe) for the issuance of
an order classifying the device in class I or class II. Within
thirty days of the filing of such a petition, the Secretary
shall notify the petitioner of any deficiencies in the petition
which prevent the Secretary from making a decision on the
petition. Except as provided in paragraph (3)(D)(ii), within
one hundred and eighty days after the filing of a petition
under this paragraph, the Secretary shall, after consultation
with the appropriate panel under section 513, by order either
deny the petition or order the classification, in accordance
with the criteria prescribed by section 513(a)(1)(A) or
513(a)(1)(B), of the device in class I or class II.
(3)(A) In the case of a device which is described in
paragraph (1)(A) and which is in class III--
(i) such device shall on the enactment date be
considered a device with an approved application under
section 515, and
(ii) the requirements applicable to such device
before the enactment date under section 505 shall
continue to apply to such device until changed by the
Secretary as authorized by this Act.
(B) In the case of a device which is described in paragraph
(1)(B) and which is in class III, an application for such
device shall be considered as having been filed under section
515 on the enactment date. The period in which the Secretary
shall act on such application in accordance with section
515(d)(1) shall be one hundred and eighty days from the
enactment date (or such greater period as the Secretary and the
applicant may agree upon after the Secretary has made the
finding required by section 515(d)(1)(B)(i)) less the number of
days in the period beginning on the date an application for
such device was filed under section 505 and ending on the
enactment date. After the expiration of such period such device
is required, unless exempt under subsection (g), to have in
effect an approved application under section 515.
(C) A device which is described in paragraph (1)(C) and which
is in class III shall be considered a new drug until the
expiration of the ninety-day period beginning on the date of
the promulgation of regulations under subsection (g) of this
section. After the expiration of such period such device is
required, unless exempt under subsection (g), to have in effect
an approved application under section 515.
(D)(i) Except as provided in clauses (ii) and (iii), a device
which is described in subparagraph (D), (E), or (F) of
paragraph (1) and which is in class III is required, unless
exempt under subsection (g) of this section, to have on and
after sixty days after the enactment date in effect an approved
application under section 515.
(ii) If--
(I) a petition is filed under paragraph (2) for a
device described in subparagraph (D), (E), or (F) of
paragraph (1), or
(II) an application for premarket approval is filed
under section 515 for such a device,
within the sixty-day period beginning on the enactment date (or
within such greater period as the Secretary, after making the
finding required under section 515(d)(1)(B), and the petitioner
or applicant may agree upon), the Secretary shall act on such
petition or application in accordance with paragraph (2) or
section 515 except that the period within which the Secretary
must act on the petition or application shall be within the one
hundred and twenty-day period beginning on the date the
petition or application is filed. If such a petition or
application is filed within such sixty-day (or greater) period,
clause (i) of this subparagraph shall not apply to such device
before the expiration of such one hundred and twenty-day
period, or if such petition is denied or such application is
denied approval, before the date of such denial, whichever
occurs first.
(iii) In the case of a device which is described in
subparagraph (E) of paragraph (1), which the Secretary in a
notice published in the Federal Register after March 31, 1976,
declared to be a new drug subject to section 505, and which is
in class III--
(I) the device shall, after eighteen months after the
enactment date, have in effect an approved application
under section 515 unless exempt under subsection (g) of
this section, and
(II) the Secretary may, during the period beginning
one hundred and eighty days after the enactment date
and ending eighteen months after such date, restrict
the use of the device to investigational use by experts
qualified by scientific training and experience to
investigate the safety and effectiveness of such
device, and to investigational use in accordance with
the requirements applicable under regulations under
subsection (g) of this section to investigational use
of devices granted an exemption under such subsection.
If the requirements under subsection (g) of this section are
made applicable to the investigational use of such a device,
they shall be made applicable in such a manner that the device
shall be made reasonably available to physicians meeting
appropriate qualifications prescribed by the Secretary.
(5)(A) Before December 1, 1991, the Secretary shall by order
require manufacturers of devices described in paragraph (1),
which are subject to revision of classification under
subparagraph (B), to submit to the Secretary a summary of and
citation to any information known or otherwise available to the
manufacturers respecting the devices, including adverse safety
or effectiveness information which has not been submitted under
section 519. The Secretary may require a manufacturer to submit
the adverse safety or effectiveness data for which a summary
and citation were submitted, if such data are available to the
manufacturer.
(B) Except as provided in subparagraph (C), after the
issuance of an order under subparagraph (A) but before December
1, 1992, the Secretary shall publish a regulation in the
Federal Register for each device which is classified in class
III under paragraph (1) revising the classification of the
device so that the device is classified into class I or class
II, unless the regulation requires the device to remain in
class III. In determining whether to revise the classification
of a device or to require a device to remain in class III, the
Secretary shall apply the criteria set forth in section 513(a).
Before the publication of a regulation requiring a device to
remain in class III or revising its classification, the
Secretary shall publish a proposed regulation respecting the
classification of a device under this subparagraph and provide
an opportunity for the submission of comments on any such
regulation. No regulation under this subparagraph requiring a
device to remain in class III or revising its classification
may take effect before the expiration of 90 days from the date
of the publication in the Federal Register of the proposed
regulation.
(C) The Secretary may by notice published in the Federal
Register extend the period prescribed by subparagraph (B) for a
device for an additional period not to exceed 1 year.
Humanitarian Device Exemption
(m)(1) To the extent consistent with the protection of the
public health and safety and with ethical standards, it is the
purpose of this subsection to encourage the discovery and use
of devices intended to benefit patients in the treatment and
diagnosis of diseases or conditions that affect not more than
8,000 individuals in the United States.
(2) The Secretary may grant a request for an exemption from
the effectiveness requirements of sections 514 and 515 for a
device for which the Secretary finds that--
(A) the device is designed to treat or diagnose a
disease or condition that affects not more than 8,000
individuals in the United States,
(B) the device would not be available to a person
with a disease or condition referred to in subparagraph
(A) unless the Secretary grants such an exemption and
there is no comparable device, other than under this
exemption, available to treat or diagnose such disease
or condition, and
(C) the device will not expose patients to an
unreasonable or significant risk of illness or injury
and the probable benefit to health from the use of the
device outweighs the risk of injury or illness from its
use, taking into account the probable risks and
benefits of currently available devic or alternative
forms of treatment.
The request shall be in the form of an application submitted to
the Secretary and such application shall include the
certification required under section 402(j)(5)(B) of the Public
Health Service Act (which shall not be considered an element of
such application). Not later than 75 days after the date of the
receipt of the application, the Secretary shall issue an order
approving or denying the application.
(3) Except as provided in paragraph (6), no person granted an
exemption under paragraph (2) with respect to a device may sell
the device for an amount that exceeds the costs of research and
development, fabrication, and distribution of the device.
(4) Devices granted an exemption under paragraph (2) may only
be used--
(A) in facilities in which clinical testing of
devices is supervised by an institutional review
committee established in accordance with the
regulations of the Secretary; and
(B) if, before the use of a device, an institutional
review committee or an appropriate local committee
approves the use in the treatment or diagnosis of a
disease or condition referred to in paragraph (2)(A),
unless a physician determines in an emergency situation
that approval from an institutional review committee or
an appropriate local committee can not be obtained in
time to prevent serious harm or death to a patient.
In a case described in subparagraph (B) in which a physician
uses a device without an approval from an institutional review
committee or an appropriate local committee, the physician
shall, after the use of the device, notify the chairperson of
the institutional review committee or an appropriate local
committee of such use. Such notification shall include the
identification of the patient involved, the date on which the
device was used, and the reason for the use.
(5) The Secretary may require a person granted an exemption
under paragraph (2) to demonstrate continued compliance with
the requirements of this subsection if the Secretary believes
such demonstration to be necessary to protect the public
health, if the Secretary has reason to believe that the
requirements of paragraph (6) are no longer met, or if the
Secretary has reason to believe that the criteria for the
exemption are no longer met. If the person granted an exemption
under paragraph (2) fails to demonstrate continued compliance
with the requirements of this subsection, the Secretary may
suspend or withdraw the exemption from the effectiveness
requirements of sections 514 and 515 for a humanitarian device
only after providing notice and an opportunity for an informal
hearing.
(6)(A) Except as provided in subparagraph (D), the
prohibition in paragraph (3) shall not apply with respect to a
person granted an exemption under paragraph (2) if each of the
following conditions apply:
(i) The device with respect to which the exemption is
granted--
(I) is intended for the treatment or
diagnosis of a disease or condition that occurs
in pediatric patients or in a pediatric
subpopulation, and such device is labeled for
use in pediatric patients or in a pediatric
subpopulation in which the disease or condition
occurs; or
(II) is intended for the treatment or
diagnosis of a disease or condition that does
not occur in pediatric patients or that occurs
in pediatric patients in such numbers that the
development of the device for such patients is
impossible, highly impracticable, or unsafe.
(ii) During any calendar year, the number of such
devices distributed during that year under each
exemption granted under this subsection does not exceed
the annual distribution number for such device. In this
paragraph, the term ``annual distribution number''
means the number of such devices reasonably needed to
treat, diagnose, or cure a population of 8,000
individuals in the United States. The Secretary shall
determine the annual distribution number when the
Secretary grants such exemption.
(iii) Such person immediately notifies the Secretary
if the number of such devices distributed during any
calendar year exceeds the annual distribution number
referred to in clause (ii).
(iv) The request for such exemption is submitted on
or before October 1, [2022] 2027.
(B) The Secretary may inspect the records relating to the
number of devices distributed during any calendar year of a
person granted an exemption under paragraph (2) for which the
prohibition in paragraph (3) does not apply.
(C) A person may petition the Secretary to modify the annual
distribution number determined by the Secretary under
subparagraph (A)(ii) with respect to a device if additional
information arises, and the Secretary may modify such annual
distribution number.
(D) If a person notifies the Secretary, or the Secretary
determines through an inspection under subparagraph (B), that
the number of devices distributed during any calendar year
exceeds the annual distribution number, as required under
subparagraph (A)(iii), and modified under subparagraph (C), if
applicable, then the prohibition in paragraph (3) shall apply
with respect to such person for such device for any sales of
such device after such notification.
(E)(i) In this subsection, the term ``pediatric patients''
means patients who are 21 years of age or younger at the time
of the diagnosis or treatment.
(ii) In this subsection, the term ``pediatric subpopulation''
means 1 of the following populations:
(I) Neonates.
(II) Infants.
(III) Children.
(IV) Adolescents.
(7) The Secretary shall refer any report of an adverse event
regarding a device described in paragraph (6)(A)(i)(I) for
which the prohibition under paragraph (3) does not apply
pursuant to paragraph (6)(A) that the Secretary receives to the
Office of Pediatric Therapeutics, established under section 6
of the Best Pharmaceuticals for Children Act (Public Law 107-
109). In considering the report, the Director of the Office of
Pediatric Therapeutics, in consultation with experts in the
Center for Devices and Radiological Health, shall provide for
periodic review of the report by the Pediatric Advisory
Committee, including obtaining any recommendations of such
committee regarding whether the Secretary should take action
under this Act in response to the report.
(8) The Secretary, acting through the Office of Pediatric
Therapeutics and the Center for Devices and Radiological
Health, shall provide for an annual review by the Pediatric
Advisory Committee of all devices described in paragraph
(6)(A)(i)(I) to ensure that the exemption under paragraph (2)
remains appropriate for the pediatric populations for which it
is granted.
Regulation of Contact Lens as Devices
(n)(1) All contact lenses shall be deemed to be devices under
section 201(h).
(2) Paragraph (1) shall not be construed as bearing on or
being relevant to the question of whether any product other
than a contact lens is a device as defined by section 201(h) or
a drug as defined by section 201(g).
(o) Regulation of Medical and Certain Decisions Support
Software.--
(1) The term device, as defined in section 201(h),
shall not include a software function that is
intended--
(A) for administrative support of a health
care facility, including the processing and
maintenance of financial records, claims or
billing information, appointment schedules,
business analytics, information about patient
populations, admissions, practice and inventory
management, analysis of historical claims data
to predict future utilization or cost-
effectiveness, determination of health benefit
eligibility, population health management, and
laboratory workflow;
(B) for maintaining or encouraging a healthy
lifestyle and is unrelated to the diagnosis,
cure, mitigation, prevention, or treatment of a
disease or condition;
(C) to serve as electronic patient records,
including patient-provided information, to the
extent that such records are intended to
transfer, store, convert formats, or display
the equivalent of a paper medical chart, so
long as--
(i) such records were created,
stored, transferred, or reviewed by
health care professionals, or by
individuals working under supervision
of such professionals;
(ii) such records are part of health
information technology that is
certified under section 3001(c)(5) of
the Public Health Service Act; and
(iii) such function is not intended
to interpret or analyze patient
records, including medical image data,
for the purpose of the diagnosis, cure,
mitigation, prevention, or treatment of
a disease or condition;
(D) for transferring, storing, converting
formats, or displaying clinical laboratory test
or other device data and results, findings by a
health care professional with respect to such
data and results, general information about
such findings, and general background
information about such laboratory test or other
device, unless such function is intended to
interpret or analyze clinical laboratory test
or other device data, results, and findings; or
(E) unless the function is intended to
acquire, process, or analyze a medical image or
a signal from an in vitro diagnostic device or
a pattern or signal from a signal acquisition
system, for the purpose of--
(i) displaying, analyzing, or
printing medical information about a
patient or other medical information
(such as peer-reviewed clinical studies
and clinical practice guidelines);
(ii) supporting or providing
recommendations to a health care
professional about prevention,
diagnosis, or treatment of a disease or
condition; and
(iii) enabling such health care
professional to independently review
the basis for such recommendations that
such software presents so that it is
not the intent that such health care
professional rely primarily on any of
such recommendations to make a clinical
diagnosis or treatment decision
regarding an individual patient.
(2) In the case of a product with multiple functions
that contains--
(A) at least one software function that meets
the criteria under paragraph (1) or that
otherwise does not meet the definition of
device under section 201(h); and
(B) at least one function that does not meet
the criteria under paragraph (1) and that
otherwise meets the definition of a device
under section 201(h),
the Secretary shall not regulate the software function
of such product described in subparagraph (A) as a
device. Notwithstanding the preceding sentence, when
assessing the safety and effectiveness of the device
function or functions of such product described in
subparagraph (B), the Secretary may assess the impact
that the software function or functions described in
subparagraph (A) have on such device function or
functions.
(3)(A) Notwithstanding paragraph (1), a software
function described in subparagraph (C), (D), or (E) of
paragraph (1) shall not be excluded from the definition
of device under section 201(h) if--
(i) the Secretary makes a finding that use of
such software function would be reasonably
likely to have serious adverse health
consequences; and
(ii) the software function has been
identified in a final order issued by the
Secretary under subparagraph (B).
(B) Subparagraph (A) shall apply only if the
Secretary--
(i) publishes a notification and proposed
order in the Federal Register;
(ii) includes in such notification the
Secretary's finding, including the rationale
and identification of the evidence on which
such finding was based, as described in
subparagraph (A)(i); and
(iii) provides for a period of not less than
30 calendar days for public comment before
issuing a final order or withdrawing such
proposed order.
(C) In making a finding under subparagraph (A)(i)
with respect to a software function, the Secretary
shall consider--
(i) the likelihood and severity of patient
harm if the software function were to not
perform as intended;
(ii) the extent to which the software
function is intended to support the clinical
judgment of a health care professional;
(iii) whether there is a reasonable
opportunity for a health care professional to
review the basis of the information or
treatment recommendation provided by the
software function; and
(iv) the intended user and user environment,
such as whether a health care professional will
use a software function of a type described in
subparagraph (E) of paragraph (1).
(4) Nothing in this subsection shall be construed as
limiting the authority of the Secretary to--
(A) exercise enforcement discretion as to any
device subject to regulation under this Act;
(B) regulate software used in the manufacture
and transfusion of blood and blood components
to assist in the prevention of disease in
humans; or
(C) regulate software as a device under this
Act if such software meets the criteria under
section 513(a)(1)(C).
(p) Diagnostic Imaging Devices Intended for Use With Contrast
Agents.--
(1) In general.--The Secretary may, subject to the
succeeding provisions of this subsection, approve an
application (or a supplement to such an application)
submitted under section 515 with respect to an
applicable medical imaging device, or, in the case of
an applicable medical imaging device for which a
notification is submitted under section 510(k), may
make a substantial equivalence determination with
respect to an applicable medical imaging device, or may
grant a request submitted under section 513(f)(2) for
an applicable medical imaging device, if such
application, notification, or request involves the use
of a contrast agent that is not--
(A) in a concentration, rate of
administration, or route of administration that
is different from those described in the
approved labeling of the contrast agent, except
that the Secretary may approve such
application, make such substantial equivalence
determination, or grant such request if the
Secretary determines that such differences in
concentration, rate of administration, or route
of administration exist but do not adversely
affect the safety and effectiveness of the
contrast agent when used with the device;
(B) in a region, organ, or system of the body
that is different from those described in the
approved labeling of the contrast agent, except
that the Secretary may approve such
application, make such substantial equivalence
determination, or grant such request if the
Secretary determines that such differences in
region, organ, or system of the body exist but
do not adversely affect the safety and
effectiveness of the contrast agent when used
with the device;
(C) in a patient population that is different
from those described in the approved labeling
of the contrast agent, except that the
Secretary may approve such application, make
such substantial equivalence determination, or
grant such request if the Secretary determines
such differences in patient population exist
but do not adversely affect the safety and
effectiveness of the contrast agent when used
with the device; or
(D) in an imaging modality that is different
from those described in the approved labeling
of the contrast agent.
(2) Premarket review.--The agency center charged with
premarket review of devices shall have primary
jurisdiction with respect to the review of an
application, notification, or request described in
paragraph (1). In conducting such review, such agency
center may--
(A) consult with the agency center charged
with the premarket review of drugs or
biological products; and
(B) review information and data provided to
the Secretary by the sponsor of a contrast
agent in an application submitted under section
505 of this Act or section 351 of the Public
Health Service Act, so long as the sponsor of
such contrast agent has provided to the sponsor
of the applicable medical imaging device that
is the subject of such review a right of
reference and the application is submitted in
accordance with this subsection.
(3) Applicable requirements.--An application
submitted under section 515, a notification submitted
under section 510(k), or a request submitted under
section 513(f)(2), as described in paragraph (1), with
respect to an applicable medical imaging device shall
be subject to the requirements of such respective
section. Such application, notification, or request
shall only be subject to the requirements of this Act
applicable to devices.
(4) Definitions.--For purposes of this subsection--
(A) the term ``applicable medical imaging
device'' means a device intended to be used in
conjunction with a contrast agent (or class of
contrast agents) for an imaging use that is not
described in the approved labeling of such
contrast agent (or the approved labeling of any
contrast agent in the same class as such
contrast agent); and
(B) the term ``contrast agent'' means a drug
that is approved under section 505 or licensed
under section 351 of the Public Health Service
Act, is intended for use in conjunction with an
applicable medical imaging device, and--
(i) is a diagnostic
radiopharmaceutical, as defined in
section 315.2 and 601.31 of title 21,
Code of Federal Regulations (or any
successor regulations); or
(ii) is a diagnostic agent that
improves the visualization of structure
or function within the body by
increasing the relative difference in
signal intensity within the target
tissue, structure, or fluid.
(q) Regulation of Over-the-Counter Hearing Aids.--
(1) Definition.--
(A) In general.--In this subsection, the term
``over-the-counter hearing aid'' means a device
that--
(i) uses the same fundamental
scientific technology as air conduction
hearing aids (as defined in section
874.3300 of title 21, Code of Federal
Regulations) (or any successor
regulation) or wireless air conduction
hearing aids (as defined in section
874.3305 of title 21, Code of Federal
Regulations) (or any successor
regulation);
(ii) is intended to be used by adults
age 18 and older to compensate for
perceived mild to moderate hearing
impairment;
(iii) through tools, tests, or
software, allows the user to control
the over-the-counter hearing aid and
customize it to the user's hearing
needs;
(iv) may--
(I) use wireless technology;
or
(II) include tests for self-
assessment of hearing loss; and
(v) is available over-the-counter,
without the supervision, prescription,
or other order, involvement, or
intervention of a licensed person, to
consumers through in-person
transactions, by mail, or online.
(B) Exception.--Such term does not include a
personal sound amplification product intended
to amplify sound for nonhearing impaired
consumers in situations including hunting and
bird-watching.
(2) Regulation.--An over-the-counter hearing aid
shall be subject to the regulations promulgated in
accordance with section 709(b) of the FDA
Reauthorization Act of 2017 and shall be exempt from
sections 801.420 and 801.421 of title 21, Code of
Federal Regulations (or any successor regulations).
* * * * * * *
SEC. 523. ACCREDITED PERSONS.
(a) In General.--
(1) Review and classification of devices.--Not later
than 1 year after the date of the enactment of the Food
and Drug Administration Modernization Act of 1997, the
Secretary shall, subject to paragraph (3), accredit
persons for the purpose of reviewing reports submitted
under section 510(k) and making recommendations to the
Secretary regarding the initial classification of
devices under section 513(f)(1).
(2) Requirements regarding review.--
(A) In general.--In making a recommendation
to the Secretary under paragraph (1), an
accredited person shall notify the Secretary in
writing of the reasons for the recommendation.
(B) Time period for review.--Not later than
30 days after the date on which the Secretary
is notified under subparagraph (A) by an
accredited person with respect to a
recommendation of an initial classification of
a device, the Secretary shall make a
determination with respect to the initial
classification.
(C) Special rule.--The Secretary may change
the initial classification under section
513(f)(1) that is recommended under paragraph
(1) by an accredited person, and in such case
shall provide to such person, and the person
who submitted the report under section 510(k)
for the device, a statement explaining in
detail the reasons for the change.
(3) Certain devices.--
(A) In general.--An accredited person may not
be used to perform a review of--
(i) a class III device;
(ii) a device classified under
section 513(f)(2) or designated under
section 515C(d);
(iii) a device that is intended to be
permanently implantable, life
sustaining, or life supporting, unless
otherwise determined by the Secretary
in accordance with subparagraph
(B)(i)(II) and listed as eligible for
review under subparagraph (B)(iii); or
(iv) a device that is of a type, or
subset of a type, listed as not
eligible for review under subparagraph
(B)(iii).
(B) Designation for review.--The Secretary
shall--
(i) issue draft guidance on the
factors the Secretary will use in
determining whether a class I or class
II device type, or subset of such
device types, is eligible for review by
an accredited person, including--
(I) the risk of the device
type, or subset of such device
type; and
(II) whether the device type,
or subset of such device type,
is permanently implantable,
life sustaining, or life
supporting, and whether there
is a detailed public health
justification for permitting
the review by an accredited
person of such device type or
subset;
(ii) not later than 24 months after
the date on which the Secretary issues
such draft guidance, finalize such
guidance; and
(iii) beginning on the date such
guidance is finalized, designate and
post on the internet website of the
Food and Drug Administration, an
updated list of class I and class II
device types, or subsets of such device
types, and the Secretary's
determination with respect to whether
each such device type, or subset of a
device type, is eligible or not
eligible for review by an accredited
person under this section based on the
factors described in clause (i).
(C) Interim rule.--Until the date on which
the updated list is designated and posted in
accordance with subparagraph (B)(iii), the list
in effect on the date of enactment the Medical
Device User Fee Amendments of 2017 shall be in
effect.
(b) Accreditation.--
(1) Programs.--The Secretary shall provide for such
accreditation through programs administered by the Food
and Drug Administration, other government agencies, or
by other qualified nongovernment organizations.
(2) Accreditation.--
(A) In general.--Not later than 180 days
after the date of the enactment of the Food and
Drug Administration Modernization Act of 1997,
the Secretary shall establish and publish in
the Federal Register criteria to accredit or
deny accreditation to persons who request to
perform the duties specified in subsection (a).
The Secretary shall respond to a request for
accreditation within 60 days of the receipt of
the request. The accreditation of such person
shall specify the particular activities under
subsection (a) for which such person is
accredited.
(B) Withdrawal of accreditation.--The
Secretary may suspend or withdraw accreditation
of any person accredited under this paragraph,
after providing notice and an opportunity for
an informal hearing, when such person is
substantially not in compliance with the
requirements of this section or poses a threat
to public health or fails to act in a manner
that is consistent with the purposes of this
section.
(C) Performance auditing.--To ensure that
persons accredited under this section will
continue to meet the standards of
accreditation, the Secretary shall--
(i) make onsite visits on a periodic
basis to each accredited person to
audit the performance of such person;
and
(ii) take such additional measures as
the Secretary determines to be
appropriate.
(D) Periodic reaccreditation.--
(i) Period.--Subject to suspension or
withdrawal under subparagraph (B), any
accreditation under this section shall
be valid for a period of 3 years after
its issuance.
(ii) Response to reaccreditation
request.--Upon the submission of a
request by an accredited person for
reaccreditation under this section, the
Secretary shall approve or deny such
request not later than 60 days after
receipt of the request.
(iii) Criteria.--Not later than 120
days after the date of the enactment of
this subparagraph, the Secretary shall
establish and publish in the Federal
Register criteria to reaccredit or deny
reaccreditation to persons under this
section. The reaccreditation of persons
under this section shall specify the
particular activities under subsection
(a), and the devices, for which such
persons are reaccredited.
(3) Qualifications.--An accredited person shall, at a
minimum, meet the following requirements:
(A) Such person may not be an employee of the
Federal Government.
(B) Such person shall be an independent
organization which is not owned or controlled
by a manufacturer, supplier, or vendor of
devices and which has no organizational,
material, or financial affiliation with such a
manufacturer, supplier, or vendor.
(C) Such person shall be a legally
constituted entity permitted to conduct the
activities for which it seeks accreditation.
(D) Such person shall not engage in the
design, manufacture, promotion, or sale of
devices.
(E) The operations of such person shall be in
accordance with generally accepted professional
and ethical business practices.
(F) Such person shall agree, at a minimum, to
include in its request for accreditation a
commitment to, at the time of accreditation,
and at any time it is performing any review
pursuant to this section--
(i) certify that reported information
accurately reflects data reviewed;
(ii) limit work to that for which
competence and capacity are available;
(iii) treat information received,
records, reports, and recommendations
as proprietary information;
(iv) promptly respond and attempt to
resolve complaints regarding its
activities for which it is accredited;
and
(v) protect against the use, in
carrying out subsection (a) with
respect to a device, of any officer or
employee of the person who has a
financial conflict of interest
regarding the device, and annually make
available to the public disclosures of
the extent to which the person, and the
officers and employees of the person,
have maintained compliance with
requirements under this clause relating
to financial conflicts of interest.
(4) Selection of accredited persons.--The Secretary
shall provide each person who chooses to use an
accredited person to receive a section 510(k) report a
panel of at least two or more accredited persons from
which the regulated person may select one for a
specific regulatory function.
(5) Compensation of accredited persons.--Compensation
for an accredited person shall be determined by
agreement between the accredited person and the person
who engages the services of the accredited person, and
shall be paid by the person who engages such services.
(c) Duration.--The authority provided by this section
terminates October 1, [2022] 2027.
* * * * * * *
SEC. 524A. PRIORITY REVIEW FOR QUALIFIED INFECTIOUS DISEASE PRODUCTS.
(a) In General.--If the Secretary designates a drug under
section 505E(d) as a qualified infectious disease product, then
the Secretary shall give priority review to the first
application submitted for approval for such drug under section
505(b) of this Act or section 351(a) of the Public Health
Service Act that requires clinical data (other than
bioavailability studies) to demonstrate safety or
effectiveness.
(b) Construction.--Nothing in this section shall prohibit the
Secretary from giving priority review to a human drug
application or efficacy supplement submitted for approval under
section 505(b) that otherwise meets the criteria for the
Secretary to grant priority review.
SEC. 524B. GUIDANCE ON DIVERSITY ACTION PLANS FOR CLINICAL STUDIES.
(a) In General.--The Secretary shall issue guidance relating
to--
(1) the format and content of the diversity action
plans required by sections 505(i)(5) and 520(g)(9)
pertaining to the sponsor's goals for clinical study
enrollment, disaggregated by age group, sex, race,
geographic location, socioeconomic status, and
ethnicity, including with respect to--
(A) the rationale for the sponsor's
enrollment goals, which may include--
(i) the estimated prevalence or
incidence in the United States of the
disease or condition for which the drug
or device is being developed or
investigated, if such estimated
prevalence or incidence is known or can
be determined based on available data;
(ii) what is known about the disease
or condition for which the drug or
device is being developed or
investigated;
(iii) any relevant pharmacokinetic or
pharmacogenomic data;
(iv) what is known about the patient
population for such disease or
condition, including, to the extent
data is available--
(I) demographic information,
including age group, sex, race,
geographic location,
socioeconomic status, and
ethnicity;
(II) non-demographic factors,
including co-morbidities
affecting the patient
population; and
(III) potential barriers to
enrolling diverse participants,
such as patient population
size, geographic location, and
socioeconomic status; and
(v) any other data or information
relevant to selecting appropriate
enrollment goals, disaggregated by
demographic subgroup, such as the
inclusion of pregnant and lactating
women;
(B) an explanation for how the sponsor
intends to meet such goals, including
demographic-specific outreach and enrollment
strategies, study-site selection, clinical
study inclusion and exclusion practices, and
any diversity training for study personnel; and
(C) procedures for the public posting of key
information from the diversity action plan that
would be useful to patients and providers on
the sponsor's website, as appropriate; and
(2) how sponsors should include in regular reports to
the Secretary--
(A) the sponsor's progress in meeting the
goals referred to in paragraph (1)(A); and
(B) if the sponsor does not expect to meet
such goals--
(i) any updates needed to be made to
a diversity action plan referred to in
paragraph (1) to help meet such goals;
and
(ii) the sponsor's reasons for why
the sponsor does not expect to meet
such goals.
(b) Issuance.--The Secretary shall--
(1) not later than 12 months after the date of
enactment of this section, issue new draft guidance or
update existing draft guidance described in subsection
(a); and
(2) not later than 9 months after closing the comment
period on such draft guidance, finalize such guidance.
SEC. 524C. ENSURING CYBERSECURITY OF DEVICES.
(a) In General.--For purposes of ensuring cybersecurity
throughout the lifecycle of a cyber device, any person who
submits a premarket submission for the cyber device shall
include such information as the Secretary may require to ensure
that the cyber device meets such cybersecurity requirements as
the Secretary determines to be appropriate to demonstrate a
reasonable assurance of safety and effectiveness, including at
a minimum the cybersecurity requirements under subsection (b).
(b) Cybersecurity Requirements.--At a minimum, the
manufacturer of a cyber device shall meet the following
cybersecurity requirements:
(1) The manufacturer shall have a plan to
appropriately monitor, identify, and address in a
reasonable time postmarket cybersecurity
vulnerabilities and exploits, including coordinated
vulnerability disclosure and procedures.
(2) The manufacturer shall design, develop, and
maintain processes and procedures to ensure the device
and related systems are cybersecure, and shall make
available updates and patches to the cyber device and
related systems throughout the lifecycle of the cyber
device to address--
(A) on a reasonably justified regular cycle,
known unacceptable vulnerabilities; and
(B) as soon as possible out of cycle,
critical vulnerabilities that could cause
uncontrolled risks.
(3) The manufacturer shall provide in the labeling of
the cyber device a software bill of materials,
including commercial, open-source, and off-the-shelf
software components.
(4) The manufacturer shall comply with such other
requirements as the Secretary may require to
demonstrate reasonable assurance of the safety and
effectiveness of the device for purposes of
cybersecurity, which the Secretary may require by an
order published in the Federal Register.
(c) Substantial Equivalence.--In making a determination of
substantial equivalence under section 513(i) for a cyber
device, the Secretary may--
(1) find that cybersecurity information for the cyber
device described in the relevant premarket submission
in the cyber device's use environment is inadequate;
and
(2) issue a nonsubstantial equivalence determination
based on this finding.
(d) Definition.--In this section:
(1) Cyber device.--The term ``cyber device'' means a
device that--
(A) includes software, including software as
or in a device;
(B) has the ability to connect to the
internet; or
(C) contains any such technological
characteristics that could be vulnerable to
cybersecurity threats.
(2) Lifecycle of the cyber device.--The term
``lifecycle of the cyber device'' includes the
postmarket lifecycle of the cyber device.
(3) Premarket submission.--The term ``premarket
submission'' means any submission under section 510(k),
513, 515(c), 515(f), or 520(m).
(e) Exemption.--The Secretary may identify devices or types
of devices that are exempt from meeting the cybersecurity
requirements established by this section and regulations
promulgated pursuant to this section. The Secretary shall
publish in the Federal Register, and update, as appropriate, a
list of the devices and types of devices so identified by the
Secretary.
Subchapter B--Drugs for Rare Diseases or Conditions
* * * * * * *
protection for drugs for rare diseases or conditions
Sec. 527. (a) Except as provided in subsection (b), if the
Secretary--
(1) approves an application filed pursuant to section
505, or
(2) issues a license under section 351 of the Public
Health Service Act
for a drug designated under section 526 for a rare disease or
condition, the Secretary may not approve another application
under section 505 or issue another license under section 351 of
the Public Health Service Act for the same drug for the [same
disease or condition] same approved indication or use within
such rare disease or condition for a person who is not the
holder of such approved application or of such license until
the expiration of seven years from the date of the approval of
the approved application or the issuance of the license.
Section 505(c)(2) does not apply to the refusal to approve an
application under the preceding sentence.
(b) During the 7-year period described in subsection (a) for
an approved application under section 505 or license under
section 351 of the Public Health Service Act, the Secretary may
approve an application or issue a license for a drug that is
otherwise the same, as determined by the Secretary, as the
already approved drug for the [same rare disease or condition]
same indication or use for which the Secretary has approved or
licensed such drug if--
(1) the Secretary finds, after providing the holder
of exclusive approval or licensure notice and
opportunity for the submission of views, that during
such period the holder of the exclusive approval or
licensure cannot ensure the availability of sufficient
quantities of the drug to meet the needs of persons
[with the disease or condition for which the drug was
designated] for whom the drug is indicated; or
(2) the holder provides the Secretary in writing the
consent of such holder for the approval of other
applications or the issuance of other licenses before
the expiration of such seven-year period.
(c) Condition of Clinical Superiority.--
(1) In general.--If a sponsor of a drug that is
designated under section 526 and is otherwise the same,
as determined by the Secretary, as an already approved
or licensed drug is seeking exclusive approval or
exclusive licensure described in subsection (a) for the
[same rare disease or condition] same indication or use
as the already approved drug, the Secretary shall
require such sponsor, as a condition of such exclusive
approval or licensure, to demonstrate that such drug is
clinically superior to any already approved or licensed
drug that is the same drug.
(2) Definition.--For purposes of paragraph (1), the
term ``clinically superior'' with respect to a drug
means that the drug provides a significant therapeutic
advantage over and above an already approved or
licensed drug in terms of greater efficacy, greater
safety, or by providing a major contribution to patient
care.
(3) Applicability.--This subsection applies to any
drug designated under section 526 for which an
application was approved under section 505 of this Act
or licensed under section 351 of the Public Health
Service Act after the date of enactment of the FDA
Reauthorization Act of 2017, regardless of the date on
which such drug was designated under section 526.
(d) Regulations.--The Secretary may promulgate regulations
for the implementation of subsection (c). Beginning on the date
of enactment of the FDA Reauthorization Act of 2017, until such
time as the Secretary promulgates regulations in accordance
with this subsection, the Secretary may apply any definitions
set forth in regulations that were promulgated prior to such
date of enactment, to the extent such definitions are not
inconsistent with the terms of this section, as amended by such
Act.
(e) Demonstration of Clinical Superiority Standard.--To
assist sponsors in demonstrating clinical superiority as
described in subsection (c), the Secretary--
(1) upon the designation of any drug under section
526, shall notify the sponsor of such drug in writing
of the basis for the designation, including, as
applicable, any plausible hypothesis offered by the
sponsor and relied upon by the Secretary that the drug
is clinically superior to a previously approved drug;
and
(2) upon granting exclusive approval or licensure
under subsection (a) on the basis of a demonstration of
clinical superiority as described in subsection (c),
shall publish a summary of the clinical superiority
findings.
* * * * * * *
Subchapter E--General Provisions Relating to Drugs and Devices
* * * * * * *
SEC. 566. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.
(a) Establishment.--The Secretary, acting through the
Commissioner of Food and Drugs, may enter into collaborative
agreements, to be known as Critical Path Public-Private
Partnerships, with one or more eligible entities to implement
the Critical Path Initiative of the Food and Drug
Administration by developing innovative, collaborative projects
in research, education, and outreach for the purpose of
fostering medical product innovation, enabling the acceleration
of medical product development, manufacturing, and
translational therapeutics, and enhancing medical product
safety.
(b) Eligible Entity.--In this section, the term ``eligible
entity'' means an entity that meets each of the following:
(1) The entity is--
(A) an institution of higher education (as
such term is defined in section 101 of the
Higher Education Act of 1965) or a consortium
of such institutions; or
(B) an organization described in section
501(c)(3) of the Internal Revenue Code of 1986
and exempt from tax under section 501(a) of
such Code.
(2) The entity has experienced personnel and clinical
and other technical expertise in the biomedical
sciences, which may include graduate training programs
in areas relevant to priorities of the Critical Path
Initiative.
(3) The entity demonstrates to the Secretary's
satisfaction that the entity is capable of--
(A) developing and critically evaluating
tools, methods, and processes--
(i) to increase efficiency,
predictability, and productivity of
medical product development; and
(ii) to more accurately identify the
benefits and risks of new and existing
medical products;
(B) establishing partnerships, consortia, and
collaborations with health care practitioners
and other providers of health care goods or
services; pharmacists; pharmacy benefit
managers and purchasers; health maintenance
organizations and other managed health care
organizations; health care insurers; government
agencies; patients and consumers; manufacturers
of prescription drugs, biological products,
diagnostic technologies, and devices; and
academic scientists; and
(C) securing funding for the projects of a
Critical Path Public-Private Partnership from
Federal and nonfederal governmental sources,
foundations, and private individuals.
(c) Funding.--The Secretary may not enter into a
collaborative agreement under subsection (a) unless the
eligible entity involved provides an assurance that the entity
will not accept funding for a Critical Path Public-Private
Partnership project from any organization that manufactures or
distributes products regulated by the Food and Drug
Administration unless the entity provides assurances in its
agreement with the Food and Drug Administration that the
results of the Critical Path Public-Private Partnership project
will not be influenced by any source of funding.
(d) Annual Report.--Not later than 18 months after the date
of the enactment of this section, and annually thereafter, the
Secretary, in collaboration with the parties to each Critical
Path Public-Private Partnership, shall submit a report to the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of
Representatives--
(1) reviewing the operations and activities of the
Partnerships in the previous year; and
(2) addressing such other issues relating to this
section as the Secretary determines to be appropriate.
(e) Definition.--In this section, the term ``medical
product'' includes a drug, a biological product as defined in
section 351 of the Public Health Service Act, a device, and any
combination of such products.
(f) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated [$6,000,000 for
each of fiscal years 2018 through 2022] $10,000,000 for each of
fiscal years 2023 through 2027.
SEC. 566A. EMERGING TECHNOLOGY PROGRAM.
(a) Program Establishment.--
(1) In general.--The Secretary shall establish a
program to support the adoption of, and improve the
development of, innovative approaches to drug product
design and manufacturing.
(2) Actions.--In carrying out the program under
paragraph (1), the Secretary may--
(A) facilitate and increase communication
between public and private entities, consortia,
and individuals with respect to innovative drug
product design and manufacturing;
(B) solicit information regarding, and
conduct or support research on, innovative
approaches to drug product design and
manufacturing;
(C) convene meetings with representatives of
industry, academia, other Federal agencies,
international agencies, and other interested
persons, as appropriate;
(D) convene working groups to support drug
product design and manufacturing research and
development;
(E) support education and training for
regulatory staff and scientists related to
innovative approaches to drug product design
and manufacturing;
(F) advance regulatory science related to the
development and review of innovative approaches
to drug product design and manufacturing;
(G) convene or participate in working groups
to support the harmonization of international
regulatory requirements related to innovative
approaches to drug product design and
manufacturing; and
(H) award grants or contracts to carry out or
support the program under paragraph (1).
(3) Grants and contracts.--To seek a grant or
contract under this section, an entity shall submit an
application--
(A) in such form and manner as the Secretary
may require; and
(B) containing such information as the
Secretary may require, including a description
of--
(i) how the entity will conduct the
activities to be supported through the
grant or contract; and
(ii) how such activities will further
research and development related to, or
adoption of, innovative approaches to
drug product design and manufacturing.
(b) Guidance.--The Secretary shall--
(1) issue or update guidance to help facilitate the
adoption of, and advance the development of, innovative
approaches to drug product design and manufacturing;
and
(2) include in such guidance descriptions of--
(A) any regulatory requirements related to
the development or review of technologies
related to innovative approaches to drug
product design and manufacturing, including
updates and improvements to such technologies
after product approval; and
(B) data that can be used to demonstrate the
identity, safety, purity, and potency of drugs
manufactured using such technologies.
(c) Report to Congress.--Not later than 4 years after the
date of enactment of this section, the Secretary shall submit
to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate a report containing--
(1) an annual accounting of the allocation of funds
made available to carry out this section;
(2) a description of how Food and Drug Administration
staff were utilized to carry out this section and, as
applicable, any challenges or limitations related to
staffing;
(3) the number of public meetings held or
participated in by the Food and Drug Administration
pursuant to this section, including meetings convened
as part of a working group described in subparagraph
(D) or (G) of subsection (a)(2), and the topics of each
such meeting; and
(4) the number of drug products approved or licensed,
after the date of enactment of this section, using an
innovative approach to drug product design and
manufacturing.
(d) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated $20,000,000 for
each fiscal year 2023 through 2027.
* * * * * * *
SEC. 569. CONSULTATION WITH EXTERNAL EXPERTS ON RARE DISEASES, TARGETED
THERAPIES, AND GENETIC TARGETING OF TREATMENTS.
(a) In General.--For the purpose of promoting the efficiency
of and informing the review by the Food and Drug Administration
of new drugs and biological products for rare diseases and
drugs and biological products that are genetically targeted,
the following shall apply:
(1) Consultation with stakeholders.--Consistent with
sections X.C and IX.E.4 of the PDUFA Reauthorization
Performance Goals and Procedures Fiscal Years 2013
through 2017, as referenced in the letters described in
section 101(b) of the Prescription Drug User Fee
Amendments of 2012, the Secretary shall ensure that
opportunities exist, at a time the Secretary determines
appropriate, for consultations with stakeholders on the
topics described in subsection (b).
(2) Consultation with external experts.--
(A) In general.--The Secretary shall develop
and maintain a list of external experts who,
because of their special expertise, are
qualified to provide advice on rare disease
issues, including topics described in
subsection (b). The Secretary may, when
appropriate to address a specific regulatory
question, consult such external experts on
issues related to the review of new drugs and
biological products for rare diseases and drugs
and biological products that are genetically
targeted, including the topics described in
subsection (b), when such consultation is
necessary because the Secretary lacks the
specific scientific, medical, or technical
expertise necessary for the performance of the
Secretary's regulatory responsibilities and the
necessary expertise can be provided by the
external experts.
(B) External experts.--For purposes of
subparagraph (A), external experts are
individuals who possess scientific or medical
training that the Secretary lacks with respect
to one or more rare diseases.
(C) Small population studies.--The external
experts on the list maintained pursuant to
subparagraph (A) may include experts on the
science of small population studies.
(b) Topics for Consultation.--Topics for consultation
pursuant to this section may include--
(1) rare diseases;
(2) the severity of rare diseases;
(3) the unmet medical need associated with rare
diseases;
(4) the willingness and ability of individuals with a
rare disease to participate in clinical trials;
(5) an assessment of the benefits and risks of
therapies to treat rare diseases;
(6) the general design of clinical trials for rare
disease populations and subpopulations; and
(7) the demographics and the clinical description of
patient populations.
(c) Classification as Special Government Employees.--The
external experts who are consulted under this section may be
considered special government employees, as defined under
section 202 of title 18, United States Code.
(d) Protection of Confidential Information and Trade
Secrets.--
(1) Rule of construction.--Nothing in this section
shall be construed to alter the protections offered by
laws, regulations, and policies governing disclosure of
confidential commercial or trade secret information,
and any other information exempt from disclosure
pursuant to section 552(b) of title 5, United States
Code, as such provisions would be applied to
consultation with individuals and organizations prior
to the date of enactment of this section.
(2) Consent required for disclosure.--The Secretary
shall not disclose confidential commercial or trade
secret information to an expert consulted under this
section without the written consent of the sponsor
unless the expert is a special government employee (as
defined under section 202 of title 18, United States
Code) or the disclosure is otherwise authorized by law.
(e) Other Consultation.--Nothing in this section shall be
construed to limit the ability of the Secretary to consult with
individuals and organizations as authorized prior to the date
of enactment of this section.
(f) No Right or Obligation.--
(1) No right to consultation.--Nothing in this
section shall be construed to create a legal right for
a consultation on any matter or require the Secretary
to meet with any particular expert or stakeholder.
(2) No altering of goals.--Nothing in this section
shall be construed to alter agreed upon goals and
procedures identified in the letters described in
section 101(b) of the Prescription Drug User Fee
Amendments of 2012.
(3) No change to number of review cycles.--Nothing in
this section is intended to increase the number of
review cycles as in effect before the date of enactment
of this section.
(g) No Delay in Product Review.--
(1) In general.--Prior to a consultation with an
external expert, as described in this section, relating
to an investigational new drug application under
section 505(i), a new drug application under section
505(b), or a biologics license application under
section 351 of the Public Health Service Act, the
Director of the Center for Drug Evaluation and Research
or the Director of the Center for Biologics Evaluation
and Research (or appropriate Division Director), as
appropriate, shall determine that--
(A) such consultation will--
(i) facilitate the Secretary's
ability to complete the Secretary's
review; and
(ii) address outstanding deficiencies
in the application; or
(B) the sponsor authorized such consultation.
(2) Limitation.--The requirements of this subsection
shall apply only in instances where the consultation is
undertaken solely under the authority of this section.
The requirements of this subsection shall not apply to
any consultation initiated under any other authority.
* * * * * * *
CHAPTER VII--GENERAL AUTHORITY
Subchapter A--General Administrative Provisions
* * * * * * *
SEC. 703. RECORDS.
(a) In General.--For the purpose of enforcing the provisions
of this Act, carriers engaged in interstate commerce, and
persons receiving food, drugs, devices, tobacco products, or
cosmetics in interstate commerce or holding such articles so
received, shall, upon the request of an officer or employee
duly designated by the Secretary, permit such officer or
employee, at reasonable times, to have access to and to copy
all records showing the movement in interstate commerce of any
food, drug, device, tobacco product, or cosmetic, or the
holding thereof during or after such movement, and the
quantity, shipper, and consignee thereof; and it shall be
unlawful for any such carrier or person to fail to permit such
access to and copying of any such record so requested when such
request is accompanied by a statement in writing specifying the
nature or kind of food, drug, device, tobacco product, or
cosmetic to which such request relates, except that evidence
obtained under this section, or any evidence which is directly
or indirectly derived from such evidence, shall not be used in
a criminal prosecution of the person from whom obtained, and
except that carriers shall not be subject to the other
provisions of this Act by reason of their receipt, carriage,
holding, or delivery of food, drugs, devices, tobacco products,
or cosmetics in the usual course of business as carriers,
except as provided in subsection (b).
(b) Food Transportation Records.--A shipper, carrier by motor
vehicle or rail vehicle, receiver, or other person subject to
section 416 shall, on request of an officer or employee
designated by the Secretary, permit the officer or employee, at
reasonable times, to have access to and to copy all records
that the Secretary requires to be kept under section
416(c)(1)(E).
(c) Applicability.--The limitations on the Secretary's use of
evidence obtained under this section, or any evidence which is
directly or indirectly derived from such evidence, in a
criminal prosecution of the person from whom such evidence was
obtained shall not apply to evidence, including records or
other information, obtained under authorities other than this
section, unless such limitations are specifically incorporated
by reference in such other authorities.
factory inspection
Sec. 704. (a)(1) For purposes of enforcement of this Act,
officers or employees duly designated by the Secretary, upon
presenting appropriate credentials and a written notice to the
owner, operator, or agent in charge, are authorized (A) to
enter, at reasonable times, any factory, warehouse, or
establishment in which food, drugs, devices, tobacco products,
or cosmetics are manufactured, processed, packed, or held, for
introduction into interstate commerce or after such
introduction, or to enter any vehicle, being used to transport
or hold such food, drugs, devices, tobacco products, or
cosmetics in interstate commerce; and (B) to inspect, at
reasonable times and within reasonable limits and in a
reasonable manner, such factory, warehouse, establishment, or
vehicle and all pertinent equipment, finished and unfinished
materials, containers, and labeling therein. In the case of any
person (excluding farms and restaurants) who manufactures,
processes, packs, transports, distributes, holds, or imports
foods, the inspection shall extend to all records and other
information described in section 414, when the standard for
records inspection under paragraph (1) or (2) of section 414(a)
applies, subject to the limitations established in section
414(d). In the case of any factory, warehouse, establishment,
or consulting laboratory in which prescription drugs,
nonprescription drugs intended for human use, [restricted
devices] devices, or tobacco products are manufactured,
processed, packed, or held, inspection shall extend to all
things therein (including records, files, papers, processes,
controls, and facilities) bearing on whether prescription
drugs, nonprescription drugs intended for human use,
[restricted devices] devices, or tobacco products which are
adulterated or misbranded within the meaning of this Act, or
which may not be manufactured, introduced into interstate
commerce, or sold, or offered for sale by reason of any
provision of this Act, have been or are being manufactured,
processed, packed, transported, or held in any such place, or
otherwise bearing on violation of this Act. No inspection
authorized by the preceding sentence or by paragraph (3) shall
extend to financial data, sales data other than shipment data,
pricing data, personnel data (other than data as to
qualifications of technical and professional personnel
performing functions subject to this Act), and research data
(other than data relating to new drugs, antibiotic drugs,
devices, and tobacco products and subject to reporting and
inspection under regulations lawfully issued pursuant to
section 505 (i) or (k), section 519, section 520(g), or chapter
IX and data relating to other drugs, devices, or tobacco
products which in the case of a new drug would be subject to
reporting or inspection under lawful regulations issued
pursuant to section 505(j)). A separate notice shall be given
for each such inspection, but a notice shall not be required
for each entry made during the period covered by the
inspection. Each such inspection shall be commenced and
completed with reasonable promptness.
(2) The provisions of the third sentence of paragraph (1)
shall not apply to--
(A) pharmacies which maintain establishments in
conformance with any applicable local laws regulating
the practice of pharmacy and medicine and which are
regularly engaged in dispensing prescription drugs or
devices, upon prescriptions of practitioners licensed
to administer such drugs or devices to patients under
the care of such practitioners in the course of their
professional practice, and which do not, either through
a subsidiary or otherwise, manufacture, prepare,
propagate, compound, or process drugs or devices for
sale other than in the regular course of their business
of dispensing or selling drugs or devices at retail;
(B) practitioners licensed by law to prescribe or
administer drugs, or prescribe or use devices, as the
case may be, and who manufacture, prepare, propagate,
compound, or process drugs, or manufacture or process
devices solely for use in the course of their
professional practice;
(C) persons who manufacture, prepare, propagate,
compound, or process drugs, or manufacture or process
devices solely for use in research, teaching, or
chemical analysis and not for sale;
(D) such other classes of persons as the Secretary
may by regulation exempt from the application of this
section upon a finding that inspection as applied to
such classes of persons in accordance with this section
is not necessary for the protection of the public
health.
(3) An officer or employee making an inspection under
paragraph (1) for purposes of enforcing the requirements of
section 412 applicable to infant formulas shall be permitted,
at all reasonable times, to have access to and to copy and
verify any records--
(A) bearing on whether the infant formula
manufactured or held in the facility inspected meets
the requirements of section 412, or
(B) required to be maintained under section 412.
(4)(A) Any records or other information that the Secretary
may inspect under this section from a person that owns or
operates [an establishment that is engaged in the manufacture,
preparation, propagation, compounding, or processing of a drug]
an establishment that is engaged in the manufacture,
preparation, propagation, compounding, or processing of a drug
or device, or that is subject to inspection under paragraph
(5)(C), shall, upon the request of the Secretary, be provided
to the Secretary by such person, in advance of or in lieu of an
inspection, within a reasonable timeframe, within reasonable
limits, and in a reasonable manner, and in either electronic or
physical form, at the expense of such person. The Secretary's
request shall include a sufficient description of the records
requested and a rationale for requesting such records or other
information in advance of, or in lieu of, an inspection.
(B) Upon receipt of the records requested under subparagraph
(A), the Secretary shall provide to the person confirmation of
receipt.
(C) The Secretary may rely on any records or other
information that the Secretary may inspect under this section
to satisfy requirements that may pertain to a preapproval or
risk-based surveillance inspection, or to resolve deficiencies
identified during such inspections, if applicable and
appropriate.
[(C)] (D) Nothing in this paragraph supplants the authority
of the Secretary to conduct inspections otherwise permitted
under this Act in order to ensure compliance with this Act.
(5) Bioresearch monitoring inspections.--
(A) In general.--The Secretary may, to ensure
the accuracy and reliability of studies and
records or other information described in
subparagraph (B) and to assess compliance with
applicable requirements under this Act or the
Public Health Service Act, enter sites and
facilities specified in subparagraph (C) in
order to inspect such records or other
information.
(B) Information subject to inspection.--An
inspection under this paragraph shall extend to
all records and other information related to
the studies and submissions described in
subparagraph (E), including records and
information related to the conduct, results,
and analyses of, and the protection of human
and animal trial participants participating in,
such studies.
(C) Sites and facilities subject to
inspection.--
(i) Sites and facilities described.--
The sites and facilities subject to
inspection by the Secretary under this
paragraph are those owned or operated
by a person described in clause (ii)
and which are (or were) utilized by
such person in connection with--
(I) developing an application
or other submission to the
Secretary under this Act or the
Public Health Service Act
related to marketing
authorization for a product
described in paragraph (1);
(II) preparing, conducting,
or analyzing the results of a
study described in subparagraph
(E); or
(III) holding any records or
other information described in
subparagraph (B).
(ii) Persons described.--A person
described in this clause is--
(I) the sponsor of an
application or submission
specified in subparagraph (E);
(II) a person engaged in any
activity described in clause
(i) on behalf of such a
sponsor, through a contract,
grant, or other business
arrangement with such sponsor;
(III) an institutional review
board, or other individual or
entity, engaged by contract,
grant, or other business
arrangement with a nonsponsor
in preparing, collecting, or
analyzing records or other
information described in
subparagraph (B); or
(IV) any person not otherwise
described in this clause that
conducts, or has conducted, a
study described in subparagraph
(E) yielding records or other
information described in
subparagraph (B).
(D) Conditions of inspection.--
(i) Access to information subject to
inspection.--Subject to clause (ii), an
entity that owns or operates any site
or facility subject to inspection under
this paragraph shall provide the
Secretary with access to records and
other information described in
subparagraph (B) that is held by or
under the control of such entity,
including--
(I) permitting the Secretary
to record or copy such
information for purposes of
this paragraph;
(II) providing the Secretary
with access to any electronic
information system utilized by
such entity to hold, process,
analyze, or transfer any
records or other information
described in subparagraph (B);
and
(III) permitting the
Secretary to inspect the
facilities, equipment, written
procedures, processes, and
conditions through which
records or other information
described in subparagraph (B)
is or was generated, held,
processed, analyzed, or
transferred.
(ii) No effect on applicability of
provisions for protection of
proprietary information or trade
secrets.--Nothing in clause (i) shall
negate, supersede, or otherwise affect
the applicability of provisions, under
this or any other Act, preventing or
limiting the disclosure of confidential
commercial information or other
information considered proprietary or
trade secret.
(iii) Reasonableness of
inspections.--An inspection under this
paragraph shall be conducted at
reasonable times and within reasonable
limits and in a reasonable manner.
(E) Studies and submissions described.--The
studies and submissions described in this
subparagraph are each of the following:
(i) Clinical and nonclinical studies
submitted to the Secretary in support
of, or otherwise related to,
applications and other submissions to
the Secretary under this Act or the
Public Health Service Act for marketing
authorization of a product described in
paragraph (1).
(ii) Postmarket safety activities
conducted under this Act or the Public
Health Service Act.
(iii) Any other clinical
investigation of--
(I) a drug subject to section
505 or 512 of this Act or
section 351 of the Public
Health Service Act; or
(II) a device subject to
section 520(g).
(iv) Any other submissions made under
this Act or the Public Health Service
Act with respect to which the Secretary
determines an inspection under this
paragraph is warranted in the interest
of public health.
(F) Clarification.--This paragraph clarifies
the authority of the Secretary to conduct
inspections of the type described in this
paragraph and shall not be construed as a basis
for inferring that, prior to the date of
enactment of this paragraph, the Secretary
lacked the authority to conduct such
inspections, including under this Act or the
Public Health Service Act.
(b)(1) Upon completion of any such inspection of a factory,
warehouse, consulting laboratory, or other establishment, and
prior to leaving the premises, the officer or employee making
the inspection shall give to the owner, operator, or agent in
charge a report in writing setting forth any conditions or
practices observed by him which, in his judgment, indicate that
any food, drug, device, tobacco product, or cosmetic in such
establishment (A) consists in whole or in part of any filthy,
putrid, or decomposed substance, or (B) has been prepared,
packed, or held under insanitary conditions whereby it may have
become contaminated with filth, or whereby it may have been
rendered injurious to health. A copy of such report shall be
sent promptly to the Secretary.
(2) In carrying out this subsection with respect to any
establishment manufacturing a drug approved under subsection
(c) or (j) of section 505 for which a notification has been
submitted in accordance with section 506C is, or has been in
the last 5 years, listed on the drug shortage list under
section 506E, or that is described in section 505(j)(11)(A), a
copy of the report shall be sent promptly to the appropriate
offices of the Food and Drug Administration with expertise
regarding drug shortages.
(c) If the officer or employee making any such inspection of
a factory, warehouse, or other establishment has obtained any
sample in the course of the inspection, upon completion of the
inspection and prior to leaving the premises he shall give to
the owner, operator, or agent in charge a receipt describing
the samples obtained.
(d) Whenever in the course of any such inspection of a
factory or other establishment where food is manufactured,
processed, or packed, the officer or employee making the
inspection obtains a sample of any such food, and an analysis
is made of such sample for the purpose of ascertaining whether
such food consists in whole or in part of any filthy, putrid,
or decomposed substance, or is otherwise unfit for food, a copy
of the results of such analysis shall be furnished promptly to
the owner, operator, or agent in charge.
(e) Every person required under section 519 or 520(g) to
maintain records and every person who is in charge or custody
of such records shall, upon request of an officer or employee
designated by the Secretary, permit such officer or employee at
all reasonable times to have access to, and to copy and verify,
such records.
(f)(1) An accredited person described in paragraph (3) shall
maintain records documenting the training qualifications of the
person and the employees of the person, the procedures used by
the person for handling confidential information, the
compensation arrangements made by the person, and the
procedures used by the person to identify and avoid conflicts
of interest. Upon the request of an officer or employee
designated by the Secretary, the person shall permit the
officer or employee, at all reasonable times, to have access
to, to copy, and to verify, the records.
(2) Within 15 days after the receipt of a written request
from the Secretary to an accredited person described in
paragraph (3) for copies of records described in paragraph (1),
the person shall produce the copies of the records at the place
designated by the Secretary.
(3) For purposes of paragraphs (1) and (2), an accredited
person described in this paragraph is a person who--
(A) is accredited under subsection (g); or
(B) is accredited under section 523.
(g)(1) The Secretary shall, subject to the provisions of this
subsection, accredit persons for the purpose of conducting
inspections of establishments that manufacture, prepare,
propagate, compound, or process class II or class III devices,
which inspections are required under section 510(h) or are
inspections of such establishments required to register under
section 510(i). The owner or operator of such an establishment
that is eligible under paragraph (6) may, from the list
published under paragraph (4), select an accredited person to
conduct such inspections.
(2) The Secretary shall publish in the Federal Register
criteria to accredit or deny accreditation to persons who
request to perform the duties specified in paragraph (1).
Thereafter, the Secretary shall inform those requesting
accreditation, within 60 days after the receipt of such
request, whether the request for accreditation is adequate for
review, and the Secretary shall promptly act on the request for
accreditation. Any resulting accreditation shall state that
such person is accredited to conduct inspections at device
establishments identified in paragraph (1). The accreditation
of such person shall specify the particular activities under
this subsection for which such person is accredited.
(3) An accredited person shall, at a minimum, meet the
following requirements:
(A) Such person may not be an employee of the Federal
Government.
(B) Such person shall be an independent organization
which is not owned or controlled by a manufacturer,
supplier, or vendor of articles regulated under this
Act and which has no organizational, material, or
financial affiliation (including a consultative
affiliation) with such a manufacturer, supplier, or
vendor.
(C) Such person shall be a legally constituted entity
permitted to conduct the activities for which it seeks
accreditation.
(D) Such person shall not engage in the design,
manufacture, promotion, or sale of articles regulated
under this Act.
(E) The operations of such person shall be in
accordance with generally accepted professional and
ethical business practices, and such person shall agree
in writing that at a minimum the person will--
(i) certify that reported information
accurately reflects data reviewed, inspection
observations made, other matters that relate to
or may influence compliance with this Act, and
recommendations made during an inspection or at
an inspection's closing meeting;
(ii) limit work to that for which competence
and capacity are available;
(iii) treat information received, records,
reports, and recommendations as confidential
commercial or financial information or trade
secret information, except such information may
be made available to the Secretary;
(iv) promptly respond and attempt to resolve
complaints regarding its activities for which
it is accredited; and
(v) protect against the use, in carrying out
paragraph (1), of any officer or employee of
the accredited person who has a financial
conflict of interest regarding any product
regulated under this Act, and annually make
available to the public disclosures of the
extent to which the accredited person, and the
officers and employees of the person, have
maintained compliance with requirements under
this clause relating to financial conflicts of
interest.
(F) Such person shall notify the Secretary of any
withdrawal, suspension, restriction, or expiration of
certificate of conformance with the quality systems
standard referred to in paragraph (7) for any device
establishment that such person inspects under this
subsection not later than 30 days after such
withdrawal, suspension, restriction, or expiration.
(G) Such person may conduct audits to establish
conformance with the quality systems standard referred
to in paragraph (7).
(4) The Secretary shall publish on the Internet site of the
Food and Drug Administration a list of persons who are
accredited under paragraph (2). Such list shall be updated to
ensure that the identity of each accredited person, and the
particular activities for which the person is accredited, is
known to the public. The updating of such list shall be no
later than one month after the accreditation of a person under
this subsection or the suspension or withdrawal of
accreditation, or the modification of the particular activities
for which the person is accredited.
(5)(A) To ensure that persons accredited under this
subsection continue to meet the standards of accreditation, the
Secretary shall (i) audit the performance of such persons on a
periodic basis through the review of inspection reports and
inspections by persons designated by the Secretary to evaluate
the compliance status of a device establishment and the
performance of accredited persons, and (ii) take such
additional measures as the Secretary determines to be
appropriate.
(B) The Secretary may withdraw accreditation of any person
accredited under paragraph (2), after providing notice and an
opportunity for an informal hearing, when such person is
substantially not in compliance with the standards of
accreditation, poses a threat to public health, fails to act in
a manner that is consistent with the purposes of this
subsection, or where the Secretary determines that there is a
financial conflict of interest in the relationship between the
accredited person and the owner or operator of a device
establishment that the accredited person has inspected under
this subsection. The Secretary may suspend the accreditation of
such person during the pendency of the process under the
preceding sentence.
(6)(A) Subject to subparagraphs (B) and (C), a device
establishment is eligible for inspection by persons accredited
under paragraph (2) if the following conditions are met:
(i) The Secretary classified the results of the most
recent inspection of the establishment as ``no action
indicated'' or ``voluntary action indicated''.
(ii) With respect to inspections of the establishment
to be conducted by an accredited person, the owner or
operator of the establishment submits to the Secretary
a notice that--
(I) provides the date of the last inspection
of the establishment by the Secretary and the
classification of that inspection;
(II) states the intention of the owner or
operator to use an accredited person to conduct
inspections of the establishment;
(III) identifies the particular accredited
person the owner or operator intends to select
to conduct such inspections; and
(IV) includes a certification that, with
respect to the devices that are manufactured,
prepared, propagated, compounded, or processed
in the establishment--
(aa) at least 1 of such devices is
marketed in the United States; and
(bb) at least 1 of such devices is
marketed, or is intended to be
marketed, in 1 or more foreign
countries, 1 of which countries
certifies, accredits, or otherwise
recognizes the person accredited under
paragraph (2) and identified under
subclause (III) as a person authorized
to conduct inspections of device
establishments.
(B)(i) Except with respect to the requirement of subparagraph
(A)(i), a device establishment is deemed to have clearance to
participate in the program and to use the accredited person
identified in the notice under subparagraph (A)(ii) for
inspections of the establishment unless the Secretary, not
later than 30 days after receiving such notice, issues a
response that--
(I) denies clearance to participate as provided under
subparagraph (C); or
(II) makes a request under clause (ii).
(ii) The Secretary may request from the owner or operator of
a device establishment in response to the notice under
subparagraph (A)(ii) with respect to the establishment, or from
the particular accredited person identified in such notice--
(I) compliance data for the establishment in
accordance with clause (iii)(I); or
(II) information concerning the relationship between
the owner or operator of the establishment and the
accredited person identified in such notice in
accordance with clause (iii)(II).
The owner or operator of the establishment, or such accredited
person, as the case may be, shall respond to such a request not
later than 60 days after receiving such request.
(iii)(I) The compliance data to be submitted by the owner or
operator of a device establishment in response to a request
under clause (ii)(I) are data describing whether the quality
controls of the establishment have been sufficient for ensuring
consistent compliance with current good manufacturing practice
within the meaning of section 501(h) and with other applicable
provisions of this Act. Such data shall include complete
reports of inspectional findings regarding good manufacturing
practice or other quality control audits that, during the
preceding 2-year period, were conducted at the establishment by
persons other than the owner or operator of the establishment,
together with all other compliance data the Secretary deems
necessary. Data under the preceding sentence shall demonstrate
to the Secretary whether the establishment has facilitated
consistent compliance by promptly correcting any compliance
problems identified in such inspections.
(II) A request to an accredited person under clause (ii)(II)
may not seek any information that is not required to be
maintained by such person in records under subsection (f)(1).
(iv) A device establishment is deemed to have clearance to
participate in the program and to use the accredited person
identified in the notice under subparagraph (A)(ii) for
inspections of the establishment unless the Secretary, not
later than 60 days after receiving the information requested
under clause (ii), issues a response that denies clearance to
participate as provided under subparagraph (C).
(C)(i) The Secretary may deny clearance to a device
establishment if the Secretary has evidence that the
certification under subparagraph (A)(ii)(IV) is untrue and the
Secretary provides to the owner or operator of the
establishment a statement summarizing such evidence.
(ii) The Secretary may deny clearance to a device
establishment if the Secretary determines that the
establishment has failed to demonstrate consistent compliance
for purposes of subparagraph (B)(iii)(I) and the Secretary
provides to the owner or operator of the establishment a
statement of the reasons for such determination.
(iii)(I) The Secretary may reject the selection of the
accredited person identified in the notice under subparagraph
(A)(ii) if the Secretary provides to the owner or operator of
the establishment a statement of the reasons for such
rejection. Reasons for the rejection may include that the
establishment or the accredited person, as the case may be, has
failed to fully respond to the request, or that the Secretary
has concerns regarding the relationship between the
establishment and such accredited person.
(II) If the Secretary rejects the selection of an accredited
person by the owner or operator of a device establishment, the
owner or operator may make an additional selection of an
accredited person by submitting to the Secretary a notice that
identifies the additional selection. Clauses (i) and (ii) of
subparagraph (B), and subclause (I) of this clause, apply to
the selection of an accredited person through a notice under
the preceding sentence in the same manner and to the same
extent as such provisions apply to a selection of an accredited
person through a notice under subparagraph (A)(ii).
(iv) In the case of a device establishment that is denied
clearance under clause (i) or (ii) or with respect to which the
selection of the accredited person is rejected under clause
(iii), the Secretary shall designate a person to review the
statement of reasons, or statement summarizing such evidence,
as the case may be, of the Secretary under such clause if,
during the 30-day period beginning on the date on which the
owner or operator of the establishment receives such statement,
the owner or operator requests the review. The review shall
commence not later than 30 days after the owner or operator
requests the review, unless the Secretary and the owner or
operator otherwise agree.
(7)(A) Persons accredited under paragraph (2) to conduct
inspections shall record in writing their inspection
observations and shall present the observations to the device
establishment's designated representative and describe each
observation. Additionally, such accredited person shall prepare
an inspection report in a form and manner designated by the
Secretary to conduct inspections, taking into consideration the
goals of international harmonization of quality systems
standards. Any official classification of the inspection shall
be determined by the Secretary.
(B) At a minimum, an inspection report under subparagraph (A)
shall identify the persons responsible for good manufacturing
practice compliance at the inspected device establishment, the
dates of the inspection, the scope of the inspection, and shall
describe in detail each observation identified by the
accredited person, identify other matters that relate to or may
influence compliance with this Act, and describe any
recommendations during the inspection or at the inspection's
closing meeting.
(C) An inspection report under subparagraph (A) shall be sent
to the Secretary and to the designated representative of the
inspected device establishment at the same time, but under no
circumstances later than three weeks after the last day of the
inspection. The report to the Secretary shall be accompanied by
all written inspection observations previously provided to the
designated representative of the establishment.
(D) Any statement or representation made by an employee or
agent of a device establishment to a person accredited under
paragraph (2) to conduct inspections shall be subject to
section 1001 of title 18, United States Code.
(E) If at any time during an inspection by an accredited
person the accredited person discovers a condition that could
cause or contribute to an unreasonable risk to the public
health, the accredited person shall immediately notify the
Secretary of the identification of the device establishment
subject to inspection and such condition.
(F) For the purpose of setting risk-based inspectional
priorities, the Secretary shall accept voluntary submissions of
reports of audits assessing conformance with appropriate
quality systems standards set by the International Organization
for Standardization (ISO) and identified by the Secretary in
public notice. If the owner or operator of an establishment
elects to submit audit reports under this subparagraph, the
owner or operator shall submit all such audit reports with
respect to the establishment during the preceding 2-year
periods.
(8) Compensation for an accredited person shall be determined
by agreement between the accredited person and the person who
engages the services of the accredited person, and shall be
paid by the person who engages such services.
(9) Nothing in this subsection affects the authority of the
Secretary to inspect any device establishment pursuant to this
Act.
(10)(A) For fiscal year 2005 and each subsequent fiscal year,
no device establishment may be inspected during the fiscal year
involved by a person accredited under paragraph (2) if--
(i) of the amounts appropriated for salaries and
expenses of the Food and Drug Administration for the
preceding fiscal year (referred to in this subparagraph
as the ``first prior fiscal year''), the amount
obligated by the Secretary for inspections of device
establishments by the Secretary was less than the
adjusted base amount applicable to such first prior
fiscal year; and
(ii) of the amounts appropriated for salaries and
expenses of the Food and Drug Administration for the
fiscal year preceding the first prior fiscal year
(referred to in this subparagraph as the ``second prior
fiscal year''), the amount obligated by the Secretary
for inspections of device establishments by the
Secretary was less than the adjusted base amount
applicable to such second prior fiscal year.
(B)(i) Subject to clause (ii), the Comptroller General of the
United States shall determine the amount that was obligated by
the Secretary for fiscal year 2002 for compliance activities of
the Food and Drug Administration with respect to devices
(referred to in this subparagraph as the ``compliance
budget''), and of such amount, the amount that was obligated
for inspections by the Secretary of device establishments
(referred to in this subparagraph as the ``inspection
budget'').
(ii) For purposes of determinations under clause (i), the
Comptroller General shall not include in the compliance budget
or the inspection budget any amounts obligated for inspections
of device establishments conducted as part of the process of
reviewing applications under section 515.
(iii) Not later than March 31, 2003, the Comptroller General
shall complete the determinations required in this subparagraph
and submit to the Secretary and the Congress a report
describing the findings made through such determinations.
(C) For purposes of this paragraph:
(i) The term ``base amount'' means the inspection
budget determined under subparagraph (B) for fiscal
year 2002.
(ii) The term ``adjusted base amount'', in the case
of applicability to fiscal year 2003, means an amount
equal to the base amount increased by 5 percent.
(iii) The term ``adjusted base amount'', with respect
to applicability to fiscal year 2004 or any subsequent
fiscal year, means the adjusted base amount applicable
to the preceding year increased by 5 percent.
(11) The authority provided by this subsection terminates on
October 1, [2022] 2027.
(12) No later than four years after the enactment of this
subsection the Comptroller General shall report to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor
and Pensions of the Senate--
(A) the number of inspections conducted by accredited
persons pursuant to this subsection and the number of
inspections conducted by Federal employees pursuant to
section 510(h) and of device establishments required to
register under section 510(i);
(B) the number of persons who sought accreditation
under this subsection, as well as the number of persons
who were accredited under this subsection;
(C) the reasons why persons who sought accreditation,
but were denied accreditation, were denied;
(D) the number of audits conducted by the Secretary
of accredited persons, the quality of inspections
conducted by accredited persons, whether accredited
persons are meeting their obligations under this Act,
and whether the number of audits conducted is
sufficient to permit these assessments;
(E) whether this subsection is achieving the goal of
ensuring more information about device establishment
compliance is being presented to the Secretary, and
whether that information is of a quality consistent
with information obtained by the Secretary pursuant to
inspections conducted by Federal employees;
(F) whether this subsection is advancing efforts to
allow device establishments to rely upon third-party
inspections for purposes of compliance with the laws of
foreign governments; and
(G) whether the Congress should continue, modify, or
terminate the program under this subsection.
(13) The Secretary shall include in the annual report
required under section 1003(g) the names of all accredited
persons and the particular activities under this subsection for
which each such person is accredited and the name of each
accredited person whose accreditation has been withdrawn during
the year.
(14) Notwithstanding any provision of this subsection, this
subsection does not have any legal effect on any agreement
described in section 803(b) between the Secretary and a foreign
country.
(15)(A) Notwithstanding any other provision of this
subsection, the Secretary may recognize auditing organizations
that are recognized by organizations established by governments
to facilitate international harmonization for purposes of
conducting inspections of--
(i) establishments that manufacture, prepare,
propagate, compound, or process devices (other than
types of devices licensed under section 351 of the
Public Health Service Act), as required under section
510(h); or
(ii) establishments required to register pursuant to
section 510(i).
(B) Nothing in this paragraph affects--
(i) the authority of the Secretary to inspect any
device establishment pursuant to this Act; or
(ii) the authority of the Secretary to determine the
official classification of an inspection.
(h)(1) In the case of inspections other than for-cause
inspections, the Secretary shall review processes and standards
applicable to inspections of domestic and foreign device
establishments in effect as of the date of the enactment of
this subsection, and update such processes and standards
through the adoption of uniform processes and standards
applicable to such inspections. Such uniform processes and
standards shall provide for--
(A) exceptions to such processes and standards, as
appropriate;
(B) announcing the inspection of the establishment
within a reasonable time before such inspection occurs,
including by providing to the owner, operator, or agent
in charge of the establishment a notification regarding
the type and nature of the inspection;
(C) a reasonable estimate of the timeframe for the
inspection, an opportunity for advance communications
between the officers or employees carrying out the
inspection under subsection (a)(1) and the owner,
operator, or agent in charge of the establishment
concerning appropriate working hours during the
inspection, and, to the extent feasible, advance notice
of some records that will be requested; and
(D) regular communications during the inspection with
the owner, operator, or agent in charge of the
establishment regarding inspection status, which may be
recorded by either party with advance notice and mutual
consent.
(2)(A) The Secretary shall, with respect to a request
described in subparagraph (B), provide nonbinding feedback with
respect to such request not later than 45 days after the
Secretary receives such request.
(B) A request described in this subparagraph is a request for
feedback--
(i) that is made by the owner, operator, or agent in
charge of such establishment in a timely manner; and
(ii) with respect to actions proposed to be taken by
a device establishment in a response to a report
received by such establishment pursuant to subsection
(b) that involve a public health priority, that
implicate systemic or major actions, or relate to
emerging safety issues (as determined by the
Secretary).
(3) Nothing in this subsection affects the authority of the
Secretary to conduct inspections otherwise permitted under this
Act in order to ensure compliance with this Act.
* * * * * * *
SEC. 714A. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND PROFESSIONAL
PERSONNEL.
(a) In General.--The Secretary may, notwithstanding title 5,
United States Code, governing appointments in the competitive
service, appoint outstanding and qualified candidates to
scientific, technical, or professional positions that support
the development, review, and regulation of [medical products]
products regulated by the Food and Drug Administration. Such
positions shall be within the competitive service.
(b) Compensation.--
(1) In general.--Notwithstanding any other provision
of law, including any requirement with respect to
General Schedule pay rates under subchapter III of
chapter 53 of title 5, United States Code, and
consistent with the requirements of paragraph (2), the
Commissioner of Food and Drugs may determine and set--
(A) the annual rate of pay of any individual
appointed under subsection (a); and
(B) for purposes of retaining qualified
employees, the annual rate of pay for any
qualified scientific, technical, or
professional personnel appointed to a position
described in subsection (a) before the date of
enactment of the 21st Century Cures Act.
(2) Limitation.--The annual rate of pay established
pursuant to paragraph (1) may not exceed the amount of
annual compensation (excluding expenses) specified in
section 102 of title 3, United States Code.
(3) Public availability.--The annual rate of pay
provided to an individual in accordance with this
section shall be publicly available information.
(c) Rule of Construction.--The authorities under this section
shall not be construed to affect the authority provided under
section 714.
[(d) Report on Workforce Planning.--
[(1) In general.--Not later than 18 months after the
date of enactment of the 21st Century Cures Act, the
Secretary shall submit a report on workforce planning
to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives that examines
the extent to which the Food and Drug Administration
has a critical need for qualified individuals for
scientific, technical, or professional positions,
including--
[(A) an analysis of the workforce needs at
the Food and Drug Administration and the
Secretary's strategic plan for addressing such
needs, including through use of the authority
under this section; and
[(B) a recruitment and retention plan for
hiring qualified scientific, technical, and
professional candidates, which may include the
use of--
[(i) recruitment through
nongovernmental recruitment or
placement agencies;
[(ii) recruitment through academic
institutions;
[(iii) recruitment or hiring bonuses,
if applicable;
[(iv) recruitment using targeted
direct hiring authorities; and
[(v) retention of qualified
scientific, technical, and professional
employees using the authority under
this section, or other applicable
authorities of the Secretary.
[(2) Recommendations.--The report under paragraph (1)
may include the recommendations of the Commissioner of
Food and Drugs that would help the Food and Drug
Administration to better recruit and retain qualified
individuals for scientific, technical, or professional
positions at the agency.]
(d) Agency-wide Strategic Workforce Plan.--
(1) In general.--Not later than 1 year after the date
of enactment of the Food and Drug Amendments of 2022,
the Commissioner of Food and Drugs shall develop and
begin implementation of an agency-wide strategic
workforce plan at the Food and Drug Administration,
which shall include--
(A) agency-wide human capital goals and
strategies;
(B) performance measures, benchmarks, or
other elements to facilitate the monitoring and
evaluation of the progress made toward such
goals and the effectiveness of such strategies;
and
(C) a process for updating such plan based on
timely and relevant information on an ongoing
basis.
(2) Report to congress.--Not later than 18 months
after the date of enactment of the Food and Drug
Amendments of 2022, the Secretary shall submit to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate a report describing
the plan under paragraph (1) and the status of its
implementation.
* * * * * * *
Subchapter C--Fees
* * * * * * *
PART 2--FEES RELATING TO DRUGS
SEC. 735. DEFINITIONS.
For purposes of this part:
(1) The term ``human drug application'' means an
application for--
(A) approval of a new drug submitted under
section 505(b), or
(B) licensure of a biological product under
subsection (a) of section 351 of the Public
Health Service Act.
Such term does not include a supplement to such an
application, does not include an application with
respect to whole blood or a blood component for
transfusion, does not include an application with
respect to a bovine blood product for topical
application licensed before September 1, 1992, [an
allergenic extract product, or] does not include an
application with respect to an allergenic extract
product licensed before October 1, 2022, does not
include an application with respect to a standardized
allergenic extract product submitted pursuant to a
notification to the applicant from the Secretary
regarding the existence of a potency test that measures
the allergenic activity of an allergenic extract
product licensed by the applicant before October 1,
2022, does not include an application with respect to
an in vitro diagnostic biologic product licensed under
section 351 of the Public Health Service Act, does not
include an application with respect to a large volume
parenteral drug product approved before September 1,
1992, does not include an application for a licensure
of a biological product for further manufacturing use
only, and does not include an application or supplement
submitted by a State or Federal Government entity for a
drug that is not distributed commercially. Such term
does include an application for licensure, as described
in subparagraph (B), of a large volume biological
product intended for single dose injection for
intravenous use or infusion.
(2) The term ``supplement'' means a request to the
Secretary to approve a change in a human drug
application which has been approved.
[(3) The term] (3)(A) The term ``prescription drug
product'' means a specific strength or potency of a
drug in final dosage form--
[(A)] (i) for which a human drug
application has been approved,
[(B)] (ii) which may be dispensed
only under prescription pursuant to
section 503(b), and
[(C)] (iii) which is on the list of
products described in section
505(j)(7)(A) (not including the
discontinued section of such list) or
is on a list created and maintained by
the Secretary of products approved
under human drug applications under
section 351 of the Public Health
Service Act (not including the
discontinued section of such list).
[Such term does not include whole blood]
(B) Such term does not include whole blood or a
blood component for transfusion, does not include a
bovine blood product for topical application licensed
before September 1, 1992, [an allergenic extract
product,] an allergenic extract product licensed before
October 1, 2022, a standardized allergenic extract
product submitted pursuant to a notification to the
applicant from the Secretary regarding the existence of
a potency test that measures the allergenic activity of
an allergenic extract product licensed by the applicant
before October 1, 2022, or an in vitro diagnostic
biologic product licensed under section 351 of the
Public Health Service Act. Such term does not include a
biological product that is licensed for further
manufacturing use only, and does not include a drug
that is not distributed commercially and is the subject
of an application or supplement submitted by a State or
Federal Government entity. Such term does include a
large volume biological product intended for single
dose injection for intravenous use or infusion.
(C)(i) If a written request to place a
product in the discontinued section of either
of the lists referenced in subparagraph
(A)(iii) is submitted to the Secretary on
behalf of an applicant, and the request
identifies the date the product is withdrawn
from sale, then for purposes of assessing the
prescription drug program fee under section
736(a)(2), the Secretary shall consider such
product to have been included in the
discontinued section on the later of--
(I) the date such request was
received; or
(II) if the product will be withdrawn
from sale on a future date, such future
date when the product is withdrawn from
sale.
(ii) For purposes of this subparagraph, a
product shall be considered withdrawn from sale
once the applicant has ceased its own
distribution of the product, whether or not the
applicant has ordered recall of all previously
distributed lots of the product, except that a
routine, temporary interruption in supply shall
not render a product withdrawn from sale.
(4) The term ``final dosage form'' means, with
respect to a prescription drug product, a finished
dosage form which is approved for administration to a
patient without substantial further manufacturing (such
as capsules, tablets, or lyophilized products before
reconstitution).
(5) The term ``prescription drug establishment''
means a foreign or domestic place of business which is
at one general physical location consisting of one or
more buildings all of which are within five miles of
each other and at which one or more prescription drug
products are manufactured in final dosage form. For
purposes of this paragraph, the term ``manufactured''
does not include packaging.
(6) The term ``process for the review of human drug
applications'' means the following activities of the
Secretary with respect to the review of human drug
applications and supplements:
(A) The activities necessary for the review
of human drug applications and supplements.
(B) The issuance of action letters which
approve human drug applications or which set
forth in detail the specific deficiencies in
such applications and, where appropriate, the
actions necessary to place such applications in
condition for approval.
(C) The inspection of prescription drug
establishments and other facilities undertaken
as part of the Secretary's review of pending
human drug applications and supplements.
(D) Activities necessary for the review of
applications for licensure of establishments
subject to section 351 of the Public Health
Service Act and for the release of lots of
biologics under such section.
(E) Monitoring of research conducted in
connection with the review of human drug
applications.
(F) Postmarket safety activities with respect
to drugs approved under human drug applications
or supplements, including the following
activities:
(i) Collecting, developing, and
reviewing safety information on
approved drugs, including adverse event
reports.
(ii) Developing and using improved
adverse-event data-collection systems,
including information technology
systems.
(iii) Developing and using improved
analytical tools to assess potential
safety problems, including access to
external data bases.
(iv) Implementing and enforcing
section 505(o) (relating to
postapproval studies and clinical
trials and labeling changes) and
section 505(p) (relating to risk
evaluation and mitigation strategies).
(v) Carrying out section 505(k)(5)
(relating to adverse event reports and
postmarket safety activities).
(7) The term ``costs of resources allocated for the
process for the review of human drug applications''
means the expenses in connection with the process for
the review of human drug applications for--
(A) officers and employees of the Food and
Drug Administration, contractors of the Food
and Drug Administration, advisory committees,
and costs related to such officers, employees,
and committees and to contracts with such
contractors,
(B) management of information, and the
acquisition, maintenance, and repair of
computer resources,
(C) leasing, maintenance, renovation, and
repair of facilities and acquisition,
maintenance, and repair of fixtures, furniture,
scientific equipment, and other necessary
materials and supplies, and
(D) collecting fees under section 736 and
accounting for resources allocated for the
review of human drug applications and
supplements.
(8) The term ``adjustment factor'' applicable to a
fiscal year is the Consumer Price Index for all urban
consumers (all items; United States city average) for
October of the preceding fiscal year divided by such
Index for October 1996.
(9) The term ``person'' includes an affiliate
thereof.
(10) The term ``active'', with respect to a
commercial investigational new drug application, means
such an application to which information was submitted
during the relevant period.
(11) The term ``affiliate'' means a business entity
that has a relationship with a second business entity
if, directly or indirectly--
(A) one business entity controls, or has the
power to control, the other business entity; or
(B) a third party controls, or has power to
control, both of the business entities.
(12) The term ``skin-test diagnostic product''--
(A) means a product--
(i) for prick, scratch, intradermal,
or subcutaneous administration;
(ii) expected to produce a limited,
local reaction at the site of
administration (if positive), rather
than a systemic effect;
(iii) not intended to be a preventive
or therapeutic intervention; and
(iv) intended to detect an immediate-
or delayed-type skin hypersensitivity
reaction to aid in the diagnosis of--
(I) an allergy to an
antimicrobial agent;
(II) an allergy that is not
to an antimicrobial agent, if
the diagnostic product was
authorized for marketing prior
to October 1, 2022; or
(III) infection with fungal
or mycobacterial pathogens; and
(B) includes positive and negative controls
required to interpret the results of a product
described in subparagraph (A).
SEC. 736. AUTHORITY TO ASSESS AND USE DRUG FEES.
(a) Types of Fees.--Beginning in [fiscal year 2018] fiscal
year 2023, the Secretary shall assess and collect fees in
accordance with this section as follows:
(1) Human drug application fee.--
(A) In general.--Each person that submits, on
or after September 1, 1992, a human drug
application shall be subject to a fee as
follows:
(i) A fee established under
subsection [(c)(5)] (c)(6) for a human
drug application for which clinical
data (other than bioavailability or
bioequivalence studies) with respect to
safety or effectiveness are required
for approval.
(ii) A fee established under
subsection [(c)(5)] (c)(6) for a human
drug application for which clinical
data (other than bioavailability or
bioequivalence studies) with respect to
safety or effectiveness are not
required for approval. Such fee shall
be half of the amount of the fee
established under clause (i).
(B) Payment.--The fee required by
subparagraph (A) shall be due upon submission
of the application.
(C) Exception for previously filed
application.--If a human drug application was
submitted by a person that paid the fee for
such application, was accepted for filing, and
was not approved or was withdrawn prior to
approval (without a waiver), the submission of
a human drug application for the same product
by the same person (or the person's licensee,
assignee, or successor) shall not be subject to
a fee under subparagraph (A).
(D) Refund of fee if application refused for
filing or withdrawn before filing.--The
Secretary shall refund 75 percent of the fee
paid under subparagraph (B) for any application
which is refused for filing or withdrawn
without a waiver before filing.
(E) Fees for applications previously refused
for filing or withdrawn before filing.--A human
drug application that was submitted but was
refused for filing, or was withdrawn before
being accepted or refused for filing, shall be
subject to the full fee under subparagraph (A)
upon being resubmitted or filed over protest,
unless the fee is waived or reduced under
subsection (d).
(F) Exception for designated orphan drug.--A
human drug application for a prescription drug
product that has been designated as a drug for
a rare disease or condition pursuant to section
526 shall not be subject to a fee under
subparagraph (A), unless the human drug
application includes an indication for other
than a rare disease or condition.
(G) Refund of fee if application withdrawn.--
If an application is withdrawn after the
application was filed, the Secretary may refund
the fee or a portion of the fee if no
substantial work was performed on the
application after the application was filed.
The Secretary shall have the sole discretion to
refund a fee or a portion of the fee under this
subparagraph. A determination by the Secretary
concerning a refund under this paragraph shall
not be reviewable.
(H) Exception for skin-test diagnostic
products.--A human drug application for a skin-
test diagnostic product shall not be subject to
a fee under subparagraph (A).
(2) Prescription drug program fee.--
(A) In general.--[Except as provided in
subparagraphs (B) and (C)]
(i) Fee._Except as provided in
subparagraphs (B) and (C), each person
who is named as the applicant in a
human drug application, and who, after
September 1, 1992, had pending before
the Secretary a human drug application
or supplement, shall pay the annual
prescription drug program fee
established for a fiscal year under
[subsection (c)(5)] subsection (c)(6)
for each prescription drug product that
is identified in such a human drug
application approved as of October 1 of
such fiscal year. Such fee shall be due
on the later of the first business day
on or after October 1 of each fiscal
year or the first business day after
the enactment of an appropriations Act
providing for the collection and
obligation of fees for such fiscal year
under this section. Such fee shall be
paid only once for each product for a
fiscal year in which the fee is
payable.
(ii) Special rule.--If a drug product
that is identified in a human drug
application approved as of October 1 of
a fiscal year is not a prescription
drug product as of that date because
the drug product is in the discontinued
section of a list referenced in section
735(3)(A)(iii), and on any subsequent
day during such fiscal year the drug
product is a prescription drug product,
then except as provided in
subparagraphs (B) and (C), each person
who is named as the applicant in a
human drug application with respect to
such product, and who, after September
1, 1992, had pending before the
Secretary a human drug application or
supplement with respect to such
product, shall pay the annual
prescription drug program fee
established for a fiscal year under
subsection (c)(6) for such prescription
drug product. Such fee shall be due on
the last business day of such fiscal
year and shall be paid only once for
each such product for a fiscal year in
which the fee is payable.
[(B) Exception for certain prescription drug
products.--A prescription drug program fee
shall not be assessed for a prescription drug
product under subparagraph (A) if such product
is--
[(i) identified on the list compiled
under section 505(j)(7) with a potency
described in terms of per 100 mL;
[(ii) the same product as another
product that--
[(I) was approved under an
application filed under section
505(b) or 505(j); and
[(II) is not in the list of
discontinued products compiled
under section 505(j)(7);
[(iii) the same product as another
product that was approved under an
abbreviated application filed under
section 507 (as in effect on the day
before the date of enactment of the
Food and Drug Administration
Modernization Act of 1997); or
[(iv) the same product as another
product that was approved under an
abbreviated new drug application
pursuant to regulations in effect prior
to the implementation of the Drug Price
Competition and Patent Term Restoration
Act of 1984.]
(B) Exception for certain prescription drug
products.--A prescription drug program fee
shall not be assessed for a prescription drug
product under subparagraph (A) if such product
is--
(i) a large volume parenteral product
(a sterile aqueous drug product
packaged in a single-dose container
with a volume greater than or equal to
100 mL, not including powders for
reconstitution or pharmacy bulk
packages) identified on the list
compiled under section 505(j)(7);
(ii) pharmaceutically equivalent (as
defined in section 314.3 of title 21,
Code of Federal Regulations (or any
successor regulation)) to another
product on the list of products
compiled under section 505(j)(7) (not
including the discontinued section of
such list); or
(iii) a skin-test diagnostic product.
(C) Limitation.--A person who is named as the
applicant in an approved human drug application
shall not be assessed more than 5 prescription
drug program fees for a fiscal year for
prescription drug products identified in such
approved human drug application.
(b) Fee Revenue Amounts.--
[(1) In general.--For each of the fiscal years 2018
through 2022, fees under subsection (a) shall, except
as provided in subsections (c), (d), (f), and (g), be
established to generate a total revenue amount under
such subsection that is equal to the sum of--
[(A) the annual base revenue for the fiscal
year (as determined under paragraph (3));
[(B) the dollar amount equal to the inflation
adjustment for the fiscal year (as determined
under subsection (c)(1));
[(C) the dollar amount equal to the capacity
planning adjustment for the fiscal year (as
determined under subsection (c)(2));
[(D) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if
applicable (as determined under subsection
(c)(3));
[(E) the dollar amount equal to the
additional direct cost adjustment for the
fiscal year (as determined under subsection
(c)(4)); and
[(F) additional dollar amounts for each
fiscal year as follows:
[(i) $20,077,793 for fiscal year
2018.
[(ii) $21,317,472 for fiscal year
2019.
[(iii) $16,953,329 for fiscal year
2020.
[(iv) $5,426,896 for fiscal year
2021.
[(v) $2,769,609 for fiscal year
2022.]
(1) In general.--For each of the fiscal years 2023
through 2027, fees under subsection (a) shall, except
as provided in subsections (c), (d), (f), and (g), be
established to generate a total revenue amount under
such subsection that is equal to the sum of--
(A) the annual base revenue for the fiscal
year (as determined under paragraph (3));
(B) the dollar amount equal to the inflation
adjustment for the fiscal year (as determined
under subsection (c)(1));
(C) the dollar amount equal to the strategic
hiring and retention adjustment for the fiscal
year (as determined under subsection (c)(2));
(D) the dollar amount equal to the capacity
planning adjustment for the fiscal year (as
determined under subsection (c)(3));
(E) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if
applicable (as determined under subsection
(c)(4));
(F) the dollar amount equal to the additional
direct cost adjustment for the fiscal year (as
determined under subsection (c)(5)); and
(G) additional dollar amounts for each fiscal
year as follows:
(i) $65,773,693 for fiscal year 2023.
(ii) $25,097,671 for fiscal year
2024.
(iii) $14,154,169 for fiscal year
2025.
(iv) $4,864,860 for fiscal year 2026.
(v) $1,314,620 for fiscal year 2027.
(2) Types of fees.--Of the total revenue amount
determined for a fiscal year under paragraph (1)--
(A) 20 percent shall be derived from human
drug application fees under subsection (a)(1);
and
(B) 80 percent shall be derived from
prescription drug program fees under subsection
(a)(2).
[(3) Annual base revenue.--For purposes of paragraph
(1), the dollar amount of the annual base revenue for a
fiscal year shall be--
[(A) for fiscal year 2018, $878,590,000; and
[(B) for fiscal years 2019 through 2022, the
dollar amount of the total revenue amount
established under paragraph (1) for the
previous fiscal year, not including any
adjustments made under subsection (c)(3) or
(c)(4).]
(3) Annual base revenue.--For purposes of paragraph
(1), the dollar amount of the annual base revenue for a
fiscal year shall be--
(A) for fiscal year 2023, $1,151,522,958; and
(B) for fiscal years 2024 through 2027, the
dollar amount of the total revenue amount
established under paragraph (1) for the
previous fiscal year, not including any
adjustments made under subsection (c)(4) or
(c)(5).
(c) Adjustments; Annual Fee Setting.--
(1) Inflation adjustment.--
(A) In general.--For purposes of subsection
(b)(1)(B), the dollar amount of the inflation
adjustment to the annual base revenue for each
fiscal year shall be equal to the product of--
(i) such annual base revenue for the
fiscal year under subsection (b)(1)(A);
and
(ii) the inflation adjustment
percentage under subparagraph (B).
(B) Inflation adjustment percentage.--The
inflation adjustment percentage under this
subparagraph for a fiscal year is equal to the
sum of--
(i) the average annual percent change
in the cost, per full-time equivalent
position of the Food and Drug
Administration, of all personnel
compensation and benefits paid with
respect to such positions for the first
3 years of the preceding 4 fiscal
years, multiplied by the proportion of
personnel compensation and benefits
costs to total costs of the process for
the review of human drug applications
(as defined in section 735(6)) for the
first 3 years of the preceding 4 fiscal
years; and
(ii) the average annual percent
change that occurred in the Consumer
Price Index for urban consumers
([Washington-Baltimore, DC-MD-VA-WV]
Washington-Arlington-Alexandria, DC-VA-
MD-WV; Not Seasonally Adjusted; All
items; Annual Index) for the first 3
years of the preceding 4 years of
available data multiplied by the
proportion of all costs other than
personnel compensation and benefits
costs to total costs of the process for
the review of human drug applications
(as defined in section 735(6)) for the
first 3 years of the preceding 4 fiscal
years.
(2) Strategic hiring and retention adjustment.--For
each fiscal year, after the annual base revenue
established in subsection (b)(1)(A) is adjusted for
inflation in accordance with paragraph (1), the
Secretary shall further increase the fee revenue and
fees by the following amounts:
(A) For fiscal year 2023, $9,000,000.
(B) For each of fiscal years 2024 through
2027, $4,000,000.
[ (2) Capacity planning adjustment.--
[(A) In general.--For each fiscal year, after
the annual base revenue established in
subsection (b)(1)(A) is adjusted for inflation
in accordance with paragraph (1), such revenue
shall be adjusted further for such fiscal year,
in accordance with this paragraph, to reflect
changes in the resource capacity needs of the
Secretary for the process for the review of
human drug applications.
[(B) Interim methodology.--
[(i) In general.--Until the capacity
planning methodology described in
subparagraph (C) is effective, the
adjustment under this paragraph for a
fiscal year shall be based on the
product of--
[(I) the annual base revenue
for such year, as adjusted for
inflation under paragraph (1);
and
[(II) the adjustment
percentage under clause (ii).
[(ii) Adjustment percentage.--The
adjustment percentage under this clause
for a fiscal year is the weighted
change in the 3-year average ending in
the most recent year for which data are
available, over the 3-year average
ending in the previous year, for--
[(I) the total number of
human drug applications,
efficacy supplements, and
manufacturing supplements
submitted to the Secretary;
[(II) the total number of
active commercial
investigational new drug
applications; and
[(III) the total number of
formal meetings scheduled by
the Secretary, and written
responses issued by the
Secretary in lieu of such
formal meetings, as identified
in section I.H of the letters
described in section 101(b) of
the Prescription Drug User Fee
Amendments of 2017.
[(C) Capacity planning methodology.--
[(i) Development; evaluation and
report.--The Secretary shall obtain,
through a contract with an independent
accounting or consulting firm, a report
evaluating options and recommendations
for a new methodology to accurately
assess changes in the resource and
capacity needs of the process for the
review of human drug applications. The
capacity planning methodological
options and recommendations presented
in such report shall utilize and be
informed by personnel time reporting
data as an input. The report shall be
published for public comment no later
than the end of fiscal year 2020.
[(ii) Establishment and
implementation.--After review of the
report described in clause (i) and any
public comments thereon, the Secretary
shall establish a capacity planning
methodology for purposes of this
paragraph, which shall--
[(I) replace the interim
methodology under subparagraph
(B);
[(II) incorporate such
approaches and attributes as
the Secretary determines
appropriate; and
[(III) be effective beginning
with the first fiscal year for
which fees are set after such
capacity planning methodology
is established.
[(D) Limitation.--Under no circumstances
shall an adjustment under this paragraph result
in fee revenue for a fiscal year that is less
than the sum of the amounts under subsections
(b)(1)(A) (the annual base revenue for the
fiscal year) and (b)(1)(B) (the dollar amount
of the inflation adjustment for the fiscal
year).
[(E) Publication in federal register.--The
Secretary shall publish in the Federal Register
notice under paragraph (5) of the fee revenue
and fees resulting from the adjustment and the
methodologies under this paragraph.]
(3) Capacity planning adjustment.--
(A) In general.--For each fiscal year, after
the annual base revenue established in
subsection (b)(1)(A) is adjusted in accordance
with paragraphs (1) and (2), such revenue shall
be adjusted further for such fiscal year, in
accordance with this paragraph, to reflect
changes in the resource capacity needs of the
Secretary for the process for the review of
human drug applications.
(B) Methodology.--For purposes of this
paragraph, the Secretary shall employ the
capacity planning methodology utilized by the
Secretary in setting fees for fiscal year 2021,
as described in the notice titled
``Prescription Drug User Fee Rates for Fiscal
Year 2021'' published in the Federal Register
on August 3, 2020 (85 Fed. Reg. 46651). The
workload categories used in applying such
methodology in forecasting shall include only
the activities described in that notice and, as
feasible, additional activities that are also
directly related to the direct review of
applications and supplements, including
additional formal meeting types, the direct
review of postmarketing commitments and
requirements, the direct review of risk
evaluation and mitigation strategies, and the
direct review of annual reports for approved
prescription drug products. Subject to the
exceptions in the preceding sentence, the
Secretary shall not include as workload
categories in applying such methodology in
forecasting any non-core review activities,
including those activities that the Secretary
referenced for potential future use in such
notice but did not utilize in setting fees for
fiscal year 2021.
(C) Limitation.--Under no circumstances shall
an adjustment under this paragraph result in
fee revenue for a fiscal year that is less than
the sum of the amounts under subsections
(b)(1)(A) (the annual base revenue for the
fiscal year), (b)(1)(B) (the dollar amount of
the inflation adjustment for the fiscal year),
and (b)(1)(C) (the dollar amount of the
strategic hiring and retention adjustment for
the fiscal year).
(D) Publication in federal register.--The
Secretary shall publish in the Federal Register
notice under paragraph (6) of the fee revenue
and fees resulting from the adjustment and the
methodologies under this paragraph.
[(3)] (4) Operating reserve adjustment.--
[(A) Increase.--For fiscal year 2018 and
subsequent fiscal years, the Secretary may, in
addition to adjustments under paragraphs (1)
and (2), further increase the fee revenue and
fees if such an adjustment is necessary to
provide for not more than 14 weeks of operating
reserves of carryover user fees for the process
for the review of human drug applications.]
(A) Increase.--For fiscal year 2023 and
subsequent fiscal years, the Secretary shall,
in addition to adjustments under paragraphs
(1), (2), and (3), further increase the fee
revenue and fees if such an adjustment is
necessary to provide for operating reserves of
carryover user fees for the process for the
review of human drug applications for each
fiscal year in at least the following amounts:
(i) For fiscal year 2023, at least 8
weeks of operating reserves.
(ii) For fiscal year 2024, at least 9
weeks of operating reserves.
(iii) For fiscal year 2025 and
subsequent fiscal years, at least 10
weeks of operating reserves.
(B) Decrease.--If the Secretary has carryover
balances for such process in excess of 14 weeks
of such operating reserves, the Secretary shall
decrease such fee revenue and fees to provide
for not more than 14 weeks of such operating
reserves.
(C) Notice of rationale.--If an adjustment
under subparagraph (A) or (B) is made, the
rationale for the amount of the increase or
decrease (as applicable) in fee revenue and
fees shall be contained in the annual Federal
Register notice under [paragraph (5)] paragraph
(6) establishing fee revenue and fees for the
fiscal year involved.
[(4) Additional direct cost adjustment.--
[(A) In general.--The Secretary shall, in
addition to adjustments under paragraphs (1),
(2), and (3), further increase the fee revenue
and fees--
[(i) for fiscal year 2018, by
$8,730,000; and
[(ii) for fiscal year 2019 and
subsequent fiscal years, by the amount
determined under subparagraph (B).
[(B) Amount.--The amount determined under
this subparagraph is--
[(i) $8,730,000, multiplied by
[(ii) the Consumer Price Index for
urban consumers (Washington-Baltimore,
DC-MD-VA-WV; Not Seasonally Adjusted;
All Items; Annual Index) for the most
recent year of available data, divided
by such Index for 2016.]
(5) Additional direct cost adjustment.--
(A) Increase.--The Secretary shall, in
addition to adjustments under paragraphs (1),
(2), (3), and (4), further increase the fee
revenue and fees--
(i) for fiscal year 2023, by
$44,386,150; and
(ii) for each of fiscal years 2024
through 2027, by the amount set forth
in clauses (i) through (iv) of
subparagraph (B), as applicable,
multiplied by the Consumer Price Index
for urban consumers (Washington-
Arlington-Alexandria, DC-VA-MD-WV; Not
Seasonally Adjusted; All Items; Annual
Index) for the most recent year of
available data, divided by such Index
for 2021.
(B) Applicable amounts.--The amounts referred
to in subparagraph (A)(ii) are the following:
(i) For fiscal year 2024,
$60,967,993.
(ii) For fiscal year 2025,
$35,799,314.
(iii) For fiscal year 2026, $35,799,
314.
(iv) For fiscal year 2027,
$35,799,314.
[(5)] (6) Annual fee setting.--The Secretary shall,
not later than 60 days before the start of each fiscal
year that begins after [September 30, 2017] September
30, 2022--
(A) establish, for each such fiscal year,
human drug application fees and prescription
drug program fees under subsection (a), based
on the revenue amounts established under
subsection (b) and the adjustments provided
under this subsection; and
(B) publish such fee revenue and fees in the
Federal Register.
[(6)] (7) Limit.--The total amount of fees charged,
as adjusted under this subsection, for a fiscal year
may not exceed the total costs for such fiscal year for
the resources allocated for the process for the review
of human drug applications.
(d) Fee Waiver or Reduction.--
(1) In general.--The Secretary shall grant to a
person who is named as the applicant in a human drug
application a waiver from or a reduction of one or more
fees assessed to that person under subsection (a) where
the Secretary finds that--
(A) such waiver or reduction is necessary to
protect the public health,
(B) the assessment of the fee would present a
significant barrier to innovation because of
limited resources available to such person or
other circumstances, or
(C) the applicant involved is a small
business submitting its first human drug
application to the Secretary for review.
(2) Considerations.--In determining whether to grant
a waiver or reduction of a fee under paragraph (1), the
Secretary shall consider only the circumstances and
assets of the applicant involved and any affiliate of
the applicant.
(3) Rules relating to small businesses.--
(A) Definition.--In paragraph (1)(C), the
term ``small business'' means an entity that
has fewer than 500 employees, including
employees of affiliates, and that does not have
a drug product that has been approved under a
human drug application and introduced or
delivered for introduction into interstate
commerce.
(B) Waiver of application fee.--The Secretary
shall waive under paragraph (1)(C) the
application fee for the first human drug
application that a small business or its
affiliate submits to the Secretary for review.
After a small business or its affiliate is
granted such a waiver, the small business or
its affiliate shall pay application fees for
all subsequent human drug applications
submitted to the Secretary for review in the
same manner as an entity that does not qualify
as a small business.
(e) Effect of Failure To Pay Fees.--A human drug application
or supplement submitted by a person subject to fees under
subsection (a) shall be considered incomplete and shall not be
accepted for filing by the Secretary until all such fees owed
by such person have been paid.
(f) Limitations.--
(1) In general.--Fees under subsection (a) shall be
refunded for a fiscal year beginning after fiscal year
1997 unless appropriations for salaries and expenses of
the Food and Drug Administration for such fiscal year
(excluding the amount of fees appropriated for such
fiscal year) are equal to or greater than the amount of
appropriations for the salaries and expenses of the
Food and Drug Administration for the fiscal year 1997
(excluding the amount of fees appropriated for such
fiscal year) multiplied by the adjustment factor
applicable to the fiscal year involved.
(2) Authority.--If the Secretary does not assess fees
under subsection (a) during any portion of a fiscal
year because of paragraph (1) and if at a later date in
such fiscal year the Secretary may assess such fees,
the Secretary may assess and collect such fees, without
any modification in the rate, for human drug
applications and prescription drug program fees at any
time in such fiscal year notwithstanding the provisions
of subsection (a) relating to the date fees are to be
paid.
(3) Limitation.--Beginning on October 1, 2023, the
authorities under section 735(7)(C) shall include only
expenditures for leasing and necessary scientific
equipment.
(g) Crediting and Availability of Fees.--
(1) In general.--Subject to paragraph (2)(C), fees
authorized under subsection (a) shall be collected and
available for obligation only to the extent and in the
amount provided in advance in appropriations Acts. Such
fees are authorized to remain available until expended.
Such sums as may be necessary may be transferred from
the Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to
such appropriation account for salaries and expenses
with such fiscal year limitation. The sums transferred
shall be available solely for the process for the
review of human drug applications.
(2) Collections and appropriation acts.--
(A) In general.--The fees authorized by this
section--
(i) subject to subparagraph (C),
shall be collected and available in
each fiscal year in an amount not to
exceed the amount specified in
appropriation Acts, or otherwise made
available for obligation, for such
fiscal year, and
(ii) shall be available to defray
increases in the costs of the resources
allocated for the process for the
review of human drug applications
(including increases in such costs for
an additional number of full-time
equivalent positions in the Department
of Health and Human Services to be
engaged in such process) over such
costs, excluding costs paid from fees
collected under this section, for
fiscal year 1997 multiplied by the
adjustment factor.
(B) Compliance.--The Secretary shall be
considered to have met the requirements of
subparagraph (A)(ii) in any fiscal year if the
costs funded by appropriations and allocated
for the process for the review of human drug
applications--
(i) are not more than 3 percent below
the level specified in subparagraph
(A)(ii); or
(ii)(I) are more than 3 percent below
the level specified in subparagraph
(A)(ii), and fees assessed for the
fiscal year following the subsequent
fiscal year are decreased by the amount
in excess of 3 percent by which such
costs fell below the level specified in
such subparagraph; and
(II) such costs are not more than 5
percent below the level specified in
such subparagraph.
(C) Provision for early payments.--Payment of
fees authorized under this section for a fiscal
year, prior to the due date for such fees, may
be accepted by the Secretary in accordance with
authority provided in advance in a prior year
appropriations Act.
(3) Authorization of appropriations.--For each of the
[fiscal years 2018 through 2022] fiscal years 2023
through 2027, there is authorized to be appropriated
for fees under this section an amount equal to the
total revenue amount determined under subsection (b)
for the fiscal year, as adjusted or otherwise affected
under subsection (c).
(h) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed under
subsection (a) within 30 days after it is due, such fee shall
be treated as a claim of the United States Government subject
to subchapter II of chapter 37 of title 31, United States Code.
[(i) Written Requests for Waivers, Reductions, and Refunds.--
To qualify for consideration for a waiver or reduction under
subsection (d), or for a refund of any fee collected in
accordance with subsection (a), a person shall submit to the
Secretary a written request for such waiver, reduction, or
refund not later than 180 days after such fee is due.]
(i) Written Requests for Waivers, Reductions, Exemptions, and
Returns; Disputes Concerning Fees.--To qualify for
consideration for a waiver or reduction under subsection (d),
an exemption under subsection (k), or the return of any fee
paid under this section, including if the fee is claimed to
have been paid in error, a person shall--
(1) not later than 180 days after such fee is due,
submit to the Secretary a written request justifying
such waiver, reduction, exemption, or return; and
(2) include in the request any legal authorities
under which the request is made.
(j) Construction.--This section may not be construed to
require that the number of full-time equivalent positions in
the Department of Health and Human Services, for officers,
employers, and advisory committees not engaged in the process
of the review of human drug applications, be reduced to offset
the number of officers, employees, and advisory committees so
engaged.
(k) Orphan Drugs.--
(1) Exemption.--A drug designated under section 526
for a rare disease or condition and approved under
section 505 or under section 351 of the Public Health
Service Act shall be exempt from prescription drug
program fees under this section, if the drug meets all
of the following conditions:
(A) The drug meets the public health
requirements contained in this Act as such
requirements are applied to requests for
waivers for prescription drug program fees.
(B) The drug is owned or licensed and is
marketed by a company that had less than
$50,000,000 in gross worldwide revenue [during
the previous year] as determined under
paragraph (2).
[(2) Evidence of qualification.--An exemption under
paragraph (1) applies with respect to a drug only if
the applicant involved submits a certification that its
gross annual revenues did not exceed $50,000,000 for
the preceding 12 months before the exemption was
requested.]
(2) Evidence of qualification.--An exemption under
paragraph (1) applies with respect to a drug only if
the applicant involved submits a certification that the
applicant's gross annual revenues did not exceed
$50,000,000 for the last calendar year ending prior to
the fiscal year for which the exemption is requested.
Such certification shall be supported by--
(A) tax returns submitted to the United
States Internal Revenue Service; or
(B) as necessary, other appropriate financial
information.
* * * * * * *
SEC. 736B. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Performance Report.--
(1) In general.--[Beginning with fiscal year 2018,
not] Not later than 120 days after the end of each
fiscal year for which fees are collected under this
part, the Secretary shall prepare and submit to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate a report concerning--
(A) the progress of the Food and Drug
Administration in achieving the goals
identified in the letters described in section
101(b) of the [Prescription Drug User Fee
Amendments of 2017] Prescription Drug User Fee
Amendments of 2022 during such fiscal year and
the future plans of the Food and Drug
Administration for meeting the goals, including
the status of the independent assessment
described in such letters; and
(B) the progress of the Center for Drug
Evaluation and Research and the Center for
Biologics Evaluation and Research in achieving
the goals, and future plans for meeting the
goals, including, for each review division--
(i) the number of original standard
new drug applications and biologics
license applications filed per fiscal
year for each review division;
(ii) the number of original priority
new drug applications and biologics
license applications filed per fiscal
year for each review division;
(iii) the number of standard efficacy
supplements filed per fiscal year for
each review division;
(iv) the number of priority efficacy
supplements filed per fiscal year for
each review division;
(v) the number of applications filed
for review under accelerated approval
per fiscal year for each review
division;
(vi) the number of applications filed
for review as fast track products per
fiscal year for each review division;
(vii) the number of applications
filed for orphan-designated products
per fiscal year for each review
division; and
(viii) the number of breakthrough
designations for a fiscal year for each
review division.
(2) Inclusion.--The report under this subsection for
a fiscal year shall include information on all previous
cohorts for which the Secretary has not given a
complete response on all human drug applications and
supplements in the cohort.
(3) Real time reporting.--
(A) In general.--[Not later than 30 calendar
days after the end of the second quarter of
fiscal year 2018, and not later than 30
calendar days after the end of each quarter of
each fiscal year thereafter] Not later than 30
calendar days after the end of each quarter of
each fiscal year for which fees are collected
under this part, the Secretary shall post the
data described in subparagraph (B) on the
internet website of the Food and Drug
Administration for such quarter and on a
cumulative basis for such fiscal year, and may
remove duplicative data from the annual
performance report under this subsection.
(B) Data.--The Secretary shall post the
following data in accordance with subparagraph
(A):
(i) The number and titles of draft
and final guidance on topics related to
the process for the review of human
drug applications, and whether such
guidances were issued as required by
statute or pursuant to a commitment
under the letters described in section
101(b) of the [Prescription Drug User
Fee Amendments of 2017] Prescription
Drug User Fee Amendments of 2022.
(ii) The number and titles of public
meetings held on topics related to the
process for the review of human drug
applications, and whether such meetings
were required by statute or pursuant to
a commitment under the letters
described in section 101(b) of the
[Prescription Drug User Fee Amendments
of 2017] Prescription Drug User Fee
Amendments of 2022.
(iii) The number of new drug
applications and biological licensing
applications approved.
(iv) The number of new drug
applications and biological licensing
applications filed.
(v) For fiscal years 2023 and 2024,
of the meeting requests from sponsors
for which the Secretary has determined
that a face-to-face meeting is
appropriate, the number of face-to-face
meetings requested by sponsors to be
conducted in person (in such manner as
the Secretary shall prescribe on the
internet website of the Food and Drug
Administration), and the number of such
in-person meetings granted by the
Secretary.
(4) Rationale for pdufa program changes.--[Beginning
with fiscal year 2020, the] The Secretary shall include
in the annual report under paragraph (1)--
(A) data, analysis, and discussion of the
changes in the number of full-time equivalents
hired as agreed upon in the letters described
in section 101(b) of the [Prescription Drug
User Fee Amendments of 2017] Prescription Drug
User Fee Amendments of 2022 and the number of
full time equivalents funded by budget
authority at the Food and Drug Administration
by each division within the Center for Drug
Evaluation and Research, the Center for
Biologics Evaluation and Research, the Office
of Regulatory Affairs, and the Office of the
Commissioner;
(B) data, analysis, and discussion of the
changes in the fee revenue amounts and costs
for the process for the review of human drugs,
including identifying drivers of such changes;
and
(C) for each of the Center for Drug
Evaluation and Research, the Center for
Biologics Evaluation and Research, the Office
of Regulatory Affairs, and the Office of the
Commissioner, the number of employees for whom
time reporting is required and the number of
employees for whom time reporting is not
required.
(5) Analysis.--For each fiscal year, the Secretary
shall include in the report under paragraph (1) an
analysis of the following:
(A) The difference between the aggregate
number of human drug applications filed and the
aggregate number of approvals, accounting for--
(i) such applications filed during
one fiscal year for which a decision is
not scheduled to be made until the
following fiscal year;
(ii) the aggregate number of
applications for each fiscal year that
did not meet the goals identified in
the letters described in section 101(b)
of the [Prescription Drug User Fee
Amendments of 2017] Prescription Drug
User Fee Amendments of 2022 for the
applicable fiscal year.
(B) Relevant data to determine whether the
Center for Drug Evaluation and Research and the
Center for Biologics Evaluation and Research
have met performance enhancement goals
identified in the letters described in section
101(b) of the [Prescription Drug User Fee
Amendments of 2017] Prescription Drug User Fee
Amendments of 2022 for the applicable fiscal
year.
(C) The most common causes and trends of
external or other circumstances affecting the
ability of the Center for Drug Evaluation and
Research, the Center for Biologics Evaluation
and Research, Office of Regulatory Affairs, and
the Food and Drug Administration to meet the
review time and performance enhancement goals
identified in the letters described in section
101(b) of the [Prescription Drug User Fee
Amendments of 2017] Prescription Drug User Fee
Amendments of 2022.
(b) Fiscal Report.--[Beginning with fiscal year 2018, not]
Not later than 120 days after the end of each fiscal year for
which fees are collected under this part, the Secretary shall
prepare and submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report on the
implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration,
of the fees collected for such fiscal year.
(c) Corrective Action Report.--[Beginning with fiscal year
2018, for] For each fiscal year for which fees are collected
under this part, the Secretary shall prepare and submit a
corrective action report to the Committee on Energy and
Commerce and the Committee on Appropriations of the House of
Representatives and the Committee on Health, Education, Labor,
and Pensions and the Committee on Appropriations of the Senate.
The report shall include the following information, as
applicable:
(1) Goals met.--For each fiscal year, if the
Secretary determines, based on the analysis under
subsection (a)(5), that each of the goals identified in
the letters described in section 101(b) of the
[Prescription Drug User Fee Amendments of 2017]
Prescription Drug User Fee Amendments of 2022 for the
applicable fiscal year have been met, the corrective
action report shall include recommendations on ways in
which the Secretary can improve and streamline the
human drug application review process.
(2) Goals missed.--For any of the goals identified in
the letters described in section 101(b) of the
[Prescription Drug User Fee Amendments of 2017]
Prescription Drug User Fee Amendments of 2022 for the
applicable fiscal year that the Secretary determines to
not have been met, the corrective action report shall
include--
(A) a detailed justification for such
determination and a description, as applicable,
of the types of circumstances and trends under
which human drug applications that missed the
review goal time were approved during the first
cycle review, or application review goals were
missed; and
(B) with respect to performance enhancement
goals that were not achieved, a description of
efforts the Food and Drug Administration has
put in place for the fiscal year in which the
report is submitted to improve the ability of
such agency to meet each such goal for the such
fiscal year.
(d) Enhanced Communication.--
(1) Communications with congress.--Each fiscal year,
as applicable and requested, representatives from the
Centers with expertise in the review of human drugs
shall meet with representatives from the Committee on
Health, Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the House
of Representatives to report on the contents described
in the reports under this section.
(2) Participation in congressional hearing.--Each
fiscal year, as applicable and requested,
representatives from the Food and Drug Administration
shall participate in a public hearing before the
Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy and Commerce of
the House of Representatives, to report on the contents
described in the reports under this section. Such
hearing shall occur not later than 120 days after the
end of each fiscal year for which fees are collected
under this part.
(e) Public Availability.--The Secretary shall make the
reports required under subsections (a) and (b) available to the
public on the Internet Web site of the Food and Drug
Administration.
(f) Reauthorization.--
(1) Consultation.--In developing recommendations to
present to the Congress with respect to the goals, and
plans for meeting the goals, for the process for the
review of human drug applications for the first 5
fiscal years after [fiscal year 2022] fiscal year 2027,
and for the reauthorization of this part for such
fiscal years, the Secretary shall consult with--
(A) the Committee on Energy and Commerce of
the House of Representatives;
(B) the Committee on Health, Education,
Labor, and Pensions of the Senate;
(C) scientific and academic experts;
(D) health care professionals;
(E) representatives of patient and consumer
advocacy groups; and
(F) the regulated industry.
(2) Prior public input.--Prior to beginning
negotiations with the regulated industry on the
reauthorization of this part, the Secretary shall--
(A) publish a notice in the Federal Register
requesting public input on the reauthorization;
(B) hold a public meeting at which the public
may present its views on the reauthorization,
including specific suggestions for changes to
the goals referred to in subsection (a);
(C) provide a period of 30 days after the
public meeting to obtain written comments from
the public suggesting changes to this part; and
(D) publish the comments on the Food and Drug
Administration's Internet Web site.
(3) Periodic consultation.--Not less frequently than
once every month during negotiations with the regulated
industry, the Secretary shall hold discussions with
representatives of patient and consumer advocacy groups
to continue discussions of their views on the
reauthorization and their suggestions for changes to
this part as expressed under paragraph (2).
(4) Public review of recommendations.--After
negotiations with the regulated industry, the Secretary
shall--
(A) present the recommendations developed
under paragraph (1) to the Congressional
committees specified in such paragraph;
(B) publish such recommendations in the
Federal Register;
(C) provide for a period of 30 days for the
public to provide written comments on such
recommendations;
(D) hold a meeting at which the public may
present its views on such recommendations; and
(E) after consideration of such public views
and comments, revise such recommendations as
necessary.
(5) Transmittal of recommendations.--Not later than
[January 15, 2022] January 15, 2027, the Secretary
shall transmit to the Congress the revised
recommendations under paragraph (4), a summary of the
views and comments received under such paragraph, and
any changes made to the recommendations in response to
such views and comments.
(6) Minutes of negotiation meetings.--
(A) Public availability.--Before presenting
the recommendations developed under paragraphs
(1) through (5) to the Congress, the Secretary
shall make publicly available, on the public
Web site of the Food and Drug Administration,
minutes of all negotiation meetings conducted
under this subsection between the Food and Drug
Administration and the regulated industry.
(B) Content.--The minutes described under
subparagraph (A) shall summarize any
substantive proposal made by any party to the
negotiations as well as significant
controversies or differences of opinion during
the negotiations and their resolution.
* * * * * * *
PART 3--FEES RELATING TO DEVICES
SEC. 737. DEFINITIONS.
For purposes of this part:
(1) The term ``premarket application'' means--
(A) an application for approval of a device
submitted under section 515(c) or section 351
of the Public Health Service Act; or
(B) a product development protocol described
in section 515(f).
Such term does not include a supplement, a premarket
report, or a premarket notification submission.
(2) The term ``premarket report'' means a report
submitted under section 515(c)(2).
(3) The term ``premarket notification submission''
means a report submitted under section 510(k).
(4)(A) The term ``supplement'', with respect to a
panel-track supplement, a 180-day supplement, a real-
time supplement, or an efficacy supplement, means a
request to the Secretary to approve a change in a
device for which--
(i) an application or report has been
approved under section 515(d), or an
application has been approved under section 351
of the Public Health Service Act; or
(ii) a notice of completion has become
effective under section 515(f).
(B) The term ``panel-track supplement'' means a
supplement to an approved premarket application or
premarket report under section 515 that requests a
significant change in design or performance of the
device, or a new indication for use of the device, and
for which substantial clinical data are necessary to
provide a reasonable assurance of safety and
effectiveness.
(C) The term ``180-day supplement'' means a
supplement to an approved premarket application or
premarket report under section 515 that is not a panel-
track supplement and requests a significant change in
components, materials, design, specification, software,
color additives, or labeling.
(D) The term ``real-time supplement'' means a
supplement to an approved premarket application or
premarket report under section 515 that requests a
minor change to the device, such as a minor change to
the design of the device, software, sterilization, or
labeling, and for which the applicant has requested and
the agency has granted a meeting or similar forum to
jointly review and determine the status of the
supplement.
(E) The term ``efficacy supplement'' means a
supplement to an approved premarket application under
section 351 of the Public Health Service Act that
requires substantive clinical data.
(5) The term ``30-day notice'' means a notice under
section 515(d)(5) that is limited to a request to make
modifications to manufacturing procedures or methods of
manufacture affecting the safety and effectiveness of
the device.
(6) The term ``request for classification
information'' means a request made under section 513(g)
for information respecting the class in which a device
has been classified or the requirements applicable to a
device.
(7) The term ``annual fee'', for periodic reporting
concerning a class III device, means the annual fee
associated with periodic reports required by a
premarket application approval order.
(8) The term ``de novo classification request'' means
a request made under section 513(f)(2)(A) with respect
to the classification of a device.
(9) The term ``process for the review of device
applications'' means the following activities of the
Secretary with respect to the review of premarket
applications, premarket reports, supplements, [and
premarket notification submissions] premarket
notification submissions, and de novo classification
requests:
(A) The activities necessary for the review
of premarket applications, premarket reports,
supplements, and premarket notification
submissions.
(B) The issuance of action letters that allow
the marketing of devices or which set forth in
detail the specific deficiencies in such
applications, reports, supplements, or
submissions and, where appropriate, the actions
necessary to place them in condition for
approval.
(C) The inspection of manufacturing
establishments and other facilities undertaken
as part of the Secretary's review of pending
premarket applications, premarket reports, and
supplements.
(D) Monitoring of research conducted in
connection with the review of such
applications, reports, supplements, [and
submissions] submissions, and requests.
(E) Review of device applications subject to
section 351 of the Public Health Service Act
for an investigational new drug application
under section 505(i) or for an investigational
device exemption under section 520(g) and
activities conducted in anticipation of the
submission of such applications under section
505(i) or 520(g).
(F) The development of guidance, policy
documents, or regulations to improve the
process for the review of premarket
applications, premarket reports, supplements,
[and premarket notification submissions]
premarket notification submissions, and de novo
classification requests.
(G) The development of voluntary test
methods, consensus standards, or mandatory
performance standards under section 514 in
connection with the review of such
applications, reports, supplements, [or
submissions] submissions, or requests and
related activities.
(H) The provision of technical assistance to
device manufacturers in connection with the
submission of such applications, reports,
supplements, [or submissions] submissions, or
requests.
(I) Any activity undertaken under section 513
or 515(i) in connection with the initial
classification or reclassification of a device
or under section 515(b) in connection with any
requirement for approval of a device.
(J) Evaluation of postmarket studies required
as a condition of an approval of a premarket
application or premarket report under section
515 or a premarket application under section
351 of the Public Health Service Act.
(K) Compiling, developing, and reviewing
information on relevant devices to identify
safety and effectiveness issues for devices
subject to premarket applications, premarket
reports, supplements, [or premarket
notification submissions] premarket
notification submissions, or de novo
classification requests.
(10) The term ``costs of resources allocated for the
process for the review of device applications'' means
the expenses in connection with the process for the
review of device applications for--
(A) officers and employees of the Food and
Drug Administration, contractors of the Food
and Drug Administration, advisory committees,
and costs related to such officers, employees,
and committees and to contracts with such
contractors;
(B) management of information, and the
acquisition, maintenance, and repair of
computer resources;
(C) leasing, maintenance, renovation, and
repair of facilities and acquisition,
maintenance, and repair of fixtures, furniture,
scientific equipment, and other necessary
materials and supplies; and
(D) collecting fees and accounting for
resources allocated for the review of premarket
applications, premarket reports, supplements,
submissions, and de novo classification
requests.
(11) The term ``adjustment factor'' applicable to a
fiscal year is the Consumer Price Index for all urban
consumers (all items; United States city average) for
October of the preceding fiscal year divided by such
Index for October [2016] 2021.
(12) The term ``person'' includes an affiliate
thereof.
(13) The term ``affiliate'' means a business entity
that has a relationship with a second business entity
(whether domestic or international) if, directly or
indirectly--
(A) one business entity controls, or has the
power to control, the other business entity; or
(B) a third party controls, or has power to
control, both of the business entities.
(14) The term ``establishment subject to a
registration fee'' means an establishment that is
registered (or is required to register) with the
Secretary under section 510 because such establishment
is engaged in the manufacture, preparation,
propagation, compounding, or processing of a device.
SEC. 738. AUTHORITY TO ASSESS AND USE DEVICE FEES.
(a) Types of Fees.--
(1) In general.--Beginning in [fiscal year 2018]
fiscal year 2023, the Secretary shall assess and
collect fees in accordance with this section.
(2) Premarket application, premarket report,
supplement, and submission fee, and annual fee for
periodic reporting concerning a class iii device.--
(A) In general.--Except as provided in
subparagraph (B) and subsections (d) and (e)
each person who submits any of the following,
on or after [October 1, 2017] October 1, 2022,
shall be subject to a fee established under
subsection (c) for the fiscal year involved in
accordance with the following:
(i) A premarket application.
(ii) For a premarket report, a fee
equal to the fee that applies under
clause (i).
(iii) For a panel track supplement, a
fee equal to [75 percent] 80 percent of
the fee that applies under clause (i).
(iv) For a 180-day supplement, a fee
equal to 15 percent of the fee that
applies under clause (i).
(v) For a real-time supplement, a fee
equal to 7 percent of the fee that
applies under clause (i).
(vi) For a 30-day notice, a fee equal
to 1.6 percent of the fee that applies
under clause (i).
(vii) For an efficacy supplement, a
fee equal to the fee that applies under
clause (i).
(viii) For a premarket notification
submission, a fee equal to [3.4
percent] 4.5 percent of the fee that
applies under clause (i).
(ix) For a request for classification
information, a fee equal to 1.35
percent of the fee that applies under
clause (i).
(x) For periodic reporting concerning
a class III device, an annual fee equal
to 3.5 percent of the fee that applies
under clause (i).
(xi) For a de novo classification
request, a fee equal to 30 percent of
the fee that applies under clause (i).
(B) Exceptions.--
(i) Humanitarian device exemption.--
An application under section 520(m) is
not subject to any fee under
subparagraph (A).
(ii) Further manufacturing use.--No
fee shall be required under
subparagraph (A) for the submission of
a premarket application under section
351 of the Public Health Service Act
for a product licensed for further
manufacturing use only.
(iii) State or federal government
sponsors.--No fee shall be required
under subparagraph (A) for a premarket
application, premarket report,
supplement, [or premarket notification
submission] premarket notification
submission, or de novo classification
request submitted by a State or Federal
Government entity unless the device
involved is to be distributed
commercially.
(iv) Premarket notifications by third
parties.--No fee shall be required
under subparagraph (A) for a premarket
notification submission reviewed by an
accredited person pursuant to section
523.
(v) Pediatric conditions of use.--
(I) In general.--No fee shall
be required under subparagraph
(A) for a premarket
application, premarket report,
premarket notification
submission, or de novo
classification request if the
proposed conditions of use for
the device involved are solely
for a pediatric population. No
fee shall be required under
such subparagraph for a
supplement if the sole purpose
of the supplement is to propose
conditions of use for a
pediatric population.
(II) Subsequent proposal of
adult conditions of use.--In
the case of a person who
submits a premarket application
or premarket report for which,
under subclause (I), a fee
under subparagraph (A) is not
required, any supplement to
such application that proposes
conditions of use for any adult
population is subject to the
fee that applies under such
subparagraph for a premarket
application.
(C) Payment.--The fee required by
subparagraph (A) shall be due upon submission
of the premarket application, premarket report,
supplement, premarket notification submission,
30-day notice, request for classification
information, [or periodic reporting concerning
a class III device] periodic reporting
concerning a class III device, or de novo
classification request. Applicants submitting
portions of applications pursuant to section
515(c)(4) shall pay such fees upon submission
of the first portion of such applications.
(D) Refunds.--
(i) Application refused for filing.--
The Secretary shall refund 75 percent
of the fee paid under subparagraph (A)
for any application, report, or
supplement that is refused for filing.
(ii) Application withdrawn before
filing.--The Secretary shall refund 75
percent of the fee paid under
subparagraph (A) for any application,
report, or supplement that is withdrawn
prior to the filing decision of the
Secretary.
(iii) Application withdrawn before
first action.--After receipt of a
request for a refund of the fee paid
under subparagraph (A) for a premarket
application, premarket report, or
supplement that is withdrawn after
filing but before a first action, the
Secretary may return some or all of the
fee. The amount of refund, if any,
shall be based on the level of effort
already expended on the review of such
application, report, or supplement.
(iv) Modular applications withdrawn
before first action.--The Secretary
shall refund 75 percent of the
application fee paid for an application
submitted under section 515(c)(4) that
is withdrawn before a second portion is
submitted and before a first action on
the first portion.
(v) Later withdrawn modular
applications.--If an application
submitted under section 515(c)(4) is
withdrawn after a second or subsequent
portion is submitted but before any
first action, the Secretary may return
a portion of the fee. The amount of
refund, if any, shall be based on the
level of effort already expended on the
review of the portions submitted.
(vi) Sole discretion to refund.--The
Secretary shall have sole discretion to
refund a fee or portion of the fee
under clause (iii) or (v). A
determination by the Secretary
concerning a refund under clause (iii)
or (v) shall not be reviewable.
(3) Annual establishment registration fee.--
(A) In general.--Except as provided in
subparagraph (B), each establishment subject to
a registration fee shall be subject to a fee
for each initial or annual registration under
section 510 beginning with its registration for
fiscal year 2008.
(B) Exception.--No fee shall be required
under subparagraph (A) for an establishment
operated by a State or Federal governmental
entity or an Indian tribe (as defined in the
Indian Self Determination and Educational
Assistance Act), unless a device manufactured
by the establishment is to be distributed
commercially.
(C) Payment.--The fee required under
subparagraph (A) shall be due once each fiscal
year, upon the later of--
(i) the initial or annual
registration (as applicable) of the
establishment under section 510; or
(ii) the first business day after the
date of enactment of an appropriations
Act providing for the collection and
obligation of fees for such year under
this section.
(b) Fee Amounts.--
(1) In general.--Subject to subsections (c), (d),
(e), and (h), for each of fiscal years [2018 through
2022] 2023 through 2027, fees under subsection (a)
shall be derived from the base fee amounts specified in
paragraph (2), to generate the total revenue amounts
specified in paragraph (3).
[(2) Base fee amounts specified.--For purposes of
paragraph (1), the base fee amounts specified in this
paragraph are as follows:
----------------------------------------------------------------------------------------------------------------
Fiscal Fiscal Fiscal Fiscal Fiscal
[Fee Type Year 2018 Year 2019 Year 2020 Year 2021 Year 2022
----------------------------------------------------------------------------------------------------------------
Premarket Application.................................... $294,000 $300,000 $310,000 $328,000 $329,000
Establishment Registration............................... $4,375 $4,548 $4,760 $4,975 $4,978]
----------------------------------------------------------------------------------------------------------------
(2) Base fee amounts specified.--For purposes of
paragraph (1), the base fee amounts specified in this
paragraph are as follows:
----------------------------------------------------------------------------------------------------------------
Fiscal Fiscal Fiscal Fiscal Fiscal
Fee Type Year 2023 Year 2024 Year 2025 Year 2026 Year 2027
----------------------------------------------------------------------------------------------------------------
Premarket Application.................................... $425,000 $435,000 $445,000 $455,000 $470,000
Establishment Registration............................... $6,250 $6,875 $7,100 $7,575 $8,465
----------------------------------------------------------------------------------------------------------------
[(3) Total revenue amounts specified.--For purposes
of paragraph (1), the total revenue amounts specified
in this paragraph are as follows:
[(A) $183,280,756 for fiscal year 2018.
[(B) $190,654,875 for fiscal year 2019.
[(C) $200,132,014 for fiscal year 2020.
[(D) $211,748,789 for fiscal year 2021.
[(E) $213,687,660 for fiscal year 2022.]
(3) Total revenue amounts specified.--For purposes of
paragraph (1), the total revenue amounts specified in
this paragraph are as follows:
(A) $312,606,000 for fiscal year 2023.
(B) $335,750,000 for fiscal year 2024.
(C) $350,746,400 for fiscal year 2025.
(D) $366,486,300 for fiscal year 2026.
(E) $418,343,000 for fiscal year 2027.
(c) Annual Fee Setting; Adjustments.--
(1) In general.--The Secretary shall, 60 days before
the start of each fiscal year after September 30,
[2017] 2022, establish fees under subsection (a), based
on amounts specified under subsection (b) and the
adjustments provided under this subsection, and publish
such fees, and the rationale for any adjustments to
such fees, in the Federal Register.
(2) Inflation adjustments.--
(A) Adjustment to total revenue amounts.--For
fiscal year [2018] 2023 and each subsequent
fiscal year, the Secretary shall adjust the
total revenue amount specified in subsection
(b)(3) for such fiscal year by multiplying such
amount by the applicable inflation adjustment
under subparagraph (B) for such year.
(B) Applicable inflation adjustment.--The
applicable inflation adjustment for [fiscal
year 2018] fiscal year 2023 and each subsequent
fiscal year is the product of--
(i) the base inflation adjustment
under subparagraph (C) for such fiscal
year; and
(ii) the product of the base
inflation adjustment under subparagraph
(C) for each of the fiscal years
preceding such fiscal year, beginning
with [fiscal year 2016] fiscal year
2022.
(C) Base inflation adjustment.--
(i) In general.--Subject to further
adjustment under clause (ii), the base
inflation adjustment for a fiscal year
is the sum of one plus--
(I) the average annual
percent change in the cost, per
full-time equivalent position
of the Food and Drug
Administration, of all
personnel compensation and
benefits paid with respect to
such positions for the first 3
years of the preceding 4 fiscal
years, multiplied by 0.60; and
(II) the average annual
percent change that occurred in
the Consumer Price Index for
urban consumers ([Washington-
Baltimore, DC-MD-VA-WV]
Washington-Arlington-
Alexandria, DC-VA-MD-WV; Not
Seasonally Adjusted; All items;
Annual Index) for the first 3
years of the preceding 4 years
of available data multiplied by
0.40.
(ii) Limitations.--For purposes of
subparagraph (B), if the base inflation
adjustment for a fiscal year under
clause (i)--
(I) is less than 1, such
adjustment shall be considered
to be equal to 1; or
(II) is greater than 1.04,
such adjustment shall be
considered to be equal to 1.04.
(D) Adjustment to base fee amounts.--For each
of [fiscal years 2018 through 2022] fiscal
years 2023 through 2027, the Secretary shall--
(i) adjust the base fee amounts
specified in subsection (b)(2) for such
fiscal year by multiplying such amounts
by the applicable inflation adjustment
under subparagraph (B) for such year;
and
(ii) if the Secretary determines
necessary, increase (in addition to the
adjustment under clause (i)) such base
fee amounts, on a uniform proportionate
basis, to generate the total revenue
amounts under subsection (b)(3), as
adjusted for inflation under
subparagraph (A).
(3) Volume-based adjustments to establishment
registration base fees.--For each of fiscal years [2018
through 2022] 2023 through 2027, after the base fee
amounts specified in subsection (b)(2) are adjusted
under paragraph (2)(D), the base establishment
registration fee amounts specified in such subsection
shall be increased, as the Secretary estimates is
necessary in order for total fee collections for such
fiscal year to generate the total revenue amounts, as
adjusted under paragraph (2).
(4) Performance improvement adjustment.--
(A) In general.--For each of fiscal years
2025 through 2027, after the adjustments under
paragraphs (2) and (3), the base establishment
registration fee amounts for such fiscal year
shall be increased to reflect changes in the
resource needs of the Secretary due to improved
review performance goals for the process for
the review of device applications identified in
the letters described in section 201(b) of the
Medical Device User Fee Amendments of 2022, as
the Secretary determines necessary to achieve
an increase in total fee collections for such
fiscal year equal to the following amounts:
(i) For fiscal year 2025, the product
of--
(I) the amount determined
under subparagraph (B)(i)(I);
and
(II) the applicable inflation
adjustment under paragraph
(2)(B) for such fiscal year.
(ii) For fiscal year 2026, the
product of--
(I) the sum of the amounts
determined under subparagraphs
(B)(i)(II), (B)(ii)(I), and
(B)(iii)(I); and
(II) the applicable inflation
adjustment under paragraph
(2)(B) for such fiscal year.
(iii) For fiscal year 2027, the
product of--
(I) the sum of the amounts
determined under subparagraphs
(B)(i)(III), (B)(ii)(II), and
(B)(iii)(II); and
(II) the applicable inflation
adjustment under paragraph
(2)(B) for such fiscal year.
(B) Amounts.--
(i) Pre-submission amount.--For
purposes of subparagraph (A), with
respect to the pre-submission written
feedback goal, the amounts determined
under this subparagraph are as follows:
(I) For fiscal year 2025,
$15,396,600 if such goal for
fiscal year 2023 is met.
(II) For fiscal year 2026:
(aa) $15,396,600 if
such goal for fiscal
year 2023 is met and
such goal for fiscal
year 2024 is not met.
(bb) $36,792,200 if
such goal for fiscal
year 2024 is met.
(III) For fiscal year 2027:
(aa) $15,396,600 if
such goal for fiscal
year 2023 is met and
such goal for each of
fiscal years 2024 and
2025 is not met.
(bb) $36,792,200 if
such goal for fiscal
year 2024 is met and
such goal for fiscal
year 2025 is not met.
(cc) $40,572,600 if
such goal for fiscal
year 2025 is met.
(ii) De novo classification amount.--
For purposes of subparagraph (A), with
respect to the de novo decision goal,
the amounts determined under this
subparagraph are as follows:
(I) For fiscal year 2026,
$6,323,500 if such goal for
fiscal year 2023 is met.
(II) For fiscal year 2027:
(aa) $6,323,500 if
such goal for fiscal
year 2023 is met and
such goal for fiscal
year 2024 is not met.
(bb) $11,765,400 if
such goal for fiscal
year 2024 is met.
(iii) Premarket notification and
premarket approval amount.--For
purposes of subparagraph (A), with
respect to the 510(k) decision goal,
510(k) shared outcome total time to
decision goal, PMA decision goal, and
PMA shared outcome total time to
decision goal, the amounts determined
under this subparagraph are as follows:
(I) For fiscal year 2026,
$1,020,000 if the four goals
for fiscal year 2023 are met.
(II) For fiscal year 2027:
(aa) $1,020,000 if
the four goals for
fiscal year 2023 are
met and one or more of
the four goals for
fiscal year 2024 are
not met.
(bb) $3,906,000 if
the four goals for
fiscal year 2024 are
met.
(C) Performance calculation.--For purposes of
this paragraph, performance of the goals listed
in subparagraph (D) shall be determined as
specified in the letters described in section
201(b) of the Medical Device User Fee
Amendments of 2022 and based on data available
as of the following dates:
(i) The performance of the pre-
submission written feedback goal shall
be based on data available as of--
(I) for fiscal year 2023,
March 31, 2024;
(II) for fiscal year 2024,
March 31, 2025; and
(III) for fiscal year 2025,
March 31, 2026.
(ii) The performance of the de novo
decision goal, 510(k) decision goal,
510(k) shared outcome total time to
decision goal, PMA decision goal, and
PMA shared outcome total time to
decision goal shall be based on data
available as of--
(I) for fiscal year 2023,
March 31, 2025; and
(II) for fiscal year 2024,
March 31, 2026.
(D) Goals defined.--For purposes of this
paragraph, the terms ``pre-submission written
feedback goal'', ``de novo decision goal'',
``510(k) decision goal'', ``510(k) shared
outcome total time to decision goal'', ``PMA
decision goal'', and ``PMA shared outcome total
time to decision goal'' refer to the goals
identified by the same names in the letters
described in section 201(b) of the Medical
Device User Fee Amendments of 2022.
(5) Hiring adjustment.--
(A) In general.--For each of fiscal years
2025 through 2027, after the adjustments under
paragraphs (2), (3), and (4), if applicable, if
the number of hires to support the process for
the review of device applications falls below
the thresholds specified in subparagraph (B)
for the applicable fiscal years, the base
establishment registration fee amounts shall be
decreased as the Secretary determines necessary
to achieve a reduction in total fee collections
equal to the hiring adjustment amount under
subparagraph (C).
(B) Thresholds.--The thresholds specified in
this subparagraph are as follows:
(i) For fiscal year 2025, the
threshold is 123 hires for fiscal year
2023.
(ii) For fiscal year 2026, the
threshold is 38 hires for fiscal year
2024.
(iii) For fiscal year 2027, the
threshold is--
(I) 22 hires for fiscal year
2025 if the base establishment
registration fees are not
increased by the amount
determined under paragraph
(4)(A)(i); or
(II) 75 hires for fiscal year
2025 if such fees are so
increased.
(C) Hiring adjustment amount.--The hiring
adjustment amount for fiscal year 2025 and each
subsequent fiscal year is the product of--
(i) the number of hires by which the
hiring goal specified in subparagraph
(D) for the fiscal year before the
prior fiscal year was not met;
(ii) $72,877; and
(iii) the applicable inflation
adjustment under paragraph (2)(B) for
the fiscal year for which the hiring
goal was not met.
(D) Hiring goals.--The hiring goals for each
of fiscal years 2023 through 2025 are as
follows:
(i) For fiscal year 2023, 144 hires.
(ii) For fiscal year 2024, 42 hires.
(iii) For fiscal year 2025:
(I) 24 hires if the base
establishment registration fees
are not increased by the amount
determined under paragraph
(4)(A)(i).
(II) 83 hires if the base
establishment registration fees
are increased by the amount
determined under paragraph
(4)(A)(i).
(E) Number of hires.--For purposes of this
paragraph, the number of hires shall be
determined by the Secretary as set forth in the
letters described in section 201(b) of the
Medical Device User Fee Amendments of 2022.
(6) Operating reserve adjustment.--
(A) In general.--For each of fiscal years
2023 through 2027, after the adjustments under
paragraphs (2), (3), (4), and (5), if
applicable, if the Secretary has operating
reserves of carryover user fees for the process
for the review of device applications in excess
of the designated amount in subparagraph (B),
the Secretary shall decrease the base
establishment registration fee amounts to
provide for not more than such designated
amount of operating reserves.
(B) Designated amount.--Subject to
subparagraph (C), for each fiscal year, the
designated amount in this subparagraph is equal
to the sum of--
(i) 13 weeks of operating reserves of
carryover user fees; and
(ii) 1 month of operating reserves
maintained pursuant to paragraph (8).
(C) Excluded amount.--For the period of
fiscal years 2023 through 2026, a total amount
equal to $118,000,000 shall not be considered
part of the designated amount under
subparagraph (B) and shall not be subject to
the decrease under subparagraph (A).
[(4)] (7) Limit.--The total amount of fees charged,
as adjusted under this subsection, for a fiscal year
may not exceed the total costs for such fiscal year for
the resources allocated for the process for the review
of device applications.
[(5)] (8) Supplement.--
(A) In general.--The Secretary may use
unobligated carryover balances from fees
collected in previous fiscal years to ensure
that sufficient fee revenues are available in
that fiscal year, so long as the Secretary
maintains unobligated carryover balances of not
less than 1 month of operating reserves for the
first month of the next fiscal year.
(B) Notice to congress.--Not later than 14
days before the Secretary anticipates the use
of funds described in subparagraph (A), the
Secretary shall provide notice to the Committee
on Health, Education, Labor, and Pensions and
the Committee on Appropriations of the Senate
and the Committee on Energy and Commerce and
the Committee on Appropriations of the House of
Representatives.
(d) Small Businesses; Fee Waiver and Fee Reduction Regarding
Premarket Approval Fees.--
(1) In general.--The Secretary shall grant a waiver
of the fee required under subsection (a) for one
premarket application, or one premarket report, where
the Secretary finds that the applicant involved is a
small business submitting its first premarket
application to the Secretary, or its first premarket
report, respectively, for review. For the purposes of
this paragraph, the term ``small business'' means an
entity that reported $30,000,000 or less of gross
receipts or sales in its most recent Federal income tax
return for a taxable year, including such returns of
all of its affiliates. In addition, for subsequent
premarket applications, premarket reports, and
supplements where the Secretary finds that the
applicant involved is a small business, the fees
specified in clauses (i) through (vii) and clauses
(ix), (x), and (xi) of subsection (a)(2)(A) may be paid
at a reduced rate in accordance with paragraph (2)(C).
(2) Rules relating to premarket approval fees.--
(A) Definition.--For purposes of this
paragraph, the term ``small business'' means an
entity that reported $100,000,000 or less of
gross receipts or sales in its most recent
Federal income tax return for a taxable year,
including such returns of all of its
affiliates.
(B) Evidence of qualification.--
(i) In general.--An applicant shall
pay the higher fees established by the
Secretary each year unless the
applicant submits evidence that it
qualifies for a waiver of the fee or
the lower fee rate.
(ii) Firms submitting tax returns to
the united states internal revenue
service.--The applicant shall support
its claim that it meets the definition
under subparagraph (A) by submission of
a copy of its most recent Federal
income tax return for a taxable year,
and a copy of such returns of its
affiliates, which show an amount of
gross sales or receipts that is less
than the maximum established in
subparagraph (A). The applicant, and
each of such affiliates, shall certify
that the information provided is a true
and accurate copy of the actual tax
forms they submitted to the Internal
Revenue Service. If no tax forms are
submitted for any affiliate, the
applicant shall certify that the
applicant has no affiliates.
(iii) Firms not submitting tax
returns to the united states internal
revenue service.--In the case of an
applicant that has not previously
submitted a Federal income tax return,
the applicant and each of its
affiliates shall demonstrate that it
meets the definition under subparagraph
(A) by submission of a signed
certification, in such form as the
Secretary may direct through a notice
published in the Federal Register, that
the applicant or affiliate meets the
criteria for a small business and a
certification, in English, from the
national taxing authority, if extant,
of the country in which the applicant
or, if applicable, affiliate is
headquartered. The certification from
such taxing authority shall bear the
official seal of such taxing authority
and shall provide the applicant's or
affiliate's gross receipts or sales for
the most recent year in both the local
currency of such country and in United
States dollars, the exchange rate used
in converting such local currency to
dollars, and the dates during which
these receipts or sales were collected.
The applicant shall also submit a
statement signed by the head of the
applicant's firm or by its chief
financial officer that the applicant
has submitted certifications for all of
its affiliates, or that the applicant
has no affiliates.
(C) Reduced fees.--Where the Secretary finds
that the applicant involved meets the
definition under subparagraph (A), the fees
established under subsection (c)(1) may be paid
at a reduced rate of--
(i) 25 percent of the fee established
under such subsection for a premarket
application, a premarket report, a
supplement, periodic reporting
concerning a class III device, or a de
novo classification request; and
(ii) 50 percent of the fee
established under such subsection for a
30-day notice or a request for
classification information.
(D) Request for fee waiver or reduction.--An
applicant seeking a fee waiver or reduction
under this subsection shall submit supporting
information to the Secretary at least 60 days
before the fee is required pursuant to
subsection (a). The decision of the Secretary
regarding whether an entity qualifies for such
a waiver or reduction is not reviewable.
(e) Small Businesses; Fee Reduction Regarding Premarket
Notification Submissions.--
(1) In general.--For fiscal year 2008 and each
subsequent fiscal year, where the Secretary finds that
the applicant involved is a small business, the fee
specified in subsection (a)(2)(A)(viii) may be paid at
a reduced rate in accordance with paragraph (2)(C).
(2) Rules relating to premarket notification
submissions.--
(A) Definition.--For purposes of this
subsection, the term ``small business'' means
an entity that reported $100,000,000 or less of
gross receipts or sales in its most recent
Federal income tax return for a taxable year,
including such returns of all of its
affiliates.
(B) Evidence of qualification.--
(i) In general.--An applicant shall
pay the higher fees established by the
Secretary each year unless the
applicant submits evidence that it
qualifies for the lower fee rate.
(ii) Firms submitting tax returns to
the united states internal revenue
service.--The applicant shall support
its claim that it meets the definition
under subparagraph (A) by submission of
a copy of its most recent Federal
income tax return for a taxable year,
and a copy of such returns of its
affiliates, which show an amount of
gross sales or receipts that is less
than the maximum established in
subparagraph (A). The applicant, and
each of such affiliates, shall certify
that the information provided is a true
and accurate copy of the actual tax
forms they submitted to the Internal
Revenue Service. If no tax forms are
submitted for any affiliate, the
applicant shall certify that the
applicant has no affiliates.
(iii) Firms not submitting tax
returns to the united states internal
revenue service.--In the case of an
applicant that has not previously
submitted a Federal income tax return,
the applicant and each of its
affiliates shall demonstrate that it
meets the definition under subparagraph
(A) by submission of a signed
certification, in such form as the
Secretary may direct through a notice
published in the Federal Register, that
the applicant or affiliate meets the
criteria for a small business and a
certification, in English, from the
national taxing authority, if extant,
of the country in which the applicant
or, if applicable, affiliate is
headquartered. The certification from
such taxing authority shall bear the
official seal of such taxing authority
and shall provide the applicant's or
affiliate's gross receipts or sales for
the most recent year in both the local
currency of such country and in United
States dollars, the exchange rate used
in converting such local currency to
dollars, and the dates during which
these receipts or sales were collected.
The applicant shall also submit a
statement signed by the head of the
applicant's firm or by its chief
financial officer that the applicant
has submitted certifications for all of
its affiliates, or that the applicant
has no affiliates.
(C) Reduced fees.--For fiscal year 2008 and
each subsequent fiscal year, where the
Secretary finds that the applicant involved
meets the definition under subparagraph (A),
the fee for a premarket notification submission
may be paid at 25 percent of the fee that
applies under subsection (a)(2)(A)(viii), and
as established under subsection (c)(1).
(D) Request for reduction.--An applicant
seeking a fee reduction under this subsection
shall submit supporting information to the
Secretary at least 60 days before the fee is
required pursuant to subsection (a). The
decision of the Secretary regarding whether an
entity qualifies for such a reduction is not
reviewable.
(f) Effect of Failure To Pay Fees.--
(1) No acceptance of submissions.--A premarket
application, premarket report, supplement, premarket
notification submission, 30-day notice, request for
classification information, periodic reporting
concerning a class III device, or de novo
classification request submitted by a person subject to
fees under subsections (a)(2) and (a)(3) shall be
considered incomplete and shall not be accepted by the
Secretary until all such fees owed by such person have
been paid.
(2) No registration.--Registration information
submitted under section 510 by an establishment subject
to a registration fee shall be considered incomplete
and shall not be accepted by the Secretary until the
registration fee under subsection (a)(3) owed for the
establishment has been paid. Until the fee is paid and
the registration is complete, the establishment is
deemed to have failed to register in accordance with
section 510.
(g) Conditions.--
(1) Performance goals; termination of program.--With
respect to the amount that, under the salaries and
expenses account of the Food and Drug Administration,
is appropriated for a fiscal year for devices and
radiological products, fees may not be assessed under
subsection (a) for the fiscal year, and the Secretary
is not expected to meet any performance goals
identified for the fiscal year, if--
(A) the amount so appropriated for the fiscal
year, excluding the amount of fees appropriated
for the fiscal year, is more than 1 percent
less than [$320,825,000] $398,566,000
multiplied by the adjustment factor applicable
to such fiscal year; or
(B) fees were not assessed under subsection
(a) for the previous fiscal year.
(2) Authority.--If the Secretary does not assess fees
under subsection (a) during any portion of a fiscal
year because of paragraph (1) and if at a later date in
such fiscal year the Secretary may assess such fees,
the Secretary may assess and collect such fees, without
any modification in the rate for premarket
applications, supplements, premarket reports, premarket
notification submissions, 30-day notices, requests for
classification information, periodic reporting
concerning a class III device, de novo classification
requests, and establishment registrations at any time
in such fiscal year, notwithstanding the provisions of
subsection (a) relating to the date fees are to be
paid.
(3) Limitation.--Beginning on October 1, 2023, the
authorities under section 737(9)(C) shall include only
leasing and necessary scientific equipment.
(h) Crediting and Availability of Fees.--
(1) In general.--Subject to paragraph (2)(C), fees
authorized under subsection (a) shall be collected and
available for obligation only to the extent and in the
amount provided in advance in appropriation Acts. Such
fees are authorized to be appropriated to remain
available until expended. Such sums as may be necessary
may be transferred from the Food and Drug
Administration salaries and expenses appropriation
account without fiscal year limitation to such
appropriation account for salaries and expenses with
such fiscal year limitation. The sums transferred shall
be available solely for the process for the review of
device applications.
(2) Collections and appropriation acts.--
(A) In general.--The fees authorized by this
section--
(i) subject to subparagraph (C),
shall be collected and available in
each fiscal year in an amount not to
exceed the amount specified in
appropriation Acts, or otherwise made
available for obligation, for such
fiscal year, and
(ii) shall be available to defray
increases in the costs of the resources
allocated for the process for the
review of device applications
(including increases in such costs for
an additional number of full-time
equivalent positions in the Department
of Health and Human Services to be
engaged in such process) over such
costs, excluding costs paid from fees
collected under this section, for
fiscal year 2009 multiplied by the
adjustment factor.
(B) Compliance.--
(i) In general.--The Secretary shall
be considered to have met the
requirements of subparagraph (A)(ii) in
any fiscal year if the costs funded by
appropriations and allocated for the
process for the review of device
applications--
(I) are not more than 3 percent below
the level specified in subparagraph
(A)(ii); or
(II)(aa) are more than 3 percent
below the level specified in
subparagraph (A)(ii), and fees assessed
for a subsequent fiscal year are
decreased by the amount in excess of 3
percent by which such costs fell below
the level specified in such
subparagraph; and
(bb) such costs are not more than 5
percent below the level specified in
such subparagraph.
(ii) More than 5 percent.--To the
extent such costs are more than 5
percent below the specified level in
subparagraph (A)(ii), fees may not be
collected under this section for that
fiscal year.
(C) Provision for early payments.--Payment of
fees authorized under this section for a fiscal
year, prior to the due date for such fees, may
be accepted by the Secretary in accordance with
authority provided in advance in a prior year
appropriations Act.
[(3) Authorizations of appropriations.--For each of
the fiscal years 2018 through 2022, there is authorized
to be appropriated for fees under this section an
amount equal to the total revenue amount specified
under subsection (b)(3) for the fiscal year, as
adjusted under subsection (c).]
(3) Authorization of appropriations.--
(A) In general.--For each of fiscal years
2023 through 2027, there is authorized to be
appropriated for fees under this section an
amount equal to the revenue amount determined
under subparagraph (B), less the amount of
reductions determined under subparagraph (C).
(B) Revenue amount.--For purposes of this
paragraph, the revenue amount for each fiscal
year is the sum of--
(i) the total revenue amount under
subsection (b)(3) for the fiscal year,
as adjusted under paragraphs (2) and
(3) of subsection (c); and
(ii) the performance improvement
adjustment amount for the fiscal year
under subsection (c)(4), if applicable.
(C) Reductions.--For purposes of this
paragraph, the amount of reductions for each
fiscal year is the sum of--
(i) the hiring adjustment amount for
the fiscal year under subsection
(c)(5), if applicable; and
(ii) the operating reserve adjustment
amount for the fiscal year under
subsection (c)(6), if applicable.
(i) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed under
subsection (a) within 30 days after it is due, such fee shall
be treated as a claim of the United States Government subject
to subchapter II of chapter 37 of title 31, United States Code.
(j) Written Requests for Refunds.--To qualify for
consideration for a refund under subsection (a)(2)(D), a person
shall submit to the Secretary a written request for such refund
not later than 180 days after such fee is due.
(k) Construction.--This section may not be construed to
require that the number of full-time equivalent positions in
the Department of Health and Human Services, for officers,
employees, and advisory committees not engaged in the process
of the review of device applications, be reduced to offset the
number of officers, employees, and advisory committees so
engaged.
SEC. 738A. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Reports.--
(1) Performance report.--
(A) In general.--
(i) General requirements.--
Beginning with [fiscal year
2018] fiscal year 2023, for
each fiscal year for which fees
are collected under this part,
the Secretary shall prepare and
submit to the Committee on
Health, Education, Labor, and
Pensions of the Senate and the
Committee on Energy and
Commerce of the House of
Representatives annual reports
concerning the progress of the
Food and Drug Administration in
achieving the goals identified
in the letters described in
section 201(b) of the [Medical
Device User Fee Amendments of
2017] Medical Device User Fee
Amendments of 2022 during such
fiscal year and the future
plans of the Food and Drug
Administration for meeting the
goals.
(ii) Additional
information.--Beginning with
[fiscal year 2018] fiscal year
2023, the annual report under
this subparagraph shall include
the progress of the Center for
Devices and Radiological Health
in achieving the goals, and
future plans for meeting the
goals, including--
(I) the number of
premarket applications
filed under section 515
per fiscal year for
each review division;
(II) the number of
reports submitted under
section 510(k) per
fiscal year for each
review division; and
(III) the number of
expedited development
and priority review
designations under
section 515C per fiscal
year.
(iii) Real time reporting.--
(I) In general.--Not
later than 30 calendar
days after the end of
the second quarter of
[fiscal year 2018]
fiscal year 2023, and
not later than 30
calendar days after the
end of each quarter of
each fiscal year
thereafter, the
Secretary shall post
the data described in
subclause (II) on the
internet website of the
Food and Drug
Administration for such
quarter and on a
cumulative basis for
such fiscal year, and
may remove duplicative
data from the annual
report under this
subparagraph.
(II) Data.--The
Secretary shall post
the following data in
accordance with
subclause (I):
(aa) The
number and
titles of draft
and final
guidance on
topics related
to the process
for the review
of devices, and
whether such
guidances were
issued as
required by
statute or
pursuant to the
letters
described in
section 201(b)
of the [Medical
Device User Fee
Amendments of
2017] Medical
Device User Fee
Amendments of
2022; and
(bb) The
number and
titles of
public meetings
held on topics
related to the
process for the
review of
devices, and if
such meetings
were required
by statute or
pursuant to a
commitment
under the
letters
described in
section 201(b)
of the [Medical
Device User Fee
Amendments of
2017] Medical
Device User Fee
Amendments of
2022.
(iv) Rationale for mdufa
program changes.--Beginning
with [fiscal year 2020] fiscal
year 2023, the Secretary shall
include in the annual report
under paragraph (1)--
(I) data, analysis,
and discussion of the
changes in the number
of full-time
equivalents hired as
agreed upon in the
letters described in
section 201(b) of the
[Medical Device User
Fee Amendments of 2017]
Medical Device User Fee
Amendments of 2022 and
the number of full time
equivalents funded by
budget authority at the
Food and Drug
Administration by each
division within the
Center for Devices and
Radiological Health,
the Center for
Biologics Evaluation
and Research, the
Office of Regulatory
Affairs, and the Office
of the Commissioner;
(II) data, analysis,
and discussion of the
changes in the fee
revenue amounts and
costs for the process
for the review of
devices, including
identifying drivers of
such changes; and
(III) for each of the
Center for Devices and
Radiological Health,
the Center for
Biologics Evaluation
and Research, the
Office of Regulatory
Affairs, and the Office
of the Commissioner,
the number of employees
for whom time reporting
is required and the
number of employees for
whom time reporting is
not required.
[(iv)] (v) Analysis.--For
each fiscal year, the Secretary
shall include in the report
under clause (i) an analysis of
the following:
(I) The difference
between the aggregate
number of premarket
applications filed
under section 515 and
aggregate reports
submitted under section
510(k) and the
aggregate number of
major deficiency
letters, not approvable
letters, and denials
for such applications
issued by the agency,
accounting for--
(aa) the
number of
applications
filed and
reports
submitted
during one
fiscal year for
which a
decision is not
scheduled to be
made until the
following
fiscal year;
and
(bb) the
aggregate
number of
applications
for each fiscal
year that did
not meet the
goals as
identified by
the letters
described in
section 201(b)
of the [Medical
Device User Fee
Amendments of
2017] Medical
Device User Fee
Amendments of
2022 for the
applicable
fiscal year.
(II) Relevant data to
determine whether the
Center for Devices and
Radiological Health has
met performance
enhancement goals
identified by the
letters described in
section 201(b) of the
[Medical Device User
Fee Amendments of 2017]
Medical Device User Fee
Amendments of 2022 for
the applicable fiscal
year.
(III) The most common
causes and trends for
external or other
circumstances affecting
the ability of the
Center for Devices and
Radiological Health,
the Office of
Regulatory Affairs, or
the Food and Drug
Administration to meet
review time and
performance enhancement
goals identified by the
letters described in
section 201(b) of the
[Medical Device User
Fee Amendments of 2017]
Medical Device User Fee
Amendments of 2022.
(B) Publication.--With regard to information
to be reported by the Food and Drug
Administration to industry on a quarterly and
annual basis pursuant to the letters described
in section 201(b) of the [Medical Device User
Fee Amendments of 2017] Medical Device User Fee
Amendments of 2022, the Secretary shall make
such information publicly available on the
Internet Web site of the Food and Drug
Administration not later than 60 days after the
end of each quarter or 120 days after the end
of each fiscal year, respectively, to which
such information applies. This information
shall include the status of the independent
assessment identified in the letters described
in such section 201(b).
(C) Updates.--The Secretary shall include in
each report under subparagraph (A) information
on all previous cohorts for which the Secretary
has not given a complete response on all device
premarket applications and reports,
supplements, and premarket notifications in the
cohort.
(2) Corrective action report.--Beginning with [fiscal
year 2018] fiscal year 2023, for each fiscal year for
which fees are collected under this part, the Secretary
shall prepare and submit a corrective action report to
the Committee on Energy and Commerce and the Committee
on Appropriations of the House of Representatives and
the Committee on Health, Education, Labor, and Pensions
and the Committee on Appropriations of the Senate. The
report shall include the following information, as
applicable:
(A) Goals met.--For each fiscal year, if the
Secretary determines, based on the analysis
under paragraph (1)(A)(iv), that each of the
goals identified by the letters described in
section 201(b) of the [Medical Device User Fee
Amendments of 2017] Medical Device User Fee
Amendments of 2022 for the applicable fiscal
year have been met, the corrective action
report shall include recommendations on ways in
which the Secretary can improve and streamline
the medical device application review process.
(B) Goals missed.--For each of the goals
identified by the letters described in section
201(b) of the [Medical Device User Fee
Amendments of 2017] Medical Device User Fee
Amendments of 2022 for the applicable fiscal
year that the Secretary determines to not have
been met, the corrective action report shall
include--
(i) a justification for such
determination;
(ii) a description of the types of
circumstances, in the aggregate, under
which applications or reports submitted
under section 515 or notifications
submitted under section 510(k) missed
the review goal times but were approved
during the first cycle review, as
applicable;
(iii) a summary and any trends with
regard to the circumstances for which a
review goal was missed; and
(iv) the performance enhancement
goals that were not achieved during the
previous fiscal year and a description
of efforts the Food and Drug
Administration has put in place for the
fiscal year in which the report is
submitted to improve the ability of
such agency to meet each such goal for
the such fiscal year.
(3) Enhanced communication.--
(A) Communications with congress.--Each
fiscal year, as applicable and requested,
representatives from the Centers with expertise
in the review of devices shall meet with
representatives from the Committee on Health,
Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the
House of Representatives to report on the
contents described in the reports under this
section.
(B) Participation in congressional hearing.--
Each fiscal year, as applicable and requested,
representatives from the Food and Drug
Administration shall participate in a public
hearing before the Committee on Health,
Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the
House of Representatives, to report on the
contents described in the reports under this
section. Such hearing shall occur not later
than 120 days after the end of each fiscal year
for which fees are collected under this part.
(4) Fiscal report.--For fiscal years [2018 through
2022] 2023 through 2027, not later than 120 days after
the end of each fiscal year during which fees are
collected under this part, the Secretary shall prepare
and submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives, a
report on the implementation of the authority for such
fees during such fiscal year and the use, by the Food
and Drug Administration, of the fees collected during
such fiscal year for which the report is made.
(5) Public availability.--The Secretary shall make
the reports required under paragraphs (1) and (2)
available to the public on the Internet Web site of the
Food and Drug Administration.
(b) Reauthorization.--
(1) Consultation.--In developing recommendations to
present to Congress with respect to the goals, and
plans for meeting the goals, for the process for the
review of device applications for the first 5 fiscal
years after fiscal year [2022] 2027, and for the
reauthorization of this part for such fiscal years, the
Secretary shall consult with--
(A) the Committee on Energy and Commerce of
the House of Representatives;
(B) the Committee on Health, Education,
Labor, and Pensions of the Senate;
(C) scientific and academic experts;
(D) health care professionals;
(E) representatives of patient and consumer
advocacy groups; and
(F) the regulated industry.
(2) Prior public input.--Prior to beginning
negotiations with the regulated industry on the
reauthorization of this part, the Secretary shall--
(A) publish a notice in the Federal Register
requesting public input on the reauthorization;
(B) hold a public meeting at which the public
may present its views on the reauthorization,
including specific suggestions for changes to
the goals referred to in subsection (a)(1);
(C) provide a period of 30 days after the
public meeting to obtain written comments from
the public suggesting changes to this part; and
(D) publish the comments on the Food and Drug
Administration's Internet Web site.
(3) Periodic consultation.--Not less frequently than
once every month during negotiations with the regulated
industry, the Secretary shall hold discussions with
representatives of patient and consumer advocacy groups
to continue discussions of their views on the
reauthorization and their suggestions for changes to
this part as expressed under paragraph (2).
(4) Public review of recommendations.--After
negotiations with the regulated industry, the Secretary
shall--
(A) present the recommendations developed
under paragraph (1) to the Congressional
committees specified in such paragraph;
(B) publish such recommendations in the
Federal Register;
(C) provide for a period of 30 days for the
public to provide written comments on such
recommendations;
(D) hold a meeting at which the public may
present its views on such recommendations; and
(E) after consideration of such public views
and comments, revise such recommendations as
necessary.
(5) Transmittal of recommendations.--Not later than
January 15, [2022] 2027, the Secretary shall transmit
to Congress the revised recommendations under paragraph
(4), a summary of the views and comments received under
such paragraph, and any changes made to the
recommendations in response to such views and comments.
(6) Minutes of negotiation meetings.--
(A) Public availability.--Before presenting
the recommendations developed under paragraphs
(1) through (5) to the Congress, the Secretary
shall make publicly available, on the public
Web site of the Food and Drug Administration,
minutes of all negotiation meetings conducted
under this subsection between the Food and Drug
Administration and the regulated industry.
(B) Content.--The minutes described under
subparagraph (A) shall summarize any
substantive proposal made by any party to the
negotiations as well as significant
controversies or differences of opinion during
the negotiations and their resolution.
* * * * * * *
PART 7--FEES RELATING TO GENERIC DRUGS
* * * * * * *
SEC. 744B. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES.
(a) Types of Fees.--Beginning in [fiscal year 2018] fiscal
year 2023, the Secretary shall assess and collect fees in
accordance with this section as follows:
(1) One-time backlog fee for abbreviated new drug
applications pending on october 1, 2012.--
(A) In general.--Each person that owns an
abbreviated new drug application that is
pending on October 1, 2012, and that has not
received a tentative approval prior to that
date, shall be subject to a fee for each such
application, as calculated under subparagraph
(B).
(B) Method of fee amount calculation.--The
amount of each one-time backlog fee shall be
calculated by dividing $50,000,000 by the total
number of abbreviated new drug applications
pending on October 1, 2012, that have not
received a tentative approval as of that date.
(C) Notice.--Not later than October 31, 2012,
the Secretary shall publish in the Federal
Register a notice announcing the amount of the
fee required by subparagraph (A).
(D) Fee due date.--The fee required by
subparagraph (A) shall be due no later than 30
calendar days after the date of the publication
of the notice specified in subparagraph (C).
(E) Sunset.--This paragraph shall cease to be
effective October 1, 2022.
(2) Drug master file fee.--
(A) In general.--Each person that owns a Type
II active pharmaceutical ingredient drug master
file that is referenced on or after October 1,
2012, in a generic drug submission by any
initial letter of authorization shall be
subject to a drug master file fee.
(B) One-time payment.--If a person has paid a
drug master file fee for a Type II active
pharmaceutical ingredient drug master file, the
person shall not be required to pay a
subsequent drug master file fee when that Type
II active pharmaceutical ingredient drug master
file is subsequently referenced in generic drug
submissions.
(C) Notice.--Not later than 60 days before
the start of each of fiscal years [2018 through
2022] 2023 through 2027, the Secretary shall
publish in the Federal Register the amount of
the drug master file fee established by this
paragraph for such fiscal year.
(D) Availability for reference.--
(i) In general.--Subject to
subsection (g)(2)(C), for a generic
drug submission to reference a Type II
active pharmaceutical ingredient drug
master file, the drug master file must
be deemed available for reference by
the Secretary.
(ii) Conditions.--A drug master file
shall be deemed available for reference
by the Secretary if--
(I) the person that owns a
Type II active pharmaceutical
ingredient drug master file has
paid the fee required under
subparagraph (A) within 20
calendar days after the
applicable due date under
subparagraph (E); and
(II) the drug master file has
not failed an initial
completeness assessment by the
Secretary, in accordance with
criteria to be published by the
Secretary.
(iii) List.--The Secretary shall make
publicly available on the Internet Web
site of the Food and Drug
Administration a list of the drug
master file numbers that correspond to
drug master files that have
successfully undergone an initial
completeness assessment, in accordance
with criteria to be published by the
Secretary, and are available for
reference.
(E) Fee due date.--
(i) In general.--Subject to clause
(ii), a drug master file fee shall be
due on the earlier of--
(I) the date on which the
first generic drug submission
is submitted that references
the associated Type II active
pharmaceutical ingredient drug
master file; or
(II) the date on which the
drug master file holder
requests the initial
completeness assessment.
(ii) Limitation.--No fee shall be due
under subparagraph (A) for a fiscal
year until the later of--
(I) 30 calendar days after
publication of the notice
provided for in subparagraph
(C); or
(II) 30 calendar days after
the date of enactment of an
appropriations Act providing
for the collection and
obligation of fees for such
year under this section.
(3) Abbreviated new drug application filing fee.--
(A) In general.--Each applicant that submits,
on or after October 1, 2012, an abbreviated new
drug application shall be subject to a fee for
each such submission in the amount established
under subsection (d).
(B) Notice.--Not later than 60 days before
the start of each of fiscal years [2018 through
2022] 2023 through 2027, the Secretary shall
publish in the Federal Register the amount of
the fees under subparagraph (A) for such fiscal
year.
(C) Fee due date.--The fees required by
subparagraphs (A) and (F) shall be due no later
than the date of submission of the abbreviated
new drug application or prior approval
supplement for which such fee applies.
(D) Refund of fee if abbreviated new drug
application is not considered to have been
received, is withdrawn prior to being received,
or is no longer received.--
(i) Applications not considered to
have been received and applications
withdrawn prior to being received.--The
Secretary shall refund 75 percent of
the fee paid under subparagraph (A) for
any abbreviated new drug application
that the Secretary considers not to
have been received within the meaning
of section 505(j)(5)(A) for a cause
other than failure to pay fees, or that
has been withdrawn prior to being
received within the meaning of section
505(j)(5)(A).
(ii) Applications no longer
received.--The Secretary shall refund
100 percent of the fee paid under
subparagraph (A) for any abbreviated
new drug application if the Secretary
initially receives the application
under section 505(j)(5)(A) and
subsequently determines that an
exclusivity period for a listed drug
should have prevented the Secretary
from receiving such application, such
that the abbreviated new drug
application is no longer received
within the meaning of section
505(j)(5)(A).
(E) Fee for an application the secretary
considers not to have been received, or that
has been withdrawn.--An abbreviated new drug
application that was submitted on or after
October 1, 2012, and that the Secretary
considers not to have been received, or that
has been withdrawn, shall, upon resubmission of
the application or a subsequent new submission
following the applicant's withdrawal of the
application, be subject to a full fee under
subparagraph (A).
(F) Additional fee for active pharmaceutical
ingredient information not included by
reference to type ii active pharmaceutical
ingredient drug master file.--An applicant that
submits a generic drug submission on or after
October 1, 2017, shall pay a fee, in the amount
determined under subsection (d)(2), in addition
to the fee required under subparagraph (A),
if--
(i) such submission contains
information concerning the manufacture
of an active pharmaceutical ingredient
at a facility by means other than
reference by a letter of authorization
to a Type II active pharmaceutical drug
master file; and
(ii) a fee in the amount equal to the
drug master file fee established in
paragraph (2) has not been previously
paid with respect to such information.
(4) Generic drug facility fee and active
pharmaceutical ingredient facility fee.--
(A) In general.--Facilities identifiedin at
least one generic drug submission that is
approved to produce a finished dosage form of a
human generic drug or an active pharmaceutical
ingredient contained in a human generic drug
shall be subject to fees as follows:
(i) Generic drug facility.--Each
person that owns a facility which is
identified in at least one generic drug
submission that is approved to produce
one or more finished dosage forms of a
human generic drug shall be assessed an
annual fee for each such facility.
(ii) Active pharmaceutical ingredient
facility.--Each person that owns a
facility which is identified in at
least one generic drug submission in
which the facility is approved to
produce one or more active
pharmaceutical ingredients or in a Type
II active pharmaceutical ingredient
drug master file referenced in at least
one such generic drug submission, shall
be assessed an annual fee for each such
facility.
(iii) Facilities producing both
active pharmaceutical ingredients and
finished dosage forms.--Each person
that owns a facility identified, or
intended to be identified, in at least
one generic drug submission that is
pending or approved to produce both one
or more finished dosage forms subject
to clause (i) and one or more active
pharmaceutical ingredients subject to
clause (ii) shall be subject only to
the fee attributable to the manufacture
of the finished dosage forms for that
facility.
(B) Amount.--The amount of fees established
under subparagraph (A) shall be established
under subsection (d).
(C) Notice.--Within the timeframe specified
in subsection (d)(1), the Secretary shall
publish in the Federal Register the amount of
the fees under subparagraph (A) for such fiscal
year.
(D) Fee due date.--For each of fiscal years
[2018 through 2022] 2023 through 2027, the fees
under subparagraph (A) for such fiscal year
shall be due on the later of--
(i) the first business day on or
after October 1 of each such year; or
(ii) the first business day after the
enactment of an appropriations Act
providing for the collection and
obligation of fees for such year under
this section for such year.
(5) Generic drug applicant program fee.--
(A) In general.--A generic drug applicant
program fee shall be assessed annually as
described in subsection (b)(2)(E).
(B) Amount.--The amount of fees established
under subparagraph (A) shall be established
under subsection (d).
(C) Notice.--Within the timeframe specified
in subsection (d)(1), the Secretary shall
publish in the Federal Register the amount of
the fees under subparagraph (A) for such fiscal
year.
(D) Fee due date.--For each of fiscal years
[2018 through 2022] 2023 through 2027, the fees
under subparagraph (A) for such fiscal year
shall be due on the later of--
(i) the first business day on or
after October 1 of each such fiscal
year; or
(ii) the first business day after the
date of enactment of an appropriations
Act providing for the collection and
obligation of fees for such fiscal year
under this section for such fiscal
year.
(6) Date of submission.--For purposes of this Act, a
generic drug submission or Type II pharmaceutical
master file is deemed to be ``submitted'' to the Food
and Drug Administration--
(A) if it is submitted via a Food and Drug
Administration electronic gateway, on the day
when transmission to that electronic gateway is
completed, except that a submission or master
file that arrives on a weekend, Federal
holiday, or day when the Food and Drug
Administration office that will review that
submission is not otherwise open for business
shall be deemed to be submitted on the next day
when that office is open for business; or
(B) if it is submitted in physical media
form, on the day it arrives at the appropriate
designated document room of the Food and Drug
Administration.
(b) Fee Revenue Amounts.--
(1) In general.--
(A) Fiscal year [2018] 2023.--For fiscal year
[2018] 2023, fees under subsection (a) shall be
established to generate a total estimated
revenue amount under such subsection of
[$493,600,000] $582,500,000.
[(B) Fiscal years 2019 through 2022.--For
each of the fiscal years 2019 through 2022,
fees under paragraphs (2) through (5) of
subsection (a) shall be established to generate
a total estimated revenue amount under such
subsection that is equal to $493,600,000, as
adjusted pursuant to subsection (c).]
(B) Fiscal years 2024 through 2027.--
(i) In general.--For each of the
fiscal years 2024 through 2027, fees
under paragraphs (2) through (5) of
subsection (a) shall be established to
generate a total estimated revenue
amount under such subsection that is
equal to the base revenue amount for
the fiscal year under clause (ii), as
adjusted pursuant to subsection (c).
(ii) Base revenue amount.--The base
revenue amount for a fiscal year
referred to in clause (i) is equal to
the total revenue amount established
under this paragraph for the previous
fiscal year, not including any
adjustments made for such previous
fiscal year under subsection (c)(3).
(2) Types of fees.--In establishing fees under
paragraph (1) to generate the revenue amounts specified
in such paragraph for a fiscal year, such fees shall be
derived from the fees under paragraphs (2) through (5)
of subsection (a) as follows:
(A) Five percent shall be derived from fees
under subsection (a)(2) (relating to drug
master files).
(B) Thirty-three percent shall be derived
from fees under subsection (a)(3) (relating to
abbreviated new drug applications).
(C) Twenty percent shall be derived from fees
under subsection (a)(4)(A)(i) (relating to
generic drug facilities). The amount of the fee
for a contract manufacturing organization
facility shall be equal to [one-third the
amount] twenty-four percent of the fee for a
facility that is not a contract manufacturing
organization facility. The amount of the fee
for a facility located outside the United
States and its territories and possessions
shall be $15,000 higher than the amount of the
fee for a facility located in the United States
and its territories and possessions.
(D) [Seven percent] Six percent shall be
derived from fees under subsection
(a)(4)(A)(ii) (relating to active
pharmaceutical ingredient facilities). The
amount of the fee for a facility located
outside the United States and its territories
and possessions shall be $15,000 higher than
the amount of the fee for a facility located in
the United States, including its territories
and possessions.
(E)(i) [Thirty-five percent] Thirty-six
percent shall be derived from fees under
subsection (a)(5) (relating to generic drug
applicant program fees). For purposes of this
subparagraph, if a person has affiliates, a
single program fee shall be assessed with
respect to that person, including its
affiliates, and may be paid by that person or
any one of its affiliates. The Secretary shall
determine the fees as follows:
(I) If a person (including its
affiliates) owns at least one but not
more than 5 approved abbreviated new
drug applications on the due date for
the fee under this subsection, the
person (including its affiliates) shall
be assessed a small business generic
drug applicant program fee equal to
one-tenth of the large size operation
generic drug applicant program fee.
(II) If a person (including its
affiliates) owns at least 6 but not
more than 19 approved abbreviated new
drug applications on the due date for
the fee under this subsection, the
person (including its affiliates) shall
be assessed a medium size operation
generic drug applicant program fee
equal to two-fifths of the large size
operation generic drug applicant
program fee.
(III) If a person (including its
affiliates) owns 20 or more approved
abbreviated new drug applications on
the due date for the fee under this
subsection, the person (including its
affiliates) shall be assessed a large
size operation generic drug applicant
program fee.
(ii) For purposes of this subparagraph, an
abbreviated new drug application shall be
deemed not to be approved if the applicant has
submitted a written request for withdrawal of
approval of such abbreviated new drug
application by April 1 of the previous fiscal
year.
(c) Adjustments.--
(1) Inflation adjustment.--For fiscal year [2019]
2024 and subsequent fiscal years, the revenues
established in subsection (b) shall be adjusted by the
Secretary by notice, published in the Federal Register,
for a fiscal year, [to equal the product of the total
revenues established in such notice for the prior
fiscal year multiplied] to equal the base revenue
amount for the fiscal year (as specified in subsection
(b)(1)(B)) multiplied by an amount equal to the sum
of--
(A) one;
(B) the average annual percent change in the
cost, per full-time equivalent position of the
Food and Drug Administration, of all personnel
compensation and benefits paid with respect to
such positions for the first 3 years of the
preceding 4 fiscal years multiplied by the
proportion of personnel compensation and
benefits costs to total costs of human generic
drug activities for the first 3 years of the
preceding 4 fiscal years; and
(C) the average annual percent change that
occurred in the Consumer Price Index for urban
consumers ([Washington-Baltimore, DC-MD-VA-WV]
Washington-Arlington-Alexandria, DC-VA-MD-WV;
Not Seasonally Adjusted; All items; Annual
Index) for the first 3 years of the preceding 4
years of available data multiplied by the
proportion of all costs other than personnel
compensation and benefits costs to total costs
of human generic drug activities for the first
3 years of the preceding 4 fiscal years.
[(2) Final year adjustment.--For fiscal year 2022,
the Secretary may, in addition to adjustments under
paragraph (1), further increase the fee revenues and
fees established in subsection (b) if such an
adjustment is necessary to provide for not more than 3
months of operating reserves of carryover user fees for
human generic drug activities for the first 3 months of
fiscal year 2023. If such an adjustment is necessary,
the rationale for the amount of the increase shall be
contained in the annual notice establishing fee
revenues and fees for fiscal year 2022. If the
Secretary has carryover balances for such activities in
excess of 3 months of such operating reserves, the
adjustment under this subparagraph shall not be made.]
(2) Capacity planning adjustment.--
(A) In general.--Beginning with fiscal year
2024, the Secretary shall, in addition to the
adjustment under paragraph (1), further
increase the fee revenue and fees under this
section for a fiscal year, in accordance with
this paragraph, to reflect changes in the
resource capacity needs of the Secretary for
human generic drug activities.
(B) Capacity planning methodology.--The
Secretary shall establish a capacity planning
methodology for purposes of this paragraph,
which shall--
(i) be derived from the methodology
and recommendations made in the report
titled ``Independent Evaluation of the
GDUFA Resource Capacity Planning
Adjustment Methodology: Evaluation and
Recommendations'' announced in the
Federal Register on August 3, 2020;
(ii) incorporate approaches and
attributes determined appropriate by
the Secretary, including approaches and
attributes made in such report, except
that in incorporating such approaches
and attributes the workload categories
used in forecasting resources shall
only be the workload categories
specified in section VIII.B.2.e. of the
letters described in section 301(b) of
the Generic Drug User Fee Amendments of
2022; and
(iii) be effective beginning with
fiscal year 2024.
(C) Limitations.--
(i) In general.--Under no
circumstances shall an adjustment under
this paragraph result in fee revenue
for a fiscal year that is less than the
sum of the amounts under subsection
(b)(1)(B)(ii) (the base revenue amount
for the fiscal year) and paragraph (1)
(the dollar amount of the inflation
adjustment for the fiscal year).
(ii) Percentage limitation.--An
adjustment under this paragraph shall
not exceed three percent of the sum
described in clause (i) for the fiscal
year, except that such limitation shall
be four percent if--
(I) for purposes of a fiscal
year 2024 adjustment, the
Secretary determines that
during the period from April 1,
2021, through March 31, 2023--
(aa) the total number
of abbreviated new drug
applications submitted
was greater than or
equal to 2,000; or
(bb) thirty-five
percent or more of
abbreviated new drug
applications submitted
related to complex
products (as that term
is defined in section
XI of the letters
described in section
301(b) of the Generic
Drug User Fee
Amendments of 2022);
(II) for purposes of a fiscal
year 2025 adjustment, the
Secretary determines that
during the period from April 1,
2022, through March 31, 2024--
(aa) the total number
of abbreviated new drug
applications submitted
was greater than or
equal to 2,300; or
(bb) thirty-five
percent or more of
abbreviated new drug
applications submitted
related to complex
products (as so
defined);
(III) for purposes of a
fiscal year 2026 adjustment,
the Secretary determines that
during the period from April 1,
2023, through March 31, 2025--
(aa) the total number
of abbreviated new drug
applications submitted
was greater than or
equal to 2,300; or
(bb) thirty-five
percent or more of
abbreviated new drug
applications submitted
related to complex
products (as so
defined); and
(IV) for purposes of a fiscal
year 2027 adjustment, the
Secretary determines that
during the period from April 1,
2024, through March 31, 2026--
(aa) the total number
of abbreviated new drug
applications submitted
was greater than or
equal to 2,300; or
(bb) thirty-five
percent or more of
abbreviated new drug
applications submitted
related to complex
products (as so
defined).
(D) Publication in federal register.--The
Secretary shall publish in the Federal Register
notice referred to in subsection (a) the fee
revenue and fees resulting from the adjustment
and the methodology under this paragraph.
(3) Operating reserve adjustment.--
(A) In general.--For fiscal year 2024 and
each subsequent fiscal year, the Secretary may,
in addition to adjustments under paragraphs (1)
and (2), further increase the fee revenue and
fees under this section for such fiscal year if
such an adjustment is necessary to provide
operating reserves of carryover user fees for
human generic drug activities for not more than
the number of weeks specified in subparagraph
(B) with respect to that fiscal year.
(B) Number of weeks.--The number of weeks
specified in this subparagraph is--
(i) 8 weeks for fiscal year 2024;
(ii) 9 weeks for fiscal year 2025;
and
(iii) 10 weeks for each of fiscal
year 2026 and 2027.
(C) Decrease.--If the Secretary has carryover
balances for human generic drug activities in
excess of 12 weeks of the operating reserves
referred to in subparagraph (A), the Secretary
shall decrease the fee revenue and fees
referred to in such subparagraph to provide for
not more than 12 weeks of such operating
reserves.
(D) Rationale for adjustment.--If an
adjustment under this paragraph is made, the
rationale for the amount of the increase or
decrease (as applicable) in fee revenue and
fees shall be contained in the annual Federal
Register notice under subsection (a) publishing
the fee revenue and fees for the fiscal year
involved.
(d) Annual Fee Setting.--
(1) Fiscal years [2018 through 2022] 2023 through
2027.--Not [more than 60 days before the first day of
each of fiscal years 2018 through 2022] later than 60
days before the first day of each of fiscal years 2023
through 2027, the Secretary shall establish the fees
described in paragraphs (2) through (5) of subsection
(a), based on the revenue amounts established under
subsection (b) and the adjustments provided under
subsection (c).
(2) Fee for active pharmaceutical ingredient
information not included by reference to type ii active
pharmaceutical ingredient drug master file.--In
establishing the fee under paragraph (1), the amount of
the fee under subsection (a)(3)(F) shall be determined
by multiplying--
(A) the sum of--
(i) the total number of such active
pharmaceutical ingredients in such
submission; and
(ii) for each such ingredient that is
manufactured at more than one such
facility, the total number of such
additional facilities; and
(B) the amount equal to the drug master file
fee established in subsection (a)(2) for such
submission.
(e) Limitations.--
(1) In general.--The total amount of fees charged, as
adjusted under subsection (c), for a fiscal year may
not exceed the total costs for such fiscal year for the
resources allocated for human generic drug activities.
(2) Leasing and necessary equipment.--Beginning on
October 1, 2023, the authorities under section
744A(11)(C) shall include only leasing and necessary
scientific equipment.
(f) Identification of Facilities.--
(1) Required submission of facility identification.--
Each person that owns a facility described in
subsection (a)(4)(A) or a site or organization required
to be identified by paragraph (3) shall submit to the
Secretary the information required under this
subsection each year. Such information shall, for each
fiscal year, be submitted, updated, or reconfirmed on
or before June 1 of the previous fiscal year.
(2) Information required to be submitted.--At a
minimum, the submission required by paragraph (1) shall
include for each such facility--
(A) identification of a facility identified
in an approved or pending generic drug
submission;
(B) whether the facility manufactures active
pharmaceutical ingredients or finished dosage
forms, or both;
(C) whether or not the facility is located
within the United States and its territories
and possessions;
(D) whether the facility manufactures
positron emission tomography drugs solely, or
in addition to other drugs;
(E) whether the facility manufactures drugs
that are not generic drugs; and
(F) whether the facility is a contract
manufacturing organization facility.
(3) Certain sites and organizations.--
(A) In general.--Any person that owns or
operates a site or organization described in
subparagraph (B) shall submit to the Secretary
information concerning the ownership, name, and
address of the site or organization.
(B) Sites and organizations.--A site or
organization is described in this subparagraph
if it is identified in a generic drug
submission and is--
(i) a site in which a bioanalytical
study is conducted;
(ii) a clinical research
organization;
(iii) a contract analytical testing
site; or
(iv) a contract repackager site.
(C) Notice.--The Secretary may, by notice
published in the Federal Register, specify the
means and format for submission of the
information under subparagraph (A) and may
specify, as necessary for purposes of this
section, any additional information to be
submitted.
(D) Inspection authority.--The Secretary's
inspection authority under section 704(a)(1)
shall extend to all such sites and
organizations.
(g) Effect of Failure To Pay Fees.--
(1) Generic drug backlog fee.--Failure to pay the fee
under subsection (a)(1) shall result in the Secretary
placing the person that owns the abbreviated new drug
application subject to that fee on a publicly available
arrears list, such that no new abbreviated new drug
applications or supplement submitted on or after
October 1, 2012, from that person, or any affiliate of
that person, will be received within the meaning of
section 505(j)(5)(A) until such outstanding fee is
paid. This paragraph shall cease to be effective on
October 1, 2022.
(2) Drug master file fee.--
(A) Failure to pay the fee under subsection
(a)(2) within 20 calendar days after the
applicable due date under subparagraph (E) of
such subsection (as described in subsection
(a)(2)(D)(ii)(I)) shall result in the Type II
active pharmaceutical ingredient drug master
file not being deemed available for reference.
(B)(i) Any generic drug submission submitted
on or after October 1, 2012, that references,
by a letter of authorization, a Type II active
pharmaceutical ingredient drug master file that
has not been deemed available for reference
shall not be received within the meaning of
section 505(j)(5)(A) unless the condition
specified in clause (ii) is met.
(ii) The condition specified in this clause
is that the fee established under subsection
(a)(2) has been paid within 20 calendar days of
the Secretary providing the notification to the
sponsor of the abbreviated new drug application
or supplement of the failure of the owner of
the Type II active pharmaceutical ingredient
drug master file to pay the drug master file
fee as specified in subparagraph (C).
(C)(i) If an abbreviated new drug application
or supplement to an abbreviated new drug
application references a Type II active
pharmaceutical ingredient drug master file for
which a fee under subsection (a)(2)(A) has not
been paid by the applicable date under
subsection (a)(2)(E), the Secretary shall
notify the sponsor of the abbreviated new drug
application or supplement of the failure of the
owner of the Type II active pharmaceutical
ingredient drug master file to pay the
applicable fee.
(ii) If such fee is not paid within 20
calendar days of the Secretary providing the
notification, the abbreviated new drug
application or supplement to an abbreviated new
drug application shall not be received within
the meaning of section 505(j)(5)(A).
(3) Abbreviated new drug application fee [and prior
approval supplement fee].--Failure to pay a fee under
subparagraph (A) or (F) of subsection (a)(3) within 20
calendar days of the applicable due date under
subparagraph (C) of such subsection shall result in the
abbreviated new drug application or the prior approval
supplement to an abbreviated new drug application not
being received within the meaning of section
505(j)(5)(A) until such outstanding fee is paid.
(4) Generic drug facility fee and active
pharmaceutical ingredient facility fee.--
(A) In general.--Failure to pay the fee under
subsection (a)(4) within 20 calendar days of
the due date as specified in subparagraph (D)
of such subsection shall result in the
following:
(i) The Secretary shall place the
facility on a publicly available
arrears list, such that no new
abbreviated new drug application or
supplement submitted on or after
October 1, 2012, from the person that
is responsible for paying such fee, or
any affiliate of that person, will be
received within the meaning of section
505(j)(5)(A).
(ii) Any new generic drug submission
submitted on or after October 1, 2012,
that references such a facility shall
not be received, within the meaning of
section 505(j)(5)(A) if the outstanding
facility fee is not paid within 20
calendar days of the Secretary
providing the notification to the
sponsor of the failure of the owner of
the facility to pay the facility fee
under subsection (a)(4)(C).
(iii) All drugs or active
pharmaceutical ingredients manufactured
in such a facility or containing an
ingredient manufactured in such a
facility shall be deemed misbranded
under section 502(aa).
(B) Application of penalties.--The penalties
under this paragraph shall apply until the fee
established by subsection (a)(4) is paid or the
facility is removed from all generic drug
submissions that refer to the facility.
(C) Nonreceival for nonpayment.--
(i) Notice.--If an abbreviated new
drug application or supplement to an
abbreviated new drug application
submitted on or after October 1, 2012,
references a facility for which a
facility fee has not been paid by the
applicable date under subsection
(a)(4)(C), the Secretary shall notify
the sponsor of the generic drug
submission of the failure of the owner
of the facility to pay the facility
fee.
(ii) Nonreceival.--If the facility
fee is not paid within 20 calendar days
of the Secretary providing the
notification under clause (i), the
abbreviated new drug application or
supplement to an abbreviated new drug
application shall not be received
within the meaning of section
505(j)(5)(A).
(5) Generic drug applicant program fee.--
(A) In general.--A person who fails to pay a
fee as required under subsection (a)(5) by the
date that is 20 calendar days after the due
date, as specified in subparagraph (D) of such
subsection, shall be subject to the following:
(i) The Secretary shall place the
person on a publicly available arrears
list.
(ii) Any abbreviated new drug
application submitted by the generic
drug applicant or an affiliate of such
applicant shall not be received, within
the meaning of section 505(j)(5)(A).
(iii) All drugs marketed pursuant to
any abbreviated new drug application
held by such applicant or an affiliate
of such applicant shall be deemed
misbranded under section 502(aa).
(B) Application of penalties.--The penalties
under subparagraph (A) shall apply until the
fee required under subsection (a)(5) is paid.
(h) Limitations.--
(1) In general.--Fees under subsection (a) shall be
refunded for a fiscal year beginning after fiscal year
2012, unless appropriations for salaries and expenses
of the Food and Drug Administration for such fiscal
year (excluding the amount of fees appropriated for
such fiscal year) are equal to or greater than the
amount of appropriations for the salaries and expenses
of the Food and Drug Administration for fiscal year
2009 (excluding the amount of fees appropriated for
such fiscal year) multiplied by the adjustment factor
(as defined in section 744A) applicable to the fiscal
year involved.
(2) Authority.--If the Secretary does not assess fees
under subsection (a) during any portion of a fiscal
year and if at a later date in such fiscal year the
Secretary may assess such fees, the Secretary may
assess and collect such fees, without any modification
in the rate, at any time in such fiscal year
notwithstanding the provisions of subsection (a)
relating to the date fees are to be paid.
(i) Crediting and Availability of Fees.--
(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to
the extent and in the amount provided in advance in
appropriations Acts, subject to paragraph (2). Such
fees are authorized to remain available until expended.
Such sums as may be necessary may be transferred from
the Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to
such appropriation account for salaries and expenses
with such fiscal year limitation. The sums transferred
shall be available solely for human generic drug
activities.
(2) Collections and appropriation acts.--
(A) In general.--The fees authorized by this
section--
(i) subject to subparagraph (C),
shall be collected and available in
each fiscal year in an amount not to
exceed the amount specified in
appropriation Acts, or otherwise made
available for obligation for such
fiscal year; and
(ii) shall be available for a fiscal
year beginning after fiscal year 2012
to defray the costs of human generic
drug activities (including such costs
for an additional number of full-time
equivalent positions in the Department
of Health and Human Services to be
engaged in such activities), only if
the Secretary allocates for such
purpose an amount for such fiscal year
(excluding amounts from fees collected
under this section) no less than
$97,000,000 multiplied by the
adjustment factor defined in section
744A(3) applicable to the fiscal year
involved.
(B) Compliance.--The Secretary shall be
considered to have met the requirements of
subparagraph (A)(ii) in any fiscal year if the
costs funded by appropriations and allocated
for human generic activities are not more than
10 percent below the level specified in such
subparagraph.
(C) Provision for early payments.--Payment of
fees authorized under this section for a fiscal
year, prior to the due date for such fees, may
be accepted by the Secretary in accordance with
authority provided in advance in a prior year
appropriations Act.
(3) Authorization of appropriations.--For each of the
[fiscal years 2018 through 2022] fiscal years 2023
through 2027, there is authorized to be appropriated
for fees under this section an amount equivalent to the
total revenue amount determined under subsection (b)
for the fiscal year, as adjusted under subsection (c),
if applicable, or as otherwise affected under paragraph
(2) of this subsection.
(j) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed under
subsection (a) within 30 calendar days after it is due, such
fee shall be treated as a claim of the United States Government
subject to subchapter II of chapter 37 of title 31, United
States Code.
(k) Construction.--This section may not be construed to
require that the number of full-time equivalent positions in
the Department of Health and Human Services, for officers,
employees, and advisory committees not engaged in human generic
drug activities, be reduced to offset the number of officers,
employees, and advisory committees so engaged.
(l) Positron Emission Tomography Drugs.--
(1) Exemption from fees.--Submission of an
application for a positron emission tomography drug or
active pharmaceutical ingredient for a positron
emission tomography drug shall not require the payment
of any fee under this section. Facilities that solely
produce positron emission tomography drugs shall not be
required to pay a facility fee as established in
subsection (a)(4).
(2) Identification requirement.--Facilities that
produce positron emission tomography drugs or active
pharmaceutical ingredients of such drugs are required
to be identified pursuant to subsection (f).
(m) Disputes Concerning Fees.--To qualify for the return of a
fee claimed to have been paid in error under this section, a
person shall submit to the Secretary a written request
justifying such return within 180 calendar days after such fee
was paid.
(n) Substantially Complete Applications.--An abbreviated new
drug application that is not considered to be received within
the meaning of section 505(j)(5)(A) because of failure to pay
an applicable fee under this provision within the time period
specified in subsection (g) shall be deemed not to have been
``substantially complete'' on the date of its submission within
the meaning of section 505(j)(5)(B)(iv)(II)(cc). An abbreviated
new drug application that is not substantially complete on the
date of its submission solely because of failure to pay an
applicable fee under the preceding sentence shall be deemed
substantially complete and received within the meaning of
section 505(j)(5)(A) as of the date such applicable fee is
received.
(o) Information on Abbreviated New Drug Applications Owned by
Applicants and Their Affiliates.--
(1) In general.--By April 1 of each year, each person
that owns an abbreviated new drug application, or a
designated affiliate of such person, shall submit, on
behalf of the person and the affiliates of such person,
to the Secretary a list of--
(A) all approved abbreviated new drug
applications owned by such person; and
(B) if any affiliate of such person also owns
an abbreviated new drug application, all
affiliates that own any such abbreviated new
drug application and all approved abbreviated
new drug applications owned by any such
affiliate.
(2) Format and method.--The Secretary shall specify
in guidance the format and method for submission of
lists under this subsection.
SEC. 744C. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Performance Report.--
(1) General requirements.--[Beginning with fiscal
year 2018, not] Not later than 120 days after the end
of each fiscal year for which fees are collected under
this part, the Secretary shall prepare and submit to
the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate a report concerning
the progress of the Food and Drug Administration in
achieving the goals identified in the letters described
in section 301(b) of the [Generic Drug User Fee
Amendments of 2017] Generic Drug User Fee Amendments of
2022 during such fiscal year and the future plans of
the Food and Drug Administration for meeting the goals.
(2) Real time reporting.--
(A) In general.--[Not later than 30 calendar
days after the end of the second quarter of
fiscal year 2018, and not later than 30
calendar days after the end of each quarter of
each fiscal year thereafter] Not later than 30
calendar days after the end of each quarter of
each fiscal year for which fees are collected
under this part, the Secretary shall post the
data described in subparagraph (B) on the
internet website of the Food and Drug
Administration, and may remove duplicative data
from the annual report under this subsection.
(B) Data.--The Secretary shall post the
following data in accordance with subparagraph
(A):
(i) The number and titles of draft
and final guidance on topics related to
human generic drug activities and
whether such guidances were issued as
required by statute or pursuant to a
commitment under the letters described
in section 301(b) of the [Generic Drug
User Fee Amendments of 2017] Generic
Drug User Fee Amendments of 2022.
(ii) The number and titles of public
meetings held on topics related to
human generic drug activities and
whether such meetings were required by
statute or pursuant to a commitment
under the letters described in section
301(b) of the [Generic Drug User Fee
Amendments of 2017] Generic Drug User
Fee Amendments of 2022.
(3) Rationale for gdufa program changes.--[Beginning
with fiscal year 2020, the] The Secretary shall include
in the annual report under paragraph (1)--
(A) data, analysis, and discussion of the
changes in the number of full-time equivalents
hired as agreed upon in the letters described
in section 301(b) of the [Generic Drug User Fee
Amendments of 2017] Generic Drug User Fee
Amendments of 2022 and the number of full time
equivalents funded by budget authority at the
Food and Drug Administration by each division
within the Center for Drug Evaluation and
Research, the Center for Biologics Evaluation
and Research, the Office of Regulatory Affairs,
and the Office of the Commissioner;
(B) data, analysis, and discussion of the
changes in the fee revenue amounts and costs
for human generic drug activities, including
identifying drivers of such changes; and
(C) for each of the Center for Drug
Evaluation and Research, the Center for
Biologics Evaluation and Research, the Office
of Regulatory Affairs, and the Office of the
Commissioner, the number of employees for whom
time reporting is required and the number of
employees for whom time reporting is not
required.
(4) Analysis.--For each fiscal year, the Secretary
shall include in the report an analysis of the
following:
(A) The difference between the aggregate
number of abbreviated new drug applications
filed and the aggregate number of approvals or
aggregate number of complete response letters
issued by the agency, accounting for--
(i) such applications filed during
one fiscal year for which a decision is
not scheduled to be made until the
following fiscal year; and
(ii) the aggregate number of
applications for each fiscal year that
did not meet the goals identified by
the letters described in section 301(b)
of the [Generic Drug User Fee
Amendments of 2017] Generic Drug User
Fee Amendments of 2022 for the
applicable fiscal year.
(B) Relevant data to determine whether the
Food and Drug Administration has met the
performance enhancement goals identified by the
letters described in section 301(b) of the
[Generic Drug User Fee Amendments of 2017]
Generic Drug User Fee Amendments of 2022 for
the applicable fiscal year.
(C) The most common causes and trends for
external or other circumstances that affected
the ability of the Secretary to meet review
time and performance enhancement goals
identified by the letters described in section
301(b) of the [Generic Drug User Fee Amendments
of 2017] Generic Drug User Fee Amendments of
2022.
(b) Fiscal Report.--[Beginning with fiscal year 2018, not]
Not later than 120 days after the end of each fiscal year for
which fees are collected under this part, the Secretary shall
prepare and submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report on the
implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration,
of the fees collected for such fiscal year.
(c) Corrective Action Report.--[Beginning with fiscal year
2018, for] For each fiscal year for which fees are collected
under this part, the Secretary shall prepare and submit a
corrective action report to the Committee on Energy and
Commerce and the Committee on Appropriations of the House of
Representatives and the Committee on Health, Education, Labor,
and Pensions and the Committee on Appropriations of the Senate.
The report shall include the following information, as
applicable:
(1) Goals met.--For each fiscal year, if the
Secretary determines, based on the analysis under
subsection (a)(4), that each of the goals identified by
the letters described in section 301(b) of the [Generic
Drug User Fee Amendments of 2017] Generic Drug User Fee
Amendments of 2022 for the applicable fiscal year have
been met, the corrective action report shall include
recommendations on ways in which the Secretary can
improve and streamline the abbreviated new drug
application review process.
(2) Goals missed.--For each of the goals identified
by the letters described in section 301(b) of the
[Generic Drug User Fee Amendments of 2017] Generic Drug
User Fee Amendments of 2022 for the applicable fiscal
year that the Secretary determines to not have been
met, the corrective action report shall include--
(A) a detailed justification for such
determination and a description, as applicable,
of the types of circumstances and trends under
which abbreviated new drug applications missed
the review goal times but were approved during
the first cycle review, or review goals were
missed; and
(B) with respect to performance enhancement
goals that were not achieved, a detailed
description of efforts the Food and Drug
Administration has put in place for the fiscal
year in which the report is submitted to
improve the ability of such agency to meet each
such goal for the such fiscal year.
(d) Enhanced Communication.--
(1) Communications with congress.--Each fiscal year,
as applicable and requested, representatives from the
Centers with expertise in the review of human drugs
shall meet with representatives from the Committee on
Health, Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the House
of Representatives to report on the contents described
in the reports under this section.
(2) Participation in congressional hearing.--Each
fiscal year, as applicable and requested,
representatives from the Food and Drug Administration
shall participate in a public hearing before the
Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy and Commerce of
the House of Representatives, to report on the contents
described in the reports under this section. Such
hearing shall occur not later than 120 days after the
end of each fiscal year for which fees are collected
under this part.
(e) Public Availability.--The Secretary shall make the
reports required under subsections (a) and (b) available to the
public on the Internet Web site of the Food and Drug
Administration.
(f) Reauthorization.--
(1) Consultation.--In developing recommendations to
present to the Congress with respect to the goals, and
plans for meeting the goals, for human generic drug
activities for the first 5 fiscal years after [fiscal
year 2022] fiscal year 2027, and for the
reauthorization of this part for such fiscal years, the
Secretary shall consult with--
(A) the Committee on Energy and Commerce of
the House of Representatives;
(B) the Committee on Health, Education,
Labor, and Pensions of the Senate;
(C) scientific and academic experts;
(D) health care professionals;
(E) representatives of patient and consumer
advocacy groups; and
(F) the generic drug industry.
(2) Prior public input.--Prior to beginning
negotiations with the generic drug industry on the
reauthorization of this part, the Secretary shall--
(A) publish a notice in the Federal Register
requesting public input on the reauthorization;
(B) hold a public meeting at which the public
may present its views on the reauthorization,
including specific suggestions for changes to
the goals referred to in subsection (a);
(C) provide a period of 30 days after the
public meeting to obtain written comments from
the public suggesting changes to this part; and
(D) publish the comments on the Food and Drug
Administration's Internet Web site.
(3) Periodic consultation.--Not less frequently than
once every month during negotiations with the generic
drug industry, the Secretary shall hold discussions
with representatives of patient and consumer advocacy
groups to continue discussions of their views on the
reauthorization and their suggestions for changes to
this part as expressed under paragraph (2).
(4) Public review of recommendations.--After
negotiations with the generic drug industry, the
Secretary shall--
(A) present the recommendations developed
under paragraph (1) to the congressional
committees specified in such paragraph;
(B) publish such recommendations in the
Federal Register;
(C) provide for a period of 30 days for the
public to provide written comments on such
recommendations;
(D) hold a meeting at which the public may
present its views on such recommendations; and
(E) after consideration of such public views
and comments, revise such recommendations as
necessary.
(5) Transmittal of recommendations.--Not later than
[January 15, 2022] January 15, 2027, the Secretary
shall transmit to the Congress the revised
recommendations under paragraph (4), a summary of the
views and comments received under such paragraph, and
any changes made to the recommendations in response to
such views and comments.
(6) Minutes of negotiation meetings.--
(A) Public availability.--Before presenting
the recommendations developed under paragraphs
(1) through (5) to the Congress, the Secretary
shall make publicly available, on the Internet
Web site of the Food and Drug Administration,
minutes of all negotiation meetings conducted
under this subsection between the Food and Drug
Administration and the generic drug industry.
(B) Content.--The minutes described under
subparagraph (A) shall summarize any
substantive proposal made by any party to the
negotiations as well as significant
controversies or differences of opinion during
the negotiations and their resolution.
PART 8--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
SEC. 744G. DEFINITIONS.
For purposes of this part:
[(1) The term ``adjustment factor'' applicable to a
fiscal year is the Consumer Price Index for urban
consumers (Washington-Baltimore, DC-MD-VA-WV; Not
Seasonally Adjusted; All items) for October of the
preceding fiscal year divided by such Index for October
2011.]
(1) The term ``adjustment factor'' applicable to a
fiscal year is the Consumer Price Index for urban
consumers (Washington-Arlington-Alexandria, DC-VA-MD-
WV; Not Seasonally Adjusted; All items; Annual Index)
for September of the preceding fiscal year divided by
such Index for September 2011.
(2) The term ``affiliate'' means a business entity
that has a relationship with a second business entity
if, directly or indirectly--
(A) one business entity controls, or has the
power to control, the other business entity; or
(B) a third party controls, or has power to
control, both of the business entities.
(3) The term ``biosimilar biological product''means a
specific strength of a biological product in final
dosage form for which a biosimilar biological product
application has been approved.
(4)(A) Subject to subparagraph (B), the term
``biosimilar biological product application'' means an
application for licensure of a biological product under
section 351(k) of the Public Health Service Act.
(B) Such term does not include--
(i) a supplement to such an application;
(ii) an application filed under section
351(k) of the Public Health Service Act that
cites as the reference product a bovine blood
product for topical application licensed before
September 1, 1992, or a large volume parenteral
drug product approved before such date;
(iii) an application filed under section
351(k) of the Public Health Service Act with
respect to--
(I) whole blood or a blood component
for transfusion;
[(II) an allergenic extract product;]
[(III)] (II) an in vitro diagnostic
biological product; or
[(IV)] (III) a biological product for
further manufacturing use only; or
(iv) an application for licensure under
section 351(k) of the Public Health Service Act
that is submitted by a State or Federal
Government entity for a product that is not
distributed commercially.
(5) The term ``biosimilar biological product
development meeting'' means any meeting, other than a
biosimilar initial advisory meeting, regarding the
content of a development program, including a proposed
design for, or data from, a study intended to support a
biosimilar biological product application.
(6) The term ``biosimilar biological product
development program'' means the program under this part
for expediting the process for the review of
submissions in connection with biosimilar biological
product development.
(7)(A) The term ``biosimilar biological product
establishment'' means a foreign or domestic place of
business--
(i) that is at one general physical location
consisting of one or more buildings, all of
which are within 5 miles of each other; and
(ii) at which one or more biosimilar
biological products are manufactured in final
dosage form.
(B) For purposes of subparagraph (A)(ii), the term
``manufactured'' does not include packaging.
(8) The term ``biosimilar initial advisory
meeting''--
(A) means a meeting, if requested, that is
limited to--
(i) a general discussion regarding
whether licensure under section 351(k)
of the Public Health Service Act may be
feasible for a particular product; and
(ii) if so, general advice on the
expected content of the development
program; and
(B) does not include any meeting that
involves substantive review of summary data or
full study reports.
(9) The term ``costs of resources allocated for the
process for the review of biosimilar biological product
applications'' means the expenses in connection with
the process for the review of biosimilar biological
product applications for--
(A) officers and employees of the Food and
Drug Administration, contractors of the Food
and Drug Administration, advisory committees,
and costs related to such officers employees
and committees and to contracts with such
contractors;
(B) management of information, and the
acquisition, maintenance, and repair of
computer resources;
(C) leasing, maintenance, renovation, and
repair of facilities and acquisition,
maintenance, and repair of fixtures, furniture,
scientific equipment, and other necessary
materials and supplies; and
(D) collecting fees under section 744H and
accounting for resources allocated for the
review of submissions in connection with
biosimilar biological product development,
biosimilar biological product applications, and
supplements.
(10) The term ``final dosage form'' means, with
respect to a biosimilar biological product, a finished
dosage form which is approved for administration to a
patient without substantial further manufacturing (such
as lyophilized products before reconstitution).
(11) The term ``financial hold''--
(A) means an order issued by the Secretary to
prohibit the sponsor of a clinical
investigation from continuing the investigation
if the Secretary determines that the
investigation is intended to support a
biosimilar biological product application and
the sponsor has failed to pay any fee for the
product required under subparagraph (A), (B),
or (D) of section 744H(a)(1); and
(B) does not mean that any of the bases for a
``clinical hold'' under section 505(i)(3) have
been determined by the Secretary to exist
concerning the investigation.
(12) The term ``person'' includes an affiliate of
such person.
(13) The term ``process for the review of biosimilar
biological product applications'' means the following
activities of the Secretary with respect to the review
of submissions in connection with biosimilar biological
product development, biosimilar biological product
applications, and supplements:
(A) The activities necessary for the review
of submissions in connection with biosimilar
biological product development, biosimilar
biological product applications, and
supplements.
(B) Actions related to submissions in
connection with biosimilar biological product
development, the issuance of action letters
which approve biosimilar biological product
applications or which set forth in detail the
specific deficiencies in such applications, and
where appropriate, the actions necessary to
place such applications in condition for
approval.
(C) The inspection of biosimilar biological
product establishments and other facilities
undertaken as part of the Secretary's review of
pending biosimilar biological product
applications and supplements.
(D) Activities necessary for the release of
lots of biosimilar biological products under
section 351(k) of the Public Health Service
Act.
(E) Monitoring of research conducted in
connection with the review of biosimilar
biological product applications.
(F) Postmarket safety activities with respect
to biologics approved under biosimilar
biological product applications or supplements,
including the following activities:
(i) Collecting, developing, and
reviewing safety information on
biosimilar biological products,
including adverse-event reports.
(ii) Developing and using improved
adverse-event data-collection systems,
including information technology
systems.
(iii) Developing and using improved
analytical tools to assess potential
safety problems, including access to
external data bases.
(iv) Implementing and enforcing
section 505(o) (relating to
postapproval studies and clinical
trials and labeling changes) and
section 505(p) (relating to risk
evaluation and mitigation strategies).
(v) Carrying out section 505(k)(5)
(relating to adverse-event reports and
postmarket safety activities).
(14) The term ``supplement'' means a request to the
Secretary to approve a change in a biosimilar
biological product application which has been approved,
including a supplement requesting that the Secretary
determine that the biosimilar biological product meets
the standards for interchangeability described in
section 351(k)(4) of the Public Health Service Act.
SEC. 744H. AUTHORITY TO ASSESS AND USE BIOSIMILAR BIOLOGICAL PRODUCT
FEES.
(a) Types of Fees.--Beginning in [fiscal year 2018] fiscal
year 2023, the Secretary shall assess and collect fees in
accordance with this section as follows:
(1) Biosimilar biological product development program
fees.--
(A) Initial biosimilar biological product
development fee.--
(i) In general.--Each person that
submits to the Secretary a meeting
request described under clause (ii) or
a clinical protocol for an
investigational new drug protocol
described under clause (iii) shall pay
for the product named in the meeting
request or the investigational new drug
application the initial biosimilar
biological product development fee
established under subsection (c)(5).
(ii) Meeting request.--The meeting
request described in this clause is a
request for a biosimilar biological
product development meeting for a
product.
(iii) Clinical protocol for ind.--A
clinical protocol for an
investigational new drug protocol
described in this clause is a clinical
protocol consistent with the provisions
of section 505(i), including any
regulations promulgated under section
505(i), (referred to in this section as
``investigational new drug
application'') describing an
investigation that the Secretary
determines is intended to support a
biosimilar biological product
application for a product.
(iv) Due date.--The initial
biosimilar biological product
development fee shall be due by the
earlier of the following:
(I) Not later than [5 days] 7
days after the Secretary grants
a request for a biosimilar
biological product development
meeting.
(II) The date of submission
of an investigational new drug
application describing an
investigation that the
Secretary determines is
intended to support a
biosimilar biological product
application.
(v) Transition rule.--Each person
that has submitted an investigational
new drug application prior to the date
of enactment of the Biosimilar User Fee
Act of 2012 shall pay the initial
biosimilar biological product
development fee by the earlier of the
following:
(I) Not later than 60 days
after the date of the enactment
of the Biosimilar User Fee Act
of 2012, if the Secretary
determines that the
investigational new drug
application describes an
investigation that is intended
to support a biosimilar
biological product application.
(II) Not later than [5 days]
7 days after the Secretary
grants a request for a
biosimilar biological product
development meeting.
(B) Annual biosimilar biological product
development fee.--
(i) In general.--A person that pays
an initial biosimilar biological
product development fee for a product
shall pay for such product, beginning
in the fiscal year following the fiscal
year in which the initial biosimilar
biological product development fee was
paid, an annual fee established under
subsection (c)(5)for the biosimilar
biological product development program
(referred to in this section as
``annual biosimilar biological product
development fee''), except where such
product (including, where applicable,
ownership of the relevant
investigational new drug application)
is transferred to a licensee, assignee,
or successor of such person, and
written notice of such transfer is
provided to the Secretary, in which
case such licensee, assignee, or
successor shall pay the annual
biosimilar biological product
development fee.
(ii) Due date.--The annual biosimilar
biological product development fee for
each fiscal year will be due on the
later of--
(I) the first business day on
or after October 1 of each such
year; or
(II) the first business day
after the enactment of an
appropriations Act providing
for the collection and
obligation of fees for such
year under this section.
(iii) Exception.--The annual
biosimilar biological product
development fee for each fiscal year
will be due on the date specified in
clause (ii), unless the person has--
(I) submitted a marketing
application for the biological
product that was accepted for
filing; [or]
(II) discontinued
participation in the biosimilar
biological product development
program for the product under
subparagraph (C)[.]; or
(III) been administratively
removed from the biosimilar
biological product development
program for the product under
subparagraph (E)(v).
(iv) Refund.--If a person submits a
marketing application for a biosimilar
biological product before October 1 of
a fiscal year and such application [is
accepted for filing on or after October
1 of such fiscal year] is subsequently
accepted for filing, the person may
request a refund equal to the annual
biosimilar biological product
development fee paid by the person for
the product for such fiscal year. To
qualify for consideration for a refund
under this clause, a person shall
submit to the Secretary a written
request for such refund not later than
180 days after the marketing
application is accepted for filing.
(C) Discontinuation of fee obligation.--A
person may discontinue participation in the
biosimilar biological product development
program for a product, effective October 1 of a
fiscal year, by, not later than August 1 of the
preceding fiscal year--
(i) if no investigational new drug
application concerning the product has
been submitted, submitting to the
Secretary a written declaration that
the person has no present intention of
further developing the product as a
biosimilar biological product; or
(ii) if an investigational new drug
application concerning the product has
been submitted, withdrawing the
investigational new drug application in
accordance with part 312 of title 21,
Code of Federal Regulations (or any
successor regulations).
[(D) Reactivation fee.--
[(i) In general.--A person that has
discontinued participation in the
biosimilar biological product
development program for a product under
subparagraph (C) shall, if the person
seeks to resume participation in such
program, pay a fee (referred to in this
section as ``reactivation fee'') by the
earlier of the following:
[(I) Not later than 5 days
after the Secretary grants a
request by such person for a
biosimilar biological product
development meeting for the
product (after the date on
which such participation was
discontinued).
[(II) Upon the date of
submission (after the date on
which such participation was
discontinued) by such person of
an investigational new drug
application describing an
investigation that the
Secretary determines is
intended to support a
biosimilar biological product
application for that product.
[(ii) Application of annual fee.--A
person that pays a reactivation fee for
a product shall pay for such product,
beginning in the next fiscal year, the
annual biosimilar biological product
development fee under subparagraph
(B).]
(D) Reactivation fee.--
(i) In general.--A person that has
discontinued participation in the
biosimilar biological product
development program for a product under
subparagraph (C), or who has been
administratively removed from the
biosimilar biological product
development program for a product under
subparagraph (E)(v), shall, if the
person seeks to resume participation in
such program, pay all annual biosimilar
biological product development fees
previously assessed for such product
and still owed and a fee (referred to
in this section as ``reactivation
fee'') by the earlier of the following:
(I) Not later than 7 days
after the Secretary grants a
request by such person for a
biosimilar biological product
development meeting for the
product (after the date on
which such participation was
discontinued or the date of
administrative removal, as
applicable).
(II) Upon the date of
submission (after the date on
which such participation was
discontinued or the date of
administrative removal, as
applicable) by such person of
an investigational new drug
application describing an
investigation that the
Secretary determines is
intended to support a
biosimilar biological product
application for that product.
(ii) Application of annual fee.--A
person that pays a reactivation fee for
a product shall pay for such product,
beginning in the next fiscal year, the
annual biosimilar biological product
development fee under subparagraph (B),
except where such product (including,
where applicable, ownership of the
relevant investigational new drug
application) is transferred to a
licensee, assignee, or successor of
such person, and written notice of such
transfer is provided to the Secretary,
in which case such licensee, assignee,
or successor shall pay the annual
biosimilar biological product
development fee.
(E) Effect of failure to pay fees.--
(i) No biosimilar biological product
development meetings.--If a person has
failed to pay an initial or annual
biosimilar biological product
development fee as required under
subparagraph (A) or (B), or a
reactivation fee as required under
subparagraph (D), the Secretary shall
not provide a biosimilar biological
product development meeting relating to
the product for which fees are owed.
(ii) No receipt of investigational
new drug applications.--Except in
extraordinary circumstances, the
Secretary shall not consider an
investigational new drug application to
have been received under section
505(i)(2) if--
(I) the Secretary determines
that the investigation is
intended to support a
biosimilar biological product
application; and
(II) the sponsor has failed
to pay an initial or annual
biosimilar biological product
development fee for the product
as required under subparagraph
(A) or (B), or a reactivation
fee as required under
subparagraph (D).
(iii) Financial hold.--
Notwithstanding section 505(i)(2),
except in extraordinary circumstances,
the Secretary shall prohibit the
sponsor of a clinical investigation
from continuing the investigation if--
(I) the Secretary determines
that the investigation is
intended to support a
biosimilar biological product
application; and
(II) the sponsor has failed
to pay an initial or annual
biosimilar biological product
development fee for the product
as required under subparagraph
(A) or (B), or a reactivation
fee for the product as required
under subparagraph (D).
(iv) No acceptance of biosimilar
biological product applications or
supplements.--If a person has failed to
pay an initial or annual biosimilar
biological product development fee as
required under subparagraph (A) or (B),
or a reactivation fee as required under
subparagraph (D), any biosimilar
biological product application or
supplement submitted by that person
shall be considered incomplete and
shall not be accepted for filing by the
Secretary until all such fees owed by
such person have been paid.
(v) Administrative removal from the
biosimilar biological product
development program.--If a person has
failed to pay an annual biosimilar
biological product development fee for
a product as required under
subparagraph (B) for a period of two
consecutive fiscal years, the Secretary
may administratively remove such person
from the biosimilar biological product
development program for the product. At
least 30 days prior to administratively
removing a person from the biosimilar
biological product development program
for a product under this clause, the
Secretary shall provide written notice
to such person of the intended
administrative removal.
(F) Limits regarding fees.--
(i) Refunds.--Except as provided in
subparagraph (B)(iv), the Secretary
shall not refund any initial or annual
biosimilar biological product
development fee paid under subparagraph
(A) or (B), or any reactivation fee
paid under subparagraph (D).
(ii) No waivers, exemptions, or
reductions.--The Secretary shall not
grant a waiver, exemption, or reduction
of any initial or annual biosimilar
biological product development fee due
or payable under subparagraph (A) or
(B), or any reactivation fee due or
payable under subparagraph (D).
(2) Biosimilar biological product application fee.--
(A) In general.--Each person that submits, on
or after October 1, 2017, a biosimilar
biological product application shall be subject
to the following fees:
(i) A fee established under
subsection (c)(5) for a biosimilar
biological product application for
which clinical data (other than
comparative bioavailability studies)
with respect to safety or effectiveness
are required for approval.
(ii) A fee established under
subsection (c)(5) for a biosimilar
biological product application for
which clinical data (other than
comparative bioavailability studies)
with respect to safety or effectiveness
are not required for approval. Such fee
shall be equal to half of the amount of
the fee described in clause (i).
(B) Rule of applicability; treatment of
certain previously paid fees.--Any person who
pays a fee under subparagraph (A), (B), or (D)
of paragraph (1) for a product before October
1, 2017, but submits a biosimilar biological
product application for that product after such
date, shall--
(i) be subject to any biosimilar
biological product application fees
that may be assessed at the time when
such biosimilar biological product
application is submitted; and
(ii) be entitled to no reduction of
such application fees based on the
amount of fees paid for that product
before October 1, 2017, under such
subparagraph (A), (B), or (D).
(C) Payment due date.--Any fee required by
subparagraph (A) shall be due upon submission
of the application for which such fee applies.
(D) Exception for previously filed
application.--If a biosimilar biological
product application was submitted by a person
that paid the fee for such application, was
accepted for filing, and was not approved or
was withdrawn prior to approval (without a
waiver), the submission of a biosimilar
biological product application for the same
product by the same person (or the person's
licensee, assignee, or successor) shall not be
subject to a fee under subparagraph (A).
(E) Refund of application fee if application
refused for filing or withdrawn before
filing.--The Secretary shall refund 75 percent
of the fee paid under this paragraph for any
application which is refused for filing or
withdrawn without a waiver before filing.
(F) Fees for applications previously refused
for filing or withdrawn before filing.--A
biosimilar biological product application that
was submitted but was refused for filing, or
was withdrawn before being accepted or refused
for filing, shall be subject to the full fee
under subparagraph (A) upon being resubmitted
or filed over protest, unless the fee is waived
under subsection (d).
(3) Biosimilar biological product program fee.--
(A) In general.--Each person who is named as
the applicant in a biosimilar biological
product application shall pay the annual
biosimilar biological product program fee
established for a fiscal year under subsection
(c)(5) for each biosimilar biological product
that--
(i) is identified in such a
biosimilar biological product
application approved as of October 1 of
such fiscal year; [and]
(ii) may be dispensed only under
prescription pursuant to section
503(b); and
[(ii)] (iii) as of October 1 of such
fiscal year, does not appear on a list,
developed and maintained by the
Secretary, of discontinued biosimilar
biological products.
(B) Due date.--The biosimilar biological
product program fee for a fiscal year shall be
due on the later of--
(i) the first business day on or
after October 1 of each such year; or
(ii) the first business day after the
enactment of an appropriations Act
providing for the collection and
obligation of fees for such year under
this section.
(C) One fee per product per year.--The
biosimilar biological product program fee shall
be paid only once for each product for each
fiscal year.
(D) Limitation.--A person who is named as the
applicant in a biosimilar biological product
application shall not be assessed more than 5
biosimilar biological product program fees for
a fiscal year for biosimilar biological
products identified in such biosimilar
biological product application.
(E) Movement to discontinued list.--
(i) Date of inclusion.--If a written
request to place a product on the list
referenced in subparagraph (A) of
discontinued biosimilar biological
products is submitted to the Secretary
on behalf of an applicant, and the
request identifies the date the product
is withdrawn from sale, then for
purposes of assessing the biosimilar
biological product program fee, the
Secretary shall consider such product
to have been included on such list on
the later of--
(I) the date such request was
received; or
(II) if the product will be
withdrawn from sale on a future
date, such future date when the
product is withdrawn from sale.
(ii) Treatment as withdrawn from
sale.--For purposes of clause (i), a
product shall be considered withdrawn
from sale once the applicant has ceased
its own distribution of the product,
whether or not the applicant has
ordered recall of all previously
distributed lots of the product, except
that a routine, temporary interruption
in supply shall not render a product
withdrawn from sale.
(iii) Special rule.--If a biosimilar
biological product that is identified
in a biosimilar biological product
application approved as of October 1 of
a fiscal year appears, as of October 1
of such fiscal year, on the list
referenced in subparagraph (A) of
discontinued biosimilar biological
products, and on any subsequent day
during such fiscal year the biosimilar
biological product does not appear on
such list, then except as provided in
subparagraph (D), each person who is
named as the applicant in a biosimilar
biological product application with
respect to such product shall pay the
annual biosimilar biological product
program fee established for a fiscal
year under subsection (c)(5) for such
biosimilar biological product.
Notwithstanding subparagraph (B), such
fee shall be due on the last business
day of such fiscal year and shall be
paid only once for each such product
for each fiscal year.
[(4) Biosimilar biological product fee.--
[(A) In general.--Each person who is named as
the applicant in a biosimilar biological
product application shall pay for each such
biosimilar biological product the annual fee
established under subsection (c)(5).
[(B) Due date.--The biosimilar biological
product fee for a fiscal year shall be due on
the later of--
[(i) the first business day on or
after October 1 of each such year; or
[(ii) the first business day after
the enactment of an appropriations Act
providing for the collection and
obligation of fees for such year under
this section.
[(C) One fee per product per year.--The
biosimilar biological product fee shall be paid
only once for each product for each fiscal
year.]
(b) Fee Revenue Amounts.--
[(1) Fiscal year 2018.--For fiscal year 2018, fees
under subsection (a) shall be established to generate a
total revenue amount equal to the sum of--
[(A) $45,000,000; and
[(B) the dollar amount equal to the fiscal
year 2018 adjustment (as determined under
subsection (c)(4)).
[(2) Subsequent fiscal years.--For each of the fiscal
years 2019 through 2022, fees under subsection (a)
shall, except as provided in subsection (c), be
established to generate a total revenue amount equal to
the sum of--
[(A) the annual base revenue for the fiscal
year (as determined under paragraph (4));
[(B) the dollar amount equal to the inflation
adjustment for the fiscal year (as determined
under subsection (c)(1));
[(C) the dollar amount equal to the capacity
planning adjustment for the fiscal year (as
determined under subsection (c)(2)); and
[(D) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if
applicable (as determined under subsection
(c)(3)).]
(1) In general.--For each of the fiscal years 2023
through 2027, fees under subsection (a) shall, except
as provided in subsection (c), be established to
generate a total revenue amount equal to the sum of--
(A) the annual base revenue for the fiscal
year (as determined under paragraph (3));
(B) the dollar amount equal to the inflation
adjustment for the fiscal year (as determined
under subsection (c)(1));
(C) the dollar amount equal to the strategic
hiring and retention adjustment (as determined
under subsection (c)(2));
(D) the dollar amount equal to the capacity
planning adjustment for the fiscal year (as
determined under subsection (c)(3));
(E) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if
applicable (as determined under subsection
(c)(4));
(F) for fiscal year 2023 an additional amount
of $4,428,886; and
(G) for fiscal year 2024 an additional amount
of $320,569.
[(3)] (2) Allocation of revenue amount among fees[;
limitations on fee amounts].--
(A) Allocation.--The Secretary shall
determine the percentage of the total revenue
amount for a fiscal year to be derived from,
respectively--
(i) initial and annual biosimilar
biological product development fees and
reactivation fees under subsection
(a)(1);
(ii) biosimilar biological product
application fees under subsection
(a)(2); and
(iii) biosimilar biological product
program fees under subsection (a)(3).
[(B) Limitations on fee amounts.--Until the
first fiscal year for which the capacity
planning adjustment under subsection (c)(2) is
effective, the amount of any fee under
subsection (a) for a fiscal year after fiscal
year 2018 shall not exceed 125 percent of the
amount of such fee for fiscal year 2018.]
[(C)] (B) Biosimilar biological product
development fees.--The initial biosimilar
biological product development fee under
subsection (a)(1)(A) for a fiscal year shall be
equal to the annual biosimilar biological
product development fee under subsection
(a)(1)(B) for that fiscal year.
[(D)] (C) Reactivation fee.--The reactivation
fee under subsection (a)(1)(D) for a fiscal
year shall be equal to twice the amount of the
annual biosimilar biological product
development fee under subsection (a)(1)(B) for
that fiscal year.
[(4) Annual base revenue.--For purposes of paragraph
(2), the dollar amount of the annual base revenue for a
fiscal year shall be the dollar amount of the total
revenue amount for the previous fiscal year, excluding
any adjustments to such revenue amount under subsection
(c)(3).]
(3) Annual base revenue.--For purposes of paragraph
(1), the dollar amount of the annual base revenue for a
fiscal year shall be--
(A) for fiscal year 2023, $43,376,922; and
(B) for fiscal years 2024 through 2027, the
dollar amount of the total revenue amount
established under paragraph (1) for the
previous fiscal year, excluding any adjustments
to such revenue amount under subsection (c)(4).
(c) Adjustments; Annual Fee Setting.--
(1) Inflation adjustment.--
(A) In general.--For purposes of [subsection
(b)(2)(B)] subsection (b)(1)(B), the dollar
amount of the inflation adjustment to the
annual base revenue for each fiscal year shall
be equal to the product of--
(i) such annual base revenue for the
fiscal year under [subsection (b)]
subsection (b)(1)(A); and
(ii) the inflation adjustment
percentage under subparagraph (B).
(B) Inflation adjustment percentage.--The
inflation adjustment percentage under this
subparagraph for a fiscal year is equal to the
sum of--
(i) the average annual percent change
in the cost, per full-time equivalent
position of the Food and Drug
Administration, of all personnel
compensation and benefits paid with
respect to such positions for the first
3 years of the preceding 4 fiscal
years, multiplied by the proportion of
personnel compensation and benefits
costs to total costs of the process for
the review of biosimilar biological
product applications (as defined in
section 744G(13)) for the first 3 years
of the preceding 4 fiscal years; and
(ii) the average annual percent
change that occurred in the Consumer
Price Index for urban consumers
([Washington-Baltimore, DC-MD-VA-WV]
Washington-Arlington-Alexandria, DC-VA-
MD-WV; Not Seasonally Adjusted; All
items; Annual Index) for the first 3
years of the preceding 4 years of
available data multiplied by the
proportion of all costs other than
personnel compensation and benefits
costs to total costs of the process for
the review of biosimilar biological
product applications (as defined in
section 744G(13)) for the first 3 years
of the preceding 4 fiscal years.
[(2) Capacity planning adjustment.--
[(A) In general.--Beginning with the fiscal
year described in subparagraph (B)(ii)(II), the
Secretary shall, in addition to the adjustment
under paragraph (1), further increase the fee
revenue and fees under this section for a
fiscal year to reflect changes in the resource
capacity needs of the Secretary for the process
for the review of biosimilar biological product
applications.
[(B) Capacity planning methodology.--
[(i) Development; evaluation and
report.--The Secretary shall obtain,
through a contract with an independent
accounting or consulting firm, a report
evaluating options and recommendations
for a new methodology to accurately
assess changes in the resource and
capacity needs of the process for the
review of biosimilar biological product
applications. The capacity planning
methodological options and
recommendations presented in such
report shall utilize and be informed by
personnel time reporting data as an
input. The report shall be published
for public comment not later than
September 30, 2020.
[(ii) Establishment and
implementation.--After review of the
report described in clause (i) and
receipt and review of public comments
thereon, the Secretary shall establish
a capacity planning methodology for
purposes of this paragraph, which
shall--
[(I) incorporate such
approaches and attributes as
the Secretary determines
appropriate; and
[(II) be effective beginning
with the first fiscal year for
which fees are set after such
capacity planning methodology
is established.
[(C) Limitation.--Under no circumstances
shall an adjustment under this paragraph result
in fee revenue for a fiscal year that is less
than the sum of the amounts under subsections
(b)(2)(A) (the annual base revenue for the
fiscal year) and (b)(2)(B) (the dollar amount
of the inflation adjustment for the fiscal
year).
[(D) Publication in federal register.--The
Secretary shall publish in the Federal Register
notice under paragraph (5) the fee revenue and
fees resulting from the adjustment and the
methodologies under this paragraph.
[(3) Operating reserve adjustment.--
[(A) Interim application; fee reduction.--
Until the first fiscal year for which the
capacity planning adjustment under paragraph
(2) is effective, the Secretary may, in
addition to the adjustment under paragraph (1),
reduce the fee revenue and fees under this
section for a fiscal year as the Secretary
determines appropriate for long-term financial
planning purposes.
[(B) General application and methodology.--
Beginning with the first fiscal year for which
the capacity planning adjustment under
paragraph (2) is effective, the Secretary may,
in addition to the adjustments under paragraphs
(1) and (2)--
[(i) reduce the fee revenue and fees
under this section as the Secretary
determines appropriate for long-term
financial planning purposes; or
[(ii) increase the fee revenue and
fees under this section if such an
adjustment is necessary to provide for
not more than 21 weeks of operating
reserves of carryover user fees for the
process for the review of biosimilar
biological product applications.
[(C) Federal register notice.--If an
adjustment under subparagraph (A) or (B) is
made, the rationale for the amount of the
increase or decrease (as applicable) in fee
revenue and fees shall be contained in the
annual Federal Register notice under paragraph
(5)(B) establishing fee revenue and fees for
the fiscal year involved.
[(4) Fiscal year 2018 adjustment.--
[(A) In general.--For fiscal year 2018, the
Secretary shall adjust the fee revenue and fees
under this section in such amount (if any) as
needed to reflect an updated assessment of the
workload for the process for the review of
biosimilar biological product applications.
[(B) Methodology.--The Secretary shall
publish under paragraph (5)(B) a description of
the methodology used to calculate the fiscal
year 2018 adjustment under this paragraph in
the Federal Register notice establishing fee
revenue and fees for fiscal year 2018.
[(C) Limitation.--No adjustment under this
paragraph shall result in an increase in fee
revenue and fees under this section in excess
of $9,000,000.]
(2) Strategic hiring and retention adjustment.--For
each fiscal year, after the annual base revenue under
subsection (b)(1)(A) is adjusted for inflation in
accordance with paragraph (1), the Secretary shall
further increase the fee revenue and fees by $150,000.
(3) Capacity planning adjustment.--
(A) In general.--For each fiscal year, the
Secretary shall, in addition to the adjustments
under paragraphs (1) and (2), further adjust
the fee revenue and fees under this section for
a fiscal year to reflect changes in the
resource capacity needs of the Secretary for
the process for the review of biosimilar
biological product applications.
(B) Methodology.--For purposes of this
paragraph, the Secretary shall employ the
capacity planning methodology utilized by the
Secretary in setting fees for fiscal year 2021,
as described in the notice titled ``Biosimilar
User Fee Rates for Fiscal Year 2021'' published
in the Federal Register on August 4, 2020 (85
Fed. Reg. 47220). The workload categories used
in applying such methodology in forecasting
shall include only the activities described in
that notice and, as feasible, additional
activities that are also directly related to
the direct review of biosimilar biological
product applications and supplements, including
additional formal meeting types, the direct
review of postmarketing commitments and
requirements, the direct review of risk
evaluation and mitigation strategies, and the
direct review of annual reports for approved
biosimilar biological products. Subject to the
exceptions in the preceding sentence, the
Secretary shall not include as workload
categories in applying such methodology in
forecasting any non-core review activities,
including those activities that the Secretary
referenced for potential future use in such
notice but did not utilize in setting fees for
fiscal year 2021.
(C) Limitations.--Under no circumstances
shall an adjustment under this paragraph result
in fee revenue for a fiscal year that is less
than the sum of the amounts under subsections
(b)(1)(A) (the annual base revenue for the
fiscal year), (b)(1)(B) (the dollar amount of
the inflation adjustment for the fiscal year),
and (b)(1)(C) (the dollar amount of the
strategic hiring and retention adjustment).
(D) Publication in federal register.--The
Secretary shall publish in the Federal Register
notice under paragraph (5) the fee revenue and
fees resulting from the adjustment and the
methodologies under this paragraph.
(4) Operating reserve adjustment.--
(A) Increase.--For fiscal year 2023 and
subsequent fiscal years, the Secretary shall,
in addition to adjustments under paragraphs
(1), (2), and (3), further increase the fee
revenue and fees if such an adjustment is
necessary to provide for at least 10 weeks of
operating reserves of carryover user fees for
the process for the review of biosimilar
biological product applications.
(B) Decrease.--
(i) Fiscal year 2023.--For fiscal
year 2023, if the Secretary has
carryover balances for such process in
excess of 33 weeks of such operating
reserves, the Secretary shall decrease
such fee revenue and fees to provide
for not more than 33 weeks of such
operating reserves.
(ii) Fiscal year 2024.--For fiscal
year 2024, if the Secretary has
carryover balances for such process in
excess of 27 weeks of such operating
reserves, the Secretary shall decrease
such fee revenue and fees to provide
for not more than 27 weeks of such
operating reserves.
(iii) Fiscal year 2025 and subsequent
fiscal years.--For fiscal year 2025 and
subsequent fiscal years, if the
Secretary has carryover balances for
such process in excess of 21 weeks of
such operating reserves, the Secretary
shall decrease such fee revenue and
fees to provide for not more than 21
weeks of such operating reserves.
(C) Federal register notice.--If an
adjustment under subparagraph (A) or (B) is
made, the rationale for the amount of the
increase or decrease in fee revenue and fees
shall be contained in the annual Federal
Register notice under paragraph (5)(B)
establishing fee revenue and fees for the
fiscal year involved.
(5) Annual fee setting.--For fiscal year [2018] 2023
and each subsequent fiscal year, the Secretary shall,
not later than 60 days before the start of each such
fiscal year--
(A) establish, for the fiscal year, initial
and annual biosimilar biological product
development fees and reactivation fees under
subsection (a)(1), biosimilar biological
product application fees under subsection
(a)(2), and biosimilar biological product
program fees under subsection (a)(3), based on
the revenue amounts established under
subsection (b) and the adjustments provided
under this subsection; and
(B) publish such fee revenue and fees in the
Federal Register.
(6) Limit.--The total amount of fees assessed for a
fiscal year under this section may not exceed the total
costs for such fiscal year for the resources allocated
for the process for the review of biosimilar biological
product applications.
(d) Application Fee Waiver for Small Business.--
(1) Waiver of application fee.--The Secretary shall
grant to a person who is named in a biosimilar
biological product application a waiver from the
application fee assessed to that person under
subsection (a)(2)(A) for the first biosimilar
biological product application that a small business or
its affiliate submits to the Secretary for review.
After a small business or its affiliate is granted such
a waiver, the small business or its affiliate shall pay
application fees for all subsequent biosimilar
biological product applications submitted to the
Secretary for review in the same manner as an entity
that is not a small business.
(2) Considerations.--In determining whether to grant
a waiver of a fee under paragraph (1), the Secretary
shall consider only the circumstances and assets of the
applicant involved and any affiliate of the applicant.
(3) Small business defined.--In this subsection, the
term ``small business'' means an entity that has fewer
than 500 employees, including employees of affiliates,
and does not have a drug product that has been approved
under a human drug application (as defined in section
735) or a biosimilar biological product application (as
defined in section 744G(4)) and introduced or delivered
for introduction into interstate commerce.
(e) Effect of Failure To Pay Fees.--A biosimilar biological
product application or supplement submitted by a person subject
to fees under subsection (a) shall be considered incomplete and
shall not be accepted for filing by the Secretary until all
such fees owed by such person have been paid.
(f) Crediting and Availability of Fees.--
(1) In general.--Subject to paragraph (2), fees
authorized under subsection (a) shall be collected and
available for obligation only to the extent and in the
amount provided in advance in appropriations Acts. Such
fees are authorized to remain available until expended.
Such sums as may be necessary may be transferred from
the Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to
such appropriation account for salaries and expenses
with such fiscal year limitation. The sums transferred
shall be available solely for the process for the
review of biosimilar biological product applications.
(2) Collections and appropriation acts.--
(A) In general.--Subject to subparagraphs (C)
and (D), the fees authorized by this section
shall be collected and available in each fiscal
year in an amount not to exceed the amount
specified in appropriation Acts, or otherwise
made available for obligation for such fiscal
year.
(B) Use of fees and limitations.--
(i) In general.--The fees authorized
by this section shall be available for
a fiscal year beginning after fiscal
year 2012 to defray the costs of the
process for the review of biosimilar
biological product applications
(including such costs for an additional
number of full-time equivalent
positions in the Department of Health
and Human Services to be engaged in
such process), only if the Secretary
allocates for such purpose an amount
for such fiscal year (excluding amounts
from fees collected under this section)
no less than $20,000,000, multiplied by
the adjustment factor applicable to the
fiscal year involved.
(ii) Leasing and necessary
equipment.--Beginning on October 1,
2023, the authorities under section
744G(9)(C) shall include only leasing
and necessary scientific equipment.
(C) Compliance.--The Secretary shall be
considered to have met the requirements of
subparagraph (B) in any fiscal year if the
costs described in such subparagraph are not
more than 15 percent below the level specified
in such subparagraph.
(D) Provision for early payments.--Payment of
fees authorized under this section for a fiscal
year, prior to the due date for such fees, may
be accepted by the Secretary in accordance with
authority provided in advance in a prior year
appropriations Act.
(3) Authorization of appropriations.--For each of
fiscal years [2018 through 2022] 2023 through 2027,
there is authorized to be appropriated for fees under
this section an amount equivalent to the total amount
of fees assessed for such fiscal year under this
section.
(g) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed under
subsection (a) within 30 days after it is due, such fee shall
be treated as a claim of the United States Government subject
to subchapter II of chapter 37 of title 31, United States Code.
[(h) Written Requests for Waivers and Refunds.--To qualify
for consideration for a waiver under subsection (d), or for a
refund of any fee collected in accordance with subsection
(a)(2)(A), a person shall submit to the Secretary a written
request for such waiver or refund not later than 180 days after
such fee is due.]
(h) Written Requests for Waivers and Returns; Disputes
Concerning Fees.--To qualify for consideration for a waiver
under subsection (d), or for the return of any fee paid under
this section, including if the fee is claimed to have been paid
in error, a person shall submit to the Secretary a written
request justifying such waiver or return and, except as
otherwise specified in this section, such written request shall
be submitted to the Secretary not later than 180 days after
such fee is due. A request submitted under this paragraph shall
include any legal authorities under which the request is made.
(i) Construction.--This section may not be construed to
require that the number of full-time equivalent positions in
the Department of Health and Human Services, for officers,
employers, and advisory committees not engaged in the process
of the review of biosimilar biological product applications, be
reduced to offset the number of officers, employees, and
advisory committees so engaged.
SEC. 744I. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Performance Report.--
(1) General requirements.--[Beginning with fiscal
year 2018, not] Not later than 120 days after the end
of each fiscal year for which fees are collected under
this part, the Secretary shall prepare and submit to
the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate a report concerning
the progress of the Food and Drug Administration in
achieving the goals identified in the letters described
in section 401(b) of the [Biosimilar User Fee
Amendments of 2017] Biosimilar User Fee Amendments of
2022 during such fiscal year and the future plans of
the Food and Drug Administration for meeting such
goals. The report for a fiscal year shall include
information on all previous cohorts for which the
Secretary has not given a complete response on all
biosimilar biological product applications and
supplements in the cohort.
(2) Additional information.--[Beginning with fiscal
year 2018, the] The report under this subsection shall
include the progress of the Food and Drug
Administration in achieving the goals, and future plans
for meeting the goals, including--
(A) information on all previous cohorts for
which the Secretary has not given a complete
response on all biosimilar biological product
applications and supplements in the cohort;
(B) the number of original biosimilar
biological product applications filed per
fiscal year, and the number of approvals issued
by the agency for such applications; and
(C) the number of resubmitted original
biosimilar biological product applications
filed per fiscal year and the number of
approvals letters issued by the agency for such
applications.
(3) Real time reporting.--
(A) In general.--[Not later than 30 calendar
days after the end of the second quarter of
fiscal year 2018, and not later than 30
calendar days after the end of each quarter of
each fiscal year thereafter] Not later than 30
calendar days after the end of each quarter of
each fiscal year for which fees are collected
under this part, the Secretary shall post the
data described in subparagraph (B) for such
quarter and on a cumulative basis for the
fiscal year on the internet website of the Food
and Drug Administration, and may remove
duplicative data from the annual report under
this subsection.
(B) Data.--The Secretary shall post the
following data in accordance with subparagraph
(A):
(i) The number and titles of draft
and final guidance on topics related to
the process for the review of
biosimilars, and whether such guidances
were required by statute or pursuant to
a commitment under the letters
described in section 401(b) of the
[Biosimilar User Fee Amendments of
2017] Biosimilar User Fee Amendments of
2022.
(ii) The number and titles of public
meetings held on topics related to the
process for the review of biosimilars,
and whether such meetings were required
by statute or pursuant to a commitment
under the letters described in section
401(b) of the [Biosimilar User Fee
Amendments of 2017] Biosimilar User Fee
Amendments of 2022.
(4) Rationale for bsufa program changes.--Beginning
with fiscal year 2020, the Secretary shall include in
the annual report under paragraph (1)--
(A) data, analysis, and discussion of the
changes in the number of full-time equivalents
hired as agreed upon in the letters described
in section 401(b) of the [Biosimilar User Fee
Amendments of 2017] Biosimilar User Fee
Amendments of 2022 and the number of full time
equivalents funded by budget authority at the
Food and Drug Administration by each division
within the Center for Drug Evaluation and
Research, the Center for Biologics Evaluation
and Research, the Office of Regulatory Affairs,
and the Office of the Commissioner;
(B) data, analysis, and discussion of the
changes in the fee revenue amounts and costs
for the process for the review of biosimilar
biological product applications, including
identifying drivers of such changes; and
(C) for each of the Center for Drug
Evaluation and Research, the Center for
Biologics Evaluation and Research, the Office
of Regulatory Affairs, and the Office of the
Commissioner, the number of employees for whom
time reporting is required and the number of
employees for whom time reporting is not
required.
(5) Analysis.--For each fiscal year, the Secretary
shall include in the report an analysis of the
following:
(A) The difference between the aggregate
number of biosimilar biological product
applications and supplements filed and the
aggregate number of approvals issued by the
agency, accounting for--
(i) such applications filed during
one fiscal year for which a decision is
not scheduled to be made until the
following fiscal year; and
(ii) the aggregate number of
applications for each fiscal year that
did not meet the goals identified by
the letters described in section 401(b)
of the [Biosimilar User Fee Amendments
of 2017] Biosimilar User Fee Amendments
of 2022 for the applicable fiscal year.
(B) Relevant data to determine whether the
Center for Drug Evaluation and Research and the
Center for Biologics Evaluation and Research
have met the performance enhancement goals
identified by the letters described in section
401(b) of the [Biosimilar User Fee Amendments
of 2017] Biosimilar User Fee Amendments of 2022
for the applicable fiscal year.
(C) The most common causes and trends for
external or other circumstances affecting the
ability of the Secretary to meet review time
and performance enhancement goals identified by
the letters described in section 401(b) of the
Biosimilar User Fee Amendments of 2017.
(b) Fiscal Report.--[Not later than 120 days after the end of
fiscal year 2018 and each subsequent fiscal year for which fees
are collected under this part] Not later than 120 days after
the end of each fiscal year for which fees are collected under
this part, the Secretary shall prepare and submit to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate a report on the implementation of
the authority for such fees during such fiscal year and the
use, by the Food and Drug Administration, of the fees collected
for such fiscal year.
(c) Corrective Action Report.--[Beginning with fiscal year
2018, and for] For each fiscal year for which fees are
collected under this part, the Secretary shall prepare and
submit a corrective action report to the Committee on Energy
and Commerce and Committee on Appropriations of the House of
Representatives and the Committee on Health, Education, Labor,
and Pensions and Committee on Appropriations of the Senate. The
report shall include the following information, as applicable:
(1) Goals met.--For each fiscal year, if the
Secretary determines, based on the analysis under
subsection (a)(5), that each of the goals identified by
the letters described in section 401(b) of the
[Biosimilar User Fee Amendments of 2017] Biosimilar
User Fee Amendments of 2022 for the applicable fiscal
year have been met, the corrective action report shall
include recommendations on ways in which the Secretary
can improve and streamline the biosimilar biological
product application review process.
(2) Goals missed.--For each of the goals identified
by the letters described in section 401(b) of the
[Biosimilar User Fee Amendments of 2017] Biosimilar
User Fee Amendments of 2022 for the applicable fiscal
year that the Secretary determines to not have been
met, the corrective action report shall include--
(A) a justification for such determination
and a description of the types of circumstances
and trends, as applicable, under which
biosimilar biological product applications
missed the review goal times but were approved
during the first cycle review, or review goals
were missed; and
(B) with respect to performance enhancement
goals that were not achieved, a description of
efforts the Food and Drug Administration has
put in place for the fiscal year in which the
report is submitted to improve the ability of
such agency to meet each such goal for the such
fiscal year.
(d) Enhanced Communication.--
(1) Communications with congress.--Each fiscal year,
as applicable and requested, representatives from the
Centers with expertise in the review of human drugs
shall meet with representatives from the Committee on
Health, Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the House
of Representatives to report on the contents described
in the reports under this section.
(2) Participation in congressional hearing.--Each
fiscal year, as applicable and requested,
representatives from the Food and Drug Administration
shall participate in a public hearing before the
Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy and Commerce of
the House of Representatives, to report on the contents
described in the reports under this section. Such
hearing shall occur not later than 120 days after the
end of each fiscal year for which fees are collected
under this part.
(e) Public Availability.--The Secretary shall make the
reports required under subsections (a) and (b) available to the
public on the Internet Web site of the Food and Drug
Administration.
(f) Reauthorization.--
(1) Consultation.--In developing recommendations to
present to the Congress with respect to the goals
described in subsection (a), and plans for meeting the
goals, for the process for the review of biosimilar
biological product applications for the first 5 fiscal
years after [fiscal year 2022] fiscal year 2027, and
for the reauthorization of this part for such fiscal
years, the Secretary shall consult with--
(A) the Committee on Energy and Commerce of
the House of Representatives;
(B) the Committee on Health, Education,
Labor, and Pensions of the Senate;
(C) scientific and academic experts;
(D) health care professionals;
(E) representatives of patient and consumer
advocacy groups; and
(F) the regulated industry.
(2) Public review of recommendations.--After
negotiations with the regulated industry, the Secretary
shall--
(A) present the recommendations developed
under paragraph (1) to the congressional
committees specified in such paragraph;
(B) publish such recommendations in the
Federal Register;
(C) provide for a period of 30 days for the
public to provide written comments on such
recommendations;
(D) hold a meeting at which the public may
present its views on such recommendations; and
(E) after consideration of such public views
and comments, revise such recommendations as
necessary.
(3) Transmittal of recommendations.--Not later than
[January 15, 2022] January 15, 2027, the Secretary
shall transmit to the Congress the revised
recommendations under paragraph (2), a summary of the
views and comments received under such paragraph, and
any changes made to the recommendations in response to
such views and comments.
* * * * * * *
CHAPTER VIII--IMPORTS AND EXPORTS
* * * * * * *
SEC. 809. RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS.
(a) Inspection.--The Secretary--
(1) may enter into arrangements and agreements with a
foreign government or an agency of a foreign government
to recognize the inspection of foreign establishments
registered under section 510(i) in order to facilitate
preapproval or risk-based inspections in accordance
with the schedule established in paragraph (2) or (3)
of section 510(h);
(2) may enter into arrangements and agreements with a
foreign government or an agency of a foreign government
under this section only with a foreign government or an
agency of a foreign government that the Secretary has
determined as having the capability of conducting
inspections that meet the applicable requirements of
this Act; and
(3) shall perform such reviews and audits of drug
safety programs, systems, and standards of a foreign
government or agency for the foreign government as the
Secretary deems necessary to determine that the foreign
government or agency of the foreign government is
capable of conducting inspections that meet the
applicable requirements of this Act.
(b) Results of Inspection.--The results of inspections
performed by a foreign government or an agency of a foreign
government under this section may be used as--
(1) evidence of compliance with section 501(a)(2)(B)
or section 801(r); and
(2) for any other purposes as determined appropriate
by the Secretary.
(c) Periodic Review.--
(1) In general.--Beginning not later than 1 year
after the date of the enactment of the Food and Drug
Amendments of 2022, the Secretary shall periodically
assess whether additional arrangements and agreements
with a foreign government or an agency of a foreign
government, as allowed under this section, are
appropriate.
(2) Reports to congress.--Beginning not later than 4
years after the date of the enactment of the Food and
Drug Amendments of 2022, and every 4 years thereafter,
the Secretary shall submit to the Committee on Energy
and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of
the Senate a report describing the findings and
conclusions of each review conducted under paragraph
(1).
* * * * * * *
----------
FDA REAUTHORIZATION ACT OF 2017
* * * * * * *
TITLE I--FEES RELATING TO DRUGS
* * * * * * *
SEC. 104. SUNSET DATES.
[(a) Authorization.--Sections 735 and 736 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease
to be effective October 1, 2022.
[(b) Reporting Requirements.--Section 736B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379h-2) shall cease to
be effective January 31, 2023.]
(c) Previous Sunset Provision.--Effective October 1, 2017,
subsections (a) and (b) of section 105 of the Food and Drug
Administration Safety and Innovation Act (Public Law 112-144)
are repealed.
* * * * * * *
TITLE II--FEES RELATING TO DEVICES
* * * * * * *
SEC. 210. SUNSET DATES.
[(a) Authorization.--Sections 737 and 738 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease
to be effective October 1, 2022.
[(b) Reporting Requirements.--Section 738A (21 U.S.C. 739j-1)
of the Federal Food, Drug, and Cosmetic Act (regarding
reauthorization and reporting requirements) shall cease to be
effective January 31, 2023.]
(c) Previous Sunset Provision.--Effective October 1, 2017,
section 207(a) of the Food and Drug Administration Safety and
Innovation Act (Public Law 112-144) is repealed.
TITLE III--FEES RELATING TO GENERIC DRUGS
* * * * * * *
SEC. 305. SUNSET DATES.
[(a) Authorization.--Sections 744A and 744B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-41; 379j-42) shall
cease to be effective October 1, 2022.
[(b) Reporting Requirements.--Section 744C of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-43) shall cease to
be effective January 31, 2023.]
(c) Previous Sunset Provision.--
(1) In general.--Effective October 1, 2017, section
304 of the Food and Drug Administration Safety and
Innovation Act (Public Law 112-144) is repealed.
(2) Conforming amendment.--The Food and Drug
Administration Safety and Innovation Act (Public Law
112-144) is amended in the table of contents in section
2 by striking the item relating to section 304.
* * * * * * *
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
* * * * * * *
SEC. 405. SUNSET DATES.
[(a) Authorization.--Sections 744G and 744H of the Federal
Food, Drug, and Cosmetic Act shall cease to be effective
October 1, 2022.
[(b) Reporting Requirements.--Section 744I of the Federal
Food, Drug, and Cosmetic Act shall cease to be effective
January 31, 2023.]
(c) Previous Sunset Provision.--
(1) In general.--Effective October 1, 2017, section
404 of the Food and Drug Administration Safety and
Innovation Act (Public Law 112-144) is repealed.
(2) Conforming amendment.--The Food and Drug
Administration Safety and Innovation Act (Public Law
112-144) is amended in the table of contents in section
2 by striking the item relating to section 404.
* * * * * * *
TITLE VIII--IMPROVING GENERIC DRUG ACCESS
* * * * * * *
SEC. 807. REPORTING ON PENDING GENERIC DRUG APPLICATIONS AND PRIORITY
REVIEW APPLICATIONS.
Not later than 180 calendar days after the date of enactment
of this Act, and quarterly thereafter until October 1, [2022]
2027, the Secretary of Health and Human Services shall post on
the internet website of the Food and Drug Administration a
report that provides, with respect to the months covered by the
report--
(1) with respect to applications filed under section
505(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)) that, during the most recent calendar
year, were subject to priority review under paragraph
(11) of such section 505(j) (as added by section 801)
or expedited development and review under section 506H
of the Federal Food, Drug, and Cosmetic Act (as added
by section 803), the numbers of such applications (with
denotation of such applications that were filed prior
to October 1, 2014) that are--
(A) awaiting action by the applicant;
(B) awaiting action by the Secretary; and
(C) approved by the Secretary;
(2) the number of applications filed under section
505(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)) and prior approval supplements withdrawn
in each month;
(3) the mean and median approval and tentative
approval times and the number of review cycles for such
applications;
(4) the number and type of meetings requested and
held under such section 506H (as added by section 803);
and
(5) the number of such applications on which the
Secretary has taken action pursuant to subsection (c)
of such section 506H (as added by section 803) and any
effect such section 506H may have on the length of time
for approval of applications under such section 505(j)
and the number of review cycles for such approvals.
* * * * * * *
TITLE IX--ADDITIONAL PROVISIONS
* * * * * * *
[SEC. 902. ANNUAL REPORT ON INSPECTIONS.
[Not later than March 1 of each year, the Secretary of Health
and Human Services shall post on the internet website of the
Food and Drug Administration information related to inspections
of facilities necessary for approval of a drug under section
505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355), approval of a device under section 515 of such Act (21
U.S.C. 360e), or clearance of a device under section 510(k) of
such Act (21 U.S.C. 360(k)) that were conducted during the
previous calendar year. Such information shall include the
following:
[(1) The median time following a request from staff
of the Food and Drug Administration reviewing an
application or report to the beginning of the
inspection, and the median time from the beginning of
an inspection to the issuance of a report pursuant to
section 704(b) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 374(b)).
[(2) The median time from the issuance of a report
pursuant to such section 704(b) to the sending of a
warning letter, issuance of an import alert, or holding
of a regulatory meeting for inspections for which the
Secretary concluded that regulatory or enforcement
action was indicated.
[(3) The median time from the sending of a warning
letter, issuance of an import alert, or holding of a
regulatory meeting to resolution of the regulatory or
enforcement action indicated for inspections for which
the Secretary concluded that such action was indicated.
[(4) The number of times that a facility was issued a
report pursuant to such section 704(b) and approval of
an application was delayed due to the issuance of a
withhold recommendation.]
SEC. 902. ANNUAL REPORT ON INSPECTIONS.
Not later than 120 days after the end of each fiscal year,
the Secretary of Health and Human Services shall post on the
public website of the Food and Drug Administration information
related to inspections of facilities necessary for approval of
a drug under subsection (c) or (j) of section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), approval
of a device under section 515 of such Act (21 U.S.C. 360e), or
clearance of a device under section 510(k) of such Act (21
U.S.C. 360(k)) that were conducted during the previous fiscal
year. Such information shall include the following:
(1) The median time following a request from staff of
the Food and Drug Administration reviewing an
application or report to the beginning of the
inspection, including--
(A) the median time for drugs described in
section 505(j)(11)(A)(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
355(j)(11)(A)(i));
(B) the median time for drugs described in
section 506C(a) of such Act (21 U.S.C. 356c(a))
only; and
(C) the median time for drugs on the drug
shortage list in effect under section 506E of
such Act (21 U.S.C. 356e).
(2) The median time from the issuance of a report
pursuant to section 704(b) of such Act (21 U.S.C.
374(b)) to the sending of a warning letter, issuance of
an import alert, or holding of a regulatory meeting for
inspections for which the Secretary concluded that
regulatory or enforcement action was indicated,
including the median time for each category of drugs
listed in subparagraphs (A) through (C) of paragraph
(1).
(3) The median time from the sending of a warning
letter, issuance of an import alert, or holding of a
regulatory meeting to resolution of the actions
indicated to address the conditions or practices
observed during an inspection.
(4) The number of facilities that failed to implement
adequate corrective or preventive actions following a
report pursuant to such section 704(b), resulting in a
withhold recommendation, including the number of such
times for each category of drugs listed in
subparagraphs (A) through (C) of paragraph (1).
* * * * * * *
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PUBLIC HEALTH SERVICE ACT
TITLE IV--NATIONAL RESEARCH INSTITUTES
* * * * * * *
Part B--General Provisions Respecting National Research Institutes
* * * * * * *
SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.
(a) List of Priority Issues in Pediatric Therapeutics.--
(1) In general.--Not later than one year after the
date of the enactment of the Best Pharmaceuticals for
Children Act of 2007, the Secretary, acting through the
Director of the National Institutes of Health and in
consultation with the Commissioner of Food and Drugs
and experts in pediatric research, shall develop and
publish a priority list of needs in pediatric
therapeutics, including drugs, biological products, or
indications that require study. The list shall be
revised every three years.
(2) Consideration of available information.--In
developing and prioritizing the list under paragraph
(1), the Secretary--
(A) shall consider--
(i) therapeutic gaps in pediatrics
that may include developmental
pharmacology, pharmacogenetic
determinants of drug response,
metabolism of drugs and biologics in
children, and pediatric clinical
trials;
(ii) particular pediatric diseases,
disorders or conditions where more
complete knowledge and testing of
therapeutics, including drugs and
biologics, and identification of
biomarkers for such diseases,
disorders, or conditions, may be
beneficial in pediatric populations;
and
(iii) the adequacy of necessary
infrastructure to conduct pediatric
pharmacological research, including
research networks and trained pediatric
investigators; and
(B) may consider the availability of
qualified countermeasures (as defined in
section 319F-1), security countermeasures (as
defined in section 319F-2), and qualified
pandemic or epidemic products (as defined in
section 319F-3) to address the needs of
pediatric populations, in consultation with the
Assistant Secretary for Preparedness and
Response, consistent with the purposes of this
section.
(b) Pediatric Studies and Research.--The Secretary, acting
through the National Institutes of Health, shall award funds to
entities that have the expertise to conduct pediatric clinical
trials or other research (including qualified universities,
hospitals, laboratories, contract research organizations,
practice groups, federally funded programs such as pediatric
pharmacology research units, other public or private
institutions, or individuals) to enable the entities to conduct
the drug studies or other research on the issues described in
paragraphs (1) and (2)(A) of subsection (a). The Secretary may
use contracts, grants, or other appropriate funding mechanisms
to award funds under this subsection.
(c) Process for Proposed Pediatric Study Requests and
Labeling Changes.--
(1) Submission of proposed pediatric study request.--
The Director of the National Institutes of Health
shall, as appropriate, submit proposed pediatric study
requests for consideration by the Commissioner of Food
and Drugs for pediatric studies of a specific pediatric
indication identified under subsection (a). Such a
proposed pediatric study request shall be made in a
manner equivalent to a written request made under
subsection (b) or (c) of section 505A of the Federal
Food, Drug, and Cosmetic Act, or section 351(m) of this
Act, including with respect to the information provided
on the pediatric studies to be conducted pursuant to
the request. The Director of the National Institutes of
Health may submit a proposed pediatric study request
for a drug for which--
(A)(i) there is an approved application under
section 505(j) of the Federal Food, Drug, and
Cosmetic Act or section 351(k) of this Act; or
(ii) there is a submitted application that
could be approved under the criteria of such
section; and
(B) there remains no patent listed pursuant
to section 505(b)(1) of the Federal Food, Drug,
and Cosmetic Act, and every three-year and
five-year period referred to in subsection
(c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv),
(j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv)
of section 505 of the Federal Food, Drug, and
Cosmetic Act, or applicable twelve-year period
referred to in section 351(k)(7) of this Act,
and any seven-year period referred to in
section 527 of the Federal Food, Drug, and
Cosmetic Act has ended for at least one form of
the drug; and
(C) additional studies are needed to assess
the safety and effectiveness of the use of the
drug in the pediatric population.
(2) Written request to holders of approved
applications.--The Commissioner of Food and Drugs, in
consultation with the Director of the National
Institutes of Health, may issue a written request based
on the proposed pediatric study request for the
indication or indications submitted pursuant to
paragraph (1) (which shall include a timeframe for
negotiations for an agreement) for pediatric studies
concerning a drug identified under subsection (a) to
all holders of an approved application for the drug.
Such a written request shall be made in a manner
equivalent to the manner in which a written request is
made under subsection (b) or (c) of section 505A of the
Federal Food, Drug, and Cosmetic Act or section 351(m)
of this Act, including with respect to information
provided on the pediatric studies to be conducted
pursuant to the request and using appropriate
formulations for each age group for which the study is
requested.
(3) Requests for proposals.--If the Commissioner of
Food and Drugs does not receive a response to a written
request issued under paragraph (2) not later than 30
days after the date on which a request was issued, the
Secretary, acting through the Director of the National
Institutes of Health and in consultation with the
Commissioner of Food and Drugs, shall publish a request
for proposals to conduct the pediatric studies
described in the written request in accordance with
subsection (b).
(4) Disqualification.--A holder that receives a first
right of refusal shall not be entitled to respond to a
request for proposals under paragraph (3).
(5) Contracts, grants, or other funding mechanisms.--
A contract, grant, or other funding may be awarded
under this section only if a proposal is submitted to
the Secretary in such form and manner, and containing
such agreements, assurances, and information as the
Secretary determines to be necessary to carry out this
section.
(6) Reporting of studies.--
(A) In general.--On completion of a pediatric
study in accordance with an award under this
section, a report concerning the study shall be
submitted to the Director of the National
Institutes of Health and the Commissioner of
Food and Drugs. The report shall include all
data generated in connection with the study,
including a written request if issued.
(B) Availability of reports.--
(i) In general.--Each report
submitted under subparagraph (A) shall
be considered to be in the public
domain (subject to section 505A(d)(4)
of the Federal Food, Drug, and Cosmetic
Act) and not later than 90 days after
submission of such report, shall be--
(I) posted on the internet
website of the National
Institutes of Health in a
manner that is accessible and
consistent with all applicable
Federal laws and regulations,
including such laws and
regulations for the protection
of--
(aa) human research
participants, including
with respect to
privacy, security,
informed consent, and
protected health
information; and
(bb) proprietary
interests, confidential
commercial information,
and intellectual
property rights; and
(II) assigned a docket number
by the Commissioner of Food and
Drugs and made available for
the submission of public
comments.
(ii) Submission of comments.--An
interested person may submit written
comments concerning such pediatric
studies to the Commissioner of Food and
Drugs, and the submitted comments shall
become part of the docket file with
respect to each of the drugs.
(C) Action by commissioner.--The Commissioner
of Food and Drugs shall take action in a timely
and appropriate manner in response to the
reports submitted under subparagraph (A), and
shall begin such action upon receipt of the
report under subparagraph (A), in accordance
with paragraph (7).
(7) Requests for labeling change.--Within the 180-day
period after the date on which a report is submitted
under paragraph (6)(A), the Commissioner of Food and
Drugs shall--
(A) review the report and such other data as
are available concerning the safe and effective
use in the pediatric population of the drug
studied;
(B) negotiate with the holders of approved
applications for the drug studied for any
labeling changes that the Commissioner of Food
and Drugs determines to be appropriate and
requests the holders to make; and
(C)(i) include in the public docket file a
reference to the location of the report on the
internet website of the National Institutes of
Health and a copy of any requested labeling
changes; and
(ii) publish through a posting on the Web
site of the Food and Drug Administration a
summary of the report and a copy of any
requested labeling changes.
(8) Dispute resolution.--
(A) Referral to pediatric advisory
committee.--If, not later than the end of the
180-day period specified in paragraph (7), the
holder of an approved application for the drug
involved does not agree to any labeling change
requested by the Commissioner of Food and Drugs
under that paragraph, the Commissioner of Food
and Drugs shall refer the request to the
Pediatric Advisory Committee.
(B) Action by the pediatric advisory
committee.--Not later than 90 days after
receiving a referral under subparagraph (A),
the Pediatric Advisory Committee shall--
(i) review the available information
on the safe and effective use of the
drug in the pediatric population,
including study reports submitted under
this section; and
(ii) make a recommendation to the
Commissioner of Food and Drugs as to
appropriate labeling changes, if any.
(9) FDA determination.--Not later than 30 days after
receiving a recommendation from the Pediatric Advisory
Committee under paragraph (8)(B)(ii) with respect to a
drug, the Commissioner of Food and Drugs shall consider
the recommendation and, if appropriate, make a request
to the holders of approved applications for the drug to
make any labeling change that the Commissioner of Food
and Drugs determines to be appropriate.
(10) Failure to agree.--If a holder of an approved
application for a drug, within 30 days after receiving
a request to make a labeling change under paragraph
(9), does not agree to make a requested labeling
change, the Commissioner of Food and Drugs may deem the
drug to be misbranded under the Federal Food, Drug, and
Cosmetic Act.
(11) No effect on authority.--Nothing in this
subsection limits the authority of the United States to
bring an enforcement action under the Federal Food,
Drug, and Cosmetic Act when a drug lacks appropriate
pediatric labeling. Neither course of action (the
Pediatric Advisory Committee process or an enforcement
action referred to in the preceding sentence) shall
preclude, delay, or serve as the basis to stay the
other course of action.
(d) Authorization of Appropriations.--
(1) In general.--There are authorized to be
appropriated to carry out this section, $25,000,000 for
each of fiscal years [2018 through 2022] 2023 through
2027.
(2) Availability.--Any amount appropriated under
paragraph (1) shall remain available to carry out this
section until expended.
* * * * * * *
----------
PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007
* * * * * * *
TITLE III--PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007
* * * * * * *
SEC. 305. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE
AVAILABILITY.
(a) In general.--
(1) Request for proposals.--Not later than 90 days
after the date of the enactment of this Act, the
Secretary of Health and Human Services shall issue a
request for proposals for 1 or more grants or contracts
to nonprofit consortia for demonstration projects to
promote pediatric device development.
(2) Determination on grants or contracts.--Not later
than 180 days after the date the Secretary of Health
and Human Services issues a request for proposals under
paragraph (1), the Secretary shall make a determination
on the grants or contracts under this section.
(b) Application.--A nonprofit consortium that desires to
receive a grant or contract under this section shall submit an
application to the Secretary of Health and Human Services at
such time, in such manner, and containing such information as
the Secretary may require.
(c) Use of Funds.--A nonprofit consortium that receives a
grant or contract under this section shall facilitate the
development, production, and distribution of pediatric medical
devices by--
(1) encouraging innovation and connecting qualified
individuals with pediatric device ideas with potential
manufacturers;
(2) mentoring and managing pediatric device projects
through the development process, including product
identification, prototype design, device development,
and marketing;
(3) connecting innovators and physicians to existing
Federal and non-Federal resources, including resources
from the Food and Drug Administration, the National
Institutes of Health, the Small Business
Administration, the Department of Energy, the
Department of Education, the National Science
Foundation, the Department of Veterans Affairs, the
Agency for Healthcare Research and Quality, and the
National Institute of Standards and Technology;
(4) assessing the scientific and medical merit of
proposed pediatric device projects;
(5) providing assistance and advice as needed on
business development, personnel training, prototype
development, postmarket needs, and other activities
consistent with the purposes of this section; and
(6) providing regulatory consultation to device
sponsors in support of the submission of an application
for a pediatric device, where appropriate.
(d) Coordination.--
(1) National institutes of health.--Each consortium
that receives a grant or contract under this section
shall--
(A) coordinate with the National Institutes
of Health's pediatric device contact point or
office, designated under section 402(b)(23) of
the Public Health Service Act, as added by
section 304(a) of this Act; and
(B) provide to the National Institutes of
Health any identified pediatric device needs
that the consortium lacks sufficient capacity
to address or those needs in which the
consortium has been unable to stimulate
manufacturer interest.
(2) Food and drug administration.--Each consortium
that receives a grant or contract under this section
shall coordinate with the Commissioner of Food and
Drugs and device companies to facilitate the
application for approval or clearance of devices
labeled for pediatric use.
(3) Effectiveness and outcomes.--Each consortium that
receives a grant or contract under this section shall
annually report to the Secretary of Health and Human
Services on the status of pediatric device development,
production, and distribution that has been facilitated
by the consortium.
(e) Authorization of appropriations.--There are authorized to
be appropriated to carry out this section $5,250,000 for each
of fiscal years [2018 through 2022] 2023 through 2027.
* * * * * * *
----------
ORPHAN DRUG ACT
grants and contracts for development of drugs for rare diseases and
conditions
Sec. 5. (a) The Secretary may make grants to and enter into
contracts with public and private entities and individuals to
assist in (1) defraying the costs of developing drugs for rare
diseases or conditions, including qualified testing expenses,
(2) defraying the costs of developing medical devices for rare
diseases or conditions, [and (3)] (3) defraying the costs of
developing medical foods for rare diseases or conditions, and
(4) developing regulatory science pertaining to the chemistry,
manufacturing, and controls of individualized medical products
to treat individuals with rare diseases or conditions.
(b) For purposes of subsection (a):
(1) The term ``qualified testing'' means--
(A) human clinical testing--
(i) which is carried out under an
exemption for a drug for a rare disease
or condition under section 505(i) of
the Federal Food, Drug, and Cosmetic
Act (or regulations issued under such
section); and
(ii) which occurs before the date on
which an application with respect to
such drug is submitted under section
505(b) of such Act or under section 351
of the Public Health Service Act;
(B) preclinical testing involving a drug for
a rare disease or condition which occurs after
the date such drug is designated under section
526 of such Act and before the date on which an
application with respect to such drug is
submitted under section 505(b) of such Act or
under section 351 of the Public Health Service
Act; and
(C) prospectively planned and designed
observational studies and other analyses
conducted to assist in the understanding of the
natural history of a rare disease or condition
and in the development of a therapy, including
studies and analyses to--
(i) develop or validate a drug
development tool related to a rare
disease or condition; or
(ii) understand the full spectrum of
the disease manifestations, including
describing genotypic and phenotypic
variability and identifying and
defining distinct subpopulations
affected by a rare disease or
condition.
(2) The term ``rare disease or condition'' means (1)
in the case of a drug, any disease or condition which
(A) affects less than 200,000 persons in the United
States, or (B) affects more than 200,000 in the United
States and for which there is no reasonable expectation
that the cost of developing and making available in the
United States a drug for such disease or condition will
be recovered from sales in the United States of such
drugs, (2) in the case of a medical device, any disease
or condition that occurs so infrequently in the United
States that there is no reasonable expectation that a
medical device for such disease or condition will be
developed without assistance under subsection (a), and
(3) in the case of a medical food, any disease or
condition that occurs so infrequently in the United
States that there is no reasonable expectation that a
medical food for such disease or condition will be
developed without assistance under subsection (a).
Determinations under the preceding sentence with
respect to any drug shall be made on the basis of the
facts and circumstances as of the date the request for
designation of the drug under section 526 of the
Federal Food, Drug, and Cosmetic Act is made.
(3) The term ``medical food'' means a food which is
formulated to be consumed or administered enterally
under the supervision of a physician and which is
intended for the specific dietary management of a
disease or condition for which distinctive nutritional
requirements, based on recognized scientific
principles, are established by medical evaluation.
(c) Authorization of Appropriations.--For grants and
contracts under subsection (a), there is authorized to be
appropriated $30,000,000 for each of fiscal years [2018 through
2022] 2023 through 2027.
----------
21ST CENTURY CURES ACT
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``21st Century
Cures Act''.
(b) Table of Contents.--The table of contents for this Act is
as follows:
Sec. 1. Short title; table of contents.
section DIVISION A--21ST CENTURY CURES
* * * * * * *
TITLE III--DEVELOPMENT
Subtitle A--Patient-Focused Drug Development
* * * * * * *
[Sec. 3003. Streamlining patient input.]
Sec. 3003. Streamlining patient and blood donor input.
* * * * * * *
DIVISION A--21ST CENTURY CURES
* * * * * * *
TITLE III--DEVELOPMENT
Subtitle A--Patient-Focused Drug Development
* * * * * * *
[SEC. 3003. STREAMLINING PATIENT INPUT.
[Chapter 35 of title 44, United States Code, shall not apply
to the collection of information to which a response is
voluntary, that is initiated by the Secretary under section
569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-8c) (as amended by section 3001) or section 3002.]
SEC. 3003. STREAMLINING PATIENT AND BLOOD DONOR INPUT.
Chapter 35 of title 44, United States Code, shall not apply
to the collection of information to which a response is
voluntary, to solicit--
(1) the views and perspectives of patients under
section 569C of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bbb-8c) (as amended by section 3001)
or section 3002; or
(2) information from blood donors or potential blood
donors to support the development of recommendations by
the Secretary of Health and Human Services acting
through the Commissioner of Food and Drugs concerning
blood donation.
* * * * * * *
[all]