[115th Congress Public Law 52]
[From the U.S. Government Publishing Office]
[[Page 131 STAT. 1005]]
Public Law 115-52
115th Congress
An Act
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. <<NOTE: Aug. 18, 2017 - [H.R. 2430]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: FDA
Reauthorization Act of 2017. 21 USC 301 note.>>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``FDA Reauthorization Act of 2017''.
SEC. 2. TABLE OF CONTENTS.
The table of contents for 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. Authority to assess and use drug fees.
Sec. 103. Reauthorization; reporting requirements.
Sec. 104. Sunset dates.
Sec. 105. Effective date.
Sec. 106. 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 review.
Sec. 207. Electronic format for submissions.
Sec. 208. Savings clause.
Sec. 209. Effective date.
Sec. 210. Sunset dates.
TITLE III--FEES RELATING TO GENERIC DRUGS
Sec. 301. Short title; finding.
Sec. 302. Definitions.
Sec. 303. Authority to assess and use human generic drug fees.
Sec. 304. Reauthorization; reporting requirements.
Sec. 305. Sunset dates.
Sec. 306. Effective date.
Sec. 307. 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.
[[Page 131 STAT. 1006]]
Sec. 407. Savings clause.
TITLE V--PEDIATRIC DRUGS AND DEVICES
Sec. 501. Best pharmaceuticals for children.
Sec. 502. Pediatric devices.
Sec. 503. Early meeting on pediatric study plan.
Sec. 504. Development of drugs and biological products for pediatric
cancers.
Sec. 505. Additional provisions on development of drugs and biological
products for pediatric use.
TITLE VI--REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS
Sec. 601. Reauthorization of provision relating to exclusivity of
certain drugs containing single enantiomers.
Sec. 602. Reauthorization of the critical path public-private
partnerships.
Sec. 603. Reauthorization of orphan grants program.
Sec. 604. Protecting and strengthening the drug supply chain.
Sec. 605. Patient experience data.
Sec. 606. Communication plans.
Sec. 607. Orphan drugs.
Sec. 608. Pediatric information added to labeling.
Sec. 609. Sense of Congress on lowering the cost of prescription drugs.
Sec. 610. Expanded access.
Sec. 611. Tropical disease product application.
TITLE VII--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS
Sec. 701. Risk-based inspections for devices.
Sec. 702. Improvements to inspections process for device establishments.
Sec. 703. Reauthorization of inspection program.
Sec. 704. Certificates to foreign governments for devices.
Sec. 705. Facilitating international harmonization.
Sec. 706. Fostering innovation in medical imaging.
Sec. 707. Risk-based classification of accessories.
Sec. 708. Device pilot projects.
Sec. 709. Regulation of over-the-counter hearing aids.
Sec. 710. Report on servicing of devices.
TITLE VIII--IMPROVING GENERIC DRUG ACCESS
Sec. 801. Priority review of generic drugs.
Sec. 802. Enhancing regulatory transparency to enhance generic
competition.
Sec. 803. Competitive generic therapies.
Sec. 804. Accurate information about drugs with limited competition.
Sec. 805. Suitability petitions.
Sec. 806. Inspections.
Sec. 807. Reporting on pending generic drug applications and priority
review applications.
Sec. 808. Incentivizing competitive generic drug development.
Sec. 809. GAO study of issues regarding first cycle approvals of generic
medicines.
TITLE IX--ADDITIONAL PROVISIONS
Sec. 901. Technical corrections.
Sec. 902. Annual report on inspections.
Sec. 903. Streamlining and improving consistency in performance
reporting.
Sec. 904. Analysis of use of funds.
Sec. 905. Facilities management.
TITLE <<NOTE: Prescription Drug User Fee Amendments of 2017.>> I--FEES
RELATING TO DRUGS
SEC. 101. SHORT TITLE; FINDING.
(a) <<NOTE: 21 USC 301 note.>> Short Title.--This title may be
cited as the ``Prescription Drug User Fee Amendments of 2017''.
(b) <<NOTE: 21 USC 379g note.>> Finding.--The Congress finds that
the fees authorized by the amendments made in 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
[[Page 131 STAT. 1007]]
Cosmetic Act, 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. AUTHORITY TO ASSESS AND USE DRUG FEES.
(a) Types of Fees.--
(1) In general.--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 2013'' and inserting ``fiscal
year 2018'';
(B) in the heading of paragraph (1), by striking
``and supplement'';
(C) in paragraph (1), by striking ``or a
supplement'' and ``or supplement'' each place either
appears;
(D) in paragraph (1)(A)--
(i) in clause (i), by striking ``(c)(4)'' and
inserting ``(c)(5)''; and
(ii) in clause (ii), by striking ``A fee
established'' and all that follows through ``are
required.'' and inserting the following: ``A fee
established under subsection (c)(5) 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.'';
(E) in the heading of paragraph (1)(C), by striking
``or supplement'';
(F) in paragraph (1)(F)--
(i) in the heading, by striking ``or
indication''; and
(ii) by striking the second sentence;
(G) by striking paragraph (2) (relating to a
prescription drug establishment fee);
(H) by redesignating paragraph (3) as paragraph (2);
(I) in the heading of paragraph (2), as so
redesignated, by striking ``Prescription drug product
fee'' and inserting ``Prescription drug program fee'';
(J) in subparagraph (A) of such paragraph (2), by
amending the first sentence to read as follows: ``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) for each prescription drug product
that is identified in such a human drug application
approved as of October 1 of such fiscal year.'';
(K) in subparagraph (B) of such paragraph (2)--
(i) in the heading of subparagraph (B), by
inserting after ``Exception'' the following: ``for
certain prescription drug products''; and
(ii) by striking ``A prescription drug product
shall not be assessed a fee'' and inserting ``A
prescription drug program fee shall not be
assessed for a prescription drug product''; and
[[Page 131 STAT. 1008]]
(L) by adding at the end of such paragraph (2) the
following:
``(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.''.
(2) Conforming amendment.--Subparagraph (C) of section
740(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-12(a)(3)) is amended to read as follows:
``(C) Limitation.--An establishment shall be
assessed only one fee per fiscal year under this
section.''.
(b) Fee Revenue Amounts.--Subsection (b) of section 736 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) is amended to read
as follows:
``(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.
``(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).''.
[[Page 131 STAT. 1009]]
(c) Adjustments; Annual Fee Setting.--Subsection (c) of section 736
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) is amended
to read as follows:
``(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; 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) 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) <<NOTE: Time period.>> Adjustment
percentage.--The adjustment percentage under this
clause for a fiscal year is the weighted change in
the 3-year average ending in the
[[Page 131 STAT. 1010]]
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) <<NOTE: Contracts. Recommenda- tions.>>
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. <<NOTE: Publication. Public
information. Deadline.>> 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) <<NOTE: Effective date.>>
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) <<NOTE: Time period.>> 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
[[Page 131 STAT. 1011]]
for not more than 14 weeks of operating reserves of
carryover user fees for the process for the review of
human drug applications.
``(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) 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) <<NOTE: Deadline. Time period.>> Annual fee
setting.--The Secretary shall, not later than 60 days before the
start of each fiscal year that begins after September 30, 2017--
``(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) <<NOTE: Federal Register, publication.>>
publish such fee revenue and fees in the Federal
Register.
``(6) 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.--Section 736(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended--
(1) in paragraph (1)--
(A) by inserting ``or'' at the end of subparagraph
(B);
(B) by striking subparagraph (C); and
(C) by redesignating subparagraph (D) as
subparagraph (C);
(2) by striking paragraph (3) (relating to use of standard
costs);
(3) by redesignating paragraph (4) as paragraph (3); and
(4) in paragraph (3), as so redesignated--
(A) in subparagraphs (A) and (B), by striking
``paragraph (1)(D)'' and inserting ``paragraph (1)(C)'';
and
[[Page 131 STAT. 1012]]
(B) in subparagraph (B)--
(i) by striking clause (ii);
(ii) by striking ``shall pay'' through ``(i)
application fees'' and inserting ``shall pay
application fees''; and
(iii) by striking ``; and'' at the end and
inserting a period.
(e) Effect of Failure To Pay Fees.--Section 736(e) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(e)) is amended by striking
``all fees'' and inserting ``all such fees''.
(f) Limitations.--Section 736(f)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(f)(2)) is amended by striking
``supplements, prescription drug establishments, and prescription drug
products'' and inserting ``prescription drug program fees''.
(g) Crediting and Availability of Fees.--Section 736(g) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)) is amended--
(1) in paragraph (3)--
(A) by striking ``2013 through 2017'' and inserting
``2018 through 2022''; and
(B) by striking ``and paragraph (4) of this
subsection''; and
(2) by striking paragraph (4).
(h) Orphan Drugs.--Section 736(k) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(k)) is amended by striking ``product and
establishment fees'' each place it appears and inserting ``prescription
drug program fees''.
SEC. 103. 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)--
(A) in the matter before subparagraph (A), by
striking ``2013'' and inserting ``2018''; and
(B) in subparagraph (A), by striking ``Prescription
Drug User Fee Amendments of 2012'' and inserting
``Prescription Drug User Fee Amendments of 2017'';
(2) in subsection (b), by striking ``2013'' and inserting
``2018''; and
(3) in subsection (d), by striking ``2017'' each place it
appears and inserting ``2022''.
SEC. 104. SUNSET DATES.
(a) <<NOTE: 21 USC 379g note.>> 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) <<NOTE: 21 USC 379h-2 note.>> 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) <<NOTE: Effective date. Repeal. 21 USC 379g note, 379h-2
note.>> 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.
SEC. 105. <<NOTE: 21 USC 379g note.>> EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2017, 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 shall be assessed
[[Page 131 STAT. 1013]]
for all human drug applications received on or after October 1, 2017,
regardless of the date of the enactment of this Act.
SEC. 106. <<NOTE: 21 USC 379g note.>> SAVINGS CLAUSE.
Notwithstanding <<NOTE: Continuation. Time period.>> the amendments
made by this title, part 2 of subchapter C of chapter VII of the Federal
Food, Drug, and Cosmetic Act, 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, 2012, but before October 1,
2017, 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 2018.
TITLE <<NOTE: Medical Device User Fee Amendments of 2017.>> II--FEES
RELATING TO DEVICES
SEC. 201. SHORT TITLE; FINDING.
(a) <<NOTE: 21 USC 301 note.>> Short Title.--This title may be
cited as the ``Medical Device User Fee Amendments of 2017''.
(b) <<NOTE: 21 USC 379i note.>> 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
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.
(a) In General.--Section 737 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379i) is amended--
(1) by redesignating paragraphs (8) through (13) as
paragraphs (9) through (14), respectively;
(2) by inserting after paragraph (7) the following new
paragraph:
``(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.'';
(3) in subparagraph (D) of paragraph (10) (as redesignated
by paragraph (1)), by striking ``and submissions'' and inserting
``submissions, and de novo classification requests''; and
(4) in paragraph (11) (as redesignated by paragraph (1)), by
striking ``2011'' and inserting ``2016''.
(b) Conforming Amendment.--Section 714(b)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379d-3(b)(1)) is amended by striking
``737(8)'' and inserting ``737(9)''.
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 2013'' and
inserting ``fiscal year 2018''; and
(2) in paragraph (2)--
(A) in subparagraph (A)--
[[Page 131 STAT. 1014]]
(i) in the matter preceding clause (i), by
striking ``October 1, 2012'' and inserting
``October 1, 2017'';
(ii) in clause (viii), by striking ``2'' and
inserting ``3.4''; and
(iii) by adding at the end the following new
clause:
``(xi) For a de novo classification request, a
fee equal to 30 percent of the fee that applies
under clause (i).''; and
(B) in subparagraph (B)(v)(I), by striking ``or
premarket notification submission'' and inserting
``premarket notification submission, 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 to read as follows:
``(b) Fee Amounts.--
``(1) In general.--Subject to subsections (c), (d), (e), and
(h), for each of fiscal years 2018 through 2022, 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
----------------------------------------------------------------------------------------------------------------
``(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.''.
(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 ``2012'' and inserting
``2017'';
(2) in paragraph (2)--
(A) in subparagraph (A), by striking ``2014'' and
inserting ``2018'';
(B) by striking subparagraph (B) and inserting the
following new subparagraph:
``(B) Applicable inflation adjustment.--The
applicable inflation adjustment for fiscal year 2018 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.'';
[[Page 131 STAT. 1015]]
(C) in subparagraph (C), in the heading, by striking
``to total revenue amounts''; and
(D) by amending subparagraph (D) to read as follows:
``(D) Adjustment to base fee amounts.--For each of
fiscal years 2018 through 2022, 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) <<NOTE: Determination.>> 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).''; and
(3) in paragraph (3)--
(A) by striking ``2014 through 2017'' and inserting
``2018 through 2022''; and
(B) by striking ``further adjusted'' and inserting
``increased''.
(d) Small Businesses; Fee Waiver and Fee Reduction Regarding
Premarket Approval Fees.--Section 738(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(d)) is amended--
(1) in paragraph (1), by striking ``specified in clauses (i)
through (v) and clauses (vii), (ix), and (x)'' and inserting
``specified in clauses (i) through (vii) and clauses (ix), (x),
and (xi)''; and
(2) in paragraph (2)(C)--
(A) by striking ``supplement, or'' and inserting
``supplement,''; and
(B) by inserting ``, or a de novo classification
request'' after ``class III device''.
(e) Small Businesses; Fee Reduction Regarding Premarket Notification
Submissions.--Section 738(e)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(e)(2)(C)) is amended by striking ``50'' and
inserting ``25''.
(f) Fee Waiver or Reduction.--
(1) Repeal.--Section 738 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j) is amended by striking subsection
(f).
(2) Conforming amendments.--
(A) Section 515(c)(4)(A) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360e(c)(4)(A)) is amended by
striking ``738(h)'' and inserting ``738(g)''.
(B) Section 738 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j), as amended by paragraph
(1), is further amended--
(i) by redesignating subsections (g) through
(l) as subsections (f) through (k);
(ii) in subsection (a)(2)(A), by striking
``(d), (e), and (f)'' and inserting ``(d) and
(e)''; and
(iii) in subsection (a)(3)(A), by striking
``and subsection (f)''.
(g) Effect of Failure To Pay Fees.--Subsection (f)(1), as so
redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j) is amended--
[[Page 131 STAT. 1016]]
(1) by striking ``or periodic reporting concerning a class
III device'' and inserting ``periodic reporting concerning a
class III device, or de novo classification request''; and
(2) by striking ``all fees'' and inserting ``all such
fees''.
(h) Conditions.--Subsection (g)(1)(A), as so redesignated, of
section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j)
is amended by striking ``$280,587,000'' and inserting ``$320,825,000''.
(i) Crediting and Availability of Fees.--Subsection (h), as so
redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j) is amended--
(1) in paragraph (3)--
(A) by striking ``2013 through 2017'' and inserting
``2018 through 2022''; and
(B) by striking ``subsection (c)'' and all that
follows through the period at the end and inserting
``subsection (c).''; and
(2) by striking paragraph (4).
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) in paragraph (1)--
(A) in subparagraph (A)--
(i) by striking ``2013'' and inserting
``2018''; and
(ii) by striking ``the Medical Device User Fee
Amendments of 2012'' and inserting ``the Medical
Device User Fee Amendments of 2017''; and
(B) in subparagraph (B), by striking ``the Medical
Device User Fee Amendments Act of 2012'' and inserting
``the Medical Device User Fee Amendments of 2017''; and
(2) in paragraph (2), by striking ``2013 through 2017'' and
inserting ``2018 through 2022''.
(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 ``2017'' and inserting
``2022''; and
(2) in paragraph (5), by striking ``2017'' and inserting
``2022''.
SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM.
(a) In General.--Section 514 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360d) is amended by adding at the end the following:
``(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.
[[Page 131 STAT. 1017]]
``(2) Secretarial review of accredited laboratory
determinations.--The Secretary may--
``(A) <<NOTE: Audits.>> 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) <<NOTE: Deadlines.>> Implementation and reporting.--
``(A) <<NOTE: Federal Register,
publication. Notice.>> 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) <<NOTE: Web posting.>> 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
[[Page 131 STAT. 1018]]
prior to such date and recognition of the accreditation
of testing laboratories pursuant to determinations made
prior to such date.''.
SEC. 206. REAUTHORIZATION OF REVIEW.
Section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360m) is amended--
(1) in subsection (a)(3)--
(A) in subparagraph (A), by striking clauses (ii)
and (iii) and inserting the following:
``(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) by striking subparagraph (B) and inserting the
following:
``(B) Designation for review.--The Secretary shall--
``(i) <<NOTE: Guidance.>> 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) <<NOTE: Deadline.>> not later than 24
months after the date on which the Secretary
issues such draft guidance, finalize such
guidance; and
``(iii) <<NOTE: Effective date. Web
posting. Lists. Determination.>> 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).''; and
(C) by adding at the end the following:
``(C) <<NOTE: Lists.>> 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.'';
(2) in subsection (b)--
(A) in paragraph (2)--
(i) by striking subparagraph (D); and
[[Page 131 STAT. 1019]]
(ii) by redesignating subparagraph (E) as
subparagraph (D); and
(B) in paragraph (3)--
(i) by redesignating subparagraph (E) as
subparagraph (F);
(ii) in subparagraph (F) (as so redesignated),
by striking ``The operations of'' and all that
follows through ``it will--'' and inserting ``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--
''; and
(iii) by inserting after subparagraph (D) the
following new subparagraph:
``(E) The operations of such person shall be in
accordance with generally accepted professional and
ethical business practices.''; and
(3) in subsection (c), by striking ``2017'' and inserting
``2022''.
SEC. 207. ELECTRONIC FORMAT FOR SUBMISSIONS.
Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379k-1(b)) is amended by adding at the end the following new
paragraph:
``(3) <<NOTE: Deadline.>> Presubmissions and submissions
solely in electronic format.--
``(A) <<NOTE: Effective date.>> In general.--
Beginning on such date as the Secretary specifies in
final guidance issued under subparagraph (C),
presubmissions and submissions for devices described in
paragraph (1) (and any appeals of action taken by the
Secretary with respect to such presubmissions or
submissions) shall be submitted solely in such
electronic format as specified by the Secretary in such
guidance.
``(B) Draft guidance.--The Secretary shall, not
later than October 1, 2019, issue draft guidance
providing for--
``(i) any further standards for the submission
by electronic format required under subparagraph
(A);
``(ii) a timetable for the establishment by
the Secretary of such further standards; and
``(iii) <<NOTE: Criteria.>> criteria for
waivers of and exemptions from the requirements of
this subsection.
``(C) Final guidance.--The Secretary shall, not
later than 1 year after the close of the public comment
period on the draft guidance issued under subparagraph
(B), issue final guidance.''.
SEC. 208. <<NOTE: 21 USC 379i note.>> SAVINGS CLAUSE.
Notwithstanding <<NOTE: Continuation. Time period.>> 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, 2012, but before October 1, 2017, 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 2018.
[[Page 131 STAT. 1020]]
SEC. 209. <<NOTE: 21 USC 379i note.>> EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2017, 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 shall be assessed for all
submissions listed in section 738(a)(2)(A) of such Act received on or
after October 1, 2017, regardless of the date of the enactment of this
Act.
SEC. 210. <<NOTE: 21 USC 378i note.>> 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) <<NOTE: 21 USC 379j-1 note.>> 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) <<NOTE: Effective date. Repeal. 21 USC 379i note.>> 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 <<NOTE: Generic Drug User Fee Amendments of 2017.>> III--FEES
RELATING TO GENERIC DRUGS
SEC. 301. SHORT TITLE; FINDING.
(a) <<NOTE: 21 USC 301 note.>> Short Title.--This title may be
cited as the ``Generic Drug User Fee Amendments of 2017''.
(b) <<NOTE: 21 USC 379j-41 note.>> Finding.--The Congress finds
that the fees authorized by the amendments made in 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, 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. DEFINITIONS.
Section 744A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-41) is amended--
(1) in paragraph (1)(B), by striking ``application for a
positron emission tomography drug.'' and inserting
``application--
``(i) for a positron emission tomography drug;
or
``(ii) submitted by a State or Federal
governmental entity for a drug that is not
distributed commercially.'';
(2) by redesignating paragraphs (5) through (12) as
paragraphs (6) through (13), respectively; and
(3) by inserting after paragraph (4) the following:
``(5) The term `contract manufacturing organization
facility' means a manufacturing facility of a finished dosage
form of a drug approved pursuant to an abbreviated new drug
application, where such manufacturing facility is not identified
in an approved abbreviated new drug application held by the
owner of such facility or an affiliate of such owner or
facility.''.
[[Page 131 STAT. 1021]]
SEC. 303. 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 2013'' and inserting ``fiscal year 2018'';
(2) in paragraph (1), by adding at the end the following:
``(E) Sunset.--This paragraph shall cease to be
effective October 1, 2022.'';
(3) in paragraph (2)--
(A) by amending subparagraph (C) to read as follows:
``(C) <<NOTE: Deadline. Time period. Federal
Register, publication.>> Notice.--Not later than 60
days before the start of each of fiscal years 2018
through 2022, the Secretary shall publish in the Federal
Register the amount of the drug master file fee
established by this paragraph for such fiscal year.'';
and
(B) in subparagraph (E)--
(i) in clause (i)--
(I) by striking ``no later than the
date'' and inserting ``on the earlier
of--
``(I) the date'';
(II) by striking the period and
inserting ``; or''; and
(III) by adding at the end the
following:
``(II) the date on which the drug
master file holder requests the initial
completeness assessment.''; and
(ii) in clause (ii), by striking ``notice
provided for in clause (i) or (ii) of subparagraph
(C), as applicable'' and inserting ``notice
provided for in subparagraph (C)'';
(4) in paragraph (3)--
(A) in the heading, by striking ``and prior approval
supplement'';
(B) in subparagraph (A), by striking ``or a prior
approval supplement to an abbreviated new drug
application'';
(C) by amending subparagraphs (B) and (C) to read as
follows:
``(B) <<NOTE: Deadline. Time period. Federal
Register, publication.>> Notice.--Not later than 60
days before the start of each of fiscal years 2018
through 2022, the Secretary shall publish in the Federal
Register the amount of the fees under subparagraph (A)
for such fiscal year.
``(C) <<NOTE: Deadline. Applicability.>> 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) in subparagraph (D)--
(i) in the heading, by inserting ``, is
withdrawn prior to being received, or is no longer
received'' after ``received''; and
(ii) by striking ``The Secretary shall'' and
all that follows through the period and inserting
the following:
``(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
[[Page 131 STAT. 1022]]
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) <<NOTE: Refunds.>> 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) in subparagraph (E), by striking ``or prior
approval supplement''; and
(F) in the matter preceding clause (i) of
subparagraph (F)--
(i) by striking ``2012'' and inserting
``2017''; and
(ii) by striking ``subsection (d)(3)'' and
inserting ``subsection (d)(2)'';
(5) in paragraph (4)--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i) and in
clause (iii), by striking ``, or intended to be
identified, in at least one generic drug
submission that is pending or'' and inserting ``in
at least one generic drug submission that is'';
(ii) in clause (i), by striking ``or intended
to be identified in at least one generic drug
submission that is pending or'' and inserting ``in
at least one generic drug submission that is'';
(iii) in clause (ii), by striking
``produces,'' and all that follows through ``such
a'' and inserting ``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''; and
(iv) in clause (iii), by striking ``to fees
under both such clauses'' and inserting ``only to
the fee attributable to the manufacture of the
finished dosage forms''; and
(B) by amending subparagraphs (C) and (D) to read as
follows:
``(C) <<NOTE: Federal Register, publication.>>
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) <<NOTE: Time period. Deadlines.>> Fee due
date.--For each of fiscal years 2018 through 2022, 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.'';
[[Page 131 STAT. 1023]]
(6) by redesignating paragraph (5) as paragraph (6); and
(7) by inserting after paragraph (4) the following:
``(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) <<NOTE: Federal Register, publication.>>
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) <<NOTE: Time period. Deadlines.>> Fee due
date.--For each of fiscal years 2018 through 2022, 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.''.
(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 ``2013'' and
inserting ``2018'';
(ii) by striking ``2013'' and inserting
``2018'';
(iii) by striking ``$299,000,000'' and
inserting ``$493,600,000''; and
(iv) by striking ``Of that amount'' and all
that follows through the end of clause (ii); and
(B) in subparagraph (B)--
(i) in the heading, by striking ``2014 through
2017'' and inserting ``2019 through 2022'';
(ii) by striking ``2014 through 2017'' and
inserting ``2019 through 2022'';
(iii) by striking ``paragraphs (2) through
(4)'' and inserting ``paragraphs (2) through
(5)''; and
(iv) by striking ``$299,000,000'' and
inserting ``$493,600,000''; and
(2) in paragraph (2)--
(A) in the matter preceding subparagraph (A)--
(i) by striking ``paragraph (1)(A)(ii) for
fiscal year 2013 and paragraph (1)(B) for each of
fiscal years 2014 through 2017'' and inserting
``such paragraph for a fiscal year''; and
(ii) by striking ``through (4)'' and inserting
``through (5)'';
(B) in subparagraph (A), by striking ``Six percent''
and inserting ``Five percent'';
(C) by amending subparagraphs (B) and (C) to read as
follows:
``(B) Thirty-three percent shall be derived from
fees under subsection (a)(3) (relating to abbreviated
new drug applications).
[[Page 131 STAT. 1024]]
``(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 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) in subparagraph (D)--
(i) by striking ``Fourteen percent'' and
inserting ``Seven percent'';
(ii) by striking ``not less than $15,000 and
not more than $30,000'' and inserting ``$15,000'';
and
(iii) by striking ``, as determined'' and all
that follows through the period at the end and
inserting a period; and
(E) by adding at the end the following:
``(E)(i) Thirty-five 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 <<NOTE: Determination.>> 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) <<NOTE: Deadline.>> 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.--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) by striking ``2014'' and inserting ``2019'';
[[Page 131 STAT. 1025]]
(B) by inserting ``to equal the product of the total
revenues established in such notice for the prior fiscal
year multiplied'' after ``a fiscal year,''; and
(C) by striking the flush text following
subparagraph (C); and
(2) in paragraph (2)--
(A) by striking ``2017'' each place it appears and
inserting ``2022'';
(B) by striking ``the first 3 months of fiscal year
2018'' and inserting ``the first 3 months of fiscal year
2023''; and
(C) by striking ``Such fees may only be used in
fiscal year 2018.''.
(d) Annual Fee Setting.--Section 744B(d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-42(d)) is amended--
(1) by striking paragraphs (1) and (2) and inserting the
following:
``(1) <<NOTE: Time period. Deadline.>> Fiscal years 2018
through 2022.--Not more than 60 days before the first day of
each of fiscal years 2018 through 2022, 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) by redesignating paragraph (3) as paragraph (2); and
(3) in paragraph (2) (as so redesignated), in the matter
preceding subparagraph (A), by striking ``fees under paragraphs
(1) and (2)'' and inserting ``fee under paragraph (1)''.
(e) Identification of Facilities.--Section 744B(f) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(f)) is amended--
(1) by striking paragraph (1);
(2) by redesignating paragraphs (2) through (4) as
paragraphs (1) through (3), respectively;
(3) in paragraph (1) (as so redesignated)--
(A) by striking ``paragraph (4)'' and inserting
``paragraph (3)''; and
(B) <<NOTE: Deadline.>> by striking ``Such
information shall'' and all that follows through the end
of subparagraph (B) and inserting ``Such information
shall, for each fiscal year, be submitted, updated, or
reconfirmed on or before June 1 of the previous fiscal
year.''; and
(4) in paragraph (2), as so redesignated--
(A) in the heading, by striking ``Contents of
notice'' and inserting ``Information required to be
submitted'';
(B) in the matter preceding subparagraph (A), by
striking ``paragraph (2)'' and inserting ``paragraph
(1)'';
(C) in subparagraph (A), by striking ``or intended
to be identified'';
(D) in subparagraph (D), by striking ``and'' at the
end;
(E) in subparagraph (E), by striking the period and
inserting ``; and''; and
(F) by adding at the end the following:
``(F) whether the facility is a contract
manufacturing organization facility.''.
(f) Effect of Failure To Pay Fees.--Section 744B(g) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(g)) is amended--
[[Page 131 STAT. 1026]]
(1) in paragraph (1), by adding at the end the following:
``This paragraph <<NOTE: Termination date.>> shall cease to be
effective on October 1, 2022.'';
(2) in paragraph (2)(C)(ii), by striking ``of 505(j)(5)(A)''
and inserting ``of section 505(j)(5)(A)''; and
(3) by adding at the end the following:
``(5) Generic drug applicant program fee.--
``(A) <<NOTE: Deadline. Time period.>> 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) <<NOTE: Public information. Lists.>>
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.''.
(g) Limitations.--Section 744B(h)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-42(h)(2)) is amended by striking ``for Type
II active pharmaceutical ingredient drug master files, abbreviated new
drug applications and prior approval supplements, and generic drug
facilities and active pharmaceutical ingredient facilities''.
(h) Crediting and Availability of Fees.--Section 744B(i) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(i)) is amended--
(1) in paragraph (2)--
(A) in subparagraph (A), by striking ``subparagraphs
(C) and (D)'' and inserting ``subparagraph (C)'';
(B) by striking subparagraph (C) (relating to fee
collection during first program year);
(C) in subparagraph (D)--
(i) in the heading, by striking ``in
subsequent years''; and
(ii) by striking ``(after fiscal year 2013)'';
and
(D) by redesignating subparagraph (D) as
subparagraph (C); and
(2) in paragraph (3), by striking ``fiscal years 2013
through 2017'' and inserting ``fiscal years 2018 through 2022''.
(i) Information on Abbreviated New Drug Applications Owned by
Applicants and Their Affiliates.--Section 744B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-42) is amended by adding at the
end the following:
``(o) Information on Abbreviated New Drug Applications Owned by
Applicants and Their Affiliates.--
``(1) <<NOTE: Deadline. Lists.>> 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--
[[Page 131 STAT. 1027]]
``(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) <<NOTE: Guidance.>> Format and method.--The Secretary
shall specify in guidance the format and method for submission
of lists under this subsection.''.
SEC. 304. 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)--
(A) by striking ``2013'' and inserting ``2018''; and
(B) by striking ``Generic Drug User Fee Amendments
of 2012'' and inserting ``Generic Drug User Fee
Amendments of 2017'';
(2) in subsection (b), by striking ``2013'' and inserting
``2018''; and
(3) in subsection (d), by striking ``2017'' each place it
appears and inserting ``2022''.
SEC. 305. SUNSET DATES.
(a) <<NOTE: 21 USC 379j-41 note.>> 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) <<NOTE: 21 USC 379j-43 note.>> 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) <<NOTE: Effective date. Repeal. 21 USC 379j-41 note,
379j-43 note.>> 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.
SEC. 306. <<NOTE: 21 USC 379j-41 note.>> EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2017, 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 shall be assessed for all
abbreviated new drug applications received on or after October 1, 2017,
regardless of the date of the enactment of this Act.
SEC. 307. <<NOTE: 21 USC 379j-41 note.>> 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,
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
[[Page 131 STAT. 1028]]
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, 2012, but before October 1,
2017, with respect to assessing and collecting any fee required by such
part for a fiscal year prior to fiscal year 2018.
TITLE <<NOTE: Biosimilar User Fee Amendments of 2017.>> IV--FEES
RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
SEC. 401. SHORT TITLE; FINDING.
(a) <<NOTE: 21 USC 301 note.>> Short Title.--This title may be
cited as the ``Biosimilar User Fee Amendments of 2017''.
(b) <<NOTE: 21 USC 379j-51 note.>> Finding.--The Congress finds
that the fees authorized by the amendments made in 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,
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-Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All
items) for October of the preceding fiscal year divided by such
Index for October 2011.''.
(b) Biosimilar Biological Product.--Section 744G(3) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51(3)) is amended by
striking ``means a product'' and inserting ``means a specific strength
of a biological product in final dosage form''.
SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR FEES.
(a) Types of Fees.--Section 744H(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-52(a)) is amended--
(1) in the matter preceding paragraph (1), by striking
``fiscal year 2013'' and inserting ``fiscal year 2018'';
(2) in the heading of paragraph (1), by striking
``Biosimilar'' and inserting ``Biosimilar biological product'';
(3) in paragraph (1)(A)(i), by striking ``(b)(1)(A)'' and
inserting ``(c)(5)'';
(4) in paragraph (1)(B)(i), by striking ``(b)(1)(B) for
biosimilar biological product development'' and inserting
``(c)(5) for the biosimilar biological product development
program'';
(5) in paragraph (1)(B)(ii), by striking ``annual biosimilar
biological product development program fee'' and inserting
``annual biosimilar biological product development fee'';
[[Page 131 STAT. 1029]]
(6) in paragraph (1)(B)(iii), by striking ``annual
biosimilar development program fee'' and inserting ``annual
biosimilar biological product development fee'';
(7) in paragraph (1)(B), by adding at the end the following:
``(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, 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 <<NOTE: Deadline.>> 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.'';
(8) in paragraph (1)(C), by striking ``for a product
effective October 1 of a fiscal year by,'' and inserting ``for a
product, effective October 1 of a fiscal year, by,'';
(9) in paragraph (1)(D)--
(A) in clause (i) in the matter preceding subclause
(I), by inserting ``, if the person seeks to resume
participation in such program,'' before ``pay a fee'';
(B) in clause (i)(I), by inserting after ``grants a
request'' the following: ``by such person''; and
(C) in clause (i)(II), by inserting after
``discontinued)'' the following: ``by such person'';
(10) in the heading of paragraph (1)(E), by striking
``biosimilar development program'';
(11) in paragraph (1)(F)--
(A) in the subparagraph heading, by striking
``biosimilar development program''; and
(B) by amending clause (i) to read as follows:
``(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).'';
(12) in paragraph (2)--
(A) in the paragraph heading, by striking ``and
supplement'';
(B) by amending subparagraphs (A) and (B) to read as
follows:
``(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).
[[Page 131 STAT. 1030]]
``(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) in the heading of subparagraph (D), by striking
``or supplement'';
(D) in subparagraphs (C) through (F), by striking
``or supplement'' each place it appears; and
(E) in subparagraph (D), by striking ``or a
supplement'';
(13) by amending paragraph (3) to read as follows:
``(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) 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) <<NOTE: Deadlines.>> 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.''.
(b) Fee Revenue Amounts.--Subsection (b) of section 744H of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended to
read as follows:
``(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
[[Page 131 STAT. 1031]]
``(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)).
``(3) Allocation of revenue amount among fees; limitations
on fee amounts.--
``(A) <<NOTE: Determination.>> 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) 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) 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).''.
(c) Adjustments; Annual Fee Setting.--Section 744H of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended--
(1) by redesignating subsections (c) through (h) as
subsections (d) through (i), respectively;
[[Page 131 STAT. 1032]]
(2) in subsections (a)(2)(F) and (h) (as redesignated by
paragraph (1)), by striking ``subsection (c)'' and inserting
``subsection (d)'';
(3) in subsection (a)(4)(A), by striking ``subsection
(b)(1)(F)'' and inserting ``subsection (c)(5)''; and
(4) by inserting after subsection (b) the following:
``(c) Adjustments; Annual Fee Setting.--
``(1) Inflation adjustment.--
``(A) In general.--For purposes of subsection
(b)(2)(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); and
``(ii) the inflation adjustment percentage
under subparagraph (B).
``(B) <<NOTE: Time periods.>> 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; 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) <<NOTE: Effective date.>> 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) <<NOTE: Contracts.>> 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
[[Page 131 STAT. 1033]]
capacity planning methodological options and
recommendations presented in such report shall
utilize and be informed by personnel time
reporting data as an
input. <<NOTE: Publication. Public
information. Deadline.>> 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) <<NOTE: Effective date.>> 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) <<NOTE: Notice.>> 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 <<NOTE: Effective date.>>
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) <<NOTE: Time period.>> 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) <<NOTE: Assessment.>> 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
[[Page 131 STAT. 1034]]
assessment of the workload for the process for the
review of biosimilar biological product applications.
``(B) <<NOTE: Federal Register,
publication. Notice.>> 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.
``(5) <<NOTE: Time period. Deadline.>> Annual fee
setting.--For fiscal year 2018 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) <<NOTE: Federal Register, publication.>>
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.--Subsection (d)(1) of
section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-52), as redesignated by subsection (c)(1), is amended--
(1) by striking subparagraph (B);
(2) by striking ``; and'' at the end of subparagraph (A) and
inserting a period; and
(3) by striking ``shall pay--'' and all that follows through
``application fees'' and inserting ``shall pay application
fees''.
(e) Effect of Failure To Pay Fees.--Subsection (e) of section 744H
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52), as
redesignated by subsection (c)(1), is amended by striking ``all fees''
and inserting ``all such fees''.
(f) Crediting and Availability of Fees.--Subsection (f) of section
744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52), as
redesignated by subsection (c)(1), is amended--
(1) in paragraph (2)--
(A) by striking subparagraph (C) (relating to fee
collection during first program year) and inserting the
following:
``(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.''; and
(B) in subparagraph (D)--
(i) in the heading, by striking ``in
subsequent years''; and
(ii) by striking ``(after fiscal year 2013)'';
and
(2) in paragraph (3), by striking ``2013 through 2017'' and
inserting ``2018 through 2022''.
[[Page 131 STAT. 1035]]
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)--
(A) by striking ``2013'' and inserting ``2018''; and
(B) by striking ``Biosimilar User Fee Act of 2012''
and inserting ``Biosimilar User Fee Amendments of
2017'';
(2) in subsection (b), by striking ``2013'' and inserting
``2018'';
(3) by striking subsection (d);
(4) by redesignating subsection (e) as subsection (d); and
(5) in subsection (d), as so redesignated, by striking
``2017'' each place it appears and inserting ``2022''.
SEC. 405. SUNSET DATES.
(a) <<NOTE: 21 USC 379j-51 note.>> Authorization.--Sections 744G
and 744H of the Federal Food, Drug, and Cosmetic Act shall cease to be
effective October 1, 2022.
(b) <<NOTE: 21 USC 379j-53 note.>> 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) <<NOTE: Effective date. Repeal. 21 USC 379j-51 note,
379j-53 note.>> 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.
SEC. 406. <<NOTE: 21 USC 379j-51 note.>> EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2017, 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 shall be assessed for all
biosimilar biological product applications received on or after October
1, 2017, regardless of the date of the enactment of this Act.
SEC. 407. <<NOTE: 21 USC 379j-51 note.>> SAVINGS CLAUSE.
Notwithstanding <<NOTE: Continuation. Time period.>> the amendments
made by this title, part 8 of subchapter C of chapter VII of the Federal
Food, Drug, and Cosmetic Act, 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, 2012, but before
October 1, 2017, with respect to assessing and collecting any fee
required by such part for a fiscal year prior to fiscal year 2018.
[[Page 131 STAT. 1036]]
TITLE V--PEDIATRIC DRUGS AND DEVICES
SEC. 501. BEST PHARMACEUTICALS FOR CHILDREN.
Section 409I of the Public Health Service Act (42 U.S.C. 284m) is
amended--
(1) in subsection (a)(2)(A)(ii), by inserting ``and
identification of biomarkers for such diseases, disorders, or
conditions,'' after ``biologics,'';
(2) in subsection (c)--
(A) in paragraph (6)--
(i) by amending subparagraph (B) to read as
follows:
``(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) <<NOTE: Web posting.>> 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) <<NOTE: Public
information.>> 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.''; and
(ii) in subparagraph (C), by striking
``appropriate action'' and all that follows
through the period and inserting ``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).''; and
(B) in paragraph (7)--
(i) in the matter preceding subparagraph (A),
by striking ``During'' and inserting ``Within'';
(ii) in subparagraph (C)(i), by striking
``place'' and all that follows through ``and of''
and inserting ``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''; and
[[Page 131 STAT. 1037]]
(iii) in clause (ii), by striking ``in the
Federal Register and'';
(3) by striking subsection (d);
(4) by redesignating subsection (e) as subsection (d); and
(5) in paragraph (1) of subsection (d), as so redesignated,
by striking ``2013 through 2017'' and inserting ``2018 through
2022''.
SEC. 502. PEDIATRIC DEVICES.
(a) Pediatric Use of Devices.--Section 515A(a)(3) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360e-1(a)(3)) is amended--
(1) by redesignating subparagraphs (B) through (D) as
subparagraphs (D) through (F), respectively;
(2) by inserting after subparagraph (A) the following:
``(B) any information, based on a review of data
available to the Secretary, regarding devices used in
pediatric patients but not labeled for such use for
which the Secretary determines that approved pediatric
labeling could confer a benefit to pediatric patients;
``(C) the number of pediatric devices that receive a
humanitarian use exemption under section 520(m);'';
(3) in subparagraph (E), as so redesignated, by striking ``;
and'' and inserting ``;'';
(4) in subparagraph (F) (as so redesignated), by striking
``(B), and (C).'' and inserting ``(C), (D), and (E);''; and
(5) by adding at the end the following:
``(G) the number of devices for which the Secretary
relied on data with respect to adults to support a
determination of a reasonable assurance of safety and
effectiveness in pediatric patients; and
``(H) the number of devices for which the Secretary
relied on data from one pediatric subpopulation to
support a determination of a reasonable assurance of
safety and effectiveness in another pediatric
subpopulation.
For the items described in this paragraph, such report shall
disaggregate the number of devices by pediatric
subpopulation.''.
(b) Humanitarian Device Exemption.--Section 520(m) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) is amended--
(1) in paragraph (4)--
(A) in subparagraph (B), by inserting ``or an
appropriate local committee'' after ``review committee''
each place such term appears; and
(B) in the matter following subparagraph (B), by
inserting ``or an appropriate local committee'' after
``review committee'' each place such term appears; and
(2) in paragraph (6)(A)(iv), by striking ``2017'' and
inserting ``2022''.
(c) Demonstration Grants for Improving Pediatric Availability.--
Section 305 of the Pediatric Medical Device Safety and Improvement Act
of 2007 (Public Law 110-85; 42 U.S.C. 282 note)) is amended--
(1) in subsection (c)--
(A) in paragraph (4), by striking ``and'' at the
end;
[[Page 131 STAT. 1038]]
(B) in paragraph (5), by striking the period and
inserting ``; and''; and
(C) by adding at the end the following:
``(6) <<NOTE: Consultation.>> providing regulatory
consultation to device sponsors in support of the submission of
an application for a pediatric device, where appropriate.''; and
(2) in subsection (e), by striking ``2013 through 2017'' and
inserting ``2018 through 2022''.
(d) Meeting on Pediatric Device Development.--
(1) <<NOTE: Deadline. Public information.>> In general.--
Not later than 1 year after the date of enactment of this Act,
the Secretary of Health and Human Services shall convene a
public meeting on the development, approval or clearance, and
labeling of pediatric medical devices. The Secretary shall
invite to such meeting representatives from the medical device
industry, academia, recipients of funding under section 305 of
the Pediatric Medical Device Safety and Improvement Act of 2007
(Public Law 110-85; 42 U.S.C. 282 note), medical provider
organizations, and organizations representing patients and
consumers.
(2) Topics.--The meeting described in paragraph (1) shall
include consideration of ways to--
(A) improve research infrastructure and research
networks to facilitate the conduct of clinical studies
of devices for pediatric populations that would result
in the approval or clearance, and labeling, of medical
devices for such populations;
(B) appropriately use extrapolation under section
515A(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360e-1(b));
(C) enhance the appropriate use of postmarket
registries and data to increase pediatric medical device
labeling;
(D) increase Food and Drug Administration assistance
to medical device manufacturers in developing devices
for pediatric populations that are approved or cleared,
and labeled, for their use; and
(E) identify current barriers to pediatric device
development and incentives to address such barriers.
(3) Report.--The report submitted under section 515A(a)(3)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e-
1(a)(3)) with respect to the calendar year in which the meeting
described in paragraph (1) is held shall include a summary of,
and responses to, recommendations raised in such meeting.
SEC. 503. EARLY MEETING ON PEDIATRIC STUDY PLAN.
(a) In General.--Clause (i) of section 505B(e)(2)(C) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)(2)(C)) is amended to
read as follows:
``(i) shall meet with the applicant--
``(I) <<NOTE: Deadlines.>> 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,
[[Page 131 STAT. 1039]]
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);''.
(b) Conforming Changes.--Section 505B(e) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355c(e)) is amended--
(1) in the heading of paragraph (2), by striking ``meeting''
and inserting ``meetings'';
(2) in the heading of paragraph (2)(C), by striking
``Meeting'' and inserting ``Meetings'';
(3) in clauses (ii) and (iii) of paragraph (2)(C), by
striking ``no meeting'' each place it appears and inserting ``no
meeting under clause (i)(II)''; and
(4) in paragraph (3) by striking ``meeting under paragraph
(2)(C)(i)'' and inserting ``meeting under paragraph
(2)(C)(i)(II)''.
SEC. 504. DEVELOPMENT OF DRUGS AND BIOLOGICAL PRODUCTS FOR
PEDIATRIC CANCERS.
(a) Molecular Targets Regarding Cancer Drugs and Biological
Products.--Section 505B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355c) is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) by redesignating subparagraphs (A) and (B)
as clauses (i) and (ii), respectively, and
adjusting the margins accordingly;
(ii) by striking ``A person'' and inserting
the following:
``(A) General requirements.--Except with respect to
an application for which subparagraph (B) applies, a
person'';
(iii) in clause (i), as so redesignated, by
striking ``, or'' at the end and inserting ``;
or''; and
(iv) by adding after subparagraph (A), as so
designated by clause (ii), the following:
``(B) <<NOTE: Time period. Reports.>> 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.'';
(B) in paragraph (2)(A), by striking ``paragraph
(1)'' and inserting ``paragraph (1)(A)'';
[[Page 131 STAT. 1040]]
(C) by redesignating paragraphs (3) and (4) as
paragraphs (4) and (5), respectively;
(D) by inserting after paragraph (2) the following:
``(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.
``(B) <<NOTE: Applicability.>> Extrapolation of
data.--Paragraph (2)(B) shall apply to investigations
described in this paragraph 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) <<NOTE: Applicability.>> 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).'';
(E) in paragraph (4), as so redesignated--
(i) by striking ``assessments required under
paragraph (1)'' each place it appears and
inserting ``assessments required under paragraph
(1)(A) or reports on the investigation required
under paragraph (1)(B)'';
(ii) in subparagraph (A)(ii)(I), by inserting
``or reports on the investigation'' after
``assessments'';
(iii) in subparagraph (B)(ii), by striking
``assessment under paragraph (1)'' and inserting
``assessment under paragraph (1)(A) or reports on
the investigation under paragraph (1)(B)''; and
(iv) in subparagraph (C)(ii)(II), by inserting
``or investigation'' after ``assessment''; and
(F) in paragraph (5), as so redesignated, by
inserting ``or reports on the investigation'' after
``assessments'' each place it appears;
(2) in subsection (d)--
(A) by striking ``subsection (a)(3)'' each place it
appears and inserting ``subsection (a)(4)'';
(B) by inserting ``and Reports on the
Investigation'' after ``Submission of Assessments'' in
the heading; and
(C) by inserting ``or the investigation described in
subsection (a)(3)'' after ``assessment described in
subsection (a)(2)'' each place it appears;
(3) in subsection (e)--
(A) in paragraph (1), by inserting ``or the
investigation described in subsection (a)(3)'' after
``under subsection (a)(2)''; and
(B) in paragraph (2)(A)(i), by inserting ``or the
investigation described in subsection (a)(3)'' after
``under subsection (a)(2)''; and
(4) by adding at the end the following:
``(m) List of Primary Molecular Targets.--
[[Page 131 STAT. 1041]]
``(1) <<NOTE: Deadline. Update. Web posting. Lists.>> 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) <<NOTE: Waiver.>> 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.''.
(b) Orphan Drugs.--Section 505B(k) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355c(k)) is amended to read as follows:
``(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).''.
(c) <<NOTE: 21 USC 355c note.>> Meeting, Consultation, and
Guidance.--
(1) <<NOTE: Deadline.>> Meeting.--The Secretary of Health
and Human Services (referred to in this subsection as the
``Secretary''), acting through the Commissioner of Food and
Drugs and in collaboration with the Director of the National
Cancer Institute, shall convene a public meeting not later than
1 year after the date of enactment of this Act to solicit
feedback from physicians and researchers (including pediatric
oncologists and rare disease specialists), patients, and other
stakeholders to provide input on development of the guidance
under paragraph (2) and the list under subsection (m) of section
505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355c), as added by subsection (a). The Secretary shall seek
input at such meeting on--
[[Page 131 STAT. 1042]]
(A) the data necessary to determine that there is
scientific evidence that a drug or biological product is
directed at a molecular target that is considered to be
substantially relevant to the growth or progression of a
pediatric cancer;
(B) the data necessary to determine that there is
scientific evidence that a molecular target is
considered to be substantially relevant to the growth or
progression of a pediatric cancer;
(C) the data needed to meet the requirement of
conducting an investigation described in section
505B(a)(3) of the Federal Food, Drug, and Cosmetic Act,
as amended by subsection (a);
(D) considerations when developing the list under
section 505B(m) of the Federal Food, Drug, and Cosmetic
Act that contains molecular targets shared between
different tumor types;
(E) <<NOTE: Lists.>> the process the Secretary
shall utilize to update regularly a list of molecular
targets that may trigger a pediatric study under section
505B of the Federal Food, Drug, and Cosmetic Act, as so
amended, and how often such updates shall occur;
(F) how to overcome the challenges related to
pediatric cancer drug and biological product
development, including issues related to the ethical,
practical, and other barriers to conducting clinical
trials in pediatric cancer with small patient
populations;
(G) scientific or operational challenges associated
with performing an investigation described in section
505B(a)(1)(B) of the Federal Food, Drug, and Cosmetic
Act, including the effect on pediatric studies currently
underway in a pediatric patient population, treatment of
a pediatric patient population, and the ability to
complete adult clinical trials;
(H) the advantages and disadvantages of innovative
clinical trial designs in addressing the development of
cancer drugs or biological products directed at
molecular targets in pediatric cancer patients;
(I) the ways in which the Secretary can improve the
current process outlined under sections 505A and 505B of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355a, 355c) to encourage additional research and
development of pediatric cancer treatments;
(J) the ways in which the Secretary might streamline
and improve the written request process, including when
studies contained in a request under such section 505A
are not feasible due to the ethical, practical, or other
barriers to conducting clinical trials in pediatric
cancer populations;
(K) how the Secretary will facilitate collaboration
among pediatric networks, academic centers and experts
in pediatric cancer to conduct an investigation
described in such section 505B(a)(3);
(L) how the Secretary may facilitate collaboration
among sponsors of same-in-class drugs and biological
products that would be subject to the requirements for
an investigation under such section 505B based on shared
molecular targets; and
[[Page 131 STAT. 1043]]
(M) the ways in which the Secretary will help to
mitigate the risks, if any, of discouraging the research
and development of orphan drugs when implementing such
section 505B as amended.
(2) <<NOTE: Deadline.>> Guidance.--Not later than 2 years
after the date of enactment of this Act, the Secretary, acting
through the Commissioner of Food and Drugs, shall issue final
guidance on implementation of the amendments to section 505B of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c)
regarding molecularly targeted cancer drugs made by this
section, including--
(A) <<NOTE: Criteria.>> the scientific criteria,
types of data, and regulatory considerations for
determining whether a molecular target is substantially
relevant to the growth or progression of a pediatric
cancer and would trigger an investigation under section
505B of the Federal Food, Drug, and Cosmetic Act, as
amended;
(B) the process by which the Secretary will engage
with sponsors to discuss determinations, investigation
requirements, deferrals, waivers, and any other issues
that need to be resolved to ensure that any required
investigation based on a molecular target can be
reasonably conducted;
(C) the scientific or operational challenges for
which the Secretary may issue deferrals or waivers for
an investigation described in subsection (a)(3) of such
section 505B, including adverse impacts on current
pediatric studies underway in a pediatric patient
population, studies involving drugs designated as orphan
drugs, treatment of a pediatric patient population, or
the ability to complete adult clinical trials;
(D) how the Secretary and sponsors will facilitate
collaboration among pediatric networks, academic
centers, and experts in pediatric cancer to conduct an
investigation described in subsection (a)(3) of such
section 505B;
(E) scientific and regulatory considerations for
study designs, including the applicability of innovative
clinical trial designs for pediatric cancer drug and
biological product developments under sections 505A and
505B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355a, 355c);
(F) approaches to streamline and improve the
amendment process, including when studies contained in a
request under such section 505A are not feasible due to
the ethical, practical, or other barriers to conducting
clinical trials in pediatric cancer populations;
(G) <<NOTE: Plan.>> the process for submission of
an initial pediatric study plan for the investigation
described in section 505B(a)(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355c(a)(3)), including
the process for a sponsor to meet and reach agreement
with the Secretary on the initial pediatric study plan;
and
(H) considerations for implementation of such
section 505B, as so amended, and waivers of the
requirements of such section 505B with regard to
molecular targets for which several drugs or biological
products may be under investigation.
[[Page 131 STAT. 1044]]
(d) Report to Congress.--Section 508(b) of the Food and Drug
Administration Safety and Innovation Act (21 U.S.C. 355c-1(b)) is
amended--
(1) in paragraph (10), by striking ``; and'' and inserting
``;''; and
(2) by striking paragraph (11) and inserting the following:
``(11) <<NOTE: Assessment.>> an assessment of the impact of
the amendments to such section 505B made by the FDA
Reauthorization Act of 2017 on pediatric research and labeling
of drugs and biological products and pediatric labeling of
molecularly targeted drugs and biological products for the
treatment of cancer;
``(12) <<NOTE: Assessment.>> an assessment of the efforts
of the Secretary to implement the plan developed under section
505C-1 of the Federal Food, Drug, and Cosmetic Act, regarding
earlier submission of pediatric studies under sections 505A and
505B of such Act and section 351(m) of the Public Health Service
Act, including--
``(A) the average length of time after the approval
of an application under section 505(b)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1)) or
section 351(a) of the Public Health Service Act (42
U.S.C. 262(a)) before studies conducted pursuant to such
section 505A, 505B, or section 351(m) are completed,
submitted, and incorporated into labeling;
``(B) the average length of time after the receipt
of a proposed pediatric study request before the
Secretary responds to such request;
``(C) the average length of time after the
submission of a proposed pediatric study request before
the Secretary issues a written request for such studies;
``(D) the number of written requests issued for each
investigational new drug or biological product prior to
the submission of an application under section 505(b)(1)
of the Federal Food, Drug, and Cosmetic Act or section
351(a) of the Public Health Service Act; and
``(E) the average number, and range of numbers, of
amendments to written requests issued, and the time the
Secretary requires to review and act on proposed
amendments to written requests;
``(13) <<NOTE: Lists.>> a list of sponsors of applications
or holders of approved applications who received exclusivity
under such section 505A or such section 351(m) after receiving a
letter issued under such section 505B(d)(1) for any drug or
biological product before the studies referred to in such letter
were completed and submitted;
``(14) <<NOTE: Lists.>> a list of assessments and
investigations required under such section 505B;
``(15) how many requests under such section 505A for
molecular targeted cancer drugs, as defined by subsection
(a)(1)(B) of such section 505B, approved prior to 3 years after
the date of enactment of the FDA Reauthorization Act of 2017,
have been issued by the Food and Drug Administration, and how
many such requests have been completed; and
``(16) <<NOTE: Assessment.>> the Secretary's assessment of
the overall impact of the amendments made by section 504 of the
FDA Reauthorization Act of 2017 on the conduct and effectiveness
of pediatric
[[Page 131 STAT. 1045]]
cancer research and the orphan drug program, as well any
subsequent recommendations.''.
(e) <<NOTE: 21 USC 355c note.>> Rule of Construction.--Nothing in
this section, including the amendments made by this section, shall limit
the authority of the Secretary of Health and Human Services to issue
written requests under section 505A of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355a) or section 351(m) of the Public Health
Service Act (42 U.S.C. 262(m)), or to negotiate or implement amendments
to such requests proposed by the an applicant.
(f) GAO Report.--
(1) <<NOTE: Effective date. Time period. Study.>> In
general.--Beginning on the date that is 5 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 this section, in the development of drugs and
biological products for pediatric cancer
indications. <<NOTE: Examination.>> The Comptroller General
shall examine--
(A) the indications and associated molecular targets
studied in assessments and investigations required for
drugs or biological products intended for the treatment
of an adult cancer;
(B) the indication for which the study was requested
as compared to the indication requested under the new
drug application filed by the sponsor;
(C) the number of pediatric cancer indications for
which assessments and investigations have been required
under such section 505B;
(D) the number of requests for deferral and waiver
of pediatric assessments and investigations required
under such section and the number of such deferral and
waiver requests granted and denied;
(E) the number of orphan-designated indications for
drugs and biological products for which assessments and
investigations were required under such section;
(F) the number of drugs and biological products
approved for the treatment of cancer in the pediatric
population for which the supportive studies were
required to be conducted under such section;
(G) the number of written requests made under
section 505A of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355a) relating to investigations required
under subsection (a)(1)(B) of such section 505B; and
(H) any additional considerations by the Secretary
regarding the effectiveness of requiring pediatric
assessments described in such section 505B in the
development of drugs and biological products for
pediatric cancer indications.
(2) <<NOTE: Criteria.>> Review.--The study under paragraph
(1) shall include a review of the Food and Drug Administration's
use of the authority under section 505B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355c), as amended by this
section, including the amendments to the deferral and waiver
criteria under such section and how such criteria have been
applied.
(3) Consultation.--In conducting the study under paragraph
(1), the Comptroller General of the United States shall consult
with appropriate stakeholders that may be required
[[Page 131 STAT. 1046]]
to conduct the trials under section 505B of the Federal Food,
Drug, and Cosmetic Act, and the ability of such stakeholders to
adhere to the requests issued by the Food and Drug
Administration.
(4) Report.--Not later than the date that is 6 years after
the date of enactment of this Act, the Comptroller General of
the United States shall submit a report containing the results
of the study under paragraph (1) to the Secretary of Health and
Human Services, the Committee on Health, Education, Labor, and
Pensions of the Senate, and the Committee on Energy and Commerce
of the House of Representatives.
SEC. 505. ADDITIONAL PROVISIONS ON DEVELOPMENT OF DRUGS AND
BIOLOGICAL PRODUCTS FOR PEDIATRIC USE.
(a) Informing Internal Review Committee.--Section 505A(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(f)) is amended by
adding at the end the following:
``(7) Informing internal review committee.--The Secretary
shall provide to the committee referred to in paragraph (1) any
response issued to an applicant or holder with respect to a
proposed pediatric study request.''.
(b) Action on Submissions.--
(1) In general.--Section 505A(d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355a(d)) is amended--
(A) by redesignating paragraphs (3) through (5) as
paragraphs (4) through (6), respectively; and
(B) by inserting after paragraph (2) the following:
``(3) <<NOTE: Deadline.>> Action on submissions.--The
Secretary shall review and act upon a submission by a sponsor or
holder of a proposed pediatric study request or a proposed
amendment to a written request for pediatric studies within 120
calendar days of the submission.''.
(2) Conforming amendments.--
(A) Federal food, drug, and cosmetic act.--Section
505A of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355a), as amended by paragraph (1), is further
amended by striking subsection ``(d)(3)'' each place it
appears and inserting ``(d)(4)''.
(B) Public health service act.--Paragraphs (2), (3),
and (4) of section 351(m) of the Public Health Service
Act (42 U.S.C. 262(m)) are amended by striking ``section
505A(d)(3)'' each place it appears and inserting
``section 505A(d)(4)''.
(c) <<NOTE: Deadline. 21 USC 355a note.>> Plan.--The Secretary of
Health and Human Services, acting through the internal review committee
established under section 505C of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355d) shall, not later than one year after the date of
enactment of this Act, develop and implement a plan to achieve, when
appropriate, earlier submission of pediatric studies under section 505A
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) or section
351(m) of the Public Health Service Act (42 U.S.C.
262(m)). <<NOTE: Recommenda- tions.>> Such plan shall include
recommendations to achieve--
(1) earlier discussion of proposed pediatric study requests
and written requests with sponsors, and if appropriate,
discussion of such requests at the meeting required under
section 505B(e)(2)(C) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355c(e)(2)(C)), as amended by section 503(a);
[[Page 131 STAT. 1047]]
(2) earlier issuance of written requests for a pediatric
study under such section 505A, including for investigational new
drugs prior to the submission of an application under section
505(b)(1) of such Act (21 U.S.C. 355(b)(1)); and
(3) shorter timelines, when appropriate, for the completion
of studies pursuant to a written request under such section 505A
or such section 351(m).
(d) Neonatology Expertise.--
(1) In general.--Section 6(d) of the Best Pharmaceuticals
for Children Act (21 U.S.C. 393a(d)) is amended by striking
``For the 5-year period beginning on the date of enactment of
this subsection, at'' and inserting ``At''.
(2) <<NOTE: Deadline. 21 USC 355a note.>> Draft guidance.--
Not later than 2 years after the date of enactment of this Act,
the Secretary shall issue draft guidance on clinical
pharmacology considerations for neonatal studies for drugs and
biological products.
(e) Submission of Assessments.--Section 505B(d)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d)(1)) is amended by adding
at the end the following: ``The Secretary shall inform the Pediatric
Advisory Committee of letters issued under this paragraph and responses
to such letters.''.
(f) Internal Committee.--Section 505C of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355d) is amended by inserting ``or pediatric
rare diseases'' after ``psychiatry''.
(g) Report on Labeling of Orphan Drugs.--
(1) <<NOTE: Public information. Web posting.>> In
general.--Not later than 2 years after the date of the enactment
of this Act, the Secretary of Health and Human Services shall
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, and make publicly available, including
through posting on the internet website of the Food and Drug
Administration, a report on the lack of information in the
labeling of drugs for indications that have received an orphan
designation under section 526 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb) with respect to the use of such
drugs pediatric populations.
(2) Contents.--The report described in paragraph (1) shall
include--
(A) <<NOTE: Lists.>> a list of drugs for which--
(i) an indication was granted an orphan
designation under section 526 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360bbb);
(ii) an application described under section
505B(a)(1) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355c(a)(1)) for such indication was
submitted to the Secretary of Health and Human
Services on or after April 1, 1999; and
(iii) the labeling for such indication lacks
important pediatric information, including
information related to safety, dosing, and
effectiveness;
(B) a description of the lack of information
referred to in subparagraph (A)(iii) for each drug for
an indication on such list; and
(C) <<NOTE: Recommenda- tions.>> Federal policy
recommendations to improve the labeling of drugs for
indications that have received an
[[Page 131 STAT. 1048]]
orphan designation under such section 526 with respect
to the use of such drugs pediatric populations.''
TITLE VI--REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS
SEC. 601. REAUTHORIZATION OF PROVISION RELATING 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 ``2017'' and inserting
``2022''.
SEC. 602. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE
PARTNERSHIPS.
Section 566(f) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-5(f)) is amended by striking ``2013 through 2017'' and
inserting ``2018 through 2022''.
SEC. 603. REAUTHORIZATION OF ORPHAN GRANTS PROGRAM.
Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended
by striking ``2013 through 2017'' and inserting ``2018 through 2022''.
SEC. 604. PROTECTING AND STRENGTHENING THE DRUG SUPPLY CHAIN.
(a) Diverted Drugs.--Paragraph (1) of section 801(d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)) is amended--
(1) by striking ``(d)(1) Except as'' and inserting
``(d)(1)(A) Except as''; and
(2) by adding at the end the following:
``(B) Except as authorized by the Secretary in the case of a drug
that appears on the drug shortage list under section 506E or in the case
of importation pursuant to section 804, no drug that is subject to
section 503(b)(1) may be imported into the United States for commercial
use if such drug is manufactured outside the United States, unless the
manufacturer has authorized the drug to be marketed in the United States
and has caused the drug to be labeled to be marketed in the United
States.''.
(b) Counterfeit Drugs.--Subsection (b) of section 303 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by adding at the
end the following:
``(8) Notwithstanding subsection (a), any person who violates
section 301(i)(3) by knowingly making, selling or dispensing, or holding
for sale or dispensing, a counterfeit drug shall be imprisoned for not
more than 10 years or fined in accordance with title 18, United States
Code, or both.''.
SEC. 605. PATIENT EXPERIENCE DATA.
Section 569C(c)(2)(A) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360bbb-8c(c)(2)(A)) is amended by striking ``impact of such
disease or condition, or a related therapy,'' and inserting ``impact
(including physical and psychosocial impacts) of such disease or
condition, or a related therapy or clinical investigation''.
[[Page 131 STAT. 1049]]
SEC. 606. COMMUNICATION PLANS.
Section 505-1(e)(3) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355-1(e)(3)) is amended--
(1) in subparagraph (B), by striking ``; or'';
(2) in subparagraph (C), by striking the period and
inserting ``; or''; and
(3) by adding at the end the following:
``(D) disseminating information to health care
providers about drug formulations or properties,
including information about the limitations or patient
care implications of such formulations or properties,
and how such formulations or properties may be related
to serious adverse drug events associated with use of
the drug.''.
SEC. 607. ORPHAN DRUGS.
(a) In General.--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 ``such drug for such disease or condition'' and
inserting ``the same drug for the same disease or condition'';
(2) in subsection (b)--
(A) <<NOTE: Time period. Determination.>> in the
matter preceding paragraph (1), by striking ``If an
application'' and all that follows through ``such
license if'' and inserting ``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 if'';
(B) in paragraph (1), by striking ``notice'' and all
that follows through ``assure'' and inserting ``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''; and
(C) in paragraph (2), by striking ``such holder
provides'' and inserting ``the holder provides''; and
(3) by adding at the end the following:
``(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 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.
``(d) <<NOTE: Applicability.>> 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
[[Page 131 STAT. 1050]]
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) <<NOTE: Notification.>> 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) <<NOTE: Publication. Summary.>> 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.''.
(b) <<NOTE: 21 USC 360cc note.>> Rule of Construction.--Nothing in
the amendments made by subsection (a) shall affect any determination
under sections 526 and 527 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360bb, 360cc) made prior to the date of enactment of the FDA
Reauthorization Act of 2017.
SEC. 608. PEDIATRIC INFORMATION ADDED TO LABELING.
Section 505A(o) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355a(o)) is amended--
(1) in the subsection heading, by striking ``under section
505(j)'';
(2) in paragraph (1)--
(A) by striking ``under section 505(j)'' and
inserting ``under subsection (b)(2) or (j) of section
505''; and
(B) by striking ``or by exclusivity under clause
(iii) or (iv) of section 505(j)(5)(F)'' and inserting
``, or by exclusivity under clause (iii) or (iv) of
section 505(j)(5)(F), clause (iii) or (iv) of section
505(c)(3)(E), or section 527(a), or by an extension of
such exclusivity under this section or section 505E'';
(3) in paragraph (2), in the matter preceding subparagraph
(A)--
(A) by inserting ``clauses (iii) and (iv) of section
505(c)(3)(E), or section 527,'' after ``section
505(j)(5)(F),''; and
(B) by striking ``drug approved under section
505(j)'' and inserting ``drug approved pursuant to an
application submitted under subsection (b)(2) or (j) of
section 505''; and
(4) by amending paragraph (3) to read as follows:
``(3) Preservation of pediatric exclusivity and
extensions.--This subsection does not affect--
``(A) the availability or scope of exclusivity
under--
``(i) this section;
``(ii) section 505 for pediatric formulations;
or
``(iii) section 527;
``(B) the availability or scope of an extension to
any such exclusivity, including an extension under this
section or section 505E;
[[Page 131 STAT. 1051]]
``(C) the question of the eligibility for approval
under section 505 of any application described in
subsection (b)(2) or (j) of such section that omits any
other aspect of labeling protected by exclusivity
under--
``(i) clause (iii) or (iv) of section
505(j)(5)(F);
``(ii) clause (iii) or (iv) of section
505(c)(3)(E); or
``(iii) section 527(a); or
``(D) except as expressly provided in paragraphs (1)
and (2), the operation of section 505 or section 527.''.
SEC. 609. SENSE OF CONGRESS ON LOWERING THE COST OF PRESCRIPTION
DRUGS.
It is the sense of the Congress that the Secretary of Health and
Human Services should commit to engaging with the House of
Representatives and the Senate to take administrative actions and enact
legislative changes that--
(1) will lower the cost of prescription drugs for consumers
and reduce the burden of such cost on taxpayers; and
(2) in lowering such cost, will--
(A) balance the need to encourage innovation with
the need to improve affordability; and
(B) strive to increase competition in the
pharmaceutical market, prevent anticompetitive behavior,
and promote the timely availability of affordable, high-
quality generic drugs and biosimilars.
SEC. 610. EXPANDED ACCESS.
(a) <<NOTE: 21 USC 360bbb note.>> Patient Access to Investigational
Drugs.--
(1) Public meeting.--
(A) <<NOTE: Coordination. Consultation. Deadline.>>
In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''),
acting through the Commissioner of Food and Drugs, in
coordination with the Director of the National
Institutes of Health, and in consultation with patients,
health care providers, drug sponsors, bioethicists, and
other stakeholders, shall, not later than 270 days after
the date of enactment of this Act, convene a public
meeting to discuss clinical trial inclusion and
exclusion criteria to inform the guidance under
paragraph (3). The Secretary shall inform the
Comptroller General of the United States of the date
when the public meeting will take place.
(B) <<NOTE: Web posting. Reports. Deadline.>>
Topics.--The Secretary shall make available on the
internet website of the Food and Drug Administration a
report on the topics discussed at the meeting described
in subparagraph (A) within 90 days of such meeting. Such
topics shall include discussion of--
(i) the rationale for, and potential barriers
for patients created by, research clinical trial
inclusion and exclusion criteria;
(ii) how appropriate patient populations can
benefit from the results of trials that employ
alternative designs;
(iii) barriers to participation in clinical
trials, including--
(I) information regarding any
potential risks and benefits of
participation;
(II) regulatory, geographical, and
socioeconomic barriers; and
[[Page 131 STAT. 1052]]
(III) the impact of exclusion
criteria on the enrollment in clinical
trials of particular populations,
including infants and children, pregnant
and lactating women, seniors,
individuals with advanced disease, and
individuals with co-morbid conditions;
(iv) clinical trial designs and methods,
including expanded access trials, that increase
enrollment of more diverse patient populations,
when appropriate, while facilitating the
collection of data to establish safe use and
support substantial evidence of effectiveness,
including data obtained from expanded access
trials; and
(v) how changes to clinical trial inclusion
and exclusion criteria may impact the complexity
and length of clinical trials, the data necessary
to demonstrate safety and effectiveness, and
potential approaches to mitigating those impacts.
(2) Report.--Not later than 1 year after the Secretary
issues the report under paragraph (1)(B), the Comptroller
General of the United States shall 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
on individual access to investigational drugs through the
expanded access program under section 561(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(b)). The report
shall include--
(A) a description of actions taken by manufacturers
and distributors under section 561A of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360bbb-0);
(B) consideration of whether Form FDA 3926 and the
guidance documents titled ``Expanded Access to
Investigational Drugs for Treatment Use--Questions and
Answers'' and ``Individual Patient Expanded Access
Applications: Form FDA 3926'', issued by the Food and
Drug Administration in June 2016, have reduced
application burden with respect to individuals and
physicians seeking access to investigational new drugs
pursuant to section 561(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360bbb) and improved clarity
for patients, physicians, and drug manufacturers about
such process;
(C) consideration of whether the guidance or
regulations issued to implement section 561 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb)
have improved access for individual patients to
investigational drugs who do not qualify for clinical
trials of such investigational drugs, and what barriers
to such access remain;
(D) <<NOTE: Assessment.>> an assessment of methods
patients and health care providers use to engage with
the Food and Drug Administration or drug sponsors on
expanded access; and
(E) <<NOTE: Analysis.>> an analysis of the
Secretary's report under paragraph (1)(B).
(3) Guidance.--
(A) <<NOTE: Deadlines.>> In general.--Not later
than 1 year after the publication of the report under
paragraph (1)(B), the Secretary, acting through the
Commissioner of Food and Drugs, shall issue one or more
draft guidances regarding
[[Page 131 STAT. 1053]]
eligibility criteria for clinical trials. Not later than
1 year after the public comment period on each such
draft guidance ends, the Secretary shall issue a revised
draft guidance or final guidance.
(B) Contents.--The guidance documents described in
subparagraph (A) shall address methodological approaches
that a manufacturer or sponsor of an investigation of a
new drug may take to--
(i) broaden eligibility criteria for clinical
trials and expanded access trials, especially with
respect to drugs for the treatment of serious and
life-threatening conditions or diseases for which
there is an unmet medical need;
(ii) develop eligibility criteria for, and
increase trial recruitment to, clinical trials so
that enrollment in such trials more accurately
reflects the patients most likely to receive the
drug, as applicable and as appropriate, while
establishing safe use and supporting findings of
substantial evidence of effectiveness; and
(iii) use the criteria described in clauses
(i) and (ii) in a manner that is appropriate for
drugs intended for the treatment of rare diseases
or conditions.
(b) <<NOTE: Deadline. Guidance. 21 USC 360bbb note.>> Improving
Institutional Review Board Review of Single Patient Expanded Access
Protocol.--Not later than 1 year after the date of enactment of this
Act, the Secretary, acting through the Commissioner of Food and Drugs,
shall issue guidance or regulations, or revise existing guidance or
regulations, to streamline the institutional review board review of
individual patient expanded access protocols submitted under 561(b) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(b)). To
facilitate the use of expanded access protocols, any guidance or
regulations so issued or revised may include a description of the
process for any person acting through a physician licensed in accordance
with State law to request that an institutional review board chair (or
designated member of the institutional review board) review a single
patient expanded access protocol submitted under such section 561(b) for
a drug. <<NOTE: Update.>> The Secretary shall update any relevant forms
associated with individual patient expanded access requests under such
section 561(b) as necessary.
(c) Expanded Access Policy Transparency.--Section 561A(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-0(f)) is
amended--
(1) in the matter preceding paragraph (1), by striking
``later'' and inserting ``earlier'';
(2) by striking paragraph (1);
(3) by redesignating paragraph (2) as paragraph (1);
(4) in paragraph (1) as so redesignated, by striking the
period at the end and inserting ``; or''; and
(5) by adding at the end the following:
``(2) <<NOTE: Time period.>> as applicable, 15 days after
the drug receives a designation as a breakthrough therapy, fast
track product, or regenerative advanced therapy under subsection
(a), (b), or (g), respectively, of section 506.''.
[[Page 131 STAT. 1054]]
SEC. 611. TROPICAL DISEASE PRODUCT APPLICATION.
(a) In General.--Subparagraph (A) of section 524(a)(4) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n(a)(4)) is amended--
(1) in clause (i), by striking ``and'' at the end; and
(2) by adding at the end the following:
``(iii) that contains reports of one or more
new clinical investigations (other than
bioavailability studies) that are essential to the
approval of the application and conducted or
sponsored by the sponsor of such application; and
``(iv) that contains an attestation from the
sponsor of the application that such reports were
not submitted as part of an application for
marketing approval or licensure by a regulatory
authority in India, Brazil, Thailand, or any
country that is a member of the Pharmaceutical
Inspection Convention or the Pharmaceutical
Inspection Cooperation Scheme prior to September
27, 2007.''.
(b) <<NOTE: 21 USC 360n note.>> Effective Date.--The amendments
made by subsection (a) shall apply to human drug applications submitted
after September 30, 2017.
TITLE VII--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS
SEC. 701. RISK-BASED INSPECTIONS FOR DEVICES.
(a) In General.--Section 510(h) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(h)) is amended--
(1) by striking paragraph (2) and inserting the following:
``(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) <<NOTE: Applicability.>> 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.''; and
(2) in paragraph (4)--
(A) in the matter preceding subparagraph (A), by
striking ``paragraph (3)'' and inserting ``paragraph (2)
or (3)''; and
[[Page 131 STAT. 1055]]
(B) in subparagraph (C), by inserting ``or device''
after ``drug''.
(b) Foreign Inspections.--Section 809(a)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 384e(a)(1)) is amended by striking
``section 510(h)(3)'' and inserting ``paragraph (2) or (3) of section
510(h)''.
SEC. 702. IMPROVEMENTS TO INSPECTIONS PROCESS FOR DEVICE
ESTABLISHMENTS.
(a) In General.--Section 704 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 374) is amended by adding at the end the following:
``(h)(1) <<NOTE: Review.>> 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) <<NOTE: Deadline.>> 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.''.
(b) <<NOTE: 21 USC 374 note.>> Guidance.--
(1) <<NOTE: Deadline.>> Draft guidance.--Not later than 18
months after the date of enactment of this Act, the Secretary of
Health and
[[Page 131 STAT. 1056]]
Human Services, acting through the Commissioner of Food and
Drugs, shall issue draft guidance that--
(A) specifies how the Food and Drug Administration
will implement the processes and standards described in
paragraph (1) of subsection (h) of section 704 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374), as
added by subsection (a), and the requirements described
in paragraph (2) of such subsection (h);
(B) provides for standardized methods for
communications described in such paragraphs;
(C) establishes, with respect to inspections of both
domestic and foreign device establishments (as referred
to in section 510(h)(2) of the Federal Food, Drug, and
Cosmetic Act, as amended by subsection (a)), a standard
timeframe for such inspections--
(i) that occurs over consecutive days; and
(ii) to which each investigator conducting
such an inspection shall adhere unless the
investigator identifies to the establishment
involved a reason that more time is needed to
conduct such investigation; and
(D) identifies practices for investigators and
device establishments to facilitate the continuity of
inspections of such establishments.
(2) <<NOTE: Deadline. Notice. Public information.>> Final
guidance.--Not later than 1 year after providing notice and
opportunity for public comment on the draft guidance issued
under paragraph (1), the Secretary of Health and Human Services
shall issue final guidance to implement subsection (h) of
section 704 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 374), as added by subsection (a).
(c) Adulterated Devices.--Subsection (j) of section 501 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amended by
inserting ``or device'' after ``drug''.
SEC. 703. 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 ``October 1, 2017'' and
inserting ``October 1, 2022''.
SEC. 704. CERTIFICATES TO FOREIGN GOVERNMENTS FOR DEVICES.
Subsection (e)(4) of section 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381(e)(4)) is amended--
(1) by adding at the end the following:
``(E)(i)(I) If the Secretary denies a request for certification
under subparagraph (A)(ii) with respect to a device manufactured in an
establishment (foreign or domestic) registered under section 510, the
Secretary shall provide in writing to the person seeking such
certification the basis for such denial, and specifically identify the
finding upon which such denial is based.
``(II) <<NOTE: Summary.>> If the denial of a request as described
in subclause (I) is based on grounds other than an injunction proceeding
pursuant to section 302, seizure action pursuant to section 304, or a
recall designated Class I or Class II pursuant to part 7, title 21, Code
of Federal Regulations, and is based on the facility being out of
compliance with part 820 of title 21, Code of Federal Regulations, the
Secretary shall provide a substantive summary of the specific grounds
for noncompliance identified by the Secretary.
``(III) With respect to a device manufactured in an establishment
that has received a report under section 704(b), the Secretary
[[Page 131 STAT. 1057]]
shall not deny a request for certification as described in subclause (I)
with respect to a device based solely on the issuance of that report if
the owner, operator, or agent in charge of such establishment has agreed
to a plan of correction in response to such report.
``(ii)(I) <<NOTE: Review.>> The Secretary shall provide a process
for a person who is denied a certification as described in clause (i)(I)
to request a review that conforms to the standards of section 517A(b).
``(II) Notwithstanding any previous review conducted pursuant to
subclause (I), a person who has been denied a certification as described
in clause (i)(I) may at any time request a review in order to present
new information relating to actions taken by such person to address the
reasons identified by the Secretary for the denial of certification,
including evidence that corrective actions are being or have been
implemented to address grounds for noncompliance identified by the
Secretary.
``(III) <<NOTE: Deadlines. Guidance.>> Not later than 1 year after
the date of enactment of the FDA Reauthorization Act of 2017, the
Secretary shall issue guidance providing for a process to carry out this
subparagraph. Not later than 1 year after the close of the comment
period for such guidance, the Secretary shall issue final guidance.
``(iii)(I) <<NOTE: Applicability.>> Subject to subclause (II), this
subparagraph applies to requests for certification on behalf of any
device establishment registered under section 510, whether the
establishment is located inside or outside of the United States, and
regardless of whether such devices are to be exported from the United
States.
``(II) <<NOTE: Applicability. Deadlines.>> If an establishment
described in subclause (I) is not located within the United States and
does not demonstrate that the devices manufactured, prepared,
propagated, compounded, or processed at such establishment are to be
exported from the United States, this subparagraph shall apply only if--
``(aa) the establishment has been inspected by the Secretary
within 3 years of the date of the request; or
``(bb) <<NOTE: Audits.>> the establishment participates in
an audit program in which the United States participates or the
United States recognizes, an audit under such program has been
conducted, and the findings of such audit are provided to the
Secretary within 3 years of the date of the request.''; and
(2) by moving the margins of subparagraphs (C) and (D) 4 ems
to the left.
SEC. 705. FACILITATING INTERNATIONAL HARMONIZATION.
Section 704(g) of the Federal Food, Drug and Cosmetic Act (21 U.S.C.
374) is amended by adding at the end the following:
``(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
[[Page 131 STAT. 1058]]
``(ii) the authority of the Secretary to determine the
official classification of an inspection.''.
SEC. 706. FOSTERING INNOVATION IN MEDICAL IMAGING.
(a) Approval of Applications for Certain Diagnostic Medical Imaging
Devices.--Section 520 of the Federal Food, Drug, and Cosmetic Act (42
U.S.C. 360j) is amended by adding at the end the following:
``(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) <<NOTE: Determinations.>> 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--
[[Page 131 STAT. 1059]]
``(A) <<NOTE: Consultation.>> 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.''.
(b) Applications for Approval of Contrast Agents Intended for Use
With Certain Diagnostic Medical Imaging Devices.--Section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by
adding at the end the following:
``(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
[[Page 131 STAT. 1060]]
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).''.
SEC. 707. RISK-BASED CLASSIFICATION OF ACCESSORIES.
(a) In General.--Subsection (f) of section 513 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by adding at the end
the following new paragraph:
``(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) <<NOTE: Applicability.>> 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) <<NOTE: Evaluation.>> 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
[[Page 131 STAT. 1061]]
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) <<NOTE: Applicability.>> 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) <<NOTE: Deadlines. Federal Register,
publication. Notice. Lists.>> 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. <<NOTE: Recommenda- tions.>> 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. <<NOTE: Notices. Time
period. Public information.>> 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). <<NOTE: Evaluation.>> 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) <<NOTE: Deadlines.>> 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. <<NOTE: Determination.>> 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. <<NOTE: Federal Register, publication. Notice.>>
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.''.
[[Page 131 STAT. 1062]]
(b) Conforming Change.--Section 513(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360c(b)) is amended by striking paragraph
(9) (relating to classification of an accessory).
(c) <<NOTE: 21 USC 360c note.>> Effective Date.--The amendments
made by subsections (a) and (b) shall take effect on the date that is 60
days after the date of enactment of this Act.
SEC. 708. DEVICE PILOT PROJECTS.
(a) Postmarket Pilot.--Section 519 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360i) is amended by adding at the end the
following:
``(i) Postmarket Pilot.--
``(1) <<NOTE: Deadline.>> In general.--In order to provide
timely and reliable information on the safety and effectiveness
of devices approved under section 515, cleared under section
510(k), or classified under section 513(f)(2), including
responses to adverse events and malfunctions, and to advance the
objectives of part 803 of title 21, Code of Federal Regulations
(or successor regulations), and advance the objectives of, and
evaluate innovative new methods of compliance with, this section
and section 522, the Secretary shall, within one year of the
date of enactment of the FDA Reauthorization Act of 2017,
initiate one or more pilot projects for voluntary participation
by a manufacturer or manufacturers of a device or device type,
or continue existing projects, in accordance with paragraph (3),
that--
``(A) are designed to efficiently generate reliable
and timely safety and active surveillance data for use
by the Secretary or manufacturers of the devices that
are involved in the pilot project;
``(B) inform the development of methods, systems,
data criteria, and programs that could be used to
support safety and active surveillance activities for
devices included or not included in such project;
``(C) may be designed and conducted in coordination
with a comprehensive system for evaluating medical
device technology that operates under a governing board
with appropriate representation of stakeholders,
including patient groups and device manufacturers;
``(D) use electronic health data including claims
data, patient survey data, or any other data, as the
Secretary determines appropriate; and
``(E) prioritize devices and device types that meet
one or more of the following criteria:
``(i) Devices and device types for which the
collection and analysis of real world evidence
regarding a device's safety and effectiveness is
likely to advance public health.
``(ii) Devices and device types that are
widely used.
``(iii) Devices and device types, the failure
of which has significant health consequences.
``(iv) Devices and device types for which the
Secretary--
``(I) has received public
recommendations in accordance with
paragraph (2)(B); and
``(II) has determined to meet one or
more of the criteria under clause (i),
(ii), or (iii) and is appropriate for
such a pilot project.
[[Page 131 STAT. 1063]]
``(2) Participation.--The Secretary shall establish the
conditions and processes--
``(A) under which a manufacturer of a device may
voluntarily participate in a pilot project described in
paragraph (1); and
``(B) for facilitating public recommendations for
devices to be prioritized under such a pilot project,
including requirements for the data necessary to support
such a recommendation.
``(3) Continuation of ongoing projects.--The Secretary may
continue or expand projects, with respect to providing timely
and reliable information on the safety and effectiveness of
devices approved under section 515, cleared under section
510(k), or classified under section 513(f)(2), that are being
carried out as of the date of the enactment of the FDA
Reauthorization Act of 2017. <<NOTE: Effective date.>> The
Secretary shall, beginning on such date of enactment, take such
steps as may be necessary--
``(A) to ensure such projects meet the requirements
of subparagraphs (A) through (E) of paragraph (1); and
``(B) to increase the voluntary participation in
such projects of manufacturers of devices and facilitate
public recommendations for any devices prioritized under
such a project.
``(4) Implementation.--
``(A) Contracting authority.--The Secretary may
carry out a pilot project meeting the criteria specified
in subparagraphs (A) through (E) of paragraph (1) or a
project continued or expanded under paragraph (3) by
entering into contracts, cooperative agreements, grants,
or other appropriate agreements with public or private
entities that have a significant presence in the United
States and meet the following conditions:
``(i) If such an entity is a component of
another organization, the entity and the
organization have established an agreement under
which appropriate security measures are
implemented to maintain the confidentiality and
privacy of the data described in paragraph (1)(D)
and such agreement ensures that the entity will
not make an unauthorized disclosure of such data
to the other components of the organization in
breach of requirements with respect to
confidentiality and privacy of such data
established under such security measures.
``(ii) In the case of the termination or
nonrenewal of such a contract, cooperative
agreement, grant, or other appropriate agreement,
the entity or entities involved shall comply with
each of the following:
``(I) The entity or entities shall
continue to comply with the requirements
with respect to confidentiality and
privacy referred to in clause (i) with
respect to all data disclosed to the
entity under such an agreement.
``(II) The entity or entities shall
return any data disclosed to such entity
pursuant to this subsection and to which
it would not otherwise have access or,
if returning such data is not
practicable, destroy the data.
[[Page 131 STAT. 1064]]
``(iii) The entity or entities shall have one
or more qualifications with respect to--
``(I) research, statistical,
epidemiologic, or clinical capability
and expertise to conduct and complete
the activities under this subsection,
including the capability and expertise
to provide the Secretary access to de-
identified data consistent with the
requirements of this subsection;
``(II) an information technology
infrastructure to support electronic
data and operational standards to
provide security for such data, as
appropriate;
``(III) experience with, and
expertise on, the development of
research on, and surveillance of, device
safety and effectiveness using
electronic health data; or
``(IV) such other expertise which
the Secretary determines necessary to
carry out such a project.
``(B) Review of contract in the event of a merger or
acquisition.--The Secretary shall review any contract,
cooperative agreement, grant, or other appropriate
agreement entered into under this paragraph with an
entity meeting the conditions specified in subparagraph
(A) in the event of a merger or acquisition of the
entity in order to ensure that the requirements
specified in this subsection will continue to be met.
``(5) Compliance with requirements for records or reports on
devices.--The participation of a manufacturer in pilot projects
under this subsection or a project continued or expanded under
paragraph (3) shall not affect the eligibility of such
manufacturer to participate in any quarterly reporting program
with respect to devices carried out under this section 519 or
section 522. <<NOTE: Determination.>> The Secretary may
determine that, for a specified time period to be determined by
the Secretary, a manufacturer's participation in a pilot project
under this subsection or a project continued or expanded under
paragraph (3) may meet the applicable requirements of this
section or section 522, if--
``(A) the project has demonstrated success in
capturing relevant adverse event information; and
``(B) the Secretary has established procedures for
making adverse event and safety information collected
from such project public, to the extent possible.
``(6) Privacy requirements.--With respect to the disclosure
of any health information collected through a project conducted
under this subsection--
``(A) individually identifiable health information
so collected shall not be disclosed when presenting any
information from such project; and
``(B) any such disclosure shall be made in
compliance with regulations issued pursuant to section
264(c) of the Health Insurance Portability and
Accountability Act of 1996 (42 U.S.C. 1320d-2 note) and
sections 552 and 552a of title 5, United States Code.
``(7) Limitations.--No pilot project under this subsection,
or in coordination with the comprehensive system described in
paragraph (1)(C), may allow for an entity participating in
[[Page 131 STAT. 1065]]
such project, other than the Secretary, to make determinations
of safety or effectiveness, or substantial equivalence, for
purposes of this Act.
``(8) <<NOTE: Applicability.>> Other projects required to
comply.--Paragraphs (1)(B), (4)(A)(i), (4)(A)(ii), (5), (6), and
(7) shall apply with respect to any pilot project undertaken in
coordination with the comprehensive system described in
paragraph (1)(C) that relates to the use of real world evidence
for devices in the same manner and to the same extent as such
paragraphs apply with respect to pilot projects conducted under
this subsection.
``(9) Report to congress.--Not later than 18 months after
the date of enactment of this Act, and annually 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 containing
a description of the pilot projects being conducted under this
subsection and projects continued or expanded pursuant to
paragraph (3), including for each such project--
``(A) how the project is being implemented in
accordance with paragraph (4), including how such
project is being implemented through a contract,
cooperative agreement, grant, or other appropriate
agreement, if applicable;
``(B) the number of manufacturers that have agreed
to participate in such project;
``(C) the data sources used to conduct such project;
``(D) the devices or device categories involved in
such project;
``(E) the number of patients involved in such
project; and
``(F) the findings of the project in relation to
device safety, including adverse events, malfunctions,
and other safety information.
``(10) Sunset.--The Secretary may not carry out a pilot
project initiated by the Secretary under this subsection after
October 1, 2022.''.
(b) <<NOTE: Review. Determination.>> Report.--Not later than
January 31, 2021, the Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, shall conduct a review
through an independent third party to evaluate the strengths,
limitations, and appropriate use of evidence collected pursuant to real
world evidence pilot projects described in the letters described in
section 201(b) of the Medical Device User Fee Amendments of 2017 and
subsection (i) of section 519 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360i), as amended by subsection (a), for informing
premarket and postmarket decisionmaking for multiple device types, and
to determine whether the methods, systems, and programs in such pilot
projects efficiently generate reliable and timely evidence about the
effectiveness or safety surveillance of devices.
SEC. 709. REGULATION OF OVER-THE-COUNTER HEARING AIDS.
(a) In General.--Section 520 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360j), as amended by section 708, is further amended by
adding at the end the following:
``(q) Regulation of Over-the-Counter Hearing Aids.--
``(1) Definition.--
[[Page 131 STAT. 1066]]
``(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).''.
(b) <<NOTE: 21 USC 360j note.>> Regulations To Establish
Category.--
(1) <<NOTE: Deadlines.>> In general.--The Secretary of
Health and Human Services (referred to in this section as the
``Secretary''), not later than 3 years after the date of
enactment of this Act, shall promulgate proposed regulations to
establish a category of over-the-counter hearing aids, as
defined in subsection (q) of section 520 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360j) as amended by subsection
(a), and, not later than 180 days after the date on which the
public comment period on the proposed regulations closes, shall
issue such final regulations.
(2) Requirements.--In promulgating the regulations under
paragraph (1), the Secretary shall--
(A) include requirements that provide reasonable
assurances of the safety and effectiveness of over-the-
counter hearing aids;
(B) include requirements that establish or adopt
output limits appropriate for over-the-counter hearing
aids;
(C) include requirements for appropriate labeling of
over-the-counter hearing aids, including requirements
that such labeling include a conspicuous statement that
the device is only intended for adults age 18 and older,
information on how consumers may report adverse events,
information on any contraindications, conditions, or
symptoms of medically treatable causes of hearing loss,
and advisements
[[Page 131 STAT. 1067]]
to consult promptly with a licensed health care
practitioner; and
(D) describe the requirements under which the sale
of over-the-counter hearing aids is permitted, without
the supervision, prescription, or other order,
involvement, or intervention of a licensed person, to
consumers through in-person transactions, by mail, or
online.
(3) <<NOTE: Determination.>> Premarket notification.--The
Secretary shall make findings under section 510(m) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(m)) to
determine whether over-the-counter hearing aids (as defined in
section 520(q) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360j), as amended by subsection (a)) require a report
under section 510(k) to provide reasonable assurance of safety
and effectiveness.
(4) Effect on state law.--No State or local government shall
establish or continue in effect any law, regulation, order, or
other requirement specifically related to hearing products that
would restrict or interfere with the servicing, marketing, sale,
dispensing, use, customer support, or distribution of over-the-
counter hearing aids (as defined in section 520(q) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as
amended by subsection (a)) through in-person transactions, by
mail, or online, that is different from, in addition to, or
otherwise not identical to, the regulations promulgated under
this subsection, including any State or local requirement for
the supervision, prescription, or other order, involvement, or
intervention of a licensed person for consumers to access over-
the-counter hearing aids.
(5) No effect on private remedies.--Nothing in this section
shall be construed to modify or otherwise affect the ability of
any person to exercise a private right of action under any State
or Federal product liability, tort, warranty, contract, or
consumer protection law.
(c) <<NOTE: Deadline. Update.>> New Guidance Issued.--Not later
than the date on which final regulations are issued under subsection
(b), the Secretary shall update and finalize the draft guidance of the
Department of Health and Human Services entitled ``Regulatory
Requirements for Hearing Aid Devices and Personal Sound Amplification
Products'', issued on November 7, 2013. Such updated and finalized
guidance shall clarify which products, on the basis of claims or other
marketing, advertising, or labeling material, meet the definition of a
device in section 201 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321) and which products meet the definition of a personal sound
amplification product, as set forth in such guidance.
(d) Report.--Not later than 2 years after the date on which the
final regulations described in subsection (b)(1) are issued, the
Secretary of Health and Human Services shall submit to Congress a report
analyzing any adverse events relating to over-the-counter hearing aids
(as defined in subsection (q)(1) of section 520 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360j)).
SEC. 710. REPORT ON SERVICING OF DEVICES.
(a) In General.--Not later than 270 days after the date of enactment
of this Act, the Secretary of Health and Human Services, acting through
the Commissioner of Food and Drugs, shall post
[[Page 131 STAT. 1068]]
on the internet website of the Food and Drug Administration a report on
the continued quality, safety, and effectiveness of devices (as defined
in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(h))) with respect to servicing (as defined in subsection (c)).
(b) Contents.--The report submitted under subsection (a) shall
contain--
(1) the status of, and findings to date, with respect to,
the proposed rule entitled ``Refurbishing, Reconditioning,
Rebuilding, Remarketing, Remanufacturing, and Servicing of
Medical Devices Performed by Third-Party Entities and Original
Equipment Manufacturers; Request for Comments'' published in the
Federal Register by the Food and Drug Administration on March 4,
2016 (81 Fed. Reg. 11477);
(2) information presented during the October 2016 public
workshop entitled ``Refurbishing, Reconditioning, Rebuilding,
Remarketing, Remanufacturing, and Servicing of Medical Devices
Performed by Third-Party Entities and Original Equipment
Manufacturers'';
(3) a description of the statutory and regulatory authority
of the Food and Drug Administration with respect to the
servicing of devices conducted by any entity, including original
equipment manufacturers and third party entities;
(4) details regarding how the Food and Drug Administration
currently regulates devices with respect to servicing to ensure
safety and effectiveness, how the agency could improve such
regulation using the authority described in paragraph (3), and
whether additional authority is recommended;
(5) information on actions the Food and Drug Administration
could take under the authority described in paragraphs (3) and
(4) to assess the servicing of devices, including the size,
scope, location, and composition of third party entities;
(6) information on actions the Food and Drug Administration
could take to track adverse events caused by servicing errors
performed by any entity, including original equipment
manufacturers and third party entities;
(7) information regarding the regulation by States, the
Joint Commission, or other regulatory bodies of device servicing
performed by any entity, including original equipment
manufacturers and third party entities; and
(8) any additional information determined by the Secretary
(acting through the Commissioner) to be relevant to ensuring the
quality, safety, and effectiveness of devices with respect to
servicing.
(c) Servicing Defined.--In this section, the term ``servicing''
includes, with respect to a device, refurbishing, reconditioning,
rebuilding, remarketing, repairing, remanufacturing, or other servicing
of the device.
TITLE VIII--IMPROVING GENERIC DRUG ACCESS
SEC. 801. PRIORITY REVIEW OF GENERIC DRUGS.
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)) is amended by adding at the end the following:
[[Page 131 STAT. 1069]]
``(11)(A) <<NOTE: Deadlines.>> 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) <<NOTE: Determination.>> 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) <<NOTE: Web posting. Update. Deadline. Lists.>> 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.''.
SEC. 802. ENHANCING REGULATORY TRANSPARENCY TO ENHANCE GENERIC
COMPETITION.
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355), as amended by section 801, is further amended by adding at
the end the following:
``(13) <<NOTE: Review. Updates.>> 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.''.
SEC. 803. COMPETITIVE GENERIC THERAPIES.
(a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506G
the following:
[[Page 131 STAT. 1070]]
``SEC. 506H. <<NOTE: 21 USC 356h.>> COMPETITIVE GENERIC
THERAPIES.
``(a) In General.--The Secretary may, at the request of an applicant
of a drug that is designated as a competitive generic therapy pursuant
to subsection (b), expedite the development and review of an abbreviated
new drug application under section 505(j) for such drug.
``(b) Designation Process.--
``(1) Request.--The applicant may request the Secretary to
designate the drug as a competitive generic therapy.
``(2) Timing.--A request under paragraph (1) may be made
concurrently with, or at any time prior to, the submission of an
abbreviated new drug application for the drug under section
505(j).
``(3) Criteria.--A drug is eligible for designation as a
competitive generic therapy under this section if the Secretary
determines that there is inadequate generic competition.
``(4) <<NOTE: Deadline.>> Designation.--Not later than 60
calendar days after the receipt of a request under paragraph
(1), the Secretary may--
``(A) determine whether the drug that is the subject
of the request meets the criteria described in paragraph
(3); and
``(B) if the Secretary finds that the drug meets
such criteria, designate the drug as a competitive
generic therapy.
``(c) Actions.--In expediting the development and review of an
application under subsection (a), the Secretary may, as requested by the
applicant, take actions including the following:
``(1) Hold meetings with the applicant and the review team
throughout the development of the drug prior to submission of
the application for such drug under section 505(j).
``(2) Provide timely advice to, and interactive
communication with, the applicant regarding the development of
the drug to ensure that the development program to gather the
data necessary for approval is as efficient as practicable.
``(3) Involve senior managers and experienced review staff,
as appropriate, in a collaborative, coordinated review of such
application, including with respect to drug-device combination
products and other complex products.
``(4) Assign a cross-disciplinary project lead--
``(A) to facilitate an efficient review of the
development program and application, including
manufacturing inspections; and
``(B) to serve as a scientific liaison between the
review team and the applicant.
``(d) Reporting Requirement.--Not later than one year after the date
of the approval of an application under section 505(j) with respect to a
drug for which the development and review is expedited under this
section, the sponsor of such drug shall report to the Secretary on
whether the drug has been marketed in interstate commerce since the date
of such approval.
``(e) Definitions.--In this section:
``(1) The term `generic drug' means a drug that is approved
pursuant to section 505(j).
``(2) The term `inadequate generic competition' means, with
respect to a drug, there is not more than one approved drugs on
the list of drugs described in section 505(j)(7)(A) (not
[[Page 131 STAT. 1071]]
including drugs on the discontinued section of such list) that
is--
``(A) the reference listed drug; or
``(B) a generic drug with the same reference listed
drug as the drug for which designation as a competitive
generic therapy is sought.
``(3) The term `reference listed drug' means the listed drug
(as such term is used in section 505(j)) for the drug
involved.''.
(b) <<NOTE: Deadlines. 21 USC 356h note.>> Guidance; Amended
Regulations.--
(1) In general.--
(A) Issuance.--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 on
section 506H of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a); and
(ii) not later than 1 year after the close of
the comment period for the draft guidance, issue
final guidance on such section 506H.
(B) Contents.--The guidance issued under this
paragraph shall--
(i) specify the process and criteria by which
the Secretary makes a designation under section
506H of the Federal Food, Drug, and Cosmetic Act,
as added by subsection (a);
(ii) specify the actions the Secretary may
take to expedite the development and review of a
competitive generic therapy pursuant to such a
designation; and
(iii) include good review management practices
for competitive generic therapies.
(2) Amended regulations.--The Secretary of Health and Human
Services shall issue or revise any regulations as may be
necessary to carry out this section not later than 2 years after
the date of enactment of this Act.
SEC. 804. ACCURATE INFORMATION ABOUT DRUGS WITH LIMITED
COMPETITION.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351
et seq.) is amended by inserting after section 506H, as added by section
803, the following:
``SEC. 506I. <<NOTE: 21 USC 356i.>> PROMPT REPORTS OF MARKETING
STATUS.
``(a) Notification of Withdrawal.--The holder of an application
approved under subsection (c) or (j) of section 505 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 and by
proprietary name, if any;
``(3) new drug application number or abbreviated 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.
[[Page 131 STAT. 1072]]
``(b) Notification of Drug Not Available for Sale.--The holder of an
application approved under subsection (c) or (j) 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 and by
proprietary name, if any;
``(2) new drug application number or abbreviated 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) <<NOTE: Review. Notification.>> 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) <<NOTE: Lists.>> 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.
``(e) <<NOTE: Lists. Deadline.>> Updates.--The Secretary shall
update the list published under subsection 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). The Secretary shall make monthly updates to the
list based on the information provided pursuant to subsections (a) and
(b), and shall update the list 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. 805. SUITABILITY PETITIONS.
(a) <<NOTE: Deadline.>> In General.--It is the sense of Congress
that the Food and Drug Administration shall meet the requirement under
section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C.
[[Page 131 STAT. 1073]]
355(j)(2)(C)) and section 314.93(e) of title 21, Code of Federal
Regulations, of responding to suitability petitions within 90 days of
submission.
(b) Report.--The Secretary of Health and Human Services shall
include in the annual reports under section 807--
(1) the number of pending petitions under section
505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)(2)(C)); and
(2) the number of such petitions pending a substantive
response for more than 180 days from the date of receipt.
SEC. 806. <<NOTE: Deadline. Protocols. Review. 21 USC 374 note.>>
INSPECTIONS.
Within 6 months of the date of enactment of this Act, the Secretary
of Health and Human Services shall develop and implement a protocol for
expediting review of timely responses to reports of observations from an
inspection under section 704 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 374). Such protocol shall--
(1) <<NOTE: Applicability.>> apply to responses to such
reports pertaining to applications submitted under section 505
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355)--
(A) for which the approval is dependent upon
remediation of conditions identified in the report;
(B) for which concerns related to observations from
an inspection under such section 704 are the only
barrier to approval; and
(C) where the drug that is the subject of the
application is a drug--
(i) for which there are not more than 3 other
approved applications under section 505(j) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)) that reference the same listed drug and
for which there are less than 6 abbreviated new
drug applications tentatively approved; or
(ii) that is included on the list under
section 506E of such Act (21 U.S.C. 356e);
(2) address expedited re-inspection of facilities, as
appropriate; and
(3) <<NOTE: Time period.>> establish a 6-month timeline for
completion of review of such responses to such reports.
SEC. 807. REPORTING ON PENDING GENERIC DRUG APPLICATIONS AND
PRIORITY REVIEW APPLICATIONS.
Not <<NOTE: Web posting.>> later than 180 calendar days after the
date of enactment of this Act, and quarterly thereafter until October 1,
2022, 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
[[Page 131 STAT. 1074]]
(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.
SEC. 808. INCENTIVIZING COMPETITIVE GENERIC DRUG DEVELOPMENT.
Section 505(j)(5) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)(5)) is amended--
(1) in subparagraph (B), by adding at the end the following:
``(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
[[Page 131 STAT. 1075]]
exclusivity period under clause (iv)
pursuant to subparagraph (D).''; and
(2) in subparagraph (D), by adding at the end the following:
``(iv) Special forfeiture rule for competitive
generic therapy.--The 180-day <<NOTE: Deadline.>>
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.''.
SEC. 809. GAO STUDY OF ISSUES REGARDING FIRST CYCLE APPROVALS OF
GENERIC MEDICINES.
(a) <<NOTE: Determination.>> Study by GAO.--The Comptroller General
of the United States shall conduct a study to determine the following:
(1) <<NOTE: Time period.>> The rate of first cycle
approvals and tentative approvals for applications submitted
under section 505(j) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(j)) during the period beginning on October 1,
2012, and ending on September 30, 2017. The rate of first cycle
approvals and tentative approvals shall be determined and
reported per each GDUFA cohort year during this period.
(2) <<NOTE: Assessment.>> If the rate determined pursuant
to paragraph (1) for any GDUFA cohort year is lower than 20
percent, the reasons contributing to the relatively low rate of
first cycle approvals and tentative approvals for generic drug
applications shall be itemized, assessed, and reported. In
making the assessment required by this paragraph, the
Comptroller General shall consider, among other things, the role
played by--
(A) the Food and Drug Administration's
implementation of approval standards for generic drug
applications;
(B) the extent to which those approval standards are
communicated clearly to industry and applied
consistently during the review process;
(C) the procedures for reviewing generic drug
applications, including timelines for review activities
by the Food and Drug Administration;
(D) the extent to which those procedures are
followed consistently (and those timelines are met) by
the Food and Drug Administration;
(E) the processes and practices for communication
between the Food and Drug Administration and sponsors of
generic drug applications; and
(F) the completeness and quality of original generic
drug applications submitted to the Food and Drug
Administration.
(3) Taking into account the determinations made pursuant to
paragraphs (1) and (2) and any review process improvements
implemented pursuant to this Act, whether there are ways the
review process for generic drugs could be improved to increase
the rate of first cycle approvals and tentative approvals for
generic drug applications. In making this determination, the
Comptroller General shall consider, among other things, options
for increasing review efficiency and communication
effectiveness.
[[Page 131 STAT. 1076]]
(b) <<NOTE: Time period. Reports.>> Completion Date.--Not later
than the expiration of the 2-year period beginning on the date of
enactment of this Act, the Comptroller General shall complete the study
under subsection (a) and submit a report describing the findings and
conclusions of the study to the Secretary, the Committee on Energy and
Commerce of the House of Representatives, and the Committee on Health,
Education, Labor, and Pensions of the Senate.
(c) Definitions.--For purposes of this section:
(1) The term ``GDUFA cohort year'' means a fiscal year.
(2) The term ``generic drug'' means a drug that is approved
or is seeking approval under section 505(j) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(j)).
(3) The term ``generic drug application'' means an
abbreviated new drug application for the approval of a generic
drug under section 505(j) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)).
(4) The term ``Secretary'' means the Secretary of Health and
Human Services.
(5)(A) The term ``first cycle approvals and tentative
approvals'' means the approval or tentative approval of a
generic drug application after the Food and Drug
Administration's complete review of the application and without
issuance of one or more complete response letters.
(B) For purposes of this paragraph, the term ``complete
response letter'' means a written communication to the sponsor
of a generic drug application or holder of a drug master file
from the Food and Drug Administration describing all of the
deficiencies that the Administration has identified in the
generic drug application (including pending amendments) or drug
master file that must be satisfactorily addressed before the
generic drug application can be approved.
TITLE IX--ADDITIONAL PROVISIONS
SEC. 901. TECHNICAL CORRECTIONS.
(a) Section 3075(a) of the 21st Century Cures Act (Public Law 114-
255) <<NOTE: 21 USC 355.>> is amended--
(1) in the matter preceding paragraph (1), by striking ``as
amended by section 2074'' and inserting ``as amended by section
3102''; and
(2) in paragraph (2), by striking ``section 2074(1)(C)'' and
inserting ``section 3102(1)(C)''.
(b) Section 506G(b)(1)(A) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 356g(b)(1)(A)) is amended by striking ``identity'' and
inserting ``identify''.
(c) Section 505F(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355g(b)) is amended by striking ``randomized'' and inserting
``traditional''.
(d) Section 505F(d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355g(d)) is amended by striking ``2'' and inserting ``3''.
(e) Section 510(h)(6) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360(h)(6)) is amended by striking ``February 1'' and
replacing with ``May 1''.
(f) <<NOTE: Effective date. 21 USC 360e-3 and note.>> Effective as
of the enactment of the 21st Century Cures Act (Public Law 114-255)--
[[Page 131 STAT. 1077]]
(1) <<NOTE: 21 USC 360e-3.>> section 3051(a) of such Act is
amended by striking ``by inserting after section 515B'' and
inserting ``by inserting after section 515A''; and
(2) section 515C of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360e-3), as inserted by such section 3051(a), is
redesignated as section 515B.
(g) Section 515B(f)(2) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360e-3(f)(2)), as redesignated by subsection (e)(2) of this
section, is amended by striking ``a proposed guidance'' and inserting
``a draft version of that guidance''.
(h) Section 513(b)(5)(D) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360c(b)(5)(D)) is amended by striking ``medical device
submissions'' and inserting ``medical devices that may be specifically
the subject of a review by a classification panel''.
SEC. 902. <<NOTE: Web posting. 21 USC 355 note.>> 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. 903. <<NOTE: Web postings. Time periods.>> STREAMLINING AND
IMPROVING CONSISTENCY IN PERFORMANCE
REPORTING.
(a) PDUFA.--Section 736B(a) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379h-2(a)), as amended by section 103, is further amended
by inserting after paragraph (2) the following:
``(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, 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,
[[Page 131 STAT. 1078]]
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.
``(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.
``(iii) The number of new drug applications
and biological licensing applications approved.
``(iv) The number of new drug applications and
biological licensing applications filed.
``(4) <<NOTE: Effective date. Analysis.>> Rationale for
pdufa 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 101(b) of the
Prescription Drug User Fee Amendments of 2017 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.''.
(b) MDUFA.--Section 738A(a)(1)(A) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-1(a)(1)(A)), as amended by section 204, is
further amended--
(1) by striking ``Beginning with'' and inserting the
following:
``(i) General requirements.--Beginning with'';
and
(2) by adding at the end the following:
``(ii) <<NOTE: Effective date.>> Additional
information.--Beginning with fiscal year 2018, 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--
[[Page 131 STAT. 1079]]
``(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, 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; 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.
``(iv) <<NOTE: Effective date. Analysis.>>
Rationale for mdufa program changes.--Beginning
with fiscal year 2020, 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 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
[[Page 131 STAT. 1080]]
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.''.
(c) GDUFA.--Section 744C(a) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j-43(a)), as amended by section 304, is further
amended--
(1) by striking ``Beginning with'' and inserting the
following:
``(1) General requirements.--Beginning with''; and
(2) by adding at the end the following:
``(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, 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.
``(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.
``(3) <<NOTE: Effective date. Analysis.>> Rationale for
gdufa 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 301(b) of the
Generic Drug User Fee Amendments of 2017 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.''.
[[Page 131 STAT. 1081]]
(d) BsUFA.--Section 744I(a) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j-53(a)), as amended by section 404, is further
amended--
(1) by striking ``Beginning with'' and inserting the
following:
``(1) General requirements.--Beginning with''; and
(2) by adding at the end the following:
``(2) <<NOTE: Effective date.>> Additional information.--
Beginning with fiscal year 2018, 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, 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.
``(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.
``(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 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
[[Page 131 STAT. 1082]]
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.''.
SEC. 904. ANALYSIS OF USE OF FUNDS.
(a) PDUFA Reports.--
(1) Analysis in pdufa performance reports.--Section 736B(a)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h-
2(a)), as amended by section 903(a), is further amended by
adding at the end the following:
``(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 for the applicable fiscal year.
``(B) <<NOTE: Determination.>> 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 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.''.
(2) Issuance of corrective action reports.--Section 736B of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h-2) is
amended--
(A) by redesignating subsections (c) and (d) as
subsections (e) and (f), respectively; and
(B) by inserting after subsection (b) the following:
``(c) <<NOTE: Effective date. Determinations.>> Corrective Action
Report.--Beginning with fiscal year 2018, for each fiscal year for which
fees are collected under this part, the Secretary shall prepare and
submit a corrective action
[[Page 131 STAT. 1083]]
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) <<NOTE: Recommenda- tions.>> 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 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 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) <<NOTE: Public information.>> 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. <<NOTE: Deadline.>> Such hearing
shall occur not later than 120 days after the end of each fiscal
year for which fees are collected under this part.''.
(b) MDUFA Reports.--
(1) Analysis in mdufa performance reports.--Section
738A(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-1(a)(1)(A)), as amended by section 903(b), is
further amended by adding at the end the following:
``(iv) Analysis.--For each fiscal year, the
Secretary shall include in the report under clause
(i) an analysis of the following:
[[Page 131 STAT. 1084]]
``(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 for the
applicable fiscal year.
``(II) <<NOTE: Determination.>>
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 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.''.
(2) Issuance of corrective action reports.--Section 738A(a)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
1(a)) is amended--
(A) by redesignating paragraphs (2) and (3) as
paragraphs (4) and (5), respectively; and
(B) by inserting after paragraph (1) the following:
``(2) <<NOTE: Effective date. Determinations.>> Corrective
action report.--Beginning with fiscal year 2018, 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) <<NOTE: Recommenda- tions.>> 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
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
[[Page 131 STAT. 1085]]
Device User Fee Amendments of 2017 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) <<NOTE: Summary.>> 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) <<NOTE: Public information.>> 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. <<NOTE: Deadline.>> Such hearing shall
occur not later than 120 days after the end of each
fiscal year for which fees are collected under this
part.''.
(c) GDUFA Reports.--
(1) Analysis in gdufa performance reports.--Section 744C(a)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
43(a)), as amended by section 903(c) is further amended by
adding at the end the following:
``(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 for the applicable fiscal year.
[[Page 131 STAT. 1086]]
``(B) <<NOTE: Determination.>> 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 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.''.
(2) Issuance of corrective action reports.--Section 744C of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-43) is
amended--
(A) by redesignating subsections (c) and (d) as
subsections (e) and (f), respectively; and
(B) by inserting after subsection (b) the following:
``(c) <<NOTE: Effective date. Determinations.>> Corrective Action
Report.--Beginning with fiscal year 2018, 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) <<NOTE: Recommenda- tions.>> 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 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 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.
[[Page 131 STAT. 1087]]
``(2) <<NOTE: Public information.>> 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. <<NOTE: Deadline.>> Such hearing
shall occur not later than 120 days after the end of each fiscal
year for which fees are collected under this part.''.
(d) BsUFA Reports.--
(1) Analysis in bsufa performance reports.--Section 744I(a)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
53(a)) as amended by section 903(d) is further amended by adding
at the end the following:
``(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 for the applicable fiscal year.
``(B) <<NOTE: Determination.>> 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 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.''.
(2) Issuance of corrective action reports.--Section 744I of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-53), as
amended by section 404, is further amended--
(A) by redesignating subsections (c) and (d) as
subsections (e) and (f), respectively; and
(B) by inserting after subsection (b) the following:
``(c) <<NOTE: Effective date. Determinations.>> Corrective Action
Report.--Beginning with fiscal year 2018, and 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
[[Page 131 STAT. 1088]]
401(b) of the Biosimilar User Fee Amendments of 2017 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 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) <<NOTE: Public information.>> 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. <<NOTE: Deadline.>> Such hearing
shall occur not later than 120 days after the end of each fiscal
year for which fees are collected under this part.''.
SEC. 905. FACILITIES MANAGEMENT.
(a) Evaluation.--
(1) <<NOTE: Time period.>> Study.--The Comptroller General
of the United States shall conduct a study on the expenses
incurred by the Food and Drug Administration related to facility
maintenance and renovation in fiscal years 2012 through 2019.
The study under this paragraph shall include the following:
(A) <<NOTE: Review.>> A review of purchases and
expenses differentiated by appropriated funds, and
resources authorized by the Food and Drug Administration
Safety and Innovation Act (Public Law 112-144) and this
Act, as applicable, that contributed to--
(i) the maintenance of scientific equipment
and any existing facility plan or plans to
maintain previously purchased scientific
equipment;
[[Page 131 STAT. 1089]]
(ii) the renovation of facilities in the
Center for Drug Evaluation and Research, the
Center for Biologics Evaluation and Research, and
the Center for Devices and Radiological Health,
and the purpose of such renovation including the
need for the renovation;
(iii) the assets purchased or repaired under
the ``repair of facilities and acquisition''
authority under parts 2, 3, 7, and 8 of subchapter
C of chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379f et seq.);
(iv) the maintenance and repair of facilities
and fixtures, including a description of any
unanticipated repairs and maintenance as well as
scheduled repairs maintenance, and the budget plan
for the scheduled or anticipated maintenance;
(v) the acquisition of furniture, a
description of the furniture purchased, and the
purpose of the furniture including purchases for
the Center for Drug Evaluation and Research, the
Center for Biologics Evaluation and Research, and
the Center for Devices and Radiological Health;
and
(vi) the acquisition of other necessary
materials and supplies by product category under
the authority under parts 2, 3, 7, and 8 of
subchapter C of chapter VII of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379f et seq.).
(B) <<NOTE: Analysis.>> An analysis of the Food and
Drug Administration's ability to further its public
health mission and review medical products by incurring
the expenses listed in clauses (i) through (vi) of
subparagraph (A). <<NOTE: Consultation.>> In conducting
the analysis, the Comptroller General shall request
information from and consult with appropriate employees,
including staff and those responsible for the fiscal
decisions regarding facility maintenance and renovation
for the agency.
(2) Report.--
(A) In general.--The Comptroller General shall issue
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 not later
than July 30, 2020, containing the results of the study
under paragraph (1).
(B) Recommendations.--As part of the report under
this paragraph, the Comptroller General may provide
recommendations, as applicable, on methods through which
the Food and Drug Administration may improve planning
for--
(i) the maintenance, renovation, and repair of
facilities;
(ii) the purchase of furniture or other
acquisitions; and
(iii) ways the Food and Drug Administration
may allocate the expenses described in clauses (i)
and (ii) of paragraph (1)(A), as informed by the
analysis under paragraph (1)(B).
(b) Administration.--
[[Page 131 STAT. 1090]]
(1) PDUFA.--Section 736(f) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(f)) is amended by adding at the end
the following:
``(3) <<NOTE: Effective date.>> Limitation.--Beginning on
October 1, 2023, the authorities under section 735(7)(C) shall
include only expenditures for leasing and necessary scientific
equipment.''.
(2) MDUFA.--Section 738(h) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(h)) is amended by adding at the end
the following:
``(3) <<NOTE: Effective date.>> Limitation.--Beginning on
October 1, 2023, the authorities under section 737(9)(C) shall
include only leasing and necessary scientific equipment.''.
(3) GDUFA.--Section 744B(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-42(e)) is amended--
(A) in the subsection heading, by striking ``Limit''
and inserting ``Limitations'';
(B) by striking ``The total amount'' and inserting
the following:
``(1) In general.--The total amount''; and
(C) by adding at the end the following:
``(2) <<NOTE: Effective date.>> Leasing and necessary
equipment.--Beginning on October 1, 2023, the authorities under
section 744A(11)(C) shall include only leasing and necessary
scientific equipment.''.
(4) BsUFA.--Section 744H(e)(2)(B) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-52(e)(2)(B)) is amended--
(A) in the subparagraph heading, by striking
``limitation'' and inserting ``limitations'';
(B) by striking ``The fees authorized'' and
inserting the following:
``(i) In general.--The fees authorized''; and
(C) by adding at the end the following:
``(ii) <<NOTE: Effective date.>> Leasing and
necessary equipment.--Beginning on October 1,
2023, the authorities under section 744G(9)(C)
shall include only leasing and necessary
scientific equipment.''.
Approved August 18, 2017.
LEGISLATIVE HISTORY--H.R. 2430 (S. 934):
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HOUSE REPORTS: No. 115-201 (Comm. on Energy and Commerce).
CONGRESSIONAL RECORD, Vol. 163 (2017):
July 12, considered and passed House.
Aug. 3, considered and passed Senate.
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