[113th Congress Public Law 14]
[From the U.S. Government Publishing Office]
[[Page 127 STAT. 451]]
Public Law 113-14
113th Congress
An Act
To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user
fee programs relating to new animal drugs and generic new animal
drugs. <<NOTE: June 13, 2013 - [S. 622]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Animal Drug and
Animal Generic Drug User Fee Reauthorization Act of 2013. 21 USC 301
note.>>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Animal Drug and Animal Generic Drug
User Fee Reauthorization Act of 2013''.
SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT.
(a) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title.
Sec. 2. Table of contents; references in Act.
TITLE I--FEES RELATING TO ANIMAL DRUGS
Sec. 101. Short title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use animal drug fees.
Sec. 104. Reauthorization; reporting requirements.
Sec. 105. Savings clause.
Sec. 106. Effective date.
Sec. 107. Sunset dates.
TITLE II--FEES RELATING TO GENERIC ANIMAL DRUGS
Sec. 201. Short title; finding.
Sec. 202. Authority to assess and use generic new animal drug fees.
Sec. 203. Reauthorization; reporting requirements.
Sec. 204. Savings clause.
Sec. 205. Effective date.
Sec. 206. Sunset dates.
(b) References in Act.--Except as otherwise specified, amendments
made by this Act to a section or other provision of law are amendments
to such section or other provision of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.).
TITLE <<NOTE: Animal Drug User Fee Amendments of 2013.>> I--FEES
RELATING TO ANIMAL DRUGS
SEC. 101. SHORT TITLE; FINDING.
(a) <<NOTE: 21 USC 301 note.>> Short Title.--This title may be
cited as the ``Animal Drug User Fee Amendments of 2013''.
(b) <<NOTE: 21 USC 379j-11 note.>> Finding.--Congress finds that
the fees authorized by the amendments made in this title will be
dedicated toward expediting the animal drug development process and the
review of new and
[[Page 127 STAT. 452]]
supplemental animal drug applications and investigational animal drug
submissions as set forth in the goals identified, for purposes of part 4
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 Energy and Commerce of the House of
Representatives and the Chairman of the Committee on Health, Education,
Labor, and Pensions of the Senate as set forth in the Congressional
Record.
SEC. 102. DEFINITIONS.
Section 739 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-11) is amended to read as follows:
``SEC. 739. DEFINITIONS.
``For purposes of this part:
``(1) The term `animal drug application' means an
application for approval of any new animal drug submitted under
section 512(b)(1). Such term does not include either a new
animal drug application submitted under section 512(b)(2) or a
supplemental animal drug application.
``(2) The term `supplemental animal drug application'
means--
``(A) a request to the Secretary to approve a change
in an animal drug application which has been approved;
or
``(B) a request to the Secretary to approve a change
to an application approved under section 512(c)(2) for
which data with respect to safety or effectiveness are
required.
``(3) The term `animal drug product' means each specific
strength or potency of a particular active ingredient or
ingredients in final dosage form marketed by a particular
manufacturer or distributor, which is uniquely identified by the
labeler code and product code portions of the national drug
code, and for which an animal drug application or a supplemental
animal drug application has been approved.
``(4) The term `animal drug establishment' means a foreign
or domestic place of business which is at one general physical
location consisting of one or more buildings all of which are
within 5 miles of each other, at which one or more animal drug
products are manufactured in final dosage form.
``(5) The term `investigational animal drug submission'
means--
``(A) the filing of a claim for an investigational
exemption under section 512(j) for a new animal drug
intended to be the subject of an animal drug application
or a supplemental animal drug application; or
``(B) the submission of information for the purpose
of enabling the Secretary to evaluate the safety or
effectiveness of an animal drug application or
supplemental animal drug application in the event of
their filing.
``(6) The term `animal drug sponsor' means either an
applicant named in an animal drug application that has not been
withdrawn by the applicant and for which approval has not been
withdrawn by the Secretary, or a person who has submitted an
investigational animal drug submission that has not been
terminated or otherwise rendered inactive by the Secretary.
[[Page 127 STAT. 453]]
``(7) The term `final dosage form' means, with respect to an
animal drug product, a finished dosage form which is approved
for administration to an animal without substantial further
manufacturing. Such term includes animal drug products intended
for mixing in animal feeds.
``(8) The term `process for the review of animal drug
applications' means the following activities of the Secretary
with respect to the review of animal drug applications,
supplemental animal drug applications, and investigational
animal drug submissions:
``(A) The activities necessary for the review of
animal drug applications, supplemental animal drug
applications, and investigational animal drug
submissions.
``(B) The issuance of action letters which approve
animal drug applications or supplemental animal drug
applications or which set forth in detail the specific
deficiencies in animal drug applications, supplemental
animal drug applications, or investigational animal drug
submissions and, where appropriate, the actions
necessary to place such applications, supplements or
submissions in condition for approval.
``(C) The inspection of animal drug establishments
and other facilities undertaken as part of the
Secretary's review of pending animal drug applications,
supplemental animal drug applications, and
investigational animal drug submissions.
``(D) Monitoring of research conducted in connection
with the review of animal drug applications,
supplemental animal drug applications, and
investigational animal drug submissions.
``(E) The development of regulations and policy
related to the review of animal drug applications,
supplemental animal drug applications, and
investigational animal drug submissions.
``(F) Development of standards for products subject
to review.
``(G) Meetings between the agency and the animal
drug sponsor.
``(H) Review of advertising and labeling prior to
approval of an animal drug application or supplemental
animal drug application, but not after such application
has been approved.
``(9) The term `costs of resources allocated for the process
for the review of animal drug applications' means the expenses
in connection with the process for the review of animal drug
applications for--
``(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees consulted with
respect to the review of specific animal drug
applications, supplemental animal drug applications, or
investigational animal drug submissions, and costs
related to such officers, employees, committees, and
contractors, including costs for travel, education, and
recruitment and other personnel activities;
``(B) management of information and the acquisition,
maintenance, and repair of computer resources;
[[Page 127 STAT. 454]]
``(C) leasing, maintenance, renovation, and repair
of facilities and acquisition, maintenance, and repair
of fixtures, furniture, scientific equipment, and other
necessary materials and supplies; and
``(D) collecting fees under section 740 and
accounting for resources allocated for the review of
animal drug applications, supplemental animal drug
applications, and investigational animal drug
submissions.
``(10) The term `adjustment factor' applicable to a fiscal
year refers to the formula set forth in section 735(8) with the
base or comparator month being October 2002.
``(11) The term `person' includes an affiliate thereof.
``(12) The term `affiliate' refers to the definition set
forth in section 735(11).''.
SEC. 103. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.
Section 740 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-12) is amended to read as follows:
``SEC. 740. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.
``(a) <<NOTE: Effective date.>> Types of Fees.--Beginning in fiscal
year 2004, the Secretary shall assess and collect fees in accordance
with this section as follows:
``(1) Animal drug application and supplement fee.--
``(A) In general.--Each person that submits, on or
after September 1, 2003, an animal drug application or a
supplemental animal drug application shall be subject to
a fee as follows:
``(i) A fee established in subsection (c) for
an animal drug application, except an animal drug
application subject to the criteria set forth in
section 512(d)(4).
``(ii) A fee established in subsection (c), in
an amount that is equal to 50 percent of the
amount of the fee under clause (i), for--
``(I) a supplemental animal drug
application for which safety or
effectiveness data are required; and
``(II) an animal drug application
subject to the criteria set forth in
section 512(d)(4).
``(B) Payment.--The fee required by subparagraph (A)
shall be due upon submission of the animal drug
application or supplemental animal drug application.
``(C) Exception for previously filed application or
supplement.--If an animal drug application or a
supplemental animal drug application was submitted by a
person that paid the fee for such application or
supplement, was accepted for filing, and was not
approved or was withdrawn (without a waiver or refund),
the submission of an animal drug application or a
supplemental animal drug application for the same
product by the same person (or the person's licensee,
assignee, or successor) shall not be subject to a fee
under subparagraph (A).
``(D) Refund of fee if application refused for
filing.--The Secretary shall refund 75 percent of the
fee paid under subparagraph (B) for any animal drug
application or supplemental animal drug application
which is refused for filing.
[[Page 127 STAT. 455]]
``(E) Refund of fee if application withdrawn.--If an
animal drug application or a supplemental animal drug
application is withdrawn after the application or
supplement was filed, the Secretary may refund the fee
or portion of the fee paid under subparagraph (B) if no
substantial work was performed on the application or
supplement after the application or supplement was
filed. The Secretary shall have the sole discretion to
refund the fee under this paragraph. A determination by
the Secretary concerning a refund under this paragraph
shall not be reviewable.
``(2) Animal drug product fee.--
``(A) In general.--Each person--
``(i) who is named as the applicant in an
animal drug application or supplemental animal
drug application for an animal drug product which
has been submitted for listing under section 510;
and
``(ii) who, after September 1, 2003, had
pending before the Secretary an animal drug
application or supplemental animal drug
application,
shall pay for each such animal drug product the annual
fee established in subsection (c).
``(B) Payment; fee due date.--Such fee shall be
payable for the fiscal year in which the animal drug
product is first submitted for listing under section
510, or is submitted for relisting under section 510 if
the animal drug product has been withdrawn from listing
and relisted. After such fee is paid for that fiscal
year, such fee shall be due each subsequent fiscal year
that the product remains listed, upon the later of--
``(i) 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; or
``(ii) January 31 of each year.
``(C) Limitation.--Such fee shall be paid only once
for each animal drug product for a fiscal year in which
the fee is payable.
``(3) Animal drug establishment fee.--
``(A) In general.--Each person--
``(i) who owns or operates, directly or
through an affiliate, an animal drug
establishment;
``(ii) who is named as the applicant in an
animal drug application or supplemental animal
drug application for an animal drug product which
has been submitted for listing under section 510;
and
``(iii) <<NOTE: Deadline.>> who, after
September 1, 2003, had pending before the
Secretary an animal drug application or
supplemental animal drug application,
shall be assessed an annual establishment fee as
established in subsection (c) for each animal drug
establishment listed in its approved animal drug
application as an establishment that manufactures the
animal drug product named in the application.
``(B) Payment; fee due date.--The annual
establishment fee shall be assessed in each fiscal year
in which the animal drug product named in the
application is
[[Page 127 STAT. 456]]
assessed a fee under paragraph (2) unless the animal
drug establishment listed in the application does not
engage in the manufacture of the animal drug product
during the fiscal year. The fee under this paragraph for
a fiscal year shall be due upon the later of--
``(i) 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; or
``(ii) January 31 of each year.
``(C) Limitation.--
``(i) In general.--An establishment shall be
assessed only one fee per fiscal year under this
section, subject to clause (ii).
``(ii) Certain manufacturers.--If a single
establishment manufactures both animal drug
products and prescription drug products, as
defined in section 735(3), such establishment
shall be assessed both the animal drug
establishment fee and the prescription drug
establishment fee, as set forth in section
736(a)(2), within a single fiscal year.
``(4) Animal drug sponsor fee.--
``(A) In general.--Each person--
``(i) who meets the definition of an animal
drug sponsor within a fiscal year; and
``(ii) <<NOTE: Deadline.>> who, after
September 1, 2003, had pending before the
Secretary an animal drug application, a
supplemental animal drug application, or an
investigational animal drug submission,
shall be assessed an annual sponsor fee as established
under subsection (c).
``(B) Payment; fee due date.--The fee under this
paragraph for a fiscal year shall be due upon the later
of--
``(i) 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; or
``(ii) January 31 of each year.
``(C) Limitation.--Each animal drug sponsor shall
pay only one such fee each fiscal year.
``(b) Fee Revenue Amounts.--
``(1) In general.--Subject to subsections (c), (d), (f), and
(g)--
``(A) for fiscal year 2014, the fees required under
subsection (a) shall be established to generate a total
revenue amount of $23,600,000; and
``(B) for each of fiscal years 2015 through 2018,
the fees required under subsection (a) shall be
established to generate a total revenue amount of
$21,600,000.
``(2) Types of fees.--Of the total revenue amount determined
for a fiscal year under paragraph (1)--
``(A) 20 percent shall be derived from fees under
subsection (a)(1) (relating to animal drug applications
and supplements);
``(B) 27 percent shall be derived from fees under
subsection (a)(2) (relating to animal drug products);
[[Page 127 STAT. 457]]
``(C) 26 percent shall be derived from fees under
subsection (a)(3) (relating to animal drug
establishments); and
``(D) 27 percent shall be derived from fees under
subsection (a)(4) (relating to animal drug sponsors).
``(c) Annual Fee Setting; Adjustments.--
``(1) Annual fee setting.--The Secretary shall establish, 60
days before the start of each fiscal year beginning after
September 30, 2003, for that fiscal year, animal drug
application fees, supplemental animal drug application fees,
animal drug sponsor fees, animal drug establishment fees, and
animal drug product fees based on the revenue amounts
established under subsection (b) and the adjustments provided
under this subsection.
``(2) <<NOTE: Notice. Federal Register, publication.>>
Inflation adjustment.--For fiscal year 2015 and subsequent
fiscal years, the revenue amounts established in subsection (b)
shall be adjusted by the Secretary by notice, published in the
Federal Register, for a fiscal year, by an amount equal to the
sum of--
``(A) one;
``(B) the average annual percent change in the cost,
per full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and
benefits paid with respect to such positions for the
first 3 of the preceding 4 fiscal years for which data
are available, multiplied by the average proportion of
personnel compensation and benefits costs to total Food
and Drug Administration costs for the first 3 years of
the preceding 4 fiscal years for which data are
available; and
``(C) 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 less food and energy; annual index)
for the first 3 years of the preceding 4 years for which
data are available multiplied by the average proportion
of all costs other than personnel compensation and
benefits costs to total Food and Drug Administration
costs for the first 3 years of the preceding 4 fiscal
years for which data are available.
The adjustment made each fiscal year under this paragraph shall
be added on a compounded basis to the sum of all adjustments
made each fiscal year after fiscal year 2014 under this
paragraph.
``(3) Workload adjustment.--For fiscal year 2015 and
subsequent fiscal years, after the revenue amounts established
in subsection (b) are adjusted for inflation in accordance with
paragraph (2), the revenue amounts shall be further adjusted for
such fiscal year to reflect changes in the workload of the
Secretary for the process for the review of animal drug
applications. With respect to such adjustment--
``(A) <<NOTE: Determination.>> such adjustment
shall be determined by the Secretary based on a weighted
average of the change in the total number of animal drug
applications, supplemental animal drug applications for
which data with respect to safety or effectiveness are
required, manufacturing supplemental animal drug
applications, investigational animal drug study
submissions, and investigational animal drug protocol
submissions submitted to the Secretary;
[[Page 127 STAT. 458]]
``(B) <<NOTE: Federal Register, publication.>> the
Secretary shall publish in the Federal Register the fees
resulting from such adjustment and the supporting
methodologies; and
``(C) under no circumstances shall such adjustment
result in fee revenues for a fiscal year that are less
than the fee revenues for that fiscal year established
in subsection (b), as adjusted for inflation under
paragraph (2).
``(4) Final year adjustment.--For fiscal year 2018, the
Secretary may, in addition to other adjustments under this
subsection, further increase the fees under this section, if
such an adjustment is necessary, to provide for up to 3 months
of operating reserves of carryover user fees for the process for
the review of animal drug applications for the first 3 months of
fiscal year 2019. If the Food and Drug Administration has
carryover balances for the process for the review of animal drug
applications in excess of 3 months of such operating reserves,
then this adjustment will not be made. <<NOTE: Notice.>> If
this adjustment is necessary, then the rationale for the amount
of the increase shall be contained in the annual notice setting
fees for fiscal year 2018.
``(5) 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 animal drug applications.
``(d) Fee Waiver or Reduction.--
``(1) In general.--The Secretary shall grant a waiver from
or a reduction of one or more fees assessed under subsection (a)
where the Secretary finds that--
``(A) the assessment of the fee would present a
significant barrier to innovation because of limited
resources available to such person or other
circumstances;
``(B) the fees to be paid by such person will exceed
the anticipated present and future costs incurred by the
Secretary in conducting the process for the review of
animal drug applications for such person;
``(C) the animal drug application or supplemental
animal drug application is intended solely to provide
for use of the animal drug in--
``(i) a Type B medicated feed (as defined in
section 558.3(b)(3) of title 21, Code of Federal
Regulations (or any successor regulation))
intended for use in the manufacture of Type C
free-choice medicated feeds; or
``(ii) a Type C free-choice medicated feed (as
defined in section 558.3(b)(4) of title 21, Code
of Federal Regulations (or any successor
regulation));
``(D) the animal drug application or supplemental
animal drug application is intended solely to provide
for a minor use or minor species indication; or
``(E) the sponsor involved is a small business
submitting its first animal drug application to the
Secretary for review.
``(2) Use of standard costs.--In making the finding in
paragraph (1)(B), the Secretary may use standard costs.
``(3) Rules for small businesses.--
[[Page 127 STAT. 459]]
``(A) Definition.--In paragraph (1)(E), the term
`small business' means an entity that has fewer than 500
employees, including employees of affiliates.
``(B) Waiver of application fee.--The Secretary
shall waive under paragraph (1)(E) the application fee
for the first animal drug application that a small
business or its affiliate submits to the Secretary for
review. After a small business or its affiliate is
granted such a waiver, the small business or its
affiliate shall pay application fees for all subsequent
animal drug applications and supplemental animal drug
applications for which safety or effectiveness data are
required in the same manner as an entity that does not
qualify as a small business.
``(C) <<NOTE: Federal Register,
publication. Lists.>> Certification.--The Secretary
shall require any person who applies for a waiver under
paragraph (1)(E) to certify their qualification for the
waiver. The Secretary shall periodically publish in the
Federal Register a list of persons making such
certifications.
``(e) Effect of Failure To Pay Fees.--An animal drug application or
supplemental animal drug application submitted by a person subject to
fees under subsection (a) shall be considered incomplete and shall not
be accepted for filing by the Secretary until all fees owed by such
person have been paid. An investigational animal drug submission under
section 739(5)(B) that is submitted by a person subject to fees under
subsection (a) shall be considered incomplete and shall not be accepted
for review by the Secretary until all fees owed by such person have been
paid. <<NOTE: Deadline.>> The Secretary may discontinue review of any
animal drug application, supplemental animal drug application or
investigational animal drug submission from a person if such person has
not submitted for payment all fees owed under this section by 30 days
after the date upon which they are due.
``(f) Assessment of Fees.--
``(1) Limitation.--Fees may not be assessed under subsection
(a) for a fiscal year beginning after fiscal year 2003 unless
appropriations for salaries and expenses of the Food and Drug
Administration for such fiscal year (excluding the amount of
fees appropriated for such fiscal year) are equal to or greater
than the amount of appropriations for the salaries and expenses
of the Food and Drug Administration for the fiscal year 2003
(excluding the amount of fees appropriated for such fiscal year)
multiplied by the adjustment factor applicable to the fiscal
year involved.
``(2) Authority.--If the Secretary does not assess fees
under subsection (a) during any portion of a fiscal year because
of paragraph (1) and if at a later date in such fiscal year the
Secretary may assess such fees, the Secretary may assess and
collect such fees, without any modification in the rate, for
animal drug applications, supplemental animal drug applications,
investigational animal drug submissions, animal drug sponsors,
animal drug establishments and animal drug products at any time
in such fiscal year notwithstanding the provisions of subsection
(a) relating to the date fees are to be paid.
``(g) Crediting and Availability of Fees.--
``(1) In general.--Subject to paragraph (2)(C), fees
authorized under subsection (a) shall be collected and available
for
[[Page 127 STAT. 460]]
obligation only to the extent and in the amount provided in
advance in appropriations Acts. <<NOTE: Appropriation
authorization.>> Such fees are authorized to be appropriated to
remain available until expended. Such sums as may be necessary
may be transferred from the Food and Drug Administration
salaries and expenses appropriation account without fiscal year
limitation to such appropriation account for salary and expenses
with such fiscal year limitation. The sums transferred shall be
available solely for the process for the review of animal drug
applications.
``(2) Collections and appropriation acts.--
``(A) In general.--The fees authorized by this
section--
``(i) subject to subparagraph (C), shall be
collected and available in each fiscal year in an
amount not to exceed the amount specified in
appropriation Acts, or otherwise made available
for obligation for such fiscal year, and
``(ii) shall be available to defray increases
in the costs of the resources allocated for the
process for the review of animal drug applications
(including increases in such costs for an
additional number of full-time equivalent
positions in the Department of Health and Human
Services to be engaged in such process) over such
costs, excluding costs paid from fees collected
under this section, for fiscal year 2003
multiplied by the adjustment factor.
``(B) Compliance.--The Secretary shall be considered
to have met the requirements of subparagraph (A)(ii) in
any fiscal year if the costs funded by appropriations
and allocated for the process for the review of animal
drug applications--
``(i) are not more than 3 percent below the
level specified in subparagraph (A)(ii); or
``(ii)(I) are more than 3 percent below the
level specified in subparagraph (A)(ii), and fees
assessed for the fiscal year following the
subsequent fiscal year are decreased by the amount
in excess of 3 percent by which such costs fell
below the level specified in subparagraph (A)(ii);
and
``(II) such costs are not more than 5 percent
below the level specified in subparagraph (A)(ii).
``(C) Provision for early payments.--Payment of fees
authorized under this section for a fiscal year, prior
to the due date for such fees, may be accepted by the
Secretary in accordance with authority provided in
advance in a prior year appropriations Act.
``(3) Authorization of appropriations.--For each of the
fiscal years 2014 through 2018, there is authorized to be
appropriated for fees under this section an amount equal to the
total revenue amount determined under subsection (b) for the
fiscal year, as adjusted or otherwise affected under subsection
(c) and paragraph (4).
``(4) Offset of overcollections; recovery of collection
shortfalls.--
``(A) Offset of overcollections.--If the sum of the
cumulative amount of fees collected under this section
for fiscal years 2014 through 2016 and the amount of
fees
[[Page 127 STAT. 461]]
estimated to be collected under this section for fiscal
year 2017 (including any increased fee collections
attributable to subparagraph (B)), exceeds the
cumulative amount appropriated pursuant to paragraph (3)
for the fiscal years 2014 through 2017, the excess
amount shall be credited to the appropriation account of
the Food and Drug Administration as provided in
paragraph (1), and shall be subtracted from the amount
of fees that would otherwise be authorized to be
collected under this section pursuant to appropriation
Acts for fiscal year 2018.
``(B) Recovery of collection shortfalls.--
``(i) Fiscal year 2016.--For fiscal year 2016,
the amount of fees otherwise authorized to be
collected under this section shall be increased by
the amount, if any, by which the amount collected
under this section and appropriated for fiscal
year 2014 falls below the amount of fees
authorized for fiscal year 2014 under paragraph
(3).
``(ii) Fiscal year 2017.--For fiscal year
2017, the amount of fees otherwise authorized to
be collected under this section shall be increased
by the amount, if any, by which the amount
collected under this section and appropriated for
fiscal year 2015 falls below the amount of fees
authorized for fiscal year 2015 under paragraph
(3).
``(iii) Fiscal year 2018.--For fiscal year
2018, the amount of fees otherwise authorized to
be collected under this section (including any
reduction in the authorized amount under
subparagraph (A)), shall be increased by the
cumulative amount, if any, by which the amount
collected under this section and appropriated for
fiscal years 2016 and 2017 (including estimated
collections for fiscal year 2017) falls below the
cumulative amount of fees authorized under
paragraph (3) for fiscal years 2016 and 2017.
``(h) <<NOTE: Deadline.>> Collection of Unpaid Fees.--In any case
where the Secretary does not receive payment of a fee assessed under
subsection (a) within 30 days after it is due, such fee shall be treated
as a claim of the United States Government subject to subchapter II of
chapter 37 of title 31, United States Code.
``(i) <<NOTE: Deadline.>> Written Requests for Waivers, Reductions,
and Refunds.--To qualify for consideration for a waiver or reduction
under subsection (d), or for a refund of any fee collected in accordance
with subsection (a), a person shall submit to the Secretary a written
request for such waiver, reduction, or refund not later than 180 days
after such fee is due.
``(j) Construction.--This section may not be construed to require
that the number of full-time equivalent positions in the Department of
Health and Human Services, for officers, employees, and advisory
committees not engaged in the process of the review of animal drug
applications, be reduced to offset the number of officers, employees,
and advisory committees so engaged.
``(k) Abbreviated New Animal Drug Applications.--The Secretary
shall--
``(1) to the extent practicable, segregate the review of
abbreviated new animal drug applications from the process for
the review of animal drug applications; and
[[Page 127 STAT. 462]]
``(2) adopt other administrative procedures to ensure that
review times of abbreviated new animal drug applications do not
increase from their current level due to activities under the
user fee program.''.
SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-13) is amended to read as follows:
``SEC. 740A. <<NOTE: Effective dates.>> REAUTHORIZATION;
REPORTING REQUIREMENTS.
``(a) Performance Report.--Beginning with fiscal year 2014, not
later than 120 days after the end of each fiscal year during which fees
are collected under this part, the Secretary shall prepare and submit to
the Committee on Health, Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the House of Representatives
a report concerning the progress of the Food and Drug Administration in
achieving the goals identified in the letters described in section
101(b) of the Animal Drug User Fee Amendments of 2013 toward expediting
the animal drug development process and the review of the new and
supplemental animal drug applications and investigational animal drug
submissions during such fiscal year, the future plans of the Food and
Drug Administration for meeting the goals, the review times for
abbreviated new animal drug applications, and the administrative
procedures adopted by the Food and Drug Administration to ensure that
review times for abbreviated new animal drug applications are not
increased from their current level due to activities under the user fee
program.
``(b) Fiscal Report.--Beginning with fiscal year 2014, not later
than 120 days after the end of each fiscal year during which fees are
collected under this part, the Secretary shall prepare and submit to the
Committee on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of Representatives a
report on the implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration, of the
fees collected during such fiscal year for which the report is made.
``(c) <<NOTE: Web posting.>> Public Availability.--The Secretary
shall make the reports required under subsections (a) and (b) available
to the public on the Internet Web site of the Food and Drug
Administration.
``(d) Reauthorization.--
``(1) <<NOTE: Recommenda- tions.>> Consultation.--In
developing recommendations to present to the Congress with
respect to the goals, and plans for meeting the goals, for the
process for the review of animal drug applications for the first
5 fiscal years after fiscal year 2018, and for the
reauthorization of this part for such fiscal years, the
Secretary shall consult with--
``(A) the Committee on Health, Education, Labor, and
Pensions of the Senate;
``(B) the Committee on Energy and Commerce of the
House of Representatives;
``(C) scientific and academic experts;
``(D) veterinary professionals;
``(E) representatives of patient and consumer
advocacy groups; and
``(F) the regulated industry.
[[Page 127 STAT. 463]]
``(2) Prior public input.--Prior to beginning negotiations
with the regulated industry on the reauthorization of this part,
the Secretary shall--
``(A) <<NOTE: Notice. Federal Register,
publication.>> publish a notice in the Federal Register
requesting public input on the reauthorization;
``(B) hold a public meeting at which the public may
present its views on the reauthorization, including
specific suggestions for changes to the goals referred
to in subsection (a);
``(C) <<NOTE: Time period.>> provide a period of 30
days after the public meeting to obtain written comments
from the public suggesting changes to this part; and
``(D) <<NOTE: Web posting.>> publish the comments
on the Food and Drug Administration's Internet Web site.
``(3) Periodic consultation.--Not less frequently than once
every 4 months during negotiations with the regulated industry,
the Secretary shall hold discussions with representatives of
veterinary, patient, and consumer advocacy groups to continue
discussions of their views on the reauthorization and their
suggestions for changes to this part as expressed under
paragraph (2).
``(4) Public review of recommendations.--After negotiations
with the regulated industry, the Secretary shall--
``(A) present the recommendations developed under
paragraph (1) to the Congressional committees specified
in such paragraph;
``(B) <<NOTE: Federal Register, publication.>>
publish such recommendations in the Federal Register;
``(C) <<NOTE: Time period.>> provide for a period
of 30 days for the public to provide written comments on
such recommendations;
``(D) hold a meeting at which the public may present
its views on such recommendations; and
``(E) after consideration of such public views and
comments, revise such recommendations as necessary.
``(5) Transmittal of recommendations.--Not later than
January 15, 2018, the Secretary shall transmit to Congress the
revised recommendations under paragraph (4) a summary of the
views and comments received under such paragraph, and any
changes made to the recommendations in response to such views
and comments.
``(6) Minutes of negotiation meetings.--
``(A) <<NOTE: Web posting.>> Public availability.--
Before presenting the recommendations developed under
paragraphs (1) through (5) to Congress, the Secretary
shall make publicly available, on the Internet Web site
of the Food and Drug Administration, minutes of all
negotiation meetings conducted under this subsection
between the Food and Drug Administration and the
regulated industry.
``(B) Content.--The minutes described under
subparagraph (A) shall summarize any substantive
proposal made by any party to the negotiations as well
as significant controversies or differences of opinion
during the negotiations and their resolution.''.
SEC. 105. <<NOTE: Extension. Time period. 21 USC 379j-11 note.>>
SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 4 of
subchapter C of chapter VII of the Federal Food, Drug, and
[[Page 127 STAT. 464]]
Cosmetic Act (21 U.S.C. 379j-11 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 animal drug applications and supplemental animal drug
applications (as defined in such part as of such day) that on or after
October 1, 2008, but before October 1, 2013, 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 2014.
SEC. 106. <<NOTE: 21 USC 379j-11 note.>> EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2013, or the date of enactment of this Act, whichever is later, except
that fees under part 4 of subchapter C of chapter VII of the Federal
Food, Drug, and Cosmetic Act, as amended by this title, shall be
assessed for all animal drug applications and supplemental animal drug
applications received on or after October 1, 2013, regardless of the
date of the enactment of this Act.
SEC. 107. SUNSET DATES.
(a) <<NOTE: 21 USC 379j-12 note.>> Authorization.--Section 740 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-12) shall cease
to be effective October 1, 2018.
(b) <<NOTE: 21 USC 379j-13 note.>> Reporting Requirements.--Section
740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-13)
shall cease to be effective January 31, 2019.
(c) Previous Sunset Provision.--
(1) <<NOTE: Repeal.>> In general.--Section 108 of the
Animal Drug User Fee Amendments of 2008 (Public Law 110-
316) <<NOTE: 21 USC 379j-11 note.>> is repealed.
(2) Conforming amendment.--The Animal Drug User Fee
Amendments of 2008 (Public Law 110-316) is amended in the table
of contents in section 1, by striking the item relating to
section 108.
(d) <<NOTE: Repeal.>> Technical Clarification.--Effective November
18, 2003, section 5 of the Animal Drug User Fee Act of 2003 (Public Law
108-130) <<NOTE: 21 USC 379j-11 note.>> is repealed.
TITLE <<NOTE: Animal Generic Drug User Fee Amendments of 2013.>> II--
FEES RELATING TO GENERIC ANIMAL DRUGS
SEC. 201. SHORT TITLE; FINDING.
(a) <<NOTE: 21 USC 301 note.>> Short Title.--This title may be
cited as the ``Animal Generic Drug User Fee Amendments of 2013''.
(b) <<NOTE: 21 USC 379j-21 note.>> Finding.--The fees authorized by
this title will be dedicated toward expediting the generic new animal
drug development process and the review of abbreviated applications for
generic new animal drugs, supplemental abbreviated applications for
generic new animal drugs, and investigational submissions for generic
new animal drugs as set forth in the goals identified in the letters
from the Secretary of Health and Human Services to the Chairman of the
Committee on Energy and Commerce of the House of Representatives and the
Chairman of the Committee on Health, Education, Labor, and Pensions of
the Senate as set forth in the Congressional Record.
[[Page 127 STAT. 465]]
SEC. 202. AUTHORITY TO ASSESS AND USE GENERIC NEW ANIMAL DRUG
FEES.
Section 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-21) is amended to read as follows:
``SEC. 741. AUTHORITY TO ASSESS AND USE GENERIC NEW ANIMAL DRUG
FEES.
``(a) <<NOTE: Effective date.>> Types of Fees.--Beginning with
respect to fiscal year 2009, the Secretary shall assess and collect fees
in accordance with this section as follows:
``(1) Abbreviated application fee.--
``(A) In general.--Each person that submits, on or
after July 1, 2008, an abbreviated application for a
generic new animal drug shall be subject to a fee as
established in subsection (c) for such an application.
``(B) Payment.--The fee required by subparagraph (A)
shall be due upon submission of the abbreviated
application.
``(C) Exceptions.--
``(i) Previously filed application.--If an
abbreviated application was submitted by a person
that paid the fee for such application, was
accepted for filing, and was not approved or was
withdrawn (without a waiver or refund), the
submission of an abbreviated application for the
same product by the same person (or the person's
licensee, assignee, or successor) shall not be
subject to a fee under subparagraph (A).
``(ii) Certain abbreviated applications
involving combination animal drugs.--An
abbreviated application which is subject to the
criteria in section 512(d)(4) and submitted on or
after October 1, 2013 shall be subject to a fee
equal to 50 percent of the amount of the
abbreviated application fee established in
subsection (c).
``(D) Refund of fee if application refused for
filing.--The Secretary shall refund 75 percent of the
fee paid under subparagraph (B) for any abbreviated
application which is refused for filing.
``(E) Refund of fee if application withdrawn.--If an
abbreviated application is withdrawn after the
application was filed, the Secretary may refund the fee
or portion of the fee paid under subparagraph (B) if no
substantial work was performed on the application after
the application was filed. The Secretary shall have the
sole discretion to refund the fee under this
subparagraph. A determination by the Secretary
concerning a refund under this subparagraph shall not be
reviewable.
``(2) Generic new animal drug product fee.--
``(A) In general.--Each person--
``(i) who is named as the applicant in an
abbreviated application or supplemental
abbreviated application for a generic new animal
drug product which has been submitted for listing
under section 510; and
``(ii) who, after September 1, 2008, had
pending before the Secretary an abbreviated
application or supplemental abbreviated
application,
[[Page 127 STAT. 466]]
shall pay for each such generic new animal drug product
the annual fee established in subsection (c).
``(B) Payment; fee due date.--Such fee shall be
payable for the fiscal year in which the generic new
animal drug product is first submitted for listing under
section 510, or is submitted for relisting under section
510 if the generic new animal drug product has been
withdrawn from listing and relisted. After such fee is
paid for that fiscal year, such fee shall be due each
subsequent fiscal year that the product remains listed,
upon the later of--
``(i) 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; or
``(ii) January 31 of each year.
``(C) Limitation.--Such fee shall be paid only once
for each generic new animal drug product for a fiscal
year in which the fee is payable.
``(3) Generic new animal drug sponsor fee.--
``(A) In general.--Each person--
``(i) who meets the definition of a generic
new animal drug sponsor within a fiscal year; and
``(ii) who, after September 1, 2008, had
pending before the Secretary an abbreviated
application, a supplemental abbreviated
application, or an investigational submission,
shall be assessed an annual generic new animal drug
sponsor fee as established under subsection (c).
``(B) Payment; fee due date.--Such fee shall be due
each fiscal year upon the later of--
``(i) 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; or
``(ii) January 31 of each year.
``(C) Amount of fee.--Each generic new animal drug
sponsor shall pay only 1 such fee each fiscal year, as
follows:
``(i) 100 percent of the amount of the generic
new animal drug sponsor fee published for that
fiscal year under subsection (c) for an applicant
with more than 6 approved abbreviated
applications.
``(ii) 75 percent of the amount of the generic
new animal drug sponsor fee published for that
fiscal year under subsection (c) for an applicant
with more than 1 and fewer than 7 approved
abbreviated applications.
``(iii) 50 percent of the amount of the
generic new animal drug sponsor fee published for
that fiscal year under subsection (c) for an
applicant with 1 or fewer approved abbreviated
applications.
``(b) Fee Amounts.--Subject to subsections (c), (d), (f), and (g),
the fees required under subsection (a) shall be established to generate
fee revenue amounts as follows:
``(1) Total fee revenues for application fees.--The total
fee revenues to be collected in abbreviated application fees
under subsection (a)(1) shall be $1,832,000 for fiscal year
2014, $1,736,000 for fiscal year 2015, $1,857,000 for fiscal
year 2016,
[[Page 127 STAT. 467]]
$1,984,000 for fiscal year 2017, and $2,117,000 for fiscal year
2018.
``(2) Total fee revenues for product fees.--The total fee
revenues to be collected in generic new animal drug product fees
under subsection (a)(2) shall be $2,748,000 for fiscal year
2014, $2,604,000 for fiscal year 2015, $2,786,000 for fiscal
year 2016, $2,976,000 for fiscal year 2017, and $3,175,000 for
fiscal year 2018.
``(3) Total fee revenues for sponsor fees.--The total fee
revenues to be collected in generic new animal drug sponsor fees
under subsection (a)(3) shall be $2,748,000 for fiscal year
2014, $2,604,000 for fiscal year 2015, $2,786,000 for fiscal
year 2016, $2,976,000 for fiscal year 2017, and $3,175,000 for
fiscal year 2018.
``(c) Annual Fee Setting; Adjustments.--
``(1) Annual fee setting.--The Secretary shall establish, 60
days before the start of each fiscal year beginning after
September 30, 2008, for that fiscal year, abbreviated
application fees, generic new animal drug sponsor fees, and
generic new animal drug product fees, based on the revenue
amounts established under subsection (b) and the adjustments
provided under this subsection.
``(2) Workload adjustment.--The fee revenues shall be
adjusted each fiscal year after fiscal year 2014 to reflect
changes in review workload. With respect to such adjustment:
``(A) <<NOTE: Determination.>> This adjustment
shall be determined by the Secretary based on a weighted
average of the change in the total number of abbreviated
applications for generic new animal drugs, manufacturing
supplemental abbreviated applications for generic new
animal drugs, investigational generic new animal drug
study submissions, and investigational generic new
animal drug protocol submissions submitted to the
Secretary. <<NOTE: Federal Register, publication.>> The
Secretary shall publish in the Federal Register the fees
resulting from this adjustment and the supporting
methodologies.
``(B) Under no circumstances shall this workload
adjustment result in fee revenues for a fiscal year that
are less than the fee revenues for that fiscal year
established in subsection (b).
``(3) Final year adjustment.--For fiscal year 2018, the
Secretary may, in addition to other adjustments under this
subsection, further increase the fees under this section, if
such an adjustment is necessary, to provide for up to 3 months
of operating reserves of carryover user fees for the process for
the review of abbreviated applications for generic new animal
drugs for the first 3 months of fiscal year 2019. If the Food
and Drug Administration has carryover balances for the process
for the review of abbreviated applications for generic new
animal drugs in excess of 3 months of such operating reserves,
then this adjustment shall not be made. <<NOTE: Notice.>> If
this adjustment is necessary, then the rationale for the amount
of the increase shall be contained in the annual notice setting
fees for fiscal year 2018.
``(4) 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
[[Page 127 STAT. 468]]
the process for the review of abbreviated applications for
generic new animal drugs.
``(d) Fee Waiver or Reduction.--The Secretary shall grant a waiver
from or a reduction of 1 or more fees assessed under subsection (a)
where the Secretary finds that the generic new animal drug is intended
solely to provide for a minor use or minor species indication.
``(e) Effect of Failure To Pay Fees.--An abbreviated application for
a generic new animal drug submitted by a person subject to fees under
subsection (a) shall be considered incomplete and shall not be accepted
for filing by the Secretary until all fees owed by such person have been
paid. An investigational submission for a generic new animal drug that
is submitted by a person subject to fees under subsection (a) shall be
considered incomplete and shall not be accepted for review by the
Secretary until all fees owed by such person have been
paid. <<NOTE: Deadline.>> The Secretary may discontinue review of any
abbreviated application for a generic new animal drug, supplemental
abbreviated application for a generic new animal drug, or
investigational submission for a generic new animal drug from a person
if such person has not submitted for payment all fees owed under this
section by 30 days after the date upon which they are due.
``(f) Assessment of Fees.--
``(1) Limitation.--Fees may not be assessed under subsection
(a) for a fiscal year beginning after fiscal year 2008 unless
appropriations for salaries and expenses of the Food and Drug
Administration for such fiscal year (excluding the amount of
fees appropriated for such fiscal year) are equal to or greater
than the amount of appropriations for the salaries and expenses
of the Food and Drug Administration for the fiscal year 2003
(excluding the amount of fees appropriated for such fiscal year)
multiplied by the adjustment factor applicable to the fiscal
year involved.
``(2) Authority.--If the Secretary does not assess fees
under subsection (a) during any portion of a fiscal year because
of paragraph (1) and if at a later date in such fiscal year the
Secretary may assess such fees, the Secretary may assess and
collect such fees, without any modification in the rate, for
abbreviated applications, generic new animal drug sponsors, and
generic new animal drug products at any time in such fiscal year
notwithstanding the provisions of subsection (a) relating to the
date fees are to be paid.
``(g) Crediting and Availability of Fees.--
``(1) In general.--Subject to paragraph (2)(C), fees
authorized under subsection (a) shall be collected and available
for obligation only to the extent and in the amount provided in
advance in appropriations Acts. <<NOTE: Appropriation
authorization.>> Such fees are authorized to be appropriated to
remain available until expended. Such sums as may be necessary
may be transferred from the Food and Drug Administration
salaries and expenses appropriation account without fiscal year
limitation to such appropriation account for salary and expenses
with such fiscal year limitation. The sums transferred shall be
available solely for the process for the review of abbreviated
applications for generic new animal drugs.
``(2) Collections and appropriation acts.--
[[Page 127 STAT. 469]]
``(A) In general.--The fees authorized by this
section--
``(i) subject to subparagraph (C), shall be
collected and available in each fiscal year in an
amount not to exceed the amount specified in
appropriation Acts, or otherwise made available
for obligation for such fiscal year; and
``(ii) shall be available to defray increases
in the costs of the resources allocated for the
process for the review of abbreviated applications
for generic new animal drugs (including increases
in such costs for an additional number of full-
time equivalent positions in the Department of
Health and Human Services to be engaged in such
process) over such costs, excluding costs paid
from fees collected under this section, for fiscal
year 2008 multiplied by the adjustment factor.
``(B) Compliance.--The Secretary shall be considered
to have met the requirements of subparagraph (A)(ii) in
any fiscal year if the costs funded by appropriations
and allocated for the process for the review of
abbreviated applications for generic new animal drugs--
``(i) are not more than 3 percent below the
level specified in subparagraph (A)(ii); or
``(ii)(I) are more than 3 percent below the
level specified in subparagraph (A)(ii), and fees
assessed for the fiscal year following the
subsequent fiscal year are decreased by the amount
in excess of 3 percent by which such costs fell
below the level specified in subparagraph (A)(ii);
and
``(II) such costs are not more than 5 percent
below the level specified in subparagraph (A)(ii).
``(C) Provision for early payments.--Payment of fees
authorized under this section for a fiscal year, prior
to the due date for such fees, may be accepted by the
Secretary in accordance with authority provided in
advance in a prior year appropriations Act.
``(3) Authorization of appropriations.--There are authorized
to be appropriated for fees under this section--
``(A) $7,328,000 for fiscal year 2014;
``(B) $6,944,000 for fiscal year 2015;
``(C) $7,429,000 for fiscal year 2016;
``(D) $7,936,000 for fiscal year 2017; and
``(E) $8,467,000 for fiscal year 2018;
as adjusted to reflect adjustments in the total fee revenues
made under this section and changes in the total amounts
collected by abbreviated application fees, generic new animal
drug sponsor fees, and generic new animal drug product fees.
``(4) Offset.--If the sum of the cumulative amount of fees
collected under this section for the fiscal years 2014 through
2016 and the amount of fees estimated to be collected under this
section for fiscal year 2017 exceeds the cumulative amount
appropriated under paragraph (3) for the fiscal years 2014
through 2017, the excess amount shall be credited to the
appropriation account of the Food and Drug Administration as
provided in paragraph (1), and shall be subtracted from the
amount of fees that would otherwise be authorized to be
collected under this section pursuant to appropriation Acts for
fiscal year 2018.
[[Page 127 STAT. 470]]
``(h) <<NOTE: Deadline.>> Collection of Unpaid Fees.--In any case
where the Secretary does not receive payment of a fee assessed under
subsection (a) within 30 days after it is due, such fee shall be treated
as a claim of the United States Government subject to subchapter II of
chapter 37 of title 31, United States Code.
``(i) <<NOTE: Deadline.>> Written Requests for Waivers, Reductions,
and Refunds.--To qualify for consideration for a waiver or reduction
under subsection (d), or for a refund of any fee collected in accordance
with subsection (a), a person shall submit to the Secretary a written
request for such waiver, reduction, or refund not later than 180 days
after such fee is due.
``(j) Construction.--This section may not be construed to require
that the number of full-time equivalent positions in the Department of
Health and Human Services, for officers, employees, and advisory
committees not engaged in the process of the review of abbreviated
applications for generic new animal drugs, be reduced to offset the
number of officers, employees, and advisory committees so engaged.
``(k) Definitions.--In this section and section 742:
``(1) Abbreviated application for a generic new animal
drug.--The terms `abbreviated application for a generic new
animal drug' and `abbreviated application' mean an abbreviated
application for the approval of any generic new animal drug
submitted under section 512(b)(2). Such term does not include a
supplemental abbreviated application for a generic new animal
drug.
``(2) Adjustment factor.--The term `adjustment factor'
applicable to a fiscal year is the Consumer Price Index for all
urban consumers (all items; United States city average) for
October of the preceding fiscal year divided by--
``(A) for purposes of subsection (f)(1), such Index
for October 2002; and
``(B) for purposes of subsection (g)(2)(A)(ii), such
Index for October 2007.
``(3) Costs of resources allocated for the process for the
review of abbreviated applications for generic new animal
drugs.--The term `costs of resources allocated for the process
for the review of abbreviated applications for generic new
animal drugs' means the expenses in connection with the process
for the review of abbreviated applications for generic new
animal drugs for--
``(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees consulted with
respect to the review of specific abbreviated
applications, supplemental abbreviated applications, or
investigational submissions, and costs related to such
officers, employees, committees, and contractors,
including costs for travel, education, and recruitment
and other personnel activities;
``(B) management of information, and the
acquisition, maintenance, and repair of computer
resources;
``(C) leasing, maintenance, renovation, and repair
of facilities and acquisition, maintenance, and repair
of fixtures, furniture, scientific equipment, and other
necessary materials and supplies; and
``(D) collecting fees under this section and
accounting for resources allocated for the review of
abbreviated
[[Page 127 STAT. 471]]
applications, supplemental abbreviated applications, and
investigational submissions.
``(4) Final dosage form.--The term `final dosage form'
means, with respect to a generic new animal drug product, a
finished dosage form which is approved for administration to an
animal without substantial further manufacturing. Such term
includes generic new animal drug products intended for mixing in
animal feeds.
``(5) Generic new animal drug.--The term `generic new animal
drug' means a new animal drug that is the subject of an
abbreviated application.
``(6) Generic new animal drug product.--The term `generic
new animal drug product' means each specific strength or potency
of a particular active ingredient or ingredients in final dosage
form marketed by a particular manufacturer or distributor, which
is uniquely identified by the labeler code and product code
portions of the national drug code, and for which an abbreviated
application for a generic new animal drug or a supplemental
abbreviated application has been approved.
``(7) Generic new animal drug sponsor.--The term `generic
new animal drug sponsor' means either an applicant named in an
abbreviated application for a generic new animal drug that has
not been withdrawn by the applicant and for which approval has
not been withdrawn by the Secretary, or a person who has
submitted an investigational submission for a generic new animal
drug that has not been terminated or otherwise rendered inactive
by the Secretary.
``(8) Investigational submission for a generic new animal
drug.--The terms `investigational submission for a generic new
animal drug' and `investigational submission' mean--
``(A) the filing of a claim for an investigational
exemption under section 512(j) for a generic new animal
drug intended to be the subject of an abbreviated
application or a supplemental abbreviated application;
or
``(B) the submission of information for the purpose
of enabling the Secretary to evaluate the safety or
effectiveness of a generic new animal drug in the event
of the filing of an abbreviated application or
supplemental abbreviated application for such drug.
``(9) Person.--The term `person' includes an affiliate
thereof (as such term is defined in section 735(11)).
``(10) Process for the review of abbreviated applications
for generic new animal drugs.--The term `process for the review
of abbreviated applications for generic new animal drugs' means
the following activities of the Secretary with respect to the
review of abbreviated applications, supplemental abbreviated
applications, and investigational submissions:
``(A) The activities necessary for the review of
abbreviated applications, supplemental abbreviated
applications, and investigational submissions.
``(B) The issuance of action letters which approve
abbreviated applications or supplemental abbreviated
applications or which set forth in detail the specific
deficiencies in abbreviated applications, supplemental
abbreviated
[[Page 127 STAT. 472]]
applications, or investigational submissions and, where
appropriate, the actions necessary to place such
applications, supplemental applications, or submissions
in condition for approval.
``(C) The inspection of generic new animal drug
establishments and other facilities undertaken as part
of the Secretary's review of pending abbreviated
applications, supplemental abbreviated applications, and
investigational submissions.
``(D) Monitoring of research conducted in connection
with the review of abbreviated applications,
supplemental abbreviated applications, and
investigational submissions.
``(E) The development of regulations and policy
related to the review of abbreviated applications,
supplemental abbreviated applications, and
investigational submissions.
``(F) Development of standards for products subject
to review.
``(G) Meetings between the agency and the generic
new animal drug sponsor.
``(H) Review of advertising and labeling prior to
approval of an abbreviated application or supplemental
abbreviated application, but not after such application
has been approved.
``(11) Supplemental abbreviated application for generic new
animal drug.--The terms `supplemental abbreviated application
for a generic new animal drug' and `supplemental abbreviated
application' mean a request to the Secretary to approve a change
in an approved abbreviated application.''.
SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-22) is amended to read as follows:
``SEC. 742. <<NOTE: Effective dates.>> REAUTHORIZATION; REPORTING
REQUIREMENTS.
``(a) Performance Reports.--Beginning with fiscal year 2014, not
later than 120 days after the end of each fiscal year during which fees
are collected under this part, the Secretary shall prepare and submit to
the Committee on Health, Education, Labor, and Pensions of the Senate,
and the Committee on Energy and Commerce of the House of Representatives
a report concerning the progress of the Food and Drug Administration in
achieving the goals identified in the letters described in section
201(b) of the Animal Generic Drug User Fee Amendments of 2013 toward
expediting the generic new animal drug development process and the
review of abbreviated applications for generic new animal drugs,
supplemental abbreviated applications for generic new animal drugs, and
investigational submissions for generic new animal drugs during such
fiscal year.
``(b) Fiscal Report.--Beginning with fiscal year 2014, not later
than 120 days after the end of each fiscal year during which fees are
collected under this part, the Secretary shall prepare and submit to
Committee on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of Representatives a
report on the implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration, of the
fees collected during such fiscal year for which the report is made.
[[Page 127 STAT. 473]]
``(c) <<NOTE: Web posting.>> Public Availability.--The Secretary
shall make the reports required under subsections (a) and (b) available
to the public on the Internet Web site of the Food and Drug
Administration.
``(d) Reauthorization.--
``(1) <<NOTE: Recommenda- tions.>> Consultation.--In
developing recommendations to present to Congress with respect
to the goals, and plans for meeting the goals, for the process
for the review of abbreviated applications for generic new
animal drugs for the first 5 fiscal years after fiscal year
2018, and for the reauthorization of this part for such fiscal
years, the Secretary shall consult with--
``(A) the Committee on Energy and Commerce of the
House of Representatives;
``(B) the Committee on Health, Education, Labor, and
Pensions of the Senate;
``(C) scientific and academic experts;
``(D) veterinary professionals;
``(E) representatives of patient and consumer
advocacy groups; and
``(F) the regulated industry.
``(2) Prior public input.--Prior to beginning negotiations
with the regulated industry on the reauthorization of this part,
the Secretary shall--
``(A) <<NOTE: Notice. Federal Register,
publication.>> publish a notice in the Federal Register
requesting public input on the reauthorization;
``(B) hold a public meeting at which the public may
present its views on the reauthorization, including
specific suggestions for changes to the goals referred
to in subsection (a);
``(C) <<NOTE: Time period.>> provide a period of 30
days after the public meeting to obtain written comments
from the public suggesting changes to this part; and
``(D) <<NOTE: Web posting.>> publish the comments
on the Food and Drug Administration's Internet Web site.
``(3) Periodic consultation.--Not less frequently than once
every 4 months during negotiations with the regulated industry,
the Secretary shall hold discussions with representatives of
veterinary, patient, and consumer advocacy groups to continue
discussions of their views on the reauthorization and their
suggestions for changes to this part as expressed under
paragraph (2).
``(4) Public review of recommendations.--After negotiations
with the regulated industry, the Secretary shall--
``(A) present the recommendations developed under
paragraph (1) to the congressional committees specified
in such paragraph;
``(B) <<NOTE: Federal Register, publication.>>
publish such recommendations in the Federal Register;
``(C) <<NOTE: Time period.>> provide for a period
of 30 days for the public to provide written comments on
such recommendations;
``(D) hold a meeting at which the public may present
its views on such recommendations; and
``(E) after consideration of such public views and
comments, revise such recommendations as necessary.
``(5) Transmittal of recommendations.--Not later than
January 15, 2018, the Secretary shall transmit to Congress
[[Page 127 STAT. 474]]
the revised recommendations under paragraph (4), a summary of
the views and comments received under such paragraph, and any
changes made to the recommendations in response to such views
and comments.
``(6) Minutes of negotiation meetings.--
``(A) <<NOTE: Web posting.>> Public availability.--
Before presenting the recommendations developed under
paragraphs (1) through (5) to Congress, the Secretary
shall make publicly available, on the Internet Web site
of the Food and Drug Administration, minutes of all
negotiation meetings conducted under this subsection
between the Food and Drug Administration and the
regulated industry.
``(B) Content.--The minutes described under
subparagraph (A) shall summarize any substantive
proposal made by any party to the negotiations as well
as significant controversies or differences of opinion
during the negotiations and their resolution.''.
SEC. 204. <<NOTE: Extension. Time period. 21 USC 379j-21 note.>>
SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 5 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act,
as in effect on the day before the date of enactment of this title,
shall continue to be in effect with respect to abbreviated applications
for a generic new animal drug and supplemental abbreviated applications
for a generic new animal drug (as defined in such part as of such day)
that on or after October 1, 2008, but before October 1, 2013, 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 2014.
SEC. 205. <<NOTE: 21 USC 379j-21 note.>> EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2013, or the date of enactment of this Act, whichever is later, except
that fees under part 5 of subchapter C of chapter VII of the Federal
Food, Drug, and Cosmetic Act, as amended by this title, shall be
assessed for all abbreviated applications for a generic new animal drug
and supplemental abbreviated applications for a generic new animal drug
received on or after October 1, 2013, regardless of the date of
enactment of this Act.
SEC. 206. SUNSET DATES.
(a) <<NOTE: 21 USC 379j-21 note.>> Authorization.--Section 741 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21) shall cease
to be effective October 1, 2018.
(b) <<NOTE: 21 USC 379j-22 note.>> Reporting Requirements.--Section
742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-22)
shall cease to be effective January 31, 2019.
(c) Previous Sunset Provision.--
(1) <<NOTE: Repeal.>> In general.--Section 204 of the
Animal Generic Drug User Fee Act of 2008 (Public Law 110-
316) <<NOTE: 21 USC 379j-21 note, 379j-22 note.>> is repealed.
(2) Conforming amendment.--The Animal Generic Drug User Fee
Act of 2008 (Public Law 110-316) is amended in
[[Page 127 STAT. 475]]
the table of contents in section 1, by striking the item
relating to section 204.
Approved June 13, 2013.
LEGISLATIVE HISTORY--S. 622:
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CONGRESSIONAL RECORD, Vol. 159 (2013):
May 8, considered and passed Senate.
June 3, considered and passed House.
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