[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1418 Introduced in House (IH)]
<DOC>
118th CONGRESS
1st Session
H. R. 1418
To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user
fee programs relating to new animal drugs and generic new animal drugs.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 7, 2023
Mr. Pence (for himself and Ms. Schrier) introduced the following bill;
which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user
fee programs relating to new animal drugs and generic new animal drugs.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Animal Drug User Fee Amendments of
2023''.
SEC. 2. TABLE OF CONTENTS.
The table of contents for this Act is the following:
Sec. 1. Short title.
Sec. 2. Table of contents.
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.
TITLE I--FEES RELATING TO ANIMAL DRUGS
SEC. 101. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Animal Drug User
Fee Amendments of 2023''.
(b) 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 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(8)(I) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-11(8)(I)) is amended to read as follows:
``(I) The activities necessary for implementation
of the United States and European Union Mutual
Recognition Agreement for Pharmaceutical Good
Manufacturing Practice Inspections, and the United
States and United Kingdom Recognition Agreement
Sectoral Annex for Pharmaceutical Good Manufacturing
Practices, and future mutual recognition agreements,
with respect to animal drug products subject to review,
including implementation activities prior to and
following product approval.''.
SEC. 103. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.
(a) Types of Fees.--Section 740(a)(1)(A)(ii) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-12(a)(1)(A)(ii)) is amended--
(1) in subclause (I), by striking ``and'' at the end;
(2) in subclause (II), by striking the period at the end
and inserting ``; and''; and
(3) by adding at the end the following:
``(III) an application for
conditional approval under section 571
of a new animal drug for which an
animal drug application submitted under
section 512(b)(1) has been previously
approved under section 512(d)(1) for
another intended use.''.
(b) Fee Revenue Amounts.--Section 740(b)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-12(b)(1)) is amended to read as
follows:
``(1) In general.--Subject to subsections (c), (d), (f),
and (g), for each of fiscal years 2024 through 2028, the fees
required under subsection (a) shall be established to generate
a total revenue amount of $33,500,000.''.
(c) Annual Fee Setting; Adjustments.--
(1) Annual fee setting.--Section 740(c)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-12(c)(1)) is
amended to read as follows:
``(1) Annual fee setting.--Not later than 60 days before
the start of each fiscal year beginning after September 30,
2023, the Secretary shall--
``(A) establish 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; and
``(B) publish such fee revenue amounts and fees in
the Federal Register.''.
(2) Inflation adjustment.--Section 740(c)(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-12(c)(2)) is
amended--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i), by
striking ``2020'' and inserting ``2025''; and
(ii) in clause (iii), by striking
``Baltimore'' and inserting ``Arlington-
Alexandria''; and
(B) in subparagraph (B), by striking ``2020'' and
inserting ``2025''.
(3) Workload adjustments.--Paragraph (3) of section 740(c)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
12(c)) is amended--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i)--
(I) by striking ``2020'' and
inserting ``2025''; and
(II) by striking ``subparagraphs
(B) and (C)'' and inserting
``subparagraph (B)'';
(ii) in clause (i) by striking ``and'' at
the end; and
(iii) by striking clause (ii) and inserting
the following:
``(ii) such adjustment shall be made for
each fiscal year that the adjustment determined
by the Secretary is greater than 3 percent,
except for the first fiscal year that the
adjustment is greater than 3 percent; and
``(iii) the Secretary shall publish in the
Federal Register notice under paragraph (1) the
amount of such adjustment and the supporting
methodologies.'';
(B) by striking subparagraph (B); and
(C) by redesignating subparagraph (C) as
subparagraph (B).
(4) Final year adjustment.--Section 740(c)(4) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-12(c)(4))
is amended to read as follows:
``(4) Operating reserve adjustment.--
``(A) In general.--For fiscal year 2025 and each
subsequent fiscal year, after the fee revenue amount
established under subsection (b) is adjusted in
accordance with paragraphs (2) and (3), the Secretary
shall--
``(i) increase the fee revenue amount for
such fiscal year, if necessary to provide an
operating reserve of not less than 12 weeks; or
``(ii) if the Secretary has an operating
reserve in excess of the number of weeks
specified in subparagraph (C) for that fiscal
year, the Secretary shall decrease the fee
revenue amount to provide not more than the
number of weeks specified in subparagraph (C)
for that fiscal year.
``(B) Carryover user fees.--For purposes of this
paragraph, the operating reserve of carryover user fees
for the process for the review of animal drug
applications does not include carryover user fees that
have not been appropriated.
``(C) Number of weeks of operating reserves.--The
number of weeks of operating reserves specified in this
subparagraph is--
``(i) 22 weeks for fiscal year 2025;
``(ii) 20 weeks for fiscal year 2026;
``(iii) 18 weeks for fiscal year 2027; and
``(iv) 16 weeks for fiscal year 2028.
``(D) Publication.--If an adjustment to the
operating reserve is made under this paragraph, the
Secretary shall publish in the Federal Register notice
under paragraph (1) the rationale for the amount of the
adjustment and the supporting methodologies.''.
(d) Exemption From Fees.--Section 740(d)(4) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-12(d)(4)) is amended to read as
follows:
``(4) Exemption from fees for certain animal drug
applications.--Fees under paragraphs (2), (3), and (4) of
subsection (a) shall not apply with respect to any person who
is the named applicant or sponsor of an animal drug
application, supplemental animal drug application, or
investigational animal drug submission if such application or
submission involves the intentional genomic alteration of an
animal that is intended to produce a drug, device, or
biological product subject to fees under section 736, 738,
744B, or 744H.''.
(e) Crediting and Availability of Fees.--
(1) Authorization of appropriations.--Section 740(g)(3) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
12(g)(3)) is amended by striking ``2019 through 2023'' and
inserting ``2024 through 2028''.
(2) Collection shortfalls.--Section 740(g) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-12(g)) is
amended--
(A) in paragraph (3), by striking ``and paragraph
(5)''; and
(B) by striking paragraph (5).
SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-13) is amended--
(1) in subsection (a), by striking ``2018'' and inserting
``2023'';
(2) by striking ``2019'' each place it appears in
subsections (a) and (b) and inserting ``2024''; and
(3) in subsection (d)--
(A) in paragraph (1), by striking ``2023'' and
inserting ``2028''; and
(B) in paragraph (5), by striking ``2023'' and
inserting ``2028''.
SEC. 105. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 4 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-11 et seq.), as in effect on the day before the date of
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, 2018,
but before October 1, 2023, 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 2024.
SEC. 106. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2023, or the date of the 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 animal drug applications and supplemental animal drug
applications received on or after October 1, 2023, regardless of the
date of the enactment of this Act.
SEC. 107. SUNSET DATES.
(a) Authorization.--Sections 739 and 740 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-12) shall cease to be effective
October 1, 2028.
(b) 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, 2029.
(c) Previous Sunset Provision.--Effective October 1, 2023,
subsections (a) and (b) of section 107 of the Animal Drug User Fee
Amendments of 2018 (Public Law 115-234) are repealed.
TITLE II--FEES RELATING TO GENERIC ANIMAL DRUGS
SEC. 201. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Animal Generic
Drug User Fee Amendments of 2023''.
(b) Finding.--Congress finds that the fees authorized by the
amendments made in 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 for purposes of part 5 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. 202. AUTHORITY TO ASSESS AND USE GENERIC NEW ANIMAL DRUG FEES.
(a) Types of Fees.--Section 741(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-21(a)) is amended by adding at the end the
following:
``(4) Generic investigational new animal drug file fee.--
``(A) In general.--
``(i) Assessment of fee.--Each person that
submits a request to establish a generic
investigational new animal drug file on or
after October 1, 2023, shall be assessed a fee
as established under subsection (c).
``(ii) Existing files.--In the case of a
generic investigational new animal drug file
established prior to October 1, 2023, each
person that makes a submission to such a file
on or after October 1, 2023, shall be assessed
a fee for the first submission on or after
October 1, 2023, as established under
subsection (c).
``(B) Payment.--The fee required by subparagraph
(A)(i) shall be due upon submission of the request to
establish the generic investigational new animal drug
file. The fee required by subparagraph (A)(ii) shall be
due upon the first submission to the generic
investigational new animal drug file.
``(C) Exceptions.--
``(i) Termination.--If a person makes a
submission to the generic investigational new
animal drug file to terminate that file, the
person shall not be subject to a fee under
subparagraph (A)(ii) for that submission.
``(ii) Transfers.--If a person makes a
submission to the generic investigational new
animal drug file to transfer that file to a
different generic new animal drug sponsor, the
person shall not be subject to a fee under
subparagraph (A)(ii) for that submission.''.
(b) Fee Revenue Amounts.--Section 741(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-21(b)) is amended--
(1) in paragraph (1)--
(A) by striking ``2019 through 2023'' and inserting
``2024 through 2028''; and
(B) by striking ``$18,336,340'' and inserting
``$25,000,000''; and
(2) in paragraph (2)--
(A) in subparagraph (A)--
(i) by striking ``25 percent'' and
inserting ``20 percent''; and
(ii) by inserting before the semicolon at
the end the following: ``and subsection (a)(4)
(relating to generic investigational new animal
drug files)'';
(B) in subparagraph (B), by striking ``37.5
percent'' and inserting ``40 percent''; and
(C) in subparagraph (C), by striking ``37.5
percent'' and inserting ``40 percent''.
(c) Annual Fee Setting; Adjustments.--
(1) Annual fee setting.-- Section 741(c)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21(c)(1)) is
amended to read as follows:
``(1) Annual fee setting.--The Secretary shall establish,
not later than 60 days before the start of each fiscal year
beginning after September 30, 2023, for that fiscal year--
``(A) abbreviated application fees that are based
on the revenue amounts established under subsection
(b), the adjustments provided under this subsection,
and the amount of fees anticipated to be collected
under subsection (a)(4) during that fiscal year;
``(B) 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; and
``(C) a generic investigation new animal drug file
fee of $50,000 for each request or submission covered
by subsection (a)(4)(A).''.
(2) Inflation adjustment.--Section 741(c)(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21(c)(2)) is
amended--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i), by
striking ``2020'' and inserting ``2025''; and
(ii) in clause (iii), by striking
``Baltimore'' and inserting ``Arlington-
Alexandria''; and
(B) in subparagraph (B), by striking ``2020'' and
inserting ``2025''.
(3) Workload adjustment.--Section 741(c)(3) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21(c)(3)) is
amended--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i), by
striking ``2020'' and inserting ``2025'';
(ii) in clause (i)--
(I) by striking ``and
investigational generic new animal drug
protocol submissions'' and inserting
``investigational generic new animal
drug protocol submissions, requests to
establish a generic investigational new
animal drug file, and generic
investigational new animal drug meeting
requests''; and
(II) by striking ``; and'' and
inserting a semicolon;
(iii) by redesignating clause (ii) as
clause (iii); and
(iv) by inserting after clause (i) the
following:
``(ii) if the workload adjustment
calculated by the Secretary for the adjustment
in clause (i) exceeds 25 percent, the Secretary
shall use 25 percent for the adjustment; and'';
and
(B) in subparagraph (B), by striking ``2021 through
2023'' and inserting ``2026 through 2028''.
(4) Final year adjustment.--Section 741(c)(4) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21(c)(4))
is amended--
(A) striking ``2023'' each place it appears and
inserting ``2028''; and
(B) striking ``2024'' and inserting ``2029''.
(d) Fee Waiver or Reduction; Exemption From Fees.--Subsection (d)
of section 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-21) is amended to read as follows:
``(d) Fee Waiver or Reduction.--The Secretary shall grant a waiver
from, or a reduction of, one 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.--Section 741(e) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21(e)) is amended by
striking ``The Secretary may discontinue'' and inserting ``A request to
establish a generic investigational new animal drug file that is
submitted by a person subject to fees under subsection (a) shall be
considered incomplete and shall not be accepted for action by the
Secretary until all fees owed by such person have been paid. The
Secretary may discontinue''.
(f) Assessment of Fees.--Section 741(f)(2) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-21(f)(2)) is amended by striking
``sponsors, and generic new animal drug products at any time'' and
inserting ``products, generic new animal drug sponsors, and generic
investigational new animal drug files at any time''.
(g) Crediting and Availability of Fees.--Section 741(g) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21(g)) is
amended--
(1) in paragraph (3), by striking ``2019 through 2023'' and
inserting ``2024 through 2028'';
(2) by striking the following:
``(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.''; and
(3) by adding at the end the following:
``(5) Recovery of collection shortfalls.--The amount of
fees otherwise authorized to be collected under this section
shall be increased--
``(A) for fiscal year 2026, by the amount, if any,
by which the amount collected under this section and
appropriated for fiscal year 2024 falls below the
amount of fees authorized for fiscal year 2024 under
paragraph (3);
``(B) for fiscal year 2027, by the amount, if any,
by which the amount collected under this section and
appropriated for fiscal year 2025 falls below the
amount of fees authorized for fiscal year 2025 under
paragraph (3); and
``(C) for fiscal year 2028, by the amount, if any,
by which the amount collected under this section and
appropriated for fiscal years 2026 and 2027 (including
estimated collections for fiscal year 2027) falls below
the amount of fees authorized for such fiscal years
under paragraph (3).''.
(h) Definitions.--Section 741(k) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-21(k)) is amended--
(1) by redesignating paragraphs (8), (9), (10), and (11) as
paragraphs (9), (10), (11), and (13), respectively;
(2) by inserting after paragraph (7) the following:
``(8) Generic investigational new animal drug meeting
request.--The term `generic investigational new animal drug
meeting request' means a request submitted by a generic new
animal drug sponsor to meet with the Secretary to discuss an
investigational submission for a generic new animal drug.'';
(3) in paragraph (11) (as so redesignated), by adding at
the end the following:
``(I) The activities necessary for exploration and
implementation of the United States and European Union
Mutual Recognition Agreement for Pharmaceutical Good
Manufacturing Practice Inspections, and the United
States and United Kingdom Recognition Agreement
Sectoral Annex for Pharmaceutical Good Manufacturing
Practices, and future mutual recognition agreements,
with respect to generic new animal drug products
subject to review, including implementation activities
prior to and following product approval.''; and
(4) by inserting after paragraph (11) (as so redesignated)
the following:
``(12) Request to establish a generic investigational new
animal drug file.--The term `request to establish a generic
investigational new animal drug file' means the submission to
the Secretary of a request to establish a generic
investigational new animal drug file to contain investigational
submissions for a generic new animal drug.''.
SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-22) is amended--
(1) in subsection (a), by striking ``2018'' and inserting
``2023'';
(2) by striking ``2019'' each place it appears in
subsections (a) and (b) and inserting ``2024''; and
(3) in subsection (d), by striking ``2023'' each place it
appears and inserting ``2028''.
SEC. 204. 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
(21 U.S.C. 379j-21 et seq.), 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, 2018, but before
October 1, 2023, 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 2024.
SEC. 205. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2023, or the date of the 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 abbreviated applications for a generic new animal drug
and supplemental abbreviated applications for a generic new animal drug
received on or after October 1, 2023, regardless of the date of
enactment of this Act.
SEC. 206. SUNSET DATES.
(a) Authorization.--Section 741 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-21) shall cease to be effective October 1,
2028.
(b) 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, 2029.
(c) Previous Sunset Provision.--Effective October 1, 2023,
subsections (a) and (b) of section 206 of the Animal Generic Drug User
Fee Amendments of 2018 (Public Law 115-234) are repealed.
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