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[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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