I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Animal Drug User Fee 

5 Amendments of 2023’’. 

6 SEC. 2. TABLE OF CONTENTS. 

7 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. 


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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. 

1 TITLE I—FEES RELATING TO 

2 ANIMAL DRUGS 

3 SEC. 101. SHORT TITLE; FINDING. 

4 (a) SHORT TITLE.—This title may be cited as the 

5 ‘‘Animal Drug User Fee Amendments of 2023’’. 

6 (b) FINDING.—Congress finds that the fees author7 ized by the amendments made in this title will be dedi8 cated toward expediting the animal drug development 

9 process and the review of new and supplemental animal 

10 drug applications and investigational animal drug submis11 sions as set forth in the goals identified for purposes of 

12 part 4 of subchapter C of chapter VII of the Federal Food, 

13 Drug, and Cosmetic Act, in the letters from the Secretary 

14 of Health and Human Services to the Chairman of the 

15 Committee on Energy and Commerce of the House of 

16 Representatives and the Chairman of the Committee on 

17 Health, Education, Labor, and Pensions of the Senate as 

18 set forth in the Congressional Record. 


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1 SEC. 102. DEFINITIONS. 

2 Section 739(8)(I) of the Federal Food, Drug, and 

3 Cosmetic Act (21 U.S.C. 379j–11(8)(I)) is amended to 

4 read as follows: 

5 ‘‘(I) The activities necessary for implemen6 tation of the United States and European 

7 Union Mutual Recognition Agreement for Phar8 maceutical Good Manufacturing Practice In9 spections, and the United States and United 

10 Kingdom Recognition Agreement Sectoral 

11 Annex for Pharmaceutical Good Manufacturing 

12 Practices, and future mutual recognition agree13 ments, with respect to animal drug products 

14 subject to review, including implementation ac15 tivities prior to and following product ap16 proval.’’. 

17 SEC. 103. AUTHORITY TO ASSESS AND USE ANIMAL DRUG 

18 FEES. 

19 (a) TYPES OF FEES.—Section 740(a)(1)(A)(ii) of the 

20 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

21 12(a)(1)(A)(ii)) is amended— 

22 (1) in subclause (I), by striking ‘‘and’’ at the 

23 end; 

24 (2) in subclause (II), by striking the period at 

25 the end and inserting ‘‘; and’’; and 

26 (3) by adding at the end the following: 


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1 ‘‘(III) an application for condi2 tional approval under section 571 of a 

3 new animal drug for which an animal 

4 drug application submitted under sec5 tion 512(b)(1) has been previously ap6 proved under section 512(d)(1) for 

7 another intended use.’’. 

8 (b) FEE REVENUE AMOUNTS.—Section 740(b)(1) of 

9 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

10 379j–12(b)(1)) is amended to read as follows: 

11 ‘‘(1) IN GENERAL.—Subject to subsections (c), 

12 (d), (f), and (g), for each of fiscal years 2024 

13 through 2028, the fees required under subsection (a) 

14 shall be established to generate a total revenue 

15 amount of $33,500,000.’’. 

16 (c) ANNUAL FEE SETTING; ADJUSTMENTS.— 

17 (1) ANNUAL FEE SETTING.—Section 740(c)(1) 

18 of the Federal Food, Drug, and Cosmetic Act (21 

19 U.S.C. 379j–12(c)(1)) is amended to read as follows: 

20 ‘‘(1) ANNUAL FEE SETTING.—Not later than 

21 60 days before the start of each fiscal year begin22 ning after September 30, 2023, the Secretary 

23 shall— 

24 ‘‘(A) establish for that fiscal year animal 

25 drug application fees, supplemental animal drug 


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1 application fees, animal drug sponsor fees, ani2 mal drug establishment fees, and animal drug 

3 product fees based on the revenue amounts es4 tablished under subsection (b) and the adjust5 ments provided under this subsection; and 

6 ‘‘(B) publish such fee revenue amounts 

7 and fees in the Federal Register.’’. 

8 (2) INFLATION ADJUSTMENT.—Section 

9 740(c)(2) of the Federal Food, Drug, and Cosmetic 

10 Act (21 U.S.C. 379j–12(c)(2)) is amended— 

11 (A) in subparagraph (A)— 

12 (i) in the matter preceding clause (i), 

13 by striking ‘‘2020’’ and inserting ‘‘2025’’; 

14 and 

15 (ii) in clause (iii), by striking ‘‘Balti16 more’’ and inserting ‘‘Arlington-Alexan17 dria’’; and 

18 (B) in subparagraph (B), by striking 

19 ‘‘2020’’ and inserting ‘‘2025’’. 

20 (3) WORKLOAD ADJUSTMENTS.—Paragraph (3) 

21 of section 740(c) of the Federal Food, Drug, and 

22 Cosmetic Act (21 U.S.C. 379j–12(c)) is amended— 

23 (A) in subparagraph (A)— 

24 (i) in the matter preceding clause 

25 (i)— 


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1 (I) by striking ‘‘2020’’ and in2 serting ‘‘2025’’; and 

3 (II) by striking ‘‘subparagraphs 

4 (B) and (C)’’ and inserting ‘‘subpara5 graph (B)’’; 

6 (ii) in clause (i) by striking ‘‘and’’ at 

7 the end; and 

8 (iii) by striking clause (ii) and insert9 ing the following: 

10 ‘‘(ii) such adjustment shall be made 

11 for each fiscal year that the adjustment de12 termined by the Secretary is greater than 

13 3 percent, except for the first fiscal year 

14 that the adjustment is greater than 3 per15 cent; and 

16 ‘‘(iii) the Secretary shall publish in 

17 the Federal Register notice under para18 graph (1) the amount of such adjustment 

19 and the supporting methodologies.’’; 

20 (B) by striking subparagraph (B); and 

21 (C) by redesignating subparagraph (C) as 

22 subparagraph (B). 

23 (4) FINAL YEAR ADJUSTMENT.—Section 

24 740(c)(4) of the Federal Food, Drug, and Cosmetic 


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1 Act (21 U.S.C. 379j–12(c)(4)) is amended to read 

2 as follows: 

3 ‘‘(4) OPERATING RESERVE ADJUSTMENT.— 

4 ‘‘(A) IN GENERAL.—For fiscal year 2025 

5 and each subsequent fiscal year, after the fee 

6 revenue amount established under subsection 

7 (b) is adjusted in accordance with paragraphs 

8 (2) and (3), the Secretary shall— 

9 ‘‘(i) increase the fee revenue amount 

10 for such fiscal year, if necessary to provide 

11 an operating reserve of not less than 12 

12 weeks; or 

13 ‘‘(ii) if the Secretary has an operating 

14 reserve in excess of the number of weeks 

15 specified in subparagraph (C) for that fis16 cal year, the Secretary shall decrease the 

17 fee revenue amount to provide not more 

18 than the number of weeks specified in sub19 paragraph (C) for that fiscal year. 

20 ‘‘(B) CARRYOVER USER FEES.—For pur21 poses of this paragraph, the operating reserve 

22 of carryover user fees for the process for the re23 view of animal drug applications does not in24 clude carryover user fees that have not been ap25 propriated. 


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1 ‘‘(C) NUMBER OF WEEKS OF OPERATING

2 RESERVES.—The number of weeks of operating 

3 reserves specified in this subparagraph is— 

4 ‘‘(i) 22 weeks for fiscal year 2025; 

5 ‘‘(ii) 20 weeks for fiscal year 2026; 

6 ‘‘(iii) 18 weeks for fiscal year 2027; 

7 and 

8 ‘‘(iv) 16 weeks for fiscal year 2028. 

9 ‘‘(D) PUBLICATION.—If an adjustment to 

10 the operating reserve is made under this para11 graph, the Secretary shall publish in the Fed12 eral Register notice under paragraph (1) the ra13 tionale for the amount of the adjustment and 

14 the supporting methodologies.’’. 

15 (d) EXEMPTION FROM FEES.—Section 740(d)(4) of 

16 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

17 379j–12(d)(4)) is amended to read as follows: 

18 ‘‘(4) EXEMPTION FROM FEES FOR CERTAIN

19 ANIMAL DRUG APPLICATIONS.—Fees under para20 graphs (2), (3), and (4) of subsection (a) shall not 

21 apply with respect to any person who is the named 

22 applicant or sponsor of an animal drug application, 

23 supplemental animal drug application, or investiga24 tional animal drug submission if such application or 

25 submission involves the intentional genomic alterVerDate Sep 11 2014 03:03 Mar 21, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H1418.IH H1418

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1 ation of an animal that is intended to produce a 

2 drug, device, or biological product subject to fees 

3 under section 736, 738, 744B, or 744H.’’. 

4 (e) CREDITING AND AVAILABILITY OF FEES.— 

5 (1) AUTHORIZATION OF APPROPRIATIONS.— 

6 Section 740(g)(3) of the Federal Food, Drug, and 

7 Cosmetic Act (21 U.S.C. 379j–12(g)(3)) is amended 

8 by striking ‘‘2019 through 2023’’ and inserting 

9 ‘‘2024 through 2028’’. 

10 (2) COLLECTION SHORTFALLS.—Section 740(g) 

11 of the Federal Food, Drug, and Cosmetic Act (21 

12 U.S.C. 379j–12(g)) is amended— 

13 (A) in paragraph (3), by striking ‘‘and 

14 paragraph (5)’’; and 

15 (B) by striking paragraph (5). 

16 SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 

17 Section 740A of the Federal Food, Drug, and Cos18 metic Act (21 U.S.C. 379j–13) is amended— 

19 (1) in subsection (a), by striking ‘‘2018’’ and 

20 inserting ‘‘2023’’; 

21 (2) by striking ‘‘2019’’ each place it appears in 

22 subsections (a) and (b) and inserting ‘‘2024’’; and 

23 (3) in subsection (d)— 

24 (A) in paragraph (1), by striking ‘‘2023’’ 

25 and inserting ‘‘2028’’; and 


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1 (B) in paragraph (5), by striking ‘‘2023’’ 

2 and inserting ‘‘2028’’. 

3 SEC. 105. SAVINGS CLAUSE. 

4 Notwithstanding the amendments made by this title, 

5 part 4 of subchapter C of chapter VII of the Federal Food, 

6 Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as 

7 in effect on the day before the date of enactment of this 

8 title, shall continue to be in effect with respect to animal 

9 drug applications and supplemental animal drug applica10 tions (as defined in such part as of such day) that on or 

11 after October 1, 2018, but before October 1, 2023, were 

12 accepted by the Food and Drug Administration for filing 

13 with respect to assessing and collecting any fee required 

14 by such part for a fiscal year prior to fiscal year 2024. 

15 SEC. 106. EFFECTIVE DATE. 

16 The amendments made by this title shall take effect 

17 on October 1, 2023, or the date of the enactment of this 

18 Act, whichever is later, except that fees under part 4 of 

19 subchapter C of chapter VII of the Federal Food, Drug, 

20 and Cosmetic Act, as amended by this title, shall be as21 sessed for animal drug applications and supplemental ani22 mal drug applications received on or after October 1, 

23 2023, regardless of the date of the enactment of this Act. 


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1 SEC. 107. SUNSET DATES. 

2 (a) AUTHORIZATION.—Sections 739 and 740 of the 

3 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

4 12) shall cease to be effective October 1, 2028. 

5 (b) REPORTING REQUIREMENTS.—Section 740A of 

6 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

7 379j–13) shall cease to be effective January 31, 2029. 

8 (c) PREVIOUS SUNSET PROVISION.—Effective Octo9 ber 1, 2023, subsections (a) and (b) of section 107 of the 

10 Animal Drug User Fee Amendments of 2018 (Public Law 

11 115–234) are repealed. 

12 TITLE II—FEES RELATING TO 

13 GENERIC ANIMAL DRUGS 

14 SEC. 201. SHORT TITLE; FINDING. 

15 (a) SHORT TITLE.—This title may be cited as the 

16 ‘‘Animal Generic Drug User Fee Amendments of 2023’’. 

17 (b) FINDING.—Congress finds that the fees author18 ized by the amendments made in this title will be dedi19 cated toward expediting the generic new animal drug de20 velopment process and the review of abbreviated applica21 tions for generic new animal drugs, supplemental abbre22 viated applications for generic new animal drugs, and in23 vestigational submissions for generic new animal drugs as 

24 set forth in the goals identified for purposes of part 5 of 

25 subchapter C of chapter VII of the Federal Food, Drug, 

26 and Cosmetic Act, in the letters from the Secretary of 


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1 Health and Human Services to the Chairman of the Com2 mittee on Energy and Commerce of the House of Rep3 resentatives and the Chairman of the Committee on 

4 Health, Education, Labor and Pensions of the Senate as 

5 set forth in the Congressional Record. 

6 SEC. 202. AUTHORITY TO ASSESS AND USE GENERIC NEW 

7 ANIMAL DRUG FEES. 

8 (a) TYPES OF FEES.—Section 741(a) of the Federal 

9 Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(a)) is 

10 amended by adding at the end the following: 

11 ‘‘(4) GENERIC INVESTIGATIONAL NEW ANIMAL

12 DRUG FILE FEE.— 

13 ‘‘(A) IN GENERAL.— 

14 ‘‘(i) ASSESSMENT OF FEE.—Each per15 son that submits a request to establish a 

16 generic investigational new animal drug 

17 file on or after October 1, 2023, shall be 

18 assessed a fee as established under sub19 section (c). 

20 ‘‘(ii) EXISTING FILES.—In the case of 

21 a generic investigational new animal drug 

22 file established prior to October 1, 2023, 

23 each person that makes a submission to 

24 such a file on or after October 1, 2023, 

25 shall be assessed a fee for the first submisVerDate Sep 11 2014 03:03 Mar 21, 2023 Jkt 039200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H1418.IH H1418

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1 sion on or after October 1, 2023, as estab2 lished under subsection (c). 

3 ‘‘(B) PAYMENT.—The fee required by sub4 paragraph (A)(i) shall be due upon submission 

5 of the request to establish the generic investiga6 tional new animal drug file. The fee required by 

7 subparagraph (A)(ii) shall be due upon the first 

8 submission to the generic investigational new 

9 animal drug file. 

10 ‘‘(C) EXCEPTIONS.— 

11 ‘‘(i) TERMINATION.—If a person 

12 makes a submission to the generic inves13 tigational new animal drug file to termi14 nate that file, the person shall not be sub15 ject to a fee under subparagraph (A)(ii) 

16 for that submission. 

17 ‘‘(ii) TRANSFERS.—If a person makes 

18 a submission to the generic investigational 

19 new animal drug file to transfer that file 

20 to a different generic new animal drug 

21 sponsor, the person shall not be subject to 

22 a fee under subparagraph (A)(ii) for that 

23 submission.’’. 


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1 (b) FEE REVENUE AMOUNTS.—Section 741(b) of the 

2 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

3 21(b)) is amended— 

4 (1) in paragraph (1)— 

5 (A) by striking ‘‘2019 through 2023’’ and 

6 inserting ‘‘2024 through 2028’’; and 

7 (B) by striking ‘‘$18,336,340’’ and insert8 ing ‘‘$25,000,000’’; and 

9 (2) in paragraph (2)— 

10 (A) in subparagraph (A)— 

11 (i) by striking ‘‘25 percent’’ and in12 serting ‘‘20 percent’’; and 

13 (ii) by inserting before the semicolon 

14 at the end the following: ‘‘and subsection 

15 (a)(4) (relating to generic investigational 

16 new animal drug files)’’; 

17 (B) in subparagraph (B), by striking ‘‘37.5 

18 percent’’ and inserting ‘‘40 percent’’; and 

19 (C) in subparagraph (C), by striking ‘‘37.5 

20 percent’’ and inserting ‘‘40 percent’’. 

21 (c) ANNUAL FEE SETTING; ADJUSTMENTS.— 

22 (1) ANNUAL FEE SETTING.— Section 741(c)(1) 

23 of the Federal Food, Drug, and Cosmetic Act (21 

24 U.S.C. 379j–21(c)(1)) is amended to read as follows: 


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1 ‘‘(1) ANNUAL FEE SETTING.—The Secretary 

2 shall establish, not later than 60 days before the 

3 start of each fiscal year beginning after September 

4 30, 2023, for that fiscal year— 

5 ‘‘(A) abbreviated application fees that are 

6 based on the revenue amounts established 

7 under subsection (b), the adjustments provided 

8 under this subsection, and the amount of fees 

9 anticipated to be collected under subsection 

10 (a)(4) during that fiscal year; 

11 ‘‘(B) generic new animal drug sponsor 

12 fees, and generic new animal drug product fees, 

13 based on the revenue amounts established 

14 under subsection (b) and the adjustments pro15 vided under this subsection; and 

16 ‘‘(C) a generic investigation new animal 

17 drug file fee of $50,000 for each request or 

18 submission covered by subsection (a)(4)(A).’’. 

19 (2) INFLATION ADJUSTMENT.—Section 

20 741(c)(2) of the Federal Food, Drug, and Cosmetic 

21 Act (21 U.S.C. 379j–21(c)(2)) is amended— 

22 (A) in subparagraph (A)— 

23 (i) in the matter preceding clause (i), 

24 by striking ‘‘2020’’ and inserting ‘‘2025’’; 

25 and 


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1 (ii) in clause (iii), by striking ‘‘Balti2 more’’ and inserting ‘‘Arlington-Alexan3 dria’’; and 

4 (B) in subparagraph (B), by striking 

5 ‘‘2020’’ and inserting ‘‘2025’’. 

6 (3) WORKLOAD ADJUSTMENT.—Section 

7 741(c)(3) of the Federal Food, Drug, and Cosmetic 

8 Act (21 U.S.C. 379j–21(c)(3)) is amended— 

9 (A) in subparagraph (A)— 

10 (i) in the matter preceding clause (i), 

11 by striking ‘‘2020’’ and inserting ‘‘2025’’; 

12 (ii) in clause (i)— 

13 (I) by striking ‘‘and investiga14 tional generic new animal drug pro15 tocol submissions’’ and inserting ‘‘in16 vestigational generic new animal drug 

17 protocol submissions, requests to es18 tablish a generic investigational new 

19 animal drug file, and generic inves20 tigational new animal drug meeting 

21 requests’’; and 

22 (II) by striking ‘‘; and’’ and in23 serting a semicolon; 

24 (iii) by redesignating clause (ii) as 

25 clause (iii); and 


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1 (iv) by inserting after clause (i) the 

2 following: 

3 ‘‘(ii) if the workload adjustment cal4 culated by the Secretary for the adjust5 ment in clause (i) exceeds 25 percent, the 

6 Secretary shall use 25 percent for the ad7 justment; and’’; and 

8 (B) in subparagraph (B), by striking 

9 ‘‘2021 through 2023’’ and inserting ‘‘2026 

10 through 2028’’. 

11 (4) FINAL YEAR ADJUSTMENT.—Section 

12 741(c)(4) of the Federal Food, Drug, and Cosmetic 

13 Act (21 U.S.C. 379j–21(c)(4)) is amended— 

14 (A) striking ‘‘2023’’ each place it appears 

15 and inserting ‘‘2028’’; and 

16 (B) striking ‘‘2024’’ and inserting ‘‘2029’’. 

17 (d) FEE WAIVER OR REDUCTION; EXEMPTION FROM

18 FEES.—Subsection (d) of section 741 of the Federal 

19 Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) is 

20 amended to read as follows: 

21 ‘‘(d) FEE WAIVER OR REDUCTION.—The Secretary 

22 shall grant a waiver from, or a reduction of, one or more 

23 fees assessed under subsection (a) where the Secretary 

24 finds that the generic new animal drug is intended solely 

25 to provide for a minor use or minor species indication.’’. 


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1 (e) EFFECT OF FAILURE TO PAY FEES.—Section 

2 741(e) of the Federal Food, Drug, and Cosmetic Act (21 

3 U.S.C. 379j–21(e)) is amended by striking ‘‘The Secretary 

4 may discontinue’’ and inserting ‘‘A request to establish a 

5 generic investigational new animal drug file that is sub6 mitted by a person subject to fees under subsection (a) 

7 shall be considered incomplete and shall not be accepted 

8 for action by the Secretary until all fees owed by such per9 son have been paid. The Secretary may discontinue’’. 

10 (f) ASSESSMENT OF FEES.—Section 741(f)(2) of the 

11 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

12 21(f)(2)) is amended by striking ‘‘sponsors, and generic 

13 new animal drug products at any time’’ and inserting 

14 ‘‘products, generic new animal drug sponsors, and generic 

15 investigational new animal drug files at any time’’. 

16 (g) CREDITING AND AVAILABILITY OF FEES.—Sec17 tion 741(g) of the Federal Food, Drug, and Cosmetic Act 

18 (21 U.S.C. 379j–21(g)) is amended— 

19 (1) in paragraph (3), by striking ‘‘2019 

20 through 2023’’ and inserting ‘‘2024 through 2028’’; 

21 (2) by striking the following: 

22 ‘‘(4) OFFSET.—If the sum of the cumulative 

23 amount of fees collected under this section for the 

24 fiscal years 2014 through 2016 and the amount of 

25 fees estimated to be collected under this section for 


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1 fiscal year 2017 exceeds the cumulative amount ap2 propriated under paragraph (3) for the fiscal years 

3 2014 through 2017, the excess amount shall be 

4 credited to the appropriation account of the Food 

5 and Drug Administration as provided in paragraph 

6 (1), and shall be subtracted from the amount of fees 

7 that would otherwise be authorized to be collected 

8 under this section pursuant to appropriation Acts 

9 for fiscal year 2018.’’; and 

10 (3) by adding at the end the following: 

11 ‘‘(5) RECOVERY OF COLLECTION SHORT12 FALLS.—The amount of fees otherwise authorized to 

13 be collected under this section shall be increased— 

14 ‘‘(A) for fiscal year 2026, by the amount, 

15 if any, by which the amount collected under this 

16 section and appropriated for fiscal year 2024 

17 falls below the amount of fees authorized for 

18 fiscal year 2024 under paragraph (3); 

19 ‘‘(B) for fiscal year 2027, by the amount, 

20 if any, by which the amount collected under this 

21 section and appropriated for fiscal year 2025 

22 falls below the amount of fees authorized for 

23 fiscal year 2025 under paragraph (3); and 

24 ‘‘(C) for fiscal year 2028, by the amount, 

25 if any, by which the amount collected under this 


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1 section and appropriated for fiscal years 2026 

2 and 2027 (including estimated collections for 

3 fiscal year 2027) falls below the amount of fees 

4 authorized for such fiscal years under para5 graph (3).’’. 

6 (h) DEFINITIONS.—Section 741(k) of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(k)) is 

8 amended— 

9 (1) by redesignating paragraphs (8), (9), (10), 

10 and (11) as paragraphs (9), (10), (11), and (13), re11 spectively; 

12 (2) by inserting after paragraph (7) the fol13 lowing: 

14 ‘‘(8) GENERIC INVESTIGATIONAL NEW ANIMAL

15 DRUG MEETING REQUEST.—The term ‘generic inves16 tigational new animal drug meeting request’ means 

17 a request submitted by a generic new animal drug 

18 sponsor to meet with the Secretary to discuss an in19 vestigational submission for a generic new animal 

20 drug.’’; 

21 (3) in paragraph (11) (as so redesignated), by 

22 adding at the end the following: 

23 ‘‘(I) The activities necessary for explo24 ration and implementation of the United States 

25 and European Union Mutual Recognition 


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1 Agreement for Pharmaceutical Good Manufac2 turing Practice Inspections, and the United 

3 States and United Kingdom Recognition Agree4 ment Sectoral Annex for Pharmaceutical Good 

5 Manufacturing Practices, and future mutual 

6 recognition agreements, with respect to generic 

7 new animal drug products subject to review, in8 cluding implementation activities prior to and 

9 following product approval.’’; and 

10 (4) by inserting after paragraph (11) (as so re11 designated) the following: 

12 ‘‘(12) REQUEST TO ESTABLISH A GENERIC IN13 VESTIGATIONAL NEW ANIMAL DRUG FILE.—The 

14 term ‘request to establish a generic investigational 

15 new animal drug file’ means the submission to the 

16 Secretary of a request to establish a generic inves17 tigational new animal drug file to contain investiga18 tional submissions for a generic new animal drug.’’. 

19 SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS. 

20 Section 742 of the Federal Food, Drug, and Cosmetic 

21 Act (21 U.S.C. 379j–22) is amended— 

22 (1) in subsection (a), by striking ‘‘2018’’ and 

23 inserting ‘‘2023’’; 

24 (2) by striking ‘‘2019’’ each place it appears in 

25 subsections (a) and (b) and inserting ‘‘2024’’; and 


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1 (3) in subsection (d), by striking ‘‘2023’’ each 

2 place it appears and inserting ‘‘2028’’. 

3 SEC. 204. SAVINGS CLAUSE. 

4 Notwithstanding the amendments made by this title, 

5 part 5 of subchapter C of chapter VII of the Federal Food, 

6 Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as 

7 in effect on the day before the date of enactment of this 

8 title, shall continue to be in effect with respect to abbre9 viated applications for a generic new animal drug and sup10 plemental abbreviated applications for a generic new ani11 mal drug (as defined in such part as of such day) that 

12 on or after October 1, 2018, but before October 1, 2023, 

13 were accepted by the Food and Drug Administration for 

14 filing with respect to assessing and collecting any fee re15 quired by such part for a fiscal year prior to fiscal year 

16 2024. 

17 SEC. 205. EFFECTIVE DATE. 

18 The amendments made by this title shall take effect 

19 on October 1, 2023, or the date of the enactment of this 

20 Act, whichever is later, except that fees under part 5 of 

21 subchapter C of chapter VII of the Federal Food, Drug, 

22 and Cosmetic Act, as amended by this title, shall be as23 sessed for abbreviated applications for a generic new ani24 mal drug and supplemental abbreviated applications for 


kjohnson on DSK79L0C42PROD with BILLS
23 

•HR 1418 IH

1 a generic new animal drug received on or after October 

2 1, 2023, regardless of the date of enactment of this Act. 

3 SEC. 206. SUNSET DATES. 

4 (a) AUTHORIZATION.—Section 741 of the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) shall 

6 cease to be effective October 1, 2028. 

7 (b) REPORTING REQUIREMENTS.—Section 742 of the 

8 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

9 22) shall cease to be effective January 31, 2029. 

10 (c) PREVIOUS SUNSET PROVISION.—Effective Octo11 ber 1, 2023, subsections (a) and (b) of section 206 of the 

12 Animal Generic Drug User Fee Amendments of 2018 

13 (Public Law 115–234) are repealed. 

Æ 


kjohnson on DSK79L0C42PROD with BILLS