118TH CONGRESS 

1ST SESSION H. R. 1418 

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. 

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

2 This Act may be cited as the ‘‘Animal Drug and Ani3 mal Generic Drug User Fee Amendments of 2023’’. 

4 SEC. 2. TABLE OF CONTENTS. 

5 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 III—SUPPORTING ANIMAL AND HUMAN HEALTH 

Sec. 301. Reporting requirements. 

Sec. 302. Definition of major species. 

Sec. 303. Antimicrobial resistance. 

6 TITLE I—FEES RELATING TO 

7 ANIMAL DRUGS 

8 SEC. 101. SHORT TITLE; FINDING. 

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

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

11 (b) FINDING.—Congress finds that the fees author12 ized by the amendments made in this title will be dedi13 cated toward expediting the animal drug development 
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1 process and the review of new and supplemental animal 

2 drug applications and investigational animal drug submis3 sions as set forth in the goals identified for purposes of 

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

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

6 the letters from the Secretary of Health and Human Serv7 ices to the Chairman of the Committee on Energy and 

8 Commerce of the House of Representatives and the Chair9 man of the Committee on Health, Education, Labor, and 

10 Pensions of the Senate as set forth in the Congressional 

11 Record. 

12 SEC. 102. DEFINITIONS. 

13 Section 739 of the Federal Food, Drug, and Cosmetic 

14 Act (21 U.S.C. 379j–11) is amended— 

15 (1) in paragraph (3), by striking ‘‘national drug 

16 code’’ and inserting ‘‘National Drug Code’’; and 

17 (2) by amending paragraph (8)(I) to read as 

18 follows: 

19 ‘‘(I) The activities necessary for implemen20 tation of the United States and European 

21 Union Mutual Recognition Agreement for Phar22 maceutical Good Manufacturing Practice In23 spections, and the United States and United 

24 Kingdom Mutual Recognition Agreement Sec25 toral Annex for Pharmaceutical Good Manufac-
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1 turing Practices, and other mutual recognition 

2 agreements, with respect to animal drug prod3 ucts subject to review, including implementation 

4 activities prior to and following product ap5 proval.’’. 

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

7 FEES. 

8 (a) IN GENERAL.—Section 740(a)(1)(A)(ii) of the 

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

10 12(a)(1)(A)(ii)) is amended— 

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

12 end; 

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

14 the end and inserting ‘‘; and’’; and 

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

16 ‘‘(III) an application for condi17 tional approval under section 571 of a 

18 new animal drug for which an animal 

19 drug application submitted under sec20 tion 512(b)(1) has been previously ap21 proved under section 512(d)(1) for 

22 another intended use.’’. 

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

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

25 379j–12(b)(1)) is amended to read as follows: 
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1 ‘‘(1) IN GENERAL.—Subject to subsections (c), 

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

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

4 shall be established to generate a total revenue 

5 amount of $33,500,000.’’. 

6 (c) ANNUAL FEE SETTING; ADJUSTMENTS.— 

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

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

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

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

11 60 days before the start of each fiscal year begin12 ning after September 30, 2023, the Secretary 

13 shall— 

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

15 drug application fees, supplemental animal drug 

16 application fees, animal drug sponsor fees, ani17 mal drug establishment fees, and animal drug 

18 product fees based on the revenue amounts es19 tablished under subsection (b) and the adjust20 ments provided under this subsection; and 

21 ‘‘(B) publish such fee revenue amounts 

22 and fees in the Federal Register.’’. 

23 (2) INFLATION ADJUSTMENT.—Section 

24 740(c)(2) of the Federal Food, Drug, and Cosmetic 

25 Act (21 U.S.C. 379j–12(c)(2)) is amended— 
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1 (A) in subparagraph (A)— 

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

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

4 and 

5 (ii) in clause (iii), by striking ‘‘Balti6 more’’ and inserting ‘‘Arlington-Alexan7 dria’’; and 

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

9 ‘‘2020’’ and inserting ‘‘2025’’. 

10 (3) WORKLOAD ADJUSTMENTS.—Section 

11 740(c)(3) of the Federal Food, Drug, and Cosmetic 

12 Act (21 U.S.C. 379j–12(c)(3)) is amended— 

13 (A) in subparagraph (A)— 

14 (i) in the matter preceding clause 

15 (i)— 

16 (I) by striking ‘‘2020’’ and in17 serting ‘‘2025’’; and 

18 (II) by striking ‘‘subparagraphs 

19 (B) and (C)’’ and inserting ‘‘subpara20 graph (B)’’; 

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

22 the end; and 

23 (iii) by striking clause (ii) and insert24 ing the following: 
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1 ‘‘(ii) such adjustment shall be made 

2 for each fiscal year that the adjustment de3 termined by the Secretary is greater than 

4 3 percent, except for the first fiscal year 

5 that the adjustment is greater than 3 per6 cent; and 

7 ‘‘(iii) the Secretary shall publish in 

8 the Federal Register notice under para9 graph (1) the amount of such adjustment 

10 and the supporting methodologies.’’; 

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

12 (C) by redesignating subparagraph (C) as 

13 subparagraph (B). 

14 (4) FINAL YEAR ADJUSTMENT.—Section 

15 740(c)(4) of the Federal Food, Drug, and Cosmetic 

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

17 as follows: 

18 ‘‘(4) OPERATING RESERVE ADJUSTMENT.— 

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

20 and each subsequent fiscal year, after the fee 

21 revenue amount established under subsection 

22 (b) is adjusted in accordance with paragraphs 

23 (2) and (3), the Secretary shall— 

24 ‘‘(i) increase the fee revenue amount 

25 for such fiscal year, if necessary to provide 
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1 an operating reserve of not less than 12 

2 weeks; or 

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

4 reserve in excess of the number of weeks 

5 specified in subparagraph (C) for that fis6 cal year, the Secretary shall decrease the 

7 fee revenue amount to provide not more 

8 than the number of weeks specified in sub9 paragraph (C) for that fiscal year. 

10 ‘‘(B) CARRYOVER USER FEES.—For pur11 poses of this paragraph, the operating reserve 

12 of carryover user fees for the process for the re13 view of animal drug applications does not in14 clude carryover user fees that have not been ap15 propriated. 

16 ‘‘(C) NUMBER OF WEEKS OF OPERATING

17 RESERVES.—The number of weeks of operating 

18 reserves specified in this subparagraph is— 

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

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

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

22 and 

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

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

25 the operating reserve is made under this para-
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1 graph, the Secretary shall publish in the Fed2 eral Register notice under paragraph (1) the ra3 tionale for the amount of the adjustment and 

4 the supporting methodologies.’’. 

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

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

7 379j–12(d)(4)) is amended to read as follows: 

8 ‘‘(4) EXEMPTION FROM FEES.—Fees under 

9 paragraphs (2), (3), and (4) of subsection (a) shall 

10 not apply with respect to any person who is the 

11 named applicant or sponsor of an animal drug appli12 cation, supplemental animal drug application, or in13 vestigational animal drug submission if such applica14 tion or submission involves the intentional genomic 

15 alteration of an animal that is intended to produce 

16 a drug, device, or biological product subject to fees 

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

18 (e) CREDITING AND AVAILABILITY OF FEES.— 

19 (1) AUTHORIZATION OF APPROPRIATIONS.— 

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

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

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

23 ‘‘2024 through 2028’’. 
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1 (2) COLLECTION SHORTFALLS.—Section 740(g) 

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

3 U.S.C. 379j–12(g)) is amended— 

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

5 paragraph (5)’’; and 

6 (B) by striking paragraph (5). 

7 SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 

8 Section 740A of the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 379j–13) is amended— 

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

11 inserting ‘‘2023’’; 

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

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

14 (3) in subsection (d)— 

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

16 and inserting ‘‘2028’’; and 

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

18 and inserting ‘‘2028’’. 

19 SEC. 105. SAVINGS CLAUSE. 

20 Notwithstanding the amendments made by this title, 

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

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

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

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

25 drug applications and supplemental animal drug applica-
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1 tions (as defined in such part as of such day) that on or 

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

3 accepted by the Food and Drug Administration for filing 

4 with respect to assessing and collecting any fee required 

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

6 SEC. 106. EFFECTIVE DATE. 

7 The amendments made by this title shall take effect 

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

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

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

11 and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as amend12 ed by this title, shall be assessed for animal drug applica13 tions and supplemental animal drug applications received 

14 on or after October 1, 2023, regardless of the date of the 

15 enactment of this Act. 

16 SEC. 107. SUNSET DATES. 

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

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

19 U.S.C. 379j–11; 379j–12) shall cease to be effective Octo20 ber 1, 2028. 

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

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

23 379j–13) shall cease to be effective January 31, 2029. 

24 (c) PREVIOUS SUNSET PROVISION.—Effective Octo25 ber 1, 2023, subsections (a) and (b) of section 107 of the 
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1 Animal Drug User Fee Amendments of 2018 (Public Law 

2 115–234) are repealed. 

3 TITLE II—FEES RELATING TO 

4 GENERIC ANIMAL DRUGS 

5 SEC. 201. SHORT TITLE; FINDING. 

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

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

8 (b) FINDING.—Congress finds that the fees author9 ized by the amendments made in this title will be dedi10 cated toward expediting the generic new animal drug de11 velopment process and the review of abbreviated applica12 tions for generic new animal drugs, supplemental abbre13 viated applications for generic new animal drugs, and in14 vestigational submissions for generic new animal drugs as 

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

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

17 and Cosmetic Act (21 U.S.C. 379j–21 et seq.), in the let18 ters from the Secretary of Health and Human Services 

19 to the Chairman of the Committee on Energy and Com20 merce of the House of Representatives and the Chairman 

21 of the Committee on Health, Education, Labor and Pen22 sions of the Senate as set forth in the Congressional 

23 Record. 
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1 SEC. 202. AUTHORITY TO ASSESS AND USE GENERIC NEW 

2 ANIMAL DRUG FEES. 

3 (a) GENERIC INVESTIGATIONAL NEW ANIMAL DRUG

4 FILE FEE.—Section 741(a) of the Federal Food, Drug, 

5 and Cosmetic Act (21 U.S.C. 379j–21(a)) is amended by 

6 adding at the end the following: 

7 ‘‘(4) GENERIC INVESTIGATIONAL NEW ANIMAL

8 DRUG FILE FEE.— 

9 ‘‘(A) IN GENERAL.— 

10 ‘‘(i) NEW FILE REQUEST.—Each per11 son that submits a request to establish a 

12 generic investigational new animal drug 

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

14 assessed a fee as established under sub15 section (c). 

16 ‘‘(ii) NEW SUBMISSION TO ESTAB17 LISHED FILE.—Each person that makes a 

18 submission to a generic investigational new 

19 animal drug file on or after October 1, 

20 2023, where such file was established prior 

21 to October 1, 2023, shall be assessed a fee 

22 for the first submission on or after October 

23 1, 2023, as established under subsection 

24 (c). 

25 ‘‘(B) PAYMENT.— 
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1 ‘‘(i) NEW FILE REQUEST.—The fee 

2 required by subparagraph (A)(i) shall be 

3 due upon submission of the request to es4 tablish the generic investigational new ani5 mal drug file. 

6 ‘‘(ii) NEW SUBMISSION TO ESTAB7 LISHED FILE.—The fee required by sub8 paragraph (A)(ii) shall be due upon the 

9 first submission to the generic investiga10 tional new animal drug file. 

11 ‘‘(C) EXCEPTIONS.— 

12 ‘‘(i) TERMINATING AN EXISTING GE13 NERIC INVESTIGATIONAL NEW ANIMAL

14 DRUG FILE.—If a person makes a submis15 sion to the generic investigational new ani16 mal drug file to terminate that file, the 

17 person shall not be subject to a fee under 

18 subparagraph (A)(ii) for that submission. 

19 ‘‘(ii) TRANSFERRING AN EXISTING GE20 NERIC INVESTIGATIONAL NEW ANIMAL

21 DRUG FILE.—If a person makes a submis22 sion to the generic investigational new ani23 mal drug file to transfer that file to a dif24 ferent generic new animal drug sponsor, 

25 the person shall not be subject to a fee 
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1 under subparagraph (A)(ii) for that sub2 mission.’’. 

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

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

5 21(b)) is amended— 

6 (1) in paragraph (1)— 

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

8 inserting ‘‘2024 through 2028’’; and 

9 (B) by striking ‘‘$18,336,340’’ and insert10 ing ‘‘$25,000,000’’; and 

11 (2) in paragraph (2)— 

12 (A) in subparagraph (A)— 

13 (i) by striking ‘‘25 percent’’ and in14 serting ‘‘20 percent’’; and 

15 (ii) by inserting before the semicolon 

16 at the end the following: ‘‘and fees under 

17 subsection (a)(4) (relating to generic inves18 tigational new animal drug files)’’; 

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

20 percent’’ and inserting ‘‘40 percent’’; and 

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

22 percent’’ and inserting ‘‘40 percent’’. 

23 (c) ANNUAL FEE SETTING; ADJUSTMENTS.— 
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1 (1) ANNUAL FEE SETTING.— Section 741(c)(1) 

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

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

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

5 shall establish, not later than 60 days before the 

6 start of each fiscal year beginning after September 

7 30, 2023, for that fiscal year— 

8 ‘‘(A) abbreviated application fees that are 

9 based on the revenue amounts established 

10 under subsection (b), the adjustments provided 

11 under this subsection, and the amount of fees 

12 anticipated to be collected under subsection 

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

14 ‘‘(B) generic new animal drug sponsor 

15 fees, and generic new animal drug product fees, 

16 based on the revenue amounts established 

17 under subsection (b) and the adjustments pro18 vided under this subsection; and 

19 ‘‘(C) a generic investigational new animal 

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

21 submission described in subsection (a)(4)(A).’’. 

22 (2) INFLATION ADJUSTMENT.—Section 

23 741(c)(2) of the Federal Food, Drug, and Cosmetic 

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

25 (A) in subparagraph (A)— 
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1 (i) in the matter preceding clause (i), 

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

3 and 

4 (ii) in clause (iii), by striking ‘‘Balti5 more’’ and inserting ‘‘Arlington-Alexan6 dria’’; and 

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

8 ‘‘2020’’ and inserting ‘‘2025’’. 

9 (3) WORKLOAD ADJUSTMENT.—Section 

10 741(c)(3) of the Federal Food, Drug, and Cosmetic 

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

12 (A) in subparagraph (A)— 

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

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

15 (ii) in clause (i)— 

16 (I) by striking ‘‘and investiga17 tional generic new animal drug pro18 tocol submissions’’ and inserting ‘‘in19 vestigational generic new animal drug 

20 protocol submissions, requests to es21 tablish a generic investigational new 

22 animal drug file, and generic inves23 tigational new animal drug meeting 

24 requests’’; and 
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1 (II) by striking ‘‘; and’’ and in2 serting a semicolon; 

3 (iii) by redesignating clause (ii) as 

4 clause (iii); and 

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

6 following: 

7 ‘‘(ii) if the workload adjustment cal8 culated by the Secretary under clause (i) 

9 exceeds 25 percent, the Secretary shall use 

10 25 percent for the adjustment; and’’; and 

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

12 ‘‘2021 through 2023’’ and inserting ‘‘2026 

13 through 2028’’. 

14 (4) FINAL YEAR ADJUSTMENT.—Section 

15 741(c)(4) of the Federal Food, Drug, and Cosmetic 

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

17 (A) by striking ‘‘2023’’ each place it ap18 pears and inserting ‘‘2028’’; and 

19 (B) by striking ‘‘2024’’ and inserting 

20 ‘‘2029’’. 

21 (d) FEE WAIVER OR REDUCTION; EXEMPTION FROM

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

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

24 amended to read as follows: 
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1 ‘‘(d) FEE WAIVER OR REDUCTION.—The Secretary 

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

3 fees assessed under subsection (a) where the Secretary 

4 finds that the generic new animal drug is intended solely 

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

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

7 741(e) of the Federal Food, Drug, and Cosmetic Act (21 

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

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

10 generic investigational new animal drug file that is sub11 mitted by a person subject to fees under subsection (a) 

12 shall be considered incomplete and shall not be accepted 

13 for action by the Secretary until all fees owed by such per14 son have been paid. The Secretary may discontinue’’. 

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

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

17 21(f)(2)) is amended by striking ‘‘sponsors, and generic 

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

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

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

21 (g) CREDITING AND AVAILABILITY OF FEES.—Sec22 tion 741(g) of the Federal Food, Drug, and Cosmetic Act 

23 (21 U.S.C. 379j–21(g)) is amended— 

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

25 through 2023’’ and inserting ‘‘2024 through 2028’’; 
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1 (2) by striking the second paragraph (4) (relat2 ing to Offset), as added by section 202 of the Ani3 mal Generic Drug User Fee Amendments of 2013 

4 (Public Law 113–14); and 

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

6 ‘‘(5) RECOVERY OF COLLECTION SHORT7 FALLS.—The amount of fees otherwise authorized to 

8 be collected under this section shall be increased— 

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

10 if any, by which the amount collected under this 

11 section and appropriated for fiscal year 2024 

12 falls below the amount of fees authorized for 

13 fiscal year 2024 under paragraph (3); 

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

15 if any, by which the amount collected under this 

16 section and appropriated for fiscal year 2025 

17 falls below the amount of fees authorized for 

18 fiscal year 2025 under paragraph (3); and 

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

20 if any, by which the amount collected under this 

21 section and appropriated for fiscal years 2026 

22 and 2027 (including estimated collections for 

23 fiscal year 2027) falls below the amount of fees 

24 authorized for such fiscal years under para25 graph (3).’’. 
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1 (h) DEFINITIONS.—Section 741(k) of the Federal 

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

3 amended— 

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

5 and (11) as paragraphs (9), (10), (11), and (13), re6 spectively; 

7 (2) by inserting after paragraph (7) the fol8 lowing: 

9 ‘‘(8) GENERIC INVESTIGATIONAL NEW ANIMAL

10 DRUG MEETING REQUEST.—The term ‘generic inves11 tigational new animal drug meeting request’ means 

12 a request submitted by a generic new animal drug 

13 sponsor to meet with the Secretary to discuss an in14 vestigational submission for a generic new animal 

15 drug.’’; 

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

17 adding at the end the following: 

18 ‘‘(I) The activities necessary for explo19 ration and implementation of the United States 

20 and European Union Mutual Recognition 

21 Agreement for Pharmaceutical Good Manufac22 turing Practice Inspections, and the United 

23 States and United Kingdom Mutual Recogni24 tion Agreement Sectoral Annex for Pharma25 ceutical Good Manufacturing Practices, and 
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1 other mutual recognition agreements, with re2 spect to generic new animal drug products sub3 ject to review, including implementation activi4 ties prior to and following product approval.’’; 

5 and 

6 (4) by inserting after paragraph (11) (as so re7 designated) the following: 

8 ‘‘(12) REQUEST TO ESTABLISH A GENERIC IN9 VESTIGATIONAL NEW ANIMAL DRUG FILE.—The 

10 term ‘request to establish a generic investigational 

11 new animal drug file’ means the submission to the 

12 Secretary of a request to establish a generic inves13 tigational new animal drug file to contain investiga14 tional submissions for a generic new animal drug.’’. 

15 SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS. 

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

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

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

19 inserting ‘‘2023’’; 

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

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

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

23 place it appears and inserting ‘‘2028’’. 
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1 SEC. 204. SAVINGS CLAUSE. 

2 Notwithstanding the amendments made by this title, 

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

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

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

6 title, shall continue to be in effect with respect to abbre7 viated applications for a generic new animal drug and sup8 plemental abbreviated applications for a generic new ani9 mal drug (as defined in such part as of such day) that 

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

11 were accepted by the Food and Drug Administration for 

12 filing with respect to assessing and collecting any fee re13 quired by such part for a fiscal year prior to fiscal year 

14 2024. 

15 SEC. 205. 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 5 of 

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

20 and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as amend21 ed by this title, shall be assessed for abbreviated applica22 tions for a generic new animal drug and supplemental ab23 breviated applications for a generic new animal drug re24 ceived on or after October 1, 2023, regardless of the date 

25 of enactment of this Act. 
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1 SEC. 206. SUNSET DATES. 

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

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

4 cease to be effective October 1, 2028. 

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

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

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

8 (c) PREVIOUS SUNSET PROVISION.—Effective Octo9 ber 1, 2023, subsections (a) and (b) of section 206 of the 

10 Animal Generic Drug User Fee Amendments of 2018 

11 (Public Law 115–234) are repealed. 

12 TITLE III—SUPPORTING ANIMAL 

13 AND HUMAN HEALTH 

14 SEC. 301. REPORTING REQUIREMENTS. 

15 Section 740A of the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 379j–13), as amended by section 

17 104, is further amended— 

18 (1) in subsection (a)— 

19 (A) by striking ‘‘Beginning with’’ and in20 serting the following: 

21 ‘‘(1) IN GENERAL.—Beginning with’’; and 

22 (B) by adding at the end the following: 

23 ‘‘(2) CONTENTS.—The report under paragraph 

24 (1) shall include the following: 

25 ‘‘(A) Data, analysis and discussion of the 

26 changes in the number of individuals hired and 
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1 funded by fees collected pursuant to section 

2 740, and data, analysis, and discussion of the 

3 number of full-time equivalents in the animal 

4 drug review program, including a breakdown by 

5 funding from fees collected pursuant to section 

6 740 versus budget authority, and by each divi7 sion within the Center for Veterinary Medicine, 

8 the Office of Regulatory Affairs, and the Office 

9 of the Commissioner. 

10 ‘‘(B) Data, analysis, and discussion of the 

11 changes in the fee revenue amounts and costs 

12 for the process for the review of animal drug 

13 applications, including identifying— 

14 ‘‘(i) the drivers of such changes; and 

15 ‘‘(ii) changes in the total cost per full16 time equivalent in the animal drug review 

17 program. 

18 ‘‘(C) Data, analysis, and discussion of 

19 changes in the average full-time equivalent 

20 hours required to complete review of each type 

21 of animal drug application. 

22 ‘‘(D) For fiscal years 2024 and 2025, of 

23 the meeting requests from animal drug spon24 sors for which the Secretary has determined 

25 that a face-to-face meeting is appropriate, the 
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1 number of face-to-face meetings requested by 

2 sponsors to be conducted in person (in such 

3 manner as the Secretary shall prescribe on the 

4 website of the Food and Drug Administration), 

5 and the number of such in-person meetings 

6 granted by the Secretary.’’; and 

7 (2) in subsection (d)— 

8 (A) in paragraph (5), by inserting a 

9 comma after ‘‘paragraph (4)’’; 

10 (B) by redesignating paragraph (6) as 

11 paragraph (7); 

12 (C) by inserting after paragraph (5) the 

13 following: 

14 ‘‘(6) UPDATES TO CONGRESS.—The Secretary, 

15 in consultation with regulated industry, shall provide 

16 regular updates on negotiations on the reauthoriza17 tion of this part to the Committee on Health, Edu18 cation, Labor, and Pensions of the Senate and the 

19 Committee on Energy and Commerce of the House 

20 of Representatives.’’; and 

21 (D) in paragraph (7) (as so redesig22 nated)— 

23 (i) in subparagraph (A)— 

24 (I) by striking ‘‘Before pre25 senting the recommendations devel-
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1 oped under paragraphs (1) through 

2 (5) to Congress, the Secretary’’ and 

3 inserting ‘‘The Secretary’’; and 

4 (II) by inserting before the pe5 riod at the end the following: ‘‘, not 

6 later than 30 days after each such ne7 gotiation meeting’’; and 

8 (ii) in subparagraph (B), by inserting 

9 ‘‘, in sufficient detail,’’ after ‘‘shall sum10 marize’’. 

11 SEC. 302. DEFINITION OF MAJOR SPECIES. 

12 Section 201(nn) of the Federal Food, Drug, and Cos13 metic Act (21 U.S.C. 321(nn)) is amended by inserting 

14 ‘‘, or remove species from,’’ after ‘‘add species to’’. 

15 SEC. 303. ANTIMICROBIAL RESISTANCE. 

16 (a) REPORT ON ANTIMICROBIAL STEWARDSHIP.— 

17 Not later than December 31, 2023, the Secretary of 

18 Health and Human Services, acting through the Commis19 sioner of Food and Drugs, shall submit to the Committee 

20 on Energy and Commerce of the House of Representatives 

21 and the Committee on Health, Education, Labor, and 

22 Pensions of the Senate a report describing— 

23 (1) activities conducted by the Center for Vet24 erinary Medicine of the Food and Drug Administra25 tion (referred to in this section as ‘‘the Center’’) 
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1 during the period of fiscal years 2019 through 2023 

2 to support antimicrobial stewardship in veterinary 

3 settings, including ongoing activities and the tar4 geted completion date of such activities; and 

5 (2) with respect to antimicrobial stewardship in 

6 veterinary settings— 

7 (A) the goals of the Center regarding sup8 porting antimicrobial stewardship in veterinary 

9 settings; 

10 (B) activities the Center plans to execute 

11 during the period of fiscal years 2024 through 

12 2028 to support such goals, including targeted 

13 completion dates for such activities; and 

14 (C) metrics the Center plans to use to 

15 evaluate progress toward its goals regarding 

16 supporting antimicrobial stewardship in veteri17 nary settings. 

18 (b) ANNUAL PROGRESS REPORTS.—Not later than 

19 120 days after the end of each fiscal year during which 

20 fees are collected under section 740, the Secretary shall 

21 submit to the Committee on Energy and Commerce of the 

22 House of Representatives and the Committee on Health, 

23 Education, Labor, and Pensions of the Senate a report 

24 that includes— 
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1 (1) a description of activities conducted by the 

2 Center in the prior fiscal year to support anti3 microbial stewardship in veterinary settings, includ4 ing progress made toward goals and activities speci5 fied in subsection (a)(2); 

6 (2) in the case of an incomplete activity de7 scribed in subsection (a)(2)(B) for which the target 

8 completion date has passed— 

9 (A) an explanation for why such target 

10 completion date was not met; and 

11 (B) if applicable, the updated expected 

12 completion date for such activity; 

13 (3) a description of emerging challenges related 

14 to antimicrobial stewardship in veterinary settings 

15 that impact Center activities; and 

16 (4) a description of activities undertaken to 

17 incentivize the development of new drugs for the 

18 treatment, prevention, or control of bacterial dis19 eases in animals. 

Passed the House of Representatives July 17, 2023. 

Attest: 

Clerk. 
118TH CONGRESS 

1ST SESSION H. R. 1418 

AN ACT 

To amend the Federal Food, Drug, and Cosmetic 

new animal drugs and generic new animal drugs. Act to reauthorize user fee programs relating to