II 

Calendar No. 210 

118TH CONGRESS 

1ST SESSION H. R. 1418 

IN THE SENATE OF THE UNITED STATES 

JULY 18, 2023 

Received 

SEPTEMBER 20, 2023 

Read twice and placed on the calendar 

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, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Animal Drug and Ani5 mal Generic Drug User Fee 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 


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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. 

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 (21 U.S.C. 379j–11 et seq.), in 

14 the letters from the Secretary of Health and Human Serv15 ices to the Chairman of the Committee on Energy and 


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1 Commerce of the House of Representatives and the Chair2 man of the Committee on Health, Education, Labor, and 

3 Pensions of the Senate as set forth in the Congressional 

4 Record. 

5 SEC. 102. DEFINITIONS. 

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

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

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

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

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

11 follows: 

12 ‘‘(I) The activities necessary for implemen13 tation of the United States and European 

14 Union Mutual Recognition Agreement for Phar15 maceutical Good Manufacturing Practice In16 spections, and the United States and United 

17 Kingdom Mutual Recognition Agreement Sec18 toral Annex for Pharmaceutical Good Manufac19 turing Practices, and other mutual recognition 

20 agreements, with respect to animal drug prod21 ucts subject to review, including implementation 

22 activities prior to and following product ap23 proval.’’. 


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

2 FEES. 

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

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

5 12(a)(1)(A)(ii)) is amended— 

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

7 end; 

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

9 the end and inserting ‘‘; and’’; and 

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

11 ‘‘(III) an application for condi12 tional approval under section 571 of a 

13 new animal drug for which an animal 

14 drug application submitted under sec15 tion 512(b)(1) has been previously ap16 proved under section 512(d)(1) for 

17 another intended use.’’. 

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

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

20 379j–12(b)(1)) is amended to read as follows: 

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

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

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

24 shall be established to generate a total revenue 

25 amount of $33,500,000.’’. 

26 (c) ANNUAL FEE SETTING; ADJUSTMENTS.— 


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

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

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

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

5 60 days before the start of each fiscal year begin6 ning after September 30, 2023, the Secretary 

7 shall— 

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

9 drug application fees, supplemental animal drug 

10 application fees, animal drug sponsor fees, ani11 mal drug establishment fees, and animal drug 

12 product fees based on the revenue amounts es13 tablished under subsection (b) and the adjust14 ments provided under this subsection; and 

15 ‘‘(B) publish such fee revenue amounts 

16 and fees in the Federal Register.’’. 

17 (2) INFLATION ADJUSTMENT.—Section 

18 740(c)(2) of the Federal Food, Drug, and Cosmetic 

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

20 (A) in subparagraph (A)— 

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

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

23 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 ADJUSTMENTS.—Section 

7 740(c)(3) of the Federal Food, Drug, and Cosmetic 

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

9 (A) in subparagraph (A)— 

10 (i) in the matter preceding clause 

11 (i)— 

12 (I) by striking ‘‘2020’’ and in13 serting ‘‘2025’’; and 

14 (II) by striking ‘‘subparagraphs 

15 (B) and (C)’’ and inserting ‘‘subpara16 graph (B)’’; 

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

18 the end; and 

19 (iii) by striking clause (ii) and insert20 ing the following: 

21 ‘‘(ii) such adjustment shall be made 

22 for each fiscal year that the adjustment de23 termined by the Secretary is greater than 

24 3 percent, except for the first fiscal year 


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1 that the adjustment is greater than 3 per2 cent; and 

3 ‘‘(iii) the Secretary shall publish in 

4 the Federal Register notice under para5 graph (1) the amount of such adjustment 

6 and the supporting methodologies.’’; 

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

8 (C) by redesignating subparagraph (C) as 

9 subparagraph (B). 

10 (4) FINAL YEAR ADJUSTMENT.—Section 

11 740(c)(4) of the Federal Food, Drug, and Cosmetic 

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

13 as follows: 

14 ‘‘(4) OPERATING RESERVE ADJUSTMENT.— 

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

16 and each subsequent fiscal year, after the fee 

17 revenue amount established under subsection 

18 (b) is adjusted in accordance with paragraphs 

19 (2) and (3), the Secretary shall— 

20 ‘‘(i) increase the fee revenue amount 

21 for such fiscal year, if necessary to provide 

22 an operating reserve of not less than 12 

23 weeks; or 

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

25 reserve in excess of the number of weeks 


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1 specified in subparagraph (C) for that fis2 cal year, the Secretary shall decrease the 

3 fee revenue amount to provide not more 

4 than the number of weeks specified in sub5 paragraph (C) for that fiscal year. 

6 ‘‘(B) CARRYOVER USER FEES.—For pur7 poses of this paragraph, the operating reserve 

8 of carryover user fees for the process for the re9 view of animal drug applications does not in10 clude carryover user fees that have not been ap11 propriated. 

12 ‘‘(C) NUMBER OF WEEKS OF OPERATING

13 RESERVES.—The number of weeks of operating 

14 reserves specified in this subparagraph is— 

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

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

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

18 and 

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

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

21 the operating reserve is made under this para22 graph, the Secretary shall publish in the Fed23 eral Register notice under paragraph (1) the ra24 tionale for the amount of the adjustment and 

25 the supporting methodologies.’’. 


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

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

3 379j–12(d)(4)) is amended to read as follows: 

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

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

6 not apply with respect to any person who is the 

7 named applicant or sponsor of an animal drug appli8 cation, supplemental animal drug application, or in9 vestigational animal drug submission if such applica10 tion or submission involves the intentional genomic 

11 alteration of an animal that is intended to produce 

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

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

14 (e) CREDITING AND AVAILABILITY OF FEES.— 

15 (1) AUTHORIZATION OF APPROPRIATIONS.— 

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

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

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

19 ‘‘2024 through 2028’’. 

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

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

22 U.S.C. 379j–12(g)) is amended— 

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

24 paragraph (5)’’; and 

25 (B) by striking paragraph (5). 


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1 SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 

2 Section 740A of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 379j–13) is amended— 

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

5 inserting ‘‘2023’’; 

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

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

8 (3) in subsection (d)— 

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

10 and inserting ‘‘2028’’; and 

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

12 and inserting ‘‘2028’’. 

13 SEC. 105. SAVINGS CLAUSE. 

14 Notwithstanding the amendments made by this title, 

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

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

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

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

19 drug applications and supplemental animal drug applica20 tions (as defined in such part as of such day) that on or 

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

22 accepted by the Food and Drug Administration for filing 

23 with respect to assessing and collecting any fee required 

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


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1 SEC. 106. EFFECTIVE DATE. 

2 The amendments made by this title shall take effect 

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

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

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

6 and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as amend7 ed by this title, shall be assessed for animal drug applica8 tions and supplemental animal drug applications received 

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

10 enactment of this Act. 

11 SEC. 107. SUNSET DATES. 

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

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

14 U.S.C. 379j–11; 379j–12) shall cease to be effective Octo15 ber 1, 2028. 

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

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

18 379j–13) shall cease to be effective January 31, 2029. 

19 (c) PREVIOUS SUNSET PROVISION.—Effective Octo20 ber 1, 2023, subsections (a) and (b) of section 107 of the 

21 Animal Drug User Fee Amendments of 2018 (Public Law 

22 115–234) are repealed. 


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1 TITLE II—FEES RELATING TO 

2 GENERIC ANIMAL DRUGS 

3 SEC. 201. SHORT TITLE; FINDING. 

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

5 ‘‘Animal Generic 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 generic new animal drug de9 velopment process and the review of abbreviated applica10 tions for generic new animal drugs, supplemental abbre11 viated applications for generic new animal drugs, and in12 vestigational submissions for generic new animal drugs as 

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

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

15 and Cosmetic Act (21 U.S.C. 379j–21 et seq.), in the let16 ters from the Secretary of Health and Human Services 

17 to the Chairman of the Committee on Energy and Com18 merce of the House of Representatives and the Chairman 

19 of the Committee on Health, Education, Labor and Pen20 sions of the Senate as set forth in the Congressional 

21 Record. 

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

23 ANIMAL DRUG FEES. 

24 (a) GENERIC INVESTIGATIONAL NEW ANIMAL DRUG

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


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

2 adding at the end the following: 

3 ‘‘(4) GENERIC INVESTIGATIONAL NEW ANIMAL

4 DRUG FILE FEE.— 

5 ‘‘(A) IN GENERAL.— 

6 ‘‘(i) NEW FILE REQUEST.—Each per7 son that submits a request to establish a 

8 generic investigational new animal drug 

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

10 assessed a fee as established under sub11 section (c). 

12 ‘‘(ii) NEW SUBMISSION TO ESTAB13 LISHED FILE.—Each person that makes a 

14 submission to a generic investigational new 

15 animal drug file on or after October 1, 

16 2023, where such file was established prior 

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

18 for the first submission on or after October 

19 1, 2023, as established under subsection 

20 (c). 

21 ‘‘(B) PAYMENT.— 

22 ‘‘(i) NEW FILE REQUEST.—The fee 

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

24 due upon submission of the request to esVerDate Sep 11 2014 00:02 Sep 21, 2023 Jkt 039200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\H1418.PCS H1418

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1 tablish the generic investigational new ani2 mal drug file. 

3 ‘‘(ii) NEW SUBMISSION TO ESTAB4 LISHED FILE.—The fee required by sub5 paragraph (A)(ii) shall be due upon the 

6 first submission to the generic investiga7 tional new animal drug file. 

8 ‘‘(C) EXCEPTIONS.— 

9 ‘‘(i) TERMINATING AN EXISTING GE10 NERIC INVESTIGATIONAL NEW ANIMAL

11 DRUG FILE.—If a person makes a submis12 sion to the generic investigational new ani13 mal drug file to terminate that file, the 

14 person shall not be subject to a fee under 

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

16 ‘‘(ii) TRANSFERRING AN EXISTING GE17 NERIC INVESTIGATIONAL NEW ANIMAL

18 DRUG FILE.—If a person makes a submis19 sion to the generic investigational new ani20 mal drug file to transfer that file to a dif21 ferent generic new animal drug sponsor, 

22 the person shall not be subject to a fee 

23 under subparagraph (A)(ii) for that sub24 mission.’’. 


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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 fees under 

15 subsection (a)(4) (relating to generic inves16 tigational 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 investigational new animal 

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

18 submission described in 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 under clause (i) 

5 exceeds 25 percent, the Secretary shall use 

6 25 percent for the adjustment; and’’; and 

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

8 ‘‘2021 through 2023’’ and inserting ‘‘2026 

9 through 2028’’. 

10 (4) FINAL YEAR ADJUSTMENT.—Section 

11 741(c)(4) of the Federal Food, Drug, and Cosmetic 

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

13 (A) by striking ‘‘2023’’ each place it ap14 pears and inserting ‘‘2028’’; and 

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

16 ‘‘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 second paragraph (4) (relat22 ing to Offset), as added by section 202 of the Ani23 mal Generic Drug User Fee Amendments of 2013 

24 (Public Law 113–14); and 

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


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1 ‘‘(5) RECOVERY OF COLLECTION SHORT2 FALLS.—The amount of fees otherwise authorized to 

3 be collected under this section shall be increased— 

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

5 if any, by which the amount collected under this 

6 section and appropriated for fiscal year 2024 

7 falls below the amount of fees authorized for 

8 fiscal year 2024 under paragraph (3); 

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

10 if any, by which the amount collected under this 

11 section and appropriated for fiscal year 2025 

12 falls below the amount of fees authorized for 

13 fiscal year 2025 under paragraph (3); and 

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

15 if any, by which the amount collected under this 

16 section and appropriated for fiscal years 2026 

17 and 2027 (including estimated collections for 

18 fiscal year 2027) falls below the amount of fees 

19 authorized for such fiscal years under para20 graph (3).’’. 

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

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

23 amended— 


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

2 and (11) as paragraphs (9), (10), (11), and (13), re3 spectively; 

4 (2) by inserting after paragraph (7) the fol5 lowing: 

6 ‘‘(8) GENERIC INVESTIGATIONAL NEW ANIMAL

7 DRUG MEETING REQUEST.—The term ‘generic inves8 tigational new animal drug meeting request’ means 

9 a request submitted by a generic new animal drug 

10 sponsor to meet with the Secretary to discuss an in11 vestigational submission for a generic new animal 

12 drug.’’; 

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

14 adding at the end the following: 

15 ‘‘(I) The activities necessary for explo16 ration and implementation of the United States 

17 and European Union Mutual Recognition 

18 Agreement for Pharmaceutical Good Manufac19 turing Practice Inspections, and the United 

20 States and United Kingdom Mutual Recogni21 tion Agreement Sectoral Annex for Pharma22 ceutical Good Manufacturing Practices, and 

23 other mutual recognition agreements, with re24 spect to generic new animal drug products sub25 ject to review, including implementation activiVerDate Sep 11 2014 00:02 Sep 21, 2023 Jkt 039200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6201 E:\BILLS\H1418.PCS H1418

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1 ties prior to and following product approval.’’; 

2 and 

3 (4) by inserting after paragraph (11) (as so re4 designated) the following: 

5 ‘‘(12) REQUEST TO ESTABLISH A GENERIC IN6 VESTIGATIONAL NEW ANIMAL DRUG FILE.—The 

7 term ‘request to establish a generic investigational 

8 new animal drug file’ means the submission to the 

9 Secretary of a request to establish a generic inves10 tigational new animal drug file to contain investiga11 tional submissions for a generic new animal drug.’’. 

12 SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS. 

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

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

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

16 inserting ‘‘2023’’; 

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

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

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

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

21 SEC. 204. SAVINGS CLAUSE. 

22 Notwithstanding the amendments made by this title, 

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

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

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


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1 title, shall continue to be in effect with respect to abbre2 viated applications for a generic new animal drug and sup3 plemental abbreviated applications for a generic new ani4 mal drug (as defined in such part as of such day) that 

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

6 were accepted by the Food and Drug Administration for 

7 filing with respect to assessing and collecting any fee re8 quired by such part for a fiscal year prior to fiscal year 

9 2024. 

10 SEC. 205. EFFECTIVE DATE. 

11 The amendments made by this title shall take effect 

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

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

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

15 and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as amend16 ed by this title, shall be assessed for abbreviated applica17 tions for a generic new animal drug and supplemental ab18 breviated applications for a generic new animal drug re19 ceived on or after October 1, 2023, regardless of the date 

20 of enactment of this Act. 

21 SEC. 206. SUNSET DATES. 

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

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

24 cease to be effective October 1, 2028. 


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

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

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

4 (c) PREVIOUS SUNSET PROVISION.—Effective Octo5 ber 1, 2023, subsections (a) and (b) of section 206 of the 

6 Animal Generic Drug User Fee Amendments of 2018 

7 (Public Law 115–234) are repealed. 

8 TITLE III—SUPPORTING ANIMAL 

9 AND HUMAN HEALTH 

10 SEC. 301. REPORTING REQUIREMENTS. 

11 Section 740A of the Federal Food, Drug, and Cos12 metic Act (21 U.S.C. 379j–13), as amended by section 

13 104, is further amended— 

14 (1) in subsection (a)— 

15 (A) by striking ‘‘Beginning with’’ and in16 serting the following: 

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

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

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

20 (1) shall include the following: 

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

22 changes in the number of individuals hired and 

23 funded by fees collected pursuant to section 

24 740, and data, analysis, and discussion of the 

25 number of full-time equivalents in the animal 


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1 drug review program, including a breakdown by 

2 funding from fees collected pursuant to section 

3 740 versus budget authority, and by each divi4 sion within the Center for Veterinary Medicine, 

5 the Office of Regulatory Affairs, and the Office 

6 of the Commissioner. 

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

8 changes in the fee revenue amounts and costs 

9 for the process for the review of animal drug 

10 applications, including identifying— 

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

12 ‘‘(ii) changes in the total cost per full13 time equivalent in the animal drug review 

14 program. 

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

16 changes in the average full-time equivalent 

17 hours required to complete review of each type 

18 of animal drug application. 

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

20 the meeting requests from animal drug spon21 sors for which the Secretary has determined 

22 that a face-to-face meeting is appropriate, the 

23 number of face-to-face meetings requested by 

24 sponsors to be conducted in person (in such 

25 manner as the Secretary shall prescribe on the 


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1 website of the Food and Drug Administration), 

2 and the number of such in-person meetings 

3 granted by the Secretary.’’; and 

4 (2) in subsection (d)— 

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

6 comma after ‘‘paragraph (4)’’; 

7 (B) by redesignating paragraph (6) as 

8 paragraph (7); 

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

10 following: 

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

12 in consultation with regulated industry, shall provide 

13 regular updates on negotiations on the reauthoriza14 tion of this part to the Committee on Health, Edu15 cation, Labor, and Pensions of the Senate and the 

16 Committee on Energy and Commerce of the House 

17 of Representatives.’’; and 

18 (D) in paragraph (7) (as so redesig19 nated)— 

20 (i) in subparagraph (A)— 

21 (I) by striking ‘‘Before pre22 senting the recommendations devel23 oped under paragraphs (1) through 

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

25 inserting ‘‘The Secretary’’; and 


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1 (II) by inserting before the pe2 riod at the end the following: ‘‘, not 

3 later than 30 days after each such ne4 gotiation meeting’’; and 

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

6 ‘‘, in sufficient detail,’’ after ‘‘shall sum7 marize’’. 

8 SEC. 302. DEFINITION OF MAJOR SPECIES. 

9 Section 201(nn) of the Federal Food, Drug, and Cos10 metic Act (21 U.S.C. 321(nn)) is amended by inserting 

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

12 SEC. 303. ANTIMICROBIAL RESISTANCE. 

13 (a) REPORT ON ANTIMICROBIAL STEWARDSHIP.— 

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

15 Health and Human Services, acting through the Commis16 sioner of Food and Drugs, shall submit to the Committee 

17 on Energy and Commerce of the House of Representatives 

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

19 Pensions of the Senate a report describing— 

20 (1) activities conducted by the Center for Vet21 erinary Medicine of the Food and Drug Administra22 tion (referred to in this section as ‘‘the Center’’) 

23 during the period of fiscal years 2019 through 2023 

24 to support antimicrobial stewardship in veterinary 


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1 settings, including ongoing activities and the tar2 geted completion date of such activities; and 

3 (2) with respect to antimicrobial stewardship in 

4 veterinary settings— 

5 (A) the goals of the Center regarding sup6 porting antimicrobial stewardship in veterinary 

7 settings; 

8 (B) activities the Center plans to execute 

9 during the period of fiscal years 2024 through 

10 2028 to support such goals, including targeted 

11 completion dates for such activities; and 

12 (C) metrics the Center plans to use to 

13 evaluate progress toward its goals regarding 

14 supporting antimicrobial stewardship in veteri15 nary settings. 

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

17 120 days after the end of each fiscal year during which 

18 fees are collected under section 740, the Secretary shall 

19 submit to the Committee on Energy and Commerce of the 

20 House of Representatives and the Committee on Health, 

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

22 that includes— 

23 (1) a description of activities conducted by the 

24 Center in the prior fiscal year to support anti25 microbial stewardship in veterinary settings, includVerDate Sep 11 2014 00:02 Sep 21, 2023 Jkt 039200 PO 00000 Frm 00028 Fmt 6652 Sfmt 6201 E:\BILLS\H1418.PCS H1418

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1 ing progress made toward goals and activities speci2 fied in subsection (a)(2); 

3 (2) in the case of an incomplete activity de4 scribed in subsection (a)(2)(B) for which the target 

5 completion date has passed— 

6 (A) an explanation for why such target 

7 completion date was not met; and 

8 (B) if applicable, the updated expected 

9 completion date for such activity; 

10 (3) a description of emerging challenges related 

11 to antimicrobial stewardship in veterinary settings 

12 that impact Center activities; and 

13 (4) a description of activities undertaken to 

14 incentivize the development of new drugs for the 

15 treatment, prevention, or control of bacterial dis16 eases in animals. 

Passed the House of Representatives July 17, 2023. 

Attest: KEVIN F. MCCUMBER, 

Clerk. 


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Calendar No. 210 

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 

SEPTEMBER 20, 2023 

Read twice and placed on the calendar 


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