IB 

Union Calendar No. 80 

118TH CONGRESS 

1ST SESSION H. R. 1418 

[Report No. 118–104] 

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 

JUNE 9, 2023 

Additional sponsor: Ms. Lee of Nevada 

JUNE 9, 2023 

Reported with an amendment, committed to the Committee of the Whole 

House on the State of the Union, and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on March 7, 2023] 


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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. 


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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 

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. 

8 TITLE I—FEES RELATING TO 

9 ANIMAL DRUGS 

10 SEC. 101. SHORT TITLE; FINDING. 

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

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


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1 (b) FINDING.—Congress finds that the fees authorized 

2 by the amendments made in this title will be dedicated to3 ward expediting the animal drug development process and 

4 the review of new and supplemental animal drug applica5 tions and investigational animal drug submissions as set 

6 forth in the goals identified for purposes of part 4 of sub7 chapter C of chapter VII of the Federal Food, Drug, and 

8 Cosmetic Act (21 U.S.C. 379j–11 et seq.), in the letters from 

9 the Secretary of Health and Human Services to the Chair10 man of the Committee on Energy and Commerce of the 

11 House of Representatives and the Chairman of the Com12 mittee on Health, Education, Labor, and Pensions of the 

13 Senate as set forth in the Congressional Record. 

14 SEC. 102. DEFINITIONS. 

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

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

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

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

19 (2) by amending paragraph (8)(I) to read as fol20 lows: 

21 ‘‘(I) The activities necessary for implemen22 tation of the United States and European Union 

23 Mutual Recognition Agreement for Pharma24 ceutical Good Manufacturing Practice Inspec25 tions, and the United States and United KingVerDate Sep 11 2014 01:11 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6203 E:\BILLS\H1418.RH H1418

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1 dom Mutual Recognition Agreement Sectoral 

2 Annex for Pharmaceutical Good Manufacturing 

3 Practices, and other mutual recognition agree4 ments, with respect to animal drug products sub5 ject to review, including implementation activi6 ties prior to and following product approval.’’. 

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

8 FEES. 

9 (a) IN GENERAL.—Section 740(a)(1)(A)(ii) of the Fed10 eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

11 12(a)(1)(A)(ii)) is amended— 

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

13 end; 

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

15 the end and inserting ‘‘; and’’; and 

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

17 ‘‘(III) an application for condi18 tional approval under section 571 of a 

19 new animal drug for which an animal 

20 drug application submitted under sec21 tion 512(b)(1) has been previously ap22 proved under section 512(d)(1) for an23 other intended use.’’. 


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

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

3 12(b)(1)) is amended to read as follows: 

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

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

6 2028, the fees required under subsection (a) shall be 

7 established to generate a total revenue amount of 

8 $33,500,000.’’. 

9 (c) ANNUAL FEE SETTING; ADJUSTMENTS.— 

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

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

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

13 ‘‘(1) ANNUAL FEE SETTING.—Not later than 60 

14 days before the start of each fiscal year beginning 

15 after September 30, 2023, the Secretary shall— 

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

17 drug application fees, supplemental animal drug 

18 application fees, animal drug sponsor fees, ani19 mal drug establishment fees, and animal drug 

20 product fees based on the revenue amounts estab21 lished under subsection (b) and the adjustments 

22 provided under this subsection; and 

23 ‘‘(B) publish such fee revenue amounts and 

24 fees in the Federal Register.’’. 


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1 (2) INFLATION ADJUSTMENT.—Section 740(c)(2) 

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

3 U.S.C. 379j–12(c)(2)) is amended— 

4 (A) in subparagraph (A)— 

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

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

7 and 

8 (ii) in clause (iii), by striking ‘‘Balti9 more’’ and inserting ‘‘Arlington-Alexan10 dria’’; and 

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

12 ‘‘2020’’ and inserting ‘‘2025’’. 

13 (3) WORKLOAD ADJUSTMENTS.—Section 

14 740(c)(3) of the Federal Food, Drug, and Cosmetic 

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

16 (A) in subparagraph (A)— 

17 (i) in the matter preceding clause (i)— 

18 (I) by striking ‘‘2020’’ and insert19 ing ‘‘2025’’; and 

20 (II) by striking ‘‘subparagraphs 

21 (B) and (C)’’ and inserting ‘‘subpara22 graph (B)’’; 

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

24 the end; and 


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1 (iii) by striking clause (ii) and insert2 ing the following: 

3 ‘‘(ii) such adjustment shall be made for 

4 each fiscal year that the adjustment deter5 mined by the Secretary is greater than 3 

6 percent, except for the first fiscal year that 

7 the adjustment is greater than 3 percent; 

8 and 

9 ‘‘(iii) the Secretary shall publish in the 

10 Federal Register notice under paragraph 

11 (1) the amount of such adjustment and the 

12 supporting methodologies.’’; 

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

14 (C) by redesignating subparagraph (C) as 

15 subparagraph (B). 

16 (4) FINAL YEAR ADJUSTMENT.—Section 

17 740(c)(4) of the Federal Food, Drug, and Cosmetic 

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

19 follows: 

20 ‘‘(4) OPERATING RESERVE ADJUSTMENT.— 

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

22 and each subsequent fiscal year, after the fee rev23 enue amount established under subsection (b) is 

24 adjusted in accordance with paragraphs (2) and 

25 (3), the Secretary shall— 


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1 ‘‘(i) increase the fee revenue amount 

2 for such fiscal year, if necessary to provide 

3 an operating reserve of not less than 12 

4 weeks; or 

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

6 reserve in excess of the number of weeks 

7 specified in subparagraph (C) for that fiscal 

8 year, the Secretary shall decrease the fee 

9 revenue amount to provide not more than 

10 the number of weeks specified in subpara11 graph (C) for that fiscal year. 

12 ‘‘(B) CARRYOVER USER FEES.—For pur13 poses of this paragraph, the operating reserve of 

14 carryover user fees for the process for the review 

15 of animal drug applications does not include 

16 carryover user fees that have not been appro17 priated. 

18 ‘‘(C) NUMBER OF WEEKS OF OPERATING

19 RESERVES.—The number of weeks of operating 

20 reserves specified in this subparagraph is— 

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

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

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

24 and 

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


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

2 the operating reserve is made under this para3 graph, the Secretary shall publish in the Federal 

4 Register notice under paragraph (1) the ration5 ale for the amount of the adjustment and the 

6 supporting methodologies.’’. 

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

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

9 12(d)(4)) is amended to read as follows: 

10 ‘‘(4) EXEMPTION FROM FEES.—Fees under para11 graphs (2), (3), and (4) of subsection (a) shall not 

12 apply with respect to any person who is the named 

13 applicant or sponsor of an animal drug application, 

14 supplemental animal drug application, or investiga15 tional animal drug submission if such application or 

16 submission involves the intentional genomic alter17 ation of an animal that is intended to produce a 

18 drug, device, or biological product subject to fees 

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

20 (e) CREDITING AND AVAILABILITY OF FEES.— 

21 (1) AUTHORIZATION OF APPROPRIATIONS.—Sec22 tion 740(g)(3) of the Federal Food, Drug, and Cos23 metic Act (21 U.S.C. 379j–12(g)(3)) is amended by 

24 striking ‘‘2019 through 2023’’ and inserting ‘‘2024 

25 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 Cosmetic 

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

10 (1) in subsection (a), by striking ‘‘2018’’ and in11 serting ‘‘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 in 

23 effect on the day before the date of enactment of this title, 

24 shall continue to be in effect with respect to animal drug 

25 applications and supplemental animal drug applications 


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1 (as defined in such part as of such day) that on or after 

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

3 by the Food and Drug Administration for filing with re4 spect to assessing and collecting any fee required by such 

5 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 sub10 chapter C of chapter VII of the Federal Food, Drug, and 

11 Cosmetic Act (21 U.S.C. 379j-11 et seq.), as amended by 

12 this title, shall be assessed for animal drug applications and 

13 supplemental animal drug applications received on or after 

14 October 1, 2023, regardless of the date of the enactment of 

15 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 U.S.C. 

19 379j–11; 379j–12) shall cease to be effective October 1, 2028. 

20 (b) REPORTING REQUIREMENTS.—Section 740A of the 

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

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

23 (c) PREVIOUS SUNSET PROVISION.—Effective October 

24 1, 2023, subsections (a) and (b) of section 107 of the Animal 


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1 Drug User Fee Amendments of 2018 (Public Law 115–234) 

2 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 authorized 

9 by the amendments made in this title will be dedicated to10 ward expediting the generic new animal drug development 

11 process and the review of abbreviated applications for ge12 neric new animal drugs, supplemental abbreviated applica13 tions for generic new animal drugs, and investigational 

14 submissions for generic new animal drugs as set forth in 

15 the goals identified for purposes of part 5 of subchapter C 

16 of chapter VII of the Federal Food, Drug, and Cosmetic Act 

17 (21 U.S.C. 379j–21 et seq.), in the letters from the Secretary 

18 of Health and Human Services to the Chairman of the 

19 Committee on Energy and Commerce of the House of Rep20 resentatives and the Chairman of the Committee on Health, 

21 Education, Labor and Pensions of the Senate as set forth 

22 in the Congressional 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, and 

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

6 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 ge12 neric investigational new animal drug file 

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

14 a fee as established under subsection (c). 

15 ‘‘(ii) NEW SUBMISSION TO ESTAB16 LISHED FILE.—Each person that makes a 

17 submission to a generic investigational new 

18 animal drug file on or after October 1, 

19 2023, where such file was established prior 

20 to October 1, 2023, shall be assessed a fee for 

21 the first submission on or after October 1, 

22 2023, as established under subsection (c). 

23 ‘‘(B) PAYMENT.— 

24 ‘‘(i) NEW FILE REQUEST.—The fee re25 quired by subparagraph (A)(i) shall be due 

26 upon submission of the request to establish 


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1 the generic investigational new animal drug 

2 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 DRUG

11 FILE.—If a person makes a submission to 

12 the generic investigational new animal drug 

13 file to terminate that file, the person shall 

14 not be subject to a fee under subparagraph 

15 (A)(ii) for that submission. 

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

18 FILE.—If a person makes a submission to 

19 the generic investigational new animal drug 

20 file to transfer that file to a different ge21 neric new animal drug sponsor, the person 

22 shall not be subject to a fee under subpara23 graph (A)(ii) for that 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 inserting 

8 ‘‘$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 at 

14 the end the following: ‘‘and fees under sub15 section (a)(4) (relating to generic investiga16 tional 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) of 

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

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


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

2 establish, not later than 60 days before the start of 

3 each fiscal year beginning after September 30, 2023, 

4 for that fiscal year— 

5 ‘‘(A) abbreviated application fees that are 

6 based on the revenue amounts established under 

7 subsection (b), the adjustments provided under 

8 this subsection, and the amount of fees antici9 pated to be collected under subsection (a)(4) dur10 ing that fiscal year; 

11 ‘‘(B) generic new animal drug sponsor fees, 

12 and generic new animal drug product fees, based 

13 on the revenue amounts established under sub14 section (b) and the adjustments provided under 

15 this subsection; and 

16 ‘‘(C) a generic investigational new animal 

17 drug file fee of $50,000 for each request or sub18 mission described in subsection (a)(4)(A).’’. 

19 (2) INFLATION ADJUSTMENT.—Section 741(c)(2) 

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

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 741(c)(3) 

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

8 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 estab18 lish a generic investigational new ani19 mal drug file, and generic investiga20 tional new animal drug meeting re21 quests’’; 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) ex5 ceeds 25 percent, the Secretary shall use 25 

6 percent for the adjustment; and’’; and 

7 (B) in subparagraph (B), by striking ‘‘2021 

8 through 2023’’ and inserting ‘‘2026 through 

9 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 Food, 

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

20 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 finds 

24 that the generic new animal drug is intended solely to pro25 vide 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) shall 

7 be considered incomplete and shall not be accepted for ac8 tion by the Secretary until all fees owed by such person 

9 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 new 

13 animal drug products at any time’’ and inserting ‘‘prod14 ucts, generic new animal drug sponsors, and generic inves15 tigational new animal drug files at any time’’. 

16 (g) CREDITING AND AVAILABILITY OF FEES.—Section 

17 741(g) of the Federal Food, Drug, and Cosmetic Act (21 

18 U.S.C. 379j–21(g)) is amended— 

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

20 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 Animal 

23 Generic Drug User Fee Amendments of 2013 (Public 

24 Law 113–14); and 

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


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1 ‘‘(5) RECOVERY OF COLLECTION SHORTFALLS.— 

2 The amount of fees otherwise authorized to be collected 

3 under this section shall be increased— 

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

5 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 fis8 cal year 2024 under paragraph (3); 

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

10 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 fis13 cal year 2025 under paragraph (3); and 

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

15 any, by which the amount collected under this 

16 section and appropriated for fiscal years 2026 

17 and 2027 (including estimated collections for fis18 cal year 2027) falls below the amount of fees au19 thorized for such fiscal years under paragraph 

20 (3).’’. 

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

22 Drug, and Cosmetic Act (21 U.S.C. 379j–21(k)) is amend23 ed— 


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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 a 

9 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 exploration 

16 and implementation of the United States and 

17 European Union Mutual Recognition Agreement 

18 for Pharmaceutical Good Manufacturing Prac19 tice Inspections, and the United States and 

20 United Kingdom Mutual Recognition Agreement 

21 Sectoral Annex for Pharmaceutical Good Manu22 facturing Practices, and other mutual recogni23 tion agreements, with respect to generic new ani24 mal drug products subject to review, including 


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1 implementation activities prior to and following 

2 product approval.’’; 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 term 

7 ‘request to establish a generic investigational new ani8 mal drug file’ means the submission to the Secretary 

9 of a request to establish a generic investigational new 

10 animal drug file to contain investigational submis11 sions 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 in16 serting ‘‘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 in 

25 effect on the day before the date of enactment of this title, 


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1 shall continue to be in effect with respect to abbreviated ap2 plications for a generic new animal drug and supplemental 

3 abbreviated applications for a generic new animal drug (as 

4 defined in such part as of such day) that on or after October 

5 1, 2018, but before October 1, 2023, were accepted by the 

6 Food and Drug Administration for filing with respect to 

7 assessing and collecting any fee required by such part for 

8 a fiscal year prior to fiscal year 2024. 

9 SEC. 205. EFFECTIVE DATE. 

10 The amendments made by this title shall take effect 

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

12 Act, whichever is later, except that fees under part 5 of sub13 chapter C of chapter VII of the Federal Food, Drug, and 

14 Cosmetic Act (21 U.S.C. 379j–21 et seq.), as amended by 

15 this title, shall be assessed for abbreviated applications for 

16 a generic new animal drug and supplemental abbreviated 

17 applications for a generic new animal drug received on or 

18 after October 1, 2023, regardless of the date of enactment 

19 of this Act. 

20 SEC. 206. SUNSET DATES. 

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

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

23 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 October 

5 1, 2023, subsections (a) and (b) of section 206 of the Animal 

6 Generic Drug User Fee Amendments of 2018 (Public Law 

7 115–234) 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 Cosmetic 

12 Act (21 U.S.C. 379j–13), as amended by section 104, is fur13 ther 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 740, 

24 and data, analysis, and discussion of the number 

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1 view program, including a breakdown by fund2 ing from fees collected pursuant to section 740 

3 versus budget authority, and by each division 

4 within the Center for Veterinary Medicine, the 

5 Office of Regulatory Affairs, and the Office of the 

6 Commissioner. 

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

8 changes in the fee revenue amounts and costs for 

9 the process for the review of animal drug appli10 cations, 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 hours 

17 required to complete review of each type of ani18 mal drug application. 

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

20 meeting requests from animal drug sponsors for 

21 which the Secretary has determined that a face22 to-face meeting is appropriate, the number of 

23 face-to-face meetings requested by sponsors to be 

24 conducted in person (in such manner as the Sec25 retary shall prescribe on the website of the Food 


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1 and Drug Administration), and the number of 

2 such in-person meetings granted by the Sec3 retary.’’; 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 fol10 lowing: 

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

12 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 of 

17 Representatives.’’; and 

18 (D) in paragraph (7) (as so redesignated)— 

19 (i) in subparagraph (A)— 

20 (I) by striking ‘‘Before presenting 

21 the recommendations developed under 

22 paragraphs (1) through (5) to Con23 gress, the Secretary’’ and inserting 

24 ‘‘The Secretary’’; and 


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1 (II) by inserting before the period 

2 at the end the following: ‘‘, not later 

3 than 30 days after each such negotia4 tion meeting’’; and 

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

6 ‘‘, in sufficient detail,’’ after ‘‘shall summa7 rize’’. 

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.—Not 

14 later than December 31, 2023, the Secretary of Health and 

15 Human Services, acting through the Commissioner of Food 

16 and Drugs, shall submit to the Committee on Energy and 

17 Commerce of the House of Representatives and the Com18 mittee on Health, Education, Labor, and Pensions of the 

19 Senate a report describing— 

20 (1) activities conducted by the Center for Veteri21 nary Medicine of the Food and Drug Administration 

22 (referred to in this section as ‘‘the Center’’) during the 

23 period of fiscal years 2019 through 2023 to support 

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1 cluding ongoing activities and the targeted completion 

2 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 evalu13 ate progress toward its goals regarding sup14 porting antimicrobial stewardship in veterinary 

15 settings. 

16 (b) ANNUAL PROGRESS REPORTS.—Not later than 120 

17 days after the end of each fiscal year during which fees are 

18 collected under section 740, the Secretary shall submit to 

19 the Committee on Energy and Commerce of the House of 

20 Representatives and the Committee on Health, Education, 

21 Labor, and Pensions of the Senate a report that includes— 

22 (1) a description of activities conducted by the 

23 Center in the prior fiscal year to support anti24 microbial stewardship in veterinary settings, includVerDate Sep 11 2014 01:11 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00029 Fmt 6652 Sfmt 6203 E:\BILLS\H1418.RH 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 com9 pletion 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 treat15 ment, prevention, or control of bacterial diseases in 

16 animals. 


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Union Calendar No. 80 

118TH CONGRESS 

1ST SESSION H. R. 1418 

[Report No. 118–104] 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

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

JUNE 9, 2023 

Reported with an amendment, committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union, 


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