Animal Drug and Animal Generic Drug User Fee Amendments of 2023

II Calendar No. 174 118TH CONGRESS 1ST SESSION S. 1844 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 SENATE OF THE UNITED STATES JUNE 7, 2023 Ms. BALDWIN (for herself and Mr. MULLIN) introduced the following bill; which was read twice and referred to the Committee on Health, Edu- cation, Labor, and Pensions JULY 26, 2023 Reported by Mr. SANDERS, with an amendment [Insert the part printed in italic] A BILL To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs and generic new animal drugs. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Animal Drug and Ani- 4 mal Generic Drug User Fee Amendments of 2023’’. 5 VerDate Sep 11 2014 06:25 Jul 27, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1844.RS S1844 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •S 1844 RS SEC. 2. TABLE OF CONTENTS. 1 The table of contents for this Act is the following: 2 Sec. 1. Short title. Sec. 2. Table of contents. TITLE I—FEES RELATING TO ANIMAL DRUGS Sec. 101. Short title; finding. Sec. 102. Definitions. Sec. 103. Authority to assess and use animal drug fees. Sec. 104. Reauthorization; reporting requirements. Sec. 105. Savings clause. Sec. 106. Effective date. Sec. 107. Sunset dates. TITLE II—FEES RELATING TO GENERIC ANIMAL DRUGS Sec. 201. Short title; finding. Sec. 202. Authority to assess and use generic new animal drug fees. Sec. 203. Reauthorization; reporting requirements. Sec. 204. Savings clause. Sec. 205. Effective date. Sec. 206. Sunset dates. TITLE III—SUPPORTING ANIMAL AND HUMAN HEALTH Sec. 301. Reporting requirements. Sec. 302. Definition of major species. Sec. 303. Antimicrobial resistance. Sec. 304. Regulation of zootechnical animal food substances. TITLE I—FEES RELATING TO 3 ANIMAL DRUGS 4 SEC. 101. SHORT TITLE; FINDING. 5 (a) SHORT TITLE.—This title may be cited as the 6 ‘‘Animal Drug User Fee Amendments of 2023’’. 7 (b) FINDING.—Congress finds that the fees author- 8 ized by the amendments made in this title will be dedi- 9 cated toward expediting the animal drug development 10 process and the review of new and supplemental animal 11 drug applications and investigational animal drug submis- 12 sions as set forth in the goals identified for purposes of 13 VerDate Sep 11 2014 06:25 Jul 27, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1844.RS S1844 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •S 1844 RS part 4 of subchapter C of chapter VII of the Federal Food, 1 Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), in 2 the letters from the Secretary of Health and Human Serv- 3 ices to the Chairman of the Committee on Energy and 4 Commerce of the House of Representatives and the Chair- 5 man of the Committee on Health, Education, Labor, and 6 Pensions of the Senate as set forth in the Congressional 7 Record. 8 SEC. 102. DEFINITIONS. 9 Section 739 of the Federal Food, Drug, and Cosmetic 10 Act (21 U.S.C. 379j–11) is amended— 11 (1) in paragraph (3), by striking ‘‘national drug 12 code’’ and inserting ‘‘National Drug Code’’; and 13 (2) by amending paragraph (8)(I) to read as 14 follows: 15 ‘‘(I) The activities necessary for implemen- 16 tation of the United States and European 17 Union Mutual Recognition Agreement for Phar- 18 maceutical Good Manufacturing Practice In- 19 spections, and the United States and United 20 Kingdom Mutual Recognition Agreement Sec- 21 toral Annex for Pharmaceutical Good Manufac- 22 turing Practices, and other mutual recognition 23 agreements, with respect to animal drug prod- 24 ucts subject to review, including implementation 25 VerDate Sep 11 2014 06:25 Jul 27, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1844.RS S1844 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •S 1844 RS activities prior to and following product ap- 1 proval.’’. 2 SEC. 103. AUTHORITY TO ASSESS AND USE ANIMAL DRUG 3 FEES. 4 (a) IN GENERAL.—Section 740(a)(1)(A)(ii) of the 5 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 6 12(a)(1)(A)(ii)) is amended— 7 (1) in subclause (I), by striking ‘‘and’’ at the 8 end; 9 (2) in subclause (II), by striking the period at 10 the end and inserting ‘‘; and’’; and 11 (3) by adding at the end the following: 12 ‘‘(III) an application for condi- 13 tional approval under section 571 of a 14 new animal drug for which an animal 15 drug application submitted under sec- 16 tion 512(b)(1) has been previously ap- 17 proved under section 512(d)(1) for 18 another intended use.’’. 19 (b) FEE REVENUE AMOUNTS.—Section 740(b)(1) of 20 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 21 379j–12(b)(1)) is amended to read as follows: 22 ‘‘(1) IN GENERAL.—Subject to subsections (c), 23 (d), (f), and (g), for each of fiscal years 2024 24 through 2028, the fees required under subsection (a) 25 VerDate Sep 11 2014 06:25 Jul 27, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1844.RS S1844 pbinns on DSKJLVW7X2PROD with $$_JOB 5 •S 1844 RS shall be established to generate a total revenue 1 amount of $33,500,000.’’. 2 (c) ANNUAL FEE SETTING; ADJUSTMENTS.— 3 (1) ANNUAL FEE SETTING.—Section 740(c)(1) 4 of the Federal Food, Drug, and Cosmetic Act (21 5 U.S.C. 379j–12(c)(1)) is amended to read as follows: 6 ‘‘(1) ANNUAL FEE SETTING.—Not later than 7 60 days before the start of each fiscal year begin- 8 ning after September 30, 2023, the Secretary 9 shall— 10 ‘‘(A) establish for that fiscal year animal 11 drug application fees, supplemental animal drug 12 application fees, animal drug sponsor fees, ani- 13 mal drug establishment fees, and animal drug 14 product fees based on the revenue amounts es- 15 tablished under subsection (b) and the adjust- 16 ments provided under this subsection; and 17 ‘‘(B) publish such fee revenue amounts 18 and fees in the Federal Register.’’. 19 (2) INFLATION ADJUSTMENT.—Section 20 740(c)(2) of the Federal Food, Drug, and Cosmetic 21 Act (21 U.S.C. 379j–12(c)(2)) is amended— 22 (A) in subparagraph (A)— 23 VerDate Sep 11 2014 06:25 Jul 27, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1844.RS S1844 pbinns on DSKJLVW7X2PROD with $$_JOB 6 •S 1844 RS (i) in the matter preceding clause (i), 1 by striking ‘‘2020’’ and inserting ‘‘2025’’; 2 and 3 (ii) in clause (iii), by striking ‘‘Balti- 4 more’’ and inserting ‘‘Arlington-Alexan- 5 dria’’; and 6 (B) in subparagraph (B), by striking 7 ‘‘2020’’ and inserting ‘‘2025’’. 8 (3) WORKLOAD ADJUSTMENTS.—Section 9 740(c)(3) of the Federal Food, Drug, and Cosmetic 10 Act (21 U.S.C. 379j–12(c)(3)) is amended— 11 (A) in subparagraph (A)— 12 (i) in the matter preceding clause 13 (i)— 14 (I) by striking ‘‘2020’’ and in- 15 serting ‘‘2025’’; and 16 (II) by striking ‘‘subparagraphs 17 (B) and (C)’’ and inserting ‘‘subpara- 18 graph (B)’’; 19 (ii) in clause (i) by striking ‘‘and’’ at 20 the end; and 21 (iii) by striking clause (ii) and insert- 22 ing the following: 23 ‘‘(ii) such adjustment shall be made 24 for each fiscal year that the adjustment de- 25 VerDate Sep 11 2014 06:25 Jul 27, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1844.RS S1844 pbinns on DSKJLVW7X2PROD with $$_JOB 7 •S 1844 RS termined by the Secretary is greater than 1 3 percent, except for the first fiscal year 2 that the adjustment is greater than 3 per- 3 cent; and 4 ‘‘(iii) the Secretary shall publish in 5 the Federal Register notice under para- 6 graph (1) the amount of such adjustment 7 and the supporting methodologies.’’; 8 (B) by striking subparagraph (B); and 9 (C) by redesignating subparagraph (C) as 10 subparagraph (B). 11 (4) FINAL YEAR ADJUSTMENT.—Section 12 740(c)(4) of the Federal Food, Drug, and Cosmetic 13 Act (21 U.S.C. 379j–12(c)(4)) is amended to read 14 as follows: 15 ‘‘(4) OPERATING RESERVE ADJUSTMENT.— 16 ‘‘(A) IN GENERAL.—For fiscal year 2025 17 and each subsequent fiscal year, after the fee 18 revenue amount established under subsection 19 (b) is adjusted in accordance with paragraphs 20 (2) and (3), the Secretary shall— 21 ‘‘(i) increase the fee revenue amount 22 for such fiscal year, if necessary to provide 23 an operating reserve of not less than 12 24 weeks; or 25 VerDate Sep 11 2014 06:25 Jul 27, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1844.RS S1844 pbinns on DSKJLVW7X2PROD with $$_JOB 8 •S 1844 RS ‘‘(ii) if the Secretary has an operating 1 reserve in excess of the number of weeks 2 specified in subparagraph (C) for that fis- 3 cal year, the Secretary shall decrease the 4 fee revenue amount to provide not more 5 than the number of weeks specified in sub- 6 paragraph (C) for that fiscal year. 7 ‘‘(B) CARRYOVER USER FEES.—For pur- 8 poses of this paragraph, the operating reserve 9 of carryover user fees for the process for the re- 10 view of animal drug applications does not in- 11 clude carryover user fees that have not been ap- 12 propriated. 13 ‘‘(C) NUMBER OF WEEKS OF OPERATING 14 RESERVES.—The number of weeks of operating 15 reserves specified in this subparagraph is— 16 ‘‘(i) 22 weeks for fiscal year 2025; 17 ‘‘(ii) 20 weeks for fiscal year 2026; 18 ‘‘(iii) 18 weeks for fiscal year 2027; 19 and 20 ‘‘(iv) 16 weeks for fiscal year 2028. 21 ‘‘(D) PUBLICATION.—If an adjustment to 22 the operating reserve is made under this para- 23 graph, the Secretary shall publish in the Fed- 24 eral Register notice under paragraph (1) the ra- 25 VerDate Sep 11 2014 06:25 Jul 27, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1844.RS S1844 pbinns on DSKJLVW7X2PROD with $$_JOB 9 •S 1844 RS tionale for the amount of the adjustment and 1 the supporting methodologies.’’. 2 (d) EXEMPTION FROM FEES.—Section 740(d)(4) of 3 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 4 379j–12(d)(4)) is amended to read as follows: 5 ‘‘(4) EXEMPTION FROM FEES.—Fees under 6 paragraphs (2), (3), and (4) of subsection (a) shall 7 not apply with respect to any person who is the 8 named applicant or sponsor of an animal drug appli- 9 cation, supplemental animal drug application, or in- 10 vestigational animal drug submission if such applica- 11 tion or submission involves the intentional genomic 12 alteration of an animal that is intended to produce 13 a drug, device, or biological product subject to fees 14 under section 736, 738, 744B, or 744H.’’. 15 (e) CREDITING AND AVAILABILITY OF FEES.— 16 (1) AUTHORIZATION OF APPROPRIATIONS.— 17 Section 740(g)(3) of the Federal Food, Drug, and 18 Cosmetic Act (21 U.S.C. 379j–12(g)(3)) is amended 19 by striking ‘‘2019 through 2023’’ and inserting 20 ‘‘2024 through 2028’’. 21 (2) COLLECTION SHORTFALLS.—Section 740(g) 22 of the Federal Food, Drug, and Cosmetic Act (21 23 U.S.C. 379j–12(g)) is amended— 24 VerDate Sep 11 2014 06:25 Jul 27, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1844.RS S1844 pbinns on DSKJLVW7X2PROD with $$_JOB 10 •S 1844 RS (A) in paragraph (3), by striking ‘‘and 1 paragraph (5)’’; and 2 (B) by striking paragraph (5). 3 SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 4 Section 740A of the Federal Food, Drug, and Cos- 5 metic Act (21 U.S.C. 379j–13) is amended— 6 (1) in subsection (a), by striking ‘‘2018’’ and 7 inserting ‘‘2023’’; 8 (2) by striking ‘‘2019’’ each place it appears in 9 subsections (a) and (b) and inserting ‘‘2024’’; and 10 (3) in subsection (d)— 11 (A) in paragraph (1), by striking ‘‘2023’’ 12 and inserting ‘‘2028’’; and 13 (B) in paragraph (5), by striking ‘‘2023’’ 14 and inserting ‘‘2028’’. 15 SEC. 105. SAVINGS CLAUSE. 16 Notwithstanding the amendments made by this title, 17 part 4 of subchapter C of chapter VII of the Federal Food, 18 Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as 19 in effect on the day before the date of enactment of this 20 title, shall continue to be in effect with respect to animal 21 drug applications and supplemental animal drug applica- 22 tions (as defined in such part as of such day) that on or 23 after October 1, 2018, but before October 1, 2023, were 24 accepted by the Food and Drug Administration for filing 25 VerDate Sep 11 2014 06:25 Jul 27, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1844.RS S1844 pbinns on DSKJLVW7X2PROD with $$_JOB 11 •S 1844 RS with respect to assessing and collecting any fee required 1 by such part for a fiscal year prior to fiscal year 2024. 2 SEC. 106. EFFECTIVE DATE. 3 The amendments made by this title shall take effect 4 on October 1, 2023, or the date of the enactment of this 5 Act, whichever is later, except that fees under part 4 of 6 subchapter C of chapter VII of the Federal Food, Drug, 7 and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as amend- 8 ed by this title, shall be assessed for animal drug applica- 9 tions and supplemental animal drug applications received 10 on or after October 1, 2023, regardless of the date of the 11 enactment of this Act. 12 SEC. 107. SUNSET DATES. 13 (a) AUTHORIZATION.—Sections 739 and 740 of the 14 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 21 15 U.S.C. 379j–11; 379j–12) shall cease to be effective Octo- 16 ber 1, 2028. 17 (b) REPORTING REQUIREMENTS.—Section 740A of 18 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 19 379j–13) shall cease to be effective January 31, 2029. 20 (c) PREVIOUS SUNSET PROVISION.—Effective Octo- 21 ber 1, 2023, subsections (a) and (b) of section 107 of the 22 Animal Drug User Fee Amendments of 2018 (Public Law 23 115–234) are repealed. 24 VerDate Sep 11 2014 06:25 Jul 27, 2023 Jkt 039200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S1844.RS S1844 pbinns on DSKJLVW7X2PROD with $$_JOB 12 •S 1844 RS TITLE II—FEES RELATING TO 1 GENERIC ANIMAL DRUGS 2 SEC. 201. SHORT TITLE; FINDING. 3 (a) SHORT TITLE.—This title may be cited as the 4 ‘‘Animal Generic Drug User Fee Amendments of 2023’’. 5 (b) FINDING.—Congress finds that the fees author- 6 ized by the amendments made in this title will be dedi- 7 cated toward expediting the generic new animal drug de- 8 velopment process and the review of abbreviated applica- 9 tions for generic new animal drugs, supplemental abbre- 10 viated applications for generic new animal drugs, and in- 11 vestigational submissions for generic new animal drugs as 12 set forth in the goals identified for purposes of part 5 of 13 subchapter C of chapter VII of the Federal Food, Drug, 14 and Cosmetic Act (21 U.S.C. 379j–21 et seq.), in the let- 15 ters from the Secretary of Health and Human Services 16 to the Chairman of the Committee on Energy and Com- 17 merce of the House of Representatives and the Chairman 18 of the Committee on Health, Education, Labor and Pen [Text truncated for display. 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