Animal Drug and Animal Generic Drug User Fee Amendments of 2023

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. Short title This Act may be cited as the Animal Drug and Animal Generic Drug User Fee Amendments of 2023 2. Table of contents 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. I Fees Relating to Animal Drugs 101. Short title; finding (a) Short title This title may be cited as the Animal Drug User Fee Amendments of 2023 (b) Finding Congress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the animal drug development process and the review of new and supplemental animal drug applications and investigational animal drug submissions as set forth in the goals identified for purposes of part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–11 et seq. 102. Definitions Section 739 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–11 (1) in paragraph (3), by striking national drug code National Drug Code (2) by amending paragraph (8)(I) to read as follows: (I) The activities necessary for implementation of the United States and European Union Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections, and the United States and United Kingdom Mutual Recognition Agreement Sectoral Annex for Pharmaceutical Good Manufacturing Practices, and other mutual recognition agreements, with respect to animal drug products subject to review, including implementation activities prior to and following product approval. . 103. Authority to assess and use animal drug fees (a) In general Section 740(a)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–12(a)(1)(A)(ii) (1) in subclause (I), by striking and (2) in subclause (II), by striking the period at the end and inserting ; and (3) by adding at the end the following: (III) an application for conditional approval under section 571 of a new animal drug for which an animal drug application submitted under section 512(b)(1) has been previously approved under section 512(d)(1) for another intended use. . (b) Fee revenue amounts Section 740(b)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–12(b)(1) (1) In general Subject to subsections (c), (d), (f), and (g), for each of fiscal years 2024 through 2028, the fees required under subsection (a) shall be established to generate a total revenue amount of $33,500,000. . (c) Annual fee setting; adjustments (1) Annual fee setting Section 740(c)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–12(c)(1) (1) Annual fee setting Not later than 60 days before the start of each fiscal year beginning after September 30, 2023, the Secretary shall— (A) establish for that fiscal year animal drug application fees, supplemental animal drug application fees, animal drug sponsor fees, animal drug establishment fees, and animal drug product fees based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and (B) publish such fee revenue amounts and fees in the Federal Register. . (2) Inflation adjustment Section 740(c)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–12(c)(2) (A) in subparagraph (A)— (i) in the matter preceding clause (i), by striking 2020 2025 (ii) in clause (iii), by striking Baltimore Arlington-Alexandria (B) in subparagraph (B), by striking 2020 2025 (3) Workload adjustments Section 740(c)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–12(c)(3) (A) in subparagraph (A)— (i) in the matter preceding clause (i)— (I) by striking 2020 2025 (II) by striking subparagraphs (B) and (C) subparagraph (B) (ii) in clause (i) by striking and (iii) by striking clause (ii) and inserting the following: (ii) such adjustment shall be made for each fiscal year that the adjustment determined by the Secretary is greater than 3 percent, except for the first fiscal year that the adjustment is greater than 3 percent; and (iii) the Secretary shall publish in the Federal Register notice under paragraph (1) the amount of such adjustment and the supporting methodologies. ; (B) by striking subparagraph (B); and (C) by redesignating subparagraph (C) as subparagraph (B). (4) Final year adjustment Section 740(c)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–12(c)(4) (4) (A) In general For fiscal year 2025 and each subsequent fiscal year, after the fee revenue amount established under subsection (b) is adjusted in accordance with paragraphs (2) and (3), the Secretary shall— (i) increase the fee revenue amount for such fiscal year, if necessary to provide an operating reserve of not less than 12 weeks; or (ii) if the Secretary has an operating reserve in excess of the number of weeks specified in subparagraph (C) for that fiscal year, the Secretary shall decrease the fee revenue amount to provide not more than the number of weeks specified in subparagraph (C) for that fiscal year. (B) Carryover user fees For purposes of this paragraph, the operating reserve of carryover user fees for the process for the review of animal drug applications does not include carryover user fees that have not been appropriated. (C) Number of weeks of operating reserves The number of weeks of operating reserves specified in this subparagraph is— (i) 22 weeks for fiscal year 2025; (ii) 20 weeks for fiscal year 2026; (iii) 18 weeks for fiscal year 2027; and (iv) 16 weeks for fiscal year 2028. (D) Publication If an adjustment to the operating reserve is made under this paragraph, the Secretary shall publish in the Federal Register notice under paragraph (1) the rationale for the amount of the adjustment and the supporting methodologies. . (d) Exemption from fees Section 740(d)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–12(d)(4) (4) Exemption from fees Fees under paragraphs (2), (3), and (4) of subsection (a) shall not apply with respect to any person who is the named applicant or sponsor of an animal drug application, supplemental animal drug application, or investigational animal drug submission if such application or submission involves the intentional genomic alteration of an animal that is intended to produce a drug, device, or biological product subject to fees under section 736, 738, 744B, or 744H. . (e) Crediting and availability of fees (1) Authorization of appropriations Section 740(g)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–12(g)(3) 2019 through 2023 2024 through 2028 (2) Collection shortfalls Section 740(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–12(g) (A) in paragraph (3), by striking and paragraph (5) (B) by striking paragraph (5). 104. Reauthorization; reporting requirements Section 740A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–13 (1) in subsection (a), by striking 2018 2023 (2) by striking 2019 2024 (3) in subsection (d)— (A) in paragraph (1), by striking 2023 2028 (B) in paragraph (5), by striking 2023 2028 105. Savings clause Notwithstanding the amendments made by this title, part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–11 et seq. 106. Effective date The amendments made by this title shall take effect on October 1, 2023, or the date of the enactment of this Act, whichever is later, except that fees under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–11 et seq. 107. Sunset dates (a) Authorization Sections 739 and 740 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 21 U.S.C. 379j–11 (b) Reporting requirements Section 740A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–13 (c) Previous sunset provision Effective October 1, 2023, subsections (a) and (b) of section 107 of the Animal Drug User Fee Amendments of 2018 ( Public Law 115–234 II Fees Relating to Generic Animal Drugs 201. Short title; finding (a) Short title This title may be cited as the Animal Generic Drug User Fee Amendments of 2023 (b) Finding Congress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the generic new animal drug development process and the review of abbreviated applications for generic new animal drugs, supplemental abbreviated applications for generic new animal drugs, and investigational submissions for generic new animal drugs as set forth in the goals identified for purposes of part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21 et seq. 202. Authority to assess and use generic new animal drug fees (a) Generic Investigational New Animal Drug File Fee Section 741(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21(a) (4) Generic investigational new animal drug file fee (A) In general (i) New file request Each person that submits a request to establish a generic investigational new animal drug file on or after October 1, 2023, shall be assessed a fee as established under subsection (c). (ii) New submission to established file Each person that makes a submission to a generic investigational new animal drug file on or after October 1, 2023, where such file was established prior to October 1, 2023, shall be assessed a fee for the first submission on or after October 1, 2023, as established under subsection (c). (B) Payment (i) New file request The fee required by subparagraph (A)(i) shall be due upon submission of the request to establish the generic investigational new animal drug file. (ii) New submission to established file The fee required by subparagraph (A)(ii) shall be due upon the first submission to the generic investigational new animal drug file. (C) Exceptions (i) Terminating an existing generic investigational new animal drug file If a person makes a submission to the generic investigational new animal drug file to terminate that file, the person shall not be subject to a fee under subparagraph (A)(ii) for that submission. (ii) Transferring an existing generic investigational new animal drug file If a person makes a submission to the generic investigational new animal drug file to transfer that file to a different generic new animal drug sponsor, the person shall not be subject to a fee under subparagraph (A)(ii) for that submission. . (b) Fee revenue amounts Section 741(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21(b) (1) in paragraph (1)— (A) by striking 2019 through 2023 2024 through 2028 (B) by striking $18,336,340 $25,000,000 (2) in paragraph (2)— (A) in subparagraph (A)— (i) by striking 25 percent 20 percent (ii) and fees under subsection (a)(4) (relating to generic investigational new animal drug files) (B) in subparagraph (B), by striking 37.5 percent 40 percent (C) in subparagraph (C), by striking 37.5 percent 40 percent (c) Annual fee setting; adjustments (1) Annual fee setting Section 741(c)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21(c)(1) (1) Annual fee setting The Secretary shall establish, not later than 60 days before the start of each fiscal year beginning after September 30, 2023, for that fiscal year— (A) abbreviated application fees that are based on the revenue amounts established under subsection (b), the adjustments provided under this subsection, and the amount of fees anticipated to be collected under subsection (a)(4) during that fiscal year; (B) generic new animal drug sponsor fees, and generic new animal drug product fees, based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and (C) a generic investigational new animal drug file fee of $50,000 for each request or submission described in subsection (a)(4)(A). . (2) Inflation adjustment Section 741(c)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21(c)(2) (A) in subparagraph (A)— (i) in the matter preceding clause (i), by striking 2020 2025 (ii) in clause (iii), by striking Baltimore Arlington-Alexandria (B) in subparagraph (B), by striking 2020 2025 (3) Workload adjustment Section 741(c)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21(c)(3) (A) in subparagraph (A)— (i) in the matter preceding clause (i), by striking 2020 2025 (ii) in clause (i)— (I) by striking and investigational generic new animal drug protocol submissions investigational generic new animal drug protocol submissions, requests to establish a generic investigational new animal drug file, and generic investigational new animal drug meeting requests (II) by striking ; and (iii) by redesignating clause (ii) as clause (iii); and (iv) by inserting after clause (i) the following: (ii) if the workload adjustment calculated by the Secretary under clause (i) exceeds 25 percent, the Secretary shall use 25 percent for the adjustment; and ; and (B) in subparagraph (B), by striking 2021 through 2023 2026 through 2028 (4) Final year adjustment Section 741(c)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21(c)(4) (A) by striking 2023 2028 (B) by striking 2024 2029 (d) Fee waiver or reduction; exemption from fees Subsection (d) of section 741 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21 (d) Fee waiver or reduction The Secretary shall grant a waiver from, or a reduction of, one or more fees assessed under subsection (a) where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication. . (e) Effect of failure To pay fees Section 741(e) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21(e) The Secretary may discontinue A request to establish a generic investigational new animal drug file that is submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for action by the Secretary until all fees owed by such person have been paid. The Secretary may discontinue (f) Assessment of fees Section 741(f)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21(f)(2) sponsors, and generic new animal drug products at any time products, generic new animal drug sponsors, and generic investigational new animal drug files at any time (g) Crediting and availability of fees Section 741(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21(g) (1) in paragraph (3), by striking 2019 through 2023 2024 through 2028 (2) by striking the second paragraph (4) (relating to Offset), as added by section 202 of the Animal Generic Drug User Fee Amendments of 2013 ( Public Law 113–14 (3) by adding at the end the following: (5) Recovery of collection shortfalls (A) for fiscal year 2026, by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2024 falls below the amount of fees authorized for fiscal year 2024 under paragraph (3); (B) for fiscal year 2027, by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2025 falls below the amount of fees authorized for fiscal year 2025 under paragraph (3); and (C) for fiscal year 2028, by the amount, if any, by which the amount collected under this section and appropriated for fiscal years 2026 and 2027 (including estimated collections for fiscal year 2027) falls below the amount of fees authorized for such fiscal years under paragraph (3). . (h) Definitions Section 741(k) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21(k) (1) by redesignating paragraphs (8), (9), (10), and (11) as paragraphs (9), (10), (11), and (13), respectively; (2) by inserting after paragraph (7) the following: (8) Generic investigational new animal drug meeting request The term generic investigational new animal drug meeting request ; (3) in paragraph (11) (as so redesignated), by adding at the end the following: (I) The activities necessary for exploration and implementation of the United States and European Union Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections, and the United States and United Kingdom Mutual Recognition Agreement Sectoral Annex for Pharmaceutical Good Manufacturing Practices, and other mutual recognition agreements ; and (4) by inserting after paragraph (11) (as so redesignated) the following: (12) Request to establish a generic investigational new animal drug file The term request to establish a generic investigational new animal drug file . 203. Reauthorization; reporting requirements Section 742 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–22 (1) in subsection (a), by striking 2018 2023 (2) by striking 2019 2024 (3) in subsection (d), by striking 2023 2028 204. Savings clause Notwithstanding the amendments made by this title, part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21 et seq. 205. Effective date The amendments made by this title shall take effect on October 1, 2023, or the date of the enactment of this Act, whichever is later, except that fees under part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21 et seq. 206. Sunset dates (a) Authorization Section 741 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21 (b) Reporting requirements Section 742 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–22 (c) Previous sunset provision Effective October 1, 2023, subsections (a) and (b) of section 206 of the Animal Generic Drug User Fee Amendments of 2018 ( Public Law 115–234 III Supporting Animal and Human Health 301. Reporting requirements Section 740A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–13 (1) in subsection (a)— (A) by striking Beginning with (1) In general Beginning with ; and (B) by adding at the end the following: (2) Contents The report under paragraph (1) shall include the following: (A) Data, analysis and discussion of the changes in the number of individuals hired and funded by fees collected pursuant to section 740, and data, analysis, and discussion of the number of full-time equivalents in the animal drug review program, including a breakdown by funding from fees collected pursuant to section 740 versus budget authority, and by each office within the Center for Veterinary Medicine, the Office of Regulatory Affairs, and the Office of the Commissioner. (B) Data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of animal drug applications, including identifying— (i) the drivers of such changes; and (ii) changes in the total cost per full-time equivalent in the animal drug review program. (C) Data, analysis, and discussion of changes in the average full-time equivalent hours required to complete review of each type of animal drug application. (D) For fiscal years 2024 and 2025 ; and (2) in subsection (d)— (A) in paragraph (5), by inserting a comma after paragraph (4) (B) by redesignating paragraph (6) as paragraph (7); (C) by inserting after paragraph (5) the following: (6) Updates to Congress The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this part to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. ; and (D) in paragraph (7) (as so redesignated)— (i) in subparagraph (A)— (I) by striking Before presenting the recommendations developed under paragraphs (1) through (5) to Congress, the Secretary The Secretary (II) by inserting before the period at the end the following: , not later than 30 days after each such negotiation meeting (ii) in subparagraph (B), by inserting , in sufficient detail, shall summarize 302. Definition of major species Section 201(nn) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(nn) , or remove species from, add species to 303. Antimicrobial resistance (a) Report on Antimicrobial Stewardship Not later than December 31, 2023, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report describing— (1) activities conducted by the Center for Veterinary Medicine of the Food and Drug Administration (referred to in this section as the Center (2) with respect to antimicrobial stewardship in veterinary settings— (A) the goals of the Center regarding supporting antimicrobial stewardship in veterinary settings; (B) activities the Center plans to execute during the period of fiscal years 2024 through 2028 to support such goals, including targeted completion dates for such activities; and (C) metrics the Center plans to use to evaluate progress toward its goals regarding supporting antimicrobial stewardship in veterinary settings. (b) Annual progress reports Not later than 120 days after the end of each fiscal year during which fees are collected under section 740, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report that includes— (1) a description of activities conducted by the Center in the prior fiscal year to support antimicrobial stewardship in veterinary settings, including progress made toward goals and activities specified in subsection (a)(2); (2) in the case of an incomplete activity described in subsection (a)(2)(B) for which the target completion date has passed— (A) an explanation for why such target completion date was not met; and (B) if applicable, the updated expected completion date for such activity; (3) a description of emerging challenges related to antimicrobial stewardship in veterinary settings that impact Center activities; and (4) a description of activities undertaken to incentivize the development of new drugs for the treatment, prevention, or control of bacterial diseases in animals.

Summary: Animal Drug and Animal Generic Drug User Fee Amendments of 2023 This bill reauthorizes the Food and Drug Administration (FDA) to collect fees for brand-name and generic animal drug applications through FY2028. It also makes related updates to fee calculations and FDA reporting requirements. The bill also (1) provides for a specific fee for requests to establish generic investigational new animal drug files and requires other application fees to be adjusted accordingly; (2) authorizes the FDA to remove species from the definition of major species (currently horses, dogs, cats, cattle, pigs, chickens, and turkeys); and (3) provides statutory authority for the FDA to report on its progress supporting antimicrobial stewardship in veterinary settings (i.e., supporting responsible use of antimicrobial drugs for animals to slow the development of drug-resistant bacteria). Animal drugs are drugs that are intended for animals other than humans (e.g., pets and livestock). Animal drugs must be approved by the FDA before they may be offered on the commercial market. The FDA is authorized to collect fees for animal drug applications in order to support its regulatory activities; this authority currently expires at the end of FY2023.