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Code · BILL · 118th Congress · H.R. 1418 (Introduced in House) — To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs and g... · Sec. 202

Sec. 202. Authority to assess and use generic new animal drug fees

1,373 words·~6 min read·/bill/118/hr/1418/ih/section-202·

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Section 741(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21(a) ) is amended by adding at the end the following: 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). In the case of a generic investigational new animal drug file established prior to October 1, 2023, each person that makes a submission to such a file on or after October 1, 2023, shall be assessed a fee for the first submission on or after October 1, 2023, as established under subsection (c).
The fee required by subparagraph (A)(i) shall be due upon submission of the request to establish the generic investigational new animal drug file. The fee required by subparagraph (A)(ii) shall be due upon the first submission to the 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. 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. .
Section 741(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21(b) ) is amended— in paragraph (1)— by striking 2019 through 2023 and inserting 2024 through 2028 ; and by striking $18,336,340 and inserting $25,000,000 ; and in paragraph (2)— in subparagraph (A)— by striking 25 percent and inserting 20 percent ; and by inserting before the semicolon at the end the following: and subsection (a)(4) (relating to generic investigational new animal drug files) ; in subparagraph (B), by striking 37.5 percent and inserting 40 percent ; and in subparagraph (C), by striking 37.5 percent and inserting 40 percent .
Section 741(c)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21(c)(1) ) is amended to read as follows: 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— 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; 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 a generic investigation new animal drug file fee of $50,000 for each request or submission covered by subsection (a)(4)(A). . Section 741(c)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21(c)(2) ) is amended— in subparagraph (A)— in the matter preceding clause (i), by striking 2020 and inserting 2025 ; and in clause (iii), by striking Baltimore and inserting Arlington-Alexandria ; and in subparagraph (B), by striking 2020 and inserting 2025 . Section 741(c)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21(c)(3) ) is amended— in subparagraph (A)— in the matter preceding clause (i), by striking 2020 and inserting 2025 ; in clause (i)— by striking and investigational generic new animal drug protocol submissions and inserting 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 ; and by striking ; and and inserting a semicolon; by redesignating clause
(ii)as clause (iii); and by inserting after clause
(i)the following: if the workload adjustment calculated by the Secretary for the adjustment in clause
(i)exceeds 25 percent, the Secretary shall use 25 percent for the adjustment; and ; and in subparagraph (B), by striking 2021 through 2023 and inserting 2026 through 2028 . Section 741(c)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21(c)(4) ) is amended— striking 2023 each place it appears and inserting 2028 ; and striking 2024 and inserting 2029 . Subsection
(d)of section 741 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21 ) is amended to read as follows: 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. . Section 741(e) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21(e) ) is amended by striking The Secretary may discontinue and inserting 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 . Section 741(f)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21(f)(2) ) is amended by striking sponsors, and generic new animal drug products at any time and inserting products, generic new animal drug sponsors, and generic investigational new animal drug files at any time . Section 741(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21(g) ) is amended— in paragraph (3), by striking 2019 through 2023 and inserting 2024 through 2028 ; by striking the following: If the sum of the cumulative amount of fees collected under this section for the fiscal years 2014 through 2016 and the amount of fees estimated to be collected under this section for fiscal year 2017 exceeds the cumulative amount appropriated under paragraph
(3)for the fiscal years 2014 through 2017, the excess amount shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for fiscal year 2018. ; and by adding at the end the following: The amount of fees otherwise authorized to be collected under this section shall be increased— 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); 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 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). . Section 741(k) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–21(k) ) is amended— by redesignating paragraphs (8), (9), (10), and
(11)as paragraphs (9), (10), (11), and (13), respectively; by inserting after paragraph
(7)the following: The term generic investigational new animal drug meeting request means a request submitted by a generic new animal drug sponsor to meet with the Secretary to discuss an investigational submission for a generic new animal drug. ; in paragraph
(11)(as so redesignated), by adding at the end the following: 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 Recognition Agreement Sectoral Annex for Pharmaceutical Good Manufacturing Practices, and future mutual recognition agreements , with respect to generic new animal drug products subject to review, including implementation activities prior to and following product approval. ; and by inserting after paragraph
(11)(as so redesignated) the following: The term request to establish a generic investigational new animal drug file means the submission to the Secretary of a request to establish a generic investigational new animal drug file to contain investigational submissions for a generic new animal drug. .
Connections11 off-index
11 references not yet in our index
  • 21 USC 379j–21(a)
  • 21 USC 379j–21(b)
  • 21 USC 379j–21(c)(1)
  • 21 USC 379j–21(c)(2)
  • 21 USC 379j–21(c)(3)
  • 21 USC 379j–21(c)(4)
  • 21 USC 379j–21
  • 21 USC 379j–21(e)
  • 21 USC 379j–21(f)(2)
  • 21 USC 379j–21(g)
  • 21 USC 379j–21(k)
Citation graph
cites case law
Sec. 202
Authority to assess and use generic new animal drug fees
Cite21 USC 379j–21(a)
Cite21 USC 379j–21(b)
Cite21 USC 379j–21(c)(1)
Cite21 USC 379j–21(c)(2)
Cite21 USC 379j–21(c)(3)
Cites 11 · showing 5Cited by 0 across 0 sources
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