Sec. 103. Authority to assess and use animal drug fees

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Section 740(a)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–12(a)(1)(A)(ii) ) is amended— in subclause (I), by striking and at the end; in subclause (II), by striking the period at the end and inserting ; and ; and by adding at the end the following: 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. .

Section 740(b)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–12(b)(1) ) is amended to read as follows: 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. . Section 740(c)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–12(c)(1) ) is amended to read as follows: Not later than 60 days before the start of each fiscal year beginning after September 30, 2023, the Secretary shall— 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 publish such fee revenue amounts and fees in the Federal Register. . Section 740(c)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–12(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 740(c)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–12(c)(3) ) is amended— in subparagraph (A)— in the matter preceding clause (i)— by striking 2020 and inserting 2025 ; and by striking subparagraphs

(B)and

(C)and inserting subparagraph

(B); in clause

(i)by striking and at the end; and by striking clause

(ii)and inserting the following: 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 the Secretary shall publish in the Federal Register notice under paragraph

(1)the amount of such adjustment and the supporting methodologies. ; by striking subparagraph (B); and by redesignating subparagraph

(C)as subparagraph (B). Section 740(c)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–12(c)(4) ) is amended to read as follows: Operating reserve adjustment 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— increase the fee revenue amount for such fiscal year, if necessary to provide an operating reserve of not less than 12 weeks; or 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. 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. The number of weeks of operating reserves specified in this subparagraph is— 22 weeks for fiscal year 2025; 20 weeks for fiscal year 2026; 18 weeks for fiscal year 2027; and 16 weeks for fiscal year 2028. 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. . Section 740(d)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–12(d)(4) ) is amended to read as follows: 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. . Section 740(g)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–12(g)(3) ) is amended by striking 2019 through 2023 and inserting 2024 through 2028 . Section 740(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–12(g) ) is amended— in paragraph (3), by striking and paragraph

(5); and by striking paragraph (5).

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21 USC 379j–12(a)(1)(A)(ii)
21 USC 379j–12(b)(1)
21 USC 379j–12(c)(1)
21 USC 379j–12(c)(2)
21 USC 379j–12(c)(3)
21 USC 379j–12(c)(4)
21 USC 379j–12(d)(4)
21 USC 379j–12(g)(3)
21 USC 379j–12(g)

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cites case law

Sec. 103

Authority to assess and use animal drug fees

Cite21 USC 379j–12(a)(1)(A)(ii)

Cite21 USC 379j–12(b)(1)

Cite21 USC 379j–12(c)(1)

Cite21 USC 379j–12(c)(2)

Cite21 USC 379j–12(c)(3)

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