Sec. 302. Authority to assess and use human generic drug fees

1,194 words·~5 min read·/bill/117/s/4535/is/section-302·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

Section 744B(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–42(a) ) is amended— in the matter preceding paragraph (1), by striking 2018 and inserting 2023 ; in paragraph (2)(C), by striking fiscal years 2018 through 2022 and inserting fiscal years 2023 through 2027 ; in paragraph (3)(B), by striking fiscal years 2018 through 2022 and inserting fiscal years 2023 through 2027 ; in paragraph (4)(D), by striking fiscal years 2018 through 2022 and inserting fiscal years 2023 through 2027 ; and in paragraph (5)(D), by striking fiscal years 2018 through 2022 and inserting fiscal years 2023 through 2027 .

Section 744B(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–42(b) ) is amended— in paragraph (1)— in subparagraph (A)— in the heading, by striking and inserting 2018 ; 2023 by striking 2018 and inserting 2023 ; and by striking $493,600,000 and inserting $582,500,000 ; and in subparagraph (B)— in the heading, by striking and inserting 2019 through 2022 ; 2024 through 2027 by striking For each and inserting the following: For each ; by striking 2019 through 2022 and inserting 2024 through 2027 ; by striking $493,600,000 and inserting the base revenue amount under clause

(ii); and by adding at the end the following: The base revenue amount for a fiscal year is the total revenue amount established under this paragraph for the previous fiscal year, not including any adjustments made for such previous fiscal year under subsection (c)(3). ; and in paragraph (2)— in subparagraph (C), by striking one-third the amount and inserting 24 percent ; in subparagraph (D), by striking Seven and inserting Six ; and in subparagraph (E)(i), by striking Thirty-five and inserting Thirty-six . Section 744B(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–42(c) ) is amended— in paragraph (1)— in the matter preceding subparagraph (A)— by striking 2019 and inserting 2024 ; and by striking the product of the total revenues established in such notice for the prior fiscal year and inserting the base revenue amount for the fiscal year determined under subsection (b)(1)(B)(ii) ; and in subparagraph (C), by striking Washington-Baltimore, DC–MD–VA–WV and inserting Washington-Arlington-Alexandria, DC–VA–MD–WV ; and by striking paragraph

(2)and inserting the following: Beginning with fiscal year 2024, the Secretary shall, in addition to the adjustment under paragraph (1), further increase the fee revenue and fees under this section for a fiscal year, in accordance with this paragraph, to reflect changes in the resource capacity needs of the Secretary for human generic drug activities. The Secretary shall establish a capacity planning methodology for purposes of this paragraph, which shall— be derived from the methodology and recommendations made in the report titled Independent Evaluation of the GDUFA Resource Capacity Planning Adjustment Methodology: Evaluation and Recommendations as announced in the Federal Register on August 3, 2020 (85 Fed. Reg. 46658); and incorporate approaches and attributes determined appropriate by the Secretary, including those made in such report recommendations, except the workload categories used in forecasting resources shall only be those specified in section VIII.B.2.e. of the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2022 . Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsection (b)(1)(B)(ii) (the base revenue amount for the fiscal year) and paragraph

(1)(the dollar amount of the inflation adjustment for the fiscal year). An adjustment under this paragraph shall not exceed 3 percent of the sum described in clause

(i)for the fiscal year, except that such limitation shall be 4 percent if— for purposes of an adjustment for fiscal year 2024, the Secretary determines that, during the period from April 1, 2021, through March 31, 2023— the total number of abbreviated new drug applications submitted was greater than or equal to 2,000; or thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as that term is defined in section XI of the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2022 ); for purposes of an adjustment for fiscal year 2025, the Secretary determines that, during the period from April 1, 2022, through March 31, 2024— the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined); for purposes of an adjustment for fiscal year 2026, the Secretary determines that, during the period from April 1, 2023, through March 31, 2025— the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined); and for purposes of an adjustment for fiscal year 2027, the Secretary determines that, during the period from April 1, 2024, through March 31, 2026— the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined). The Secretary shall publish in the Federal Register notice under subsection (a), the fee revenue and fees resulting from the adjustment and the methodology under this paragraph. For fiscal year 2024 and subsequent fiscal years, the Secretary may, in addition to adjustments under paragraphs

(1)and (2), further increase the fee revenue and fees under this section if such an adjustment is necessary to provide operating reserves of carryover user fees for human generic drug activities for not more than the number of weeks specified in subparagraph (B). The number of weeks specified in this subparagraph is— 8 weeks for fiscal year 2024; 9 weeks for fiscal year 2025; and 10 weeks for each of fiscal year 2026 and 2027. If the Secretary has carryover balances for human generic drug activities in excess of 12 weeks of the operating reserves referred to in subparagraph (A), the Secretary shall decrease the fee revenue and fees referred to in such subparagraph to provide for not more than 12 weeks of such operating reserves. If an adjustment under this paragraph is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under subsection

(a)publishing the fee revenue and fees for the fiscal year involved. . Section 744B(d)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–42(d)(1) ) is amended— in the heading, by striking and inserting 2018 through 2022 ; 2023 through 2027 by striking more and inserting later ; and by striking 2018 through 2022 and inserting 2023 through 2027 . The heading of paragraph

(3)of section 744B(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–42(g) ) is amended by striking . and prior approval supplement fee Section 744B(i)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–42(i)(3) ) is amended by striking 2018 through 2022 and inserting 2023 through 2027 .

Connections7 off-index

7 references not yet in our index

21 USC 379j–42(a)
21 USC 379j–42(b)
21 USC 379j–42(c)
85 FR 46658
21 USC 379j–42(d)(1)
21 USC 379j–42(g)
21 USC 379j–42(i)(3)

Citation graph

cites case law

Sec. 302

Authority to assess and use human generic drug fees

Cite21 USC 379j–42(a)

Cite21 USC 379j–42(b)

Cite21 USC 379j–42(c)

Fed. Reg.85 FR 46658

Cite21 USC 379j–42(d)(1)

Cites 7 · showing 5Cited by 0 across 0 sources