Sec. 3002. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES
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## SEC. 3002 AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES ###
(a)Types of Fees Section 744B(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(a)) is amended— ####
(1)in the matter preceding paragraph (1), by striking “2018” and inserting “2023”; ####
(2)in paragraph (2)(C), by striking “2018 through 2022” and inserting “2023 through 2027”; ####
(3)in paragraph (3)(B), by striking “2018 through 2022” and inserting “2023 through 2027”; ####
(4)in paragraph (4)(D), by striking “2018 through 2022” and inserting “2023 through 2027”; and ####
(5)in paragraph (5)(D), by striking “2018 through 2022” and inserting “2023 through 2027”. ###
(b)Fee Revenue Amounts Section 744B(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(b)) is amended— ####
(1)in paragraph (1)— #####
(A)in subparagraph (A)— ######
(i)in the heading, by striking “2018” and inserting “2023”; ######
(ii)by striking “2018” and inserting “2023”; and ######
(iii)by striking “$493,600,000” and inserting “$582,500,000”; and #####
(B)by amending subparagraph
(B)to read as follows: > > ##### “(B) Fiscal years 2024 through 2027 > > > ###### “(i) In general > > For each of the fiscal years 2024 through 2027, fees under paragraphs
(2)through
(5)of subsection
(a)shall be established to generate a total estimated revenue amount under such subsection that is equal to the base revenue amount for the fiscal year under clause (ii), as adjusted pursuant to subsection (c). > > > ###### “(ii) Base revenue amount > > The base revenue amount for a fiscal year referred to in clause
(i)is equal to 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 ####
(2)in paragraph (2)— #####
(A)in subparagraph (C), by striking “one-third the amount” and inserting “twenty-four percent”; #####
(B)in subparagraph (D), by striking “Seven percent” and inserting “Six percent”; and #####
(C)in subparagraph (E)(i), by striking “Thirty-five percent” and inserting “Thirty-six percent”. ###
(c)Adjustments Section 744B(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(c)) is amended— ####
(1)in paragraph (1)— #####
(A)in the matter preceding subparagraph (A)— ######
(i)by striking “2019” and inserting “2024”; and ######
(ii)by striking “to equal the product of the total revenues established in such notice for the prior fiscal year multiplied” and inserting “to equal the base revenue amount for the fiscal year (as specified in subsection (b)(1)(B)(ii)) multiplied”; and #####
(B)in subparagraph (C), by striking “Washington-Baltimore, DC-MD-VA-WV” and inserting “Washington-Arlington-Alexandria, DC-VA-MD-WV”; and ####
(2)by striking paragraph
(2)and inserting the following: > > #### “(2) Capacity planning adjustment > > > ##### “(A) In general > > 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. > > > ##### “(B) Capacity planning methodology > > The Secretary shall establish a capacity planning methodology for purposes of this paragraph, which shall— > > > ###### “(i) > > 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’ announced in the Federal Register on August 3, 2020 (85 Fed. Reg. 46658); and > > > ###### “(ii) > > incorporate approaches and attributes determined appropriate by the Secretary, including approaches and attributes made in such report, except that in incorporating such approaches and attributes the workload categories used in forecasting resources shall only be the workload categories specified in section VIII.B.2.e. of the letters described in section 3001(b) of the Generic Drug User Fee Amendments of 2022. > > > ##### “(C) Limitations > > > ###### “(i) In general > > 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). > > > ###### “(ii) Additional limitation > > 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— > > > ###### “(I) > > for purposes of a fiscal year 2024 adjustment, the Secretary determines that during the period from April 1, 2021, through March 31, 2023— > > > ###### “(aa) > > the total number of abbreviated new drug applications submitted was greater than or equal to 2,000; or > > > ###### “(bb) > > 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 3001(b) of the Generic Drug User Fee Amendments of 2022); > > > ###### “(II) > > for purposes of a fiscal year 2025 adjustment, the Secretary determines that during the period from April 1, 2022, through March 31, 2024— > > > ###### “(aa) > > the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or > > > ###### “(bb) > > thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined); > > > ###### “(III) > > for purposes of a fiscal year 2026 adjustment, the Secretary determines that during the period from April 1, 2023, through March 31, 2025— > > > ###### “(aa) > > the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or > > > ###### “(bb) > > thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined); and > > > ###### “(IV) > > for purposes of a fiscal year 2027 adjustment, the Secretary determines that during the period from April 1, 2024, through March 31, 2026— > > > ###### “(aa) > > the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or > > > ###### “(bb) > > thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined). > > > ##### “(D) Publication in federal register > > The Secretary shall publish in the Federal Register notice referred to in subsection
(a)the fee revenue and fees resulting from the adjustment and the methodology under this paragraph. > > > #### “(3) Operating reserve adjustment > > > ##### “(A) In general > > For fiscal year 2024 and each subsequent fiscal year, the Secretary may, in addition to adjustments under paragraphs
(1)and (2), further increase the fee revenue and fees under this section for such fiscal year 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)with respect to that fiscal year. > > > ##### “(B) Number of weeks > > The number of weeks specified in this subparagraph is— > > > ###### “(i) > > 8 weeks for fiscal year 2024; > > > ###### “(ii) > > 9 weeks for fiscal year 2025; and > > > ###### “(iii) > > 10 weeks for each of fiscal year 2026 and 2027. > > > ##### “(C) Decrease > > 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. > > > ##### “(D) Rationale for adjustment > > 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.” > . ###
(d)Annual Fee Setting Section 744B(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(d)(1)) is amended— ####
(1)in the paragraph heading, by striking “2018 through 2022” and inserting “2023 through 2027”; and ####
(2)by striking “more than 60 days before the first day of each of fiscal years 2018 through 2022” and inserting “later than 60 days before the first day of each of fiscal years 2023 through 2027”. ###
(e)Effect of Failure to Pay Fees 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”. ###
(f)Crediting and Availability of Fees Section 744B(i)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(i)(3)) is amended by striking “fiscal years 2018 through 2022” and inserting “fiscal years 2023 through 2027”.
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- 85 FR 46658
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