Sec. 103. Authority to assess and use drug fees
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Section 736(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h(a) ) is amended— in the matter preceding paragraph (1), by striking 2018 and inserting 2023 ; in paragraph (1)— in subparagraph (A), by striking subsection (c)(5) each place it appears and inserting subsection (c)(6) ; in subparagraph (C), by inserting prior to approval after or was withdrawn ; and by adding at the end the following: A human drug application for a skin-test diagnostic product shall not be subject to a fee under subparagraph (A). ; and in paragraph (2)— in subparagraph (A)— by striking subsection (c)(5) and inserting subsection (c)(6) ; by striking Except as provided and inserting the following:
Except as provided ; and by adding at the end the following: If a drug product that is identified in a human drug application approved as of October 1 of a fiscal year is not a prescription drug product as of that date because the drug product is in the discontinued section of a list identified in section 735(3), and on any subsequent day during such fiscal year the drug product is a prescription drug product, then except as provided in subparagraphs
(B)and (C), each person who is named as the applicant in a human drug application with respect to such product, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(6) for such prescription drug product. Such fee shall be due on the last business day of such fiscal year and shall be paid only once for each product for a fiscal year in which the fee is payable. ; and by amending subparagraph
(B)to read as follows: A prescription drug program fee shall not be assessed for a prescription drug product under subparagraph
(A)if such product is— a large volume parenteral product (a sterile aqueous drug product packaged in a single-dose container with a volume greater than or equal to 100 mL, not including powders for reconstitution or pharmacy bulk packages) identified on the list compiled under section 505(j)(7); pharmaceutically equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)), to another product on the list of products compiled under section 505(j)(7) (not including the discontinued section of such list); or a skin-test diagnostic product. . Section 736(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h(b) ) is amended— in paragraph (1)— in the matter preceding subparagraph (A), by striking 2018 through 2022 and inserting 2023 through 2027 ; by redesignating subparagraphs
(C)through
(F)as subparagraphs
(D)through (G), respectively; by inserting after subparagraph
(B)the following: The dollar amount equal to the strategic hiring and retention adjustment for the fiscal year (as determined under subsection (c)(2)); ; in subparagraph (D), as so redesignated, by striking (c)(2) and inserting (c)(3) ; in subparagraph (E), as so redesignated, by striking (c)(3) and inserting (c)(4) ; in subparagraph (F), as so redesignated, by striking (c)(4) and inserting (c)(5) ; and in subparagraph (G), as so redesignated, by striking clauses
(i)through
(v)and inserting the following: $65,773,693 for fiscal year 2023. $25,097,671 for fiscal year 2024. $14,154,169 for fiscal year 2025. $4,864,860 for fiscal year 2026. $1,314,620 for fiscal year 2027. ; and in paragraph (3)— in subparagraph (A), by striking 2018, $878,590,000 and inserting 2023, $1,151,522,958 ; and in subparagraph (B)— by striking 2019 through 2022 and inserting 2024 through 2027 ; and by striking subsection (c)(3) or (c)(4) and inserting subsection (c)(4) or (c)(5) . Section 736(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h(c) ) is amended— in paragraph (1)(B)(ii), by striking Washington-Baltimore, DC–MD–VA–WV and inserting Washington–Arlington–Alexandria, DC–VA–MD–WV ; by redesignating paragraphs
(2)through
(6)as paragraphs
(3)through (7), respectively; by inserting after paragraph
(1)the following: For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), the Secretary shall further increase the fee revenue and fees— for fiscal year 2023, by $9,000,000; and for fiscal year 2024 and each subsequent fiscal year, by $4,000,000. ; in paragraph (3), as so redesignated— in subparagraph (A)— by striking for inflation ; and by striking paragraph
(1)and inserting paragraphs
(1)and
(2); by amending subparagraph
(B)to read as follows: For purposes of this paragraph, the Secretary shall employ the capacity planning methodology utilized by the Secretary in setting fees for fiscal year 2021, as described in the notice titled Prescription Drug User Fee Rates for Fiscal Year 2021 (85 Fed. Reg. 46651; August 3, 2020). The workload categories used in forecasting shall include only the activities described in such notice and, as feasible, additional activities that are directly related to the direct review of applications and supplements, including additional formal meeting types, the direct review of postmarketing commitments and requirements, the direct review of risk evaluation and mitigation strategies, and the direct review of annual reports for approved prescription drug products. Subject to the exceptions in the preceding sentence, the Secretary shall not include as workload categories in forecasting any non-core review activities, including any activities that the Secretary referenced for potential future use in such notice but did not utilize in the setting fees for fiscal year 2021. ; by striking subparagraph (C); by redesignating subparagraphs
(D)and
(E)as subparagraphs
(C)and (D), respectively; in subparagraph (C), as so redesignated— by striking year) and and inserting year), ; and by striking the period and inserting , and subsection (b)(1)(C) (the dollar amount of the strategic hiring and retention adjustment). ; and in subparagraph (D), as so redesignated, by striking paragraph
(5)and inserting paragraph
(6); in paragraph (4), as so redesignated— by amending subparagraph
(A)to read as follows: For fiscal year 2023 and subsequent fiscal years, the Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees if such an adjustment is necessary to provide for at least the following amounts of operating reserves of carryover user fees for the process for the review of human drug applications for each fiscal year, as follows: For fiscal year 2023, at least 8 weeks of operating reserves. For fiscal year 2024, at least 9 weeks of operating reserves. For fiscal year 2025 and subsequent fiscal years, at least 10 weeks of operating reserves. ; and in subparagraph (C), by striking paragraph
(5)and inserting paragraph
(6); by amending paragraph (5), as so redesignated, to read as follows: The Secretary shall, in addition to adjustments under paragraphs (1), (2), (3), and (4), further increase the fee revenue and fees— for fiscal year 2023, by $44,386,150; and for fiscal years 2024 through 2027, by the amount set forth in clauses
(i)through (iv), as applicable, multiplied by the Consumer Price Index for urban consumers (Washington–Arlington–Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All Items; Annual Index) for the most recent year of available data, divided by such Index for 2021— for fiscal year 2024, $60,967,993; for fiscal year 2025, $35,799,314; for fiscal year 2026, $35,799,314; and for fiscal year 2027, $35,799,314. ; and in paragraph (6), as so redesignated, by striking 2017 and inserting 2022 . Section 736(g)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h(g)(3) ) is amended by striking 2018 through 2022 and inserting 2023 through 2027 . Section 736(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h(i) ) is amended to read as follows: To qualify for consideration for a waiver or reduction under subsection (d), an exemption under subsection (k), or the return of any fee paid under this section, including if the fee is claimed to have been paid in error, a person shall submit to the Secretary a written request justifying such waiver, reduction, exemption, or return not later than 180 days after such fee is due. A request submitted under this paragraph shall include any legal authorities under which the request is made. . Section 736(k) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h(k) ) is amended— in paragraph (1)(B), by striking during the previous year and inserting , as determined under paragraph
(2); and in paragraph (2), by striking that its gross annual revenues and all that follows through the period at the end and inserting supported by tax returns submitted to the Internal Revenue Service, or, as necessary, by other appropriate financial information, that its gross annual revenues did not exceed $50,000,000 for the last calendar year ending prior to the fiscal year for which the exemption is requested. .
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- 85 FR 46651
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