Sec. 1003. AUTHORITY TO ASSESS AND USE DRUG FEES
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## SEC. 1003 AUTHORITY TO ASSESS AND USE DRUG FEES ###
(a)Types of Fees ####
(1)Human drug application fee Section 736(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)) is amended— #####
(A)in the matter preceding paragraph (1), by striking “fiscal year 2018” and inserting “fiscal year 2023”; #####
(B)in paragraph (1)(A), by striking “(c)(5)” each place it appears and inserting “(c)(6)”; #####
(C)in paragraph (1)(C), by inserting “prior to approval” after “or was withdrawn”; and #####
(D)in paragraph (1), by adding at the end the following: > > ##### “(H) Exception for skin-test diagnostic products > > A human drug application for a skin-test diagnostic product shall not be subject to a fee under subparagraph (A).” > . ####
(2)Prescription drug program fee Section 736(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)(2)) is amended— #####
(A)in subparagraph (A)— ######
(i)by striking “ Except as provided in subparagraphs
(B)and
(C)” and inserting the following: > > ###### “(i) Payment of fees > > Except as provided in subparagraphs
(B)and (C)” > ; ######
(ii)by striking “subsection (c)(5)” and inserting “subsection (c)(6)”; and ######
(iii)by adding at the end the following: > > ### “(ii) Special rule for previously discontinued drug products > > 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 referenced in section 735(3)(A)(iii), 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 such product for a fiscal year in which the fee is payable.” > ; and #####
(B)by amending subparagraph
(B)to read as follows: > > ##### “(B) Exception for certain prescription drug products > > A prescription drug program fee shall not be assessed for a prescription drug product under subparagraph
(A)if such product is— > > > ###### “(i) > > 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); > > > ###### “(ii) > > pharmaceutically equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulation)) to another product on the list of products compiled under section 505(j)(7) (not including the discontinued section of such list); or > > > ###### “(iii) > > a skin-test diagnostic product.” > . ###
(b)Fee Revenue Amounts ####
(1)In general Paragraph
(1)of section 736(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is amended to read as follows: > > #### “(1) In general > > For each of the fiscal years 2023 through 2027, fees under subsection
(a)shall, except as provided in subsections (c), (d), (f), and (g), be established to generate a total revenue amount under such subsection that is equal to the sum of— > > > ##### “(A) > > the annual base revenue for the fiscal year (as determined under paragraph (3)); > > > ##### “(B) > > the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1)); > > > ##### “(C) > > the dollar amount equal to the strategic hiring and retention adjustment for the fiscal year (as determined under subsection (c)(2)); > > > ##### “(D) > > the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(3)); > > > ##### “(E) > > the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(4)); > > > ##### “(F) > > the dollar amount equal to the additional direct cost adjustment for the fiscal year (as determined under subsection (c)(5)); and > > > ##### “(G) > > additional dollar amounts for each fiscal year as follows: > > > ###### “(i) > > $65,773,693 for fiscal year 2023. > > > ###### “(ii) > > $25,097,671 for fiscal year 2024. > > > ###### “(iii) > > $14,154,169 for fiscal year 2025. > > > ###### “(iv) > > $4,864,860 for fiscal year 2026. > > > ###### “(v) > > $1,314,620 for fiscal year 2027.” > . ####
(2)Annual base revenue Paragraph
(3)of section 736(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is amended to read as follows: > > #### “(3) Annual base revenue > > For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be— > > > ##### “(A) > > for fiscal year 2023, $1,151,522,958; and > > > ##### “(B) > > for fiscal years 2024 through 2027, the dollar amount of the total revenue amount established under paragraph
(1)for the previous fiscal year, not including any adjustments made under subsection (c)(4) or (c)(5).” > . ###
(c)Adjustments; Annual Fee Setting ####
(1)Inflation adjustment Section 736(c)(1)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)(1)(B)(ii)) is amended by striking “Washington-Baltimore, DC-MD-VA-WV” and inserting “Washington-Arlington-Alexandria, DC-VA-MD-WV”. ####
(2)Strategic hiring and retention adjustment Section 736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is amended— #####
(A)by redesignating paragraphs
(2)through
(6)as paragraphs
(3)through (7), respectively; and #####
(B)by inserting after paragraph
(1)the following: > > #### “(2) Strategic hiring and retention adjustment > > 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 by the following amounts: > > > ##### “(A) > > For fiscal year 2023, $9,000,000. > > > ##### “(B) > > For each of fiscal years 2024 through 2027, $4,000,000.” > . ####
(3)Capacity planning adjustment Paragraph (3), as redesignated, of section 736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as follows: > > #### “(3) Capacity planning adjustment > > > ##### “(A) In general > > For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted in accordance with paragraphs
(1)and (2), such revenue shall be adjusted further for such fiscal year, in accordance with this paragraph, to reflect changes in the resource capacity needs of the Secretary for the process for the review of human drug applications. > > > ##### “(B) Methodology > > 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’ published in the Federal Register on August 3, 2020 (85 Fed. Reg. 46651). The workload categories used in applying such methodology in forecasting shall include only the activities described in that 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 applying such methodology in forecasting any non-core review activities, including those activities that the Secretary referenced for potential future use in such notice but did not utilize in setting fees for fiscal year 2021. > > > ##### “(C) Limitation > > 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 subsections (b)(1)(A) (the annual base revenue for the fiscal year), (b)(1)(B) (the dollar amount of the inflation adjustment for the fiscal year), and (b)(1)(C) (the dollar amount of the strategic hiring and retention adjustment for the fiscal year). > > > ##### “(D) Publication in federal register > > The Secretary shall publish in the Federal Register notice under paragraph
(6)of the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph.” > . ####
(4)Operating reserve adjustment Paragraph (4), as redesignated, of section 736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is amended— #####
(A)by amending subparagraph
(A)to read as follows: > > ##### “(A) Increase > > 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 operating reserves of carryover user fees for the process for the review of human drug applications for each fiscal year in at least the following amounts: > > > ###### “(i) > > For fiscal year 2023, at least 8 weeks of operating reserves. > > > ###### “(ii) > > For fiscal year 2024, at least 9 weeks of operating reserves. > > > ###### “(iii) > > For fiscal year 2025 and subsequent fiscal years, at least 10 weeks of operating reserves.” > ; and #####
(B)in subparagraph (C), by striking “paragraph (5)” and inserting “paragraph (6)”. ####
(5)Additional direct cost adjustment Paragraph (5), as redesignated, of section 736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as follows: > > #### “(5) Additional direct cost adjustment > > > ##### “(A) Increase > > The Secretary shall, in addition to adjustments under paragraphs (1), (2), (3), and (4), further increase the fee revenue and fees— > > > ###### “(i) > > for fiscal year 2023, by $44,386,150; and > > > ###### “(ii) > > for each of fiscal years 2024 through 2027, by the amount set forth in clauses
(i)through
(iv)of subparagraph (B), 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. > > > ##### “(B) Applicable amounts > > The amounts referred to in subparagraph (A)(ii) are the following: > > > ###### “(i) > > For fiscal year 2024, $60,967,993. > > > ###### “(ii) > > For fiscal year 2025, $35,799,314. > > > ###### “(iii) > > For fiscal year 2026, $35,799, 314. > > > ###### “(iv) > > For fiscal year 2027, $35,799,314.” > . ####
(6)Annual fee setting Paragraph (6), as redesignated, of section 736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is amended by striking “September 30, 2017” and inserting “September 30, 2022”. ###
(d)Crediting and Availability of Fees Section 736(g)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(3)) is amended by striking “fiscal years 2018 through 2022” and inserting “fiscal years 2023 through 2027”. ###
(e)Written Requests for Waivers, Reductions, Exemptions, and Returns; Disputes Concerning Fees Section 736(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(i)) is amended to read as follows: > > ### “(i) Written Requests for Waivers, Reductions, Exemptions, and Returns; Disputes Concerning Fees > > 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— > > > #### “(1) > > not later than 180 days after such fee is due, submit to the Secretary a written request justifying such waiver, reduction, exemption, or return; and > > > #### “(2) > > include in the request any legal authorities under which the request is made.” > . ###
(f)Orphan Drugs Section 736(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(k)) is amended— ####
(1)in paragraph (1)(B), by striking “during the previous year” and inserting “as determined under paragraph (2)”; and ####
(2)by amending paragraph
(2)to read as follows: > > #### “(2) Evidence of qualification > > An exemption under paragraph
(1)applies with respect to a drug only if the applicant involved submits a certification that the applicant’s 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. Such certification shall be supported by— > > > ##### “(A) > > tax returns submitted to the United States Internal Revenue Service; or > > > ##### “(B) > > as necessary, other appropriate financial information.” > .
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- 85 FR 46651
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