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Code · BILL · 117th Congress · H.R. 7667 (Engrossed in House) — To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs,... · Sec. 403

Sec. 403. Authority to assess and use biosimilar fees

2,150 words·~10 min read·/bill/117/hr/7667/eh/section-403·

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The matter preceding paragraph
(1)in section 744H(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–52(a) ) is amended by striking fiscal year 2018 and inserting fiscal year 2023 . Clauses (iv)(I) and (v)(II) of section 744H(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–52(a)(1)(A) ) are each amended by striking 5 days and inserting 7 days . Section 744H(a)(1)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–52(a)(1)(B) ) is amended— in clause (i), by inserting before the period at the end the following: , except where such product (including, where applicable, ownership of the relevant investigational new drug application) is transferred to a licensee, assignee, or successor of such person, and written notice of such transfer is provided to the Secretary, in which case such licensee, assignee, or successor shall pay the annual biosimilar biological product development fee ; in clause (iii)— in subclause (I), by striking or at the end; in subclause (II), by striking the period at the end and inserting ; or ; and by adding at the end the following: been administratively removed from the biosimilar biological product development program for the product under subparagraph (E)(v). ; and in clause (iv), by striking is accepted for filing on or after October 1 of such fiscal year and inserting is subsequently accepted for filing . Section 744H(a)(1)(D) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–52(a)(1)(D) ) is amended to read as follows: A person that has discontinued participation in the biosimilar biological product development program for a product under subparagraph (C), or who has been administratively removed from the biosimilar biological product development program for a product under subparagraph (E)(v), shall, if the person seeks to resume participation in such program, pay all annual biosimilar biological product development fees previously assessed for such product and still owed and a fee (referred to in this section as reactivation fee ) by the earlier of the following: Not later than 7 days after the Secretary grants a request by such person for a biosimilar biological product development meeting for the product (after the date on which such participation was discontinued or the date of administrative removal, as applicable). Upon the date of submission (after the date on which such participation was discontinued or the date of administrative removal, as applicable) by such person of an investigational new drug application describing an investigation that the Secretary determines is intended to support a biosimilar biological product application for that product. A person that pays a reactivation fee for a product shall pay for such product, beginning in the next fiscal year, the annual biosimilar biological product development fee under subparagraph (B), except where such product (including, where applicable, ownership of the relevant investigational new drug application) is transferred to a licensee, assignee, or successor of such person, and written notice of such transfer is provided to the Secretary, in which case such licensee, assignee, or successor shall pay the annual biosimilar biological product development fee. . Section 744H(a)(1)(E) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–52(a)(1)(E) ) is amended by adding at the end the following: If a person has failed to pay an annual biosimilar biological product development fee for a product as required under subparagraph
(B)for a period of two consecutive fiscal years, the Secretary may administratively remove such person from the biosimilar biological product development program for the product. At least 30 days prior to administratively removing a person from the biosimilar biological product development program for a product under this clause, the Secretary shall provide written notice to such person of the intended administrative removal. . Section 744H(a)(2)(D) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–52(a)(2)(D) ) is amended by inserting after or was withdrawn the following: prior to approval . Section 744H(a)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–52(a)(3) ) is amended— in subparagraph (A)— in clause (i), by striking and at the end; by redesignating clause
(ii)as clause (iii); and by inserting after clause
(i)the following: may be dispensed only under prescription pursuant to section 503(b); and ; and by adding at the end the following: If a written request to place a product on the list referenced in subparagraph
(A)of discontinued biosimilar biological products is submitted to the Secretary on behalf of an applicant, and the request identifies the date the product is withdrawn from sale, then for purposes of assessing the biosimilar biological product program fee, the Secretary shall consider such product to have been included on such list on the later of— the date such request was received; or if the product will be withdrawn from sale on a future date, such future date when the product is withdrawn from sale. For purposes of clause (i), a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product, whether or not the applicant has ordered recall of all previously distributed lots of the product, except that a routine, temporary interruption in supply shall not render a product withdrawn from sale. If a biosimilar biological product that is identified in a biosimilar biological product application approved as of October 1 of a fiscal year appears, as of October 1 of such fiscal year, on the list referenced in subparagraph
(A)of discontinued biosimilar biological products, and on any subsequent day during such fiscal year the biosimilar biological product does not appear on such list, then except as provided in subparagraph (D), each person who is named as the applicant in a biosimilar biological product application with respect to such product shall pay the annual biosimilar biological product program fee established for a fiscal year under subsection (c)(5) for such biosimilar biological product. Notwithstanding subparagraph (B), 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 each fiscal year. . Section 744H(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–52(a) ) is amended by striking paragraph (4). Subsection
(b)of section 744H of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–52 ) is amended— by striking paragraph (1); by redesignating paragraphs
(2)through
(4)as paragraphs
(1)through (3), respectively; by amending paragraph
(1)(as so redesignated) to read as follows: For each of the fiscal years 2023 through 2027, fees under subsection
(a)shall, except as provided in subsection (c), be established to generate a total revenue amount equal to the sum of— the annual base revenue for the fiscal year (as determined under paragraph (3)); the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1)); the dollar amount equal to the strategic hiring and retention adjustment (as determined under subsection (c)(2)); the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(3)); the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(4)); for fiscal year 2023 an additional amount of $4,428,886; and for fiscal year 2024 an additional amount of $320,569 . ; in paragraph
(2)(as so redesignated)— in the paragraph heading, by striking ; ; limitations on fee amounts by striking subparagraph (B); and by redesignating subparagraphs
(C)and
(D)as subparagraphs
(B)and (C), respectively; and by amending paragraph
(3)(as so redesignated) to read as follows: For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be— for fiscal year 2023, $43,376,922; and for fiscal years 2024 through 2027, the dollar amount of the total revenue amount established under paragraph
(1)for the previous fiscal year, excluding any adjustments to such revenue amount under subsection (c)(4). . Section 744H(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–52(c) ) is amended— in paragraph (1)— in subparagraph (A)— in the matter preceding clause (i), by striking subsection (b)(2)(B) and inserting subsection (b)(1)(B) ; and in clause (i), by striking subsection
(b)and inserting subsection (b)(1)(A) ; and in subparagraph (B)(ii), by striking Washington-Baltimore, DC–MD–VA–WV and inserting Washington-Arlington-Alexandria, DC–VA–MD–WV ; by striking paragraphs
(2)through
(4)and inserting the following: For each fiscal year, after the annual base revenue under subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), the Secretary shall further increase the fee revenue and fees by $150,000. For each fiscal year, the Secretary shall, in addition to the adjustments under paragraphs
(1)and (2), further adjust the fee revenue and fees under this section for a fiscal year to reflect changes in the resource capacity needs of the Secretary for the process for the review of biosimilar biological product applications. 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 Biosimilar User Fee Rates for Fiscal Year 2021 published in the Federal Register on August 4, 2020 (85 Fed. Reg. 47220). 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 also directly related to the direct review of biosimilar biological product 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 biosimilar biological 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. 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). The Secretary shall publish in the Federal Register notice under paragraph
(5)the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph. 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 10 weeks of operating reserves of carryover user fees for the process for the review of biosimilar biological product applications. For fiscal year 2023, if the Secretary has carryover balances for such process in excess of 33 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 33 weeks of such operating reserves. For fiscal year 2024, if the Secretary has carryover balances for such process in excess of 27 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 27 weeks of such operating reserves. For fiscal year 2025 and subsequent fiscal years, if the Secretary has carryover balances for such process in excess of 21 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 21 weeks of such operating reserves. If an adjustment under subparagraph
(A)or
(B)is made, the rationale for the amount of the increase or decrease in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (5)(B) establishing fee revenue and fees for the fiscal year involved. ; and in paragraph (5), in the matter preceding subparagraph (A), by striking 2018 and inserting 2023 . Subsection (f)(3) of section 744H of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–52(f)(3) ) is amended by striking 2018 through 2022 and inserting 2023 through 2027 . Section 744H(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–52(h) ) is amended to read as follows: To qualify for consideration for a waiver under subsection (d), or for 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 or return and, except as otherwise specified in this section, such written request shall be submitted to the Secretary 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. .
Connections12 off-index
12 references not yet in our index
  • 21 USC 379j–52(a)
  • 21 USC 379j–52(a)(1)(A)
  • 21 USC 379j–52(a)(1)(B)
  • 21 USC 379j–52(a)(1)(D)
  • 21 USC 379j–52(a)(1)(E)
  • 21 USC 379j–52(a)(2)(D)
  • 21 USC 379j–52(a)(3)
  • 21 USC 379j–52
  • 21 USC 379j–52(c)
  • 85 FR 47220
  • 21 USC 379j–52(f)(3)
  • 21 USC 379j–52(h)
Citation graph
cites case law
Sec. 403
Authority to assess and use biosimilar fees
Cite21 USC 379j–52(a)
Cite21 USC 379j–52(a)(1)(A)
Cite21 USC 379j–52(a)(1)(B)
Cite21 USC 379j–52(a)(1)(D)
Cite21 USC 379j–52(a)(1)(E)
Cites 12 · showing 5Cited by 0 across 0 sources
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