Sec. 403. Authority to assess and use biosimilar biological product fees

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Section 744H(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–52(a) ) is amended— in the matter preceding paragraph (1), by striking 2018 and inserting 2023 ; in paragraph (1)— in subparagraph (A)— in clause (iv)(I), by striking 5 days and inserting 7 days ; and in clause (v)(II), by striking 5 days and inserting 7 days ; in subparagraph (B)— in clause (i), by inserting , except that, in the case that 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, such licensee, assignee or successor shall pay the annual biosimilar biological product development fee before the period; in clause (iii)— in subclause (I), by striking ; or and inserting a semicolon; in subclause (II), by striking the period 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 accepted for filing on or after October 1 of such fiscal year and inserting subsequently accepted for filing ; in subparagraph (D)— in clause (i)— in the matter preceding subclause (I), by striking shall, if the person seeks to resume participation in such program, pay and inserting or who has been administratively removed from such 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 ; in subclause (I)— by striking 5 days and inserting 7 days ; and by inserting or the date of administrative removal, as applicable after discontinued ; and in subclause (II), by inserting or the date of administrative removal, as applicable after discontinued ; and in clause (ii), by inserting , except that, in the case that 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, such licensee, assignee or successor shall pay the annual biosimilar biological product development fee before the period at the end; and in subparagraph (E), 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 2 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. ; in paragraph (2)(D), by inserting prior to approval after withdrawn ; in paragraph (3)— in subparagraph (A)— in clause (i), by striking ; and and inserting a semicolon; by redesignating clause

(ii)as clause (iii); and by inserting the following after clause (i): 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 of discontinued biosimilar biological products referred to in subparagraph (A)(iii) is submitted to the Secretary on behalf of an applicant, and the request identifies the date the product is, or will be, 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 this clause, 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 of discontinued biosimilar biological products referred to in subparagraph (A)(iii), and on any subsequent day during such fiscal year the biosimilar biological product does not appear on such list, except as provided in subparagraph (D), each person who is named as the applicant in the biosimilar biological product application 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 product for each fiscal year. ; and by striking paragraph (4). Section 744H(b) of the Federal Food, Drug, and Cosmetic Act (( 21 U.S.C. 379j–52(b) ) is amended— by striking paragraph (1); by redesignating paragraphs

(2)through

(4)as paragraphs

(1)through (3), respectively; in paragraph (1), as so redesignated— in the paragraph heading, by striking and inserting Subsequent fiscal years ; In general in the matter preceding subparagraph (A), by striking 2019 through 2022 and inserting 2023 through 2027 ; in subparagraph (A), by striking paragraph

(4)and inserting paragraph

(3); by redesignating subparagraphs

(C)and

(D)as subparagraphs

(D)and (E), respectively; by inserting after subparagraph

(B)the following: the dollar amount equal to the strategic hiring and retention adjustment (as determined under subsection (c)(2)); ; in subparagraph (D), as so redesignated, by striking subsection (c)(2)); and and inserting subsection (c)(3)); ; in subparagraph (E), as so redesignated, by striking subsection (c)(3)). and inserting subsection (c)(4)); and ; and by adding at the end the following: for fiscal years 2023 and 2024, additional dollar amounts equal to— $4,428,886 for fiscal year 2023; and $320,569 for fiscal year 2024. ; in paragraph (2), as so redesignated— in the paragraph heading, by striking ; ; limitations on fee amounts by striking subparagraph (B); and by redesignating subaparagraphs

(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 paragraph (4); by redesignating paragraphs

(2)and

(3)as paragraphs

(3)and (4), respectively; by inserting after paragraph

(1)the following: For each fiscal year beginning in fiscal year 2023, 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. ; in paragraph (3), as so redesignated— in subparagraph (A)— by striking Beginning with the fiscal year described in subparagraph (B)(ii)(II) and inserting For each fiscal year ; and by striking adjustment under paragraph (1), further increase and inserting adjustments under paragraphs

(1)and (2), further adjust ; 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 Biosimilar User Fee Rates for Fiscal Year 2021 (85 Fed. Reg. 47220; August 4, 2020). The workload categories used in forecasting shall include only the activities described in such 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 and 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 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 setting fees for fiscal year 2021. ; and in subparagraph (C)— by striking subsections (b)(2)(A) and inserting subsections (b)(1)(A) ; by striking and (b)(2)(B) and inserting , (b)(1)(B) ; and by inserting , and (b)(1)(C) (the dollar amount of the strategic hiring and retention adjustment) before the period at the end; by amending paragraph (4), as so redesignated, 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 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 the process for the review of biosimilar biological product applications 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 the process for the review of biosimilar biological product applications 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 the process for the review of biosimilar biological product applications 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 (as applicable) 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 . Section 744H(f)(3) 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 . Subsection

(h)of section 744H of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–52 ) is amended to read as follows: To qualify for consideration for a waiver under subsection (d), 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 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. .

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6 references not yet in our index

21 USC 379j–52(a)
21 USC 379j–52(b)
21 USC 379j–52(c)
85 FR 47220
21 USC 379j–52(f)(3)
21 USC 379j–52

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cites case law

Sec. 403

Authority to assess and use biosimilar biological product fees

Cite21 USC 379j–52(a)

Cite21 USC 379j–52(b)

Cite21 USC 379j–52(c)

Fed. Reg.85 FR 47220

Cite21 USC 379j–52(f)(3)

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