Sec. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR FEES
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## SEC. 403 AUTHORITY TO ASSESS AND USE BIOSIMILAR FEES ###
(a)Types of Fees Section 744H(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52(a)) is amended— ####
(1)in the matter preceding paragraph (1), by striking “fiscal year 2013” and inserting “fiscal year 2018”; ####
(2)in the heading of paragraph (1), by striking “Biosimilar” and inserting “Biosimilar biological product”; ####
(3)in paragraph (1)(A)(i), by striking “(b)(1)(A)” and inserting “(c)(5)”; ####
(4)in paragraph (1)(B)(i), by striking “(b)(1)(B) for biosimilar biological product development” and inserting “(c)(5) for the biosimilar biological product development program”; ####
(5)in paragraph (1)(B)(ii), by striking “annual biosimilar biological product development program fee” and inserting “annual biosimilar biological product development fee”; ####
(6)in paragraph (1)(B)(iii), by striking “annual biosimilar development program fee” and inserting “annual biosimilar biological product development fee”; ####
(7)in paragraph (1)(B), by adding at the end the following: > > ###### “(iv) Refund > > If a person submits a marketing application for a biosimilar biological product before October 1 of a fiscal year and such application is accepted for filing on or after October 1 of such fiscal year, the person may request a refund equal to the annual biosimilar biological product development fee paid by the person for the product for such fiscal year. To qualify for consideration for a refund under this clause, a person shall submit to the Secretary a written request for such refund not later than 180 days after the marketing application is accepted for filing.” > ; ####
(8)in paragraph (1)(C), by striking “for a product effective October 1 of a fiscal year by,” and inserting “for a product, effective October 1 of a fiscal year, by,”; ####
(9)in paragraph (1)(D)— #####
(A)in clause
(i)in the matter preceding subclause (I), by inserting “, if the person seeks to resume participation in such program,” before “pay a fee”; #####
(B)in clause (i)(I), by inserting after “grants a request” the following: “by such person”; and #####
(C)in clause (i)(II), by inserting after “discontinued)” the following: “by such person”; ####
(10)in the heading of paragraph (1)(E), by striking “biosimilar development program”; ####
(11)in paragraph (1)(F)— #####
(A)in the subparagraph heading, by striking “biosimilar development program”; and #####
(B)by amending clause
(i)to read as follows: > > ###### “(i) Refunds > > Except as provided in subparagraph (B)(iv), the Secretary shall not refund any initial or annual biosimilar biological product development fee paid under subparagraph
(A)or (B), or any reactivation fee paid under subparagraph (D).” > ; ####
(12)in paragraph (2)— #####
(A)in the paragraph heading, by striking “and supplement”; #####
(B)by amending subparagraphs
(A)and
(B)to read as follows: > > ##### “(A) In general > > Each person that submits, on or after October 1, 2017, a biosimilar biological product application shall be subject to the following fees: > > > ###### “(i) > > A fee established under subsection (c)(5) for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are required for approval. > > > ###### “(ii) > > A fee established under subsection (c)(5) for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are not required for approval. Such fee shall be equal to half of the amount of the fee described in clause (i). > > > ##### “(B) Rule of applicability; treatment of certain previously paid fees > > Any person who pays a fee under subparagraph (A), (B), or
(D)of paragraph
(1)for a product before October 1, 2017, but submits a biosimilar biological product application for that product after such date, shall— > > > ###### “(i) > > be subject to any biosimilar biological product application fees that may be assessed at the time when such biosimilar biological product application is submitted; and > > > ###### “(ii) > > be entitled to no reduction of such application fees based on the amount of fees paid for that product before October 1, 2017, under such subparagraph (A), (B), or (D).” > ; #####
(C)in the heading of subparagraph (D), by striking “or supplement”; #####
(D)in subparagraphs
(C)through (F), by striking “or supplement” each place it appears; and #####
(E)in subparagraph (D), by striking “or a supplement”; ####
(13)by amending paragraph
(3)to read as follows: > > #### “(3) Biosimilar biological product program fee > > > ##### “(A) In general > > Each person who is named as the applicant in a biosimilar biological product application shall pay the annual biosimilar biological product program fee established for a fiscal year under subsection (c)(5) for each biosimilar biological product that— > > > ###### “(i) > > is identified in such a biosimilar biological product application approved as of October 1 of such fiscal year; and > > > ###### “(ii) > > as of October 1 of such fiscal year, does not appear on a list, developed and maintained by the Secretary, of discontinued biosimilar biological products. > > > ##### “(B) Due date > > The biosimilar biological product program fee for a fiscal year shall be due on the later of— > > > ###### “(i) > > the first business day on or after October 1 of each such year; or > > > ###### “(ii) > > the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section. > > > ##### “(C) One fee per product per year > > The biosimilar biological product program fee shall be paid only once for each product for each fiscal year. > > > ##### “(D) Limitation > > A person who is named as the applicant in a biosimilar biological product application shall not be assessed more than 5 biosimilar biological product program fees for a fiscal year for biosimilar biological products identified in such biosimilar biological product application.” > . ###
(b)Fee Revenue Amounts Subsection
(b)of section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended to read as follows: > > ### “(b) Fee Revenue Amounts > > > #### “(1) Fiscal year 2018 > > For fiscal year 2018, fees under subsection
(a)shall be established to generate a total revenue amount equal to the sum of— > > > ##### “(A) > > $45,000,000; and > > > ##### “(B) > > the dollar amount equal to the fiscal year 2018 adjustment (as determined under subsection (c)(4)). > > > #### “(2) Subsequent fiscal years > > For each of the fiscal years 2019 through 2022, fees under subsection
(a)shall, except as provided in subsection (c), be established to generate a total revenue amount equal to the sum of— > > > ##### “(A) > > the annual base revenue for the fiscal year (as determined under paragraph (4)); > > > ##### “(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 capacity planning adjustment for the fiscal year (as determined under subsection (c)(2)); and > > > ##### “(D) > > the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(3)). > > > #### “(3) Allocation of revenue amount among fees; limitations on fee amounts > > > ##### “(A) Allocation > > The Secretary shall determine the percentage of the total revenue amount for a fiscal year to be derived from, respectively— > > > ###### “(i) > > initial and annual biosimilar biological product development fees and reactivation fees under subsection (a)(1); > > > ###### “(ii) > > biosimilar biological product application fees under subsection (a)(2); and > > > ###### “(iii) > > biosimilar biological product program fees under subsection (a)(3). > > > ##### “(B) Limitations on fee amounts > > Until the first fiscal year for which the capacity planning adjustment under subsection (c)(2) is effective, the amount of any fee under subsection
(a)for a fiscal year after fiscal year 2018 shall not exceed 125 percent of the amount of such fee for fiscal year 2018. > > > ##### “(C) Biosimilar biological product development fees > > The initial biosimilar biological product development fee under subsection (a)(1)(A) for a fiscal year shall be equal to the annual biosimilar biological product development fee under subsection (a)(1)(B) for that fiscal year. > > > ##### “(D) Reactivation fee > > The reactivation fee under subsection (a)(1)(D) for a fiscal year shall be equal to twice the amount of the annual biosimilar biological product development fee under subsection (a)(1)(B) for that fiscal year. > > > #### “(4) Annual base revenue > > For purposes of paragraph (2), the dollar amount of the annual base revenue for a fiscal year shall be the dollar amount of the total revenue amount for the previous fiscal year, excluding any adjustments to such revenue amount under subsection (c)(3).” > . ###
(c)Adjustments; Annual Fee Setting Section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended— ####
(1)by redesignating subsections
(c)through
(h)as subsections
(d)through (i), respectively; ####
(2)in subsections (a)(2)(F) and
(h)(as redesignated by paragraph (1)), by striking “subsection (c)” and inserting “subsection (d)”; ####
(3)in subsection (a)(4)(A), by striking “subsection (b)(1)(F)” and inserting “subsection (c)(5)”; and ####
(4)by inserting after subsection
(b)the following: > > ### “(c) Adjustments; Annual Fee Setting > > > #### “(1) Inflation adjustment > > > ##### “(A) In general > > For purposes of subsection (b)(2)(B), the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of— > > > ###### “(i) > > such annual base revenue for the fiscal year under subsection (b); and > > > ###### “(ii) > > the inflation adjustment percentage under subparagraph (B). > > > ##### “(B) Inflation adjustment percentage > > The inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of— > > > ###### “(i) > > the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications (as defined in section 744G(13)) for the first 3 years of the preceding 4 fiscal years; and > > > ###### “(ii) > > the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications (as defined in section 744G(13)) for the first 3 years of the preceding 4 fiscal years. > > > #### “(2) Capacity planning adjustment > > > ##### “(A) In general > > Beginning with the fiscal year described in subparagraph (B)(ii)(II), 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 to reflect changes in the resource capacity needs of the Secretary for the process for the review of biosimilar biological product applications. > > > ##### “(B) Capacity planning methodology > > > ###### “(i) Development; evaluation and report > > The Secretary shall obtain, through a contract with an independent accounting or consulting firm, a report evaluating options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs of the process for the review of biosimilar biological product applications. The capacity planning methodological options and recommendations presented in such report shall utilize and be informed by personnel time reporting data as an input. The report shall be published for public comment not later than September 30, 2020. > > > ###### “(ii) Establishment and implementation > > After review of the report described in clause
(i)and receipt and review of public comments thereon, the Secretary shall establish a capacity planning methodology for purposes of this paragraph, which shall— > > > ###### “(I) > > incorporate such approaches and attributes as the Secretary determines appropriate; and > > > ###### “(II) > > be effective beginning with the first fiscal year for which fees are set after such capacity planning methodology is established. > > > ##### “(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)(2)(A) (the annual base revenue for the fiscal year) and (b)(2)(B) (the dollar amount of the inflation adjustment for the fiscal year). > > > ##### “(D) Publication in federal register > > 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. > > > #### “(3) Operating reserve adjustment > > > ##### “(A) Interim application; fee reduction > > Until the first fiscal year for which the capacity planning adjustment under paragraph
(2)is effective, the Secretary may, in addition to the adjustment under paragraph (1), reduce the fee revenue and fees under this section for a fiscal year as the Secretary determines appropriate for long-term financial planning purposes. > > > ##### “(B) General application and methodology > > Beginning with the first fiscal year for which the capacity planning adjustment under paragraph
(2)is effective, the Secretary may, in addition to the adjustments under paragraphs
(1)and (2)— > > > ###### “(i) > > reduce the fee revenue and fees under this section as the Secretary determines appropriate for long-term financial planning purposes; or > > > ###### “(ii) > > increase the fee revenue and fees under this section if such an adjustment is necessary to provide for not more than 21 weeks of operating reserves of carryover user fees for the process for the review of biosimilar biological product applications. > > > ##### “(C) Federal register notice > > 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. > > > #### “(4) Fiscal year 2018 adjustment > > > ##### “(A) In general > > For fiscal year 2018, the Secretary shall adjust the fee revenue and fees under this section in such amount (if any) as needed to reflect an updated assessment of the workload for the process for the review of biosimilar biological product applications. > > > ##### “(B) Methodology > > The Secretary shall publish under paragraph (5)(B) a description of the methodology used to calculate the fiscal year 2018 adjustment under this paragraph in the Federal Register notice establishing fee revenue and fees for fiscal year 2018. > > > ##### “(C) Limitation > > No adjustment under this paragraph shall result in an increase in fee revenue and fees under this section in excess of $9,000,000. > > > #### “(5) Annual fee setting > > For fiscal year 2018 and each subsequent fiscal year, the Secretary shall, not later than 60 days before the start of each such fiscal year— > > > ##### “(A) > > establish, for the fiscal year, initial and annual biosimilar biological product development fees and reactivation fees under subsection (a)(1), biosimilar biological product application fees under subsection (a)(2), and biosimilar biological product program fees under subsection (a)(3), based on the revenue amounts established under subsection
(b)and the adjustments provided under this subsection; and > > > ##### “(B) > > publish such fee revenue and fees in the Federal Register. > > > #### “(6) Limit > > The total amount of fees assessed for a fiscal year under this section may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of biosimilar biological product applications.” > . ###
(d)Application Fee Waiver for Small Business Subsection (d)(1) of section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52), as redesignated by subsection (c)(1), is amended— ####
(1)by striking subparagraph (B); ####
(2)by striking “; and” at the end of subparagraph
(A)and inserting a period; and ####
(3)by striking “shall pay—” and all that follows through “application fees” and inserting “shall pay application fees”. ###
(e)Effect of Failure To Pay Fees Subsection
(e)of section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52), as redesignated by subsection (c)(1), is amended by striking “all fees” and inserting “all such fees”. ###
(f)Crediting and Availability of Fees Subsection
(f)of section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52), as redesignated by subsection (c)(1), is amended— ####
(1)in paragraph (2)— #####
(A)by striking subparagraph
(C)(relating to fee collection during first program year) and inserting the following: > > ##### “(C) Compliance > > The Secretary shall be considered to have met the requirements of subparagraph
(B)in any fiscal year if the costs described in such subparagraph are not more than 15 percent below the level specified in such subparagraph.” > ; and #####
(B)in subparagraph (D)— ######
(i)in the heading, by striking “in subsequent years”; and ######
(ii)by striking “(after fiscal year 2013)”; and ####
(2)in paragraph (3), by striking “2013 through 2017” and inserting “2018 through 2022”.
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Sec. 403
AUTHORITY TO ASSESS AND USE BIOSIMILAR FEES
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