21 USC 379 - Authority to assess and use biosimilar biological product fees

View all text of Subpart 8 [§ 379j-51 - § 379j-53]

§ 379j–52. Authority to assess and use biosimilar biological product fees

(a) Types of fees

Beginning in fiscal year 2023, the Secretary shall assess and collect fees in accordance with this section as follows:

(1) Biosimilar biological product development program fees

(A) Initial biosimilar biological product development fee

(i) In general

(ii) Meeting request

(iii) Clinical protocol for IND

(iv) Due date

The initial biosimilar biological product development fee shall be due by the earlier of the following:

(I) Not later than 7 days after the Secretary grants a request for a biosimilar biological product development meeting.(II) The date of submission of an investigational new drug application describing an investigation that the Secretary determines is intended to support a biosimilar biological product application.

(v) Transition rule

Each person that has submitted an investigational new drug application prior to July 9, 2012, shall pay the initial biosimilar biological product development fee by the earlier of the following:

(I) Not later than 60 days after July 9, 2012, if the Secretary determines that the investigational new drug application describes an investigation that is intended to support a biosimilar biological product application.(II) Not later than 7 days after the Secretary grants a request for a biosimilar biological product development meeting.

(B) Annual biosimilar biological product development fee

(i) In general

(ii) Due date

The annual biosimilar biological product development fee for each fiscal year will 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.

(iii) Exception

The annual biosimilar biological product development fee for each fiscal year will be due on the date specified in clause (ii), unless the person has—

(I) submitted a marketing application for the biological product that was accepted for filing;(II) discontinued participation in the biosimilar biological product development program for the product under subparagraph (C); or(III) been administratively removed from the biosimilar biological product development program for the product under subparagraph (E)(v).

(iv) Refund

A person may discontinue participation in the biosimilar biological product development program for a product, effective October 1 of a fiscal year, by, not later than August 1 of the preceding fiscal year—

(i) if no investigational new drug application concerning the product has been submitted, submitting to the Secretary a written declaration that the person has no present intention of further developing the product as a biosimilar biological product; or

(ii) if an investigational new drug application concerning the product has been submitted, withdrawing the investigational new drug application in accordance with part 312 of title 21, Code of Federal Regulations (or any successor regulations).

(D) Reactivation fee

(i) In general

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 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 a fee (referred to in this section as “reactivation fee”) by the earlier of the following:

(I) 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).(II) 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.

(ii) Application of annual fee

(E) Effect of failure to pay fees

(i) No biosimilar biological product development meetings

(ii) No receipt of investigational new drug applications

Except in extraordinary circumstances, the Secretary shall not consider an investigational new drug application to have been received under section 355(i)(2) of this title if—

(I) the Secretary determines that the investigation is intended to support a biosimilar biological product application; and(II) the sponsor has failed to pay an initial or annual biosimilar biological product development fee for the product as required under subparagraph (A) or (B), or a reactivation fee as required under subparagraph (D).

(iii) Financial hold

Notwithstanding section 355(i)(2) of this title, except in extraordinary circumstances, the Secretary shall prohibit the sponsor of a clinical investigation from continuing the investigation if—

(iv) No acceptance of biosimilar biological product applications or supplements

(v) Administrative removal from the biosimilar biological product development program

(F) Limits regarding fees

(i) Refunds

(ii) No waivers, exemptions, or reductions

(2) Biosimilar biological product application fee

(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).

(D) Exception for previously filed application

(E) Refund of application fee if application refused for filing or withdrawn before filing

(F) Fees for applications previously refused for filing or withdrawn before filing

(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;

(ii) may be dispensed only under prescription pursuant to section 353(b) of this title; and

(iii) 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.

(D) Limitation

(E) Movement to discontinued list

(i) Date of inclusion

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, 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—

(I) the date such request was received; or(II) if the product will be withdrawn from sale on a future date, such future date when the product is withdrawn from sale.

(ii) Treatment as withdrawn from sale

(iii) Special rule for products removed from discontinued list

(b) Fee revenue amounts

(1) In general

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—

(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));

(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) for fiscal year 2023 an additional amount of $4,428,886; and

(G) for fiscal year 2024 an additional amount of $320,569.

(2) Allocation of revenue amount among fees

(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) Biosimilar biological product development fees

(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, $43,376,922; 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, excluding any adjustments to such revenue amount under subsection (c)(4).

(1) Inflation adjustment

(A) In general

For purposes of subsection (b)(1)(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)(1)(A); 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 379j–51(13) of this title) 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-Arlington-Alexandria, DC–VA–MD–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 379j–51(13) of this title) for the first 3 years of the preceding 4 fiscal years.

(2) Strategic hiring and retention adjustment

(3) Capacity planning adjustment

(A) In general

(B) Methodology

(D) Publication in Federal Register

(4) Operating reserve adjustment

(A) Increase

(B) Decrease

(i) Fiscal year 2023

(ii) Fiscal year 2024

(iii) Fiscal year 2025 and subsequent fiscal years

(5) Annual fee setting

For fiscal year 2023 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

(d) Application fee waiver for small business

(1) Waiver of application fee

(2) Considerations

(3) Small business defined

(e) Effect of failure to pay fees

(f) Crediting and availability of fees

(1) In general

(2) Collections and appropriation Acts

(A) In general

(B) Use of fees and limitations

(i) In general

The fees authorized by this section shall be available—

(I) for fiscal year 2023, to defray the costs of the process for the review of biosimilar biological product applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the Secretary allocates for such purpose an amount for such fiscal year (excluding amounts from fees collected under this section) no less than $20,000,000, multiplied by the adjustment factor applicable to such fiscal year; and(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the process for the review of biosimilar biological product applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with the process for the review of biosimilar biological product applications, is no less than $20,000,000, multiplied by the adjustment factor applicable to the fiscal year involved.

(ii) Leasing and necessary equipment

(D) Provision for early payments

(3) Authorization of appropriations

(g) Collection of unpaid fees

(h) Written requests for waivers and returns; disputes concerning fees

(i) Construction

(June 25, 1938, ch. 675, § 744H, as added Pub. L. 112–144, title IV, § 402, July 9, 2012, 126 Stat. 1029; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(V), Dec. 13, 2016, 130 Stat. 1155; Pub. L. 115–52, title IV, § 403, title IX, § 905(b)(4), Aug. 18, 2017, 131 Stat. 1028, 1090; Pub. L. 116–136, div. A, title III, § 3856(b)(1), Mar. 27, 2020, 134 Stat. 458; Pub. L. 117–180, div. F, title IV, § 4003, Sept. 30, 2022, 136 Stat. 2160; Pub. L. 117–328, div. FF, title III, § 3625(b), Dec. 29, 2022, 136 Stat. 5880.)