---
kind: "section"
citation: "21 U.S.C. § 379j–52"
title: "21"
title_heading: "Food and Drugs"
number: "379j–52"
heading: "Authority to assess and use biosimilar biological product fees"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/379j-52"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter VII — General Authority"
  - "Part C — Fees"
  - "Subpart 8 — fees relating to biosimilar biological products"
---

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

- (a) **Types of fees—** Beginning in fiscal year 2023, the [Secretary](/usc/21/321.md?p=d) 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—** Each [person](/usc/21/379j–51.md?p=12) that submits to the [Secretary](/usc/21/321.md?p=d) a meeting request described under [clause (ii)](#a-1-A-ii) or a clinical protocol for an investigational [new drug](/usc/21/321.md?p=p) protocol described under [clause (iii)](#a-1-A-iii) shall pay for the [product](/usc/21/360eee.md?p=13) named in the meeting request or the investigational [new drug](/usc/21/321.md?p=p) application the initial [biosimilar biological product](/usc/21/379j–51.md?p=3) development fee established under [subsection (c)(5)](#c-5).
      - (ii) **Meeting request—** The meeting request described in this clause is a request for a [biosimilar biological product development meeting](/usc/21/379j–51.md?p=5) for a [product](/usc/21/360eee.md?p=13).
      - (iii) **Clinical protocol for IND—** A clinical protocol for an investigational [new drug](/usc/21/321.md?p=p) protocol described in this clause is a clinical protocol consistent with the provisions of [section 355(i) of this title](/usc/21/355.md?p=i), including any regulations promulgated under [section 355(i) of this title](/usc/21/355.md?p=i), (referred to in this section as “investigational [new drug](/usc/21/321.md?p=p) application”) describing an investigation that the [Secretary](/usc/21/321.md?p=d) determines is intended to support a [biosimilar biological product application](/usc/21/379j–51.md?p=4-A) for a [product](/usc/21/360eee.md?p=13).
      - (iv) **Due date—** The initial [biosimilar biological product](/usc/21/379j–51.md?p=3) development fee shall be due by the earlier of the following:
        - (I) Not later than 7 days after the [Secretary](/usc/21/321.md?p=d) grants a request for a [biosimilar biological product development meeting](/usc/21/379j–51.md?p=5).
        - (II) The date of submission of an investigational [new drug](/usc/21/321.md?p=p) application describing an investigation that the [Secretary](/usc/21/321.md?p=d) determines is intended to support a [biosimilar biological product application](/usc/21/379j–51.md?p=4-A).
      - (v) **Transition rule—** Each [person](/usc/21/379j–51.md?p=12) that has submitted an investigational [new drug](/usc/21/321.md?p=p) application prior to July 9, 2012, shall pay the initial [biosimilar biological product](/usc/21/379j–51.md?p=3) development fee by the earlier of the following:
        - (I) Not later than 60 days after July 9, 2012, if the [Secretary](/usc/21/321.md?p=d) determines that the investigational [new drug](/usc/21/321.md?p=p) application describes an investigation that is intended to support a [biosimilar biological product application](/usc/21/379j–51.md?p=4-A).
        - (II) Not later than 7 days after the [Secretary](/usc/21/321.md?p=d) grants a request for a [biosimilar biological product development meeting](/usc/21/379j–51.md?p=5).
    - (B) **Annual biosimilar biological product development fee—**
      - (i) **In general—** A [person](/usc/21/379j–51.md?p=12) that pays an initial [biosimilar biological product](/usc/21/379j–51.md?p=3) development fee for a [product](/usc/21/360eee.md?p=13) shall pay for such [product](/usc/21/360eee.md?p=13), beginning in the fiscal year following the fiscal year in which the initial [biosimilar biological product](/usc/21/379j–51.md?p=3) development fee was paid, an annual fee established under [subsection (c)(5)](#c-5) for the [biosimilar biological product development program](/usc/21/379j–51.md?p=6) (referred to in this section as “annual [biosimilar biological product](/usc/21/379j–51.md?p=3) development fee”), except that, in the case that such [product](/usc/21/360eee.md?p=13) (including, where applicable, ownership of the relevant investigational [new drug](/usc/21/321.md?p=p) application) is transferred to a licensee, assignee, or successor of such [person](/usc/21/379j–51.md?p=12), and written notice of such transfer is provided to the [Secretary](/usc/21/321.md?p=d), such licensee, assignee, or successor shall pay the annual [biosimilar biological product](/usc/21/379j–51.md?p=3) development fee.
      - (ii) **Due date—** The annual [biosimilar biological product](/usc/21/379j–51.md?p=3) 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](/usc/21/379j–51.md?p=3) development fee for each fiscal year will be due on the date specified in [clause (ii)](#a-1-B-ii), unless the [person](/usc/21/379j–51.md?p=12) has—
        - (I) submitted a marketing application for the biological [product](/usc/21/360eee.md?p=13) that was accepted for filing;
        - (II) discontinued participation in the [biosimilar biological product development program](/usc/21/379j–51.md?p=6) for the [product](/usc/21/360eee.md?p=13) under [subparagraph (C)](#a-1-C); or
        - (III) been administratively removed from the [biosimilar biological product development program](/usc/21/379j–51.md?p=6) for the [product](/usc/21/360eee.md?p=13) under [subparagraph (E)(v)](#a-1-E-v).
      - (iv) **Refund—** If a [person](/usc/21/379j–51.md?p=12) submits a marketing application for a [biosimilar biological product](/usc/21/379j–51.md?p=3) before October 1 of a fiscal year and such application is subsequently accepted for filing, the [person](/usc/21/379j–51.md?p=12) may request a refund equal to the annual [biosimilar biological product](/usc/21/379j–51.md?p=3) development fee paid by the [person](/usc/21/379j–51.md?p=12) for the [product](/usc/21/360eee.md?p=13) for such fiscal year. To qualify for consideration for a refund under this clause, a [person](/usc/21/379j–51.md?p=12) shall submit to the [Secretary](/usc/21/321.md?p=d) a written request for such refund not later than 180 days after the marketing application is accepted for filing.
    - (C) **Discontinuation of fee obligation—** A [person](/usc/21/379j–51.md?p=12) may discontinue participation in the [biosimilar biological product development program](/usc/21/379j–51.md?p=6) for a [product](/usc/21/360eee.md?p=13), effective October 1 of a fiscal year, by, not later than August 1 of the preceding fiscal year—
      - (i) if no investigational [new drug](/usc/21/321.md?p=p) application concerning the [product](/usc/21/360eee.md?p=13) has been submitted, submitting to the [Secretary](/usc/21/321.md?p=d) a written declaration that the [person](/usc/21/379j–51.md?p=12) has no present intention of further developing the [product](/usc/21/360eee.md?p=13) as a [biosimilar biological product](/usc/21/379j–51.md?p=3); or
      - (ii) if an investigational [new drug](/usc/21/321.md?p=p) application concerning the [product](/usc/21/360eee.md?p=13) has been submitted, withdrawing the investigational [new drug](/usc/21/321.md?p=p) 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](/usc/21/379j–51.md?p=12) that has discontinued participation in the [biosimilar biological product development program](/usc/21/379j–51.md?p=6) for a [product](/usc/21/360eee.md?p=13) under [subparagraph (C)](#a-1-C), or who has been administratively removed from such program for a [product](/usc/21/360eee.md?p=13) under [subparagraph (E)(v)](#a-1-E-v), shall, if the [person](/usc/21/379j–51.md?p=12) seeks to resume participation in such program, pay all annual [biosimilar biological product](/usc/21/379j–51.md?p=3) development fees previously assessed for such [product](/usc/21/360eee.md?p=13) 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](/usc/21/321.md?p=d) grants a request by such [person](/usc/21/379j–51.md?p=12) for a [biosimilar biological product development meeting](/usc/21/379j–51.md?p=5) for the [product](/usc/21/360eee.md?p=13) (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](/usc/21/379j–51.md?p=12) of an investigational [new drug](/usc/21/321.md?p=p) application describing an investigation that the [Secretary](/usc/21/321.md?p=d) determines is intended to support a [biosimilar biological product application](/usc/21/379j–51.md?p=4-A) for that [product](/usc/21/360eee.md?p=13).
      - (ii) **Application of annual fee—** A [person](/usc/21/379j–51.md?p=12) that pays a reactivation fee for a [product](/usc/21/360eee.md?p=13) shall pay for such [product](/usc/21/360eee.md?p=13), beginning in the next fiscal year, the annual [biosimilar biological product](/usc/21/379j–51.md?p=3) development fee under [subparagraph (B)](#a-1-B), except that, in the case that such [product](/usc/21/360eee.md?p=13) (including, where applicable, ownership of the relevant investigational [new drug](/usc/21/321.md?p=p) application) is transferred to a licensee, assignee, or successor of such [person](/usc/21/379j–51.md?p=12), and written notice of such transfer is provided to the [Secretary](/usc/21/321.md?p=d), such licensee, assignee, or successor shall pay the annual [biosimilar biological product](/usc/21/379j–51.md?p=3) development fee.
    - (E) **Effect of failure to pay fees—**
      - (i) **No biosimilar biological product development meetings—** If a [person](/usc/21/379j–51.md?p=12) has failed to pay an initial or annual [biosimilar biological product](/usc/21/379j–51.md?p=3) development fee as required under subparagraph [(A)](#a-1-A) or [(B)](#a-1-B), or a reactivation fee as required under [subparagraph (D)](#a-1-D), the [Secretary](/usc/21/321.md?p=d) shall not provide a [biosimilar biological product development meeting](/usc/21/379j–51.md?p=5) relating to the [product](/usc/21/360eee.md?p=13) for which fees are owed.
      - (ii) **No receipt of investigational new drug applications—** Except in extraordinary circumstances, the [Secretary](/usc/21/321.md?p=d) shall not consider an investigational [new drug](/usc/21/321.md?p=p) application to have been received under [section 355(i)(2) of this title](/usc/21/355.md?p=i-2) if—
        - (I) the [Secretary](/usc/21/321.md?p=d) determines that the investigation is intended to support a [biosimilar biological product application](/usc/21/379j–51.md?p=4-A); and
        - (II) the [sponsor](/usc/21/360fff.md?p=8) has failed to pay an initial or annual [biosimilar biological product](/usc/21/379j–51.md?p=3) development fee for the [product](/usc/21/360eee.md?p=13) as required under subparagraph [(A)](#a-1-A) or [(B)](#a-1-B), or a reactivation fee as required under [subparagraph (D)](#a-1-D).
      - (iii) **Financial hold—** Notwithstanding [section 355(i)(2) of this title](/usc/21/355.md?p=i-2), except in extraordinary circumstances, the [Secretary](/usc/21/321.md?p=d) shall prohibit the [sponsor](/usc/21/360fff.md?p=8) of a clinical investigation from continuing the investigation if—
        - (I) the [Secretary](/usc/21/321.md?p=d) determines that the investigation is intended to support a [biosimilar biological product application](/usc/21/379j–51.md?p=4-A); and
        - (II) the [sponsor](/usc/21/360fff.md?p=8) has failed to pay an initial or annual [biosimilar biological product](/usc/21/379j–51.md?p=3) development fee for the [product](/usc/21/360eee.md?p=13) as required under subparagraph [(A)](#a-1-A) or [(B)](#a-1-B), or a reactivation fee for the [product](/usc/21/360eee.md?p=13) as required under [subparagraph (D)](#a-1-D).
      - (iv) **No acceptance of biosimilar biological product applications or supplements—** If a [person](/usc/21/379j–51.md?p=12) has failed to pay an initial or annual [biosimilar biological product](/usc/21/379j–51.md?p=3) development fee as required under subparagraph [(A)](#a-1-A) or [(B)](#a-1-B), or a reactivation fee as required under [subparagraph (D)](#a-1-D), any [biosimilar biological product application](/usc/21/379j–51.md?p=4-A) or [supplement](/usc/21/379j–51.md?p=14) submitted by that [person](/usc/21/379j–51.md?p=12) shall be considered incomplete and shall not be accepted for filing by the [Secretary](/usc/21/321.md?p=d) until all such fees owed by such [person](/usc/21/379j–51.md?p=12) have been paid.
      - (v) **Administrative removal from the biosimilar biological product development program—** If a [person](/usc/21/379j–51.md?p=12) has failed to pay an annual [biosimilar biological product](/usc/21/379j–51.md?p=3) development fee for a [product](/usc/21/360eee.md?p=13) as required under [subparagraph (B)](#a-1-B) for a period of 2 consecutive fiscal years, the [Secretary](/usc/21/321.md?p=d) may administratively remove such [person](/usc/21/379j–51.md?p=12) from the [biosimilar biological product development program](/usc/21/379j–51.md?p=6) for the [product](/usc/21/360eee.md?p=13). At least 30 days prior to administratively removing a [person](/usc/21/379j–51.md?p=12) from the [biosimilar biological product development program](/usc/21/379j–51.md?p=6) for a [product](/usc/21/360eee.md?p=13) under this clause, the [Secretary](/usc/21/321.md?p=d) shall provide written notice to such [person](/usc/21/379j–51.md?p=12) of the intended administrative removal.
    - (F) **Limits regarding fees—**
      - (i) **Refunds—** Except as provided in [subparagraph (B)(iv)](#a-1-B-iv), the [Secretary](/usc/21/321.md?p=d) shall not refund any initial or annual [biosimilar biological product](/usc/21/379j–51.md?p=3) development fee paid under subparagraph [(A)](#a-1-A) or [(B)](#a-1-B), or any reactivation fee paid under [subparagraph (D)](#a-1-D).
      - (ii) **No waivers, exemptions, or reductions—** The [Secretary](/usc/21/321.md?p=d) shall not grant a waiver, exemption, or reduction of any initial or annual [biosimilar biological product](/usc/21/379j–51.md?p=3) development fee due or payable under subparagraph [(A)](#a-1-A) or [(B)](#a-1-B), or any reactivation fee due or payable under [subparagraph (D)](#a-1-D).
  - (2) **Biosimilar biological product application fee—**
    - (A) **In general—** Each [person](/usc/21/379j–51.md?p=12) that submits, on or after October 1, 2017, a [biosimilar biological product application](/usc/21/379j–51.md?p=4-A) shall be subject to the following fees:
      - (i) A fee established under [subsection (c)(5)](#c-5) for a [biosimilar biological product application](/usc/21/379j–51.md?p=4-A) 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)](#c-5) for a [biosimilar biological product application](/usc/21/379j–51.md?p=4-A) 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)](#a-2-A-i).
    - (B) **Rule of applicability; treatment of certain previously paid fees—** Any [person](/usc/21/379j–51.md?p=12) who pays a fee under subparagraph [(A)](#a-1-A), [(B)](#a-1-B), or [(D)](#a-1-D) of paragraph (1) for a [product](/usc/21/360eee.md?p=13) before October 1, 2017, but submits a [biosimilar biological product application](/usc/21/379j–51.md?p=4-A) for that [product](/usc/21/360eee.md?p=13) after such date, shall—
      - (i) be subject to any [biosimilar biological product application](/usc/21/379j–51.md?p=4-A) fees that may be assessed at the time when such [biosimilar biological product application](/usc/21/379j–51.md?p=4-A) is submitted; and
      - (ii) be entitled to no reduction of such application fees based on the amount of fees paid for that [product](/usc/21/360eee.md?p=13) before October 1, 2017, under such subparagraph [(A)](#a-2-A), [(B)](#a-2-B), or [(D)](#a-2-D).
    - (C) **Payment due date—** Any fee required by [subparagraph (A)](#a-2-A) shall be due upon submission of the application for which such fee applies.
    - (D) **Exception for previously filed application—** If a [biosimilar biological product application](/usc/21/379j–51.md?p=4-A) was submitted by a [person](/usc/21/379j–51.md?p=12) that paid the fee for such application, was accepted for filing, and was not approved or was withdrawn prior to approval (without a waiver), the submission of a [biosimilar biological product application](/usc/21/379j–51.md?p=4-A) for the same [product](/usc/21/360eee.md?p=13) by the same [person](/usc/21/379j–51.md?p=12) (or the [person](/usc/21/379j–51.md?p=12)’s licensee, assignee, or successor) shall not be subject to a fee under [subparagraph (A)](#a-2-A).
    - (E) **Refund of application fee if application refused for filing or withdrawn before filing—** The [Secretary](/usc/21/321.md?p=d) shall refund 75 percent of the fee paid under this paragraph for any application which is refused for filing or withdrawn without a waiver before filing.
    - (F) **Fees for applications previously refused for filing or withdrawn before filing—** A [biosimilar biological product application](/usc/21/379j–51.md?p=4-A) that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under [subparagraph (A)](#a-2-A) upon being resubmitted or filed over protest, unless the fee is waived under [subsection (d)](#d).
  - (3) **Biosimilar biological product program fee—**
    - (A) **In general—** Each [person](/usc/21/379j–51.md?p=12) who is named as the applicant in a [biosimilar biological product application](/usc/21/379j–51.md?p=4-A) shall pay the annual [biosimilar biological product](/usc/21/379j–51.md?p=3) program fee established for a fiscal year under [subsection (c)(5)](#c-5) for each [biosimilar biological product](/usc/21/379j–51.md?p=3) that—
      - (i) is identified in such a [biosimilar biological product application](/usc/21/379j–51.md?p=4-A) approved as of October 1 of such fiscal year;
      - (ii) may be dispensed only under prescription pursuant to [section 353(b) of this title](/usc/21/353.md?p=b); and
      - (iii) as of October 1 of such fiscal year, does not appear on a list, developed and maintained by the [Secretary](/usc/21/321.md?p=d), of discontinued [biosimilar biological products](/usc/21/379j–51.md?p=3).
    - (B) **Due date—** The [biosimilar biological product](/usc/21/379j–51.md?p=3) 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](/usc/21/379j–51.md?p=3) program fee shall be paid only once for each [product](/usc/21/360eee.md?p=13) for each fiscal year.
    - (D) **Limitation—** A [person](/usc/21/379j–51.md?p=12) who is named as the applicant in a [biosimilar biological product application](/usc/21/379j–51.md?p=4-A) shall not be assessed more than 5 [biosimilar biological product](/usc/21/379j–51.md?p=3) program fees for a fiscal year for [biosimilar biological products](/usc/21/379j–51.md?p=3) identified in such [biosimilar biological product application](/usc/21/379j–51.md?p=4-A).
    - (E) **Movement to discontinued list—**
      - (i) **Date of inclusion—** If a written request to place a [product](/usc/21/360eee.md?p=13) on the list referenced in [subparagraph (A)](#a-3-A) of discontinued [biosimilar biological products](/usc/21/379j–51.md?p=3) is submitted to the [Secretary](/usc/21/321.md?p=d) on behalf of an applicant, and the request identifies the date the [product](/usc/21/360eee.md?p=13) is, or will be, withdrawn from sale, then for purposes of assessing the [biosimilar biological product](/usc/21/379j–51.md?p=3) program fee, the [Secretary](/usc/21/321.md?p=d) shall consider such [product](/usc/21/360eee.md?p=13) to have been included on such list on the later of—
        - (I) the date such request was received; or
        - (II) if the [product](/usc/21/360eee.md?p=13) will be withdrawn from sale on a future date, such future date when the [product](/usc/21/360eee.md?p=13) is withdrawn from sale.
      - (ii) **Treatment as withdrawn from sale—** For purposes of [clause (i)](#a-3-E-i), a [product](/usc/21/360eee.md?p=13) shall be considered withdrawn from sale once the applicant has ceased its own [distribution](/usc/21/360eee.md?p=5) of the [product](/usc/21/360eee.md?p=13), whether or not the applicant has ordered recall of all previously distributed lots of the [product](/usc/21/360eee.md?p=13), except that a routine, temporary interruption in supply shall not render a [product](/usc/21/360eee.md?p=13) withdrawn from sale.
      - (iii) **Special rule for products removed from discontinued list—** If a [biosimilar biological product](/usc/21/379j–51.md?p=3) that is identified in a [biosimilar biological product application](/usc/21/379j–51.md?p=4-A) 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)](#a-3-A) of discontinued [biosimilar biological products](/usc/21/379j–51.md?p=3), and on any subsequent day during such fiscal year the [biosimilar biological product](/usc/21/379j–51.md?p=3) does not appear on such list, except as provided in [subparagraph (D)](#a-3-D), each [person](/usc/21/379j–51.md?p=12) who is named as the applicant in a [biosimilar biological product application](/usc/21/379j–51.md?p=4-A) with respect to such [product](/usc/21/360eee.md?p=13) shall pay the annual [biosimilar biological product](/usc/21/379j–51.md?p=3) program fee established for a fiscal year under [subsection (c)(5)](#c-5) for such [biosimilar biological product](/usc/21/379j–51.md?p=3). Notwithstanding [subparagraph (B)](#a-3-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](/usc/21/360eee.md?p=13) for each fiscal year.
- (b) **Fee revenue amounts—**
  - (1) **In general—** For each of the fiscal years 2023 through 2027, fees under [subsection (a)](#a) shall, except as provided in [subsection (c)](#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-3));
    - (B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under [subsection (c)(1)](#c-1));
    - (C) the dollar amount equal to the strategic hiring and retention adjustment (as determined under [subsection (c)(2)](#c-2));
    - (D) the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under [subsection (c)(3)](#c-3));
    - (E) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under [subsection (c)(4)](#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](/usc/21/321.md?p=d) 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](/usc/21/379j–51.md?p=3) development fees and reactivation fees under [subsection (a)(1)](#a-1);
      - (ii) [biosimilar biological product application](/usc/21/379j–51.md?p=4-A) fees under [subsection (a)(2)](#a-2); and
      - (iii) [biosimilar biological product](/usc/21/379j–51.md?p=3) program fees under [subsection (a)(3)](#a-3).
    - (B) **Biosimilar biological product development fees—** The initial [biosimilar biological product](/usc/21/379j–51.md?p=3) development fee under [subsection (a)(1)(A)](#a-1-A) for a fiscal year shall be equal to the annual [biosimilar biological product](/usc/21/379j–51.md?p=3) development fee under [subsection (a)(1)(B)](#a-1-B) for that fiscal year.
    - (C) **Reactivation fee—** The reactivation fee under [subsection (a)(1)(D)](#a-1-D) for a fiscal year shall be equal to twice the amount of the annual [biosimilar biological product](/usc/21/379j–51.md?p=3) development fee under [subsection (a)(1)(B)](#a-1-B) for that fiscal year.
  - (3) **Annual base revenue—** For purposes of [paragraph (1)](#b-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)](#b-1) for the previous fiscal year, excluding any adjustments to such revenue amount under [subsection (c)(4)](#c-4).
- (c) **Adjustments; annual fee setting—**
  - (1) **Inflation adjustment—**
    - (A) **In general—** For purposes of [subsection (b)(1)(B)](#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](/usc/21/360eee.md?p=13) of—
      - (i) such annual base revenue for the fiscal year under [subsection (b)(1)(A)](#b-1-A); and
      - (ii) the inflation adjustment percentage under [subparagraph (B)](#c-1-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](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) 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](/usc/21/379j–51.md?p=13) (as defined in [section 379j–51(13) of this title](/usc/21/379j–51.md?p=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-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](/usc/21/379j–51.md?p=13) (as defined in [section 379j–51(13) of this title](/usc/21/379j–51.md?p=13)) for the first 3 years of the preceding 4 fiscal years.
  - (2) **Strategic hiring and retention adjustment—** For each fiscal year, after the annual base revenue under [subsection (b)(1)(A)](#b-1-A) is adjusted for inflation in accordance with [paragraph (1)](#c-1), the [Secretary](/usc/21/321.md?p=d) shall further increase the fee revenue and fees by $150,000.
  - (3) **Capacity planning adjustment—**
    - (A) **In general—** For each fiscal year, the [Secretary](/usc/21/321.md?p=d) shall, in addition to the adjustments under paragraphs [(1)](#c-1) and [(2)](#c-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](/usc/21/321.md?p=d) for the [process for the review of biosimilar biological product applications](/usc/21/379j–51.md?p=13).
    - (B) **Methodology—** For purposes of this paragraph, the [Secretary](/usc/21/321.md?p=d) shall employ the capacity planning methodology utilized by the [Secretary](/usc/21/321.md?p=d) 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 directly related to the direct review of [biosimilar biological product applications](/usc/21/379j–51.md?p=4-A) and [supplements](/usc/21/379j–51.md?p=14), 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](/usc/21/379j–51.md?p=3). Subject to the exceptions in the preceding sentence, the [Secretary](/usc/21/321.md?p=d) shall not include as workload categories in applying such methodology in forecasting any non-core review activities, including those activities that the [Secretary](/usc/21/321.md?p=d) referenced for potential future use in such notice but did not utilize in setting fees for fiscal year 2021.
    - (C) **Limitations—** 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)](#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).
    - (D) **Publication in Federal Register—** The [Secretary](/usc/21/321.md?p=d) shall publish in the Federal Register notice under [paragraph (5)](#c-5) the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph.
  - (4) **Operating reserve adjustment—**
    - (A) **Increase—** For fiscal year 2023 and subsequent fiscal years, the [Secretary](/usc/21/321.md?p=d) shall, in addition to adjustments under paragraphs [(1)](#c-1), [(2)](#c-2), and [(3)](#c-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](/usc/21/379j–51.md?p=13).
    - (B) **Decrease—**
      - (i) **Fiscal year 2023—** For fiscal year 2023, if the [Secretary](/usc/21/321.md?p=d) has carryover balances for such process in excess of 33 weeks of such operating reserves, the [Secretary](/usc/21/321.md?p=d) shall decrease such fee revenue and fees to provide for not more than 33 weeks of such operating reserves.
      - (ii) **Fiscal year 2024—** For fiscal year 2024, if the [Secretary](/usc/21/321.md?p=d) has carryover balances for such process in excess of 27 weeks of such operating reserves, the [Secretary](/usc/21/321.md?p=d) shall decrease such fee revenue and fees to provide for not more than 27 weeks of such operating reserves.
      - (iii) **Fiscal year 2025 and subsequent fiscal years—** For fiscal year 2025 and subsequent fiscal years, if the [Secretary](/usc/21/321.md?p=d) has carryover balances for such process in excess of 21 weeks of such operating reserves, the [Secretary](/usc/21/321.md?p=d) shall decrease such fee revenue and fees to provide for not more than 21 weeks of such operating reserves.
    - (C) **Federal Register notice—** If an adjustment under subparagraph [(A)](#c-4-A) or [(B)](#c-4-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)](#c-5-B) establishing fee revenue and fees for the fiscal year involved.
  - (5) **Annual fee setting—** For fiscal year 2023 and each subsequent fiscal year, the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/379j–51.md?p=3) development fees and reactivation fees under [subsection (a)(1)](#a-1), [biosimilar biological product application](/usc/21/379j–51.md?p=4-A) fees under [subsection (a)(2)](#a-2), and [biosimilar biological product](/usc/21/379j–51.md?p=3) program fees under [subsection (a)(3)](#a-3), based on the revenue amounts established under [subsection (b)](#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](/usc/21/379j–51.md?p=13).
- (d) **Application fee waiver for small business—**
  - (1) **Waiver of application fee—** The [Secretary](/usc/21/321.md?p=d) shall grant to a [person](/usc/21/379j–51.md?p=12) who is named in a [biosimilar biological product application](/usc/21/379j–51.md?p=4-A) a waiver from the application fee assessed to that [person](/usc/21/379j–51.md?p=12) under [subsection (a)(2)(A)](#a-2-A) for the first [biosimilar biological product application](/usc/21/379j–51.md?p=4-A) that a small business or its [affiliate](/usc/21/379j–51.md?p=2) submits to the [Secretary](/usc/21/321.md?p=d) for review. After a small business or its [affiliate](/usc/21/379j–51.md?p=2) is granted such a waiver, the small business or its [affiliate](/usc/21/379j–51.md?p=2) shall pay application fees for all subsequent [biosimilar biological product applications](/usc/21/379j–51.md?p=4-A) submitted to the [Secretary](/usc/21/321.md?p=d) for review in the same manner as an entity that is not a small business.
  - (2) **Considerations—** In determining whether to grant a waiver of a fee under [paragraph (1)](#d-1), the [Secretary](/usc/21/321.md?p=d) shall consider only the circumstances and assets of the applicant involved and any [affiliate](/usc/21/379j–51.md?p=2) of the applicant.
  - (3) **Small business defined—** In this subsection, the term “small business” means an entity that has fewer than 500 employees, including employees of [affiliates](/usc/21/379j–51.md?p=2), and does not have a [drug product](/usc/21/321.md?p=dd) that has been approved under a human [drug](/usc/21/321.md?p=g-1) application (as defined in [section 379g of this title](/usc/21/379g.md)) or a [biosimilar biological product application](/usc/21/379j–51.md?p=4-A) (as defined in [section 379j–51(4) of this title](/usc/21/379j–51.md?p=4)) and introduced or delivered for introduction into [interstate commerce](/usc/21/321.md?p=b).
- (e) **Effect of failure to pay fees—** A [biosimilar biological product application](/usc/21/379j–51.md?p=4-A) or [supplement](/usc/21/379j–51.md?p=14) submitted by a [person](/usc/21/379j–51.md?p=12) subject to fees under [subsection (a)](#a) shall be considered incomplete and shall not be accepted for filing by the [Secretary](/usc/21/321.md?p=d) until all such fees owed by such [person](/usc/21/379j–51.md?p=12) have been paid.
- (f) **Crediting and availability of fees—**
  - (1) **In general—** Subject to [paragraph (2)](#f-2), fees [authorized](/usc/21/360eee.md?p=2) under [subsection (a)](#a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are [authorized](/usc/21/360eee.md?p=2) to remain available until expended. Such sums as may be necessary may be transferred from the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the [process for the review of biosimilar biological product applications](/usc/21/379j–51.md?p=13).
  - (2) **Collections and appropriation Acts—**
    - (A) **In general—** Subject to subparagraphs [(C)](#f-2-C) and [(D)](#f-2-D), the fees [authorized](/usc/21/360eee.md?p=2) by this section shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year.
    - (B) **Use of fees and limitations—**
      - (i) **In general—** The fees [authorized](/usc/21/360eee.md?p=2) 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](/usc/21/379j–51.md?p=13) (including such costs for an additional number of full-time equivalent positions in the [Department](/usc/21/321.md?p=c) of Health and Human Services to be engaged in such process), only if the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/379j–51.md?p=1) 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](/usc/21/379j–51.md?p=13) (including such costs for an additional number of full-time equivalent positions in the [Department](/usc/21/321.md?p=c) of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the [Secretary](/usc/21/321.md?p=d) for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of [facilities](/usc/21/364.md?p=3-A) 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](/usc/21/379j–51.md?p=13), is no less than $20,000,000, multiplied by the [adjustment factor](/usc/21/379j–51.md?p=1) applicable to the fiscal year involved.
      - (ii) **Leasing and necessary equipment—** Beginning on October 1, 2023, the authorities under [section 379j–51(9)(C) of this title](/usc/21/379j–51.md?p=9-C) shall include only leasing and necessary scientific equipment.
    - (C) **Compliance—** The [Secretary](/usc/21/321.md?p=d) shall be considered to have met the requirements of [subparagraph (B)(i)](#f-2-B-i) in any fiscal year if the costs allocated as described in subclause [(I)](#f-2-B-i-I) or [(II)](#f-2-B-i-II) of such subparagraph, as applicable, are not more than 15 percent below the level specified in such subparagraph.
    - (D) **Provision for early payments—** Payment of fees [authorized](/usc/21/360eee.md?p=2) under this section for a fiscal year, prior to the due date for such fees, may be accepted by the [Secretary](/usc/21/321.md?p=d) in accordance with authority provided in advance in a prior year appropriations Act.
  - (3) **Authorization of appropriations—** For each of fiscal years 2023 through 2027, there is [authorized](/usc/21/360eee.md?p=2) to be appropriated for fees under this section an amount equivalent to the total amount of fees assessed for such fiscal year under this section.
- (g) **Collection of unpaid fees—** In any case where the [Secretary](/usc/21/321.md?p=d) does not receive payment of a fee assessed under [subsection (a)](#a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31.
- (h) **Written requests for waivers and returns; disputes concerning fees—** To qualify for consideration for a waiver under [subsection (d)](#d), or for the [return](/usc/21/360eee.md?p=17) of any fee paid under this section, including if the fee is claimed to have been paid in error, a [person](/usc/21/379j–51.md?p=12) shall submit to the [Secretary](/usc/21/321.md?p=d) a written request justifying such waiver or [return](/usc/21/360eee.md?p=17) and, except as otherwise specified in this section, such written request shall be submitted to the [Secretary](/usc/21/321.md?p=d) 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.
- (i) **Construction—** This section may not be construed to require that the number of full-time equivalent positions in the [Department](/usc/21/321.md?p=c) of Health and Human Services, for officers, employers, and [advisory committees](/usc/21/360fff.md?p=1) not engaged in the process of the review of [biosimilar biological product applications](/usc/21/379j–51.md?p=4-A), be reduced to offset the number of officers, employees, and [advisory committees](/usc/21/360fff.md?p=1) so engaged.

## Source credit

(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.)

## Notes

### Termination of Section

For termination of section by section 4005(a) of Pub. L. 117–180, see Effective and Termination Dates note set out below.

### Editorial Notes

### Amendments

2022—Subsec. (a). Pub. L. 117–180, § 4003(a)(1), substituted “fiscal year 2023” for “fiscal year 2018” in introductory provisions.

Subsec. (a)(1)(A)(iv)(I), (v)(II). Pub. L. 117–180, § 4003(a)(2), substituted “7 days” for “5 days”.

Subsec. (a)(1)(B)(i). Pub. L. 117–180, § 4003(a)(3)(A), inserted before period at end “, 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”.

Subsec. (a)(1)(B)(iii)(III). Pub. L. 117–180, § 4003(a)(3)(B), added subcl. (III).

Subsec. (a)(1)(B)(iv). Pub. L. 117–180, § 4003(a)(3)(C), substituted “is subsequently accepted for filing” for “is accepted for filing on or after October 1 of such fiscal year”.

Subsec. (a)(1)(D). Pub. L. 117–180, § 4003(a)(4), amended subpar. (D) generally. Prior to amendment, subpar. (D) related to payment of a reactivation fee for resuming participation in the biosimilar biological product development program and application of annual biosimilar biological product development fee for a person paying a reactivation fee.

Subsec. (a)(1)(E)(v). Pub. L. 117–180, § 4003(a)(5), added cl. (v).

Subsec. (a)(2)(D). Pub. L. 117–180, § 4003(a)(6), inserted “prior to approval” after “or was withdrawn”.

Subsec. (a)(3)(A)(ii), (iii). Pub. L. 117–180, § 4003(a)(7)(A), added cl. (ii) and redesignated former cl. (ii) as (iii).

Subsec. (a)(3)(E). Pub. L. 117–180, § 4003(a)(7)(B), added subpar. (E).

Subsec. (a)(4). Pub. L. 117–180, § 4003(a)(8), struck out par. (4) which related to the annual fee for each biosimilar biological product in a biosimilar biological product application.

Subsec. (b)(1). Pub. L. 117–180, § 4003(b)(2), (3), redesignated par. (2) as (1) and amended it generally. Prior to amendment, par. related to fee revenue amounts for fiscal years 2019 through 2022. Former par. (1) struck out.

Pub. L. 117–180, § 4003(b)(1), struck out par. (1) which related to fee revenue amounts for fiscal year 2018.

Subsec. (b)(2). Pub. L. 117–180, § 4003(b)(2), (4)(A), redesignated par. (3) as (2) and struck out “; limitations on fee amounts” after “among fees” in heading. Former par. (2) redesignated (1).

Subsec. (b)(2)(B) to (D). Pub. L. 117–180, § 4003(b)(4)(B), (C), redesignated subpars. (C) and (D) as (B) and (C), respectively, and struck out former subpar. (B). Prior to amendment, text of subpar. (B) read as follows: “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.”

Subsec. (b)(3), (4). Pub. L. 117–180, § 4003(b)(2), (5), redesignated par. (4) as (3) and amended it generally. Prior to amendment, text read as follows: “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).” Former par. (3) redesignated (2).

Subsec. (c)(1)(A). Pub. L. 117–180, § 4003(c)(1)(A)(i), substituted “subsection (b)(1)(B)” for “subsection (b)(2)(B)” in introductory provisions.

Subsec. (c)(1)(A)(i). Pub. L. 117–180, § 4003(c)(1)(A)(ii), substituted “subsection (b)(1)(A)” for “subsection (b)”.

Subsec. (c)(1)(B)(ii). Pub. L. 117–180, § 4003(c)(1)(B), substituted “Washington-Arlington-Alexandria, DC–VA–MD–WV” for “Washington-Baltimore, DC–MD–VA–WV”.

Subsec. (c)(2) to (4). Pub. L. 117–180, § 4003(c)(2), added pars. (2) to (4) and struck out former pars. (2) to (4) which related to application and methodology of capacity planning adjustment, operating reserve adjustment, and fiscal year 2018 adjustment, respectively.

Subsec. (c)(5). Pub. L. 117–180, § 4003(c)(3), substituted “2023” for “2018” in introductory provisions.

Subsec. (f)(2)(B)(i). Pub. L. 117–328, § 3625(b)(1), substituted “available—” for “available for a fiscal year beginning after fiscal year 2012”, designated remainder of existing provisions as subcl. (I), inserted “for fiscal year 2023,” before “to defray the costs”, substituted “such fiscal year; and” for “the fiscal year involved.”, and added subcl. (II).

Subsec. (f)(2)(C). Pub. L. 117–328, § 3625(b)(2), substituted “subparagraph (B)(i) in any fiscal year if the costs allocated as described in subclause (I) or (II) of such subparagraph, as applicable,” for “subparagraph (B) in any fiscal year if the costs described in such subparagraph”.

Subsec. (f)(3). Pub. L. 117–180, § 4003(d), substituted “2023 through 2027” for “2018 through 2022”.

Subsec. (h). Pub. L. 117–180, § 4003(e), amended subsec. (h) generally. Prior to amendment, text read as follows: “To qualify for consideration for a waiver under subsection (d), or for a refund of any fee collected in accordance with subsection (a)(2)(A), a person shall submit to the Secretary a written request for such waiver or refund not later than 180 days after such fee is due.”

2020—Subsec. (f)(2)(B). Pub. L. 116–136, § 3856(b)(1), amended Pub. L. 115–52, § 905(b)(4). See 2017 Amendment note below.

2017—Subsec. (a). Pub. L. 115–52, § 403(a)(1), substituted “fiscal year 2018” for “fiscal year 2013” in introductory provisions.

Subsec. (a)(1). Pub. L. 115–52, § 403(a)(2), substituted “Biosimilar biological product” for “Biosimilar” in heading.

Subsec. (a)(1)(A)(i). Pub. L. 115–52, § 403(a)(3), substituted “(c)(5)” for “(b)(1)(A)”.

Subsec. (a)(1)(B)(i). Pub. L. 115–52, § 403(a)(4), substituted “(c)(5) for the biosimilar biological product development program” for “(b)(1)(B) for biosimilar biological product development”.

Subsec. (a)(1)(B)(ii). Pub. L. 115–52, § 403(a)(5), substituted “annual biosimilar biological product development fee” for “annual biosimilar biological product development program fee” in introductory provisions.

Subsec. (a)(1)(B)(iii). Pub. L. 115–52, § 403(a)(6), substituted “annual biosimilar biological product development fee” for “annual biosimilar development program fee”.

Subsec. (a)(1)(B)(iv). Pub. L. 115–52, § 403(a)(7), added cl. (iv).

Subsec. (a)(1)(C). Pub. L. 115–52, § 403(a)(8), substituted “for a product, effective October 1 of a fiscal year, by,” for “for a product effective October 1 of a fiscal year by,” in introductory provisions.

Subsec. (a)(1)(D)(i). Pub. L. 115–52, § 403(a)(9)(A), inserted “, if the person seeks to resume participation in such program,” before “pay a fee” in introductory provisions.

Subsec. (a)(1)(D)(i)(I). Pub. L. 115–52, § 403(a)(9)(B), inserted “by such person” after “grants a request”.

Subsec. (a)(1)(D)(i)(II). Pub. L. 115–52, § 403(a)(9)(C), inserted “by such person” after “discontinued)”.

Subsec. (a)(1)(E). Pub. L. 115–52, § 403(a)(10), struck out “biosimilar development program” after “pay” in heading.

Subsec. (a)(1)(F). Pub. L. 115–52, § 403(a)(11)(A), struck out “biosimilar development program” after “regarding” in heading.

Subsec. (a)(1)(F)(i). Pub. L. 115–52, § 403(a)(11)(B), amended cl. (i) generally. Prior to amendment, text read as follows: “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).”

Subsec. (a)(2). Pub. L. 115–52, § 403(a)(12)(A), struck out “and supplement” after “application” in heading.

Subsec. (a)(2)(A), (B). Pub. L. 115–52, § 403(a)(12)(B), amended subpars. (A) and (B) generally. Prior to amendment, subpars. (A) and (B) related to the fee for a biosimilar biological product application or a supplement submitted on or after Oct. 1, 2012, and to a reduction in certain fees, respectively.

Subsec. (a)(2)(C). Pub. L. 115–52, § 403(a)(12)(D), struck out “or supplement” after “application”.

Subsec. (a)(2)(D). Pub. L. 115–52, § 403(a)(12)(C)–(E), in heading, struck out “or supplement” after “application” and in text, substituted “application was submitted” for “application or supplement was submitted”, “application, was accepted” for “application or supplement, was accepted”, and “application for the same product” for “application or a supplement for the same product”.

Subsec. (a)(2)(E). Pub. L. 115–52, § 403(a)(12)(D), struck out “or supplement” after “application”.

Subsec. (a)(2)(F). Pub. L. 115–52, § 403(c)(2), substituted “subsection (d)” for “subsection (c)”.

Pub. L. 115–52, § 403(a)(12)(D), struck out “or supplement” after “application”.

Subsec. (a)(3). Pub. L. 115–52, § 403(a)(13), amended par. (3) generally. Prior to amendment, par. (3) consisted of subpars. (A) to (E) which related to biosimilar biological product establishment fee, assessment, due date, assessment and division of fee for a biosimilar biological product establishment that manufactures for multiple applicants, and exception for new products, respectively.

Subsec. (a)(4)(A). Pub. L. 115–52, § 403(c)(3), substituted “subsection (c)(5)” for “subsection (b)(1)(F)”.

Subsec. (b). Pub. L. 115–52, § 403(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) consisted of pars. (1) and (2) which related to fee amounts and limit to total amount of fees, respectively.

Subsec. (c). Pub. L. 115–52, § 403(c)(4), added subsec. (c). Former subsec. (c) redesignated (d).

Subsec. (d). Pub. L. 115–52, § 403(c)(1), redesignated subsec. (c) as (d). Former subsec. (d) redesignated (e).

Subsec. (d)(1). Pub. L. 115–52, § 403(d), substituted “affiliate shall pay” for “affiliate shall pay—” and “not a small business.” for “not a small business; and”, struck out subpar. (A) designation before “application fees for all”, and struck out subpar. (B) which read as follows: “all supplement fees for all supplements to biosimilar biological product applications submitted to the Secretary for review in the same manner as an entity that is not a small business.”

Subsec. (e). Pub. L. 115–52, § 403(e), substituted “all such fees” for “all fees”.

Pub. L. 115–52, § 403(c)(1), redesignated subsec. (d) as (e). Former subsec. (e) redesignated (f).

Subsec. (f). Pub. L. 115–52, § 403(c)(1), redesignated subsec. (e) as (f). Former subsec. (f) redesignated (g).

Subsec. (f)(2)(B). Pub. L. 115–52, § 905(b)(4), as amended by Pub. L. 116–136, § 3856(b)(1), substituted “limitations” for “limitation” in heading, designated existing provisions as cl. (i) and inserted heading, and added cl. (ii).

Subsec. (f)(2)(C). Pub. L. 115–52, § 403(f)(1)(A), added subpar. (C) and struck out former subpar. (C). Prior to amendment, text read as follows: “Until the date of enactment of an Act making appropriations through September 30, 2013, for the salaries and expenses account of the Food and Drug Administration, fees authorized by this section for fiscal year 2013 may be collected and shall be credited to such account and remain available until expended.”

Subsec. (f)(2)(D). Pub. L. 115–52, § 403(f)(1)(B), struck out “in subsequent years” after “payments” in heading and “(after fiscal year 2013)” after “fiscal year” in text.

Subsec. (f)(3). Pub. L. 115–52, § 403(f)(2), substituted “2018 through 2022” for “2013 through 2017”.

Subsec. (g). Pub. L. 115–52, § 403(c)(1), redesignated subsec. (f) as (g). Former subsec. (g) redesignated (h).

Subsec. (h). Pub. L. 115–52, § 403(c)(2), substituted “subsection (d)” for “subsection (c)”.

Pub. L. 115–52, § 403(c)(1), redesignated subsec. (g) as (h). Former subsec. (h) redesignated (i).

Subsec. (i). Pub. L. 115–52, § 403(c)(1), redesignated subsec. (h) as (i).

2016—Subsec. (a)(1)(A)(v). Pub. L. 114–255, § 3101(a)(2)(V)(i), which directed technical amendment in paragraph (1)(A)(v) to reference in original act which appears in text as reference to July 9, 2012, was executed by making the amendment in introductory provisions and in subcl. (I), to reflect the probable intent of Congress.

Subsec. (a)(2)(B). Pub. L. 114–255, § 3101(a)(2)(V)(ii), substituted “Biosimilar User Fee Act of 2012” for “Biosimilars User Fee Act of 2012”.

### Statutory Notes and Related Subsidiaries

### Effective Date of 2022 Amendment

Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all biosimilar biological product applications received on or after Oct. 1, 2022, see section 4006 of Pub. L. 117–180, set out as a note under section 379j–51 of this title.

### Effective Date of 2020 Amendment

Pub. L. 116–136, div. A, title III, § 3856(b)(2), Mar. 27, 2020, 134 Stat. 458, provided that: “The amendment made by paragraph (1) [amending Pub. L. 115–52 which amended this section] shall take effect as of the enactment of the FDA Reauthorization Act of 2017 (Public Law 115–52).”

### Effective Date of 2017 Amendment

Amendment by section 403 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all biosimilar biological product applications received on or after Oct. 1, 2017, see section 406 of Pub. L. 115–52, set out as a note under section 379j–51 of this title.

### Effective and Termination Dates

Section ceases to be effective Oct. 1, 2027, see section 4005(a) of Pub. L. 117–180, set out as a note under section 379j–51 of this title.

Section effective Oct. 1, 2012, with fees under this subpart to be assessed for all biosimilar biological product applications received on or after Oct. 1, 2012, see section 405 of Pub. L. 112–144, set out as a note under section 379j–51 of this title.