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Over-the-Counter Monograph Drug User Fee Amendments · Reported in House (2025-09-17) · Congress.wiki

H.R. 4273

119th CONGRESS 1st Session

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user fee program for over-the-counter monograph drugs, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES · July 2, 2025 · Sponsor: Mr. Latta · Committee: Committee on Energy and Commerce

H.R. 4273

SEC. 1. Short title

This Act may be cited as the Over-the-Counter Monograph Drug User Fee Amendments.

SEC. 2. Finding

Congress finds that the fees authorized by the amendments made in this Act will be dedicated to OTC monograph drug activities, as set forth in the goals identified for purposes of part 10 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate, as set forth in the Congressional Record. 21 U.S.C. 379j–71 et seq.

SEC. 3. Definitions

Section 744L(9)(A) of the Federal Food, Drug, and Cosmetic Act () is amended— 21 U.S.C. 379j–71(9)(A)
- in clause (v), by striking and inserting a semicolon;
- in clause (vi)—
- by adding at the end the following:

SEC. 4. Authority to assess and use OTC monograph fees

(a) Types of fees
- Section 744M(a)(1) of the Federal Food, Drug, and Cosmetic Act () is amended— 21 U.S.C. 379j–72(a)(1)
- Types of fees
  - in subparagraph (A)—
    - by striking on December 31 of the fiscal year or at any time during the preceding 12-month periodand inserting at any time during the applicable period specified in clause (ii) for a fiscal year;
    - by striking and inserting the following:
      - (i) Each person
      - (ii) For purposes of clause (i), the applicable period is—
      - for fiscal year 2026, the 12-month period ending on December 31, 2025;
      - for fiscal year 2027, the 9-month period ending on September 30, 2026; and
      - for fiscal year 2028 and each subsequent fiscal year, the 12-month period ending on September 30 of the preceding fiscal year.
    - by adding at the end the following:
    - has ceased all activities related to OTC monograph drugs prior to—
    - for purposes of fiscal year 2026, January 1, 2025;
    - for purposes of fiscal year 2027, January 1, 2026; and
    - for purposes of fiscal year 2028 and each subsequent fiscal year, October 1 of the preceding fiscal year; and
  - in subparagraph (B)(i), by amending subclause (I) to read as follows:
    - (D) Due date
      - (i) For fiscal year 2026, the facility fees required under subparagraph (A) shall be due on the later of—
      - the first business day of June of such year; or
      - the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees under this section for such year.
      - (ii) For fiscal year 2027, the facility fees required under subparagraph (A) shall be due—
      - in a first installment representing 50 percent of such fee, on the later of—
      - October 1, 2026; or
      - the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees under this section for such year; and
      - in a second installment representing the remaining 50 percent of such fee, on—
      - February 1, 2027; or
      - if an appropriations Act described in subclause (I)(bb) is not in effect on February 1, 2027, the first business day after enactment of such an appropriations Act.
      - (iii) For fiscal year 2028 and each subsequent fiscal year, the facility fees required under subparagraph (A) shall be due on the later of—
      - the first business day on or after October 1 of the fiscal year; or
      - the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees under this section for the fiscal year.
  - by amending subparagraph (D) to read as follows:

SEC. 5. Reauthorization; reporting requirements

Section 744N of the Federal Food, Drug, and Cosmetic Act () is amended— 21 U.S.C. 379j–73
- in subsection (a)—
  - by striking Beginning with fiscal year 2021, and not later than 120 calendar days after the end of each fiscal year thereafterand inserting Not later than 120 calendar days after the end of each fiscal year; and
  - by striking and inserting ;
- in subsection (b), by striking fiscal year 2021 and each subsequent fiscal yearand inserting each fiscal year; and
- in subsection (d), by striking each place it appears and inserting .

SEC. 6. Regulation of certain nonprescription drugs that are marketed without an approved drug application

(a) Development advice to sponsors or requestors
- Section 505G(h) of the Federal Food, Drug, and Cosmetic Act () is amended by striking sponsors or requestorsand inserting sponsors, requestors, or organizations nominated by sponsors or requestors to represent their interests in a proceeding. 21 U.S.C. 355h(h)
(b) Technical correction
- Section 505G(b)(2)(A)(iv)(III) of the Federal Food, Drug, and Cosmetic Act () is amended by striking requestorsand inserting sponsors or requestors. 21 U.S.C. 355h(b)(2)(A)(iv)(III)

SEC. 7. Sunset dates

(a) Authorization
- Sections 744L and 744M of the Federal Food, Drug, and Cosmetic Act (; 379j–72) shall cease to be effective October 1, 2030. 21 U.S.C. 379j–71
(b) Reporting requirements
- Section 744N of the Federal Food, Drug, and Cosmetic Act () shall cease to be effective January 31, 2031. 21 U.S.C. 379j–73

SEC. 8. Effective date

The amendments made by this Act shall take effect on October 1, 2025, or the date of the enactment of this Act, whichever is later, except that fees under part 10 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act () shall be assessed beginning October 1, 2025, regardless of the date of the enactment of this Act. 21 U.S.C. 379j–71 et seq.

SEC. 9. Savings clause

Notwithstanding the amendments made by this Act, part 10 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (), as in effect on the day before the date of enactment of this Act, shall continue to be in effect with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2026. 21 U.S.C. 379j–71 et seq.

Section 744M(c) of the Federal Food, Drug, and Cosmetic Act () is amended— 21 U.S.C. 379j–72
- in paragraph (1)—
  - in subparagraph (A), in the matter preceding clause (i)—
    - (i) by striking subsection (b)(2)(B)and inserting subsection (b)(1)(B); and
    - (ii) by striking fiscal year 2022 and each subsequent fiscal yearand inserting each fiscal year;
  - in subparagraph (B), by striking and all that follows through the period at the end and inserting the following:
    - a fiscal year shall be equal to the product of—
      - (i) for fiscal year 2026—
      - the fee for fiscal year 2025 under subsection (a)(2); and
      - the inflation adjustment percentage under subparagraph (C); and
      - (ii) for each of fiscal years 2027 through 2030—
      - the applicable fee under subsection (a)(2) for the preceding fiscal year; and
      - the inflation adjustment percentage under subparagraph (C).
  - in subparagraph (C)—
    - (i) in the matter preceding clause (i), by inserting after ;
    - (ii) by striking clause (i);
    - (iii) by redesignating subclauses (I) and (II) of clause (ii) as clauses (i) and (ii), respectively, and adjusting the margins accordingly;
    - (iv) by striking ; and
    - (v) in clause (ii), as so redesignated, by striking Washington-Baltimore, DC–MD–VA–WVand inserting Washington–Arlington–Alexandria–DC–VA–MD–WV;
- in paragraph (2)—
  - in subparagraph (A)—
    - (i) by striking fiscal year 2021 and subsequent fiscal yearsand inserting each fiscal year;
    - (ii) by striking subsections (b)(1)(B) and (b)(2)(C)and inserting subsection (b)(1)(C); and
    - (iii) by striking the number of weeks specified in subparagraph (B)and inserting 10 weeks;
  - by striking subparagraph (B);
  - by redesignating subparagraphs (C) and (D) as subparagraphs (B) and (C), respectively; and
  - in subparagraph (C), as so redesignated, by striking paragraph (4) establishingand inserting paragraph (5) publishing;
- in paragraph (3)—
  - in the matter preceding subparagraph (A), by striking subsection (b)(2)(D)and inserting subsection (b)(1)(D); and
    - $135,000 for fiscal year 2026;
    - $300,000 for fiscal year 2027;
    - $55,000 for fiscal year 2028;
    - $30,000 for fiscal year 2029; and
    - $0 for fiscal year 2030.
  - by striking subparagraphs (A) through (E) and inserting the following:
  - (4) One-time facility fee workload adjustment
    - (A) In general
      - In addition to the adjustments under paragraphs (1), (2), and (3), the Secretary may further increase the fee revenues and fees through a one-time adjustment made for fiscal year 2028, 2029, or 2030, in accordance with this paragraph.
      - In general
    - (B) Adjustment described
      - (i) An adjustment under this paragraph may be made for a fiscal year only if—
      - an adjustment under this paragraph had not been made for any prior fiscal year;
      - the average number of OTC monograph drug facilities subject to a facility fee under subsection (a)(1) over the period of the preceding 3 fiscal years exceeds 1,625; and
      - with respect to facilities described in subclause (II), the average number of such facilities (expressed as a percentage) that appeared on the arrears lists pursuant to subsection (e)(1)(A)(i) over the period of the preceding 3 fiscal years is less than 30 percent.
      - (ii) An adjustment under this paragraph for a fiscal year shall equal the product of—
      - the total facility revenue amount determined under subsection (b) for the fiscal year, exclusive of the adjustment under this paragraph for such fiscal year; and
      - the excess facility percentage described in clause (iii).
      - (iii) The excess facility percentage described in this clause is—
      - the amount by which the average number of OTC monograph drug facilities subject to a facility fee under subsection (a)(1) over the preceding 3 fiscal years exceeds 1,625; divided by
      - 1,625.
  - (5) Annual fee setting
    - The Secretary shall, not later than 60 days before the first day of each fiscal year—
      - establish for such fiscal year, based on the revenue amounts under subsection (b) and the adjustments provided under this subsection—
        
        (i) OTC monograph drug facility fees under subsection (a)(1); and
        
        (ii) OTC monograph order request fees under subsection (a)(2); and
      - publish such fee revenue amounts, facility fees, and OTC monograph order request fees in the Federal Register.
- by striking paragraph (4) and inserting the following: