H.R. 4273 — Over-the-Counter Monograph Drug User Fee Amendments

This section states Congress's finding that fees authorized by the Act's amendments will be dedicated to over-the-counter (OTC) monograph drug activities under part 10 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-71 et seq.), as set forth in goals identified in letters from the Secretary of Health and Human Services to the Chairmen of the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions Committee, as published in the Congressional Record.

This section amends the definition in section 744L(9)(A) of the Federal Food, Drug, and Cosmetic Act to—(1) make technical punctuation and terminology changes to clauses (v) and (vi); and (2) add clause (vii) to include the addition or modification of a testing procedure applicable to one or more OTC monograph drugs, if such testing procedure reflects a voluntary consensus standard for pharmaceutical quality that is (I) established by a national or international standards development organization and (II) recognized by FDA through a process described in its July 2023 guidance for industry (or successor guidance) on voluntary consensus standards for pharmaceutical quality.

This section revises the Over-the-Counter (OTC) Monograph User Fee program, which authorizes FDA to collect facility fees from manufacturers and processors of OTC monograph drugs (i.e., nonprescription drugs developed under FDA monographs) to fund related review activities. Specifically, it (1) changes the facility fee assessment period to the 12-month period ending December 31, 2025, for FY2026; the 9-month period ending September 30, 2026, for FY2027; and the 12-month period ending September 30 of the preceding fiscal year for FY2028 and subsequent years (from December 31 of the fiscal year or the preceding 12-month period); (2) updates the date by which small business facility fee exemptions require cessation of OTC monograph drug activities to January 1, 2025 (FY2026), January 1, 2026 (FY2027), or October 1 of the preceding fiscal year (FY2028+); (3) sets new facility fee due dates to the later of June 1, 2026, or enactment of FY2026 appropriations (FY2026); two 50% installments on the later of October 1, 2026, or FY2027 appropriations enactment and February 1, 2027, or later appropriations enactment (FY2027); and the later of October 1 or appropriations enactment (FY2028+); (4) establishes FY2026-2030 facility fee revenue targets as the sum of annual base revenue (FY2025 amount for FY2026; prior-year amount for FY2027-2030), inflation adjustment, operating reserve adjustment (if applicable), direct cost adjustments, specified additional amounts of $2.373 million (FY2026), $1.233 million (FY2027), and $0.854 million (FY2028), and any one-time workload adjustment; and (5) modifies inflation adjustment calculations to apply to FY2026 base fees using the FY2025 fee and subsequent years using the prior-year fee, updates certain subsection references, and revises the CPI index to "Washington–Arlington–Alexandria–DC" (from "Washington-Baltimore, DC–MD–VA–WV").

This section reauthorizes the Medical Device User Fee Amendments (MDUFA)—which authorizes the Food and Drug Administration (FDA) to collect fees from medical device manufacturers to fund review of premarket applications, reports, supplements, notifications, and related submissions for class III devices and others—through FY2030 (from FY2025). It further (1) revises the requirement in subsection (a) for FDA to publish annual fee amounts not later than 120 calendar days after the end of each fiscal year (previously, beginning with FY2021), and replaces a cross-reference to a CARES Act provision with one to section 2 of the Over-the-Counter Monograph Drug User Fee Amendments; and (2) revises subsection (b) to apply to each fiscal year (previously, FY2021 and subsequent fiscal years).

This section amends section 505G of the Federal Food, Drug, and Cosmetic Act, which governs nonprescription drugs marketed without an approved new drug application, as follows: (1) revises subsection (h) to authorize the Secretary to provide development advice to sponsors, requestors, or organizations nominated by sponsors or requestors to represent their interests in a proceeding (from sponsors or requestors); and (2) makes a technical correction in subsection (b)(2)(A)(iv)(III) by inserting "sponsors or" before "requestors".

This section revises the sunset date for the authorization under sections 744L and 744M of the Federal Food, Drug, and Cosmetic Act to October 1, 2030 (from October 1, 2027), and revises the sunset date for reporting requirements under section 744N to January 31, 2031 (from January 31, 2028).

This section establishes the effective date for amendments made by the Act as the later of October 1, 2025, or the date of enactment, except that medical device user fees under part 10 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-71 et seq.)—which include fees for premarket applications, supplements, premarket notifications, and periodic reporting for class III devices—shall be assessed beginning October 1, 2025, regardless of enactment date.

This section provides a savings clause preserving the medical device user fee authorities (21 U.S.C. 379j–71 et seq.), as in effect prior to enactment, for assessing and collecting fees for fiscal years prior to fiscal year 2026. (Thus, amendments made by this Act do not affect fees for FY2023–FY2025.)