S. 2292 — Over-the-Counter Monograph Drug User Fee Amendments

This section states a congressional finding that fees authorized by the amendments made in this Act will be dedicated to over-the-counter (OTC) monograph drug activities, as set forth in goals identified for 21 U.S.C. 379j-71 et seq. in letters from the Secretary of Health and Human Services to the Chairmen of the House Energy and Commerce Committee and Senate Health, Education, Labor, and Pensions Committee, as printed in the Congressional Record.

This section amends the definition of facility changes exempt from fees under the over-the-counter (OTC) monograph drug user fee program by making technical grammatical corrections to clauses (v) and (vi) of section 744L(9)(A) and adding clause (vii) to include the addition or modification of a testing procedure applicable to one or more OTC monograph drugs, provided the procedure reflects a voluntary consensus standard for pharmaceutical quality that (I) is established by a national or international standards development organization and (II) is recognized by FDA through the process described in its July 2023 guidance for industry (or successor), which is publicly available on FDA's website.

This section revises FDA's authority to assess and collect over-the-counter (OTC) monograph facility fees under the OTC Monograph Drug User Fee Amendments (ODUFA; i.e., fees on facilities that manufacture or process OTC monograph drugs to fund FDA review activities). Specifically, it (1) changes the facility fee assessment period to the 12-month period ending December 31, 2025 (FY2026), the 9-month period ending September 30, 2026 (FY2027), or the 12-month period ending September 30 of the preceding fiscal year (FY2028 and subsequent years) (from the December 31 of the fiscal year or preceding 12-month period); (2) sets facility fee due dates as the later of specified dates in June 2026 (FY2026), in two 50% installments on October 1, 2026, and February 1, 2027 (FY2027), or on or after October 1 of the fiscal year (FY2028 and subsequent years), or the first business day after enactment of the relevant appropriations act; (3) establishes total facility fee revenue targets for FY2026 through FY2030 as the sum of annual base revenue (initially tied to FY2025 revenue excluding certain adjustments), inflation and other adjustments, specified additional amounts of $2,373,000 (FY2026), $1,233,000 (FY2027), and $854,000 (FY2028), and any one-time workload adjustment; and (4) modifies inflation adjustment formulas to apply annually starting FY2026 (from FY2022) using fees from the prior year and updates the CPI index to Washington-Arlington-Alexandria, DC-VA-MD-WV (from Washington-Baltimore, DC-MD-VA-WV).

This section reauthorizes the Medical Device User Fee Amendments (MDUFA) program—under which FDA collects fees from medical device manufacturers to fund the review of premarket applications, reports, supplements, notifications, and related submissions for class III devices and others—through FY2030 (from FY2025) by amending the expiration provision in subsection (d). The section further (1) revises the annual reporting requirement in subsection (a) to apply not later than 120 calendar days after the end of each fiscal year (removing the prior limitation to beginning in FY2021) and updates a cross-reference from a CARES Act provision to section 2 of the Over-the-Counter Monograph Drug User Fee Amendments; and (2) revises subsection (b) to apply the relevant requirement to each fiscal year (removing the prior limitation to FY2021 and subsequent years).

This section extends the effectiveness of sections 744L and 744M of the Federal Food, Drug, and Cosmetic Act—which authorize FDA's Medical Device User Fee Amendments (MDUFA) program to assess and collect fees on premarket applications, premarket reports, supplements, 510(k) premarket notifications, de novo classification requests, and annual fees for periodic reporting on class III devices (among other submissions)—through FY2030 (from FY2027), or until October 1, 2030. The section also extends reporting requirements under section 744N through January 31, 2031.

This section sets the effective date for amendments made by the Act as October 1, 2025, or the date of enactment, whichever is later, except that fees under the Medical Device User Fee Amendments program shall be assessed beginning October 1, 2025, regardless of enactment date. (Thus, the new fee structure for premarket applications, supplements, notifications, and periodic reports for class III devices takes effect in FY2026.)

This section preserves the pre-enactment fee authorities under the Medical Device User Fee Amendments (21 U.S.C. 379j-71 et seq.)—which require fees for FDA review of premarket applications, supplements, notifications, and periodic reports for class III devices, among others—for assessing and collecting fees for fiscal years prior to FY2026, notwithstanding amendments made by this Act.