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  1. FDA User Fee Programs

OMUFA Reauthorization: Fiscal Years 2026 - 2030

On March 27, 2020, “the Coronavirus Aid, Relief, and Economic Security Act” (or the “CARES Act”) (Public Law No. 116-136,) was signed into law. The CARES Act added to the FD&C Act section 505G, which reforms and modernizes the regulation of OTC monograph drugs.  The CARES Act also added to the FD&C Act section 744M, authorizing FDA to assess and collect user fees dedicated to OTC monograph drug activities, and accompanying sections 744L and 744N.

The OTC Monograph Drug User Fee Program, which we refer to as “OMUFA,” is modeled after the successful Prescription Drug User Fee Act (PDUFA). Under the OMUFA program, industry-paid fees help support FDA’s regulatory activities related to OTC monograph drugs and FDA agrees to adhere to performance goals negotiated by FDA and industry, including specific time frames for conducting certain OTC monograph activities. The current legislative authority for OMUFA expires September 30, 2025. At that time, new legislation will be required to reauthorize the OMUFA program for future fiscal years.

FDA has begun the statutorily-directed negotiation process for developing recommendations to reauthorize OMUFA for fiscal years (FYs) 2026 through 2030. Minutes from each FDA meeting with industry will be posted here once they become available.

FDA held a public meeting on OMUFA reauthorization on September 28, 2023, with a docket opened for public comment. Additional details are below. A second public meeting will be announced to the public after negotiation meetings with industry have concluded.

Industry Discussions on Reauthorization

Public Meetings on Reauthorization

 
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