*OMSIRA (OMUFA) - Implementation & Capabilities New Contract
Forecast New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $3,000,000 to $7,000,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 541519 Other Computer Related Services
- Points of contact
-
- CDER Acquisition Liaison cderacquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration is procuring implementation and capabilities enhancement for OMSIRA (OMUFA), the Over-the-Counter Monograph Drug User Fee Program, with an estimated solicitation release on November 1, 2026, and award targeted for April 1, 2027. The contract will modernize FDA's IT platform supporting OMUFA II (fiscal years 2026–2030), which governs how FDA evaluates OTC monograph drugs and administers industry-paid user fees. Work encompasses six reform goals: building IT infrastructure, enabling industry-initiated monograph changes, enhancing FDA-industry communication, streamlining safety-driven labeling changes, completing outstanding Generally Recognized as Safe and Effective (GRASE) determinations, and monitoring program performance across the Agency.
The estimated award value ranges from $3 million to $7 million under NAICS 541519 (Other Computer Related Services), with no set-aside applied. Contact the Food and Drug Administration's Acquisition Liaison mailbox at cderacquisitions@fda.hhs.gov for additional information.
Forecast text
OMUFA, the Over-the-Counter (OTC) Monograph Drug User Fee Program, was established by the CARES Act in 2020 to fundamentally reform how OTC drugs are regulated in the United States. It modernized a decades-old, paper-based rulemaking process by introducing electronic submissions, automated workflows, administrative orders, and industry-paid user fees that provide FDA with dedicated resources to meet specific performance goals. At its core, OMUFA governs how FDA evaluates OTC monograph drugs - products regulated under monographs that describe the conditions under which an OTC drug in a given therapeutic category is Generally Recognized as Safe and Effective (GRASE). OMUFA II, covering fiscal years 2026-2030, builds upon the foundation established during OMUFA I through active development, modernization, and enhancement of the underlying IT platform. This includes introducing enhanced performance goals, expanded procedural requirements, and more sophisticated informatics capabilities organized around six reform goals: Infrastructure, to build the necessary IT systems; Innovation, to enable industry-initiated monograph changes; Communication, to enhance transparency between FDA and industry; Safety, to streamline safety-driven labeling changes; Finalization, to complete outstanding GRASE determinations; and Tracking, to monitor program performance across the Agency.
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