*OMSIRA (OMUFA) - Implementation & Capabilities New Contract

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.