In a pre-publication Federal Register Notice (FRN) (here) on FDA’s webpage on Over-The-Counter Monograph Drug User Fee Program (OMUFA) (here), the FDA announced the OTC Monograph User Fees for FY 2027. The Notice explains how the fees were set and the change where “beginning with FY 2027, FDA is consolidating the separate facility fee notices and OMOR fee notices (as used for FYs 2024 through 2026) into a single, unified FRN, for publication before the start of the fiscal year. This change:
- Resumes the use of a single FRN for announcing OMUFA fees
- Helps accommodate the FY 2027 transition to an October 1 facility fee due date
- Streamlines the annual fee announcement process”
The FRN discussed the fee increases based on inflation as well as described that, under “OMUFA, FDA may further increase the FY 2027 facility fee revenue and fees if such an adjustment is necessary to provide up to 10 weeks of operating reserves of carryover user fees for OTC monograph drug activities.”
