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Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027
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Federal Register Documents published on or after 08/24/2025
[ ]For FY 2027, the OMUFA fee rates are: MDF facility fees ($47,891), CMO facility fees ($31,927), Tier 1 OMOR fees ($614,608), and Tier 2 OMOR fees ($122,921).
Facility Fee Revenues and FeesFor FY 2027, facility fee rates are being established to generate a total target revenue amount, as determined under the statute, equal to $36,972,000 (rounded to the nearest thousand dollars).
V. Fee Schedule for FY 2027The fee rates for FY 2027 are displayed in Table 4.
Table 4—Fee Schedule for FY 2027 Fee category FY 2027 fee rates Facility: MDF $47,891 CMO 31,927 OMOR: Tier 1 614,608 Tier 2 122,921VI.
The OTC Monograph Drug User Fee Cover Sheet will not be available for FY 2027 payments.