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Over-The-Counter Monograph Drug User Fee Program (OMUFA)

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On March 16, 2022, FDA announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2022 in a Federal Register Notice (FRN) titled “Over-The-Counter Monograph Drug User Fee Rates for Fiscal Year 2022.” This FRN publishes fees for OTC monograph drug facilities and OTC Monograph Order Requests (OMORs) for FY 2022.

To calculate the facility fee rates, in accordance with our statutory authority, FDA bases its calculations on factors for each fiscal year that include the 1) number of fee-liable facilities, 2) ratio of Monograph Drug Facilities (MDF) to Contract Manufacturing Organizations (CMO), and 3) increases in the total target revenue due to inflation and other adjustments. FDA recognizes that the FY 2022 facility fee rates are an increase of 19 percent in comparison to the FY 2021 facility fee rates and this increase is largely attributed to the decrease in the number of fee-liable facilities, change in the FY 2022 MDF to CMO ratio to 65:35 from the FY 2021 ratio of 90:10, and the inflation and operating reserve adjustments.

Fiscal Year (FY) 2022 User Fee Rates

FY 2022 Facility User Fee Rates
Monograph Drug Facility (MDF) Facility Fee $24,178
Contract Manufacturing Organization (CMO) Facility Fee $16,119
FY 2022 OMOR Fee Rates
Tier 1 $507,021
Tier 2 $101,404

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