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  1. FDA User Fee Programs

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

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The FY 2021 Over-The-Counter Monograph Drug User Fee Program (OMUFA) facility fee invoices were emailed on June 25, 2021, to those facilities that have not satisfied their OMUFA user fee(s) as required under section 744M of the FD&C Act, as added by the Coronavirus Aid, Relief, and Economic Security Act.

On June 14, 2021, FDA, in accordance with section 744M(e)(1)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), published an arrears list for those facilities that have not satisfied the Over-The-Counter Monograph User Fee Program (OMUFA) facility fee(s) as required under section 744M of the FD&C Act, as added by the Coronavirus Aid, Relief, and Economic Security Act. The arrears list is available to the public in the User Fee Lists section of this webpage. FDA plans to periodically update the arrears list to reflect facility payments.

FDA updated and reissued the rates for over-the-counter (OTC) monograph Drug User Fees for fiscal year (FY) 2021 in a Federal Register Notice (FRN) titled “Fee Rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021.” This FRN announced fees established under the Federal Food, Drug, and Cosmetic (FD&C) Act with respect to OTC monograph drug facilities and OTC Monograph Order Requests (OMORs) for FY 2021. OTC monograph drug facility fees for FY 2021 were due on May 10, 2021. FDA also posted an FDA-In-Brief about this action.

Fiscal Year (FY) 2021 User Fee Rates

FY 2021 Facility User Fee Rates
Monograph Drug Facility (MDF) Facility Fee $20,322
Contract Manufacturing Organization (CMO) Facility Fee $13,548
 
FY 2021 OMOR Fee Rates
Tier 1 $500,000
Tier 2 $100,000

 



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