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  1. FDA User Fee Programs

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

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On Friday, March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to aid response efforts and ease the economic impact of COVID-19. In addition to the COVID-19 response efforts, the CARES Act includes an important legislative initiative that reforms and modernizes the way certain nonprescription, over-the-counter (or OTC) drugs are regulated in the United States. These drugs, known as OTC monograph drugs, may be marketed without an approved drug application under section 505 of the Federal Food, Drug, and Cosmetic (FD&C Act) if they meet the requirements of section 505G of the FD&C Act, as well as other applicable requirements.

Section 744M of the FD&C Act, as added by the CARES Act, establishes an OTC monograph drug user fee program, under which FDA will assess and collect fees from submitters of OTC Monograph Order Requests (OMORs) as well as facility fees from certain manufacturers of OTC monograph drugs, to support the agency's OTC monograph drug activities. As with our other user fee programs, we anticipate that this new user fee program will provide additional resources to help the agency conduct these important regulatory activities in a timely manner and ultimately help provide the public with access to innovative OTC monograph drugs.

FDA plans to publish a Federal Register Notice (FRN) to establish fees with respect to OTC monograph drug facilities and OMORs for FY 2021. This FRN will be published after an appropriation for these fees is enacted as part of an FY 2021 appropriations act for FDA. OTC monograph drug facility fees for FY 2021 will be due 45 days after publication of this FRN.

FDA will collect two types of user fees under OMUFA: Facility Fees and OTC Monograph Order Request (OMOR) fees. 

Fiscal Year (FY) 2021 user fee rates

FY 2021 Facility User Fee Rates 
Facility Fee Facility fees will be published in a Federal Register notice
FY 2021 OMOR Fee Rates
Tier 1  $500,000 
Tier 2  $100,000 

 

 



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