Dec. 28, 2020

FDA Announces OTC Monograph Drug User Fee Rates for FY2021

Today, the U.S. Food and Drug Administration announced 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 establishes fees with respect to OTC monograph drug facilities and OTC Monograph Order Requests (OMORs) for FY 2021. The FRN includes information about facility fee calculations, OMOR fee calculations, fee due dates, and fee payment options and procedures. OTC monograph drug facility fees for FY 2021 will be due 45 days after publication of this FRN.


On March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). In addition to the COVID-19 response efforts, the CARES Act includes statutory provisions that reform and modernize the way OTC monograph drugs are regulated in the United States. Section 744M of the Federal Food, Drug, and Cosmetic 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 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 timelier manner and ultimately help provide the public with access to innovative OTC monograph drugs.


For more information please refer to the FRN or FDA’s Over-the-Counter Monograph Drug User Fee Program (OMUFA) webpage.


The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance, education and updates for regulated industry.