On March 26, 2021, the FDA announced it will collect OTC user fees for Fiscal Year 2021 from owners of OTC Monograph Facilities that were in operation for the period from January 2020 through December 2020. As we previously reported here and here, and confirmed in today’s notice, facilities that responded to the COVID-19 Public Health Emergency by producing hand sanitizers under the Emergency Use Authorizations (EUA) will be exempt from paying User fees. Manufacturers of active drug ingredients are also exempt from paying user fees.
User Fees are Due Monday, May 10, 20211
The Federal Register notice announcing collection of the FY OTC User fees highlighted the sections of the OTC Reform bill that define Monograph Facilities that are required to pay user fees:
The FDA’s User Fee announcement can be found here. Note there is no reduction for small businesses. Users will be identified based upon FDA’s OTC registration and listing data basis.
1 FDA’s Notice states that the facility fees will be due 45 days after the date of publication of this notice.
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