US OTC Monograph Facilty Fees Increase With Pandemic-Inspired Sanitizer Makers Exempted
FDA publishes second notice on FY2021 rates for OTC monograph drug user fee program. With fewer firms paying, those still subject to facility fees will pay more so the total collected matches amount Congress authorized agency to collect, nearly $23.3m.
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The 31 March cut-off date brings to a comparatively low-profile end a well-chronicled saga of FDA acting to increase OTC hand sanitizer production as consumer demand soared in response to COVID-19.
OMORs to FDA also will cost more under the FY2022 OMUFA rates published in Federal Register notice, which sets total facility registration fees at nearly $23.9, up from nearly $23.3m for FY2021.
Firms making OTC monograph drugs won’t have to pay facility fees twice during FY2021, says Theresa Michele, FDA Office of Nonprescription Drugs director.