US FDA OTC Monograph User Fees Increase For FY2022 With Fewer Facilities Required To Pay
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.
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Draft acknowledges firms likely will expect refunds when they withdraw OMORs. When sponsor withdraws OMOR before FDA accepts or refuses to file, agency will refund 75% of the without a written request. But refunds aren’t so simple if an OMOR is withdrawn later in process.
Agency publishes Prescription Drug User Fee Act rates for FY2023, the first of five covered in reauthorization of program Congress approved on 30 September as legislation added to a continuing resolution to fund federal agencies through 16 December.
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.