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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FY2023 OTC monograph user fee target facility fee revenue is $25.4m from manufacturers’ fees of $26,153 and contract manufacturers’ fees of $17,435, all due by 1 June. OMOR fees are $517,381 for Tier 1 requests and $103,476 for Tier 2.
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 But refunds aren’t so simple if an OMOR is withdrawn later in process.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.