No ‘Surprise’ Facility Fees For Sanitizer Makers After Responding To COVID-19 Emergency In US
HHS says FDA made subject to monograph program facility fees businesses that began making hand sanitizers in response to temporary guidance easing manufacturing standards "about the same time” the department withdrew the user fee schedule.
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Agency conducting all-day online meeting on 28 September to discuss proposed first reauthorization of OMUFA program established with its first five-year authorization in 2020 in legislation to overhaul the OTC monograph program.
Last of 32 OTC monographs finalized as required in 2020 reform legislation as some stakeholders ask if the agency is collecting user fees yet.
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.