No ‘Surprise’ Facility Fees For Sanitizer Makers After Responding To COVID-19 Emergency In US
Executive Summary
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.
You may also be interested in...
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.
‘OMUFA Fee Liable’ Trending In US OTC Drug Industry To Pay For FDA's Monograph Reform
Some firms with sales in nonprescription drug space are exempt from program’s facility fees, but own-label OTC drug marketers aren’t among them. Although FDA allows fee discounts for small businesses in other areas, it’s not trimming monograph user fee rates.
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.