The Food and Drug Administration could not have known, when it gained authority for OTC monograph facility fees, the lengths it would need to go to explain whether businesses are subject to the fees after unplanned and short-lived OTC production during the COVID-19 pandemic.
Three years after withdrawing before republishing its first-ever notice for the annual fees, covering fiscal year 2021, because it didn’t exclude firms that had been but no longer were making alcohol-based hand sanitizers in response to soaring pandemic-driven demand, the FDA “is highlighting” in its FY2024 facility fees announcement, and using italics for “emphasis added” for
Otherwise, in the notice to published in the 29 March Federal Register – docket