This Is Not A Drill . . . FDA Publishes Fee Rates Under the

On March 26, 2021, the Food and Drug Administration (FDA) issued a new
Federal
Register notice finally announcing the fee rates under the Over-the-Counter (OTC) Monograph Drug User Fee Program for Fiscal Year 2021.
1  As we discussed in a previous Bulletin, the CARES Act, among other things, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow FDA to assess and collect user fees from qualifying owners of OTC monograph drug facilities
2  and qualifying submitters of OTC monograph order requests (OMORs).
3  The fees are meant to support FDA in its OTC monograph drug activities, including inspections of facilities associated with such products.

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