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On January 6, 2021, the U.S. Department of Health and Human Services (HHS) ordered the Food and Drug Administration (FDA) to “cease further collection efforts” related to the Over-the-Counter (OTC) Drug Monograph User Fee Program, issuing a Withdrawal Notice on user fee rates. The December 29 Notice had sparked concern from distilleries and breweries that entered the market under FDA’s March 2020 temporary guidance
, which encouraged firms that were not traditional drug manufacturers to make hand sanitizer for consumer use under certain conditions specified in the guidance. On January 8, HHS issued another notice (“Exemption Notice