Originally published on December 30, 2020, this article was last updated on January 6, 2021. On January 4, 2021, FDA unexpectedly withdrew the notice entitled Fee Rates Under the Over the Counter Monograph User Fee Program for Fiscal Year 2021 stating that it had been ordered to cease further collection efforts pending approval from the Secretary of the Department of Health and Human Services (HHS). The withdrawal notice states that the original notice issued without such Secretarial approval. Under the CARES Act, the Secretary is required to establish and collect OTC drug manufacturer fac...