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 facility fees annually, and further, FDA can only accept and review an OTC Monograph Order Request (OMOR) upon receipt of full payment of the OMOR fee. The HHS is significantly behind in setting, assessing, and collecting the 2021 facility fees in light of October 1, 2021 congressional appropriations to support this mandate.
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