On December 28, 2020, we published a blog post on the OMUFA fee structure for new OTC reviews and facilities (here). Today, in the prepublication of the Federal Register (FR) here, the FDA abruptly withdrew the FR Notice.
Looks like someone along the way goofed as the notice bluntly indicates that “[T]he Department of Health and Human Services is issuing this Notice to withdraw FDA’s December 29, 2020 Federal Register Notice entitled Fee Rates Under the Over-the Counter Monograph User Fee Program for Fiscal Year 2021 because FDA lacked the delegated authority to issue the Notice. The Department is further informing the public that FDA has been ordered to cease further collection efforts related to the Over-the-Counter Drug Monograph User Fee Program until further action is announced in the Federal Register.”
Seems like the HHS Secretary did not approve the issuance of the notice and, because of that, the “FDA has also been ordered to cease collections activities related to the Over-the-Counter Monograph User Fee Program (“OMUFA”) until, with the approval of the Secretary, the Department issues further direction concerning FDA’s administration of OMUFA which provides the public with notice and opportunity for comment.”
Is this another end-of-administration power play or did the screw-up happen for another reason? Seems like one thing after another with the left hand not knowing what the right hand is doing in the waning days of this administration. So where does that leave the Over-the-Counter user fee program? Your guess is as good as mine!
ERRATA: Please note that an earlier version of this post had an incorrect link to the earlier blog post. It has been corrected.