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23 hours ago, Bier Distillery said:

"The HHS Office of the General Counsel (OGC) has reviewed the matter and determined that the manner in which the fees were announced and issued has the force and effect of a legislative rule. Only the HHS Secretary has the authority to issue legislative rules, and he would never have authorized such an action during a time in which the Department is maximizing its regulatory flexibility to empower Americans to confront and defeat COVID-19. Because HHS OGC has determined the notice is really a legislative rule and that no one at FDA has been delegated authority to issue such a rule, the notice is void. HHS leadership, based on this legal opinion, has ordered the Federal Register Notice to be withdrawn from the Federal Register, meaning these surprise user fees will not need to be paid.  "

So it seems the whole thing is null and void after the HHS slapped down the FDA hard (FDA is a part of HHS).  It makes me wonder what the FDA is going to try to do next.  


This was my interpretation. I guess we're still waiting for the FDA to issue the retraction notice / withdraw the FRN from the register - appears to still be up on the website (although it only mentions 2021 fees/dues...did it originally have verbiage mentioning 2020?)


I didn't de-register, still trying to figure out if they're trying to keep the fees in place for 2021/going forward...but again, the HHS statement would seem to indicate that the FDA is currently grounded, mom and dad are pissed, and the FDA still working on how to spin the PR to "explain the error"....

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