The confusion regarding the initial publication of the OTC User Fee Act announcing the user fee structure originally published here and its subsequent withdrawal published here is (for the most part) clarified now by the January 12, 2021 FR Notice here that identifies the issue precipitating in the withdrawal.
In the current FR Notice, the Department of Health and Human Services clarifies that the facility fees for those entities that entered the hand-sanitizer market in response to the COVID-19 public health emergency are not to be charged a facility fee. The Notice states that, since Congress waived the alcohol excise tax on distilleries and entities that entered into the hand-sanitizer market in response to the emergency, it was clearly not the intent of Congress to then slap them with a $14,000 facility fee.
As mentioned in the Notice withdrawing the December notice, Secretary Azar had not approved the December notice announcing the fee schedule and now he is the signatory on the January 12th Notice, coming to the rescue of all of the firms that rescued the public from the hand-sanitizer shortage. If, however, firms making hand sanitizer also manufacture other over-the-counter monograph drugs, they cannot escape the fees.
Well, one thing is cleared up today, but there are still other issues about when fees are actually due. In an email received this morning, the FDA said “FDA intends to continue implementation of the OTC monograph drug user fee program enacted by Congress in an appropriate and transparent manner, including with respect to facility fees, and in accordance with the HHS notice. We will provide additional updates on this work as soon as we are able on FDA’s OMUFA webpage.” (here)
One of Q&As provided on the OMUFA website is:
“Q: When will OMUFA fees be due for fiscal years after FY 2021?
A: For fiscal years after FY 2021, OMUFA facility fees will be due on the later of (a) the first business day of June of each year or (b) the first business day after the enactment of an appropriations act providing for the collection and obligation of OMUFA fees for such year, as described in section 744M(a)(1)(D)(ii) of the FD&C Act. The facility fee amounts will be set in advance of the due date through a Federal Register notice, in accordance with the process specified under the statute.
Fees for OTC monograph order requests (OMORs) are due on the date of submission of the OTC monograph order request, as stated in section 744M(a)(2)(B) of the FD&C Act.”
I am still a bit confused; are the FY 2021 fees are due at this time? Maybe you can help me out! The withdrawn Notice says the FY 2021 facility fees are due forty-five days after the publication of that Notice. Maybe that is the answer!
