By: Jacqueline J. Chan and Justine E. Lenehan
In earlier posts published on December 29, 2020, and January 4, 2021, we discussed FDA’s announcement of the Over-the-Counter (OTC) Monograph Drug user fees for Fiscal Year (FY) 2021 and the Department of Health and Human Services’ (DHHS) subsequent withdrawal of FDA’s Federal Register notice.
FDA has again announced the fee rates for FY 2021 under the OTC Monograph Drug user fee program (OMUFA). As described in our December 29 post, the CARES Act (Pub. L. No. 116-136) authorized FDA’s assessment and collection of user fees from (1) qualifying owners of OTC monograph drug facilities and (2) submitters of OTC monograph order requests (OMORs).
OTC Monograph Drug Facility Fees
FDA will assess OTC monograph drug facility fees with respect to each facility that is identified as a Monograph Drug Facility (MDF) or Contract Manufacturing Organization (CMO) facility between January 2020 and December 2020. See our December 29 post for descriptions of what constitutes an MDF and CMO facility.
The MDF fee for FY 2021 will be $20,322, increased from $14,060 in FDA’s initial Federal Register notice.
The CMO facility fee for FY 2021 will be $13,548, increased from $9,373 in FDA’s initial Federal Register notice.
These fee rates are effective as of October 1, 2020, and will remain in effect through September 30, 2021. The facility fees will be due 45 days after the publication date of FDA’s notice. The notice is scheduled to be published on March 26, 2021, so facility fees must be paid by May 10, 2021.
As noted in FDA’s initial Federal Register notice, the Agency exempts the following OTC monograph drug facilities from FY 2021 OMUFA fees:
- Facilities that ceased OTC monograph drug activities and updated their registration with FDA reflecting the same prior to December 31, 2019;
- Facilities manufacturing solely the active pharmaceutical ingredient (API) of an OTC monograph drug; and
- Facilities that carry out only the following manufacturing or processing activities: (a) production of clinical research supplies, (b) testing, or (c) placement of outer packaging on packages containing multiple products, for such purposes as creating multipacks, when each monograph drug product contained within the overpackaging is already in a final packaged form prior to placement in the outer overpackaging.
Notably, to reflect DHHS’ position in a January 12, 2021, Federal Register notice,[1] FDA’s latest announcement also exempts the following facilities from the FY 2021 OMUFA fees:
- Any entity that registered with FDA during the COVID-19 pandemic whose sole activity with respect to OTC monograph drugs consists of (or consisted of) manufacturing OTC hand sanitizer products.
OTC Monograph Order Request (OMOR) Fees
As described in our December 29 post, the CARES Act established the OMOR pathway under which submitters may request that FDA determine that any drug or combination, or any change to a condition of use of a currently authorized drug (i.e., a drug that is already considered generally recognized as safe and effective (GRASE)), is a lawful OTC drug. FDA is authorized to assess and collect fees from such submitters, except for OMORs requesting certain safety-related changes.[2]
For FY 2021, the fee for an OMOR “Tier 1” request is $500,000 and for an OMOR “Tier 2” request is $100,000, both unchanged from FDA’s initial Federal Register notice. See our December 29 post for a brief description of what constitutes a “Tier 1” versus “Tier 2” request.
Please contact us if we can be of any assistance in navigating OMUFA or other OTC drug reform issues.
[1] 86 Fed. Reg. 2,420.
[2] Specifically, a fee will not be imposed under OMUFA if FDA finds that the OMOR seeks to change the drug facts labeling of an OTC monograph drug in a way that would add to or strengthen: (1) a contraindication, warning, or precaution; (2) a statement about risk associated with misuse or abuse; or (3) an instruction about dosage and administration that is intended to increase the safe use of the OTC monograph drug.