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GUIDANCE DOCUMENT

Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program November 2022

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
2021-709
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance provides stakeholders with information regarding FDA’s implementation of the Over-the-Counter Monograph Drug User Fee Program under sections 744L and 744M of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as added by the Coronavirus Aid, Relief, and Economic Security Act (or the CARES Act), which authorize FDA to assess and collect user fees from qualifying manufacturers of over-the-counter (OTC) monograph drugs and requestors of OTC Monograph Order Requests (OMORs), other than OMORs for certain safety changes. This guidance describes the types of OMUFA fees, the due dates for fee payment, and the exceptions to certain fees. In addition, this guidance describes the process for submitting fee payments to FDA, the consequences for failing to pay the required fees, and the process for submitting refund requests or disputing FDA’s assessment of OMUFA fees.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2021-709.

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