Issue Date: November 1, 2022
Issued by: Center for Drug Evaluation and Research
Topic(s): User Fees,
Status: Draft
Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program
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.
Download the Guidance Document
