FDA-TRACK: Over-The-Counter Monograph Drug User Fee Program Performance OTC Monograph Order Requests

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OTC Monograph Order Request Submissions

Procedural Notifications and Responses

Meeting
Management

• • Current Performance
• • Historical Performance
• • Goals Summary

• • Current Performance
• • Historical Performance
• • Goals Summary

• • Current Performance
• • Historical Performance
• • Goals Summary

Relevant Links:

1. • OMUFA Performance Goals and Procedures
2. • OMUFA Performance Goals and Procedures - FY 2021 to FY 2025
3. • Over-The-Counter Monograph Drug User Fee Program
4. • Coronavirus Aid, Relief, and Economic Security Act
5. • FDA-TRACK: OMUFA Performance Reports

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136) was signed into law.  In addition to aiding the COVID-19 response efforts, the CARES Act amended the FD&C Act to include statutory provisions that (1) reform and modernize the way over-the-counter (OTC) monograph drug products are regulated in the United States and (2) authorize the U.S. Food and Drug Administration (FDA or Agency) to assess and collect user fees from qualifying manufacturers of OTC monograph drug products and submitters of OTC monograph order requests.

Download OTC Monograph Order Request Submissions Dataset

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Footnotes:

•   * FDA did not receive any applicable OMOR submissions in FY 2025.
• ** Does not include any Tier 1 OMORs for Certain Safety Changes Only as those are reported separately.