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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Over-The-Counter Monograph Drug User Fee Program (OMUFA) Performance Dashboards

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FDA-TRACK: CDER
OMUFA Performance Dashboards User Guide
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OTC Monograph Order Request Submissions

Procedural Notifications and Responses

Meeting
Management

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.

The Over-The-Counter (OTC) Monograph Drug User Fee Program Performance Dashboards (OMUFA Dashboards) provide a concise, interactive, and visual presentation of data presented in the legislatively mandated OMUFA Performance Report to Congress for the Over-The-Counter Monograph Drug User Fee Program (the Report). The OMUFA Dashboards are not intended to replace the Report and are to be used as a supplemental tool for viewing the data. The OMUFA Dashboards reflect performance on submissions received and actions taken as of September 30, 2025. The OMUFA Dashboards present final performance in meeting OMUFA goals for FY 2024 and preliminary performance for FY 2025. Final OMUFA performance data for FY 2025 will be presented in the FY 2026 OMUFA Report and referenced in updated versions of the OMUFA Dashboards.

FDA-Track icon: OMUFA OTC Monograph Drug

OTC Monograph Order Request Submissions

The OTC Monograph Order Request Submissions Dashboard displays current performance relating to the review of:

  • Tier 1 and Tier 2 Over-The-Counter Monograph Order Requests (OMORs)
  • Tier 1 OMORs for Certain Safety Changes Only
  • Tier 1 OMORs with Generally Recognized as Safe and Effective (GRASE) Finalization

Procedural Notifications and Responses

The Procedural Notifications and Responses Dashboard displays current performance relating to the review of/responses to:

  • Dispute Resolutions
FDA-TRACK: OMUFA Procedural Notifications and Responses
FDA-TRACK icon: OMUFA Meeting Management

Meeting Management

The Meeting Management Dashboard displays Aggregate Meeting Management performance which includes responses to/issuance of:

  • Type X, Y, and Z Meeting Requests
  • Type X, Y, and Z Meetings Scheduled
  • Type X, Y, and Z Written Responses
  • Preliminary Responses for Type Y Meetings
  • Type X, Y, and Z Meeting Minutes

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