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  4. OTC Monograph Drug User Fee Amendments (OMUFA): Understanding FY 2026 User Fees and Registration - 05/05/2026
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Webcast | Virtual

Event Title
OTC Monograph Drug User Fee Amendments (OMUFA): Understanding FY 2026 User Fees and Registration
May 5, 2026

Date:
May 5, 2026
Time:
1:00 p.m. - 2:00 p.m. ET

Register Here

Visit CDER Small Business and Industry Assistance (SBIA) Homepage

The webinar provides an overview of the Over-the-Counter Drug User Fee Amendments (OMUFA) and describes the key elements of the amendments as it relates to OMUFA user fees. Topics to be discussed include:

  • Overview of OMUFA as it relates to user fees, fees liable period and due dates
  • Registration process for over-the-counter monograph drug facilities
  • Different fee types for OMUFA
  • Fiscal year 2026 target revenue, fee rates, and timelines
  • Penalties associated with failure to pay OMUFA user fees
  • Fee payment process.
  • OMUFA refund eligibility
  • OMUFA frequently asked questions

Intended Audience

  • Regulatory affairs professionals working on over-the-counter monograph drug products and/or non-prescription drugs or who submit over-the-counter monograph order requests
  • Industry partners following the FDA’s implementation of the Over-the-Counter Monograph Drug User Fee Amendments known as OMUFA
  • Researchers and Foreign Regulators testing over-the-counter monograph drug products and/or non-prescription drugs
  • Consultants focused on processing, manufacturing, developing of over-the-counter monograph drug products and/or non-prescription drugs
  • Clinical research coordinators
  • Importers and supply chains of over-the-counter monograph drug products and/or non-prescription drugs
  • Healthcare professionals specializing in over-the-counter monograph drug products and/or non-prescription drugs
  • General public with an interest in over-the-counter monograph drug products and/or non-prescription drugs

Learning Objectives

  • Gain knowledge on the fees associated with the Over-the-Counter Monograph Drug User Fee Amendments (OMUFA).
  • Describe the registration process for over-the-counter monograph drug facilities.
  • Discern the different fee types for OMUFA.
  • Understand the fee collection and payment process for OMUFA.

Speakers

Tramara Dam, Pharm.D., MBA, BCSCP, GWCPM
Commander, United States Public Health Service
Senior Program Management Officer
Policy and Operations Branch (POB)
Division of User Fee Management (DUFM)
Office of Finance, Budget, and Acquisitions (OFBA)
Center for Drug Evaluation and Research (CDER) | FDA

Madeline Faunce, GWCPM
Branch Chief
POB | DUFM
OFBA | CDER | FDA

Continuing Education (CE)

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

  • RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
  • SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

FDA Resources

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