- Date:
- May 20, 2025
- Time:
- 1:00 p.m. - 2:00 p.m. ET
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About this Event (Hosted by CDER SBIA)
This webinar will provide an overview of the Over-the-Counter Drug User Fee Program (OMUFA) and describe the key elements of the program as it relates to OMUFA user fees. Topics to be discussed include:
- Registration process for over-the-counter monograph drug facilities
- Different fee types for OMUFA
- Fiscal year 2025 target revenue, fee rates, and timelines
- Penalties associated with failure to pay OMUFA user fees
- Overview of the fee payment process
- OMUFA refund eligibility
- Update for facilities that first registered with FDA on or after the declaration of the COVID-19 Public Health Emergency (PHE) for the sole purpose of producing hand sanitizer products during the COVID-19 PHE
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 Program known as OMUFA.
- General public with an interest in over-the-counter monograph drug products and/or non-prescription drugs.
- Researchers testing over-the-counter monograph drug products and/or non-prescription drugs.
- Foreign regulators of 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.
- Healthcare professionals specializing in over-the-counter monograph drug products and/or non-prescription drugs.
- Importers of over-the-counter monograph drug products and/or non-prescription drugs.
- Supply chain of over-the-counter monograph drug products and/or non-prescription drugs.
Learning Objectives
- Develop knowledge on the fees associated with the Over-the-Counter Monograph Drug User Fee Program (OMUFA).
- Describe the registration process for over-the-counter monograph drug facilities.
- Outline the different fee types for OMUFA.
- Explain the fee collection and payment process for OMUFA.
- Define the timelines for OMUFA.
- Clarify the process for entities that registered with FDA during the Coronavirus Disease 2019 (COVID-19) pandemic whose sole activity with respect to OTC monograph drugs consisted of manufacturing OTC hand sanitizer products.
Speakers
CDR Tramara Dam, PharmD., MBA, BCSCP, GWCPM
Senior Program Management Officer
Division of User Fee Management (DUFM)
Policy and Operations Branch (POB)
Office of Management (OM)
Center for Drug Evaluation and Research (CDER) | FDA
LCDR Yajun (Jason) Tu, Pharm.D., Ph.D., BCSCP
Program Management Officer
DUFM | POB | OM | CDER | FDA
FDA Resources
Continuing Education
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.
