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ABOUT THIS WEBINAR

The webinar provides an overview of the Over-the-Counter Drug User Fee Program (OMUFA) and describes the key elements of the program as it relates to OMUFA user fees.

TOPICS COVERED

• Provide an overview of OMUFA as it relates to user fees
• Discuss the registration process for over-the-counter monograph drug facilities
• Describe the different fee types for OMUFA
• Discuss fiscal year 2023 target revenue, fee rates, and timelines
• Discuss the penalties associated with failure to pay OMUFA user fees
• Provide an overview of the fee payment process
• Discuss OMUFA refund eligibility
• Provide an overview of OMUFA draft guidance for industry titled “Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program.”

LEARNING OBJECTIVES

• Gain 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
• Describe the different fee types for OMUFA
• Describe the fee collection and payment process for OMUFA
• Describe the timelines for OMUFA

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

FDA SPEAKERS

CAPT Matt Brancazio, Pharm.D., MBA, RAC
Branch Chief, Policy and Operations Branch, DUFM
Office of Management | CDER | FDA

LCDR Tramara Dam, Pharm.D., BCSCP, GWCPM
Program Management Officer, Policy and Operations Branch, DUFM
Office of Management | CDER | FDA

LCDR Yajun (Jason) Tu, Pharm.D., Ph.D
Program Management Officer, Policy and Operations Branch, DUFM
Office of Management | CDER | FDA

FDA RESOURCES

• Over-The-Counter Monograph User Fee Program (OMUFA)
• November 2, 2022: OMUFA draft guidance for industry titled “Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program.”
• February 1, 2022: OMUFA Draft guidance “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs”
• Updated Over-the-Counter Monograph User Fee Program Performance Goals Dates– Fiscal Years 2021-2025
• OMUFA Cover Sheet and Payment Information
• An Exciting New Chapter in OTC Drug History: OTC Monograph Reform in the CARES Act

CONTINUING EDUCATION

This webinar has been approved for 1.00 contact hour of continuing education for physicians, pharmacists, and nurses. Please see detailed announcement for more information. After the course concludes, that day's attendees will receive an email with instructions and a code to claim their credit. Only participants who attend the live broadcast via Adobe Connect will receive the claim code.

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 webinar 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.
• pre-approved by 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.
• pre-approved by 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
• approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

• To optimize your webinar experience, use Chrome when viewing Adobe Connect in a browser.
• Please contact [email protected] for all technical questions.
• If you encounter any technical issues before or during the event, please visit the Technical Issues Support.
• Test your PC for use with Adobe Connect prior to the day of the event. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.