OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration June 18, 2024

Virtual | Virtual

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• Date: June 18, 2024
• Time: 1:00 PM - 2:00 PM ET

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Register for This Event

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Visit CDER Small Business and Industry Assistance Page

ABOUT THIS EVENT

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. Presentations will:

• Provide an overview of
  • OMUFA as it relates to user fees
  • The fee payment process
  • The OMUFA draft guidance for industry titled “Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program."
  • An update for facilities that first registered with FDA on or after the declaration of the COVID-19 PHE for the sole purpose of producing hand sanitizer products during the COVID-19 PHE
• Discuss
  • The registration process for over-the-counter monograph drug facilities
  • The different fee types for OMUFA
  • Fiscal year 2024 target revenue, fee rates, and timelines
  • The penalties associated with failure to pay OMUFA user fees
  • OMUFA refund eligibility

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.

OBJECTIVES

• Review 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.
• Identify the different fee types for OMUFA.
• Explain the fee collection and payment process for OMUFA.
• State the timelines for OMUFA.
• Discuss 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

LCDR Tramara Dam, Pharm.D., MBA, BCSCP, GWCPM
Senior Program Management Officer
Division of User Fee Management (DUFM)
Policy and Operations Branch (POB)
Office of Management (OM) | CDER | FDA

LCDR Yajun (Jason) Tu, Pharm.D., Ph.D., BCSCP
Program Management Officer
DUFM | POB | OM | CDER | FDA

FDA RESOURCES

• Over-The-Counter Monograph User Fee Program (OMUFA)
• OMUFA draft guidance for industry titled “Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program."
• 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 event has been approved for 1 contact hour of continuing education for physicians, pharmacists, and nurses.

Please see detailed announcement for more information.

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.

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