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  4. OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration - 06/18/2024
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Virtual | Virtual

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


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

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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
  • 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

 
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