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

June 18, 2024

About This Course

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  • The OMUFA draft guidance for industry titled “Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program.”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.

Topics Covered

• 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.

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

visit the FDA.gov webpage