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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• Provide an overview of OMUFA draft guidance for industry titled “Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program.”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 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• November 2, 2022: OMUFA draft guidance for industry titled “Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program.”
• February 1, 2022: OMUFA Draft guidance “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs”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

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