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

June 18, 2024

1:00 PM – 2:00 PM ET

This webinar/conference is FREE

Registration

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

TOPICS

• Provide an overview of the user fee aspects of OMUFA 
• Discuss the registration process for OTC monograph drug facilities
• Describe the different fee types for OMUFA
• Discuss fiscal year 2024 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• Provide an overview of OMUFA draft guidance for industry titled “Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program”
• Provide update for facilities that first registered with FDA on or after the declaration of the COVID-19 Public Health Emergency (PHE) for the sole purpose of producing hand sanitizer products during the COVID-19 PHE