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  4. OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2021 User Fees Webinar - 06/03/2021 - 06/03/2021
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Event Title
OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2021 User Fees Webinar
June 3, 2021


Date:
June 3, 2021
Time:
1:00 PM - 2:00 PM ET

 

 

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ABOUT

FDA will provide an overview of the Over-The-Counter Monograph Drug User Fee Program (OMUFA) and describe 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 2021 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

FDA SPEAKERS

CAPT Teresa Ramson, Pharm.D., MBA, RAC
Deputy Director, Division of User Fee Management (DUFM)
Office of Management (OM) | CDER | FDA

CAPT Matt Brancazio, Pharm.D., MBA, RAC
Branch Chief, Policy and Operations Branch
DUFM | OM | CDER | FDA

LCDR Tramara Dam, Pharm.D., GWCPM
Program Management Officer, Policy and Operations Branch
DUFM | OM | CDER | FDA

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 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

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