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  4. OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2023 User Fees and Registration - 05/16/2023
  1. News & Events for Human Drugs

Virtual | Virtual

Event Title
OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2023 User Fees and Registration
May 16, 2023

Date:
May 16, 2023
Time:
1:00 p.m. - 2:00 p.m. ET

Topic & Presentations

Speakers

OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2023 User Fees and Registration

 

OMUFA Background, Registration, and Listing

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

OMUFA User Fees

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

Penalties for Failure to Pay OMUFA User Fees

LCDR Yajun (Jason) Tu, Pharm.D., Ph.D.
Program Management Officer, Policy and Operations Branch, DUFM
Office of Management | CDER | FDA

Q&A Discussion Panel

Same as above

Visit CDER Small Business and Industry Assistance Page

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  • Provide an overview of OMUFA draft guidance for industry titled “Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program.”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

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