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  4. OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2021 User Fees Webinar - 06/03/2021 - 06/03/2021
  1. News & Events for Human Drugs

Public

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

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

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course:

  • has been pre-approved by RAPS as eligible for credits (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
  • has been pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION AND QUESTIONS

 

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