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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research
Activity Outline
CDER Small Business and Industry Assistance 1 Hour Web Series: OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration
June 18, 2024
Virtual

Activity Coordinators:
Forest Ford (Forest.Ford@fda.hhs.gov),  Brenda Stodart (Brenda.Stodart@fda.hhs.gov),  Matthew Palumbo (Matthew.Palumbo@fda.hhs.gov),  Nora Lim (Nora.Lim@fda.hhs.gov)
Series Description

FDA's CDER Small Business and Industry Assistance (SBIA) educational webinars target the needs of health care professionals working in the pharmaceutical industry. Subject matter experts from the FDA explain trending drug development topics, (e.g. labeling, adverse events, quality) new guidance's or regulations, and/or FDA regulatory processes. These webinars support FDA's mission of promoting and protecting public health by bridging knowledge gaps about emerging regulatory issues or areas with frequently asked questions.

Lecture Description
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.
References
  • Over-The-Counter Monograph User Fee Program (OMUFA) https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-user-fee-program-omufa
  • Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-user-fees-under-over-counter-monograph-drug-user-fee-program
  • Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs Guidance for Industry https://www.fda.gov/media/155864/download
  • Over-the-Counter Monograph User Fee Program Performance Goals and Procedures - Fiscal Years 2021-2025 https://www.fda.gov/media/146283/download
  • OMUFA Cover Sheet and Payment Information https://userfees.fda.gov/OA_HTML/omufaCAcdLogin.jsp
  • An Exciting New Chapter in OTC Drug History: OTC Monograph Reform in the CARES Act https://www.fda.gov/news-events/fda-voices/exciting-new-chapter-otc-drug-history-otc-monograph-reform-cares-act
Series Objectives
  • Demonstrate the ability to solve FDA drug regulatory issues as they arise.
  • Explain new FDA regulatory initiatives.
Learning Objectives After completion of this activity, the participant will be able to:
  • Explain the Over the Counter Monograph Drug User Fee Program (OMUFA)
  • Describe the registration process for over-the-counter monograph drug facilities.
  • Discuss the registration process for entities that registered with FDA during the COVID-19 pandemic solely to manufacture OTC hand sanitizer products.
Target Audience
This activity is intended for physicians, pharmacists, and nurses.
Registration Information
Registration is complimentary; therefore refunds are not applicable. For information on how to register to attend this activity, please contact the Activity Coordinator(s) listed above.
Agenda

Lecture 1 June 18, 2024
Time Topic Speaker
1:00 - 2:00 PM EDT OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration Tramara Dam, PharmD, MBA, BCSCP, GWCPM
Yajun Tu, PhD, PharmD, BCSCP
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 1 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1.00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-24-012-L99-P for 1.00 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).
Requirements for Receiving CE Credit

All learners claiming credit must attest to their attendance and complete all required activity evaluation(s) in the FDA CE Portal (ceportal.fda.gov) within 14 days after an activity ends. Upon completion, learners may view/print statement of credit.

Attention NABP Pharmacists and Pharmacy Technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy (NABP) provided you add your NABP ID and date of birth to your profile in the FDA CE Portal. The only official Statement of Credit is the one you pull from CPE Monitor. If you do not see your credit reflected on CPE Monitor* after 45 days of attestation, please contact FDACETeam@fda.hhs.gov. *CPE Monitor sets a strict 60-day limit on uploading credits.

Disclosure

Faculty
  • Dam, Tramara, PharmD, MBA, BCSCP, GWCPM, Program Management Officer, FDA/CDER/OM/DUFM - nothing to disclose
  • Tu, Yajun, PhD, PharmD, BCSCP, Program Management Officer, FDA - nothing to disclose

Planning Committee
  • Brodsky, Eric, MD, Associate Director, FDA/CDER/OND/Labeling Policy Team - nothing to disclose
  • Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose
  • Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose

CE Consultation and Accreditation Team
  • Henderson, Darlise, MBA, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
  • Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
  • Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose
Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.