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  4. Public Meeting on the Reauthorization of the Over-the-Counter Monograph Drug User Fee Program (OMUFA) - 09/28/2023 - 09/28/2023
  1. News & Events for Human Drugs

Meeting

Event Title
Public Meeting on the Reauthorization of the Over-the-Counter Monograph Drug User Fee Program (OMUFA) - 09/28/2023
September 28, 2023

Date:
September 28, 2023
Time:
9:00 AM - 5:00 PM ET

The Food and Drug Administration (FDA or Agency) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Over-the-Counter Monograph Drug User Fee program (OMUFA) for fiscal years (FYs) 2026 through 2030. OMUFA authorizes FDA to collect user fees to support OTC monograph drug activities. The current legislative authority for OMUFA expires September 30, 2025. At that time, new legislation will be required to reauthorize the OMUFA program for future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs that FDA consult with the public on OMUFA reauthorization process. FDA invites public comment as the Agency begins the process to reauthorize the program in FYs 2026 through 2030.

You can register for the meeting here to let FDA know that you plan to attend. Though registration is voluntary and not required to attend, registrants will receive email updates and notices when new information becomes available.

Date: September 28, 2023

Time: 9:00 AM - 5:00 PM ET

Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, Rm. 1503, Silver Spring, MD  20993. 

Webcast

Please submit any comments or feedback regarding the proposed enhancements to the OMUFA program at the Federal Register Notice link below. To submit your comment, click the green button at the top of the page on the right-hand side that reads “Submit a formal comment.” You may also upload files (e.g. slides). All comments are considered part of the public record and will be publicly available.

Federal Register Notice

 
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