The Food and Drug Administration (FDA) is announcing a public meeting to gather stakeholder input on the potential development of a user fee program for nonprescription (over-the-counter or OTC) monograph drugs. A user fee program would provide funding to supplement congressional non user-fee appropriations, and would support timely and efficient FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in a monograph. FDA invites public comment on a potential OTC monograph user fee program and also invites suggestions regarding the features such a user fee program should include.
Date: June 10, 2016
Time: 9:00 a.m. to 5:00 p.m. EDT
FDA White Oak Campus
10903 New Hampshire Ave
Building 31 Conference Center, Room 1503A
Silver Spring, Maryland 20993
Entrance for the public meeting participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information refer to: Public Meetings at the FDA White Oak Campus
Attendance and Registration to Speak
The FDA Conference Center at the White Oak location is a federal facility. The public meeting is free and seating will be on a first-come, first served basis.
If you wish to attend the public meeting either in person or by viewing the webcast, FDA asks that you please register through Eventbrite by Tuesday, May 31, 2016, in order for FDA to estimate the number of attendees (Over-the-Counter Monograph User Fees Public Meeting).
If you wish to make an oral presentation at the public meeting, you must register through Eventbrite by Tuesday, May 31, 2016 (Over-the-Counter Monograph User Fees Public Meeting).
If you need special accommodations because of disability, please contact FDA at
OTCMonographUserFeeProgram@fda.hhs.gov no later than Friday, May 27, 2016.
Webcast of Meeting
You may access the webcast via this link: https://collaboration.fda.gov/otc2016/
Adobe Connect Minimum Requirements for accessing the webcast are below:
- View meetings on Windows, Macs, Unix, and Linux platforms
- Lan or Broadband internet connection
- Supports Internet Explorer, Firefox, Safari, Netscape Navigator, AOL
- Adobe Flash Player (no other downloads needed)
- VPN and Parachute compatible but not required
- Test my computer for Adobe Connect-Readiness
- Federal Register Notice
- Agenda (PDF - 175 KB)
- Transcript (PDF - 479KB)
- FDA Presentations
- Panel Presentations
- Frequently Asked Questions: June 10, 2016 Public Meeting on OTC Monograph User Fees
- Potential Over-the-Counter Monograph User Fees