|CFSAN||December 16-17, 2014||8:30 a.m. – 5 p.m.||FDA White Oak Conference Center Building 31, Room 1503A 10903 New Hampshire Avenue Silver Spring, MD 20993|
The committee will discuss science issues surrounding susceptible life stages or populations and the circumstances under which FDA might decide to conduct a separate risk assessment for these populations. Also, FDA is requesting advice from the Food Advisory Committee on how to integrate concern for susceptible populations into its risk assessment procedures and methodologies including under what conditions a separate risk assessment should be conducted.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting.
The background materials will be posted at least five days before the meeting start date.
Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
- Written submissions may be made to the contact person on or before December 8, 2014.
- Oral presentations from the public will be scheduled between approximately 11:00 a.m. to 12:00 p.m. on December 17, 2014. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before November 24, 2014.
Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by December 1, 2014.
CFSAN plans to provide a free of charge, live webcast of the December 16-17, 2014, meeting of the Food and Drug Advisory Committee. While CFSAN is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. Visit the Food Advisory Committee Web site at 2014 Food Advisory Committee Meeting Materials. The Webcast link will become active shortly before the open session begins at 8:30 a.m.
- Karen L. Strambler, M.B.A.
Designated Federal Officer
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway, Room 1C-106
College Park, MD 20740
Telephone: (240) 402-2589
Fax: (301) 436-2637
- FDA Advisory Committee Information Line
1-800-741-8138 (301-443-0572 in the Washington DC area)
Please call the Information Line for up-to-date information on this meeting
A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.
Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Karen Strambler at least 7 days in advance of the meeting.
Information regarding ground transportation, airport information, lodging, driving directions and visitor parking, and security can be accessed at: Public Meetings at the FDA White Oak Campus.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).