November 15, 2010: Science Board to the FDA Meeting Announcement
|OC||November 15, 2010||8:30 a.m. - 4:00 p.m.||Bethesda Marriott|
5151 Pooks Hill Road
Bethesda, MD 20814
The Science Board will receive information from the ongoing review of the Pharmacovigilance Program at the Center for Drug Evaluation and Research (CDER). The Center for Food Safety and Applied Nutrition (CFSAN) will present its evaluation and review of the Subcommittee's Final Report on Research at CFSAN and provide an overview of its strategic plan. The Board will be provided with updates on the development and broad priorities of FDA’s Strategic Science Plan, and the FDA Medical Countermeasures Initiative, including planning for its regulatory science component. In addition, new information and updates will be provided concerning FDA’s activities in support of Comparative Effectiveness Research.
FDA intends to make the complete 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.
- Background material
Public Participation and Sponsor Information
Interested persons and Sponsors (representatives from industry) 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 November 1, 2010. Comments received on or before November 8, will be provided to the committee before the meeting.
- Oral presentations from the public (excluding Sponsors) will be scheduled between approximately 1 p.m. and 2 p.m. on November 15, 2010. Those desiring to make 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 8, 2010.
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 November 1, 2010.
Office of Chief Scientist
Office of the Commissioner
Food and Drug Administration
White Oak 32
10903 New Hampshire Ave.
Silver Spring, Maryland 20993
- FDA Advisory Committee Information Line
(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 Website and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.
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.
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 Martha Monser at (301) 796-4627 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site 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).