Contact Person:Martha Monser, Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4286, Silver Spring, MD 20993, 301-796-4627, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), to find out further information regarding FDA advisory committee information. A notice in theFederal Registerabout 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 athttp://www.fda.gov/AdvisoryCommittees/Calendar/default.htmand scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.
Agenda:The Science Board will be presented with a draft charge to establish a new subcommittee to evaluate the Agency's continuing work to address the challenges identified in the Board's 2007 "Science and Mission at Risk" Report. The Science Board will be provided with updates from the Center for Devices and Radiological Health Research Review subcommittee and the Global Health subcommittee. The Science Board will also hear progress updates on nanotechnology and the ongoing activities in the priority areas outlined in the Strategic Plan for Regulatory Science. Overviews of genomics activities at the National Center for Toxological Research and the Center for Biologics Evaluation and Research will be presented. Finally, the recipients of the FY2012 Scientific Achievement awards (selected by the Science Board) will provide overviews of the activities for which the awards were given.
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. Background material is available athttp://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to theappropriate advisory committee meeting link.
Procedure: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 Wednesday, September 26, 2012. Oral presentations from the public will be scheduled between approximately 1 p.m. and 1:30 p.m. 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 Tuesday, September 18, 2012. 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 Wednesday, September 19, 2012.
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 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 athttp://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htmfor 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).