January 6, 2012: Science Board to the FDA Meeting Announcement

For those unable to attend in person, the meeting will also be webcast. The link for the webcast is available at https://collaboration.fda.gov/scienceboard. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading "Resources for You," click on "Public Meetings at the FDA White Oak Campus." Please note that visitors to the White Oak Campus must enter through Building 1.

Agenda

The Science Board will hear about and provide input regarding the Centers for Excellence in Regulatory Science and Innovation. The Science Board will also hear an update regarding the Scientific Computing/JANUS program. FDA’s Modernizing Toxicology Working Group will present an overview to the Science Board for input and discussion. The Center for Drug Evaluation and Research will provide their response to the May 2011 Subcommittee Report regarding the Review of the FDA/CDER Pharmacovigilance Program. The Board will be provided with an update from Subcommittee for the science review of the Center for Devices and Radiological Health.

Meeting Materials

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
  • 2012 Meeting Materials, Science Board to the FDA

Public Participation and Sponsor 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 Friday December 30, 2011.
• Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on January 6, 2012. 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 Thursday, December 22, 2011.

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 Friday, December 23, 2011.

Contact Information

Martha Monser
Office of Chief Scientist
Office of the Commissioner
Food and Drug Administration
White Oak Bldg 32, Room 4286
10903 New Hampshire Ave.
Silver Spring, Maryland 20993
Phone: 301–796-4627
Fax: 301-847-8617
E-mail: martha.monser@fda.hhs.gov

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 Advisory Committee Information Line 1-800-741-8138 (301-443-0572 in the Washington DC area) and follow the prompts to the desired center or product area.
  Please call the Information Line for up-to-date information on this 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).