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U.S. Department of Health and Human Services

Advisory Committees

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February 22, 2010: Science Board to the FDA Meeting Announcement

Center

Date

Time

Location

OC

February 22, 2010

8:00 a.m. - 3:00 p.m.

Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814

Agenda

The Science Board will hear about and discuss an interim report from its subcommittee reviewing research at the Center for Food Safety and Applied Nutrition (CFSAN). The Science Board will also hear about and discuss plans to establish another subcommittee to review research programs at the Center for Drug Evaluation and Research (CDER). The Science Board will then hear and discuss updates on science programs at the Office of Regulatory Affairs (ORA) and the National Center for Toxicological Research (NCTR).

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.

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 February 15, 2010. Comments received on or before February 18, 2010, 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 February 22, 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 February 5, 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 February 8, 2010.

Contact Information
  • Doreen Kezer, MSN
    Office of Science and Public Health
    Office of the Commissioner (HF–33)
    Food and Drug Administration
    5600 Fishers Lane (for express delivery, rm. 14–65)
    Rockville, MD 20857
    Phone: 301–827–1249
    Fax: 301-827-3042
    E-mail: doreen.kezer@fda.hhs.gov
  • FDA Advisory Committee Information Line
    1-800-741-8138
    (301-443-0572 in the Washington DC area)
    Code:8732310001
    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 Doreen Kezer, MSN at (301) 827-1249 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).