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Pediatric Advisory Committee

Agenda:
On Wednesday, November 16, 2005, the committee will hear and discuss the recommendation of the Pediatric Ethics Subcommittee from its meeting on November 15, 2005, regarding a referral by an Institution Review Board of a proposed clinical investigation involving children as subjects that is regulated by FDA and is conducted or supported by the Department of Health and Human Services (DHHS). The committee will also discuss pediatric obesity and clinical trial designs for the evaluation of devices intended to treat pediatric obesity.

On Thursday, November 17, 2005, the committee continue its discussion of clinical trial designs for, and ethical issues related to, the evaluation of devices intended to treat pediatric obesity.

Background material and meeting information meeting dates will become available no later than one business day before each meeting day (simply scroll down to the appropriate committee heading).

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 by November 4, 2005. Oral presentations from the public will be scheduled on Wednesday, November 16, 2005, between approximately 1:30 p.m. and 2:30 p.m., and Thursday, November 17, 2005 between approximately 9:15 a.m. and 10:15 a.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before November 4, 2005, 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. 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 Jan N. Johannessen, at least 7 days in advance of the meeting.

Contact Person:
Jan N. Johannessen, Office of Science and Health Coordination of the Office of the Commissioner (HF-33), Food and Drug Administration, 5600 Fishers Lane (for express delivery, Rm. 14C-06), Rockville, MD 20857, 301-827-6687, or by e-mail: jjohannessen@fda.gov.

Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 8732310001.