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Pediatric Ethics Subcommittee of the Pediatric Advisory Committee

Agenda:
The Pediatric Ethics Subcommittee of the Pediatric Advisory Committee will meet to discuss a referral by an Institutional Review Board (IRB) of a proposed clinical investigation involving children as subjects, that is regulated by FDA and may be supported by HHS. The proposed clinical investigation is entitled "Gonadotropin-releasing Hormone (GnRH) Agonist Test in Disorders of Puberty." Because the proposed clinical investigation would be regulated by FDA, and conducted or supported by HHS, both FDA and the Office for Human Research Protections, HHS, will participate in the meeting.

After presentation of an overview of the IRB referral process, background information on disorders of puberty and hormonal actions of leuprolide, an overview of the protocol and the referring IRB's deliberations on the protocol, and a summary of public comments received concerning whether the protocol should proceed, the subcommittee will discuss the proposed protocol and develop a recommendation regarding whether the protocol should proceed.

The subcommittee's recommendation will then be presented to the FDA Pediatric Advisory Committee on November 16, 2005. Follow this link to the announcement of the November 16 and 17, 2005, Pediatric Advisory Committee meeting.

Also, a notice announcing a public comment period concerning whether the proposed clinical investigation should proceed has been posted. Information regarding submitting comments during that period is contained in that notice.

Background material and meeting information for the subcommittee's meeting on November 15, 2005 will become available no later than one business day before the meeting (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 between approximately 11 a.m. and 12 noon. 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 Johannessen at least 7 days in advance of the meeting.

Addresses:
Electronic copies of the documents for public review can be viewed on the Pediatric Advisory Committee web page. (simply scroll down to the Pediatric Ethics Subcommittee meeting for 11-15-05) Electronic comments should be submitted to the e-Comment web page of the Division of Dockets Management. Select Docket No. 2005N-0404, entitled "Leuprolide IRB Referral" and follow the prompts to submit your statement. Written comments should be submitted to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Please submit comments by 4:30 p.m. on November 1, 2005. Received comments may be viewed on the Dockets web page, or may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Contact Person:
Jan N. Johannessen, 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.