[Federal Register: October 7, 2005 (Volume 70, Number 194)]
[Page 58711-58712]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0404]

Pediatric Ethics Subcommittee of the Pediatric Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    This notice announces a forthcoming meeting of the Pediatric Ethics 
Subcommittee of the Pediatric Advisory Committee of the Food and Drug 
Administration (FDA). The meeting will be open to the public.
    Name of Committee: Pediatric Ethics Subcommittee of the Pediatric 
Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Pediatric Advisory Committee on FDA, and certain 
Department of Health and Human Services (HHS), regulatory issues.
    Date and Time: The meeting will be held on November 15, 2005, from 
8:30 a.m. to 4 p.m.
    Addresses: Electronic copies of the documents for public review can 
be viewed at the Pediatric Advisory Committee (PAC) Docket site at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2005 

and scroll down to Pediatric Ethics Subcommittee meeting for 11-15-05.) 
Electronic comments should be submitted to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 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 FDA Web site at: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets
, or may be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., Monday through Friday.
    Location: Washington DC North/Gaithersburg Hilton, 620 Perry Pkwy., 
Gaithersburg, MD.
    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. Please call the FDA Advisory Information Line, 1-

800-741-8138 (301-443-0572 in the Washington, DC area), code 
8732310001, for up-to-date information on this meeting.
    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

[[Page 58712]]

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; the announcement of 
the November 16 and 17, 2005, Pediatric Advisory Committee meeting can 
be found elsewhere in this issue of the Federal Register.
    Elsewhere in this issue of the Federal Register is also a notice 
announcing a public comment period concerning whether the proposed 
clinical investigation should proceed. Information regarding submitting 
comments during that period is contained in that notice.
    The background materials for the subcommittee meeting will be made 
publicly available no later than the day before the meeting and will be 
posted under the PAC Docket site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm.
 (Click on the year 2005 and scroll down to Pediatric 

Advisory Committee, Pediatric Ethics Subcommittee meetings.)
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the subcommittee. 
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 by 
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 
    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 notify Jan Johannessen at 
least 7 days prior to the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 3, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. 05-20302 Filed 10-5-05; 11:25 am]