[Federal Register Volume 69, Number 149 (Wednesday, August 4, 2004)]
[Notices]
[Page 47157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17824]



[[Page 47157]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0337]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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's and 
certain Department of Health and Human Services' (HHS) regulatory 
issues.
    Date and Time: The meeting will be held on September 10, 2004, from 
8:30 a.m. to 3:30 p.m.
    Addresses: Electronic copies of the documents for public review can 
be viewed at the Pediatric Advisory Committee (PAC) Docket site at 
http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2004 
and scroll down to PAC meetings.) Electronic comments should be 
submitted to http://www.fda.gov/dockets/ecomments. Select Docket Number 
2004N-0337, entitled ``Subpart D 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. Received comments may 
be viewed on the FDA Web site at: http://www.fda.gov/ohrms/dockets/dockets/04n0337/04n0337.htm or may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
    Location: Regency Room, DoubleTree Hotel, 1750 Rockville Pike, 
Rockville, MD.
    Contact Person: Jan N. Johannessen, Office of the Commissioner (HF-
33), Food and Drug Administration, 5600 Fishers Lane (for express 
delivery, rm. 17-51), Rockville, MD 20857, 301-827-6687, or by e-mail: 
[email protected]. 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: On Friday, September 10, 2004, the Pediatric Ethics 
Subcommittee of the Pediatric Advisory Committee will meet to discuss a 
referral by an Institution Review Board (IRB) of a proposed clinical 
investigation that involves both an FDA-regulated product and research 
involving children as subjects that is conducted or supported by HHS. 
The proposed clinical investigation is entitled ``Effects of a Single 
Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder 
(ADHD): A Functional Magnetic Resonance Study.'' 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 ADHD, 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 September 15, 2004; the announcement of 
the September 15, 2004, meeting can be found elsewhere in this issue of 
the Federal Register.
    Also elsewhere in this issue of the Federal Register is a document 
announcing a public comment period concerning whether the proposed 
clinical investigation should proceed. Information regarding submitting 
comments during that period is contained in that document.
    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 Pediatric Advisory Committee (PAC) Docket site at 
http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2004 
and scroll down to PAC 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 August 25, 
2004. 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 
August 25, 2004, 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 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: July 29, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-17824 Filed 7-30-04; 3:42 pm]
BILLING CODE 4160-01-S