[Federal Register: August 4, 2004 (Volume 69, Number 149)]
[Notices]
[Page 47157]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04au04-80]
[[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://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 2004
and scroll down to PAC meetings.) 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 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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:
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: 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://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 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]
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