[Federal Register: May 25, 2005 (Volume 70, Number 100)]
[Notices]
[Page 30126-30127]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25my05-123]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0184]
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 certain
regulatory issues with regard to FDA and Department of Health and Human
Services (HHS).
Date and Time: The meeting will be held on June 28, 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 06-28-05.)
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-0184, entitled ``Surfactant IRB
Referral'' and follow the prompts to submit your statement. Written
comments should be submitted to Division of Dockets Management (HFA-
[[Page 30127]]
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Please submit comments by June 7, 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: U.S. Food and Drug Administration, 5630 Fishers Lane, rm.
1066, Rockville, 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 that involves both an
FDA regulated product and research involving children as subjects that
may be supported by HHS. The proposed clinical investigation is
entitled ``Precursor Preference in Surfactant Synthesis of Newborns.''
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 surfactant synthesis, 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 June 29, 2005; the announcement of the
June 29 and June 30, 2005, meeting can be found elsewhere in this issue
of the Federal Register.
Also elsewhere in this issue of the Federal Register is 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 one 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 June 17, 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
June 17, 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 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: May 19, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-10437 Filed 5-24-05; 8:45 am]
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