[Federal Register: October 26, 2006 (Volume 71, Number 207)]
[Notices]
[Page 62595]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26oc06-43]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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 a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Pediatric Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues. The committee
also advises and makes recommendations to the Secretary of Health and
Human Services under 21 CFR 50.54 and 45 CFR 46.407 on research
involving children as subjects that is conducted or supported by the
Department of Health and Human Services, when that research is also
regulated by FDA.
Date and Time: The meeting will be held on November 16, 2006, from
8 a.m. to 4 p.m.
Location: Advisory Committee Conference Room, rm. 1066, 5630
Fishers Lane, Rockville, MD.
Contact Person: Jan Johannessen, Office of Science and Health
Coordination, Office of the Commissioner (HF-33), Food and Drug
Administration, 5600 Fishers Lane, (for express delivery, rm. 14B-08),
Rockville, MD 20857, 301-827-6687, e-mail: Jan.Johannessen@fda.hhs.gov
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 8732310001. Please call the
Information Line for up to date information on this meeting.
Agenda: The Pediatric Advisory Committee will hear and discuss a
report by the agency, as mandated in section 17 of the Best
Pharmaceuticals for Children Act, on adverse event reports for
ertapenem (INVANZ), gemcitabine (GEMZAR), glimepiride (AMARYL), insulin
aspart recombinant (NOVOLOG), linezolid (ZYVOX), meloxicam (MOBIC),
ondansetron (ZOFRAN), oxcarbazepine (TRILEPTAL), ritonavir (NORVIR),
rosiglitazone (AVANDIA), sirolimus (RAPAMUNE). The committee will also
receive updates to adverse event reports for atorvastatin (LIPITOR),
citalopram (CELEXA), oseltamivir (TAMIFLU), oxybutynin (DITROPAN), and
simvastatin (ZOCOR), which were requested by the Pediatric Advisory
Committee or its predecessor, the Pediatric Subcommittee of the Anti-
Infective Drugs Advisory Committee, when the reports were first
presented.
The background material will become available no later than 1
business day before the meeting and will be posted on FDA's Web 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 2006
and scroll down to Pediatric Advisory Committee link.)
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 on or before
November 1, 2006. Oral presentations from the public will be scheduled
between approximately 1:30 p.m. and 2:30 p.m. on November 16, 2006.
Time allotted for each presentation may be limited. Those desiring to
make formal oral presentations should notify the contact person 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 on or before by November 1, 2006.
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 N. Johannessen
at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: October 23, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-17965 Filed 10-25-06; 8:45 am]
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