[Federal Register: January 10, 2005 (Volume 70, Number 6)]
[Notices]
[Page 1721]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10ja05-41]
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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 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 February 14, 2005, from
2 p.m. to 6 p.m. and on February 15, 2005, from 8 a.m. to 4:30 p.m.
Location: Center for Drug Evaluation and Research Advisory
Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
Contact Person: Jan N. Johannessen, Office of Science and Health
Coordination of the 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, e-mail: jjohannessen@fda.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: On Monday, February 14, 2005, the committee will discuss an
agency report on Adverse Event Reporting, as mandated in Section 17 of
the Best Pharmaceuticals for Children Act (BPCA), for LOTENSIN
(benazepril), BREVIBLOC (esmolol), MALARONE (atovaquone/proguanil),
VIRACEPT (nelfinavir), XENICAL (orlistat), and GLUCOVANCE (glyburide/
metformin). The committee will also be asked to advise the agency on
how to improve the process and content of the adverse event reviews and
reporting as mandated by BPCA.
On Tuesday, February 15, 2005, the committee will discuss risk
evaluation, labeling, risk communication, and dissemination of
information on potential cancer risk among pediatric patients treated
for atopic dermatitis with topical dermatological immunosuppressants.
The background material will become available no later than the day
before the meeting and will be posted under the Pediatric Advisory
Committee (PAC) docket 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 2005 and scroll down to PAC meetings).
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 by February 7,
2005. Oral presentations from the public will be scheduled on Monday,
February 14, 2005, between approximately 4 p.m. and 4:30 p.m. and on
Tuesday, February 15, 2005, between approximately 12 noon and 12:30
p.m. Time allotted for each presentation may be limited. Those desiring
to make formal oral presentations should notify the contact person by
February 7, 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 in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: December 30, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 05-382 Filed 1-7-05; 8:45 am]
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