[Federal Register: January 10, 2005 (Volume 70, Number 6)]
[Page 1721]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Pediatric Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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 
    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]