[Federal Register: November 4, 2005 (Volume 70, Number 213)]
[Page 67179]
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 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 Friday, November 18, 
2005, from 8 a.m. to 2 p.m.
    Location: Washington DC North/Gaithersburg Hilton, 620 Perry Pkwy., 
Gaithersburg, 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, or by 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: The committee will discuss a report by the agency on 
Adverse Event Reporting, as mandated in Section 17 of the Best 
Pharmaceuticals for Children Act, for AGRYLIN (anagrelide), PARAPLATIN 
(carboplatin), DIFLUCAN (fluconazole), CAMPTOSAR (irinotecan), TAMIFLU 
(oseltamivir), VIOXX (rofecoxib), FERRLECIT (sodium ferric gluconate 
complex), and IMITREX (sumatriptan).
    The background material will become available no later than the day 
before the meeting and will be posted under the Pediatric Advisory 
Committee 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 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 November 10, 
2005. Oral presentations from the public will be scheduled on Friday, 
November 18, 2005, between approximately 8:30 a.m. and 9:30 a.m. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person by November 
10, 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 contact 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: October 31, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. 05-22014 Filed 11-3-05; 8:45 am]