[Federal Register: November 4, 2005 (Volume 70, Number 213)]
[Notices]
[Page 67179]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04no05-61]
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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 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
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 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]
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