[Federal Register: January 6, 2006 (Volume 71, Number 4)]
[Notices]
[Page 942-943]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06ja06-61]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Pediatric Oncology Subcommittee of the Oncologic Drugs 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.
[[Page 943]]
Name of Committee: Pediatric Oncology Subcommittee of the Oncologic
Drugs Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held March 14, 2006, from 8 a.m.
to 5 p.m.
Location: Gaithersburg Hilton, The Ballrooms, 620 Perry Pkwy.,
Gaithersburg, MD.
Contact Person: Johanna M. Clifford, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane,
(for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD
20857, 301-827-7001, FAX: 301-827-6776, e-mail: cliffordj@cder.fda.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 3014512542. Please call the
Information Line for up-to-date information on this meeting.
Agenda: The subcommittee will discuss the following: (1) Clinical
studies of methotrexate and daunomycin to be conducted under the Best
Pharmaceuticals for Children Act; (2) phase 4 requirements for
Deferasirox, Norvartis Pharmaceuticals, as mandated under accelerated
approval; and (3) the Center for Drug Evaluation and Research's process
for handling drug shortages. The background material will become
available no later than the 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
under the heading ``Oncologic Drugs Advisory Committee; Pediatric
Oncology'' (click on the year 2006 and scroll down to the previously
named committee).
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the subcommittee.
Written submissions may be made to the contact person by March 7, 2006.
Oral presentations from the public will be scheduled between
approximately 2 p.m. to 3 p.m. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person before March 7, 2006, 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 Johanna M. Clifford
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 27, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E5-8332 Filed 1-5-06; 8:45 am]
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