[Federal Register: August 22, 2000 (Volume 65, Number 163)]
[Notices]
[Page 50994]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22au00-72]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Joint Meeting of the Pediatric Subcommittee of the Anti-Infective
Drugs Advisory Committee and the 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 public advisory
subcommittees of the Food and Drug Administration (FDA). The meeting
will be open to the public.
Name of Committee: The Pediatric Subcommittee of the Anti-Infective
Drugs Advisory Committee and the Pediatric Oncology Subcommittee of the
Oncologic Drugs Advisory Committee.
General Function of the Committees: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on September 12, 2000, 8
a.m. to 12 noon.
Location: Hyatt Regency, Baccarat/Haverford Rooms, One Bethesda
Metro Center, Bethesda, MD.
Contact Person: Jayne E. Peterson or Karen M. Templeton-Somers,
Center for Drug Evaluation and Research (HFD-21), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7001,
or e-mail: at PetersonJ@cder.fda.gov or SomersK@cder.fda.gov, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 12530. Please call the Information Line
for up-to-date information on this meeting.
Agenda: The subcommittees will meet jointly to discuss the
approaches and processes used in pediatric oncology for the development
of drugs to treat serious and life threatening diseases with limited
patient populations.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the
subcommittees. Written submissions may be made to the contact persons
by September 6, 2000. Oral presentations from the public will be
scheduled between approximately 10 a.m. and 11 a.m. Time allotted for
each presentation may be limited. Those desiring to make formal oral
presentations should notify the contact persons before September 6,
2000, 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. After the scientific
presentations, a 30-minute open public session may be conducted for
interested persons who have submitted their request to speak by
September 6, 2000, to address issues specific to the topic before the
subcommittees.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: August 10, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-21247 Filed 8-21-00; 8:45 am]
BILLING CODE 4160-01-F