[Federal Register: August 22, 2000 (Volume 65, Number 163)]
[Notices]
[Page 50995]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22au00-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Pediatric Subcommittee of the Anti-Infective 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.
Name of Committee: Pediatric Subcommittee of the Anti-Infective
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 on September 11, 2000, 8
a.m. to 5:30 p.m.
Location: Hyatt Regency, Baccarat/Haverford Rooms, One Bethesda
Metro Center, Bethesda, MD.
Contact Person: Jayne E. Peterson, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5630 Fishers Lane,
Rockville, MD 20857, 301-827-7001, e-mail: at PETERSONJ@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: On September 11, 2000, beginning at 8 a.m., the
subcommittee will discuss ethical considerations in the conduct of
placebo-controlled clinical trials in the pediatric population.
Beginning at 3 p.m., the subcommittee will discuss the development of
psychotropic drugs for use in young children.
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 September 5,
2000. On September 11, 2000, oral presentations from the public will be
scheduled between approximately 8:15 and 8:45 a.m. and between
approximately 3 p.m. and 3:30 p.m. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should
notify the contact person before September 5, 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.
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. 00-21250 Filed 8-21-00; 8:45 am]
BILLING CODE 4160-01-F