[Federal Register Volume 65, Number 163 (Tuesday, August 22, 2000)]
[Notices]
[Page 50995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-21250]


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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 [email protected], 
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