[Federal Register: March 23, 2001 (Volume 66, Number 57)]
[Page 16251]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Pediatric Subcommittee of the Anti-Infective Drugs Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: 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 April 23, 2001, 8 
a.m. to 5:30 p.m. and on April 24, 2001, 8 a.m. to 3 p.m.
    Location: Center for Drug Evaluation and Research Advisory 
Committee conference room 1066, 5630 Fishers Lane, Rockville, MD 
    Contact: 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: 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 April 23, 2001, beginning at 8 a.m., the subcommittee 
will discuss issues in drug development for pediatric patients with 
chronic hepatitis C. Beginning at 3:30 p.m., the agency will provide 
an update to the subcommittee as to recent efforts to ensure 
adequate labeling and proper pediatric use of therapies. On April 
24, 2001, the subcommittee will discuss issues involved in designing 
clinical trials to study anti-muscarinics for drooling in children 
with cerebral palsy and other neurologic diseases, as well as the 
ethical issues involved in performing studies with children having 
special needs.
    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 April 13, 2001. On April 23 and 24, 2001, oral presentations from 
the public will be scheduled between approximately 10:30 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 
person before April 13, 2001, 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: March 16, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-7186 Filed 3-22-01; 8:45 am]