[Federal Register Volume 64, Number 202 (Wednesday, October 20, 1999)]
[Notices]
[Page 56509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27419]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99N-4236]
Pediatric Advisory Subcommittee of the Anti-Infective Drugs
Advisory Committee; Notice of Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 Advisory 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 November 15, 1999, from
8 a.m. to 5:30 p.m., and on November 16, 1999, from 8 a.m. to 1 p.m.
Interested persons and organizations may submit written comments by
November 8, 1999, to the Dockets Management Branch (address below).
Location and Addresses: Holiday Inn, Kennedy Grand Ballroom, 8777
Georgia Ave., Silver Spring, MD.
Submit written comments to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
Contact: Jayne E. Peterson, Center for Drug Evaluation and Research
(HFD-21), Food and Drug Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-6767, 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 subcommittee will discuss broad pediatric issues as
recommended in the final rule entitled ``Regulations Requiring
Manufacturers to Assess the Safety and Effectiveness of New Drugs and
Biologic Products in Pediatric Patients'' (63 FR 66632, December 2,
1998).
On November 15, 1999, the subcommittee will discuss ethical
considerations in the conduct of pediatric clinical trials involving a
drug or biologic product, specifically the role of pediatric subjects/
volunteers who do not have the disease under study.
On November 16, 1999, the subcommittee will discuss whether or not
there is a public health need for the pharmaceutical industry to extend
their drug development program for sleep disorders into the pediatric
population.
In order to prepare presentations and discussions for the meeting,
the agency is requesting interested persons to submit in writing data,
information, and views relevant to the agenda items. These submissions
should contain the docket number 99N-4236 and be submitted to the
Dockets Management Branch (address above).
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person by November 8,
1999. Oral presentations from the public will be scheduled between
approximately 11 a.m. and 12 noon on November 15, 1999, and between
approximately 10:30 a.m. and 11 a.m. on November 16, 1999. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person before
November 8, 1999, 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: October 12, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-27419 Filed 10-19-99; 8:45 am]
BILLING CODE 4160-01-F
