[Federal Register: February 19, 2003 (Volume 68, Number 33)]
[Page 8029]
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.


    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 March 3, 2003, from 8 
a.m. to 5 p.m.
    Location: Center for Drug Evaluation and Research Advisory 
Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
    Contact Person: Thomas H. Perez, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for 
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 
301-827-7001, or e-mail: perezt@cder.fda.gov or FDA Advisory 
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 March 3, 2003, the subcommittee will discuss the 
development of antiretroviral drugs in human immunodeficiency virus 
(HIV)-infected and HIV-exposed neonates younger than 4 weeks of age. 
Following this at 2:45 p.m., the agency will provide an update to the 
subcommittee on the Adverse Event Reporting plan as mandated in section 
17 of the Best Pharmaceuticals for Children Act. After this 
presentation, at approximately 3:45 p.m., the agency will provide an 
update on pediatric initiatives within the agency.
    The background material for this meeting will be posted on the 
Internet when available, or 1 working day before the meeting at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/menu.htm
    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 February 21, 
2003. Oral presentations from the public will be scheduled between 
approximately 9:50 a.m. and 10:50 a.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person by February 21, 2003, 
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.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please notify Thomas Perez at least 
7 days in advance of the meeting.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the Pediatric Subcommittee of the Anti-Infective Drugs Advisory 
Committee meeting. Because the agency believes there is some urgency to 
bring this issue to public discussion and qualified members of the 
Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee 
were available at this time, the Commissioner of Food and Drugs 
concluded that it was in the public interest to hold this meeting even 
if there was not sufficient time for the customary 15-day public 
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February, 10, 2003.
Linda Arey Skladany,
Associate Commissioner for External Relations.
[FR Doc. 03-4001 Filed 2-18-03; 8:45 am]