FDA Home | Search FDA Site | A-Z Index | Contact FDA

Anti-Infective Drugs Advisory Committee - Pediatric Subcommittee

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 /ohrms/dockets/ac/acmenu.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 outlets.

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.

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.

[Full FR Notice]