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You are receiving this message as a subscriber to the FDA HIV/AIDS electronic list serve. The purpose of the list serve is to relay important information about HIV/AIDS-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.
The Food and Drug Administration (FDA) will hold a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on September 23, 2004, from 9:00 a.m. to 12:15 p.m. at the Holiday Inn - Select, 8120 Wisconsin Avenue, Bethesda, MD 20814.
The purpose of the meeting is to update the Committee on the phase 3 Thai trial of ALVAC vCP 1521 [Aventis Pasteur, Inc.] with AIDSVAX B/E [VaxGen, Inc.] (HIV-1 Recombinant Canarypox-Vectored Vaccine with Recombinant gp 120 B/E) for the prevention of HIV-1 infection.
Please note, this meeting will be closed from 11 a.m. to 12:15 p.m. to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)).
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee during an open public hearing portion of the meeting, scheduled between approximately 10:15 and 10:45 a.m. Those wishing to speak or present data to the committee during the open public hearing should notify either Christine Walsh, R.N. (Walshc@...), or Denise Royster (Royster@...), Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD, 301-827-0314, of their intent to speak by September 16, 2004. Those who wish to present should 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. Time allotted for each presentation may be limited.Background materials related to the September 23 meeting will be posted on the FDA web site at least 24 hours prior to the meeting, at:
http://www.fda.gov/ohrms/dockets/ac/cber04.html#VaccinesandRelatedBiological
FDA welcomes the attendance of the public at its advisory committee meetings. No preregistration is necessary. FDA will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Christine Walsh or Denise Royster at least 7 days in advance of the meeting.
Those attending FDA advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
If you need directions or accommodations, please contact the hotel directly at 301-652-2000.
Please call the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512391, for up-to-date information on this meeting.
Richard
Klein
HIV/AIDS Program Director
Food and Drug
Administration
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