[Federal Register: September 3, 2004 (Volume 69, Number 171)]
[Page 53925-53926]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Vaccines and Related Biological Products 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). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Vaccines and Related Biological Products 
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 September 22, 2004, from 
8:15 a.m. to 4:30 p.m. and on September 23, 2004, from 9 a.m. to 12:15 
    Location: Holiday Inn Select Bethesda, 8120 Wisconsin Ave., 
Bethesda, MD 20814.
    Contact Person: Christine Walsh or Denise Royster, Center for 
Biologics Evaluation and Research (HFM-71), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD, 20852, 301-827-
0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-
443-0572 in the Washington, DC area), code 3014512391. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: On September 22, 2004, the committee will consider the 
safety and

[[Page 53926]]

efficacy of a tetravalent meningococcal conjugate vaccine, Menactra, 
manufactured by Aventis Pasteur, Inc. On September 23, 2004, the 
committee will hear an update on the phase 3 Thai trial of ALVAC vCP 
1521 (Aventis Pasteur, Inc.) with AIDSVAX B/E (VaxGen, Inc.) for the 
prevention of HIV-1 infection.
    Procedure: On September 22, 2004, from 10 a.m. to 4:30 p.m. and on 
September 23, 2004, from 9 a.m. to 10:45 a.m. the meeting is open to 
the public. 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 September 15, 2004. 
Oral presentations from the public will be scheduled between 
approximately 2 p.m. and 2:30 p.m. on September 22, 2004, and between 
approximately 10:15 a.m. and 10:45 a.m. on September 23, 2004. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before 
September 16, 2004, 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.
    Closed Presentation of Data: On September 22, 2004, from 8:15 a.m. 
to 9:45 a.m. and on September 23, 2004, from 11 a.m. to 12:15 p.m., the 
meeting will be closed to permit discussion and review of trade secret 
and/or confidential information (5 U.S.C. 552b(c)(4)).
    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 contact Christine Walsh or 
Denise Royster at least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: August 30, 2004.
Lester M. Crawford,
Acting Commissioner of Food and Drugs.
[FR Doc. 04-20179 Filed 9-2-04; 8:45 am]