[Federal Register: September 3, 2004 (Volume 69, Number 171)]
[Notices]
[Page 53925-53926]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03se04-81]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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
p.m.
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
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 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]
BILLING CODE 4160-01-S