[Federal Register: January 27, 2005 (Volume 70, Number 17)]
[Page 3936]
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 February 16, 2005, from 
8:30 a.m. to approximately 5 p.m., and on February 17, 2005, from 8:30 
a.m. to approximately 2:05 p.m.
    Location: Holiday Inn Select Bethesda, 8120 Wisconsin Ave., 
Bethesda, MD.
    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 February 16, 2005, the committee will review and discuss 
the selection of strains to be included in the influenza virus vaccine 
for the 2005-2006 season. On February 17, 2005, the committee will hear 
updates on FDA Critical Path Initiative and Research Programs in the 
Center for Biologics Evaluation and Research.
    Procedure: On February 16, 2005, from 8:30 a.m. to 5 p.m. and on 
February 17, 2005, from 8:30 a.m. to 11:25 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 February 9, 2005. Oral 
presentations from the public will be scheduled between approximately 1 
p.m. and 1:30 p.m. on February 16, 2005, and approximately 8:45 a.m. 
and 9:15 a.m. on February 17, 2005. Time allotted for each presentation 
may be limited. Those desiring to make formal oral presentations should 
notify the contact person before February 9, 2005, 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 
    Closed Committee Deliberations: On February 17, 2005, from 
approximately 12 noon to 2:05 p.m., the meeting will be closed to 
permit discussion where disclosure would constitute a clearly 
unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)) and to 
permit discussion and review of trade secret and/or confidential 
information (5 U.S.C. 552b(c)(4)). The committee will discuss 
individual Research Programs in the Center for Biologics Evaluation and 
Research and receive an update on a product under review.
    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 301-827-0314 at least 7 days in advance of the 
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: January 18, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-1474 Filed 1-26-05; 8:45 am]