[Federal Register: January 22, 2004 (Volume 69, Number 14)]
[Page 3148]
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). The meeting will 
be open 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 18, 2004, from 
8:30 a.m. to 4:30 p.m.; and on February 19, 2004, from 8:30 a.m. to 
12:30 p.m.
    Location: The meeting will be held at the Sheraton Four-Points 
Hotel, 8400 Wisconsin Ave., Bethesda, MD.
    Contact Person: William Freas or Denise H. Royster, Food and Drug 
Administration, Center for Biologics Evaluation and Research (CBER) 
(HFM-71), 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: The committee will review and discuss the selection of 
strains to be included in the influenza virus vaccine for the 2004-2005 
season. The committee and CBER will begin a discussion of the potential 
suitability for use in vaccine manufacture of influenza isolates that 
have been passaged through mammalian cells (e.g., Madin-Darby Canine 
Kidney cells or Vero cells).
    Procedure: On February 18 and 19, 2004, 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 4, 2004. Oral 
presentations from the public will be scheduled between approximately 1 
p.m. to 1:30 p.m. on February 18, 2004, and between 8:45 a.m. to 9:15 
a.m. on February 19, 2004. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should notify 
the contact person before February 13, 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 
    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 William Freas or 
Denise H. 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: January 12, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-1264 Filed 1-21-04; 8:45 am]