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| Center | Date | Time | Location |
|---|---|---|---|
| CBER | February 18, 2004 February 19, 2004 |
8:30 a.m. - 4:30
p.m. 8:30 a.m. - 12:30 p.m. |
Sheraton Four-Points
Hotel |
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 (MDCK) cells or Vero cells).
Background material and meeting information will become available no later than the day before the meeting (Simply select the appropriate committee link).
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 presentation. 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 William Freas or Denise H. Royster at least
7 days in advance of the meeting.
Contact Person:
William Freas or Denise H. Royster, Food and Drug Administration,
Center for Biologics Evaluation and Research (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.
[ Full FR Notice ]