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Vaccines and Related Biological Products Advisory Committee

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May 11-12, 2000 Meeting

Date and Time

The meeting will be held on May 11, 2000, 8:00 am to 5:30 pm; and on May 12, 2000, 8:00 am to 3:00 pm.

Location

Holiday Inn, Kennedy Grand Ballroom, 8777 Georgia Avenue, Silver Spring, MD 20910, 301-563-3721.

Contact Person

Nancy T. Cherry or Denise H. Royster, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12391. Please call the Information Line for up-to-date information on this meeting.

Oral Presentations

On May 11, 2000, between approximately 12:20 to 12:50 pm; and on May 12, 2000, between approximately 10:35 to 10:50 am and 1:30 to 1:45 pm oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before May 4, 2000.

Agenda

On May 11, 2000, the committee will hear updates on activities in the Office of Vaccines Research and Review. The committee will also be informed of issues pertaining to the status of vaccines for the prevention of rotavirus disease. On May 12, 2000, the committee will review issues related to the development of policy regarding the use of various types of neoplastic cells as substrates for vaccine manufacture.

Closed Committee Deliberations

On May 11, 2000, from 8:00 to 9:00 am, and from approximately 1:45 to 5:30 pm; and on May 12, 2000, from 8:00 to 9:00 am the meeting will be closed to permit discussion and review of trade secret and/or confidential information. (5 U.S.C. 552b(c)(4)). These portions will be closed to permit discussion of pending investigational new drug applications or pending product licensing applications.

 

 
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