Transmissible Spongiform Encephalopathies Advisory Committee
June 26-27, 2002 Meeting
Date and Time:
The meeting will be held on June 26, 2002, 8:00 a.m. to 5:30 p.m.; and June 27, 2002, 8:30 a.m. to 12:00 p.m.
Location:
Gaithersburg Holiday Inn, 2 Montgomery Village Avenue, Gaithersburg, MD 20877, 301-948-8900.
Contact Person:
William Freas, Ph.D., or Sheila D. Langford, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12392. Please call the Information Line for up-to-date information on this meeting.
Agenda:
On June 26, 2002, the committee will discuss validation of procedures to prevent contamination and cross-contamination with TSE agents of human tissue intended for transplantation. In the afternoon, the committee will discuss the "FDA Draft Guidance on Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products". On June 27, 2002 the committee will listen to updates on: implementation of blood donor deferrals for risk of vCJD, recent reports of infectivity detected in blood of sheep experimentally infected with BSE and scrapie agents, and recent reports of abnormal prion proteins and infectivity detected in muscles of experimentally infected mice.
Oral Presentations:
Between approximately 12:15 p.m. and 1:15 p.m. on June 26, 2002; and 10:30 a.m. and 11:30 a.m. on June 27, 2002, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before June 21, 2002.
Closed Committee Deliberations:
On June 26, 2002, from 2:15 p.m. to 3:00 p.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552 b (c) (4)). This portion of the meeting will be closed to permit discussion of this material.
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