Transmissible Spongiform Encephalopathies Advisory Committee
June 28-29, 2001 Meeting
Date and Time
The meeting will be held on June 28, 2001, 8:00 a.m. to 5:00 p.m.; and on June 29, 2001, 8:00 to 11:30 a.m.
Location
Holiday Inn, Versailles Ballroom I and II, 8120 Wisconsin Avenue, Bethesda, MD 20814, 301-652-2000.
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 28, 2001, the committee will review and discuss the suitability of blood donors who have lived or traveled in various countries based on recent information concerning new-variant Creutzfeldt-Jakob disease (vCJD) and bovine spongiform encephalopathy (BSE) in those countries. In the afternoon the committee will discuss the safety of FDA-regulated plasma derivatives prepared in establishments proposing to use on the same manufacturing line, plasma which does and plasma which does not comply with current U.S. standards, with regard to donor deferral for vCJD risk factors. On June 29, 2001, the committee will discuss the interim results of a new study on the inactivation of TSE agent by the manufacturing process for gelatin.
Oral Presentations
Between approximately 10:50 and 11:30 a.m., and 2:30 and 3:10 p.m. on June 28, 2001; and between 10:00 and 10:30 a.m. on June 29, 2001, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before June 15, 2001.
Closed Committee Deliberations:
On June 28, 2001, from 4:30 to 5:00 p.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b (c)(4)). This portion of the meeting will be closed to permit discussion of this material.
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