TSE Advisory Committee Meeting Oct. 25, 2001


Transmissible Spongiform Encephalopathies Advisory Committee

Date and Time: The meeting will be held on October 25, 2001, 8:00 a.m. to 3:30 p.m.; and October 26, 2001, 8:00 a.m. to 4:30 p.m.

Location: Holiday Inn, Kennedy Ballroom, 8777 Georgia Avenue, Silver Spring, MD 20910, 301-563-3722

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Agenda: On October 25, 2001, the committee will discuss FDA's Draft Guidance on Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products (published in the Federal Register on August 29, 2001, http://www.fda.gov/cber/gdlns/cjdvcjd.pdf). Later that morning the committee will discuss amino acid sourcing and production, and the theoretical risk of transmission of the BSE agent through their use in vaccines, other biologicals and human drugs. On October 26, 2001, the committee will discuss the risk of bovine brains and other neurological tissue for human use.

Oral Presentations: Between approximately 9:00 to 9:30 a.m. and 1:40 to 2:10 p.m. on October 25, 2001; and 1:00 to 1:30 p.m. on October 26, 2001, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before October 18, 2001.

Closed Committee Deliberations: On October 25, 2001, from 1:10 to 1:40 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)(4)). This portion of the meeting will be closed to permit discussion of this material.

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