Joint Meeting of the Transmissible Spongiform Encephalopathies Advisory Committee and the Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

This notice announces a forthcoming joint meeting of two public advisory committees of the Food and Drug Administration (FDA). At least one portion of the joint meeting will be closed to the public.

Names of Committees: Transmissible Spongiform Encephalopathies Advisory Committee and the Vaccines and Related Biological Products Advisory Committee.

General Function of the Committees: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on July 27, 2000, 8 a.m. to 4 p.m.

Location: Holiday Inn, Versailles Ballrooms I and II, 8120 Wisconsin Ave., Bethesda, MD.

Contact Person: William Freas or Sheila D. Langford; Nancy Cherry or Denise H. Royster, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 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), codes 12392 and 12391. Please call the Information Line for up-to-date information on this meeting.

Agenda: On July 27, 2000, in joint session, the committees will discuss bovine spongiform encephalopathy issues related to the manufacture of vaccines, specifically the use of European fetal calf serum in cell banks and viral seeds, and the use of European beef skeletal muscle and other tissues in manufacturing vaccines.

Procedure: On July 27, 2000, from 9 a.m. to 4 p.m., 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 July 13, 2000. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before July 17, 2000, 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 presentations.

Closed Committee Deliberations: On July 27, 2000, from 8 a.m. to 9 a.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)).

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).