[Federal Register Volume 65, Number 88 (Friday, May 5, 2000)]
[Notices]
[Page 26217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-11200]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Transmissible Spongiform Encephalopathies (TSE) Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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

    Name of Committee: Transmissible Spongiform Encephalopathies 
(TSE) Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on June 1, 2000, 8:30 
a.m. to 5:30 p.m. and on June 2, 2000, 8:30 a.m. to 3:30 p.m.
    Location: Holiday Inn, Ballroom II, Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: William Freas, or Sheila D. Langford, Center for 
Biologics Evaluation and Research (HFM-71), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448; 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 1, 2000, the committee will discuss policies for 
deferral of blood and plasma donors because of their possible 
exposure to the agent of bovine spongiform encephalopathy (BSE). On 
June 2, 2000, the committee will discuss the scientific merit of 
leukoreduction as a method to reduce the theoretical risk of 
Creutzfeldt-Jakob Disease (CJD) and/or new variant CJD (nvCJD) in 
blood and blood components for transfusions as well as plasma for 
manufacture into derivatives. In the afternoon, the committee will 
receive an update on the regulatory status of human dura mater.
    Procedure: On June 1, 2000, from 8:30 a.m. to 5 p.m. and June 2, 
2000, from 8:30 a.m. to 3:30 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 May 15, 
2000. Oral presentations from the public will be scheduled between 
approximately 8:30 a.m. to 9 a.m., and 1 p.m. to 1:30 p.m. on June 
1, 2000, and between 8:30 a.m. to 9 a.m. and 1 p.m. to 1:30 p.m. on 
June 2, 2000. Time allotted for each presentation may be limited. 
These desiring to make formal oral presentations should notify the 
contact person before May 22, 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 
presentation.
    Closed Committee Deliberations: On June 1, 2000, from 5 p.m. to 
5:30 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.
    Notice of this is given under the Federal Advisory Committee Act 
(5 U.S.C. app. 2).

    Dated: April 21, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-11200 Filed 5-4-00; 8:45 am]
BILLING CODE 4160-01-M