[Federal Register: May 30, 2002 (Volume 67, Number 104)]
[Page 37845]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Transmissible Spongiform Encephalopathies 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 
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 26, 2002, from 8 
a.m. to 5:30 p.m.; and June 27, 2002, from 8:30 a.m. to 12 noon.
    Location: Holiday Inn, The Ballroom, Two 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 26, 2002, the committee will discuss validation of 
procedures to prevent contamination and cross-contamination with 
transmissable spongiform encephalopathies 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discuss the ``FDA Draft Guidance on Preventive Measures to Reduce the 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: (1) Implementation of blood donor deferrals 
for risk of vCJD; (2) recent reports of infectivity detected in blood 
of sheep experimentally infected with bovine spongiform 
encephalopathies and scrapie agents; and (3) recent reports of abnormal 
prion proteins and infectivity detected in muscles of experimentally 
infected mice.
    Procedure: On June 26, 2002, from 8 a.m. to 2:15 p.m. and from 3 
p.m. to 5:30 p.m.; and on June 27, 2002, from 8:30 a.m. to 12 noon, 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 
June 19, 2002. Oral presentations from the public will be scheduled 
between approximately 12:15 p.m. and 1:15 p.m. on June 26, 2002; and 
between 10:30 a.m. and 11:30 a.m. on June 27, 2002. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before June 21, 2002, 
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 26, 2002, from 2:15 p.m. to 
3 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 
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact William Freas or 
Sheila D. Langford at least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: May 23, 2002.
Linda A. Suydam,
Senior Associate Commissioner for Communications and Constituent 
[FR Doc. 02-13591 Filed 5-29-02; 8:45 am]