[Federal Register: May 30, 2002 (Volume 67, Number 104)]
[Notices]
[Page 37845]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30my02-110]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Transmissible Spongiform Encephalopathies Advisory Committee;
Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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discuss the ``FDA Draft Guidance on Preventive Measures to Reduce the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
material.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
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
Relations.
[FR Doc. 02-13591 Filed 5-29-02; 8:45 am]
BILLING CODE 4160-01-S