[Federal Register Volume 65, Number 249 (Wednesday, December 27, 2000)]
[Notices]
[Pages 81876-81877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-33021]
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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.
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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 (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 January 18, 2001, 8:30
a.m. to 5:30 p.m. and January 19, 2001, 8:30 a.m. to 5:30 p.m.
Location: Holiday Inn, Versailles Ballrooms I and II, 8120
Wisconsin Ave., Bethesda, 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, 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 January 18, 2001, the committee will discuss whether
recent information about new variant Creutzfeldt-Jakob disease (nvCJD)
in France and bovine spongiform encephalopathy in France and other
European countries suggests a need to reconsider FDA policies on
suitability of blood donors who lived or traveled in those countries.
In the afternoon, the committee will discuss the risks of Creutzfeldt-
Jakob disease (CJD) and vCJD transmission by human cells, tissues and
cellular and tissue-based products intended for implantation,
transplantation, infusion, or transfer that are currently or proposed
to be regulated by FDA, and the possible deferral of donors who have
resided in the United Kingdom. On January 19, 2001, the committee will
discuss issues related to deer and elk infected with or exposed to
chronic wasting disease in the United States and potential for human
exposure. In the afternoon, the committee will discuss whether a
history of possible exposure to various animal transmissible spongiform
encephalopathy agents should be considered by FDA in determining
suitability of blood donors.
Procedure: On January 18, 2001, from 8:30 a.m. to 5 p.m. and
January 19, 2001, from 8:30 a.m. to 5:30 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 January 12, 2001. Oral
presentations from the public will be scheduled between approximately
10:30
[[Page 81877]]
a.m. to 10:50 a.m., and 3 p.m. to 3:20 p.m. on January 18, 2001; and
between 10:30 a.m. to 10:50 a.m., and 3 p.m. to 3:20 p.m. on January
19, 2001. Time allotted for each presentation may be limited. Those
desiring to make formal oral presentations should notify the contact
person before January 12, 2001, 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 January 18, 2001, 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 meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: December 18, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-33021 Filed 12-26-00; 8:45 am]
BILLING CODE 4160-01-F