[Federal Register Volume 63, Number 222 (Wednesday, November 18, 1998)]
[Notices]
[Page 64093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30748]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0966]


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). The meeting will 
be open 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 December 18, 1998, 8 
a.m. to 5:30 p.m. Written comments must be submitted on or before 
Friday, December 4, 1998.
    Location: Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, MD.
    Addresses: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, e-mail ``[email protected]''. Comments 
should be identified with the docket number found in brackets in the 
heading of this document.
    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: The committee will discuss possible deferral of blood or 
plasma donors based on geographical criteria linked to possible 
foodborne exposure to the agent of Bovine Spongiform Encephalopathy as 
a measure to reduce the potential for transmission of new variant 
Creutzfeldt-Jakob Disease (nvCJD) through blood and blood products. The 
potential effects of such deferrals on the supply of blood and blood 
products will be considered as part of the committee's deliberations.
    Procedure: 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 Dockets Management Branch 
(address above) on or before December 4, 1998, as described under the 
Comments caption. Oral presentations from the public will be scheduled 
between approximately 2:15 p.m. and 3:15 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before December 9, 1998, 
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.
    Comments: Interested persons may, on or before December 4, 1998, 
submit to the Dockets Management Branch (address above) written 
comments regarding this subject. Received comments will be given to the 
committee for review and made available to the public. Two copies of 
any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. The received comments may be 
seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.
     Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: November 9, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-30748 Filed 11-17-98; 8:45 am]
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