[Federal Register Volume 68, Number 16 (Friday, January 24, 2003)]
[Notices]
[Pages 3535-3536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-1566]


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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). 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 February 20, 2003; 8 
a.m. to 5:30 p.m.
    Location: Holiday Inn, 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 20852-1449, 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 February 20, 2003, the committee will listen to updates 
on: Implementation of the variant Creutzfeldt-Jakob Disease (vCJD)

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guidance (``Guidance for Industry: Revised Preventive Measures to 
Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease 
(CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood 
Products''; this guidance can be accessed at http://www.fda.gov/cber/guidelines.htm) and its affect on blood supply, and an update on bovine 
spongiform encephalopathy epidemiology and food chain controls. The 
committee will then discuss consideration of labeling claims for 
transmissible spongiform encephalopathy (TSE) agent clearance in plasma 
derivatives.
    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 contact person by February 13, 
2003. Oral presentations from the public will be scheduled between 
approximately 10:10 a.m. to 10:30 a.m. and between approximately 3 p.m. 
to 3:40 p.m. on February 20, 2003. Time allotted for each presentation 
may be limited. Those desiring to make formal oral presentations should 
notify the contact person before February 13, 2003, 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.
    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: January 14, 2003.
Linda Arey Skladany,
Associate Commissioner for External Relations.
[FR Doc. 03-1566 Filed 1-23-03; 8:45 am]
BILLING CODE 4160-01-S