[Federal Register: January 24, 2003 (Volume 68, Number 16)]

[Notices]               

[Page 3535-3536]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr24ja03-83]                         





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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)





[[Page 3536]]





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]



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