[Federal Register: September 22, 2004 (Volume 69, Number 183)]
[Page 56771]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Transmissible Spongiform Encephalopathies Advisory Committee; 
Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


    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 October 14, 2004, from 8 
a.m. to 5:30 p.m.
    Location: Hilton Hotel, 8727 Colesville Rd., Silver Spring, 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, 301-827-0314, or 
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 
in the Washington, DC area), code 3014512392. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: On October 14, 2004, the committee will hear updates on the 
following issues: USDA-licensed tests for the diagnosis of bovine 
spongiform encephalopathy (BSE) and other transmissible spongiform 
encephalopathies (TSE), review of the worldwide BSE situation, new FDA/
Center for Food Safety and Applied Nutrition BSE-food safety rules, and 
labeling claims for TSE clearance studies for plasma derivative 
products. The committee will then discuss and make recommendations 
regarding presumptive transfusion transmissions of variant Creutzfeldt 
Jakob Disease (vCJD) and current FDA-recommended safeguards.
    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 October 5, 
2004. Oral presentations from the public will be scheduled between 
approximately 9:20 a.m. and 9:50 a.m., and 2:45 p.m. and 3:15 p.m. on 
October 14, 2004. Time allotted for each presentation may be limited. 
Those desiring to make formal oral presentations should notify the 
contact person before October 7, 2004, 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 
    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: September 15, 2004.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 04-21282 Filed 9-21-04; 8:45 am]