[Federal Register: January 26, 2004 (Volume 69, Number 16)]
[Page 3588]
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 February 12, 2004, from 
8 a.m. to 5:30 p.m., and on February 13, 2004, from 8 a.m. to 3:30 p.m.
    Location: Holiday Inn, 8777 Georgia Ave., 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 20852-1448, 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 February 12, 2004, the committee will hear an 
informational presentation on a presumptive transfusion-transmitted 
case of variant Creutzfeldt-Jakob Disease (vCJD) reported recently in 
the United Kingdom, and hear updates on related experimental studies in 
animals on transmission of transmissible spongiform encephalopathies 
(TSE) agents by blood, and relevant epidemiology of human TSEs. In the 
afternoon, the committee will receive an update on the case of bovine 
spongiform encephalopathy (BSE) recently recognized in the United 
States, and will have a general discussion about potential models of 
risk-based approaches to sourcing of bovine materials used to make 
medical products. On February 13, 2004, the committee will have a 
preliminary discussion about FDA's current recommendations on measures 
to minimize risk from TSE agents in various types of medical products.
    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 5, 
2004. Oral presentations from the public will be scheduled between 
approximately 11:30 a.m. and 12 noon, and 3 p.m. and 3:30 p.m. on 
February 12, 2004; and between 11 a.m. and 12 noon on February 13, 
2004. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before February 9, 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: January 16, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-1495 Filed 1-23-04; 8:45 am]