[Federal Register: January 19, 2005 (Volume 70, Number 12)]
[Page 3045-3046]
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 8, 2005, 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 20852, 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: The committee will discuss the following: (1) Risk 
assessments for potential exposure to the variant Creutzfeldt-Jakob 
disease (vCJD) agent in plasma products, (2) possible vCJD risk from 
investigational coagulation Factor XI manufactured in the 1990s from 
plasma of donors residing in the United Kingdom, and (3) potential 
deferral of blood and plasma donors for history of transfusion in 
France and other European countries.
    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 1, 
2005. Oral presentations from the public will be scheduled between 
approximately 11:50 a.m. and 12:30 p.m., 3:15 p.m. and 3:30 p.m., and 
4:15 p.m. and 4:35 p.m. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should notify 
the contact person before February 3, 2005, 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 
    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).

[[Page 3046]]

    Dated: January 11, 2005.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 05-957 Filed 1-18-05; 8:45 am]