[Federal Register: September 15, 2006 (Volume 71, Number 179)]
[Page 54500]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Transmissible Spongiform Encephalopathies Advisory Committee; 
Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    The Food and Drug Administration (FDA) is announcing an amendment 
to the notice of the meeting of the Transmissible Spongiform 
Encephalopathies Advisory Committee. This meeting was announced in the 
Federal Register of August 3, 2006 (71 FR 44035). The amendment is 
being made to reflect a change in the Date and Time, Agenda, and 
Procedure portions of the document. Specifically, the open public 
hearing times in the Procedure portion of the document were changed. 
Because of a change in the agenda, the afternoon committee discussion 
topic will be cancelled. There are no changes other than those stated 
in this announcement.

FOR FURTHER INFORMATION CONTACT: William Freas or Rosanna L. Harvey, 
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.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 3, 2006, 
FDA announced that a meeting of the Transmissible Spongiform 
Encephalopathies Advisory Committee would be held September 18, 2006 
from 8 a.m. to 4:30 p.m. and September 19, 2006 from 8 a.m. to 1 p.m. 
On page 44035, in the third column, the Date and Time portion of the 
notice is amended to read as follows:
    Date and Time: The meeting will be held on September 18, 2006, from 
8:30 a.m. to 4 p.m. and September 19, 2006, from 8 a.m. to 1 p.m.
    On page 44036, in the first column, the Agenda and Procedure 
portions of the notice are amended to read as follows:
    Agenda: On September 18, 2006, the committee will hear updates on 
the following topics: United States and worldwide bovine spongiform 
encephalopathies (BSE); variant Creutzfeldt-Jakob disease (vCJD) 
epidemiology and transfusion-transmission; blood and plasma donor 
deferral for transfusion in France since 1980 guidance; and critical 
factors influencing prion decontamination using sodium hydroxide. The 
committee will then discuss experimental clearance of transmissible 
spongiform encephalopathy infectivity in plasma-derived Factor VIII 
products. In the afternoon, the committee will hear updates on the 
status of FDA's initiative on communication of the potential exposure 
to vCJD risk from an investigational product, plasma derived FACTOR XI 
that was manufactured from UK donor plasma, and a summary of World 
Heath Organization consultation on distribution of infectivity in 
tissues of animals and humans with transmissible spongiform 
encephalopathies. On September 19, 2006, the committee will discuss 
possible criteria for approval of donor screening tests for vCJD.
    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 on or before 
September 6, 2006. Oral presentations from the public will be scheduled 
between approximately 11:30 a.m. and 12 noon and 3:30 p.m. and 4 p.m. 
on September 18, 2006, and between approximately 11:25 a.m. and 11:45 
a.m. on September 19, 2006. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should notify 
the contact person 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 on or before 
September 11, 2006.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app.2) and 21 CFR part 14, relating to the advisory committees.

    Dated: September 6, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-15283 Filed 9-14-06; 8:45 am]