[Federal Register: September 15, 2006 (Volume 71, Number 179)]
[Notices]
[Page 54500]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15se06-50]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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]
BILLING CODE 4160-01-S