[Federal Register Volume 71, Number 149 (Thursday, August 3, 2006)]
[Notices]
[Pages 44035-44036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-12567]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Transmissible Spongiform Encephalopathies Advisory Committee;
Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 September 18, 2006, from
8 a.m. to 4:30 p.m. and September 19, 2006, from 8 a.m. to 1 p.m.
Location: Holiday Inn Gaithersburg, Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: William Freas or Rosanna Harvey, Center for
Biologics Evaluation and Research (HFM-71),
[[Page 44036]]
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 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; FDA's current
assessment and plans regarding the potential exposure to vCJD from an
investigational product, FXI, 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. The committee will then
discuss experimental clearance of transmissible spongiform
encephalopathy infectivity in plasma-derived Factor VIII products. In
the afternoon, the committee will discuss FDA's risk assessment for
potential exposure to vCJD from human plasma-derived antihemophilic
factor (FVIII) products and potential responses. 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 10:45 a.m. and 11:15 a.m. and 2:30 p.m. and 3
p.m. on September 18, 2006, and between approximately 10:15 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.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
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
Rosanna Harvey 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: July 27, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-12567 Filed 8-2-06; 8:45 am]
BILLING CODE 4160-01-S