[Federal Register: October 14, 2005 (Volume 70, Number 198)]
[Notices]
[Page 60095]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14oc05-53]
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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 October 31, 2005, from 8
a.m. to 5:30 p.m.
Location: Holiday Inn Select, 8120 Wisconsin Ave., Bethesda, 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: On October 31, 2005, the committee will hear updates on the
following topics: Current status of bovine spongiform encephalopathy
(BSE) in the United States, incidence and prevalence worldwide of
variant Creutzfeldt-Jakob Disease (vCJD), and a summary of FDA's device
panel discussion on September 27, 2005, on criteria for considering
label claims of effective decontamination for surgical instruments
exposed to transmissible spongiform encephalopathy (TSE) agents. The
committee will then discuss progress in development of a risk
assessment model for vCJD in U.S.-licensed human plasma-derived
Antihemophilic Factor (Factor VIII). The latter discussion will focus
on selection of input parameters for the model. In the afternoon, the
committee will discuss labeling claims for TSE clearance studies for
blood component filters.
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 October 21,
2005. Oral presentations from the public will be scheduled between
approximately 12:30 p.m. and 1 p.m., and 4:15 p.m. and 4:45 p.m. on
October 31, 2005. Time allotted for each presentation may be limited.
Those desiring to make formal oral presentations should notify the
contact person before October 25, 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 presentation.
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
Sheila 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: October 6, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. 05-20558 Filed 10-13-05; 8:45 am]
BILLING CODE 4160-01-S