[Federal Register: January 26, 2004 (Volume 69, Number 16)]
[Notices]
[Page 3588]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ja04-54]
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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 February 12, 2004, from
8 a.m. to 5:30 p.m., and on February 13, 2004, from 8 a.m. to 3:30 p.m.
Location: Holiday Inn, 8777 Georgia Ave., 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 20852-1448, 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 February 12, 2004, the committee will hear an
informational presentation on a presumptive transfusion-transmitted
case of variant Creutzfeldt-Jakob Disease (vCJD) reported recently in
the United Kingdom, and hear updates on related experimental studies in
animals on transmission of transmissible spongiform encephalopathies
(TSE) agents by blood, and relevant epidemiology of human TSEs. In the
afternoon, the committee will receive an update on the case of bovine
spongiform encephalopathy (BSE) recently recognized in the United
States, and will have a general discussion about potential models of
risk-based approaches to sourcing of bovine materials used to make
medical products. On February 13, 2004, the committee will have a
preliminary discussion about FDA's current recommendations on measures
to minimize risk from TSE agents in various types of medical products.
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 5,
2004. Oral presentations from the public will be scheduled between
approximately 11:30 a.m. and 12 noon, and 3 p.m. and 3:30 p.m. on
February 12, 2004; and between 11 a.m. and 12 noon on February 13,
2004. Time allotted for each presentation may be limited. Those
desiring to make formal oral presentations should notify the contact
person before February 9, 2004, 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 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).
Dated: January 16, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-1495 Filed 1-23-04; 8:45 am]
BILLING CODE 4160-01-S