[Federal Register: June 16, 2003 (Volume 68, Number 115)]
[Notices]
[Page 35679-35680]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16jn03-72]
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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 July 17, 2003, from 8
a.m. to 6 p.m., and on July 18, 2003, from 8 a.m. to 4:30 p.m.
Location: Holiday Inn Select, 8120 Wisconsin Ave., Bethesda, MD,
301-652-2000.
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 12392. Please call the
Information Line for up-to-date information on this meeting.
Agenda: On July 17, 2003, the committee will discuss the safety of
bovine bone gelatin in oral and topical drugs, food and cosmetics. The
committee will then discuss bovine spongiform encephalopathy in Canada
and potential implications for FDA-regulated products. In the
afternoon, the committee will hear presentations on transmissible
spongiform encephalopathies (TSEs) and decontamination of medical
equipment and facilities. On Friday, July 18, 2003, the committee will
discuss designing, interpreting, and validating studies to evaluate
reprocessing methods for removing TSE contamination from medical
devices. In the afternoon, the committee will discuss methods to
decontaminate facilities and equipment used to prepare human cellular
and tissue products, and human blood products, including plasma
derivatives, to reduce the theoretical risk of transmitting TSE agents.
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 July 10, 2003.
Oral presentations from the public will be scheduled between
approximately 11:35 a.m. and 11:55 a.m., and 1:55 p.m. and 2:25 p.m. on
July 17, 2003; and between approximately 9:50 a.m. and 10:20 a.m., and
1:30 p.m. and 2 p.m. on July 18, 2003. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before July 11, 2003,
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
[[Page 35680]]
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: June 9, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-15105 Filed 6-13-03; 8:45 am]
BILLING CODE 4160-01-S