[Federal Register: June 16, 2003 (Volume 68, Number 115)]
[Page 35679-35680]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Transmissible Spongiform Encephalopathies Advisory Committee; 
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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, 
    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 
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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]