[Federal Register Volume 66, Number 114 (Wednesday, June 13, 2001)]
[Notices]
[Page 31938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-14812]


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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). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Transmissible Spongiform Encephalopathies (TSE) 
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 June 28, 2001, 8 a.m. to 
5 p.m. and on June 29, 2001, 8 a.m. to 11:30 a.m.
    Location: Holiday Inn, Versailles Ballroom I and II, 8120 Wisconsin 
Ave., Bethesda, MD.
    Contact: 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 12392. Please call the Information Line for 
up-to-date information on this meeting.
    Agenda: On June 28, 2001, the committee will review and discuss the 
suitability of blood donors who have lived or traveled in various 
countries based on recent information concerning new-variant 
Creutzfeldt-Jakob disease and bovine spongiform encephalopathy in those 
countries. In the afternoon, the committee will discuss the safety of 
FDA-regulated plasma derivatives prepared in establishments proposing 
to use on the same manufacturing line, plasma which does and plasma 
which does not comply with current U.S. standards, with regard to donor 
deferral for vCJB risk factors. On June 29, 2001, the committee will 
discuss the interim results of a new study on the inactivation of TSE 
agent by the manufacturing process for gelatin.
    Procedure: On June 28, 2001, from 8 a.m. to 4:30 p.m. and June 29, 
2001, from 8 a.m. to 11:30 a.m., the meeting is open to the public. 
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 June 15, 2001. Oral presentations 
from the public will be scheduled between approximately 10:50 a.m. and 
11:30 a.m., and between approximately 2:30 p.m. and 3:10 p.m. on June 
28, 2001, and between approximately 10 a.m. and 10:30 a.m. on June 29, 
2001. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before June 15, 2001, 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.
    Closed Committee Deliberations: On June 28, 2001, from 4:30 p.m. to 
5 p.m., the meeting will be closed to permit discussion and review of 
trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). 
This portion of the meeting will be closed to permit discussion of this 
material.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: June 5, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-14812 Filed 6-12-01; 8:45 am]
BILLING CODE 4160-01-S