[Federal Register: October 12, 2001 (Volume 66, Number 198)]
[Notices]               
[Page 52141-52142]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12oc01-98]                         

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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 
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 25, 2001, from 8 
a.m. to 3:30 p.m., and on October 26, 2001, from 8 a.m. to 4:30 p.m.
    Location: Holiday Inn, Kennedy Ballroom, 8777 Georgia Ave., Silver 
Spring, MD.
    Contact: William Freas, or Sheila D. Langford, Center for Biologics

[[Page 52142]]

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 October 25, 2001, the committee will discuss FDA's draft 
document entitled ``Guidance for Industry: Revised Preventive Measures 
to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob 
Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and 
Blood Products'' (published in the Federal Register on August 29, 2001 
(66 FR 45683), http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/gdlns/cjdvcjd.pdf). Later that 
morning the committee will discuss amino acid sourcing and production, 
and the theoretical risk of transmission of the BSE agent through their 
use in vaccines, other biologicals and human drugs. On October 26, 
2001, the committee will discuss the risk of bovine brains and other 
neurological tissue for human use.
    Procedure: On October 25, 2001, from 8 a.m. to 1:10 p.m. and from 
1:40 p.m. to 3:30 p.m., and on October 26, 2001, from 8 a.m. to 4:30 
p.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 October 18, 2001. Oral presentations from the public will be 
scheduled between approximately 9 a.m. to 9:30 a.m., and 1:40 p.m. to 
2:10 p.m. on October 25, 2001; and between 1 p.m. to 1:30 p.m. on 
October 26, 2001. Time allotted for each presentation may be limited. 
Those desiring to make formal oral presentations should notify the 
contact person before October 18, 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 October 25, 2001, from 1:10 p.m. 
to 1:40 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)).
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 4, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-25607 Filed 10-11-01; 8:45 am]
BILLING CODE 4160-01-S