[Federal Register Volume 67, Number 2 (Thursday, January 3, 2002)]
[Notices]
[Page 335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-45]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Joint Meeting of the Transmissible Spongiform Encephalopathies 
Advisory Committee and the Blood Products Advisory Committee; Notice of 
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming joint meeting of two public 
advisory committees of the Food and Drug Administration (FDA). At least 
one portion of the joint meeting will be closed to the public.
    Name of Committees: Transmissible Spongiform Encephalopathies 
Advisory Committee and the Blood Products Advisory Committee.
     General Function of the Committees: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on January 16, 2002, from 1 
p.m. to 4:30 p.m.; and on January 17, 2002, from 8 a.m. to 5:15 p.m.
    Location: Holiday Inn, Versailles Ballrooms 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 January 17, 2002, the committees will listen to updates 
on the ``Revised FDA Guidance on 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'' 
document, and other related topics. For the purpose of further 
evaluating the adequacy of our present blood deferral recommendations, 
the committee will then discuss the effectiveness of measures taken to 
protect humans from foodborne exposure to the bovine spongiform 
encephalopathy (BSE) agent in countries with BSE.
    Procedure: On January 17, 2002, from 8 a.m. to 4 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 
January 11, 2002. Oral presentations from the public will be scheduled 
between approximately 1:20 p.m. and 2:20 p.m. on January 17, 2002. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before 
January 11, 2002, 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 January 16, 2002, from 1 p.m. to 
4 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.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the January 16 and 17, 2002, Joint Meeting of the Transmissible 
Spongiform Encephalopathies Advisory Committee and the Blood Products 
Advisory Committee meeting. Because the agency believes there is some 
urgency to bring these issues to public discussion and qualified 
members of the Joint Meeting of the Transmissible Spongiform 
Encephalopathies Advisory Committee and the Blood Products Advisory 
Committee were available at this time, the Commissioner of Food and 
Drugs concluded that it was in the public interest to hold this meeting 
even if there was not sufficient time for the customary 15-day public 
notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: December 26, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 02-45 Filed 1-2-02; 8:45 am]
BILLING CODE 4160-02-S