[Federal Register: January 3, 2002 (Volume 2, Number 67)]
[Notices]
[Page 335]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03ja02-56]
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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