[Federal Register Volume 64, Number 97 (Thursday, May 20, 1999)]
[Notices]
[Page 27582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12653]
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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 June 2, 1999, 8:30 a.m.
to 5:30 p.m., and June 3, 1999, 8:30 a.m. to 4 p.m.
Location: Holiday Inn, Ballroom II, Montgomery Village Ave.,
Gaithersburg, 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 20852-1448, 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 2, 1999, the committee will continue the discussion
from its December 18, 1998, meeting on the possible deferral of blood
or blood product donors based on geographical criteria linked to
possible food-borne exposure to the agent of bovine spongiform
encephalopathy as a measure to reduce the potential for transmission of
new variant Creutzfeldt-Jakob Disease (nvCJD). The transcripts of the
December meeting are available on the FDA home page (http://
www.fda.gov/ohrms/dockets/ac/98tctm.htm). The potential effects of such
deferrals on the supply of blood and blood products will be considered
as part of the committee's deliberations. The results of a survey of
blood donors for duration and time periods of their visits to U.K.
countries are expected to be presented. On June 3, 1999, the committee
will receive an update on dura mater allograft materials. The committee
will then discuss precautions needed to assure safe sources of sheep-
derived and goat-derived materials contained in or used to manufacture
injectable or implantable FDA-regulated products.
Procedure: On June 2, 1999, from 8:30 a.m. to 5:30 p.m., and June
3, 1999, from 8:30 a.m. to 3:45 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 May 26, 1999. Oral
presentations from the public will be scheduled between approximately
1:45 p.m. and 2:45 p.m. on June 2, 1999, and between 1 p.m. and 1:30
p.m. on June 3, 1999. Time allotted for each presentation may be
limited. Those desiring to make formal oral presentations should notify
the contact person before May 26, 1999, 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 3, 1999, from 3:45 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 June 2, 1999, Transmissible Spongiform Encephalopathies Advisory
Committee meeting. Because the agency believes there is some urgency to
bring these issues to public discussion and qualified members of the
Transmissible Spongiform Encephalopathies Advisory Committee were
available at this time, the Commissioner 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: May 11, 1999.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 99-12653 Filed 5-19-99; 8:45 am]
BILLING CODE 4160-01-F
