TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES
ADVISORY COMMITTEE Date and Time: The meeting will be held on June 2,
1999, 8:30am to 5:30pm and June 3, 1999, 8:30am to 4:00pm.
Location: Holiday Inn-Gaithersburg, Ballroom, 2 Montgomery Village Avenue,
Gaithersburg, MD 20879.
Contact Person: William Freas or Sheila D. Langford, (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 this December meeting
are available on the FDA Home Page. 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.
Oral Presentations: Between approximately 1:45 to 2:45pm on June 2, 1999, and
1:00 to 1:30pm on June 3, 1999 oral presentations from the public will be scheduled. Those
desiring to make formal oral presentations should notify the contact person before May 26,
1999.
Closed Committee Deliberations: On June 3, 1999, from 3:45 to 4:00pm the meeting
will be closed to permit discussion and review of trade secret and/or confidential
information (5 U.S.C. 552b(c)(4)).
SUBCOMMITTEE OF THE BIOLOGICAL RESPONSE MODIFIERS ADVISORY
COMMITTEE
Date and Time: The meeting will be held on June 3, 1999, 8:30am to 6:00pm and
June 4, 1999, 8:00am to 3:00pm.
Location: Holiday Inn-Bethesda, Versailles Ballrooms I and II, 8120 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Gail Dapolito or Rosanna L. Harvey, 301-827-0314. or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 12389. Please call the Information Line for up-to-date information on this
meeting.
Agenda: One June 3-4, 1999, the Xenotransplantation Subcommittee will discuss
the following public health issues concerning porcine xenotransplantation: 1) update of
scientific data concerning porcine endogenous retrovirus, 2) update of patient monitoring
and screening data concerning patients who have received porcine xenograft, 3) update on
FDA xenotransplantation policy development and 4) proposals for solid organ
xenotransplantation.
Oral presentations: Between approximately 8:45 to 9:15am and 5:30 to 6:00pm on
June 3, 1999, oral presentations will be scheduled. Those desiring to make formal oral
presentations should notify the contact person before May 20, 1999.
BLOOD PRODUCTS ADVISORY COMMITTEE
Date and Time: The meeting will be held on June 17-18, 1999, beginning at 8:00am
on both days.
Location: DoubleTree Hotel, 1750 Rockville Pike, Rockville, MD 20852
Contact Person: Linda A. Smallwood, Ph.D., 301-827-3514, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code
19516.
Agenda: On June 17, 1999, the committee will discuss and provide recommendations
on Inadvertent Contamination of Plasma Pools for Fractionation: Risk Issues. In the
afternoon, the committee will hear a presentation on Strategies for Insuring Compliance in
the Plasma Fractionation Industry, and discuss and comment on the topic of Supply and
Demand of Plasma Derivatives. On June 18, the committee will hear informational
presentations on the Device Action Plan and the Blood Action Plan, discuss and provide
recommendations on the topic of Deferral of Blood Donors at Risk of Malaria, and discuss
and provide comments on the topic of HTLV Supplemental Tests.
Oral Presentations: Between approximately 10:00 to 10:30am, 1:30 to 2:00pm, and
4:00 to 4:30pm on June 17, 1999; and 10:30 to 11:00am and 2:00 to 2:30pm on June 18, 1999,
oral presentations from the public will be scheduled. Those desiring to make formal oral
presentations should notify the contact person before June 7, 1999.
Last Updated: 5/17/99
