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June 1999 Advisory Committee Meetings 

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

 

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