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Hyatt Regency Bethesda One Bethesda Metro Center Bethesda, MD 20814 November 4 and 5, 2002 Workshop Goals and Objectives FDA's Center for Biologics Evaluation and Research, in cooperation with the Centers for Disease Control and Prevention, the National Heart, Lung, and Blood Institute, NIH, and the Health Resources Services Administration, is sponsoring a public workshop entitled " Development of Screening Assays for West Nile Virus". The workshop will focus on scientific issues related to the development of tests that are suitable for screening donors for West Nile Virus (WNV). WNV is an arthropod-borne virus that belongs to the Japanese encephalitis complex of flaviviridae. WNV is transmitted primarily in birds through mosquito bites while humans are incidental hosts. The ongoing epidemic of WNV infections has raised concern that WNV can be transmitted through blood transfusions. At present, transmission of WNV by blood transfusion has not been proven. However, during this year's WNV outbreak there were several cases of encephalitis in patients who had received blood transfusions. In addition, WNV has been confirmed in epidemiological surveys in the case of 4 organ recipients from a single organ donor. There are no tests available to screen blood and organ/-tissue donors for WNV nor is the data available about the stability of WNV in such tissues. FDA is holding a workshop to review current developments in WNV transmission in the U.S. and to explore strategies to address issues related to the development of donor screening tests and the utility of virus inactivation methods. The goals and objectives of this workshop are to review and discuss the following: Current status of WNV pathogenicity and epidemiology in the U.S. Methodologies suitable for screening of WNV in donors. Prospective studies for establishing the transmission to recipients of blood, or human cells, tissues, and cellular or tissue based products (HCT/Ps). Development of WNV screening assays for future large-scale implementation in the donor screening setting. Issues relevant to the implementation of WNV tests. FDA's expectations for licensure of WNV test. Strategies for inactivation of WNV. Location Hyatt Regency Bethesda One Bethesda Metro Center Bethesda, MD 20814 Phone: 301-657-1234 Workshop Committee Hira Nakhasi, FDA chairperson Elizabeth Callaghan, FDA Luiz Barbosa, NIH Mary Chamberland, CDC Robin Biswas, FDA Melissa Greenwald, FDA Liana Harvath, NIH Maria Rios, FDA Indira Hewlett, FDA Carolyn Wilson, FDA Bill Hobson, HRSA Pawan Jain, FDA Andy Dayton, FDA Mahmood Farshid, FDA Preliminary Agenda The workshop will take place from 8:00 a.m. to 5:00 p.m. on both days. On the first day, the workshop will deal with the topics of WNV pathogenicity and epidemiology, methodologies suitable for screening WNV in blood and tissue/organ donors, studies on transmission through human cells, tissues and cellular or tissue based products, and development of WNV screening assays for future large-scale implementation in donor screening setting. On the second day it will focus on the prospective studies for establishing the transmission to recipients of blood, issues relevant to implementation of WNV tests, FDA's expectation for licensure of WNV test, and strategies for inactivation. Final Agenda Registration There is no registration fee for this meeting; however, seating space is limited and early registration is recommended. On-site registration will be limited to space available on the days of the workshop beginning at 7:30 a.m. Complete the attached registration form in this announcement and mail, fax or e-mail it to: Joseph Wilczek, Food and Drug Administration, HFM-302, 1401 Rockville Pike, Rockville, MD 20852; Fax: 301-827-2843; E-mail: wilczek@cber.fda.gov Overnight Accommodations A block of rooms has been reserved for participants requiring overnight accommodations at the Hyatt Regency Bethesda. Contact the hotel directly and refer to the FDA workshop to receive a discounted room rate of $150.00/night plus tax. There are only a limited number of rooms available at the discounted rate. For Program Information Contact Joseph Wilczek Program Coordinator Food and Drug Administration Office of Blood Research & Review Center for Biologics Evaluation and Research 1401 Rockville Pike, HFM-302 Rockville, MD 20852 Phone: 301-827-6129 Fax: 301-827-2843 e-mail: wilczek@cber.fda.gov Call for Development of Blood Donor Screening and Supplemental Tests for Infections with West Nile Virus (WNV) Information about West Nile Virus and Blood Safety

Updated June 16, 2008

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