[Federal Register Volume 67, Number 206 (Thursday, October 24, 2002)]
[Notices]
[Pages 65359-65360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-27097]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Development of Donor Screening Assays for West Nile Virus; Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Development of Screening Assays for West Nile 
Virus.'' The objectives of the workshop are to review current 
developments in West Nile Virus (WNV) transmission in the United States 
and to explore strategies to address issues related to the development 
of donor screening tests and the utility of virus inactivation methods.
    Date and Time: The workshop will be held November 4 and 5, 2002, 
from 8 a.m. to approximately 5 p.m. on both days.
    Location: The workshop will be held at the Hyatt Regency Bethesda, 
One Metro Center, Bethesda, MD.
    Contact Person: Joseph Wilczek, Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852, 301-827-6129, FAX 301-827-2843, e-
mail: [email protected].

SUPPLEMENTARY INFORMATION: FDA, Office of the Secretary/Office of 
Public Health and Science, the Centers for Disease Control and 
Prevention, the National Heart, Lung and Blood Institute at the 
National Institutes of Health, and the Health Resources Services 
Administration are co-sponsoring a public workshop to focus on 
scientific issues related to the development of tests that are suitable 
for screening blood and organ/tissue donors for WNV. The ongoing 
epidemic of WNV infections has raised concerns that WNV can be 
transmitted through blood transfusions and organ/tissue donations. 
Currently, there are no tests available to screen blood and organ/
tissue donors for WNV nor are there data available about the stability 
of WNV in such tissues.
    On the first day, the workshop will deal with the topics of WNV 
pathogenicity and epidemiology, methodologies suitable for screening 
WNV in blood and organ/tissue donors, and development of WNV screening 
assays for future large-scale implementation in a donor screening 
setting. On the second day, it will focus on the prospective studies 
for establishing the transmission to

[[Page 65360]]

recipients of blood, or human cells, tissues, and cellular or tissue 
based products, issues relevant to implementation of WNV tests, FDA's 
expectation for licensure of WNV tests, and strategies for 
inactivation.
    Registration: Because seating space is limited, we recommend early 
registration. Mail, fax, or e-mail your registration information 
(including name, title, firm name, address, telephone, and fax number) 
to Joseph Wilczek (see Contact Person). Registration at the site will 
be done on a space available basis on the days of the workshop, 
beginning at 7:30 a.m. There is no registration fee for the workshop. 
If you need special accommodations due to a disability, please contact 
Joseph Wilczek at least 7 days in advance.
    Transcripts: Transcripts of the meeting may be requested in writing 
from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857, 
approximately 15 working days after the meeting at a cost of 10 cents 
per page. In addition, the transcript will be placed on the FDA Web 
site at http://www.fda.gov/cber/minutes/workshop-min.htm.

    Dated: October 17, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-27097 Filed 10-23-02; 8:45 am]
BILLING CODE 4160-01-S