Public Workshop: Emerging Arboviruses: Risk Assessment for Blood, Cell, Tissue and Organ Safety

Public Workshop: Emerging Arboviruses: Risk Assessment for Blood, Cell, Tissue and Organ Safety

December 14, 2009
8:30 a.m. – 5:30 p.m.

December 15, 2009
8:30 a.m. – 5:30 p.m.

Workshop Goals and Objectives

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Emerging Arboviruses: Risk Assessment for Blood, Cell, Tissue and Organ Safety.” The purpose of the public workshop is to assess the risk and discuss approaches to minimize the incidence of transmission of arboviruses (arthropod-borne viruses) via transfusion, infusion, implantation or transplantation in the United States (U.S.). The public workshop will feature presentations and roundtable discussions led by experts from academic institutions, government, and industry.

Arboviruses are a large group of viruses that are spread by certain invertebrate animals, most commonly blood-sucking insects. Arboviruses are found throughout the world, including the U.S. Arboviruses such as Dengue virus, Japanese Encephalitis virus (JE), tick-borne encephalitis virus (TBE) and West Nile virus (WNV) are becoming increasingly widespread. Transmission of WNV and Dengue virus through blood transfusion has been well documented. Transfusion transmission of the Colorado tick fever (CTF) virus, a tick-borne agent present in the U.S., also has been reported. Other arboviruses, including JE, TBE, and St. Louis Encephalitis are of concern to blood, cell, tissue and organ safety because of the possibility of viremia in asymptomatic human infections. Dengue outbreaks have recently occurred in Texas, Hawaii, Puerto Rico and the U.S. Virgin Islands. Dengue virus, as well as TBE and JE, have the potential to become endemic in certain regions of the U.S. Therefore, proactive discussions among the HHS Public Health Agencies, including the FDA, National Institutes of Health and the Centers for Disease Control and Prevention, academia, industry, blood establishments, cell and tissue establishments, and other stakeholders are necessary to address blood, cell, tissue and organ safety in response to the emerging arboviruses.

The public workshop will facilitate a scientific discussion on approaches to reduce the risk of transmission of arboviruses via transfusion, infusion, implantation or transplantation in the U.S. Topics to be discussed include: 1) biology and pathogenesis of arboviruses; 2) epidemiology and prevention of arbovirus vectors and hosts in the U.S.; 3) laboratory detection and prevention of arbovirus infection in humans; 4) transfusion, infusion, implantation or transplantation transmission of arboviruses in the U.S.; and 5) potential approaches, including donor testing and pathogen inactivation, to reduce the risk of transfusion transmission of arboviruses.

Requests for Presentations of Data

Interested persons are invited to present data related to technologies for the detection or inactivation of arboviruses in blood products, organs or tissues. Those desiring to make presentations at the workshop should notify the Contact Person and submit a brief statement of the general nature of the presentation before November 20, 2009. Presentations will be scheduled in the afternoon of December 15, 2009. Time allotted for each presentation will be limited depending on the number of individuals requesting to speak.

Location

Natcher Conference Center, Main Auditorium
Building 45
National Institutes of Health*
8800 Rockville Pike
Bethesda, MD 20894

*Please visit http://www.nih.gov/about/visitor/index.htm for NIH campus maps and NIH visitor information on security requirements, visitor parking and public transportation.

Registration

There is no registration fee for the workshop. Early registration is recommended before November 20, 2009, as seating is limited. Registration on the day of the workshop will be provided on a space available basis beginning at 7:30 a.m. To register, complete the attached registration form in this announcement and mail, fax or e-mail it to Rhonda Dawson, Food and Drug Administration, HFM-302, 1401 Rockville Pike, Rockville, MD 20852; Fax: 301-827-2843; E-mail: rhonda.dawson@fda.hhs.gov. Registrants will receive an e-mail confirmation.

If you need special accommodations due to a disability, please contact Rhonda Dawson at least seven days in advance of the workshop.

Contact Person

Rhonda Dawson
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: rhonda.dawson@fda.hhs.gov

abrir aquí para acceder al documento FDA y al formulario de registración:
Public Workshop: Emerging Arboviruses: Risk Assessment for Blood, Cell, Tissue and Organ Safety