Document ID: FDA-2009-N-0664-0108
Agency: fda
Document Type: Notice
Title: Emerging Arboviruses: Risk Assessment for Blood, Cell, Tissue, and Organ Safety; Public Workshop
Posted Date: 2009-10-27T04:00Z

[Federal Register: October 27, 2009 (Volume 74, Number 206)]
[Notices]               
[Page 55244-55245]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27oc09-68]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

 
Emerging Arboviruses: Risk Assessment for Blood, Cell, Tissue, 
and Organ Safety; 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 ``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

[[Page 55245]]

(arthropod-borne viruses), by transfusion, infusion, implantation, or 
transplantation in the United States. The public workshop will feature 
presentations and roundtable discussions led by experts from academic 
institutions, government, and industry.
    Date and Time: The public workshop will be held on December 14, 
2009, from 8:30 a.m. to 5:30 p.m. and December 15, 2009, from 8:30 a.m. 
to 5:30 p.m.
    Location: The public workshop will be held at the Natcher 
Conference Center, Main Auditorium, Bldg. 45, National Institutes of 
Health, 8800 Rockville Pike, Bethesda, MD 20894.
    Contact Person: Rhonda Dawson, Center for Biologics Evaluation and 
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike, 
suite 550N, Rockville, MD 20852-1448, 301-827-6129, FAX: 301-827-2843, 
e-mail: rhonda.dawson@fda.hhs.gov.
    Registration: Mail, fax, or e-mail your registration information 
(including name, title, firm name, address, telephone and fax numbers) 
to the Contact Person by November 20, 2009. There is no registration 
fee for the public workshop. Early registration is recommended because 
seating is limited. Registration on the day of the public workshop will 
be provided on a space available basis beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please 
contact Rhonda Dawson (see Contact Person) at least 7 days in advance.
    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. If 
you are interested in presenting, submit a brief statement of the 
general nature of the presentation to the Contact Person by November 
20, 2009 (see section II of this document for additional information).

SUPPLEMENTARY INFORMATION:

I. Background

    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 United States. 
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 United States, 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 United States. 
Therefore, proactive discussions among the Department of Health and 
Human Services 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 by 
transfusion, infusion, implantation, or transplantation in the United 
States. Topics to be discussed include: (1) Biology and pathogenesis of 
arboviruses; (2) epidemiology and prevention of arbovirus vectors and 
hosts in the United States; (3) laboratory detection and prevention of 
arbovirus infection in humans; (4) transfusion, infusion, implantation 
or transplantation transmission of arboviruses in the United States; 
and (5) potential approaches, including donor testing and pathogen 
inactivation, to reduce the risk of transfusion transmission of 
arboviruses.

II. 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 on the afternoon of December 15, 
2009. Time allotted for each presentation will be limited depending on 
the number of individuals requesting to speak.
    Transcripts: Transcripts of the public workshop may be requested in 
writing from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, 
approximately 15 working days after the public workshop at a cost of 10 
cents per page. A transcript of the public workshop will be available 
on the Internet at http://www.fda.gov/BiologicsBloodVaccines/
NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm.

    Dated: October 22, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25802 Filed 10-26-09; 8:45 am]

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