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Notice

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

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

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 Start Printed 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).

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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.

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Dated: October 22, 2009.

David Horowitz,

Assistant Commissioner for Policy.

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[FR Doc. E9-25802 Filed 10-26-09; 8:45 am]

BILLING CODE 4160-01-S