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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

NOTICE: NOTICES

ACTION: Meetings:

DOCUMENT ACTION: Notice of public workshop.

SUBJECT CATEGORY: Approaches to Reduce Risk of Transfusion-Transmitted Babesiosis in the United States; Public Workshop

DOCUMENT SUMMARY:

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Approaches to Reduce the Risk of Transfusion Transmitted Babesiosis in the United States.'' The purpose of the public workshop is to discuss the risk and possible approaches to minimize the incidence of transfusiontransmitted babesiosis in the United States. We are convening this workshop at the present time because FDA has observed a recent increase in the number of reports of transfusiontransmitted babesiosis, thus warranting additional discussion to address this blood safety issue. 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 September 12, 2008, from 7:30 a.m. to 5:30 p.m.

Location: The public workshop will be held at the Lister Hill Center Auditorium, Bldg. 38A, National Institutes of Health, 8800 Rockville Pike, Bethesda, MD 20894.

Contact Person: Rhonda Dawson, Center for Biologics Evaluation and Research (HFM302), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 208521448, 3018276129, FAX: 3018272843, email: rhonda.dawson@fda.hhs.gov.

Registration: Mail, fax or email your registration information (including name, title, firm name, address, telephone and fax numbers) to the contact person by August 25, 2008. There is no registration fee for the public workshop. Early registration is recommended because seating is limited to 175 attendees. 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.

SUMMARY: Approaches to Reduce Risk of Transfusion-Transmitted Babesiosis in the United States,

DOCUMENT BODY:

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Approaches to Reduce the Risk of Transfusion Transmitted Babesiosis in the United States.'' The purpose of the public workshop is to discuss the risk and possible approaches to minimize the incidence of transfusiontransmitted babesiosis in the United States. We are convening this workshop at the present time because FDA has observed a recent increase in the number of reports of transfusiontransmitted babesiosis, thus warranting additional discussion to address this blood safety issue. 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 September 12, 2008, from 7:30 a.m. to 5:30 p.m.

Location: The public workshop will be held at the Lister Hill Center Auditorium, Bldg. 38A, National Institutes of Health, 8800 Rockville Pike, Bethesda, MD 20894.

Contact Person: Rhonda Dawson, Center for Biologics Evaluation and Research (HFM302), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 208521448, 3018276129, FAX: 3018272843, email: rhonda.dawson@fda.hhs.gov.

Registration: Mail, fax or email your registration information (including name, title, firm name, address, telephone and fax numbers) to the contact person by August 25, 2008. There is no registration fee for the public workshop. Early registration is recommended because seating is limited to 175 attendees. 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.

SUPPLEMENTAL INFORMATION

Babesiosis is a malaria-like illness caused by infection of erythrocytes with protozoan parasites belonging to the genus Babesia. Transfusiontransmitted babesiosis is caused by transfusion of blood or blood components collected from donors infected with Babesia parasites. During the last 40 years, more than 60 cases of transfusiontransmitted babesiosis have been recognized in the United States. In fiscal years 2006 and 2007, FDA received a total of five reports of fatal transfusiontransmitted babesiosis (primary or contributory cause of death) in the United States.

The public workshop will facilitate a scientific discussion on approaches to reduce the risk of transfusiontransmitted babesiosis in the United States. Topics to be discussed include: (1) Biology, pathogenesis, transmission and epidemiology of babesiosis; (2) risk of Babesia infections through transfusion of blood and blood components; (3) laboratory testing to detect Babesia infections; and, (4) possible approaches, including donor testing and donor deferral, to reduce the risk of transfusiontransmitted babesiosis while maintaining blood availability and safety.

Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Governmentwide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov.

Transcripts: Transcripts of the public workshop may be requested in writing from the Freedom of Information Office (HFI35), Food and Drug Administration, 5600 Fishers Lane, rm. 630, 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/cber/minutes/workshopmin.htm.

Dated: July 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E815799 Filed 71008; 8:45 am]
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