Document ID: FDA-2008-N-0038-0049
Agency: fda
Document Type: Notice
Title: Approaches to Reduce Risk of Transfusion-Transmitted Babesiosis in the United States; Public Workshop
Posted Date: 2008-07-11T04:00Z

[Federal Register: July 11, 2008 (Volume 73, Number 134)]
[Notices]               
[Page 39972]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11jy08-54]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Approaches to Reduce Risk of Transfusion-Transmitted Babesiosis 
in the United States; 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 ``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 transfusion-transmitted 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 
transfusion-transmitted 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 (HFM-302), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, 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 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.

SUPPLEMENTARY INFORMATION: Babesiosis is a malaria-like illness caused 
by infection of erythrocytes with protozoan parasites belonging to the 
genus Babesia. Transfusion-transmitted 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 
transfusion-transmitted babesiosis have been recognized in the United 
States. In fiscal years 2006 and 2007, FDA received a total of five 
reports of fatal transfusion-transmitted 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 transfusion-transmitted 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 transfusion-transmitted 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 Government-wide, 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 (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/cber/minutes/workshop-min.htm.

    Dated: July 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-15799 Filed 7-10-08; 8:45 am]

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