[Federal Register: June 21, 2005 (Volume 70, Number 118)]
[Notices]               
[Page 35684-35685]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jn05-89]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0227]

 
Update on Leukocyte Reduction of Blood and Blood Components; 
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 ``Update on Leukocyte Reduction of Blood and Blood 
Components.'' The public workshop sponsors are FDA; the National 
Institutes of Health (NIH) National Heart, Lung, and Blood Institute 
(NHLBI); and the Office of Public Health and Science (OPHS) in the 
Department of Health and Human Services. The purpose of the public 
workshop is to address current issues related to leukocyte-reduced 
blood and blood components.
    Date and Time: The public workshop will be held on July 20, 2005, 
from 8 a.m. to 5:30 p.m.
    Location: The public workshop will be held at the National 
Institutes of Health, Lister Hill Center Auditorium, Bldg. 38A, 8600 
Rockville Pike, Bethesda, MD 20894.
    Contact: Rhonda Dawson, Center for Biologics Evaluation and 
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, 301-827-3514, FAX: 301-827-2843, e-mail: 
dawsonr@cber.fda.gov.
    Registration: Send registration information (including name, title, 
firm name, address, telephone, and fax number) to Rhonda Dawson (see 
Contact) by July 1, 2005. Because seating is limited, we recommend 
early registration. Registration at the site on the day of the public 
workshop will be

[[Page 35685]]

provided on a space available basis beginning at 7:15 a.m. There is no 
registration fee for the public workshop.
    If you need special accommodations due to a disability, please 
contact Rhonda Dawson at least 7 days in advance.

SUPPLEMENTARY INFORMATION: FDA, NHLBI, and OPHS are sponsoring a public 
workshop entitled ``Update on Leukocyte Reduction of Blood and Blood 
Components.'' The workshop will include the following topics:
     Leukoreduction in targeted and non-targeted recipients;
     Current data on the potential advantages and hazards 
ofproviding leukocyte-reduced blood and blood components;
     A review of observed clinical adverse events and 
manufacturing failures associated with leukoreduction procedures;
     FDA's current considerations for regulatory standards for 
leukocyte-reduced components and approaches to quality control testing; 
and
     New scientific developments in filtration, including 
developing technologies for prion removal from blood components.
    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. 12A-16, 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/minutes/workshop-min.htm.


    Dated: June 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12185 Filed 6-20-05; 8:45 am]

BILLING CODE 4160-01-S