[Federal Register: November 30, 1999 (Volume 64, Number 229)]
[Notices]               
[Page 66920]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30no99-97]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Implementation of Universal Leukoreduction; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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     The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Workshop on Implementation of Universal 
Leukoreduction.'' The purpose of the public workshop is to stimulate 
public discussion on how to implement pre-storage leukoreduction as a 
routine step in the manufacture of whole blood, red blood cells, and 
platelets that are intended for human transfusion.
    Date and Time: The public workshop will be held on December 10, 
1999, 8:30 a.m. to 4:45 p.m.
    Location: The public workshop will be held at the National 
Institutes of Health, Natcher Conference Center, 45 Center Dr., Bldg. 
45, Bethesda, MD.
    Contact: For information regarding this notice: Joseph Wilczek, 
Center for Biologics Evaluation and Research (HFM-350), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-6129, 
FAX 301-827-2843. For information regarding the public workshop and 
registration: Jennifer Gormley, Laurel Consulting Group, 1815 Fort 
Meyer Dr., suite 300, Arlington, VA 22209, 703-351-7676, FAX 703-528-
0716, E-mail: jgormley@lcgnet.com.
    Registration: Early registration is recommended on or before 
December 3, 1999. Mail or fax registration information (including name, 
title, firm name, address, telephone, and fax number) to Jennifer 
Gormley (address above). Registration at the site will be on a space 
available basis on the day of the workshop, beginning at 7:30 a.m. 
There is no registration fee for the workshop. If you need special 
accommodations due to a disability, please contact Jennifer Gormley at 
least 7 days in advance.
    Agenda: FDA anticipates that the ideas and experiences exchanged at 
the workshop will serve as a source of information for the blood 
industry and the public in planning for universal leukoreduction, as 
well as guide FDA in formulating specific regulatory recommendations. 
Issues to be discussed include: (1) The experiences in implementing 
leukoreduction as a routine blood manufacturing step and in the use of 
leukocyte reduced blood products; (2) whether and in what timeframe 
universal leukoreduction should be recognized as a blood manufacturing 
standard; and (3) what experiences exist to date in the United States 
with respect to implementing leukoreduction as a routine blood 
manufacturing step. An open panel discussion will include a critique of 
the experiences in the United States to date in implementing 
leukoreduction as a routine blood manufacturing step, as well as 
proposals for the FDA to consider in formulating new blood 
recommendations and regulations. All members of the transfusion 
community are encouraged to participate with the understanding that the 
workshop will focus on operational issues, rather than scientific, 
clinical and economic merits of universal leukoreduction.
    Transcripts: Transcripts of the meeting 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 meeting at a cost of 10 cents 
per page. In addition, the transcript will be placed on the FDA 
Internet site at www.fda.gov/cber/minutes/workshop-min.htm.

    Dated: November 23, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 99-30956 Filed 11-29-99; 8:45 am]
BILLING CODE 4160-01-F