[Federal Register Volume 67, Number 137 (Wednesday, July 17, 2002)]
[Notices]
[Page 46991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-18037]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Safety and Efficacy of Methods for Reducing Pathogens in Cellular 
Blood Products Used in Transfusion; 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 ``Safety and Efficacy of Methods for Reducing 
Pathogens in Cellular Blood Products Used in Transfusion.'' The 
workshop will provide a forum for discussion of the scientific aspects 
of using state of the art methods for pathogen reduction in cellular 
blood products.
    Date and Time: The 2-day public workshop will be held on August 7 
and 8, 2002, from 8 a.m. to 5 p.m.
    Location: The workshop will be held at Jack Masur Auditorium, 
National Institutes of Health, Bldg. 10, 9000 Rockville Pike, Bethesda, 
MD 20892.
    Contact:
    For information about this notice: Michael D. Anderson, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20857, 301-827-6210, 
FAX 301-594-1944.
    For information about the public workshop: Joseph Wilczek, Center 
for Biologics Evaluation and Research (HFM-305), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6129, FAX 301-827-2843, e-mail at [email protected].
    Registration: Mail, fax, or e-mail your registration information 
(including name, professional degree, title, e-mail address, firm name, 
address, telephone, and fax number) to Joseph Wilczek by July 26, 2002. 
There is no registration fee for the public workshop. Space is limited, 
therefore, interested parties are encouraged to register early. There 
will be onsite registration done on a space available basis on the days 
of the workshop beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please 
contact Joseph Wilczek at least 7 days in advance.

SUPPLEMENTARY INFORMATION: FDA is sponsoring a public workshop on 
evaluating methods for reducing pathogens in cellular blood products. 
Although there are no currently approved methods on the market today 
for pathogen reduction in cellular blood products, FDA is sponsoring 
this workshop for discussion of the scientific aspects of such 
methodologies. The objectives of the workshop are to discuss the 
criteria to define the efficacy of such products and appropriate ways 
to evaluate their toxicities to the transfusion products and to the 
recipients of these products. A public discussion of these topics will 
help the transfusion community better understand the development of 
these methods for cellular blood products intended for transfusion. The 
workshop will also help FDA prepare for the review of related 
applications. The public workshop agenda is posted on the FDA Internet 
at http://www.fda.gov/cber/scireg.htm.
    Transcripts: Transcripts of the meeting may be requested in writing 
from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857, 
approximately 15 working days after the meeting at a cost of 10 per 
page. The public workshop transcript will also be available on the 
Internet at http://www.fda.gov/cber/minutes/workshop-min.htm.

    Dated: July 11, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-18037 Filed 7-16-02; 8:45 am]
BILLING CODE 4160-01-S