[Federal Register: July 17, 2002 (Volume 67, Number 137)]
[Notices]
[Page 46991]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17jy02-92]
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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 wilczek@cber.fda.gov.
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