[Federal Register Volume 61, Number 27 (Thursday, February 8, 1996)]
[Notices]
[Page 4786]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2845]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0026]


Peripheral Blood Stem Cells: Discussion of Procedures for 
Collection, Processing, and Product Characterization; Notice of Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop to discuss procedures for preparation, processing, and 
characterization of human peripheral blood stem cells. The purpose of 
this scientific workshop, sponsored by FDA and the National Heart, 
Lung, and Blood Institute, National Institutes of Health, is to 
identify and discuss the steps for the collection, processing, and 
storage of peripheral blood stem cells for transplantation and to 
identify areas in need of further research. The scientific information 
presented at this workshop will aid FDA in regulating peripheral blood 
stem cells and identifying product standards.

DATES: The public workshop will be held on February 22 and 23, 1996, 
from 8 a.m. to 4:30 p.m. Preregistration is recommended because seating 
is limited. Registration is requested by February 16, 1996.

ADDRESSES: The public workshop will be held at the National Institutes 
of Health, Bldg. 10, Masur Auditorium, 9000 Rockville Pike, Bethesda, 
MD.

FOR FURTHER INFORMATION CONTACT:
    Regarding information on registration: Dawn Apple, KRA Corp., 1010 
Wayne Ave., suite 850, Silver Spring, MD 20910, 301-495-1591, or FAX 
301-495-9410.
    Regarding information on the workshop agenda: Richard Lewis, Center 
for -Biologics Evaluation and Research (HFM-380), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-3524.
SUPPLEMENTARY INFORMATION: The purpose of this workshop is to identify 
and discuss steps for collection, processing, and storage of peripheral 
blood stem cells for transplantation and to identify what additional 
scientific data is needed in this area.
    Topics to be discussed include the following: Product viability 
testing, donor leukopheresis, donor testing, product storage/transfer 
conditions, definition of cell types and numbers in the product, and 
differences between allogeneic and autologous use of peripheral blood 
stem cells.
    FDA intends to make available at this workshop a draft document 
discussing the regulatory approach FDA believes is appropriate for 
human peripheral blood stem cell products for transplantation and, 
shortly thereafter, will publish in the Federal Register a notice of 
availability for the draft document. FDA will solicit written comments 
on its draft document. Written comments received will be reviewed and 
considered in determining whether amendments to, or revisions of, the 
approach are warranted.

    Dated: February 5, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-2845 Filed 2-6-96; 11:47 am]
BILLING CODE 4160-01-F