[Federal Register Volume 60, Number 226 (Friday, November 24, 1995)]
[Notices]
[Page 58088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28838]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 95N-0368]


Cord Blood Stem Cells: Discussion of Procedures for Preparation 
and Storage; 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 and storage of cord 
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 cord blood for transplantation 
and to identify areas in need of further research. The scientific 
information presented at this workshop will aid FDA in regulating cord 
blood stem cells and identifying product standards.

DATES: The public workshop will be held on December 13, 1995, from 8 
a.m. to 4:30 p.m. Preregistration is recommended because seating is 
limited. Registration is requested by December 7, 1995.

ADDRESSES: The public workshop will be held at the National Institutes 
of Health, Natcher Conference Center, 9000 Rockville Pike, Bldg. 45, 
conference room E, Bethesda, MD.

FOR FURTHER INFORMATION CONTACT:
    Regarding information on registration: Wanda Keyes, Prospect --
Associates, 1801 Rockville Pike, suite 500, Rockville, MD 20852, 301-
468-6555, or FAX 301-770-5164.
    Regarding information on this document: Liana Harvath, Center for 
Biologics Evaluation and Research (HFM-335), Food and Drug 
Administration, 8800 Rockville Pike, Bldg. 29, rm. 321, Bethesda, MD 
20892, 301-496-2577.

SUPPLEMENTARY INFORMATION: The purpose of this workshop is to identify 
and discuss, insofar as present technology permits, steps for 
collection, processing, and storage of cord blood stem cells for 
transplantation and to identify what additional scientific data is 
needed in this area.
    Topics to be discussed include the following: informed consent, 
medical history, screening of the donor's mother and cord blood stem 
cells for infectious agents, collection location, collection 
containers, anticoagulants, red blood cell depletion methods, short-
term and long-term storage conditions, freezing methods, 
histocompatibility testing, development of cord blood product 
standards, and a quality assurance program.
    FDA intends to make available at this workshop a draft document 
discussing the regulatory approach FDA believes is appropriate for 
placental umbilical cord 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: November 20, 1995.
William K. Hubbard,
Associate Commissioner for Policy.
[FR Doc. 95-28838 Filed 11-21-95; 11:32 am]
BILLING CODE 4160-01-F