[Federal Register Volume 61, Number 248 (Tuesday, December 24, 1996)]
[Notices]
[Page 67842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32584]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Heart, Lung, and Blood Institute (NHLBI); Request for 
Capability Statements From Parties Interested in Collaborating With the 
NHLBI on the Provision and/or Design of State-of-the-Art Disposable 
Plasticware Systems for the Collection, Processing, Cryopreservation, 
Storage, Thawing and Infusion of Umbilical Cord Blood Stem and 
Progenitor Cells for Transplantation

AGENCY: National Institutes of Health, PHS, NIH.

ACTION: Notice.

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SUMMARY: The National Heart, Lung, and Blood Institute (NHLBI) is 
seeking Capability Statements from parties interested in collaborating 
on a specific aspect of a large, multicenter clinical study. Statements 
should be focused on the ability to provide state of the art disposable 
plasticware systems or to design, develop and manufacture a system for 
the collection, processing, cryopreservation, storage, thawing and 
infusion of umbilical cord blood stem and progenitor cells for 
transplantation.
    The responding party submit Capability Statements demonstrating 
previous experience in developing blood collection and processing 
systems similar to those used for obtaining blood and its components 
for transfusion. The final system must be a sterile, closed system of 
disposable plasticware with or without sterile docking capability and 
containing appropriate processing and cryoprotectant solutions. The 
system must be produced using good manufacturing practices. It is 
expected that the responding party will submit the necessary filings 
with the United States Food and Drug Administration to gain regulatory 
approval for the system and that there will be coordination with the 
NHLBI in gaining regulatory approval for all aspects of this study.
    This system is to be used in an NHLBI-sponsored multicenter 
clinical study to determine if stem and progenitor cells from umbilical 
cord blood units are a clinically acceptable alternative to those from 
bone marrow or peripheral blood for unrelated-donor allogeneic 
transplantation. Cord blood banks will be established as part of the 
study consisting of a total of approximately 15,000 cryopreserved cord 
bloods units. Collections of cord blood units are planned to begin in 
the Spring of 1997. This is not a Request for Proposals (RFP), and 
responses should not include budgetary information. Firms responding to 
this advertisement should provide pertinent information to the 
requirements mentioned above within thirty (30) days of this 
publication. The nature and extent of this collaboration and the 
contractual mechanism under which it will be implemented will be 
determined based on review of the Capability Statements received.
    Capability Statements should be submitted to Dr. Harold T. 
Safferstein, Technology Development Coordinator, National Heart, Lung, 
and Blood Institute, Technology Transfer and Commercialization Team, 31 
Center Drive, MSC 2490, Bldg. 31/Room 1B32, Bethesda, Maryland 20892-
2490, Phone: (301) 402-5579, Fax: (301) 594-3080. E-mail your 
Capability Statements to: . Capability Statements must be 
received by the NHLBI on or before January 24, 1997.

    Dated: December 16, 1996.
Sheila E. Merritt,
Executive Officer, NHLBI.
[FR Doc. 96-32584 Filed 12-23-96; 8:45 am]
BILLING CODE 4140-01-M