[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
