SOURCES SOUGHT
Q -- Sources Sought Announcement for COBLT CBBs
- Notice Date
- 10/2/2003
- Notice Type
- Sources Sought
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Institute, Contracts Operations Branch 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, MD, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-HB-04-24
- Response Due
- 11/4/2003
- Archive Date
- 11/19/2003
- Point of Contact
- Lynda Bindseil, Contracting Officer, Phone (301) 435-0355, Fax (301) 480-3432,
- E-Mail Address
-
lb31p@nih.gov
- Description
- The National Heart, Lung, and Blood Institute (NHLBI) is conducting a market survey to determine if there are organizations or businesses with an interest in obtaining the contents of the two Cord Blood Banks (CBBs) funded as part of the Cord Blood Transplantation Study (COBLT). The COBLT banking program was initiated in 1996 with support from NHLBI and conducted under a Food and Drug Administration (FDA) accepted Investigational New Drug (IND) application. The overall goals of the program were to 1)develop standard operating procedures for the collection, testing, processing, cryopreservation, and thawing of unrelated donor umbilical cord blood and 2)build ethnically diverse CBBs to support a stem cell transplantation research protocol. The program included three banks, multiple collection centers, a CBB committee, and a coordinating center. Currently, the contents of the banks are located at Duke University, Durham, North Carolina, and the University of California at Los Angeles, California. Contents of the banks include over 8,000 well characterized, inventoried, Human Leukocyte Antigen (HLA) typed, cryopreserved umbilical cord blood units; electronic data bases with a unit inventory and HLA typing information; frozen plasma, red cell/granulocyte, and viable cell samples for each cord blood unit; and electronic and paper files with screening and characterization data. The cord blood units were collected from December 1997 through June 2000 using standardized procedures. The data for each unit has been double reviewed at the COBLT CBB and confirmed by a computer algorithm as eligible for use as a stem cell source on the COBLT transplant protocol. Units are stored in liquid nitrogen freezers (Standard and Thermogenesis BioArchive) in 25 mL bags. Red cell/granulocyte and plasma samples are stored frozen in mechanical freezers. Full details of the collection, processing, cryopreservation, screening, and characterization of the units can be found in the COBLT CBB Standard Operating Procedures at http://www.emmes.com . All laboratory equipment necessary to maintain this valuable resource will be included. PLEASE NOTE: No funds to maintain and run a cord blood bank program will be provided. Interested parties should submit a capability statement describing their ability to: ? Manage and maintain a cord blood bank program ? Provide adequate facilities and staff to run a cord blood banking program ? Comply with federal and other regulations regarding licensure, need for IND, annual reports, confidentiality ? Make the units available to potential transplant recipients through an established stem cell search registry ? Abide by the terms of the original donor informed consent ? Ensure that transplant outcome data is sent to an established registry program In addition, a fee may be charged to cord blood unit recipients by the cord blood bank. The fee for non-licensed use should be estimated using the cost to replace the unit in the bank inventory. The fee for licensed use may be based on the market value. The capability statement should include an estimate and description of fees the bank would use. The capability statement must be submitted on or before November 4, 2003 and must reference number NHLBI-HB-04-24. Seven (7) copies of your capability statement should be delivered to Lynda Bindseil, Contracting Officer, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 6134, Bethesda, Maryland 20892-7902.
- Record
- SN00446468-W 20031004/031002213100 (fbodaily.com)
- Source
-
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