SOLICITATION NOTICE
A -- Somatic Cell Therapy Processing - Administrative Center
- Notice Date
- 12/19/2002
- Notice Type
- Solicitation Notice
- 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-03-07
- Response Due
- 3/3/2003
- Archive Date
- 3/18/2003
- Point of Contact
- Joanna Magginas, Contracting Officer, Phone (301) 435-0355, Fax (301) 480-3432, - Patricia Davis, Chief, BDR Section, Phone (301) 435-0355, Fax (301) 480-3432,
- E-Mail Address
-
jb532r@nih.gov, pd15j@nih.gov
- Description
- The Division of Blood Diseases and Resources of the National Heart, Lung, and Blood Institute (NHLBI) seeks contractors to develop novel somatic cellular therapies that will aid investigators by providing support in areas ranging from basic science to animal studies to proof-of-principle and eventually human trials. This project will involve a) an administrative center; and b) up to three somatic cell therapy processing facilities (to be awarded under a separate RFP). The administrative center will serve as the monitor and coordinator for the production of cell therapies and FDA regulatory aspects of the project. Responsibilities of the administrative center include, but are not limited to, the following: 1) design and maintain a manual of procedures; 2) provide management and coordination of the cell processing facilities which includes assisting facilities in developing and preparing protocols and standard operating procedures and developing, obtaining, and maintaining any INDs required for manufactured cellular therapies; 3) in conjunction with facilities, develop and implement procedures for the evaluation, prioritization and processing of requests for service; 4) promote communication among facilities; 5) participate as a member of the steering committee and arrange, manage, and provide minutes for meetings of the steering committee and external review panel; 6) prepare statistical reports; 7) arrange for additional sample testing; 8) accumulate and maintain electronic data files; 9) assure prompt accumulation, entry, and editing of product-related data; 10) provide data management and analytical services for substudies; 11) analyze data collected and participate in analysis and writing of manuscripts and reports; 12) develop and obtain a customer satisfaction survey; 13) monitor and report adverse events; 14) coordinate and assist facilities in initiating and maintaining inventories of reagents; 15) participate with facilities in training interested investigators in regulatory procedures; and 16) conduct site visits. It is anticipated that one five-year cost reimbursement, performance based, type contract will be awarded on or about September 30, 2003. This is NOT a Request for Proposals (RFP). RFP NHLBI-HB-03-07 will be available on or about January 2, 2003 and may be accessed at the following URL location: http://www.nhlbi.nih.gov/funding/inits/index.htm#rfp. No paper copies of the RFP will be available. Note: The RFP for the somatic cell processing facilities will be available on or about January 2, 2003 under Broad Agency Announcement (BAA) NHLBI-HB-03-06.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/NIH/NHLBI/NHLBI-HB-03-07/listing.html)
- Record
- SN00227556-F 20021221/021219214336 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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