SOLICITATION NOTICE
A -- Somatic Cell Therapy Processing Facilities
- 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
- BAA-NHLBI-HB-03-06
- 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 (to be awarded under a separate RFP); and b) up to three somatic cell therapy processing facilities. A Broad Agency Announcement (BAA) will be issued requesting proposals for the somatic cell therapy processing facilities in which awards will be made, each with varying technical/scientific approaches, for the production of clinical grade reagents. There are four research and technical objectives: 1) to provide for rapid, safe, and equable transition of basic research ideas in clinical practice; 2) to develop and implement procedures for the evaluation, prioritization, and processing of requests for service; 3) to prepare programs or mechanisms to facilitate the training and development of junior investigators in areas of cell therapy clinical studies/manufacturing with a focus on clinical grade reagent production and FDA regulatory procedures; and 4) to process, store, ship, and analyze reagents produced by the facility. Additional somatic cell processing facility project requirements are: 1) with the assistance of the administrative center, develop and prepare protocols and standards of procedures for each request for services and develop, obtain, and maintain any IND or IDE required for manufactured cellular therapies; 2) participate in developing a manual of procedures; 3) prepare reports; 4) assure prompt accumulation, entry, and editing of product-related data; 5) report all adverse events; 6) provide protocol information, including quality control and quality assurance methods, to the administrative center; 7) participate in the analysis and writing of study manuscripts and reports; 8) prepare archival samples to be sent to repository; 9) maintain inventories of reagents produced; 10) participate in site visits to be conducted jointly by the administrative center and NHLBI staff; and 11) participate as a member of the steering committee. It is anticipated that up to three cost reimbursement type contracts will be awarded on or about September 30, 2003. This is NOT a Request for Proposals (RFP). BAA NHLBI-HB-03-06 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 administrative center will be available on or about January 2, 2003 under RFP NHLBI-HB-03-07.
- Record
- SN00226914-W 20021221/021219213518 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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