SOURCES SOUGHT
A -- Somatic Cell Therapy Processing - Administrative Center
- Notice Date
- 12/19/2002
- 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-03-07
- Archive Date
- 12/21/2002
- 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 Blood Diseases and Resources Program of the National Heart, Lung, and Blood Institute (NHLBI) is conducting a market survey to assess the availability and potential technical capability of small business firms as defined by the Small Business Act. The applicable NAICS code is 541710 and the size is 500 employees which is the conversion of SIC code 8731. Small businesses are sought to perform as the Administrative Center for the Somatic Cell Therapy Processing project. The objective of this project is to develop novel cellular therapies that will aid investigators by providing support in areas ranging from basic science through animal studies to proof-of-principle and eventually human trials. It is anticipated that up to three somatic cell processing facilities will be awarded under separate contracts. The facilities will implement the rapid, safe, and smooth transition of basic research ideas to clinical practice as well as supply clinical grade products produced in a manner that is compliant with all regulatory requirements. The Administrative Center will have oversight of the cell processing facilities and will have the following responsibilities: 1) provide management and coordination of the cell processing facilities and assist investigators in developing and preparing protocols and standards of procedures; 2) knowledge of current FDA regulations and assist facilities in developing, obtaining, and maintaining any INDs required for manufactured cellular therapies; 3) implement and maintain quality control and quality assurance procedures for manufacturing processes; 4) participate with facilities to train interested investigators in regulatory procedures; 5) monitor and report adverse events associated with products manufactured in the facilities; 6) assure prompt accumulation, entry, and editing of product-related data in accordance with protocols; 7) initiate and maintain inventories of reagents produced by the facilities; 8) arrange for additional sample testing and/or substudies on products manufactured by the facilities; and 9) analyze study data, participate in the writing of manuscripts and reports, design and maintain a manual of procedures as well as performing other administrative functions pertaining to the project. Small business firms having demonstrated experience in performing tasks 1-9 above are invited to submit capability statements (original and two copies). Capability statements must provide evidence of experience in performing the responsibilities described above and demonstrate the following: 1) qualifications and availability of staff needed to perform the work, including expertise in preparing regulatory submissions to the FDA, biostatistics, data collection, data monitoring, data analysis, quality control, quality assurance, and standardization; 2) experience and expertise of both staff and the organization in the operation of an administrative center in coordinating, monitoring and managing all activities required for collaborative development of cell processing protocols including, but not limited to, oversight of facilities operations and communication, assisting facilities in developing regulatory submissions for the FDA, and assisting in archiving samples for repository placement; 3) evidence of prior experience in monitoring multicenter studies related to cell processing or transfusion medicine, both in the collection of data from multiple sites, as well as experience in monitoring quality and timeliness of data; 4) evidence in soliciting cooperation from the facilities and exercising leadership in data acquisition, management, and analysis; 5) facilities and resources necessary for the performance of the requirements listed above; and 6) the firm's status as a small business under NAICS code 541710. Capability statements in response to this market survey that do not provide sufficient information for evaluation will not be considered. This is NOT a Request for Proposals (RFP), and responses should not include budgetary information. The RFP release date is pending. The government intends to negotiate one contract for the period of five years with an approximate date of award September 30, 2003. Firms responding to this market survey should provide pertinent information to the requirements mentioned above within fifteen (15) calendar days from the date of this announcement to the address shown above.
- Record
- SN00226913-W 20021221/021219213517 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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