SOURCES SOUGHT
A -- Assessing Safety of Cell Substrates And Vaccine Components
- Notice Date
- 10/31/2003
- Notice Type
- Sources Sought
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Contract Management Branch 6700 B Rockledge Room 2230 MSC7612, Bethesda, MD, 20892-7605
- ZIP Code
- 20892-7605
- Solicitation Number
- SS-NIH-NIAID-DMID-04-22
- Response Due
- 11/14/2003
- Archive Date
- 11/29/2003
- Point of Contact
- Paul McFarlane, Senior Contracting Officer, Phone 301-496-0349, Fax 301-402-0972, - Paul McFarlane, Senior Contracting Officer, Phone 301-496-0349, Fax 301-402-0972,
- E-Mail Address
-
pm24v@nih.gov, pm24v@nih.gov
- Description
- The Contract Management Program of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) is seeking capability statements from small business organizations with technical expertise and facilities to support the Division of Microbiology and Infectious Diseases (DMID), NIAID in achieving its goal of providing unique and quality assured biodefense-related reagents and resources to the scientific community. NIAID is seeking contractors to development, characterization and validation of in vitro assays and in vivo animal models to assess the safety of cell substrates and vaccine components that are being considered for use in vaccine manufacturing. The need for contemporary in vitro assays and in vivo animal models has arisen from 1) the development of vaccine candidates that can only be grown in cell substrates and/or require use of excipients or adjuvants that have not previously been used to manufacture licensed vaccines, and 2) previously unrecognized theoretical safety questions. For example, few tests are available to specifically assess certain safety issues that are unique to new cell substrates. These issues include tumorgenicity of the whole cell substrate, oncogenicity of the cellular DNA, and the detection of latent/occult adventitious agents in the cell substrate. Experimental data are needed regarding these issues in order for manufacturers and regulatory agencies to meaningfully assess and analyze the safety of vaccines manufactured in these new cell substrates. This is a new effort; there is no incumbent contractor. These critical contracts will develop both in vitro assays and in vivo animal models to assess current and future safety concerns that arise regarding vaccines and vaccine manufacturing and/or formulation, including 1) assessing the tumorgenic potential of cell substrates; 2) assessing the oncogenic potential of cell substrate DNA; and 3) screening for latent/occult adventitious agents in cell substrates. The contractors must have the capacity and capability to work with at least one of the following specific areas of in vitro assay development or in vivo animal model development: 1. Develop, characterize and validate in vivo animal model(s) to assess tumorgenic potential of cell substrates. 2. Develop, characterize and validate in vitro assays to assess and characterize tumorgenic potential of cell substrates. 3. Develop, characterize and validate in vivo animal models to analyze the oncogenic potential of cellular DNA. 4. Develop, characterize and validate in vitro assays to analyze the oncogenic potential of cellular DNA. 5. Develop, characterize and validate assays for detection of novel or latent/occult adventitious agents in cell substrates. To the extent possible, efforts should focus on applying existing technologies, reagents, techniques, and animal strains to animal model development. For example, proposals to develop assays for in vitro analysis of the oncogenic potential of live cells could include a more thorough development and validation effort of the currently used growth in soft agar assay. The contracts will be awarded as cost-reimbursement effort type with the emphasis being on the contractors? ability for the development, characterization and validation of in vitro assays and in vivo animal models to assess the safety of cell substrates and vaccine components that are being considered for use in vaccine manufacturing. Any capability statement submitted must address the requirements in sufficient detail so that technical approach, including develop and validate the in vitro assays and in vivo animal models, production and quality control; ability to provide contract management, including start up, facility operations and transition, inventory control and distribution may be evaluated. The Government anticipates multiple awards. It is anticipated that the duration of the contracts will be five years with an estimated level-of-effort of 8,500 labor hours per year. Interested Small Business organizations should submit two (2) copies of their capability statement addressing each of the areas cited above. No submission shall exceed a maximum of 25 1-sided pages in a 12 point font. No collect calls will be accepted and no facsimile transmissions will be accepted. THIS IS NOT A REQUEST FOR PROPOSALS AND DOES NOT COMMIT THE GOVERNMENT TO ISSUE A SOLICITATION OR TO AWARD A CONTRACT NOW OR IN THE FUTURE. NO SOLICITATION IS AVAILABLE AT THIS TIME. BASED ON CAPABILITY STATEMENTS RECEIVED FROM THIS SOURCES SOUGHT, THIS ACQUISITION MAY BE SOLICITED AS A 100% SMALL BUSINESS SET-ASIDE, NAICS CODE 54171, WITH A SIZE STANDARD OF 500 EMPLOYEES. See contact information above.
- Place of Performance
- Address: To Be Determined
- Zip Code: TBD
- Country: TBD
- Zip Code: TBD
- Record
- SN00462890-W 20031102/031031213236 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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