SOURCES SOUGHT
A -- Tuberculosis Clinical Diagnostics Research Consortium (CDRC)
- Notice Date
- 5/2/2008
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 6700 B Rockledge Room 3214 MSC7612, Bethesda, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- RFP-NIAID-DMID-NIHAI2008026
- Point of Contact
- Andrew Q Cherry,, Phone: 301-402-2442, Karen M. Gamble,, Phone: 301-402-2234
- E-Mail Address
-
cherryan@niaid.nih.gov, gamblek@niaid.nih.gov
- Small Business Set-Aside
- N/A
- Description
- Sources Sought Notice Information Introduction THIS NOTICE IS FOR INFORMATION AND PLANNING PURPOSES ONLY. THIS IS NOT A REQUEST FOR PROPOSAL AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT NOW OR IN THE FUTURE. NO SOLICITATION IS AVAILABLE AT THIS TIME. BASED ON CAPABILITY STATEMENTS RECEIVED IN RESPONSE TO THIS SOURCES SOUGHT ANNOUNCEMENT THIS ACQUISITION MAY BE SOLICITED AS A 100% SMALL BUSINESS SET-ASIDE. ALL SMALL BUSINESS ORGANIZATIONS (SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB) ARE ENCOURAGED TO RESPOND TO THIS NOTICE. SMALL BUSINESS ORGANIZATIONS MUST HAVE THEIR SIZE STATUS CERTIFIED BY THE SMALL BUSINESS ADMINISTRATION. THE NAICS CODE IS 541711 WITH A SIZE STANDARD OF 500 employees. Description The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. This contract shall establish the Tuberculosis Clinical Diagnostics Research Consortium (CDRC), a consortium of clinical study sites in TB-endemic countries to assess the performance of novel, early stage TB diagnostics in the context of existing clinical diagnostic algorithms. Diagnostic devices, technologies and assays eligible for evaluation under this contract must have demonstrated preliminary specificity and sensitivity against the target organism(s) and must be available as at least a quality assured prototype diagnostic device, assay or test. CDRC clinical studies shall be designed to determine how new diagnostics can most effectively impact treatment decisions in comparison to, or in concert with, currently utilized diagnostics, and to ready diagnostic tests for further development by commercial and/or other non-governmental sponsors. The goal of the Tuberculosis CDRC is to determine, early in the development process, how investigational diagnostics can contribute most effectively in a TB-endemic country (www.who.int/tb/publications/global_report/2007/pdf/full.pdf, as updated yearly) to inform treatment decisions. This strategy will also assure that early stage clinical evaluation of diagnostics is not solely dependent on comparison to stand alone “gold standard” diagnostics tests, but rather will enable evaluation of how these diagnostics perform within a clinical algorithm. This is particularly important since the “gold standard” currently used for TB diagnosis (the acid fast stain) is an antiquated test with limited specificity and sensitivity. This strategy is expected to demonstrate that even diagnostic tests with limited sensitivity and specificity may nevertheless show great utility when evaluated in the context of a diagnostic process. The CDRC shall also serve as a resource to the research community to provide support and advice for the early stage development of TB diagnostics in the clinical setting and contribute to the overall scheme for moving diagnostics into clinical validation. Initially, the Contractor shall provide up to two diagnostic tests for assessment by the CDRC; additional diagnostics may be identified by either the Contractor or by the research community. This project will NOT support: the development of new clinical research facilities and laboratories for testing new diagnostics; the development of new diagnostics and new assays; interventional clinical trials; studies to collect data to support a 510(k) application with the FDA; the establishment or maintenance of a publicly accessible specimen repository; or any research related to the development and testing of investigational products for the treatment or prevention of TB. The contractor shall be required to: (1) establish and maintain the Tuberculosis Clinical Diagnostics Research Consortium, including clinical study sites and a CDRC data management center; (2) adhere to objectives and requirements for CDRC clinical studies, including study design and evaluation of diagnostic tests; (3) solicit, review, prioritize and recommend additional diagnostic candidates from the community; (4) develop clinical study plans and protocols for diagnostics; (5) provide protocol implementation, management, oversight, reporting and analysis; (6) establish an external scientific advisory group; and (7) develop and maintain the CDRC website. Capability statements submitted in response to this announcement should demonstrate the offerors’ qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to the following: Technical Capability: 1) Adequacy and appropriateness of proposed clinical sites, including a) experience in the diagnosis and treatment of TB and established relationships with local TB control programs; and b) experience in conducting clinical studies of human TB, including obtaining clearances from in-country human subject review boards and adherence to Good Clinical Practice guidelines; 2) Data management capabilities, and experience in designing and implementing clinical protocols, including: a) proposed plans and procedures for data collection, management, quality control and reporting, training of clinical study site personnel, and required interactions with clinical study site personnel; b) experience in providing database management services, particularly for projects involving multi-national collaborations and foreign sites in resource-limited countries; and c) understanding of methodological considerations, challenges, and potential limitations in statistical design and analysis of investigational TB diagnostics in TB-endemic countries, and recommendations for overcoming/minimizing such challenges and limitations; and 3) Clinical study protocols, specifically the proposed process to provide for substantial involvement of clinical study site investigators and clinicians from TB-endemic countries in protocol development and to address current health care practices in the context of protocol design. Personnel/Management: expertise, experience, and availability of the key professional and technical staff with a project of similar size, scope, and complexity. It is estimated that the total effort of approximately 20.95 FTEs per year will be required to conduct this project. All capable small business organizations are encouraged to submit capability statements based on this announcement. Interested organizations should submit two copies of their capability statement addressing each of the areas cited above. Any proprietary information should be so marked. Written capability statements should be received by the Contracting Officer on/before May 16, 2008. Please reference the solicitation number on all related correspondence. No collect calls will be accepted. Facsimile and e-mail transmissions will be accepted. Information submitted in the capability statement should be pertinent and specific in the technical area under consideration, on each of the following qualifications: (1) Experience: An outline of previous projects, specific work previously performed or being performed and any in-house research and development effort; (2) Personnel: Name, professional qualifications and specific experience of scientists and technical personnel who may be assigned as a principal investigator and/or project manager; (3) Facilities: Availability and description of special facilities required to perform in the technical areas under consideration. Any other specific and pertinent information as pertains to this particular area that would enhance our consideration and evaluation of the information submitted.
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- SN01565945-W 20080504/080502220344-1d8f7bab31683d3006f3a2dedcb373c7 (fbodaily.com)
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