SOURCES SOUGHT
A -- Tuberculosis Research Unit (TBRU)
- Notice Date
- 10/27/2005
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Contract Management Program 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- Reference-Number-SS-RFP-NIH-NIAID-DMID-07-17
- Response Due
- 11/10/2005
- Archive Date
- 11/25/2005
- Description
- THIS IS NOT A REQUEST FOR PROPOSALS 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 FROM THIS SOURCES SOUGHT THIS ACQUISITION MAY BE SOLICITED AS AN 8(a) SET-ASIDE; 100% SMALL BUSINESS SET-ASIDE OR AS FULL AND OPEN. ALL SIZE ORGANIZATIONS ARE ENCOURAGED TO RESPOND. THE NAICS CODE IS 541710 WITH A SIZE STANDARD OF 500 EMPLOYEES. The Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) supports research to understand, and ultimately prevent and/or treat, infectious and immune-mediated diseases that continue to threaten millions of lives each year. The Respiratory Diseases Branch (RDB), DMID, NIAID, NIH, has a requirement for a multi-disciplinary clinical research contract in tuberculosis to integrate, basic and human clinical research to help answer outstanding critical questions in human tuberculosis. This is a recompetition of Contract Number N01-AI-95383 with Case Western Reserve University. A solicitation will be issued seeking a contractor that will support an established consortium of investigators and institutions with expertise in the areas of epidemiology, microbiology, and immunity to conduct multi-disciplinary, multi-national research of host-pathogen interactions in tuberculosis (TB). The overall goal of the clinical studies to be carried out by the contract is to fill critical gaps in translational TB research and to provide tools needed to advance new health care interventions. The Contractor will conduct and direct specific studies that are expected to provide answers to long-standing questions about the interaction of Mycobacterium tuberculosis (Mtb) with its human host and to contribute to the successful development of new health care interventions. These questions include: (1) Why does Bacillus Calmette Guerin (BCG) protect some individuals from TB disease and not others and what are the kinetics of the immune response after vaccination with BCG versus after infection with Mtb? Answers to this question are expected to facilitate the selection of boosting strategies for vaccine studies of the human immune response to BCG in target populations, such as children, and to better define clinical endpoints and expected outcomes for new vaccines; (2) Why do most individuals successfully control Mtb infection while others progress to active disease? The answers to this question are expected to facilitate characterization of infected persons and those at highest risk of progression to active disease for entry into clinical studies and facilitate the development of diagnostics; (3) What immune responses or other biological markers that predict relevant clinical outcomes can be measured in response to drug therapy and vaccines? The answers to these questions are expected to define early surrogate markers of efficacy and possible approaches for combining drug therapy with vaccination strategies. Clinical studies to be carried out under this contract will be conducted in TB endemic countries (see Dye et al.- http://jama.ama-assn.org/cgi/content/full/282/7/677) with substantial contributions by local investigators and, where possible, will include the creation of data that will be relevant to TB care and research in the host countries. The collaboration must include at least one country outside of the United States in which TB is endemic and which offers an established infrastructure capable of carrying out the clinical studies, including local investigators experienced in the conduct of multi-disciplinary human clinical research in TB, laboratory facilities and personnel to perform protocol-specific tests, and access to appropriate patient populations. The contract shall also include a Data Management Center for the receipt, storage, quality control and evaluation of all data derived from this contract, and a Specimen Repository for the storage and inventory of mycobacterial strains and human-derived materials. Supporting non-clinical studies, as well as administrative management may be conducted in the U.S. or non-U.S. countries. Information submitted in your capability statement shall be pertinent and specific in the technical area under consideration in each of the following qualifications: (1) Expertise in the design and conduct of high quality clinical studies in TB endemic countries (see Dye et al.- http://jama.ama-assn.org/cgi/content/full/282/7/677) in accordance with all requirements listed in 45 CFR 46, or equivalent international guidelines, for the conduct of ethical and safe human subjects research; (2) Expertise in managing complex, multi-disciplinary studies in human TB; (3) Expertise with ethics committees and human subjects review boards in TB endemic countries; (4) Expertise in TB research and thorough knowledge of the status of clinical TB research, as well as applied knowledge in related fundamental and translational research areas such as human immunology; (5) Availability of/access to collaborators and clinical research infrastructure in TB endemic countries with the expertise to conduct human clinical studies in TB; (6) Laboratory infrastructure in TB endemic countries and/or in the U.S. or other non U.S. countries to provide, where applicable, immunology, microbiology, and biochemistry support; (7) Access to relevant volunteer and patient populations needed to conduct clinical studies in TB endemic countries; (8) Personnel in the U.S. and/or non U.S. countries and in TB endemic countries who are experienced in conducting human clinical studies and laboratory studies needed for the development of tools and assays for human clinical studies; (9) Expertise in developing and operating specimen repositories, and in developing and maintaining databases to support specimen and clinical data; and (10) Expertise in the development and operation of database systems for the receipt, storage and quality control of clinical and non clinical study data. The Government anticipates a single award. The NIAID recognizes that a single organization or institution may not have all the expertise and facilities necessary to carry out this requirement. Consequently, a contractor would be expected to include collaborations and subcontracts with qualified U.S. and/or non-U.S. institutions to provide the scientific and technical expertise and resources needed for human clinical studies in TB. The contractor shall utilize already established and well experienced clinical collaborations and infrastructure in TB endemic countries to conduct research, as well as an established clinical data management infrastructure to conduct this work. Small business and 8(a) contractors are reminded that in order to quality as a set-aside, 51% of the direct labor must be performed by the prime contractor. It should be noted that this contract will NOT support the establishment and development of new clinical trial infrastructure and capacity at TB endemic sites or the evaluation of new diagnostics, drug and vaccine candidates that are submitted by the research community for clinical testing. However, the contract may integrate experimental and/or approved drugs, vaccines and/or diagnostics into its clinical studies to define and validate markers that will provide improved information for future human clinical studies for TB interventions. It is anticipated that the duration of the contracts will be a maximum of seven (7) years with an anticipated total effort of approximately 29 FTEs. Interested organizations are encouraged to respond and are required to submit two (2) copies of their capability statement addressing the areas cited above. Please identify the NAICS and size status of your organization. See Government-Wide Numbered Note 22. NO COLLECT CALLS WILL BE ACCEPTED. FACSIMILE AND E-MAIL TRANSMISSIONS WILL BE ACCEPTED. Point of Contact Kala Shankar, Contract Specialist, Phone 301-402-6289, Fax 301-480-4675, Email shankak@mail.nih.gov
- Record
- SN00922224-W 20051029/051027211744 (fbodaily.com)
- Source
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