National Institutes of Health, National Institute of Allergy and Infectious Diseases, Contract Management Branch, Solar Bldg., Room 3C07, 6003 Executive Blvd. MSC 7610, Bethesda, MD 20892-7610

A -- IMMUNOLOGY QUALITY ASSESSMENT PROGRAM SOL RFP-NIH-NIAID-DAIDS-99-01 DUE 092297 POC Ms. Nancy Hershey, Contracting Officer, 301-496-0193 The National Institute of Allergy and Infectious Diseases (NIAID), is seeking SMALL BUSINESS firms (under Standard Industrial Code 8731) with the capability to operate and maintain the Division of AIDS (DAIDS) Immunology Quality Assessment Program (IQA). The basic functions of the IQA are: Acquisition of materials/reagents, their characterization, preparation into panels and distribution to external testing laboratories; receipt of test results from laboratories, their collation and transmission for external statistical analysis; and forwarding results of statistical analysis back to testing laboratories and other investigators. In the current DAIDS Immunophenotyping Quality Assessment Program the basic functions were applied towards efforts to: reduce inter- and intra-laboratory variability in the measurement of CD4+ and CD8+ T cells from patients enrolled in HIV/AIDS clinical investigations; facilitate the development of simpler, more cost effective CD4 enumeration methodologies; develop and disseminate standardized methodologies for 3-color immunophenotyping, and; develop improved methodologies to facilitate fluorescence intensity measurements, required to measure activation antigens and other functional correlates both in the research setting and in the clinical flow cytometry laboratory. The current five year contract is with FAST Systems, Inc. In the next seven years, this Program, now called the Immunology Quality Assessment Program (IQA) will support three areas of activity: 1) It will continue to assess the ability of laboratories to reliably measure CD4+, CD8+ and other clinically relevant lymphocyte subsets (proficiency testing). This well-established component of the Program is expected to require approximately 30% of the effort. 2) The Program will continue to support comparative evaluations of cytometric methods and instruments as alternatives to current labor intensive, costly and variable technologies. This component of the Program is expected to require approximately 30% of the effort.3) The Program will emphasize the facilitation of development, standardization and implementation of new immunological assays for use in multi-site therapeutic, vaccine, prevention, epidemiological and preclinical HIV investigations. This new component of the Program is expected to require approximately 40% of the effort. The total number of laboratories participating in the CD4/CD8 flow cytometry QA program (proficiency testing) will range from 80-100. Each comparative evaluation or an assay development project would likely be conducted by 5-20 laboratories with the support of the contract. Laboratories will be located within the continental United States, Puerto Rico and Hawaii, and a few may be international. Successful operation, management and coordination of the AIDS Immunology Quality Assessment Program requires: (1) access to, and acquisition of a variety of biological materials from well-characterized HIV-infected adult and pediatric subjects at various stages of disease, including but not limited to whole blood, plasma, tissue; and acquisition of materials and reagents such as monoclonal antibodies, mitogens, HIV-specific antigens, T cell lines and commercial reference standards. (2) characterization/screening of materials (e.g. CD4 counts, levels of plasma cytokines, proliferative response to antigens, titer of neutralizing antibodies, HIV RNA level, lot-to-lot reagent checks). (3) maintenance of materials (e.g. long-term culturing of cell lines); their inventory and storage at appropriate temperatures; and distribution to laboratories in accordance with all relevant shipping regulations. (4) a computerized inventory and relational database system supports relevant information about materials/reagents, compilation of testing results obtained from laboratories, and generation of reports. The system must include a database in a DBF-compatible file format that allows data exports into spreadsheet programs, include a graphics program that can directly link to data on spreadsheets, and include a window-based word processing program. (5) adequate facilities to handle hazardous and infectious materials (P2 facility and radioactive materials license), maintain viability/activity of materials (e.g. hoods, incubators), and store materials. The proposed Principal Investigator must have documented evidence of broad-based knowledge in the development and evaluation of immunological assays and their implementation in multi-site clinical investigations; evidence of experience in the principles and practices of immunology quality assessment, and understanding of laboratory data management issues; and evidence of supervisory experience. The Project Manager must have documented evidence of the relevance and extent of experience with efficiently managing and coordinating multiple projects as related to the performance of immunological assays, good oral and written communication skills, customer service and laboratory trouble shooting skills, as well as evidence of experience in the principles and practices of laboratory computerized data management. Other professional and technical staff must have relevant experience in the area of immunological methodologies, and in laboratory database management, and must be appropriately trained in the safe handling and distribution of biohazardous and infectious materials. In your capability statement, please address the following: your understanding of the project. a plan, and documentation of feasibility, for acquiring biological materials from HIV infected and uninfected adult and pediatric donors. documented capability to perform immunological assays, such as lymphocyte subset immunophenotyping, proliferation, cytotoxicity and ELISA-based assays. qualifications and experience of the proposed Principal Investigator and the Project Manager. a plan for hiring, retaining and replacing qualified staff, as well as planned ongoing training. documented access to additional scientific expertise (e.g., consultants, etc.). a detailed floor plan indicating where work will be performed and a list of laboratory and computer equipment to be dedicated to the project. The contract period is expected to be seven (7) years, beginning approximately October 1, 1998, and one cost-reimbursement contract, is expected to be awarded. Sources who believe that they have the capability necessary to undertake this project should submit complete documentation to support this capability. If it is expected that parts of the requirement will be subcontracted, you must discuss how this will be accomplished. At this time, responses are only sought from SMALL BUSINESSES (under 500 employees -- SIC Code 8731). Five (5) copies of this documentation must be submitted by Monday, September 22, 1997, to Ms. Nancy Hershey, Contracting Officer, National Institutes of Health, Contract Management Branch, Solar Building, Room 3C07, 6003 Executive Boulevard, MSC 7610, Rockville, MD 20892-7610. The documentation submitted must be complete to allow evaluation without further discussions. We are not requesting proposals at this time, and responses should not include budgetary information. No collect calls will be accepted. (0240)

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