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 -- CLINICAL TRIALS AND CLINICAL MARKERS FOR IMMUNOLOGIC DISEASES SOL RFP NIH-NIAID-DAID-BAA-99-12 DUE 010599 POC Cynthia Cotter, Contracting Officer, (301) 402-0641 The Clinical Immunology Branch, DAIT, promotes and supports a broad range of research aimed at the elucidation of the immune mechanisms underlying disease and the translation of this basic knowledge to clinical applications that will benefit individuals affected by immunologic diseases (including autoimmune diseases, primary immunodeficiency diseases, allergy and asthma, and graft rejection in solid organ and cell transplantation). The ultimate goal of this research and at the core of NIAID's mission, is effective and specific diagnosis, treatment, and prevention of these diseases. Gaps in both knowledge and in research effort exist which represent opportunities for the NIAID to contribute to progress in this area. The purpose of this Broad Agency Announcement is to solicit proposals for research which will increase clinical application of knowledge gained from basic research on immunologic diseases. The general research areas are: A. Clinical trials of immunomodulation in immunologic diseases that are unlikely to be conducted without government support. Trials can be either a pilot or Phase I/II trial to assess safety and determine if an intervention shows promising effects which warrant further evaluation, or an appropriately controlled pivotal (Phase II/III) trial to determine efficacy. These trials must include evaluation of immunologic and other relevant parameters in order to study the mechanisms underlying the intervention and the mechanisms of disease pathogenesis. B. Development of immunologic or other markers which can be used in mmunologic diseases for measuring disease activity or risk, therapeutic effect, or as diagnostic criteria. These studies shall use new technologies and approaches to develop and validate reliable and reproducible assays of relevant molecules or cells. RFP NIH-NIAID-DAIT-BAA 99-12 will be available electronically on or about 8-14-98 and may be accessed through the NIAID Contract Management Branch (CMB) Homepage, by the following electronic address and instructions: NIAID/CMB Homepage (via the World Wide Web): Access by: http://ww.niaid.nih.gov/contract and select the "RFPs" link. Please note that the RFP for this acquisition has been revised to include only the Research and Technical Objectives, deliverable and reporting requirements, special requirements, and mandatory qualifications, if any, the Technical Evaluation Criteria, and the proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. Following proposal submission and review, offerors may be requested to provide additional documentation to the Contracting Officer. Proposals in response to this RFP will be due on or about 1-5-99. Any responsible offeror may submit a proposal which will be considered by the Government. This advertisement does not commit the Government to award a contract. It is anticipated that approximately six cost-reimbursement contracts covering one or more of the Research Areas listed above will be awarded for amaximum period of five (5) years. Point of Contact: Cynthia Cotter National Institute of Allergy and Infectious Diseases Contract Management Branch Solar Building, Rm. 3C-07 6003 Executive Blvd. Bethesda, MD 20892 Electronic Mail Address: cc41w@nih.gov Telephone: 301-402-0641 FAX: 301-402-0972 No collect calls will be accepted Posted 07/24/98 (W-SN228001). (0205)

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