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 -- STATISTICAL AND CLINICAL COORDINATING CENTER (SACCC) SOL NIH-NIAID-DAIT-99-26 DUE 040999 POC Jacqueline C. Holden, Contracting Officer, (301) 496-7119 The Division of Allergy, Immunology and Transplantation of the National Institute of Allergy and Infectious Diseases (NIAID), NIH, has a requirement for a Contractor having the capabilities and facilities to establish and manage a Statistical and Clinical Coordinating Center (SACCC) to support two NIAID research programs: the Collaborative Network for Clinical Research on Immune Tolerance, to be established in FY 2000, and the Autoimmunity Centers of Excellence, to be established in FY 1999. The goals of the Collaborative Network are to: (1) design and conduct clinical trials to evaluate the safety, toxicity and efficacy of tolerogenic treatments for multiple immune-mediated diseases; (2) design and conduct studies of the underlying mechanisms of the induction, maintenance and loss of tolerance; and (3) develop and validate tolerance assays. The Autoimmunity Centers of Excellence is a cooperative research program designed to establish a network of centers to carry out a multidisciplinary program of basic, pre-clinical and clinical research on tolerance induction and immune modulation to treat and prevent multiple autoimmune diseases. Specifically, the SACCC Contractor shall: (1) provide statistical leadership for the design, implementation and monitoring of all phases of clinical trials and studies of underlying mechanisms of tolerance induction and immune modulation for multiple immune-mediated diseases; (2) design and conduct analyses of interim and final study results; (3) conduct clinical site monitoring and training; (4) establish and administer data collection, management, quality assurance and reporting systems; (5) support regulatory functions and requirements associated with Investigational New Drug Applications and clinical trials of experimental therapies; (6) distribute and ensure quality control of study products; (7) support the technical and administrative functions of the governing bodies of the Collaborative Network and the Autoimmunity Centers; and (8) coordinate the activities of an independent Data and Safety Monitoring Board. It is anticipated that one indefinite delivery requirements type contract will be awarded for a period of nine (9) years. RFP NIH-NIAID-DAIT-99-26 will be available electronically on or about December 10, 1998, and may be accessed through the NIAID Contract Management Branch (CMB) Homepage by using the following electronic address and instructions: NIAID-CMB Homepage (via the World Wide Web): Access by: http://www.niaid.nih.gov/contract . Once you are at the NIAID Contracts page, select "RFPs" and then select "RFP-NIH-NIAID-DAIT-99-26". Please note that the RFP for this acquisition has been revised to include only the Work Statement, deliverables and reporting requirements, special requirements, 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 the initial review process, offerors comprising the competitive range will be requested to provide additional documentation to the Contracting Officer. Responses to this RFP will be due on April 9, 1999. Any responsible offeror may submit a proposal that will be considered by the Government. This advertisement does not commit the Government to award a contract. Posted 11/25/98 (W-SN274805). (0329)

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