National Institutes of Health, National Institute of Allergy and Infectious Diseases, Contract Management Branch, Room 2230, 6700-B Rockledge Drive, MSC 7612, Bethesda, MD 20892-7612

A -- CLINICAL AND STATISTICAL COORDINATING CENTER: COOPERATIVE CLINICAL TRIALS IN PEDIATRIC TRANSPLANTATION SOL NIH-NIAID-DAIT-01-08 DUE 050500 POC Ms. Cyndie Cotter, Contracting Officer, 301-402-0641 The Division of Allergy, Immunology and Transplantation (DAIT) 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 Clinical and Statistical Coordinating Center (CASCC) to support the NIAID Cooperative Clinical Trials in Pediatric Transplantation (CCTPT) established in FY 1994 and renewed in FY 1999. The purpose of this RFP is to support a program of prospective, multi-site cooperative clinical trials in pediatric kidney transplantation, including the following components: -- Clinical trials to evaluate the safety and efficacy of new and innovative therapeutic approaches to improve graft and patient survival; -- Clinical trials of the safety and efficacy of modifications in standard therapeutic approaches both to improve short- and long-term graft/patient survival and to reduce the deleterious side effects of current immunosuppressive regimens; -- Adjunct studies of theunderlying mechanisms of action of the therapeutic approaches being evaluated, including changes in immune response and function, measures of donor-specific tolerance and loss of tolerance; and -- Adjunct studies to develop, evaluate and validate sensitive immune and/or surrogate markers of short- and long-term graft survival and rejection, with particular emphasis on defining clinically relevant predictors of acute and chronic rejection. All participating clinical sites will utilize uniform controlled study designs and standardized data collection procedures. Pediatric patients up to 21 years of age may be studied, with the specific age groups to be determined by the design of the common protocols. Specifically, this contract shall provide the statistical, clinical, regulatory, technical and administrative expertise necessary to support clinical trials and mechanistic studies of therapies to prolong graft survival and effect standards of care in pediatric kidney transplantation, including: (1) statistical leadership in the design, implementation and analysis of clinical trials and studies of underlying mechanisms; (2) establishment and administration of systems for the collection, storage, management, quality assurance and reporting of study data; (3) clinical site monitoring and training; (4) regulatory and technical functions and requirements associated with Investigational New Drug (IND) Applications; (5) preparation and final analyses of study data; (6) coordination and support of technical and administrative activities of the CCTPT Steering Committee and subcommittees and an independent Data and Safety Monitoring Board (DSMB); and (7) provide for the receipt, storage and distribution of study drugs or biologics being tested. This proposed contract is a 100% small business set-aside. The Standard Industrial Classification (SIC) code for this project is 7379. The size standard is $18 million. RFP NIH-NIAID-DAIT-01-08 will be available electronically on or about February 7, 2000, and may be accessed through the NIAID Contract Management Branch (CMB) Homepage by following electronic address and instructions: NIAID-CMB Homepage (via the World Wide Web): Access by: http://www.niaid.nih.gov/contract and select the "RFPs" link. Please note that the RFP for this acquisition has been revised to include only the Statement of Work, deliverables 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 the initial review process, offerors within the competitive range will be requested to provide additional documentation to the Contracting Officer. Proposals in response to this RFP will be due on or about May 5, 2000. All responsible small businesses may submit a proposal, which will be considered by the Government. This advertisement does not commit the Government to awarda contract. It is anticipated that one cost-reimbursement type contract will be awarded for a period of five (5) years, beginning approximately January 25, 2001. Point of Contract: Cyndie Cotter, Contracting Officer Electronic Mail Address: cc41w@nih.gov Telephone: (301) 402-0641 Facsimile: (301) 402-0972 NO COLLECT CALLS WILL BE ACCEPTED See Note 1. Posted 01/21/00 (W-SN417518). (0021)

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