The Division of Allergy, Immunology and Transplantation (DAIT), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), has a requirement to establish and implement a Clinical Studies Consortium. One award is anticipated. The Clinical Studies Consortium will be one of three components of an Atopic Dermatitis and Vaccinia Immunization Network that will be created via contract awards in mid fiscal year 2004. The Network will have three components: a Clinical Studies Consortium, an Animal Studies Consortium, and a Statistical and Data Coordinating Center. Each component will be established under separate contracts. Subcontracting will be encouraged. The purpose of the Clinical Studies Consortium is to develop and implement a plan to eliminate the risk for eczema vaccinatum in atopic dermatitis (AD) patients who are immunized with vaccinia. The Consortium will perform clinical studies on AD patients to evaluate innate and adaptive immune responses. These studies should provide important information about immune abnormalities that account for susceptibility to eczema vaccinatum, and should facilitate future design of safer and more effective vaccines for AD patients. The tasks that the Clinical Studies Consortium must fulfill will be coordinated with the Animal Studies Consortium and the Statistical and Data Coordinating Center. In their capability statement, organizations capable of fulfilling this effort, at a minimum, must demonstrate capabilities to: 1) Establish a Clinical Studies Consortium consisting of institutions capable of providing the clinical, scientific, technical and administrative expertise necessary to perform clinical studies in patients with AD; 2) Manage an organizational plan that must include processes for: a) establishing research priorities; b) reviewing, modifying, approving and disapproving research studies; c) allocating resources; d) monitoring and evaluating progress and performance; e) redirecting scientific focus and reallocating resources; and f) establishing and maintaining effective working relationships with pharmaceutical and biotechnology industries and with other NIAID-supported programs on biodefense and relevant non-biodefense research; 3) Propose a governance plan for the Network Executive Committee and chair and participate in this committee, which will be the governing body of the Network for all three components; 4) Design and implement safe protocols that assess immune function and gene expression in atopic dermatitis patients, both in vivo and in vitro, in response to: a) a defined set of antigens; and b) immunization with selected attenuated viruses; 5) Obtain and store blood and tissue samples from atopic dermatitis patients; 6) Identify atopic dermatitis patients with documented disseminated vaccinia and/or disseminated herpes simplex and/or severe molluscum contagiosum infection, for recruitment in a Registry; 7) Provide appropriate resources critical to clinical, scientific, technical and administrative support in a cost-effective manner. 8) Ensure an orderly transition of contract-related activities and materials to a successor Contractor or the Government at contract completion. It is anticipated that the period of performance for the contracts will be five (5) years, beginning approximately February 17, 2004. RFP-NIH-NIAID-DAIT-04-06 will be available electronically on or about April 18, 2003 and may be accessed through the NIAID Contract Management Branch (CMB) Home Page http://www.niaid.nih.gov/contract, and will be posted on FedBizOpps. Receipt of proposals will be due on or about July 28, 2003. 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. No collect calls will be accepted. No facsimile transmissions will be accepted. Original Point of Contact Barry Johnson, Contract Specialist, Phone 301.451.3694, Fax 301-402-0972, Email:[email protected] - Lawrence Butler, Contracting Officer, Phone 301-496-0192, Fax 301-402-0972, Email:[email protected]

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