A -- Consortium for the Longitudinal Evaluation of African-Americans with Early Rheumatoid Arthritis (CLEAR) Registry

The National Heart Lung and Blood Institute, on behalf of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, intends to negotiate on a sole source basis with the University of Alabama at Birmingham to extend and expand the scope of their current contract for an additional five years. The University of Alabama at Birmingham was originally awarded a contract for a five year period in September 2000 for a project entitled "Consortium for the Longitudinal Evaluation of African-Americans with Early Rheumatoid Arthritis (CLEAR) Registry." The purpose of this contract is to establish a registry (CLEAR) which serves to identify genetic and non-genetic prognostic factors of disease outcome using radiographic presence of bony erosions as the primary outcome measure (at 3 years disease duration). The registry (400 completers) will serve as the basis for prospective analyses of factors predictive of the clinical phenotype and outcomes. Four major academic medical centers in the southeast U.S. will gather data which will provide a resource for investigators interested in the genetics of RA in African Americans. The Contractor will continue to 1) complete longitudinal evaluation of 400 African-Americans with early RA and 200 matched controls; 2) complete the 3 and 5 year disease duration visits; 3) enroll an additional 600 African-American subjects with RA and an additional 300 matched controls; 4) establish a cross-sectional cohort of 600 subjects; 5) collect clinical, demographic, and socioeconomic information; 6) obtain radiographs of the hands and feet at entry into the study; and 7) collect blood for serum, genomic DNA, and RNA suitable for microarrays. Pursuant to 41 U.S.C. 253(c)(1) as set forth in FAR 6.302 1, University of Alabama at Birmingham is the only source capable of performing this requirement due to their prerequisite knowledge and experience because of their preliminary and current work. Due to the inherent duplication of cost and unacceptable delays in performance, a noncompetitive procurement is in the best interest of the Government. Interested parties may identify their interest and capability to respond to the requirements, as described above. A determination not to compete the proposed work based upon responses to this notice is solely within the discretion of the Contracting Officer. This notice of intent is not an announcement of the availability of a Request for Proposals (RFP), nor is a RFP available. See Numbered Note 22.