National Institutes of Health, Office of Procurement Management, 6120 Executive Blvd., (EPS), Rockville, Maryland 20892-7260

B -- STUDIES OF AFRICAN-AMERICAN AND CAUCASIAN FAMILIES WITH IRON OVERLOAD SOL 263-97-P(G)-0043 DUE 092897 POC Dorothy Nickens, Contract Specialist, (301) 496-0301, Fax (301) 402-3406 NIH intends to negotiate on a sole-source basis, a contract to provide a clinical researcher to conduct studies of African-American and Caucasian families with iron overload with George Washington University, Washington, D.C. This action is taken under the authority of 41 U.S.C.253(c)(1) (FAR 6.302-1(b). The anticipated contract shall require the contractor to have experience improving the following: The firm shall (1) identify 30 African-American index subjects with primary iron overload nation wide. (a) Shall make personal contact with physicians who specialize in treating patients with iron overload. (b) Shall make presentations at hospital conferences and scientific meetings to alert physicians of the need to identify African-Americans with primary iron overload. ( c ) Shall investigate patients published in the literature or presented at conferences as potential index subjects. (2) Shall perform clinical studies of 20 of these index subjects and their first degree family members at the Clinical Center of the NIH. This work shall include a thorough characterization of iron status, hematologic status, and hepatic and cardiac function (a) Shall characterize iron status with indirect measurers such as serum ferritin, repeated fasting transferrin saturation, serum transferrin receptor, serum ceruloplasmin. (b) Shall perform or arrange for direct measures of iron status as appropriate: liver biopsy and bone marrow evaluation. ( c ) Shall rule out secondary causes of iron overload: ineffective erythropoiesis, blood transfusions. (d) Shall evaluate for conditions that may perturb iron measure: inflammation, bone marrow hypoplasia, ineffective erythropoiesis, hepatocellular injury, ascorbic acid deficiency, alcohol and other drugs. (e) Shall assess patients for cardiac dysfunction related to disordered iron metabolism. (3) Shall coordinate appropriate epidemiologic and genetic analyses of the clinical data that is produced. Shall interpret the findings with similar data that has been generated from pedigrees in Africa. (a) Shall compare the findings in these pedigrees with normal values form the US population as indicated in NHANESS III. (b) Shall arrange for segregation and linkage analysis of phenotypic markers. (c ) Shall perform detailed comparisons of the clinical and genetic data obtained from African-American pedigrees with similar data obtained from pedigrees in Africa. 4. Shall correlate the clinical, epidemiologic and genetic findings with molecular biological studies conducted in the Cell Biology and Metabolism Branch. (a) Shall attend weekly seminars with the molecular biologists at CBMB who are working with the samples obtained from the pedigrees. (b) Shall provide on-going clinical correlations with the molecular biological findings in an interactive manner. 5. Shall perform similar studies as described in nos. 1-4 with Caucasians with non-HLA-H primary iron overload and with members of other racial groups with primary iron overload. (a) Shall have Caucasian pedigrees with index subjects who are not homozygous for the Cys282Tyr mutation will be studied. (b) Shall have Asian, Native American and Polynesian pedigrees with familial iron overload shall be studied. 6. Shall coordinate data analysis and the presentation and publications of results. Shall have ten years or more of published experience in clinical studies of iron overload, to include all three areas: (I) iron overload in Africa, (2) iron overload in African-Americans, and (3) HLA-linked hemochromatosis. Shall have a subspecialty certification in a disincline of internal medicine with relevance to the field of iron overload. Shall have a laboratory that is proficient in the determination of serum iron and total iron binding capacity according to the recommendations of the International Committee for Standardization in Hematology, and in the determination of chemical hepatic iron concentration. NIH believes that the above reference firm is the only source that can provide this requirement. The contract shall be for one year with one option for an additional year. Any other firm that feels they are qualified to provide such services must submit by the response date (45 calendar days from date of this publication) a detailed capability statement documenting their ability to provide this services by meeting the requirements stated above. Information furnished shall include enough material to perform a proper evaluation. Respondents will not be notified of the evaluation results. Closing date will be 45 calendar days after publication of this notice. See Number Note(s): 22 (0226)

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