National Institutes of Environmental Health Sciences, Research Contracts Branch, DERT, P.O. Box 12874, Building 4401, Research Commons, 79 T.W. Alexander Drive, Research Triangle Park, NC 27709

A -- COORDINATING CENTER FOR THE AFRICA-AMERICA DIABETES MELLITUS STUDY NETWORK SOL NO1-HG-85432 DUE 093099 POC Contact Velvet M. Torain, Contract Specialist, 919/541-0440/Phillip D. Jones, Contracting WEB: None, None. E-MAIL: None, None. The National Institute of Environmental Health Sciences intends to negotiate a contract modification with Howard University, College of Medicine, Washington D.C. to expand recruitment of study participants to include 200 unaffected spouse controls from whom the same data will be collected as for the original cases. The unaffected spouse controls shall be as follows: (1) The unaffected spouse controls shall be above 25 years old and have no clinical laboratory evidence of non-insulin dependent diabetes mellitus (NIDDM) (2) shall have a spouse affected with NIDDM (3) shall have no more than one diabetic parent (4) shall not have classical features of IDDM (5) shall have no first degree relatives with IDDM (6) shall not be pregnant at time of this study (for females only). The Contractor shall also conduct a study of informed consent procedures in urban and rural Nigeria. It is the Government's estimate that this expansion will require approximately 29,000 additional labor hours over the remaining four-year period. The expansion is due to start approximately October 11, 1999. Authority: 41USC 253(c)(1), as set forth in FAR 6.302-1 -- Only One Responsible Source. The contract (NO1-HG-85432) was awarded to Howard University on a sole-source basis on September 29, 1998. The need to modify the contract arises from its success and from some initially unanticipated changes in the research design. Newer statistical modeling suggests that the addition of unaffected controls will add power to the study. An understanding of interaction between researchers and potential subjects that results in consent to participate in genetic research will increase the potential to obtain adequate study participants. The same type of data will be collected and the same database will be utilized. See Numbered Notes 22 and 26.***** Posted 08/17/99 (W-SN368966). (0229)

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