Genetics of Type 2 Diabetes in Kenya Study

The National Heart, Lung, and Blood Institute(NHLBI) Office of Acquisitions (OA) for the National Institutes of Health's (NIH) National Human Genome Research Institute (NHGRI), Center for Research on Genomics and Global Health(CRGGH), intends to negotiate on a sole source basis with Moi University, Department of Behavioural Sciences, School of Medicine Nandi Road, 2nd Floor, Eldoret, Kenya 30100 to provide an expert from their lab to study the genetic basis of Type 2 Diabetes (T2D) in Kenyans. This new study will add to the larger effort ongoing in Nigeria and Ghana. The successful completion of this project will greatly enhance the ability of CRGGH investigators to conduct Genome-Wide Association Studies (GWAS). The contractor will: 1) Enroll and examine 400 unrelated cases of T2D and 400 ethnicity matched controls from the Eldoret area in Kenya, 2) Conduct clinical examinations and complete study questionnaires to obtain demographic and clinical data including age, gender, personal and family health history, blood pressure and anthropometrics, 3) Obtain and process blood samples on each subject. Separate collection biological samples into required aliquot of plasma, serum, and DNA, 4) Conduct basis biochemistries on all subjects. Biochemistries will include fasting blood glucose, insulin, albumin, and lipid profile (LDL, HDL, triglyceride and total cholesterol) and 5) Ship collected samples to the CRGGH at the NIH's NHGRI. Dr. Duncan Ngare, Professor of Public Health, was selected for this project due to his extensive experience with this kind of research project. The program area has established a collaboration with him over the past several years from two previous collaborations, Engaging African Communities for the HapMap Project and Translational Genomics Research in the African Diaspora which will be invaluable to the implementation of this project. Over 800 persons were enrolled in the previous collaboration that was done by Dr. Ngare's clinic and laboratory staff. Dr. Ngare's lab is uniquely qualified to conduct this research project in a timely and cost efficient manner. The Government will conduct a training workshop in Eldoret, Kenya before the enrollment of subjects and conduct a one site visit during the 18 months of the project to monitor project progess and to provide additional training to study staff as needed. The CRGGH will provide the contractor with the following items: 1) All required barcode labels for the project, 2) Developed data entry screen, 3) Developed quality control procedures for the project and 4) Timely feedback on materials received from the contractor. Inspection and acceptance - all collected data items will be checked by the CRGGH data manager for errors and outliers. All detected inconsistencies will be sent back to the vendor for checking and correction or replacement. Collected biological specimens must be kept frozen at -20 degrees or lower temperature at the site and during shipment to the United States. Samples are to be shipped using international couriers in dry ice. Samples with inconsistencies occurring due to vendor lab processing error (e.g., gender) will be replaced by the vendor. The period of performance is June 1, 2009 - May 31, 2010. The place of performance is the National Institutes of Health, National Human Genome Research Institute, Bethesda, Maryland. The reference number for this notice is NHLBI-PB-(HG)-2009-157-TMB The resultant acquisition will be conducted in accordance with FAR Part 13, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-32. The total estimated amount of this contract is NOT expected to exceed the simplified acquisition threshold of $100,000.00. The intended procurement will be classified under North American Industry Classification System code 541990, with size standard of $7.0m per annum. Market Research conducted by the Government in accordance with the Federal Acquisition Regulations (FAR) Part 10, Market Research, has determined that Moi University is currently the only organization that can continue to collaborate with the ongoing services specified herein. This notice is not a request for competitive proposals. The resulting acquisition will be entered into pursuant to the acquisition authority set forth in FAR 6.302-1 and 41 U.S.C. 253(c)(1) and HHSAR 306-302-1. Only one responsible source and no other supplies or services will satisfy agency requirements. Interested parties may identify their interest and capability to respond to the requirement or submit a response. This notice of intent is not a request for competitive proposals. Responses to this announcement, referencing synopsis number NHLBI-PB-(HG)-2009-157-TMB may be submitted to the National Heart, Lung and Blood Institute, Office of Acquisitions, Procurement Branch, 6701 Rockledge Drive, Suite 6042, Bethesda, MD 20892-7902, Attention: Tracy Brooks. Responses may be submitted electronically to brookstr@nhlbi.nih.gov. Responses are due May 27, 2009 7:30am EST. Responses will only be accepted if dated and signed by an authorized company representative. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.