Whole Genome Association Studies for the Study in Type 2 Diabetes

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), for the National Human Genome Research Institute (NHGRI) intends to negotiate and award a purchase order on a non-competitive basis to the University College Hospital, Ibadan, Nigeria to conduct Whole Genome Association Studies (GWAS) for the study of genetics in type 2 diabetes by providing for the enrollment, examination, and the conduction of tests on 600 individuals (300 unrelated T2D subjects and 300 ethnicity matched controls. STATEMENT OF WORK: Specifically, the Contract shall enroll and examine 300 unrelated cases of T2D and 300 ethnicity matched controls from Ibadan, Nigeria. Conduct clinical examination and complete study questionnaires to obtain demographic and clinical data including age, gender, personal and family health history, blood pressure and anthropometrics. Obtain and process blood samples on each participant. Separate collected biological samples into required aliquot of plasma, serum and DNA. Conduct basic biochemistries on all participants. Biochemistries shall include fasting blood glucose, insulin, albumin, and lipid profile (LDL, HDL, triglyceride and total cholesterol). Shipped collected samples to the National Intramural Center for Genomics and Health Disparities (NICGHD) at the NHGRI/NIH. I. Contractor Requirements A. Enroll 600 cases and controls using the following eligibility and exclusion criteria: Cases - persons with confirmed type 2 diabetes mellitus that are either on treatment for diabetes or newly diagnose with blood sugar reading on more that one occasion exceeding or equal to 126 mg/dl. These persons must be above the age of 25 years. Controls - persons with fasting plasma glucose (FPG) less than 100 mg/dl (5.6 mmol/l). Controls must be at least 40 years of age or older and shall be ethnically matched to the cases. For example, if a Yoruba case is enrolled a Yoruba control shall be enrolled. Also, a female case shall have a female control. B. Each participant shall be assigned a unique 7 digit barcode ID as provided by the NICGHD. The first 3 digits of the 7-digit ID identify the site. C. Specimen Collection and Processing 45 ml of venous blood shall be collected per participant during clinic examination and put into two 10 ml lavender tops, two 10 ml red tops and one 5 ml grey top. Only experienced phlebotomists shall draw blood from all consenting participants. Once blood is drawn, the tubes shall be inverted several times to completely dissolve their contents. The mixed tubes are then to be cooled to 4oC by placing them in the refrigerator or an ice bucket. Plasma and buffy coat shall be separated within 1 hour of collection by centrifuging for 15 minutes at 2500 rpm. Filled vials shall be placed into cryogenic cardboard freeze-storage boxes in a -20oC to -70oC freezer until ready for shipment. Spot urine shall be collected from all participants in the special urine collection container provided during clinic visit. One 2ml aliquot shall be obtained and frozen at -20o C or -70o C within 24 hours of collection. aliquoting of Specimen: Blood shall be centrifuged at 2500rpm for 15 minutes and divided into aliquot as follows: Type of tube # of Vials Two 10ml Lavender (equal volume) 4 (2 from each 10ml tube) Two 10ml red top (equal volume) 4 (2 from each 10ml tube) One 5ml grey top (equal volume) 2 DNA (buffy coat - from lavender tops) 1 DNA (buffy coat - from lavender tops) 1 DNA (clot - red top) 1 DNA (clot - red top) 1 DNA (buffy coat grey top) 1 Urine (2ml vials) 1 Storage and Shipment Policy Properly labeled vials shall be stored sequentially in the provided cryogenic freeze-storage boxes by type of specimen (i.e., plasma, DNA, and urine samples shall be stored in separate boxes). The corresponding barcode for each specimen type shall be placed into the space provided in the storage forms. These entries shall be double-checked for errors by entering the barcodes and sample locations into the provided Access Microsoft database. A copy of the completed inventory forms shall accompany all shipment to the United States. Frozen urine, plasma, serum, clot and buffy coat shall be shipped frozen in dry ice packed in the large polyfoam shipping containers provided to each site. The containers shall be completely covered (filled to the top) with dry ice before sealing the box. Shipment shall be achieved by using well established international express services including FedEx and DHL This project is expected to be completed in 12 months starting from the date of award. The sole source determination is based upon the extensive familiarity and expertise of the laboratory of Professor Clement Adebamowo at the University of Ibadan with the Yoruba communities and hospitals that shall form the basis for the enrollment and examination of all study participants. Dr. Adebamowo has ongoing projects on the genetics of diabetes and breast cancer in these communities. In addition, Dr. Adebamowo's laboratory is already using the well established manual of operation for our ongoing NIH funded genetics of type 2 diabetes in three (3) African countries (Ghana, Kenya and Nigeria). His laboratory will require minimum training in sample processing, labeling, storage and shipment. In this regard, Dr. Adebamowo's laboratory is uniquely qualified to conduct this research project in a timely and cost efficient manner. An award to any other source would affect NHGRI's anticipated outcome based upon the University of Ibadan's experience, and would not provide a cost savings to the Government. The North American Industry Classification (NAICS) Code is 541990 and the Size Standard is $6.0M. The acquisition is being conducted under FAR Part 13, simplified acquisition procedures. This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this requirement. Responses to this announcement referencing synopsis number - NHLBI-PB-(HG)-2008-166-GMC may be submitted to the National Heart, Lung, and Blood Institute, Office of Acquisitions, Division of Extramural Research Activities (DERA), Procurement Branch, 6701 Rockledge Drive, Room 6146, Bethesda, MD 20892-7902. Attention: Gina M. Cianflone. Fax responses shall only be accepted if dated and signed by an authorized representative.