SOLICITATION NOTICE
Q -- Genetic Testing Services in Africa
- Notice Date
- 5/11/2012
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-CSB-(HG)-2012-122-DLM
- Archive Date
- 6/2/2012
- Point of Contact
- Dorothy Maxwell, Phone: 301-435-0352
- E-Mail Address
-
maxwelld@mail.nih.gov
(maxwelld@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 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 Heart, Lung, and Blood Institute (NHLBI) Office of Acquisition (OA) intends to negotiate and award a purchase order on a noncompetitive sole source basis to the Institute of Human Virology, Plot 252 Herbert Macaulay Way, CBD, Abuja, Nigeria laboratory to provide services on the genetics of type 2 diabetes in Africa. The sole source determination is based on the fact that National Institute of Health (NIH) is the nation's leading medical research agency and the primary Federal agency conducting and supporting medical discoveries that improve people's health and save lives. The National Human Genome Research Institute (NHGRI), mission of the Center for Research on Genomics and Global Health (CRGGH) is to advance research into the role of culture, lifestyle, genetics and genomics in health disparities. The CRGGH will develop genetic epidemiology models and conduct population genetics research that explores the patterns and determinants of common complex diseases, such as Type 2 Diabetes, hypertension and obesity in the US, Africa and China. The CRGGH will give particular thought to ways in which scientist document and describe the non-random pattern of human genetic variation and its link to disease risks in different populations. The overall goal of the Center for Research on Genomics and Global Health (CRGGH) project on the genetics of type 2 diabetes among Yoruba is to accumulate sufficient number of cases and controls (n > 4000 persons) to conduct Whole Genome Association studies (GWAS). The current proposal will contribute 400 persons (200 unrelated T2D subjects and 200 ethnicity matched controls) to this larger effort. Objectives for the project are : 1. Enroll and examine 250 unrelated cases of T2D and 250 ethnicity matched controls from Abuja, Nigeria. 2. 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. 3. Obtain and process blood samples on each participant. Separate collected biological samples into required aliquot of plasma, serum and DNA. 4. Conduct basic biochemistries on all participants. Biochemistries will include fasting blood glucose, insulin, albumin, and lipid profile (LDL, HDL, triglyceride and total cholesterol). 5. Ship collected samples to the CRGGH at the NIH/NHGRI. 6. The project is expected to be completed in 12 months starting from the date of initial award. I. Contractor Requirements A. The Contractor shall enroll 500 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 than 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 should be ethnically matched to the cases. For example, if a Yoruba case is enrolled a Yoruba control should be enrolled. Also, a female case should have a female control. B. The Contractor shall be responsible for each participant being assigned a unique 7 digit barcode ID as provided by the CRGGH. The first 3 digits of the 7-digit ID identify the site. C. Specimen Collection and Processing The Contractor shall be responsible for 45 ml of venous blood to 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 will draw blood from all consenting participants. Once blood is drawn, the tubes should 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 will be separated within 1 hour of collection by centrifuging for 15 minutes at 2500 rpm. Filled vials will be placed into cryogenic cardboard freeze-storage boxes in a -20oC to -70oC freezer until ready for shipment. Spot urine will be collected from all participants in the special urine collection container provided during clinic visit. One 2ml aliquot will be obtained and frozen at -20o C or -70o C within 24 hours of collection. ALIQUOTING OF SPECIMEN : Blood should 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 The Contractor shall be responsible for how the properly labeled vials should be stored sequentially in the provided cryogenic freezer storage boxes by type of specimen (i.e., plasma, DNA, and urine samples should be stored in separate boxes). The corresponding barcode for each specimen type should be placed into the space provided on the storage forms. These entries should 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 should accompany all shipment to the United States. Frozen urine, plasma, serum, clot and buffy coat should be shipped frozen on dry ice packed in the large polyfoam shipping containers provided to each site. The containers should be completely covered (filled to the top) with dry ice before sealing the box. The Contractor shall ship the containers by using well established international express services including FedEx and DHL. Government Responsibilities A. The Government shall conduct a training workshop in Abuja, Nigeria before the project begins. B. The Government/CRGGH shall provide the contractor the following items: 1. All required barcode labels for the project; 2. Develop data entry screen; 3. Develop and implement quality control procedures for the project; and 4. Provide timely feedback on materials received from vendor. C. The Government shall conduct one site visit during the 12 months of the project to monitor project progress and to provide additional training to study staff as needed. D. Inspection and acceptance - all collected data items will be checked by the Government/ 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. Reporting Requirements and Deliverables E. Deliverables will include: 1. completed informed consent forms on all enrolled participants; 2. completed questionnaires on all enrolled participants; 3. electronic databases containing information from questionnaires and other study instruments; and 4. processed biological specimens (plasma, serum, buffy coat and urine). Industry Classification (NAICS) Code is 541712, Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) with size standard of 500 Employees. The acquisition is being conducted under FAR Part 13, simplified acquisition procedures, therefore the requirements of FAR Part 6 B Competitive Requirements are not applicable (FAR Part 6.001).and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-59 (May 10, 2012). This requirement is under the SAT of $150,000.00. This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this synopsis, by May 18, 2012, 7:30 a.m. Eastern Standard Time. The determination by the Government not to compete the 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 future competitive procurement. Inquires to this announcement, referencing synopsis number NHLBI-CSB-(HG)-2012-122-DLM, may be submitted to the National Heart, Lung and Blood Institute, Office of Acquisition, COAC Services Branch, 6701 Rockledge Drive, Suite 6149, Bethesda, Maryland 20892-7902, Attention: Dorothy Maxwell. Response may be submitted electronically to maxwelld@mail.nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative. Note: In order to receive an award from the NHLBI, contractors must have a valid registration in the Central Contractor Registration (CCR) www.ccr.gov, and ORCA https://orca.bpn.gov/login.aspx.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-(HG)-2012-122-DLM/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02746366-W 20120513/120511235903-376490cdda5f8126755f71addd963dd2 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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