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Genetics Research of Type 2 Diabetes In Kenya, Nigeria and Ghana

Solicitation Number: NHLBI-CSB-HG-2012-087-DLM
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD
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NHLBI-CSB-HG-2012-087-DLM
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Sources Sought
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Added: Feb 28, 2012 1:56 pm
This Sources Sought Notice (SS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Heart, Lung, and Blood Institute (NHLBI).

The purpose of this SS is to identify businesses that are interested in a study of Kenya, Ghana and Nigeria subjects on "Genetics of Type 2 Diabetes".


The NHLBI does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted. As a result of this Sources Sought notice, the NHLBI may issue a Request for Quote (RFQ).



THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NHLBI shall arise as a result of a response to this Sources Sought notice or the NHLBI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement.


The NHLBI is seeking capability statements from all eligible businesses, under the North American Industry Classification System (NAICS) code 923120.


Background:

The mission of the National Human Genome Research Institute (NHGRI), 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 will 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 will 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 Contrctor will 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 will 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 will 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).


Interested parties are expected to review this notice to familiarize yourself with the requirements of this project; failure to do so will be at your firm's own risk. Interested parties should submit a tailored capability statement for this requirement, not to exceed 20 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above and in the attached draft statement of work. All proprietary information should be marked as such. Statements should also include an indication of current certified business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner.


All capability Statements sent in response to this SOURCES SOUGHT notice must be submitted electronically (via email) to Dorothy Maxwell, Contract Specialist, at maxwelld@mail.nih.gov in either MS Word or Adobe Portable Document Format (PDF), March 14, 2012, 7:30 AM, EST. All responses must be received by the specified due date and time in order to be considered.


 

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Office of Acquisitions
6701 Rockledge Dr RKL2/6100 MSC 7902
Bethesda, Maryland 20892-7902
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Nigeria, Ghana and Kenya as well as Bethesda Maryland

United States
:
Dorothy Maxwell
Phone: 301-435-0352
Fax: 301-480-3345