SOLICITATION NOTICE
B -- Follow-On to continue study on Genetics of type 2 diabetes in Africa.
- Notice Date
- 9/12/2013
- 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
- HHS-NIH-NHLBI-CSB-(HG)-2013-306-DLM
- Archive Date
- 10/3/2013
- 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
- INTRODUCTION: THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). 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. This is a Follow-On requirement. Background: The 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), Center for Research on Genomics and Global Health (CRGGH) has clinically and genetically characterized a large cohort of African individuals and families with diabetes throughout the years and published the results of these investigations in peer-review journals. As a direct result of these investigations, we have made a number of epidemiological observations that warrant further elucidation. For example, persons with T2D in West Africa are not, on average, as heavy as African Americans with diabetes suggesting perhaps the involvement of other mechanisms in the development of T2D. Familial clustering of diabetes is much higher in West Africans compared to African Americans perhaps reflecting the lower prevalence of deleterious environmental risk factors including lower prevalence of obesity, higher physical activities and metabolically friendlier diet. Interestingly, lipid profile (especially HDL and triglycerides) are remarkably similar between West Africans and African Americans despite radically different dietary pattern. To investigate these observations at the molecular and cellular levels, we sought to study the gene expression profile of skeletal muscles and white adipose tissue. These tissues represent key players in carbohydrates and lipids metabolisms and also participate in the low grade inflammation characteristic of both obesity and T2D in West-African obese T2D and lean T2D. We plan to enroll 100 participants over 24 months. Both tissues will be biopsied on each participant and blood samples will also be obtained. The table below summarizes the study design. T2D (cases) Non- T2D (controls) Obese BMI>=30 kg/m2 25 25 non-obese (lean) BMI<25 kg/m2 25 25 Purpose and Objective : 1. Enroll and examine 50 unrelated cases of T2D (25 obese + 25 non-obese) and 50 (25 obese + 25 non-obese) 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, muscle and adipose tissue biopsy samples on each participant. Separate collected biological samples into required aliquot of plasma, serum and DNA and freeze tissue samples accordingly to preserve nucleic acids (e.g. RNA) necessary for gene expression profiling. 4. Ship collected samples to the CRGGH at the NHGRI/NIH. 5. The project is expected to be completed in 24 months starting from the date of initial funding. Anticipated Period of Performance Upon Award : Base Year: 12 Months Upon Award Option Year 1: 12 Months Option Year 2: 12 Months Option Year 3: 12 Months Option Year 4: 12 Months Contractor Requirements : Enroll 100 cases and controls using the following eligibility and exclusion criteria : 1. 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 and must be either obese (BMI>= 30 kg/m2) or lean (BMI< 25 kg/m2).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 and must be either obese (BMI>= 30 kg/m2) or lean (BMI< 25 kg/m2). 2. Each participant will be assigned a unique 7 digit barcode ID as provided by the CRGGH. The first 3 digits of the 7-digit ID identify the site. Specimen Collection and Processing : 1. 45 ml of venous blood will 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. 2. 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. 3. 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. 4. Adipose tissue and muscle biopsies will be performed during a scheduled and needed clinical care procedure not a surgical procedure under this protocol. Biopsy samples will be immediately frozen in portable liquid nitrogen containers to preserve tissue integrity. 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 : 1. 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. 2. Frozen urine, plasma, serum, clot, muscle and adipose tissue biopsy samples, 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. 3. Shipment may be achieved by using well established international express services including FedEx and DHL Government Responsibilities : A. The Government will conduct a training workshop in Abuja, Nigeria before the project begins. The Government will provide the vendor the following items: a. All required barcode labels for the project; b. Develop data entry screen; c. Develop and implement quality control procedures for the project; and d. Provide timely feedback on materials received from vendor. B. 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. C. Inspection and acceptance - all collected data items will be checked by the Government 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 : D. Deliverables will include : Completed informed consent forms on all enrolled participants: 1. completed questionnaires on all enrolled participants; 2. electronic databases containing information from questionnaires and other study instruments; and 3. processed biological specimens (plasma, serum, buffy coat and urine) PROJECT B : II. General Information, Purpose and Objectives of the Requirement: CRGGH is also interested in the accuracy of laboratory test that are routinely used in clinical settings for the therapeutic or lifestyles management of diabetes especially in the context of hemoglobinopathies including sickle cell trait. The effectiveness of the treatment or intervention of diabetes is routinely monitored by measuring hemoglobin A1C (HbA1C); HbA1C is a form of hemoglobin that is primarily measured to determine the level of blood glucose over prolonged periods of time (usually up to three months). While this test has been the standard to measure the effectiveness of treatment and to assess glycemic control in diabetes and recommended by the American Diabetes Association (ADA), there is accumulating evidence that HbA1C may not have the best predictive value in individuals who have hemoglobinopathy such as sickle cell disease or trait because HbA1C test is based on normal hemoglobin (HbA). The prevalence of sickle cell trait in West Africa is about 25 % and an unreliable test to follow up diabetes and its complications in this group of individuals presents a public health challenge. To address this pressing public health issue, we sought to investigate the relationship between HbA1C measurements, T2D, diabetes duration and health outcomes in newly diagnosed T2D individuals who also carry the sickle cell trait (HbS). As part of this study, we plan to recruit 350 individuals and to follow them up for 3 years. Year 1: baseline (T0) 2013-2014 Year 2: baseline for new enrollees (T0) and follow up (T1) 2014-2015 Year 3: baseline for new enrollees (T0) and Follow up (T1, T2) 2015-2016 Year 4: Follow up (T1, T2, T3) 2016-2017 Year 5: Follow up only (T2, T3) 2017-2018 T2D (cases) Non- T2D (controls) HbA 100 100 HbS 50* 100 * given the prevalence of T2D and sickle cell trait in West Africa, it is expected that the occurrence of the two conditions concomitantly will be low, hence a much larger number of individuals has to be screened to reach our initial goal of 100 for this cell compared to the other 3 cells for the study duration. Thus we aim to recruit 50 T2D/HbS for the duration of the study. Objectives for the project are: 1. Enroll and examine 350 unrelated and new cases of T2D and ethnicity matched controls from Abuja, Nigeria as shown in table above. 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. Ship collected samples to the CRGGH at the NHGRI/NIH. 5. The project is expected to be completed in 5 years starting from the date of initial funding. 6. Period of performance: September 2013 - September 30, 2018 : Year 1: baseline (T0) 2013-2014 Year 2: baseline for new enrollees (T0) and follow up (T1) 2014-2015 Year 3: baseline for new enrollees (T0) and Follow up (T1, T2) 2015-2016 Year 4: Follow up (T1, T2, T3) 2016-2017 Year 5: Follow up only (T2, T3) 2017-2018 II. Contractor Requirements: A. Enroll 350 cases and controls using the following eligibility and exclusion criteria: Cases - persons newly diagnosed 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. One hundred participants with normal hemoglobin (HbA) and 50 participants with the sickle cell trait (HbS). 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. Hundred (100) participants with normal hemoglobin (HbA) and 100 participants with the sickle cell trait (HbS) B. Each participant will be 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 45 ml of venous blood will 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: 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. Shipment may be achieved by using well established international express services including FedEx and DHL Government Responsibilities: A. The Government will conduct a training workshop in Abuja, Nigeria before the project begins. The Government will provide the vendor 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. B. The Government will 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. C. 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: D. 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; 4. processed biological specimens (plasma, serum, buffy coat and urine); and 5. HbA1C levels and sickle cell genotyping Regulatory Authority : The statutory authorities justifying this sole-source acquisition are 41 U.S.C. 253(c)(1), and FAR 6.302-1. The services required are available only from one responsible source based on unique capabilities. Additional Information : 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). The resultant Contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-69 (September 3, 2013). This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." 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. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by September 18, 2013 and must reference synopsis number HHS-NIH- NHLBI-CSB-(HG)-2013-306-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. "All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-CSB-(HG)-2013-306-DLM/listing.html)
- Place of Performance
- Address: 252 Herbert Macaulay Way, CBD, Abuja, Nigeria, Nigeria
- Record
- SN03186637-W 20130914/130913000453-c21cd3f5c0bd5d7f589db987d2895da7 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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