SOURCES SOUGHT
B -- Genetics of Type 2 Diabetes in Africa
- Notice Date
- 9/5/2013
- Notice Type
- Sources Sought
- 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)-2013-272-DLM
- Archive Date
- 9/26/2013
- 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
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice." 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 in Africa". The NHLBI is seeking capability statements from all eligible businesses, under the North American Industry Classification System (NAICS) code 541712 and small business size standards 500 employees. A. Background: The National Institute of Health (NIH), 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 B. Purpose and Objectives: 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. 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. B. 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. C. 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. D. 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: 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 4. 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. Period of performance : 12 Months with 4 Option Years (2013 - 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. B. 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 4. Provide timely feedback on materials received from vendor C. 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. D. 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. Reporting Requirements and Deliverables: E. Deliverables will including : 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) 5. HbA1C levels and sickle cell genotyping F. Anticipated Period of Performance Upon Award: Base Year: 12 Months Option Year 1: 12 Months Option Year 2: 12 Months Option Year 3: 12 Months Option Year 4: 12 Months F. Capability Statement /Information: Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk. The following information shall be included in the capability statement: 1. A general overview of the respondents' opinions about the difficulty and /or feasibility of the potential requirement, and any information regarding innovative ideas or concepts. 2. Information in sufficient details of the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. 3. The respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc) pursuant to the North American Industry Classification System (NAICS) code: 541712 and small business size standards 500 employees. 4. Any other information that may be helpful in developing or finalizing the requirements of the potential acquisition. 5. The capability statement shall not exceed 20 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, in either Microsoft Word or Adobe Portable Document Format (PDF), with 8-1/2 by 11 inch paper size, and 1 inch top, bottom, left and right margins. All proprietary information should be marked as such. Statements should also include an indication of current certified small 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. G. Closing Statement: The capability statement should be submitted electronically (via email) to Dorothy Maxwell, Contract Specialist, at maxwelld@mail.nih.gov, on or below September 11, 2013, 7:30 AM, EST. All responses must be received by the specified due date and time in order to be considered. 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 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 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 notice or the NHLBI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. "Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)."
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-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-CSB-(HG)-2013-272-DLM/listing.html)
- Place of Performance
- Address: Ethiopia/NIH 31 Center Drive, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03175710-W 20130907/130905235624-174ab4a62d897fc2e7c33350fcbe4432 (fbodaily.com)
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