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FBO DAILY - FEDBIZOPPS ISSUE OF MAY 17, 2018 FBO #6019
SOLICITATION NOTICE

R -- Provide services on the genetics of type 2 diabetes in Africa

Notice Date
5/15/2018
 
Notice Type
Presolicitation
 
NAICS
541380 — Testing Laboratories
 
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
75N92018Q0163
 
Archive Date
6/6/2018
 
Point of Contact
Dorothy Maxwell, Phone: 301-827-7729
 
E-Mail Address
maxwelld@mail.nih.gov
(maxwelld@mail.nih.gov)
 
Small Business Set-Aside
N/A
 
Description
PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS SOLICITATION NUMBER: 75N92018Q0163 Introduction: THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION. The National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisition (OA) on behalf of the National Human Genome Research Institute, (NHGRI), intends to negotiate and award a purchase order on a noncompetitive sole source basis without providing for full and open competition to West African Bioethics, 102 Bashorun Ashi Road, Ibadan Nigeria to provide the following: THIS IS A FOLLOW-ON REQUIREMENT Procurement (Base and Four Options): 1. To provide services on the genetics of type 2 diabetes in Africa, including enroll and collect samples from subjects in Nigeria with type 2 diabetes (T2D) and subjects with T2D who carry the sickle cell trait. North American Industry Classification System (NAICS) Code: The intended procurement is classified under Industry Classification (NAICS) Code is 541380, Administrative Management and General Management Consulting Servicesand the Small Business Size Standard is Testing Laboratories and the size is $15.0M. 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. The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-97, January 24, 2018. This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13 Simplified Acquisition Procedures (SAP). Statutory Authority : This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), Soliciting from a single source is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13--Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. Background: The National Institutes of Health (NIH) mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. NIH provides leadership and direction to programs designed to improve the health of the Nation by conducting and supporting research. The National Human Genome Research Institute (NHGRI) vision and mission is to improve the health of all humans through advances in genomics research, serve as a leading authority in the field of genomics and to accelerate scientific and medical breakthroughs that improve human health. NHGRI does this by driving cutting-edge research, developing new technologies, and studying the impact of genomics on society. The Center for Research on Genomics and Global Health (CRGGH), NHGRI, NIH 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, a number of epidemiological observations have been made 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, the gene expression profile of skeletal muscles and white adipose tissue will be studied. 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. The Contractor shall enroll 100 participants over 24 months. Both tissues shall be biopsied on each participant and blood samples shall also be obtained. Type 2 diabetes (T2D) is a major public health problem in the US and globally. However, the mechanisms and changes that are involved in the development of T2D are not well understood. A number of tissues and organs play key roles in the pathophysiology of T2D including muscles and adipose tissue (AT). A comprehensive understanding of the molecular and histological changes that occur in these tissues or organs would help the scientific community in the management of the disease as well as in the development of new therapeutics and preventive strategies.   Purpose and Objective: The purpose of this procurement is for the Center for Bioethics & Research to enroll and collect samples from subjects in Nigeria with type 2 diabetes (T2D) and subjects with T2D who carry the sickle cell trait for a study being conducted by NHGRI to map gene(s) underlying susceptibility to T2D in West African ancestral populations of African Americans. 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, the relationship between HbA1C measurements, T2D, diabetes duration and health outcomes in newly diagnosed T2D individuals who also carry the sickle cell trait (HbS) will be investigated. As part of this study, the Contractor shall recruit 350 individuals and follow them up for 3 years. Sole Source Justification: Ths procurement will be awarded to West African Bioethics (Previously Institute of Human Virology) who is the only source that can provide the provide services on the genetics of type 2 diabetes in Africa. West African Bioethics and their scientific investigators have been providing the services to the clincal study since 2011, therefore it would detriment to change contractors to provide these services. Project Requirements: Base and Four Options: 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. 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). 2. 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). 3. 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; 3. HbA1C levels and sickle cell genotyping; and 4. processed biological specimens (plasma, serum, buffy coat and urine). Place of Performance: The place of performance with be at the Contractor's site. Period of Performance: Base Year: 12 Months Option 1: 12 Months Option 2: 12 Months Option 3: 12 Months Option 4: 12-Months Contracting Without Providing For Full or Open Competition (Including Brand-Name Determination) The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research. The intended source for this acquisition is to be awarded to West African Bioethics (Previously Institute of Human Virology) who is the only source that can provide the provide services on the genetics of type 2 diabetes in Africa. West African Bioethics and their scientific investigators have been providing the services to the clincal study since 2011, therefore it would detriment to change contractors to provide these services. Closing Statement: 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 May 22, 2018 at 7:30 a.m. EST. Responses must be submitted via the FedConnect webportal (www.fedconnect.net) under Solicitation Number: 75N92018Q0163. Potential Offerors do not need to register to view a notice; however, in order to submit questions and/or response to this Notice, an account will need to be established. Should you require a waiver not to use FedConnect, please contact the Contracting Officer listed in this notice. National, Heart, Lung and Blood Institute, Section 3, Branch B, Office of Acquisitions, Office of Management, 6701 Rockledge Drive, Suite 6149, Bethesda, Maryland 20892-7902, Attention: Dorothy Maxwell, Contracting Officer (maxwelld@nih.gov). Faxes will not be accepted. "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/75N92018Q0163/listing.html)
 
Record
SN04923559-W 20180517/180515230930-acc3b0dfe24f6029b24af81dce95b677 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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