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FBO DAILY - FEDBIZOPPS ISSUE OF JUNE 19, 2016 FBO #5322
SOLICITATION NOTICE

R -- NHLBI Urine Sodium Substudy - Transfer of Samples

Notice Date

6/17/2016
 

Notice Type

Presolicitation
 

NAICS

622110 — General Medical and Surgical Hospitals
 

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-(HL)-2016-180-JML
 

Archive Date

7/9/2016
 

Point of Contact

Jonathan M. Lear,
 

E-Mail Address

john.lear@nih.gov
(john.lear@nih.gov)
 

Small Business Set-Aside

N/A
 

Description

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 Acquisitions (OA), intends to negotiate and award a purchase order on a noncompetitive sole source basis to University of Vermont, 111 Colchester Ave., Burlington, VT 05401-1473 to provide support services for the Urine Sodium Substudy Biorepository in accordance with the following information. BACKGROUND In 2011, the Centers for Disease Control (CDC) conducted a Urinary Sodium Calibration Study in a population of young adults to evaluate equations that use sodium estimated from timed spot urine specimens to predict 24-hour urinary sodium excretion (considered to be the gold standard for dietary sodium intake). The purpose was to monitor sodium in the US population in the National Health and Nutrition Examination Survey (NHANES). To extend the findings to middle-age and older adults, a portion of the funds NHLBI approved to contribute to the NHANES collection were also approved to fund a Urine Sodium Substudy (USS) in the MESA and CARDIA cohorts at the Northwestern University Field Center for the two studies. The USS collected urine samples on 554 participants (and 186 repeat samples) and serum in a subgroup. The CDC performed assays using of some of the collected urine samples and sent the remaining volumes from those samples to the MESA biorepository at the University of Vermont for long-term storage. Samples that have not been through a freeze-thaw cycle still remain stored at Northwestern University. These samples are valuable because 24-hour urine collections are uncommon, in part, because they require substantial participant burden to collect. The 24-hour urine in this study was a "fractional collection." That is, every time a participant voided, it was collected in a separate container allowing the collection of "timed spot samples." Most cohort studies do not have such precise urine samples. These specimens represent a national resource for the development of cost-efficient studies of urinary biomarkers of diet and metabolism and their potential influence on cardiovascular disease outcomes. As such, all of the samples should be stored at the same facility for consistency and cost efficiencies in long-term storage as well as efficiencies in sample distribution to qualified investigators in the future. PURPOSE The purpose of this acquisition is to relocate the Urine Sodium Substudy biospecimen repository to the University of Vermont. Long-term maintenance and management of the repository after completion of this work will be supported via a separate contract. The objectives of this acquisition are as follows: -Arrange for the transfer of the USS samples from Northwestern University to the University of Vermont -Provide storage and an inventory system for the USS samples at the University of Vermont -Comply with relevant MESA and CARDIA Policies and Procedures (found at https://www.mesa-nhlbi.org and http://www.cardia.dopm.uab.edu). TASK TO BE PERFORMED -Arrange for and execute transfer of the Urine Sodium Substudy urine and serum sample collection from Northwestern University to the University of Vermont using best practices as described in http://biospecimens.cancer.gov/practices/ and http://www.isber.org/. Provide for all services, qualified personnel, supplies, and equipment needed for the transfer. -Upon receipt of the USS samples, ensure their proper storage including adequate freezer space, appropriate storage conditions, and inventory database. -Establish a plan for communication and cooperation with MESA and CARDIA Coordinating Centers on storage and inventory of the biospecimens. -Respond to inquiries from the NHLBI in a timely manner. -Incorporate the USS samples and inventory system into the MESA biorepository for long-term management. PERIOD OF PERFORMANCE The period of performance will be for one (1) year. JUSTIFICATION The sole source determination is based on the following: -Beginning in 2000, through a full and open competition, the University of Vermont (UVM) was awarded the NHLBI contract for the MESA laboratory analyses and management and served as the biorepository, which provided storage and maintenance of samples and inventory tracking and control. Under the current MESA contract, awarded in August 2015, the University of Vermont is now supported for the same purpose as a subcontractor to the University of Washington. The University of Vermont is uniquely qualified to continue providing biorepository services for the following reasons: -The University of Vermont currently houses the large MESA biorepository, including a portion of the USS samples received from the CDC. The MESA prime contract, the University of Washington (UW), holds the link between the sample IDs and the study IDs as well as all other data collected from the MESA participants. Housing the MESA USS samples in one location with the rest of the biospecimen collection by UW's subcontractor will maximize efficiency in communicating about and coordinating distribution of samples to qualified researchers. This will avoid potential delays and inconvenience to researchers with limited research grant funding and time to conduct their research projects. It also avoids the need to obtain samples from at least two different sources. -The CARDIA Coordination Center (CC) at the University of Alabama, Birmingham, has indicated that its biorepository does not have space to store the CARDIA USS samples and agrees that the complete substudy collection should be kept together in one location. The CARDIA CC will provide appropriate CARDIA sample IDs to UVM as needed to pull and provide samples to qualified investigators. -The collection and storage of samples are not barcoded. Unlike commercial repositories, whose inventory systems rely on barcoded samples, the University of Vermont has the demonstrated ability to manage the USS collection and to integrate the existing inventory system into its current system for sample storage and distribution at minimal expense. -The MESA and CARDIA study designs, huge data sets, and availability of biorepository samples are complicated. Using them most effectively for research requires the expertise and input of investigators and staff familiar with them who can advise and collaborate with researchers in designing research projects that are doable and make good and efficient use of the resources. This is particularly true for use of the limited resource of the biospecimen collection. The personnel at the University of Vermont, who have worked with the MESA samples and biorepository for 15 years, are uniquely qualified to provide this expertise. The biorepository director is a highly accomplished and internationally recognized scientist. REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1(b), Soliciting from a single source (for purchases not exceeding the simplified acquisition threshold), and only one responsible source and no other supplies or services will satisfy agency requirements. ADDITIONAL INFORMATION The North American Industry Classification System (NAICS) Code is 622110, General Medical and Surgical Hospitals, and the Small Business Size Standard is $38.5M. This acquisition is being conducted under FAR Part 13, Simplified Acquisition Procedures, therefore the requirements of FAR Part 6, Competitive Requirements, are not applicable and the resultant award will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-88 (June 15, 2016). 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 June 24, 2016 at 9:00am EST and must reference synopsis number NHLBI-CSB-(HL)-2016-180-JML. Responses shall be submitted to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch, 6701 Rockledge Drive, Room 6151, Bethesda, Maryland 20892-7902, Attention: Jonathan M. Lear. Responses may be submitted electronically to john.lear@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/NHLBI-CSB-(HL)-2016-180-JML/listing.html)
 

Place of Performance

Address: National Institutes of Health / NHLBI, Bethesda, Maryland, 20892, United States

Zip Code: 20892
 

Record

SN04153594-W 20160619/160617234229-b50b6a9c73113ff9ccc2f4e29582b01c (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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