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FBO DAILY - FEDBIZOPPS ISSUE OF SEPTEMBER 03, 2016 FBO #5398
SOLICITATION NOTICE

65 -- NHLBI Heart and Lung Sample Collection Project - Statement of Work

Notice Date

9/1/2016
 

Notice Type

Presolicitation
 

NAICS

325414 — Biological Product (except Diagnostic) Manufacturing
 

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-2016-280-JML
 

Archive Date

9/23/2016
 

Point of Contact

Jonathan M. Lear,
 

E-Mail Address

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

Small Business Set-Aside

N/A
 

Description

Contractor requirements / Statement of Work 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 Johns Hopkins University, 601 North Caroline St., Baltimore, MD 21205 to provide samples for the NHLBI Heart and Lung Transplant Sample Collection Project. BACKGROUND The mission of the NHLBI Division of Intramural Research (DIR) is to perform robust scientific and clinical research leading to a better understanding of biology and clinical pathology. To attain this goal, we have built a strong basic science foundation and coupled it closely with innovative technology development and outstanding clinical research both at the NIH Clinical Center and in partnership with local hospitals. The purview of DIR's research is broad, encompassing investigations into the basic principles of molecular, cellular, and organ-level biology and their relationship to disease. Some current areas of fundamental interest include single molecule structure; protein assembly; molecular and cell biology; cell signaling and motility; membrane trafficking; physiology; systems biology; engineering and technology development. Insights into disease mechanisms derived from basic studies form the basis for translational research into new diagnostic and therapeutic approaches. DIR investigators also conduct concept-based clinical studies in the areas of interventional and surgical cardiology; pulmonary medicine; sickle cell anemia; bone marrow transplant; and hematologic disorders. Heart and lung transplantation are well-established treatment options for selected patients with end-stage heart and lung disease, respectively. Advances in surgical techniques have significantly reduced post-operative complications, resulting in 1-year survival that often exceeds 90 percent. Unfortunately, long-term graft viability is still limited by chronic rejection, which is manifested in heart grafts as chronic allograft vasculopathy (CAV) and in lung grafts as chronic lung allograft dysfunction (CLAD). The most common CAV risk factor is acute rejection (AR), which occurs in up to 20 percent of heart-transplant patients within the first 6 months after transplantation. Given this high prevalence, heart-transplant patients undergo repeated invasive endomysial biopsies (EMB) to monitor for the presence of AR. Unfortunately, AR can often occur in a non-uniform pattern in the heart, and since EMB only sample a small percentage of the heart, this results in a high false-negative rate in addition to high cost and procedure-related complications. A low concordance rate between pathologists' biopsy grading presents further problems. PURPOSE Acute rejection (AR) occurs within the first 6 months after transplantation in 20 percent of heart-transplant patients and in 50 percent of lung-transplant patients. Given the often silent clinical presentation of AR, these patients require monitoring with repeated invasive and costly endomyocardial (EMB) or transbronchial biopsies (TBBx). Since organ transplantation is essentially genomic transplantation, our prior studies leveraged the use of distinctive graft and recipient genotype single-nuclear polymorphisms (SNPs) to barcode donor DNA circulating in recipient serum. We have shown that levels of donor DNA measured as the percentage of circulating cell-free donor-derived DNA (%ccfdDNA) correlates with AR diagnosis and severity as detected by biopsy. The performance receiver operator curve (ROC) of %ccfdDNA yielded an area under the curve (AUC) of 0.83. Using this technique, we can diagnose AR by measuring elevations in %ccfdDNA up to 5 months before EMB-detected pathology. While these findings suggest that monitoring %ccfdDNA may offer a high-performing, non-invasive, and early diagnostic tool of AR, further validation studies are required to determine its clinical utility. The ability to diagnose AR earlier than that possible with a biopsy opens a window also enables our ability to investigate early immunologic changes as well as to identify potential AR biomarkers. Thus, the primary objective of this project is to validate the predictive accuracy and ROC characteristics of %ccfdDNA in a study using various clinical samples obtained from surrounding transplant centers. The secondary objectives are: 1) to compare %ccfdDNA characteristics in AMR (antibody-mediated rejection) and ACR (acute cellular rejection), 2) to determine whether %ccfdDNA can accurately predict the development of chronic rejection as reflected by cardiac allograft vasculopathy (CAV) and chronic lung allograft dysfunction (CLAD) in heart- and lung-transplant recipients, respectively; and 3) to study early immunological changes associated with a significant rise in %ccfdDNA. CONTRACTOR REQUIREMENTS Please see attachment titled "Statement of Work." PERIOD OF PERFORMANCE The period of performance is estimated to be for two (2) years. JUSTIFICATION 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. Per the authority of FAR 6.302-1, the services are available from only one source. This acquisition is part of a large research consortium with surrounding heart / lung transplant centers. Only those centers within a 100-mile radius and / or two-hour drive of the National Institutes of Health main campus are eligible for this research consortium. This is because NIH employees must make frequent, sometimes unexpected trips to and from each center throughout the span of the consortium. As a result, all heart / lung transplant centers within the 100-mile radius and / or 2.5 hour drive have been selected to participate in this consortium. These centers include; The University of Maryland Medical Center, Johns Hopkins Hospital, Virginia Commonwealth University Medical Center, Inova Fairfax Hospital, and Washington Hospital Center. These are the only centers capable of performing the work outlined in this document. 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 325414, Biological Product (except Diagnostic) Manufacturing, and the Small Business Size Standard is 1,250 employees. 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) 05-89-1 (August 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 September 8, 2016 at 9:00AM EST and must reference synopsis number NHLBI-CSB-HL-2016-280-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. 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-2016-280-JML/listing.html)
 

Place of Performance

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

Zip Code: 20892
 

Record

SN04252787-W 20160903/160902000424-b509490f7fd248a1a153a2a14f051fb5 (fbodaily.com)
 

Source

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

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