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FBO DAILY - FEDBIZOPPS ISSUE OF SEPTEMBER 27, 2017 FBO #5787
SOLICITATION NOTICE

65 -- Genomic Research Alliance for Transplantation (GRAfT) - Contractor Requirements

Notice Date

9/25/2017
 

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

HHSN26818HL00006S
 

Archive Date

10/14/2017
 

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 for the GRAfT contract. Introduction This is a pre-solicitation non-competitive (notice of intent) synopsis to award a purchase order without providing for full and 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 the University of Maryland to provide heart and lung transplant samples to the NHLBI Division of Intramural Research (DIR) in accordance with the following information. Background Information Heart and lung transplantation are well-established treatment options for selected patients with end-stage heart and lung disease. 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. There is little understood about the nature of AR. For this reason, Dr. Hannah Valantine, Director of the Laboratory of Transplantation Genomics in the National Heart, Lung, and Blood Institute (NHLBI) established a local research consortium-Genomic Research Alliance for Transplantation (GRAfT)-dedicated to learning more about the disease. GRAfT is comprised of various heart/lung-transplant centers throughout the Washington, D.C. metropolitan area. Each center contributes biological samples from consenting heart/lung-transplant patients to GRAfT's bio-bank located at NHLBI's facilities for further sequencing and analysis. Purpose and Objectives The Laboratory of Transplantation Genomics is in need of biological samples from heart/lung-transplant patients in order to allow GRAfT to effectively observe AR and begin validating the predictive accuracy and ROC characteristics of %ccfdDNA. Samples collected from the Contractor will be sequenced by NHLBI, and the resultant data will be added to an existing data set for further analysis. Effective analysis cannot occur without the full quantity of samples. Contractor Requirements See attached document titled "Contractor Requirements." Sole Source Justification This acquisition is part of a large research consortium with surrounding heart and lung transplant centers. Only those centers within a 100-mile radius and/or two-hour drive of the National Institutes of Health (NIH) 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 and lung transplant centers within the 100-mile radius and/or two-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 the statement of work. 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. (1) For purchases not exceeding the simplified acquisition threshold, contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, or industrial mobilization). FAR Clauses The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. The provision at FAR clause 52.212-2, Evaluation - Commercial Items, is applicable. The Government will award a contract resulting from this notice to the offeror listed above. The following factors shall be used to evaluate the offer: The contractor shall demonstrate its ability to provide samples that meet the required specifications listed. FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items, is applicable. An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (p) of this provision. FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items, applies to this acquisition. Additional Information The North American Industry Classification System (NAICS) Code is 325414 and the Small Business Size Standard is 1,250. 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) 05-95 (January 19, 2017). 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 29, 2017 at 12:00PM EST and must reference synopsis number HHSN26818HL00006S. Responses shall 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/HHSN26818HL00006S/listing.html)
 

Place of Performance

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

Zip Code: 20892
 

Record

SN04692567-W 20170927/170925231332-0c3a97200f2a220e344d624f0cb00f8c (fbodaily.com)
 

Source

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

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