Notice of Intent to Sole Source for A Study to Explore the Feasibility of using Combined Modalities to Test the Safety of the CardioMEMS Device in PAH Patients

INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Heart, Lung, and Blood Institute (NHLBI) intends to negotiate and award a contract modification for additional work without providing for full and open competition to Allegheny-Singer Research Institute, 320 E. North Avenue Pittsburgh, PA 15212-4756 for "A Study to Explore the Feasibility of using Combined Modalities to Test the Safety of the CardioMEMS Device in PAH Patients." NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541712 with a Size Standard of 500. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-89. This acquisition is conducted under the procedures as prescribed in FAR subpart 15-contracting by Negotiations at an amount exceeding the simplified acquisition threshold ($150,000). STATUTORY AUTHORITY This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302-1-Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1). DESCRIPTION OF REQUIREMENT Background Although there are now therapeutic options that improve long-term outcomes, pulmonary arterial hypertension (PAH) remains fatal. Thus, there is a need not only for further investigations to provide new targets for therapeutics, but there is an overriding need for better surrogate markers for outcome prediction and monitoring of treatment efficacy in order to improve survival and quality of life for these patients. This contract provided valuable insight into both of these clinical needs by creating and testing several novel and dynamic prognostication tools, which combined ambulatory in vivo hemodynamic monitoring using the CardioMEMs deviceTM with cardiac MRI technology coupled with a unique integrative learning software that has both potential applications for research and clinical practice. Four unique innovations arose out of this Stage A of the VITA contract: 1) The first use of the implantable CardioMEMs ambulatory hemodynamic sensor in PAH to monitor disease progress 2) The first combined use of the CardioMEMs sensor with cardiac MRI to develop a unique right ventricular-pulmonary arterial coupling element 3) The first use in PAH patients of the CardioMEMs sensor to obtain real time exercise hemodynamics 4) The testing of a unique machine leaning software, ALiE, to decipher patterns real time in longitudinal hemodynamic data and other prognostic variables, which may predict outcome in PAH. It is our hope that these innovations will serve as superior surrogate markers for outcome prediction and monitoring of treatment efficacy that will lead to an improvement survival and quality of life for our patients. Purpose and Objectives Purpose is to extend the funded research entitled "A Study to Explore the Feasibility of using Combined Modalities to Test the Safety of the CardioMEMS Device in PAH Patients," contract number HHSN268201400008C, and funded under Vascular Interventions/Innovations and Therapeutic Advances (VITA) Stage A, BAA-NHLBI-CSB-HV-2013-02-JS. This extension is needed as the current revised enrollment criteria is under DSMB and IRB review which may take a few months to complete the review and revision process. In order to complete the last 3 patients' enrollment, the investigator requested an extension to complete the current proposed project after receiving the IRB and DMSB approval. Period of Performance This will be a cost- reimbursement option period with a period of performance from December 1, 2016 through May 31, 2017. Project Description The purpose of this extension is to 1) Continue to collect data on the 17 previously implanted patients; and, 2) To allow the implantation of the last 2-3 consented patients with at least a 6 month follow-up for safety and functional assessments. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION This requirement was initially posted as a BAA and therefore, a sources sought notice was not required as the purpose for using this mechanism was to promote and broaden competition and research. As this added work is a continuation of an existing contract funded under the BAA, further market research will not be conducted. 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 3pm EST on November 25, 2016. Responses must be submitted via email to Jennifer.Swift@nih.gov. All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.