PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS 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. The National Institutes of Health, National Institute of Child Health and Development (NICHD), in support of the work of the National Institute of Diabetes, Digestive, and Kidney Disease (NIDDK), Laboratory of Bioorganic Chemistry intends to award a purchase order without providing for full and open competition to AtCor Medical Inc, 184 Shuman Blvd, Suite 515, Naperville, IL 60563 acquire SphygmoCor® XCEL PWA and PWV System Non invasive Pulse Wave Velocity system. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 339112 with a Size Standard 1000. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Regulation (FAR) Circular (FAC) 2020-06 effective 05-06-2020. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000) and FAR Subpart 12- Acquisition of Commercial Items. 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 and 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. Place of Performance National Institutes of Health 9000 Rockville Pike Bethesda MD 20892 United States DESCRIPTION OF REQUIREMENT Arterial stiffness is an established indicator and independent risk factor of atherosclerotic heart disease, a major cause of morbidity and mortality in the world. The assessment of arterial stiffness by pulse wave velocity and central blood pressure is a validated marker for the development and progression of cardiovascular disease and is an important risk assessment tool. Arterial stiffness may be affected by endothelial function through differences in vessel wall smooth muscle tone or by alternations in the integrity of the vessel wall. Importantly, endothelial dysfunction and hence arterial stiffness may be modifiable, especially in certain high-risk groups. This proposal is to purchase the SphygmoCor XCEL PWA/PWV system and the associated supplies needed to study patients at the NIH on IRB-approved research protocols. The machine will be used by multiple investigators in NIDDK, including but not limited to Dr. Stephanie Chung, Dr. Rebecca Brown, and Dr. Amber Courville. The SphygmoCor XCEL PWA/PWV system is the only FDA-cleared device indicated for the measurement of central blood pressure and pulse wave velocity with combined technology in one machine. It is an innovating, safe and non-invasive testing device that reflects the vascular health of medium to large vessels. The procedure takes only 15 minutes produces test reliable and reproducible results. This makes it a specialized tool for research in special populations, such as children and adolescents. Using this FDA-cleared device will minimize risk and maximize benefit to our research participants and provide high quality research data needed for NIH studies. The contractor shall provide the following: SphygmoCor® XCEL PWA and PWV System Noninvasive Pulse Wave Velocity system, including: SphygmoCor® XCEL Software Suite AtCor Medical Electronics Module AtCor Medical brachial blood pressure cuffs (3 sizes) AtCor Medical/Millar pressure tonometer AtCor Medical femoral blood pressure cuff (1 size) PWV Cuff XL Adult SphygmoCor XCEL Calibration Kit Notebook computer with factory installation and testing of SphygmoCor ® software SphygmoCor XCEL cuff storage tray Hardware and Software Maintenance Contract Freight Charge 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. Only one source is available: Per FAR 13.106-1(b)(1) the Contracting Officer has determined AtCoR Medical Inc is the developer and sole provider for the FDA-cleared SphygmoCor system. They hold proprietary patents and knowledge for this type of capability. There is only one available source. The SphygmoCor CPV and SphygmoCor XCEL PWA/PWV is the only FDA-cleared device that combines the technology to measure central blood pressure and carotix femoral pulse wave velocity in a single platform. The device is needed to evaluate patients on NIH IRB approved protocols to fulfill the NIDDK mission of improving care and understanding of patients with diabetes and metabolic diseases. 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, 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 to this notice shall be submitted electronically by 11:00 am Eastern Standard Time, on June 18, 2020 to Verne Griffin,
[email protected] and shall reference solicitation number NICHD-20-117 in the subject line.