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INTRODUCTION: THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL AND OPEN COMPETITION (INCLUDING BRAND-NAME). The N... INTRODUCTION: THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL AND OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA) on behalf of the National Institute of Digestive and Diabetes and Kidney Diseases (NIDDK) intends to award a purchase order without providing for full and open competition (including brand-name) to AtCor Medical, Inc. for the procurement of SphygmoCor System. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE: The intended procurement is classified under NAICS code 339112 with a Small Business Size Standard of 1,000 employees. REGULATORY AUTHORITY: The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2023-02 effective February 14, 2023. This acquisition is conducted under the procedures prescribed in FAR Part 13 - Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000). 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 for purchases not exceeding the simplified acquisition threshold. Contracts awarded using FAR Part 13 - Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6 - Competition Requirements. BACKGROUND: The mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to conduct and support medical research and research training and to disseminate science-based information on diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases, to improve people’s health and quality of life. The NIDDK supports a wide range of medical research through grants to universities and other medical research institutions across the country. The Institute also supports government scientists who conduct basic, translational, and clinical research across a broad spectrum of research topics and serious, chronic diseases and conditions related to the Institute's mission. In addition, the NIDDK supports research training for students and scientists at various stages of their careers and a range of education and outreach programs to bring science-based information to patients and their families, health care professionals, and the public. 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. The SphygmoCor System is the only Food and Drug Administration (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 fifteen 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 The National Institutes of Health (NIH) studies. OBJECTIVE: The objective of this requirement is to purchase The SphygmoCor System and to coordinate clinical research and study patients at The NIH on Institutional Review Board (IRB) approved research protocols. SALIENT / REQUIRED FEATURES AND SPECIFICATIONS: The required features and specifications below are necessary to conduct clinical research and study patients at the NIH: SphygmoCor System: SphygmoCor tonometer PWV Cuff Adult (11-85cm) PWV Cuff Large Adult (13-124cm) PWA Cuff Adult 23-33 cm PWA Cuff Large Adult 31-40cm PWA Cuff Ex-Large Adult 38-50cm _ ARM only Power adaptor Power cable – US USB Cable Cuff Hose 2m Notebook Computer: Type: IBM Compatible PC Processor: Intel or Compatible 32 or 64 bits Normal Speed: 2GHz Minimum Memory: 2GB RAM Minimum Size 40GB Hard Disk: 2GB for Installation 10GB for Database Accessories: DVD Drive Printer Drivers: User Provided Communications: USB port Minimum Display 1366 X 768 Pixels Operating Systems Version 1.3: Windows Pro 7, 8.1 Pro, 10 Pro TASK AREAS: Independently, and not as an agent of the Government, the Contractor shall perform all the detailed Task Areas listed below: Task Area 1 – Shipping The SphygmoCor System will need to be delivered to: The National Institutes of Health, NIDDK, Building 10-CRC, 9000 Rockville Pike, Bethesda, MD 20892. Task Area 2 – Warranty Contractor shall provide a 12-month parts and labor warranty, with a 48-hour targeted technical and onsite labor response (including travel time and expenses), all necessary spare parts for the electronics module and the tonometer (including all accessories listed on the contract), and software updates (as required). Task Area 3 – Delivery Delivery shall be within 14 days (ARO) after receipt of order by the vendor. Task Area 4 – Training Training support is available from field engineering staff, training support will be scheduled with user within 48 hours of receipt of shipped system (initial training support is available in person and/or virtual setting). CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION: The SphygmoCor System is already in use at the NIH for protocol procedures and a second identical device is needed to meet the protocol needs and ensure integrity in data collection. AtCor Medical Inc. is the developer and sole provider for the FDA-cleared SphygmoCor system in the USA. AtCor Medical Inc., has the latest technology developed SphygmoCor system to non-invasively determine central (i.e., ascending aortic) blood pressure, carotid-femoral pulse wave velocity (cf-PWV), and associated clinical parameters. AtCor Medical Inc.’s SphygmoCor system provides accurate blood pressure results and has been utilized in the most critical research laboratories. 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 that AtCor Medical, Inc. to be the only reasonably available source to provide the SphygmoCor System the NIDDK requires. PERIOD OF PERFORMANCE: The Contractor shall provide delivery within 14 days (ARO) upon awarded PO with a 12-month warranty. PLACE OF PERFORMANCE: National Institutes of Health National Institute of Digestive and Diabetes and Kidney Diseases Building 10 – CRC 9000 Rockville Pike Bethesda MD 20892 PAYMENT BREAKDOWN FOR SYSTEM: Payment will be in one lump sum. Payment terms will be per the vendor allowance with the vendor being a small business (net 30). CLOSING STATEMENT: This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability in response 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: descriptive literature, delivery timeframe, warranties and/or other information that demonstrates that the offer meets all the foregoing requirements, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity ID (UEI), 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.” Vendor/Contractor – Must be able to accept payments via IPP (Invoice Processing Platform) – The contractor may submit a request for an exception. See below for IPP, IPP helpdesk information and applicable Health and Human Services addendum clause. INVOICING PROCESSING PLATFORM (IPP) In compliance with the Office of Management and Budget (OMB) M-15-19 memorandum “Improving Government Efficiency and Saving Taxpayer Dollars through Electronic Invoicing” directing Federal agencies to adopt electronic invoicing as the primary means to disburse payment to vendors. Invoices submitted under any award resulting from this solicitation will be required to utilize the Invoice Processing Platform (IPP) in accordance with HHSAR 352.232-71, Electronic Submission and Processing of Payment Requests” IPP is a secure, web-based electronic invoicing system provided by the U.S. Department of the Treasury’s Bureau of the Fiscal Service, in partnership with the Federal Reserve Bank of St. Louis (FRSTL). Respondents to this solicitation are encouraged to register an account with IPP if they have not already done so. If your organization is already registered to use IPP, you will not be required to re-register however, we encourage you make sure your organization and designated IPP user accounts are valid and up to date. The IPP website address is: https://www.ipp.gov If you require assistance registering or IPP account access, please contact the IPP Helpdesk at (866) 973-3131 (M-F 8AM to 6PM ET), or IPPCustomerSupport@fiscal.treasury.gov Note: Should an Offeror feel that use of the IPP would be unduly burdensome, the response to this solicitation should include an explanation of this position for a determination by the Contracting Officer. HHSAR 352.232-71 Electronic Submission of Invoice Payment Requests (Feb 2022) will apply when this requirement is solicited and awarded. As stated: (a) Definitions. As used in this clause— Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract. (b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site. (c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures. (d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request. (END OF CLAUSE) 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 9:00 a.m. Eastern Standard Time on Monday, April 24, 2023 to the Contract Specialist, Kerry-Ann Chisholm, at kerry-ann.chisholm@nih.gov. ASSESSMENT OF CAPABILITY: Lowest Price Technically Acceptable