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 Cellular and Developmental Biology intends to award a purchase order without providing for full and open competition for Fibroscan 430 Mini (transient elastography) for DECRS studies from Fidelis, 204 West Spear Street, Suite 3319, Carson City, NJ 89703. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 423450 with a Size Standard 500. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Regulation (FAR) Circular (FAC) 2020-05 effective 03-30-2020. 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 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302- FAR 6.302-1—Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1). Place of Performance National Institutes of Health National Institute of Diabetes, Digestive, and 1550 E. Indian School Road #1 Phoenix, AZ 85014, United States Description of the Requirement : FibroScan 430 Mini+ Package - M/XL Probe, CAP Software, Initial Install & Training, and 1 Yr Premium Diabetes Genetic Epidemiology Section, Phoenix Epidemiology and Clinical Research Branch has been conducting outpatient studies of diabetes, and its complications in American Indians. Recent literature has shown that structural changes in the liver (hepatic steatosis and fibrosis) are associated with obesity and development of diabetes. These changes may be of particular importance in American Indians and in youth. In fact, non-alcoholic fatty liver disease (NAFLD) is the most common form of liver disease in youth. Obesity and insulin resistance are strongly correlated with NAFLD, and NAFLD is highly prevalent in type 2 diabetes. Transient ultrasonographic elastography (Fibroscan) offers a simple validated way to measure hepatic steatosis and fibrosis, and we are planning to incorporate this into our studies (which will include youth 12-years old as well as adults). This should allow us to assess the role of hepatic changes in the development of diabetes, and the relationships with other diabetes risk factors, in this population. 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 previous 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 Fidelis Sustainability Distribution is the sole provider of the FibroScan 430. The FibroScan® 430 Mini+ is intended to provide 50Hz shear wave speed measurements and estimates of tissue stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter) in internal structures of the body. FibroScan® 430 Mini+ is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter). The shear wave speed and stiffness, and CAP may be used as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver. Shear wave speed and stiffness may be used as an aid to clinical management of pediatric patients with liver disease. No other equipment on the open market can replicate the characteristics of the FibroScan 430. 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 to this notice shall be submitted electronically by 11:00 am Eastern Standard Time, on April 27, 2020 to Verne Griffin,
[email protected] and shall reference solicitation number 75N94020Q00011 . Assessment of Capability Award will be made to the contractor who provides the most advantageous quote to the government. Technical factors and price considered. In order to be considered technically acceptable the offeror must provide the services listed under “Description of the Requirement”.