Inactive Total Small Business Set-Aside (FAR 19.5)

The U.S. Food & Drug Administration (FDA) intends to issue a Sole Source award to Emulate, Inc. for procurement of One (1) each of the Human Emulation System® Zoe Culture Module 2, Part# ZOE-CM2 and O... The U.S. Food & Drug Administration (FDA) intends to issue a Sole Source award to Emulate, Inc. for procurement of One (1) each of the Human Emulation System® Zoe Culture Module 2, Part# ZOE-CM2 and One (1) each of Orb Hub Module, Part# ORB-HM1. The Government intends to issue a sole source award in accordance with FAR 6.302-1, only one responsible source and no other will satisfy the agency requirements for the above stated equipment. FDA program office is currently utilizing the Emulate Human Emulation System® for organ-chip research. This research utilizes both the Zoe Culture Module and the Orb Hub Module. The systems function with specific compatible components called “Organ-Chips”, pods, and reagents that are used by the FDA to be able to conduct research using the Human Emulation System®. Additional Emulate systems are required to meet the FDA research mission and goal for the cell culture growth conditions of the FDA project. Since the FDA lab has developed, optimized and approved a protocol specific to Emulate systems that fits the scope of the FDA research project and has currently ongoing experiments using the Emulate system, 100% compatibility is required for the added systems. This will ensure that the added systems maintain consistency with the existing consumables, reagents, and FDA protocols to continue to support the FDA Centers mission of protecting human and animal health. The Human Emulation System® Zoe Culture Module 1 and Orb Hub Module are unique in its operation and many of the features and benefits of the technology are not known to be available in other commercially available instruments that may perform similar functions. Human Emulation System® unique capability such as being able to operate outside of a CO2 incubator and provide gas and vacuum to the culture module supports the parameters set for the FDA research experiments. The Human Emulation System® is the only known source to be capable of providing seamless consistency and continuation of parameters to support FDA program office requirement. Emulate, Inc. is the sole source provider of the Human Emulation System®, which is a platform comprised of (i) Organ-Chips (ii) automated instruments (Pod Portable Module, Zoe Culture Module, and Orb Hub Module) and (iii) software applications, designed to work with various Organ-Chips for integration and analysis. This will be a firm fixed price award. The NAICS Code is: 334516 Analytical Laboratory Instrument Manufacturing Emulate, Inc. 27 Drydock Avenue, 5th Floor Boston, MA 02210 This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement to Sarah Hussain, sarah.hussain@fda.hhs.gov in writing and must be within 14 days after date of publication of this notice which may be considered by the agency. A determination by the Government not to compete as a result of information received is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No phone calls will be accepted.