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 Five (5) each Liver Human Emulation System 24 pk Quad Liver Chip Kits. The Government... The U.S. Food & Drug Administration (FDA) intends to issue a Sole Source award to Emulate, Inc. for procurement of Five (5) each Liver Human Emulation System 24 pk Quad Liver Chip Kits. 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. The FDA’s CFSAN Division of Toxicology currently has the Emulate Human Liver Organ-on-chips system which consist of the Zoe Culture Module and Orb Hub Module. FDA has conducted several plans and programs utilizing the Emulate system to support the Advancing Regulatory Science Plan. This plan recognized that the agency needed more predictive models to assess the safety of the products that it regulates. The microphysiological system (MPS) technology, which uses human cells, could provide the FDA important data that could fill some pressing regulatory gaps across the Agency. To continue assessment and evaluation of the Emulate system, FDA CFSAN would like to purchase five (5) additional 24pk Quad Liver Chip kits. This will continue to develop performance guidelines that can be utilized by other laboratories, both nationally and internationally, to conduct research which accesses the hepatotoxic potential of chemicals of concern found in foods. 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. The Quad Liver Chip kits is only compatible with the Human Emulation System®. 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.