Inactive Total Small Business Set-Aside (FAR 19.5)

The U.S. Food & Drug Administration (FDA), intends to issue a Sole Source award to STEMCELL Technologies Inc. (STEMCELL) for procurement of one (1) each Automated Cell Separation Instrument RoboSep®. ... The U.S. Food & Drug Administration (FDA), intends to issue a Sole Source award to STEMCELL Technologies Inc. (STEMCELL) for procurement of one (1) each Automated Cell Separation Instrument RoboSep®. 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 currently owns and operates a RoboSep® cell separator instrument to support research of Antibody-dependent functions of innate cells such as Natural Killer Cells and Monocytes. The current cell separator is obsolete, and maintenance is no longer supported by the manufacturer, STEMCELL. Therefore, FDA requires an upgraded automated cell separation instrument that needs to be compatible with existing qualified SOPs and assays developed using the original RoboSep® to continue the FDA mission in research and expand capability with advanced technology. The instrument shall be fully automated where the protocol steps need to be done inside the instrument. It shall also be able to use the same customized and qualified protocols, proprietary reagents, accessories and consumables that were used and developed using the existing FDA instrument to maintain the consistency of procedures in place. RoboSep® is unique in its operation and many of the features and benefits of the technology are not available in other commercially available instruments that may perform similar functions. It is the only known source to be capable of providing seamless transfer of parameters and support FDA program office requirement. STEMCELL is the sole source manufacturer and supplier of the RoboSep® instrument, software and ancillary products. Previous award to STEMCELL has been made for the old model of the Automated Cell Separation Instrument, RoboSep®, this award will be to procure the upgraded model. This will be a firm fixed price award. The NAICS Code is: 334516 Analytical Laboratory Instrument Manufacturing STEMCELL Technologies Inc. 6425 S 216TH ST, KENT, WA 98032 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 seven (7) 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.