Inactive Total Small Business Set-Aside (FAR 19.5)

The U.S. Food & Drug Administration (FDA) intends to issue a Sole Source award to NanoString Technologies for procurement of NanoString cassettes and reagents. The Government intends to issue a sole s... The U.S. Food & Drug Administration (FDA) intends to issue a Sole Source award to NanoString Technologies for procurement of NanoString cassettes and reagents. 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 CDER Division of Applied Regulatory Science (DARS) is conducting a research program to evaluate the usefulness of humanized mice (HM) for regulatory purposes. FDA is currently utilizing the nCounter® MAX Analysis System to conduct research. To continue immunogenicity studies and evaluation of the nCounter® system, FDA CDER would like to purchase compatible cassettes and reagents. Nanostring Technologies is the sole source provider of the nCounter® Analysis System. Compatible consumables provided by NanoString are provided exclusively by NanoString Technologies and are only available from NanoString. The nCounter platform utilizes a digital technology, proprietary to NanoString. This will be a firm fixed price award. The NAICS Code is: 334516 Analytical Laboratory Instrument Manufacturing Nanostring Technologies 530 Fairview Avenue North Seattle, WA 98109 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 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.