Inactive

The U.S. Food & Drug Administration (FDA) intends to issue a Sole Source award to Thermo Fisher Scientific for procurement of cell line engineering services utilizing the Invitrogen™ Flp-In™ 293 cell ... The U.S. Food & Drug Administration (FDA) intends to issue a Sole Source award to Thermo Fisher Scientific for procurement of cell line engineering services utilizing the Invitrogen™ Flp-In™ 293 cell line and proprietary cell line with control. 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 planned and optimized drug metabolizing assays to assess functionality of the variant compared to wild-type and cell control. FDA has established cell line assays to assess functionality of the cell line. To maintain established assays and parameters of the research, FDA CDER would like to purchase cell line engineering services and cell line from Thermo Fisher Scientific. Thermo Fisher Scientific is the sole source provider of cell line engineering services utilizing the Invitrogen™ Flp-In™ 293 cell line. As such, services to generate the isogenic cell lines are generated in the Invitrogen™ Flp-In™ 293 cell line. The cell line engineering and the cell line is proprietary to Thermo Fisher Scientific. This will be a firm fixed price award. The NAICS Code is: 334516 Analytical Laboratory Instrument Manufacturing Thermo Fisher Scientific 5781 Van Allen Way Carlsbad, CA 92008 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.