IVD Device Infectious Disease Mapping Manual

Subject: Notice of Intent to Sole Source
FDA-1182445
Date: April 24, 2017

The U.S. Food & Drug Administration intends to issue a sole-source purchase order to Regenstrief Institute for one (1) IVD Device Infectious Disease LOINC Mapping Manual that provides a consensus standard to unambiguously define how to map existing infectious disease IVD tests to existing LOINC codes. Award will be made in accordance with Federal Acquisition Regulation (FAR) Part 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirements using Simplified Acquisition Procedures per FAR Part 13. Regenstrief Institute is the sole-supplier and only company that is able to provide all of the above requirements. This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement within five (5) days after the publication of this synopsis which shall be considered by the agency. Responses received after 5 days or without the required information may not be considered. 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 normally be considered solely for the purpose of determining whether to conduct a competitive procurement. For information concerning this acquisition, contact Heather Kinsey, Contract Specialist at Heather.Kinsey@fda.hhs.gov or call (240) 402 - 7591.