Intent to Sole Source (Temperature Monitoring System)

Food and Drug Administration (FDA)

Notice of Intent to Sole Source Subject: Sole Source Fixed Price Contract for the procurement of a Temperature Monitoring System under Request for Quote FDA-RFQ-24- 1276098 Notice of Intent to Sole Source to:

Mesa Labs.

Pursuant to the authority of 41 USC 3304(a)(1), as implemented by Federal Acquisition Regulation (FAR) Subpart 6.302-1, (there is only one responsible source and no other supplies or services will satisfy agency requirements), the Food and Drug Administration (FDA) intends to award a Sole Source Fixed-Price contract to Mesa Labs located at: Mesa Labs12100 W 6th Ave Lakewood, CO 80228 FDA has a requirement to procure Temperature Monitoring System under Request for Quote FDA-RFQ-24-1276098 as a sole source acquisition.

Mesa Labs is the sole manufacturer and the only source which provides the Temperature Monitoring System. If this acquisition contract is not awarded to Mesa Laboratory Inc., an alternate vendor would not have access to OEM parts and would not be able to provide the service necessary probe specifications to ensure the safe and effective operation of the ViewPoint Continuous Environmental Monitoring System. Without access to these probes the instrument would not be able to be in compliance with A2LA.

Without periodic maintenance and operational qualification of these probes, the data generated by the instrument would be unreliable and not in compliance with laboratory policy. Furthermore, acquisition by an alternate vendor would violate the Mesa Laboratory support warranty. The NAICS Code for this procurement is:

541990- All Other Professional, Scientific, and Technical Services This notice is not a request for competitive proposals. However, any party that believes it is capable of meeting this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement.

A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. It is anticipated that an award will be issued to Cerulean within approximately fifteen (15) days after the closing date of this notice unless the Government determines that any other organization has the capacity to meet this requirement.

Response Date: 10:00 a.m. EST 8/6/2024. Please email responses to Warren Jackson at warren.jackson@fda.hhs.gov