Notice of Intent to Sole Source.docx

PLEASE READ THIS NOTICE CAREFULLY AS IT CONSTITUTES THE ONLY NOTICE THAT WILL BE PUBLISHED.

The Food and Drug Administration (FDA) intends to negotiate a sole source, firm-fixed-price contract with MESA LABORATORIES, INC. for Calibration and Maintenance Support Services

The FDA’s SEAHAFL requires a service maintenance contract that shall include providing annual calibration service for government owned VPx temperature and/or humidity sensors, DataTrace MPIII datalogger sensors, MPRF datalogger sensors. Additionally, the contract shall include technical support in the diagnostic, troubleshooting, and potential repair of government-owned temperature monitoring devices and software used to monitor and respond to strict temperature limits in regulatory equipment such as refrigerators, freezers, and incubators. The calibration service requires appropriate equipment and trained personnel that meets ISO/IEC 17025 requirements and the results of the calibration documented on ISO/IEC 17025 compliant certificates. This type of service is regularly purchased from commercial source(s) throughout most federal regulatory agencies. Currently, there are no contract vehicles or viable competitive small or large business concerns capable of performing this requirement specifically due to proprietary stipulations.

Government’s Minimum Requirement:

1. Vendor shall schedule and calibrate PNL’s 92 VPx sensors on-site at SEAHAFL on or before December 31st of each calendar year as the sensors cannot be taken offline beyond 24-hours for calibration service. The calibrated VPx sensors shall meet or exceed OEM specifications and requirements.

2. 10 DataTrace MPIII sensors shall be sent to Mesa Labs in Lakewood, Colorado sequentially (10 at a time) on or before April 15th for calibration service so that SEAHAFL does not lose temperature distribution mapping capability at any given period of time. 10 DataTrace sensors are expected to be returned to SEAHAFL no later than 3 weeks after receipt. All return shipping cost shall be included in the awarded contract. The calibrated DataTrace sensors shall meet or exceed OEM specifications and requirements.

3. 5 MPRF sensors shall be sent to Mesa Labs in Lakewood, Colorado during the contract performance period for calibration. The calibrated MPRF sensors shall be returned no later than 3 weeks after receipt and meet or exceed OEM specifications and requirements. All return shipping cost shall be included in the awarded contract.

4. Each DataTrace, MPRF and VPx sensor shall be calibrated once per calendar year.

5. After calibration, the DataTrace, MPRF and VPx sensors shall meet or exceed the manufacturer’s published specifications for at a minimum of one calendar year. Vendor shall include statements in the Certificate of Calibration to state the following: a. Calibration results “As received” and “After calibration” for each calibrated sensor probe.

b. Serial number of the calibrated sensor probe.

c. Date when the next calibration is due.

d. DataTrace, MPRF and VPx sensor calibration results were obtained using equipment capable of producing results that are traceable through NIST to the International System of Units (SI)

e. DataTrace, MPRF and VPx sensor calibration results are in compliance with ISO/IEC17025 requirements.

f. DataTrace, MPRF and VPx sensor calibration process has a Test Uncertainty Ratio of 4:1 or greater.

g. DataTrace, MPRF and VPx sensor calibration data acquisition software has been validated and complies with Title 21, Code of Federal Regulations Part 11 requirements for electronic records, if applicable.

Tentative Period of Performance 4/1/2025 – 3/31/2026 - Base Year 4/1/2026 – 3/31/2027 – Option Year One 4/1/2027 – 3/31/2028 – Option Year Two 4/1/2028 – 3/31/2029 – Option Year Three 4/1/2029 – 3/31/2030 – Option Year Four

This notice will be distributed solely through the Official U.S. Government System for Contract Opportunities website (SAM), http://www.sam.gov. Interested parties are responsible for monitoring this site to ensure they have the most up-to-date information about this acquisition. The North American Industry Classification System (NAICS) Code is 811210, Electronic and Precision Equipment Repair and Maintenance. The Product or Service Code (PSC) is J066.

The FDA intends to negotiate with only one source under the authority of FAR 13.501(a)(1)(ii). This notice of intent is NOT a request for competitive quotations; however, in accordance with FAR 5.207(c)(16)(i), all responsible sources may submit a quotation which shall be considered by the agency. All quotes shall be submitted to the Contract Specialist, Andrea Howard, via email at andrea.howard1@fda.hhs.gov . Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Telephone requests will not be considered. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.

Vendors must be registered in SAM to receive government contracts. Please ensure that your company’s SAM registration information is updated, accurate, and complete.

All information submitted must be received by the Contract Specialist no later than expiration of this notice. This Notice of Intent to sole source will close at 05:00 PM EST on March 18, 2025.

Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).