NOI SS_Liquid Helium Fill Service.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 BRUKER BIOSPIN CORPORATION for a 12-month liquid helium fill service for a Bruker 600 MHz Nuclear Magnetic Resonance (NMR) spectrometer.

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, Maintenance, Repair, and Rebuilding of Equipment – Instruments and Laboratory Equipment.

The FDA intends to negotiate with only one source under the authority of FAR 12.201-1. THIS NOTICE IS NOT A REQUEST FOR QUOTES; however, all responsible sources may submit a quotation which shall be considered by the agency at no cost to the Government. All quotes shall be submitted to the Contract Specialist, Andrea Howard, via email at andrea.howard1@fda.hhs.gov no later than 10:00 A.M., EST on Friday, March 13, 2026. 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. No contract award will be executed based on the information received in response to this notice. Oral communications are not acceptable in response to this notice.

The contractor shall comply with all Federal, State, and local laws and regulations pertaining to Advance 600 MHz Nuclear Magnetic Resonance Spectrometer liquid helium fill service. Prior to contract start date, the contractor shall obtain all necessary permits, registrations, and licenses for the Advance 600 MHz Nuclear Magnetic Resonance Spectrometer liquid helium fill service for the jurisdiction in which services are to be performed. The contract is subject to the FAR clause 52.246-4, Inspection of Services – Fixed-Price, which provides for adequate enforcement to ensure satisfactory performance.

Background

OPQR-STL (Office of Pharmaceutical Quality Research in St. Louis, MO) is a world-class regulatory laboratory and actively conducts research and testing projects related to the safety and efficiency of pharmaceuticals. Nuclear magnetic resonance (NMR) spectroscopy is an advanced analytical technique used in determining the molecular structure and quantification of a compound. A Bruker AVANCE NEO 600 MHz NMR spectrometer is located within the OPQR-STL lab to collect multidimensional high-resolution solution-state NMR spectra for both qualitative and quantitative analysis of drug products, including regulatory analysis of critical drugs including heparin and semaglutide. The spectrometer is composed of a superconducting magnet immersed in liquid helium that requires a regular supply of liquid helium to keep it cold and superconductive.

To ensure adequate liquid helium supply and proper functioning of the spectrometer, OPQR requires an annual helium fill service by an authorized original equipment manufacturer (OEM) supply provider.

Scope To procure liquid helium fill service for FY2026 for a Bruker 600 MHz Nuclear Magnetic Resonance (NMR) spectrometer located at the U.S. Food and Drug Administration, Center for Drug Evaluation and Research’s, Office of Pharmaceutical Quality Research in St. Louis, MO (OPQR-STL) for ensuring the functionality of the instrument. Period of Performance of this contract will (PoP) of 4/1/2026 to 3/31/2027.

Minimum Service Requirements The vendor shall perform the following to ensure successful performance:

· Helium fill service should be provided for an annual period of 12 months for the instrument Bruker NEO 600 MHz spectrometer AVANCE 600/54 Ascend ULH, System Type: AV4600, System ID: 10277811.

The vendor shall provide liquid helium and fill the instrument with 160 L of helium as needed, which is anticipated approximately twice a year. Each fill increases the liquid helium level from 50% to 100%. The OPQR POC will check the helium level of the instrument and request a filling date when the helium level is approximately 55%. In FY2026, the magnet will require a refill in late March and another six to seven months later in August or September.

· The vendor shall be an OEM authorized contractor to ensure proper filling of the liquid helium in the equipment. A certification and/or letter from the OEM is required to validation vendor’s abilities to comply with the OEM specification for liquid helium refill.

· The vendor shall ensure the liquid helium level of the instrument (System Type: AV4600 System ID: 10277811) is more than 55%, as measured by OPQR, during the period stated in the contract and will provide a fill, as needed, within 5 business days upon request.

· The vendor shall be an OEM certified contractor and shall have technical expertise to respond to a quench, which may occur in very rare instances, by the helium fill service in which case the magnet loses magnetic properties rendering the NMR not functional. If such an event occurs, the vendor is responsible for returning the magnet to performance levels that were attained prior to the quench under the scope of this requirement at no additional cost to the Government.

· The vendor shall provide a service report to the Technical Point of Contact (TPOC) for signature with each nitrogen fill indicating the helium levels before and after filling.

· The vendor shall ensure proper handling and transport of the liquid helium in accordance with federal, state, and local regulations.

4. Deliverable

5. Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI) 600 MHz NMR spectrometer, System Type: AV4600 System ID: 10277811

6. Acceptance Criteria Inspection and Inspection will be performed after the completion of each supply refill by the assigned TPOC.

7. Period of Performance The period of performance 4/1/2026 – 3/31/2027.

8. Place of performance/delivery address

FDA/CDER/OPQ/OPQR

645 S Newstead Ave.

St. Louis, MO 63110

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.

Vendors must be registered and active in SAM for the purpose to receive ALL Government contract awards. 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 10:00 A.M., EST on Friday, March 13, 2026.

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).