A17_JA_Redacted_1.pdf

United States Department of the Interior

INTERIOR BUSINESS CENTER

Washington, DC 20240

SOLE SOURCE JUSTIFICATION

SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS

AUTHORITY: FAR 13.501(a), 41 U.S.C. 1901

SOLICITATION # 140D0425Q0183

1. Identification of the agency and the contracting activity, and specific identification of the document as a “Sole Source Justification.”

This document is a justification for other than full and open competition for the procurement by the U.S. Department of the Interior (DOI), Interior Business Center (IBC), Acquisition Services Directorate (AQD), Division III Branch IV on behalf of the U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH).

2. Nature and/or description of the action being approved.

The purpose of this document is to outline the rationale for procuring a service agreement for Azenta laboratory equipment for NIH National Center for Advancing Translational Sciences (NCATS), Division of Preclinical Innovation (DPI) on a sole source basis from Azenta US, Inc (Azenta), an other than small business. This is a new requirement with no acquisition history and is anticipated to be awarded as a stand-alone purchase order.

3. A description of supplies or services required to meet the agency’s needs (including the estimated value).

NCATS DPI requires a service agreement to support the Azenta SampleStore II (2), tube auditor

(1) and CryoStore units (3). These units are designed for the storage and preservation of biological samples and are critical to the research performed at NCATS. The SampleStore and associated tube auditor are located in the Compound Management group at NCATS (CoMa). The Azenta SampleStores holds 90% of the compounds used by Compound Management at -20C, which are then distributed and used by every group at NCATS DPI. They were modified during a relocation to a new, larger space, designed to ensure sample capacity for years to come. The modified store was manufactured by Brooks Life Sciences, now known as Azenta Life Sciences, and the modifications could only be performed by Brooks since only their equipment and spare parts were compatible. Additionally, only Brooks (now Azenta) could incorporate the parts from the store being modified into a new store as well as support picking/placing/scanning of the FluidX Acoustic tubes. Due to these modifications and specifications, only Azenta can perform service and maintenance on the equipment.

The estimated value of this requirement is (rounded). The Period of Performance (PoP) for this requirement is two years: a base period of 12 months and an option period of 12 months.

4. An identification of the statutory authority permitting sole source acquisition.

This is an acquisition conducted under the authority of the Simplified Procedures for Certain Commercial Items. The statutory authority permitting sole source acquisition is 41 U.S.C 1901 as implemented by FAR 13.501(a)(1)(ii).

5. A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

The Azenta B3C CryoStore and SampleStore units are highly specialized and sensitive piece of equipment that require service and maintenance by technicians with specific expertise in these exact makes and models. Azenta, as the original equipment manufacturer and sole authorized service provider, is the only contractor authorized and capable of delivering the necessary repairs and support for these proprietary systems. The Azenta SampleStore II and CryoStore units are used by Compound Management to store approximately 90% of all compounds purchased and maintained at the request of various groups within NCATS. The contents of these systems represent a significant financial investment, and the storage environments are maintained at extremely low temperatures of -20°C or -190°C. It is critical that any technical issues with these instruments are addressed promptly to prevent loss of valuable samples. Azenta is uniquely qualified to provide these services, as they have the capability to monitor the status of the systems remotely and take immediate action in the event of significant temperature fluctuations or other urgent issues. The service contract includes coverage for HVAC repairs and replacement parts, ensuring that any temperature-related problems will be addressed by Azenta.

Only Azenta can provide factory-trained and certified technicians with the requisite knowledge and access to genuine replacement parts. Utilizing technicians lacking Azenta-specific training or employing third-party components may result in improper repairs and could compromise equipment integrity and performance. Since the acquisition of these units, Azenta-trained personnel have successfully provided all required preventative maintenance and repairs. Finally, due to the proprietary nature of the equipment and the necessity of using certified technicians and genuine parts to ensure proper functionality and warranty compliance, Azenta is the only source capable of meeting these service requirements.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as practicable, including whether a notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

In accordance with FAR 5.203(a), a Notice of Intent to Sole Source was publicized on the System for Award Management (SAM) on August 7, 2025, with any responses to the notice due on August 14, 2025. The notice included a draft Statement of Work (SOW) and requested capability statements from interested parties that clearly demonstrated the capability to provide the required service agreement. No responses were received.

7. A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable.

The contracting officer will determine the pricing is fair and reasonable in accordance with FAR 13.106-3(a)(2). Evaluation will include comparison with similar, recently awarded requirements, the Independent Government Estimate (IGE) which was based upon previous awards, as well as price lists or catalog prices.

8. A description of the market research conducted (see Part 10) and the results or a statement of the reason market research was not conducted.

Market research included searching previous purchases of similar acquisitions and publicizing a Notice of Intent to Sole Source on SAM.gov. The results confirmed that only Azenta can meets the agency’s needs.

9. Any other facts supporting the use of other than full and open competition.

None.

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

None.

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

For future acquisitions, the Government will conduct new market research to determine whether any additional Azenta authorized service providers are available.

12. Contracting officer certification that the justification is accurate and complete to the best of the contracting officer’s knowledge and belief.

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer U.S. Department of the Interior/Interior Business Center Acquisition Services Directorate

13. Requirements personnel certification.

I certify that the technical data which forms a basis for this justification is complete and accurate and meets the Government’s minimum needs.

Contracting Officer’s Representative Department of Health and Human Services National Institutes of Health The National Center for Advancing Translational Sciences

14. Reviews and Approvals

Approve

Contracting Officer U.S. Department of the Interior/Interior Business Center Acquisition Services Directorate