JA QuantStudio.pdf

FEDERAL BUREAU OF INVESTIGATION

FINANCE AND FACILITIES DIVISION | PROCUREMENT SECTION

JUSTIFICATION AND APPROVAL (J&A) FOR OTHER THAN

FULL AND OPEN COMPETITION

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION IN ACCORDANCE WITH 41 U.S.C. 3304 (A) (X)

Requisition Number: SHOP-PR-26-001227

Date: 03/09/2026

Estimated Contract Dollar Value:

1. Identification of the agency and contracting activity.

The U.S. Department of Justice, Federal Bureau of Investigation (FBI), Procurement Section (PS), National Acquisition Programs Unit (NAPU), has prepared this justification for other than full and open competition for the acquisition of an Applied Biosystem QuantStudio 5 Real-Time Polymerase Chain Reaction (PCR) system on behalf of the Laboratory Division (LD), Biometrics Analysis Section (BAS), DNA Support Unit

(DSU).

The nature and/or description of the action being approved, i.e., sole source, limited competition, establishment of a new source, etc.

In accordance with a statutory exception to the fair opportunity process, the FBI requests the award of a sole-source, firm-fixed-price contract to ThermoFisher Scientific/Life Technologies Corporation [CAGE Code 1F3R7], 5781 Van Allen Way, Carlsbad, CA 92008-7321 for an Applied Biosystems QuantStudio 5 (QS5) Real-Time PCR system.

2. A description of the supplies or services required to meet the agency’s needs.

A real-time PCR system (qPCR) instrument is a laboratory device that amplifies DNA while simultaneously measuring its amount in real time using fluorescence. ThermoFisher Scientific has discontinued the Applied Biosystems 7500 and 7500 Fast systems, with sales ending on October 31, 2025. Because the DCU and the DSU currently rely on the 7500 system for critical DNA quantification, a replacement is necessary to maintain operations. The QS5 PCR system is the designated successor to the 7500. Since the currently validated FBI Laboratory qPCR assays are designed specifically for Applied Biosystems instruments, transitioning to the QS5 would only require a material modification study. In contrast, moving to a different manufacturer’s platform would necessitate a full, costly, and time-consuming validation.

JUSTIFICATION AND APPROVAL (J&A) FOR OTHER THAN

FULL AND OPEN COMPETITION

3. The statutory authority permitting other than full and open competition.

The statutory authority permitting other than full and open competition is 41 U.S.C. 3304 (a)(1) as implemented by the Federal Acquisition Regulation (FAR) Subpart 6.103-1entitled, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.”

4. Demonstrate the unique qualifications of the proposed contractor or the nature of the action requiring the use of the authority.

ThermoFisher Scientific/Life Technologies Corporation is the sole manufacturer, distributor and provider of maintenance programs for their products. There are no authorized resellers. Moreover, there are no authorized third-party vendors who can provide the QuantStudio 5 instrument validation and maintenance services.

5. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.1 and, if not, which exception under 5.101 applies.

A Notice of Intent (NOI) to award a sole-source Purchase Order (PO) to ThermoFisher Scientific/Life Technologies Corporation will be posted on the SAM.gov website. This announcement will also give an opportunity for other vendors to demonstrate their ability to meet the FBI's specific needs through submission of their technical capabilities and cost information for consideration prior to an award being issued.

6. The anticipated dollar value of the proposed acquisition, including options if applicable, and a determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

Prior to issuing an award, the Contracting Officer will determine that the proposed price is fair and reasonable in accordance with FAR13.106-3.

7. A description of the market research conducted and the results.

Market research was conducted online and it was determined that the product was not available through a third party vendor.

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

JUSTIFICATION AND APPROVAL (J&A) FOR OTHER THAN

FULL AND OPEN COMPETITION

See section 5 above.

9. A listing of any sources that expressed a written interest in the acquisition.

A synopsis will be posted on the SAM.gov website. This synopsis will give an opportunity for other vendors to demonstrate their ability to meet the FBI's specific needs through a submission of technical capabilities and cost information.

10. A statement of any actions the agency may take to remove or overcome any barriers to competition, if subsequent acquisitions are anticipated.

The FBI will continue to conduct market surveys and research available through industry shows and technology releases in the form of papers and journals. This will be used to identify potential sources for subsequent acquisitions.