NOI-JNA-PR-24-002212.pdf

FEDERAL BUREAU OF INVESTIGATION

FINANCE AND FACILITIES DIVISION | PROCUREMENT SECTION

JUSTIFICATION

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION IN ACCORDANCE WITH 41 U.S.C. 3304 (A) (1)

Requisition Number: PR-24-002812

Date: 06/10/2025

Estimated Contract Dollar Value: xxx

1. Identification of the agency and contracting activity.

The U.S. Department of Justice, Federal Bureau of Investigation (FBI), National Acquisition Programs Unit (NAPU), have prepared this justification for other than full and open competition for a Firm-Fixed-Price contract for three (3) Thermo Fisher Scientific 3500xL Genetic Analyzers on behalf of the Laboratory Division’s (LD), Federal DNA Database Unit (FDDU).

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

The proposed requirement is for a sole source procurement with ThermoFisher (formerly Life Technologies), located at 3175 Staley Road, Grand Island, NY 14072.

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

The FDDU has a need to purchase three (3) 3500xL Genetic Analyzers for Human Identification.

The 3500xL series is a new-generation Genetic Analyzer designed with a specific feature set and workflow for the human identification process. The complete system combines Thermo Fisher Scientific’s reagents, consumables, and software that significantly improve the ease of use and application efficiencies. The 3500xL has a throughput of 300 samples a day with an injection time of 30 minutes for 24 capillaries; additionally, the reagents are pre-packaged so hours of reagent preparation work will be saved.

4. 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 6.302-1entitled, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.”

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

JUSTIFICATION

The FDDU already utilizes Thermo Fisher Scientific instruments. Research and validation for the processing of database samples that are placed in CODIS has been completed on the requested instruments. No other vendor is approved to provide these unique items needed to keep the Laboratory working effectively. Therefore, Thermo Fisher Scientific is the only company that is uniquely qualified to provide these instruments to the FDDU.

This purchase is for the LD BAS DNA LAN which is a STANDALONE system and does not connect to or interface with any FBI/FISMA systems. This purchase does not compete with nor interfere in any services provided by the FBI’s IT Divisions.

6. 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 5.2 and, if not, which exception under 5.202 applies.

The FBI will publicize this requirement on the Federal Business Opportunities website on SAM.gov. The announcement will give an opportunity for other vendors to demonstrate their ability to meet the FBI's specific needs through the submission of technical capabilities and cost information.

7. 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.

The estimated cost for the proposed contract for reagents and consumables is approximately

xxx. The Contracting Officer concluded that prices are comparable to similar contracts purchasing equipment exclusive to Thermo Fisher Scientific in the past.

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

The FBI conducted market research for this requirement through internet searches and reviewing technology releases from journals and papers.

Market research determined that the Genetic Analyzers and associated software contain a dedicated computer that is customized to operate the system and is compatible with the manufacturer’s software. The computers attached to these systems are imaged specifically, for Thermo Fisher Scientific and are not available from another source.

The market research also concluded the Applied Biosystems Genetic Analyzers are the only commercially available 4, 8, and 24 capillary systems that have been validated according to SWGDAM guidelines to analyze DNA samples for the purpose of Human Identification.

https://www.acquisition.gov/far/html/Subpart%205_2.html#wp1107980 https://www.acquisition.gov/far/html/Subpart%205_2.html#wp1107980 https://www.acquisition.gov/far/html/Subpart%205_2.html#wp1107990

JUSTIFICATION

In addition, Thermo Fisher Scientific is the sole distributor of validated system consumables including capillaries, cartridges, chips, polymer, buffers, size standards, and replacement parts.

Due to the technical nature of these products and because Thermo Fisher Scientific is the sole manufacturer of these highly unique instruments, the recommended source for the purchase is Thermo Fisher Scientific.

The Contracting Officer contacted Thermo Fisher Scientific to verify that there are no other authorized resellers of the requested equipment. Per the manufacturer, Thermo Fisher Scientific is the sole manufacturer and distributor of the Applied Biosystems Genetic Analyzers, real-time PCR thermal cyclers, thermal cyclers, Ion Torrent Next Generation Sequencing, RapidHIT ID Systems and associated software.

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

If we do not acquire the Genetic Analyzers for Human Identification, it will cost the Laboratory Division time and money. Without these products, the FDDU will use much more reagents and have increased downtime, which will negatively affect the unit’s ability to process the high quantity of samples being submitted to the Laboratory. This is compounded by the fact that the samples are mandated by law to be collected and processed per the DNA Fingerprint Act of 2005.

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

A search was conducted on SAM.gov of past Request for Information (RFI) and Notice of Intent (NOI) and resulted in no vendors expressing interest in meeting the Bureau’s needs.

Please see notice IDs DJF-18-0700-PR-0005410 and DJF-18-0700-PR-0005663.

Additionally, an NOI will be posted to SAM.gov by the contracting officer to give potential interested vendors the ability to submit a capability statement.

11. 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 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. If potential sources are identified, they will be required to submit to compatibility and validation testing, which the FBI continues to conduct subject to resource limitations. The initial compatibility study is to ensure that the FBI Laboratories robotic systems, which are a substantial capital investment for the Federal Government, are compatible with the offeror's solution. The second study is to validate the science, equipment, and materials behind the offeror’s technology. The FBI Laboratory holds itself to the highest standards within the forensic community and ensures that any technology used is proven, tested technology.