IlluminaJofocSAMgov.pdf

SHOP-PR-26-000580 JOFOC

FEDERAL BUREAU OF INVESTIGATION

FINANCE DIVISION

PROCUREMENT SECTION

SOLE-SOURCE JUSTIFICATION

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

Requisition Number: SHOP-PR-26-000580

Date: 03/18/2026

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 Illumina reagents and consumables on behalf of the Laboratory Division (LD), Biometrics Analysis Section (BAS), DNA Support Unit (DSU).

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

The FBI intends to award a sole-source, commercial item, Indefinite Delivery Indefinite Quantity (IDIQ), firm-fixed-price (FFP) contract to Illumina, Inc., (CAGE Code 1WCS2), 5200 Illumina Way, San Diego, California, 92122 for Illumina reagents and consumables.

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

The Federal Bureau of Investigation (FBI) mission is to protect and defend the United States against terrorist and foreign intelligence threats, to uphold and enforce the criminal laws of the United States, and to provide leadership and criminal justice services to federal, states, municipal, and international agencies and partners. The FBI performs these responsibilities in a manner that is responsive to the needs of the public and is faithful to the needs of the public and is faithful to the Constitution of the United States of America.

The FBI’s Laboratory Division (LD) has a requirement for reagents and consumables manufactured by Illumina, Inc. These laboratory materials and substances will support the Laboratory’s mission in the following ways: 1) Develop a single-nucleotide polymorphism (SNP) profile to support Investigative Genetic Genealogy (IGG) investigations; and 2) perform DNA sequencing for information-investigation-intelligence (i3) casework.

The FBI procured two (2) Illumina sequencing instruments September 2025, via Contract Number 15F06721C0003061, Modification Number P00009. This acquisition included one (1) Illumina NextSeq 2000 sequencing system and one (1) MiSeq i100 Plus benchtop sequencer system. These instruments utilize Sequencing by Synthesis (SBS), which is a high-throughput, next-generation sequencing technology.

Illumina sequencing instruments can only operate with Illumina sequencing consumables. The reagents and consumables are necessary for both the preparation of DNA sequencing and the subsequent operation of the Illumina instruments.

Presently, the Biometrics Analysis Section (BAS) will be performing testing and validation of IGG laboratory processes and will also continue to conduct i3 testing. The quantity of reagents required for these purposes is best supported by a new contract action (i.e. one-year with four option periods). The government purchasing card (GPC) substantially limits the quantity of reagents that can be procured at one time. As a result, GPC restrictions limit the efficiency and speed at which these sequencing tasks may be performed. These Illumina reagents and consumables are critical to laboratory operations. IGG is one of the Laboratory Division’s (LD) fiscal year (FY) 2026 priorities per the LD Assistant Director (AD). Without these Illumina reagents and consumables, the BAS cannot meet this AD requirement.

Illumina sequencing instruments are proprietary systems that require Illumina manufactured reagents and consumables to function properly as the reagents are uniquely formulated and calibrated to Illumina’s chemistry and SBS technology. Illumina maintains exclusive intellectual property rights over their sequencing chemistry. Therefore, there are no third-party manufacturers of equivalent reagents and consumables.

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

For purposes of this acquisition, the statutory authority permitting other than full and open competition is delineated at 41 U.S.C. 3304 (a) (1) and implemented at FAR 6.302-1, “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.

Illumina. Inc. is the manufacturer and the sole distributor of Illumina products for this requirement. There are no authorized resellers.

Illumina is the only responsible source that can provide the following Illumina patented products:

• Item No. 20019101, AmpliSeq Library PLUS (24 reactions)

• Item No. 20019104, AmpliSeq UD Indexes for Illumina (24 Indexes, 24 Samples)

• Item No. 20060059, DNA Prep, (M) Tagmentation (96 Samples, IPB)

• Item No. 20060060, DNA Prep, (M) Tagmentation (24 Samples, IPB)

• Item No. 20041794, DNA PCR-Free Prep, Tagmentation (24 Samples)

• Item No. 20041795, DNA PCR-Free Prep, Tagmentation (96 Samples)

• Item No. 20025524, DNA Prep with Enrichment, (S) Tagmentation (96 Samples)

• Item No. 20025523, DNA Prep with Enrichment, (S) Tagmentation (16 Samples)

• Item No. FC-110-3001, PhiX Control v3

• Item No. 20151542, PhiX Indexed Control (1000 cycles)

• Item No. 20091654, DNA/RNA UD Indexes Set A, Tagmentation (96 Indexes, 96 Samples)

• Item No. 20091656, DNA/RNA UD Indexes Set B, Tagmentation (96 Indexes, 96 Samples)

• Item No. 20091658, DNA/RNA UD Indexes Set C, Tagmentation (96 Indexes, 96 Samples)

• Item No. 20091660, DNA/RNA UD Indexes Set D, Tagmentation (96 Indexes, 96 Samples)

• Item No. 20141598, MiSeq i100 Plus 100M Reagent Kit (100 cycles)

• Item No. 20141599, MiSeq i100 Plus 100M Reagent Kit (300 cycles)

• Item No. 20126567, MiSeq i100 Series 25M Reagent Kit (100 cycles)

• Item No. 20148254, MiSeq i100 Series 25M Reagent Kit (1000 cycles)

• Item No. 20126568, MiSeq i100 Series 25M Reagent Kit (300 cycles)

• Item No. 20115696, MiSeq i100 Series 25M Reagent Kit (600 cycles)

• Item No. 20141597, MiSeq i100 Plus 50M Reagent Kit (600 cycles)

• Item No. 20126565, MiSeq i100 Series 5M Reagent Kit (300 cycles)

• Item No. 20126566, MiSeq i100 Series 5M Reagent Kit (600 cycles)

• Item No. 20100983, NextSeq P1 XLEAP-SBS Reagent Kit (100 cycles)

• Item No. 20100982, NextSeq P1 XLEAP-SBS Reagent Kit (300 cycles)

• Item No. 20100981, NextSeq P1 XLEAP-SBS Reagent Kit (600 cycles)

• Item No. 20100987, NextSeq P2 XLEAP-SBS Reagent Kit (100 cycles)

• Item No. 20100986, NextSeq P2 XLEAP-SBS Reagent Kit (200 cycles)

• Item No. 20100985, NextSeq P2 XLEAP-SBS Reagent Kit (300 cycles)

• Item No. 20100984, NextSeq P2 XLEAP-SBS Reagent Kit (600 cycles)

• Item No. 20100990, NextSeq P3 XLEAP-SBS Reagent Kit (100 cycles)

• Item No. 20100989, NextSeq P3 XLEAP-SBS Reagent Kit (200 cycles)

• Item No. 20100988, NextSeq P3 XLEAP-SBS Reagent Kit (300 cycles)

• Item No. 20100994, NextSeq P4 XLEAP-SBS Reagent Kit (100 cycles)

• Item No. 20100993, NextSeq P4 XLEAP-SBS Reagent Kit (200 cycles)

• Item No. 20100992, NextSeq P4 XLEAP-SBS Reagent Kit (300 cycles)

• Item No. 20100995, NextSeq P4 XLEAP-SBS Reagent Kit (50 cycles)

These items are commercially available supplies and products. Reagents and consumables are products widely used by numerous forensic laboratories in the United States. While these are commercial products, these items are very specific to the laboratory instruments they are being used on.

It is imperative that the FBI Laboratory obtain reagents and consumables for both the MiSeq i100 Plus benchtop sequencer system and the NextSeq 2000 sequencing system to properly maintain the instruments and to efficiently process and analyze DNA samples submitted to the FBI Laboratory.

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.

A Notice of Intent (NOI) to award a sole-source contract to Illumina, Inc. 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 the submission of their technical capabilities and cost information for consideration prior to an award being issued.

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

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.

Before awarding a contract, the Contracting Officer will perform a determination of price reasonableness in accordance with FAR 13.106-3 and 13.501(a)(2)(i).

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

Market research was conducted by DSU personnel, (Senior Biologist and Program Manager), using commercial manufacturer websites, technical calls with presentations, and internal BAS requirement meetings.

Illumina is the only responsible source capable of providing Illumina reagents and consumables for both the MiSeq i100 Plus benchtop sequencer system and the NextSeq 2000 sequencing system. Illumina maintains exclusive intellectual property rights over its sequencing chemistry. There are no third-party substitute equivalents of Illumina’s reagents and consumables.

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

See section 5 above.

10. 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 the submission of technical capabilities and cost information.

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 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.

REVIEWS AND APPROVALS (NOT EXCEEDING $900,000.00)

Requestor:

I certify that the facts and representations under my cognizance, which are included in this justification, and which form a basis for this justification, are complete and accurate.

Date Contracting Officer’s Representative (COR) Management and Program Analyst CODIS Unit, BAS Business Office Quantico, Virginia

Contracting Officer:

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

Bryan Lane Date National Acquisition Programs Unit Quantico, Virgina bvlane@fbi.gov mailto:bvlane@fbi.gov