JOFOC_MiSeq_OC-2026-132529_Redacted.pdf

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

(Simplified Acquisition of Commercial Products and Commercial Services – RFO FAR

Part 12 and FAR Part 13)

1. Contracting Activity

U.S. Food and Drug Administration (FDA)

Office of Acquisitions and Grants Services (OAGS)

Facilities Support Branch (FSB)

2. Nature and/or Description of the Action

This justification supports the procurement of one (1) Illumina MiSeq i100 Whole

Genome Sequencing System using RFO FAR Part 12, Acquisition of Commercial

Products and Commercial Services, on a sole-source basis, as only one source is reasonably available to satisfy the Government’s minimum requirements.

The Government intends to award a firm-fixed-price purchase order for one (1) Illumina

MiSeq i100 System, including associated components, software, and manufacturer warranty support.

3. Description of Supplies/Services

The contractor shall provide one (1) Illumina MiSeq i100 Whole Genome Sequencing

System, including all necessary components, software, materials, and support required for full system functionality.

The system shall support the FDA Irvine Medical Products Laboratory (IRVLMP) microbiological testing mission and must be fully compatible with existing validated laboratory workflows, consumables, analytical methods, and operational procedures currently utilized within FDA laboratories.

4. Authority

This acquisition is conducted using RFO FAR Part 12, Acquisition of Commercial

Products and Commercial Services.

Pursuant to FAR 13.106-1(b)(1), the Contracting Officer determined that only one source is reasonably available to satisfy the Government’s minimum requirements.

5. Rationale for Restricting Competition

The Illumina MiSeq i100 System is the only system known to the Government that can satisfy the FDA’s minimum requirements for compatibility with existing validated laboratory workflows, consumables, sequencing methods, and analytical procedures without requiring modification or revalidation.

The FDA laboratory operates under validated and accredited laboratory procedures.

Use of a different sequencing platform would require substantial method redevelopment, validation testing, retraining of laboratory personnel, modification of established procedures, and interruption to ongoing laboratory operations.

In addition, compatibility with existing consumables, software environments, sequencing workflows, and validated testing methods is required to maintain operational continuity and avoid unacceptable delays and additional costs to the Government.

Accordingly, the Contracting Officer has determined that only one source is reasonably available to satisfy the Government’s minimum needs.

6. Efforts to Obtain Competition

Market research was conducted through issuance of a Sources Sought Notice to assess industry capability and identify potential sources.

One vendor responded, indicating the ability to provide the required product through its

GSA Schedule contract. However, after clarification and correction of the technical requirements contained within the requirement documentation, the responding vendor confirmed it could not provide a product meeting the Government’s minimum requirements.

Based on the results of market research, the Government determined that no other source could satisfy the requirement without requiring significant modification to existing validated workflows and laboratory procedures.

7. Determination of Fair and Reasonable Cost

The Government will determine price reasonableness in accordance with FAR 13.106-3 through evaluation of the vendor’s proposed pricing, comparison with historical pricing, market research, and any other relevant pricing information available to the Contracting

Officer.

8. Actions to Increase Competition in the Future

The Government will continue to review available sequencing technologies and monitor the marketplace for potential future competitive sources capable of meeting FDA operational and compatibility requirements.

Certification

I certify that this justification is accurate and complete to the best of my knowledge and belief and that this procurement is conducted in accordance with applicable laws and regulations.

Contracting Officer: ___________________________ Date: ___________________