Intent to Sole Source ( Illumina MiSeq System)

Subject: Sole Source Fixed Price Contract for the procurement of (1) Illumina MiSeq System under Request for Quote FDA-RFQ-24-1276621.

Notice of Intent to Sole Source to:

Illumina Inc. Pursuant to the authority of 41 USC 3304(a)(1), as implemented by Federal Acquisition Regulation (FAR) Subpart 6.302-1, (there is only one responsible source and no other supplies or services will satisfy agency requirements), the Food and Drug Administration (FDA) intends to award a Sole Source Fixed-Price contract to Illumina Inc. located at: Illumina Inc. 5200 Illumina Way San Diego, CA.

92112 tel 1-800-809-4566 FDA has a requirement to procure (1) Illumina MiSeq System for the Request for Quote FDA-RFQ-24-1276621 as a sole source acquisition. Illumina is the sole manufacturer and the only source which provides the Illumina MiSeq System. Illumina provided a letter stating “Illumina has authorized Verogen, Inc. to sell certain Illumina products to entities primarily engaged in forensics.

Illumina has not authorized Verogen or any other third-party intermediary to provide Illumina products for this particular transaction (Quotation #4612118) and is thereby the only supplier of Illumina products for this transaction with FDA. In a limited number of transactions, Illumina may, upon specific request, sell the above-referenced products through third parties acting as intermediaries of the end use.” The NAICS Code for this procurement is:

334516- Analytical Laboratory Instrument Manufacturing This notice is not a request for competitive proposals. However, any party that believes it can meet this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement.

A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. It is anticipated that an award will be issued to Illumina within approximately fifteen (15) days after the closing date of this notice unless the Government determines that any other organization has the capacity to meet this requirement.

Response Date: 07:00 a.m. EST 6/12/2024. Please email responses to Warren Jackson at warren.jackson@fda.hhs.gov