Notice of Intent to Sole Source

Subject: Sole Source Fixed Price Contract for the procurement of Preventative Maintenance & Repair Services for two (2) Illumina MiSeq under Request for Quote FDA-RFQ-24-1275627.

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 Preventative Maintenance & Repair Services for two (2) Illumina MiSeq Systems under Request for Quote FDA-RFQ-24-1275627 as a sole source acquisition.

Illumina is the sole manufacturer and the only source which provides the maintenance and repair services for the MiSeq System.

Illumina provided a letter stating “Illumina, Inc. is the sole equipment manufacturer for the Illumina MiSeq software, parts, training, technical support, and at-your-site service and support procedures. Only Illumina service representatives are certified through current and ongoing factory training and hold factory authorization to perform service on Illumina equipment. Illumina Inc. does not certify, authorize, or warrant any individuals, third parties, or other equipment manufacturers outside Illumina’s authorized service provider network to provide service or support for any Illumina product. Services performed by providers who are not Illumina factory-authorized could: invalidate Illumina’s warranties, and/or lead to irreparable damage, and/or cause safety hazards.”

The NAICS Code for this procurement is: 811210- Electronic and Precision Equipment Repair and Maintenance

This notice is not a request for competitive proposals. However, any party that believes it is capable of meeting 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.

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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: 11:59 pm. EST 4/9/2024. Please email responses to Warren Jackson at warren.jackson@fda.hhs.gov

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