Intent to Sole Source (PM for Genius XE70 Nitrogen Generator)

Food and Drug Administration (FDA)

Notice of Intent to Sole Source Subject: Sole Source Fixed Price Contract for the procurement of Preventative Maintenance & Repair Services for (1) Genius XE70 Nitrogen Generator PM under Request for Quote FDA-RFQ-24-1276618.

Notice of Intent to Sole Source to:

Peak Scientific 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 Cerulean located at: Peak Scientific Inc. 210 Littleton Road Westford, MA. 01886 Ph.

978-860-9503 FDA has a requirement to procure Preventative Maintenance & Repair Services for Genius XE70 Nitrogen Generator PM under Request for Quote FDA-RFQ-24-1276618 as a sole source acquisition. Peak Scientific is the sole manufacturer and the only source which provides the maintenance and repair services for the XE70 Nitrogen Generator.

Peak Scientific letter stating” I hereby confirm that Peak Scientific Inc. is the sole provider for service, OEM parts, technical support, and contractual maintenance for all Peak Scientific gas generators located within the North American Territory. Peak Scientific Inc. does not train, nor authorize, any other organizations within North America to service or maintain Peak Scientific laboratory gas generators”. The NAICS Code for this procurement is:

541990- All Other Professional, Scientific, and Technical Services 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. It is anticipated that an award will be issued to Cerulean 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: 10:00 a.m. EST 7/18/2024. Please email responses to Warren Jackson at warren.jackson@fda.hhs.gov