SM450i Linear Cigarette Smoking Machine

Subject: Sole Source Fixed Price Contract for the procurement of Preventative Maintenance & Repair Services for one (1) SM450i Linear Cigarette Smoking Machine under Request for Quote FDA-RFQ-24-1277145.

Notice of Intent to Sole Source to:

Cerulean. 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: Cerulean 501 Southlake Blvd Richmond, VA.

23236 Tel 804-601-3204 FDA has a requirement to procure Preventative Maintenance & Repair Services for one SM450i Linear Cigarette Smoking Machine under Request for Quote FDA-RFQ-24-1277145 as a sole source acquisition. Cerulean is the sole manufacturer and the only source which provides the maintenance and repair services for the SM450i.

Cerulean provided a letter stating” This letter is to advise interested parties that GD USA Inc. dba Cerulean is the exclusive authorized agent and sole source representative of MPRD Ltd. t/a Cerulean in North America for Cerulean equipment including the SM450i.” 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 5/9/2024. Please email responses to Warren Jackson at warren.jackson@fda.hhs.gov