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Food and Drug Administration (FDA)

Notice of Intent to Sole Source

Subject: Sole Source Fixed Price Contract for the procurement of Preventative Maintenance Inspection (PMI), Preventative Maintenance (PM) and Qualification Service (QS) for GERSTEL MPS Autosampler Rails and Solvent Filling Station plus 3 Option Years.

Notice of Intent to Sole Source to: Gerstel, 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 purchase order to Gerstel, Inc., located at:

Gerstel, Inc.,

701 Digital Drive, Suite J

Linthicum, MD

FDA has a requirement to obtain Preventative Maintenance Inspection (PMI), Preventative Maintenance (PM) and Qualification Service (QS) for GERSTEL MPS Autosampler Rails and Solvent Filling Station under Request for Quote FDA-24-1274754 as a sole source acquisition.

Gerstel, Inc. is the sole-source vendor for preventive maintenance on the current Gerstel Multi-Purpose Autosampler purchased by Southeast Tobacco Laboratory. Gerstel, Inc is also the only vendor that can provide validated parts necessary for replacement or repair on the current Autosampler. To ensure that the Autosampler maintains its instrument qualifications this procurement should be sole sourced to Gerstel Inc.

The determination not to compete this proposed contract action solely within the discretion of the Government. Information received will normally be considered for the purposes of determining whether to conduct a competitive procurement. The Government will not be responsible for any costs incurred by responding to this notice.

The NAICS Code for this procurement is: 541990

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 Gerstel, Inc. 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: 3:00 p.m. EST 4/23/2024. Please email responses to Elena Tatarov at Elena.Tatarov@fda.hhs.gov

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