Notice of Intent to Sole Source_CFSAN-2024-121884.pdf
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- Solicitation number
- CFSAN-2024-121884
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This document is a Notice of Intent to Sole Source from the U.S. Food & Drug Administration (FDA) for the acquisition of an Elemental Analysis/Liquid Chromatography-Isotope Ratio Mass Spectrometry (EA/LC-IRMS) system. The FDA intends to issue a sole-source commercial product purchase order to ELEMENTAR AMERICAS, INC. for this requirement under Simplified Acquisition Procedures. The EA/LC-IRMS system is needed to develop methods for food authenticity and identification of food adulteration. ELEMENTAR AMERICAS, INC. is the only contractor capable of meeting the specific technical requirements, which include a high temperature oxidation interface coupled to the liquid chromatograph and a limited space footprint. The FDA is providing an opportunity for any other parties who believe they can meet the requirement to submit capability statements by the response date of May 2, 2024 at 3:00 p.m. ET. If no other qualified entities are identified, the FDA anticipates awarding the contract to ELEMENTAR AMERICAS, INC. within approximately 15 days after the response date.
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Notice of Intent to Sole Source
The U.S. Food & Drug Administration (FDA) intends to issue a sole-source commercial product purchase order to ELEMENTAR AMERICAS, INC. located at 119 Comac St. Ronkonkoma, New York 11779-6931.
An award is anticipated to be made using Simplified Acquisition Procedures for Certain Commercial Items under the authority of Federal Acquisition Regulation (FAR) Part 13.501(a)(1)(ii) wherein the circumstances of the proposed contract action deem only one source reasonably available.
The FDA Center for Food Safety and Applied Nutrition, Office of Regulatory Science, Division of Analytical Chemistry, Method Development Branch has a requirement for the purchase of an Elemental Analysis/ Liquid Chromatography-Isotope Ratio Mass Spectrometry (EA/LC-IRMS) system needed to develop methods for food authenticity. The acquisition is needed to provide the FDA with expanded capacity in the identification of food adulteration. The instrument will be used in conjunction with other methods to accurately identify food authenticity and protect the public from economic adulteration. The methods developed with the new acquisition will be made available to FDA field labs to provide regulatory enforcement. The sole source identified is the only Contractor capable of meeting both the availability of a high temperature oxidation interface coupled to the liquid chromatograph as well as being able to accommodate the limited space footprint that the instrument/needed peripherals must fit in at the required site location.
This notice is not a request for competitive quotations. 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 award based upon responses to this notice is solely within the discretion of the Government.
It is anticipated that an award will be issued to ELEMENTAR AMERICAS, INC. within approximately fifteen (15) days after the response date of this notice unless the Government determines that any other entity has the capability to meet this requirement.
Response Date: 05/02/2024 at 3:00 p.m. ET. Please email responses to Contracting Officer Benjamin Dorgan at benjamin.dorgan@fda.hhs.gov. No phone calls will be accepted.
mailto:benjamin.dorgan@fda.hhs.gov
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