Notice of Intent to Sole Source.pdf

Notice of Intent to Sole Source

Subject: Fixed Price (FFP) Purchase Order Type for the procurement of a DFPST-Hyperspectral Imaging and Enhanced Darkfield Microscope Accessory as a Sole Source acquisition to Horiba Scientific LLC., under Request for Quote FDA-RFQ-CFSAN-2022-111818, plus one year (12 months) of Preventative Maintenance Agreement (PMA).

Notice of Intent to Sole Source to: Horiba Scientific LLC.

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 (FFP) Purchase Order Type to Horiba Scientific LLC., located at:

20 Knightsbridge Road, Piscataway, NJ 08854 Email: nolan.wong@horiba.com ATTN Nolan Wong Phone: 732-546-1791 Email Order to HoribaSales.us@horiba.com

FDA requires a Hyperspectral Imaging (HIS) and Enhanced Darkfield Microscope Accessory by Horiba Scientific LLC. HSI is an imaging technique that acquires high resolution spectral data of biological (food, soil, and clinical) or a biological (polymers, glass, etc.) materials. It is particularly well suited for the characterization and quantification of particulates dispersed in complex carbon-based matrixes, which is challenging to do with more conventional analytical methods. There is currently substantial interest in using HSI to support food safety investigations, particularly for detecting microplastics and other low-contrast micro- and nano-objects in foods and environmental samples.

DFPST currently owns a state-of-the-art Horiba XPLORA confocal Raman imaging system that is used to support food packaging and nanosensing projects. Horiba has recently partnered with another company, CytoViva, to offer a dedicated accessory for the XPLORA that seamlessly adds HSI functionality to this piece of equipment that already exists in DFPST laboratories. An equivalent accessory is not currently offered by any other manufacturer. Although other HSI instruments are available on the market, they require purchasing new, dedicated equipment and do not offer the advantages of simultaneous analysis using HSI and Raman that the XPLORA platform offers.

HORIBA Scientific is the exclusive provider of the integrated confocal Raman and enhanced darkfield optical and hyperspectral microscope system in North America. Combined on the same platform, this integrated multi-modal imaging system is very tailored for nanoscale studies and allows easy mailto:nolan.wong@horiba.com mailto:HoribaSales.us@horiba.com observation, characterization and identification of multiple sample targets at the nanoscale. This integrated microscope package leverages the proven XploRA Plus Raman microscope from HORIBA Scientific and provides for full confocal Raman and the ability to select from single or multiple laser illumination options. Horiba Scientific LLC., certifies, that it is the only supplier of the requested instruments and that all instruments and related instrument/service bundles are solely distributed by the manufacturer subsidiaries and official distributors, with no thirty party re-sellers.

The associated NAICS Code is: 334516-Analytical Laboratory Instrument Manufacturing.

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 Horiba Scientific LLC., within approximately fifteen

(15) days after the date of this notice unless the Government determines that any other organization has the capacity to meet this requirement.

Response Date: 12:00 p.m. EST 04/30/2022. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov mailto:Emmanuel.mbah@fda.hhs.gov