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TARGETED DESORPTION ELECTROSPRAY IONIZATION X-SPOT MASS SPECTROMETRY IMAGING (DESI XS MSI) INSTRUMENT

Waiver type - Procurement: Nonavailability

Agency: FOOD AND DRUG ADMINISTRATION (7524) • Product Service Code (PSC) : 6640 | Last Modified: 09/10/2024

Procurement Summary

The acquisition of a targeted DESI XS MSI is crucial for the establishment of the Emerging Chemicals of Concern Program Area within CFSAN’s Office of Applied Research and Safety Assessment (ORSA), Division of Virulence Assessment (DVA). This advanced analytical tool allows for detailed imaging and analysis of chemical compounds directly on surfaces, particularly in complex samples such as plant tissues. The DESI XS MSI is a sophisticated analytical technique used to perform high-resolution imaging and analysis of chemical compounds directly on surfaces. This method allows for the detection and visualization of molecules in complex samples, such as plant tissues. When applied to assessing the presence of chemicals like Perfluoroalkyl Substances (PFAS), DESI XS MSI enables sensitive and specific detection of these compounds as they move within plant tissues from the soil or water sources during crop growth. DESI XS MSI functions by generating a charged aerosol of microdroplets that are sprayed onto a surface to desorb and ionize molecules for subsequent analysis by mass spectrometry. Notably, this technique requires minimal sample preparation, enabling the rapid detection and mapping of various compounds including chemicals, drugs, metabolites, and lipids in diverse sample types.

Waiver Rationale Summary

Based on the results of the market research conducted as well as querying GSA eLibrary, it is determined that the only item capable of meeting the Government’s need is not produced or manufactured in the United States in sufficient and/or reasonably available commercial quantities of a satisfactory quality. Therefore, a domestically manufactured item is not available to meet the FDA’s need.

Did / Will the solicitation include one of the standard BAA provisions announcing the agency’s intention to provide a price preference for domestic end products and construction material?

Yes

Was a sources sought or Request for Information issued?

No

OMB Determination

Consistent with Policy

Product

LABORATORY EQUIPMENT AND SUPPLIES

NAICS

334516 - Analytical Laboratory Instrument Manufacturing

Date Submitted

08/30/2024

Procurement Instrument Identifier (PIID)

75F40124Q00497

Solicitation ID

75F40124Q00497

Procurement Stage

Post-solicitation

Expected Maximum Duration of the Proposed Waiver

Between 6 months and 1 year

Waiver Coverage

Individual Waiver

Funding Agency

FOOD AND DRUG ADMINISTRATION