Notice of Intent to Sole Source- Nitrogen Generator Instrument Service Agreement

The purpose of this request is to acquire a new service agreement for the Nitrogen Generator (Model:

Infinity XE6030, S/N: 722080281). Nitrogen generator provides a constant flow of high purity nitrogen gas to five Liquid Chromatograph/Mass Spectrometer (LC/MS) systems in the Division of Color Certification and Color Technology (DCCT). The LC/MS instruments are used to analyze batches of color additives intended for use in foods, drugs, medical devices, and cosmetics in the United States. DCCT uses the LC/MS instruments for trace level analysis (sub ppm levels) in color additives submitted for certification.

Acquisition of a new service agreement for the Nitrogen Generator Instrument is urgent because the current warranty coverage has expired. Reliable and timely services, preventive maintenance, and repair services are critical for the instrument performance of the Nitrogen Generator.

The Nitrogen Generator (Model:

Infinity XE6030, S/N: 722080281) is essential to ensuring program continuity within the Color Certification Program, as it is used to determine whether each batch of color additive meets specifications outlined in 21 CFR Parts 74 and 82.