Solicitation- Notice of Intent to Sole Source- OC-2026-135595-Final.docx

NOTICE OF INTENT TO SOLE SOURCE

In support of Project No: OC-2026-135595 The U.S. Food and Drug Administration, Office of Acquisitions and Grants Services, Division of Color Certification and Color Technology (DCCT) intends to award a firm fixed price purchase order to Peak Scientific, 210 Littleton Road, Suite 110, Westford MA, 01886 for the purchase of the Model: Infinity XE6030, S/N: 722080281 Nitrogen Generator Instrument for the Office of Cosmetics and Colors (OCAC). A new annual preventive maintenance agreement is needed for the OCAC’s Nitrogen Generator system. The service agreement will ensure optimal instrument performance and extend instrument life expectancy, thereby supporting the Color Certification Program’s mission. Moreover, the agreement requires 48-hour on-site response time during normal business hours, unlimited labor and travel during normal business hours, and unlimited emergency calls.

The 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.

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.

The Nitrogen Generator system shall be maintained and repaired under the new preventive maintenance agreement:

The sole source letter and the quote from PEAK Scientific Inc. have been attached. Consequently, this procurement is being conducted in accordance with FAR subpart 13.106-1(b)(1)(i) which allows for the Contracting Officer to solicit one source if only one source is reasonably available. The North American Industry Classification System Code (NAICS) is 811210- Other Electronic and Precision Equipment Repair and Maintenance.. The Product Service Code (PSC) is J066-Maintenance, Repair, and Rebuild of Equipment- Electrical and Electronic Equipment Components.

This notice is being distributed through the System for Awards Management website (www.SAM.gov). As Peak Scientific is the only source that can meet the Government’s need at this time, this notice is not a request for competitive quotes. However, if any interested parties, especially a small business, believes it can meet the Government’s needs, it may identify their interests and/or capability in relation to this procurement to the Contracting Officer, Brandon Rafus, at brandon.rafus@fda.hhs.gov no later than 4:00 PM EST on September 9, 2026.

The primary objective of this Notice of Intent is to inform potential contractors of the government's intent to proceed with a sole source procurement while providing an opportunity for other parties to demonstrate comparable capabilities. Although this is not a competitive solicitation and no formal solicitation document exists, interested parties may submit capability statements demonstrating their ability by the September 9, 2026 deadline. All capability statements must be submitted electronically via email to brandon.rafus@fda.hhs.gov in Microsoft Office Word, Excel, or Adobe PDF format. The government will consider all capability statements received by the closing date, though the final determination whether to compete the requirement remains at the government's sole discretion. This notice represents a standard pre-award transparency measure that allows the marketplace to respond before a sole source award is finalized.

All responses must include the following business information:

a. Unique Entity Identification (UEI) Number

b. Company Name, address, primary point of contact and their email and phone number

c. Type of company as validated in SAM.gov. All interested parties must be registered in SAM.gov to receive consideration of government contracts.

d. Technical capability to meet the requirement need as detailed in the attached Statement of Work (SOW).

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