Attachment 2 - Single-Source Justification (REDACTED) - Leco FP928.pdf

Commercial Single-Source Justification

(Open Market, RFO Part 12 Exceeding MPT, Not Exceeding

SAT)

Section 1 General Information

Requiring Activity: FDA / HFP / OLOAS / ORTS / Atlanta Human and Animal Food Laboratory

(ATLHAFL), Nutrient Analysis Branch (NAB)

Program / Project Title: Combustion Protein Analyzer (CIN HFP-OLOAS-26-C-B029; ALP HFP-2026-

134729)

Proposed Contractor: Leco Corporation, 3000 Lakeview Avenue, St. Joseph, MI 49085 (CAGE OJ626)

NAICS Code: 334516 - Analytical Laboratory Instrument Manufacturing (size standard 1,000 employees)

Estimated Total Value: $[REDACTED] (base equipment $[REDACTED] plus four one-year Gold

Maintenance option periods)

Period of Performance: August 1, 2026 through July 31, 2027 (base period; plus four one-year option periods through July 31, 2031 if exercised)

Description of Products or Services: Purchase of one (1) Leco FP928 Boom-Mounted

Touchscreen/Autoloader PC Macro Nitrogen Determinator (combustion/Dumas protein analyzer) with a five-year Gold Maintenance Plan (Leco SVC-800-GLD-FP928). Used for protein/nitrogen determination under AOAC Official Method 990.03 and LIB 4635 on infant formula, medical foods, foods, and dietary supplements. Replaces an obsolete, unserviceable Leco TruMac; the laboratory capability is currently down.

Section 2 Authority and Determination

Authority: This single-source justification is executed under RFO 12.102(a), which authorizes the contracting officer, for acquisitions valued at or below the SAT, to restrict competition by documenting the decision that only one source is available and the basis for that decision. The competition standard being limited is at RFO 12.201-1(c), which directs the contracting officer to promote competition to the maximum extent practicable when acquiring commercial products or commercial services at or below the SAT and sets a default of soliciting quotations from at least three sources (RFO 12.201-1(c)(2)). Where the requirement specifies a brand name or a product or feature peculiar to one manufacturer, RFO 11.204 applies and the brand-name documentation in Section 4.3 is required.

Determination: The Contracting Officer determines in writing that only one source is reasonably available for the products or services identified in Section 1 and that providing for competition to the maximum extent practicable is not feasible. The basis is identified in Section 3 and supported by the narrative in Section 4.

Section 3 Basis for Single Source

☒ A. Items particular to one manufacturer (brand name)

☐ B. Exclusive licensing agreement

☐ C. Urgency

☐ D. Other circumstances making only one source reasonably available

Summary: N/A — basis is 3.A (brand name); see Section 4.3.

Section 4 Justification

4.1 Agency Need

The ATLHAFL Nutrient Analysis Branch (NAB) tests and verifies the declared nutritional claims of domestic and imported products, including infant formula, medical foods, foods, and dietary supplements.

Protein is a key regulated nutrient historically subject to economic adulteration (dilution or filler/solvent substitution), and infant formula and medical foods carry stricter requirements because they may serve as a consumer's sole source of nutrition. Protein is determined by combustion (Dumas) nitrogen analysis under AOAC Official Method 990.03 and LIB 4635. The laboratory's existing Leco TruMac analyzer has been designated obsolete by the manufacturer and is unserviceable, leaving this capability down; a replacement combustion protein analyzer is required to restore and sustain it.

4.2 Why Only One Source Is Reasonably Available

The requirement is met only by the Leco FP928, a proprietary combustion nitrogen/protein analyzer manufactured by Leco Corporation. The laboratory's validated methods (AOAC 990.03 and LIB 4635) require nitrogen determination by combustion on a Leco nitrogen/protein analyzer, and the FP928 embodies proprietary Leco technology - including the Cornerstone control and diagnostic software, boom-mounted touchscreen interface, dual-loop aliquot doser, reagent-free furnace, and SmartLine remote diagnostics - that is not available from any other manufacturer. Because the action also replaces an obsolete Leco TruMac and must preserve continuity with the laboratory's validated Leco-based methods, no other source can furnish an acceptable instrument without full, costly method re-validation.

4.3 Brand Name Addendum (RFO 11.204)

4.3.1 Essential Brand-Specific Feature(s):

(1) The Leco FP928 combustion (Dumas) nitrogen/protein analyzer architecture; (2) Leco Cornerstone control and diagnostic software; (3) compatibility with the laboratory's validated AOAC 990.03 and LIB

4635 methods developed on the Leco platform; (4) the Leco Gold Maintenance Plan (SVC-800-GLD-

FP928) for OEM-certified service, parts, and software updates.

4.3.2 Why Each Feature Is Essential:

The FP928's proprietary combustion furnace and Cornerstone software produce the nitrogen/protein results the validated methods depend on; AOAC 990.03 and LIB 4635 specify combustion determination on a Leco analyzer. Substituting another platform would require costly re-validation of accredited methods and would jeopardize continuity of results for infant formula and medical foods, where protein content is safety-critical. Only Leco can furnish the FP928 and the OEM Gold Maintenance needed to keep the instrument qualified.

4.3.3 Market Research Showing No Equal:

Per the Market Research Report (Combustion Protein Analyzer), prepared by Rossana Kelton, Biologist, ATLHAFL, and completed April 20, 2026, only Leco Corporation was identified as capable, owing to its proprietary technology and unique expertise; no two capable small businesses and no equivalent alternative were found. Research included GSA Advantage, the Leco online catalog (leco.com), internet searches, and review of prior purchases of similar items.

4.3.4 Equivalent Products Considered and Rejected:

No equivalent instrument was identified. Other nitrogen/protein analyzers cannot run the laboratory's validated Leco-based methods without full re-validation and do not provide the proprietary Leco FP928 architecture or Cornerstone software; accordingly, no alternative was acceptable.

Section 5 Fair and Reasonable Price

Per RFO 12.204(a), the Contracting Officer must determine the price to be fair and reasonable.

Where competitive quotations are not available because the acquisition is single-source, the determination is based on price analysis.

Price analysis method and result: Price analysis will be performed by comparing Leco Corporation's quotation to the Independent Government Cost Estimate ($[REDACTED] base; $[REDACTED] total including options) and to Leco's published commercial catalog and GSA pricing for the FP928 and the Gold

Maintenance Plan. Because no prior award for this instrument exists and no competitive quotations are available (single source), the determination rests on this price analysis. Upon receipt of the quotation, the quoted price of $[quote] will be documented as within [X]% of the IGCE, and the Contracting Officer will determine the price fair and reasonable.

Section 6 Posting / Publication

For acquisitions involving a brand name or item peculiar to one manufacturer, the documentation must be posted for acquisitions over $25,000 (RFO 11.204(a)(3)). For other single-source actions, post a presolicitation notice in the Governmentwide Point of Entry under subpart 5.1 unless an exception at 5.101(b) applies. State which applies:

This is a brand‑name single‑source action (Section 3.A) with an estimated value exceeding $25,000. The justification will be posted in the Governmentwide Point of Entry (SAM.gov) as required by RFO

11.204(a)(3).

Section 7 Contracting Officer Certification

I, the undersigned Contracting Officer, having considered the agency's need and the facts set forth in this justification, determine in writing that only one source is reasonably available for the products or services identified in Section 1 and that competition to the maximum extent practicable is not feasible. This justification is executed in accordance with RFO 12.201-1(c) and

RFO 13.101(b), and, where Section 3.A is selected, RFO 11.204.

Contracting Officer Name James P. Jenrette

Date 7/10/2026

Signature James P. Jenrette III