Brand_Name_Justification_FAR13_Heratherm_Incubator redacted.pdf

BRAND NAME JUSTIFICATION FOR OTHER THAN FULL AND OPEN

COMPETITION

FAR 13.106-1(b)(1)(i) — Single Source, Simplified Acquisition Procedures

1. Identification of the Agency and Contracting Activity

a. Federal Agency and Contracting Activity: FDA/OCS/NYMPL

b. Sponsoring Organization: FDA New York District Laboratory (NYMPL)

c. Contracting Officer's Representative (COR) / Requiring Activity POC:

REDACTED

2. Nature and/or Description of the Action Being Approved The FDA New York District Laboratory (NYMPL), under the Office of Criminal Investigations/Office of Regulatory Affairs, requires the acquisition of two (2) Thermo Scientific Heratherm Environmental Incubation Chamber to replace multiple incubators that are currently inoperable. This is a new requirement processed as a commercial item acquisition using Simplified Acquisition Procedures (SAP) under FAR Part 13, with a total estimated value of REDACTED. This brand name justification is prepared pursuant to FAR 13.106-1(b)(1)(i) and will be posted to SAM.gov in accordance with FAR 5.102(a)(6).

3. Description of Supplies or Services Required

a. Project Title: Thermo Scientific Heratherm Environmental Incubation Chamber

b. Project Description:

NYMPL will use the Thermo Scientific Heratherm Environmental Incubation Chamber to satisfy temperature requirements across four (4) distinct program areas during microbiological analytical testing conducted in accordance with USP Chapters <60> through <62> and <71>. The chamber provides precise control over microbiological temperature—encompassing both heating and cooling functionality—which is essential for maintaining continuity of operations throughout the week. This capability will increase analytical set-up days from two (2) days per week to five (5) days per week, directly improving laboratory throughput and supporting mission-critical pharmaceutical safety testing.

Requirement Type: Support Services (Non-R&D) Type of Action: New Requirement Proposed Contract/Order Type: Firm-Fixed-Price (FFP) — Commercial Item Acquisition Method: Simplified Acquisition Procedures (SAP) — FAR Part 13 Total Estimated Dollar Value: REDACTED Performance/Delivery Period: One-time delivery; Base Year only

4. Applicable Regulatory Authority This brand name justification is prepared pursuant to the following FAR provisions:

FAR 13.106-1(b)(1)(i): Authorizes a contracting officer to solicit from one source under Simplified Acquisition Procedures when the contracting officer determines that the circumstances of the contract action deem only one source reasonably available.

Applicable circumstances include urgency, exclusive licensing agreements, brand-name requirements, or industrial mobilization.

FAR 5.102(a)(6): Requires that the brand name justification or documentation be posted to SAM.gov at the time the solicitation is issued or, if the justification is not prepared until after issuance, as soon as practicable thereafter. This justification will be posted to SAM.gov concurrent with the solicitation.

FAR 11.104 and 11.105: Govern the use of brand name or equal purchase descriptions. Where a brand name or equal description is used, the solicitation must identify the salient physical, functional, or performance characteristics that an equal item must meet. These characteristics are identified in Section 5 below.

5. Proposed Contractor and Brand Name Rationale

a. Name and Address of Proposed Contractor:

Fisher Scientific Company LLC 300 Industry Drive Pittsburgh, PA 15275

b. Brand Name Item: Thermo Scientific Heratherm Environmental Incubation Chamber (750L)

c. Rationale for Brand Name Requirement:

The Contracting Officer has determined that only one source is reasonably available for this requirement based on the following brand-specific attributes that are essential to NYMPL's mission and cannot be met by currently available equal products:

1. 750-Liter Capacity: The Thermo Scientific Heratherm Environmental Incubation Chamber is the only commercially available incubator offering a 750-liter capacity.

This capacity is required to accommodate the current workload across four (4) program areas simultaneously. Competing vendors—including Binder (KB series), Memmert (IPP/IPPeco series), Panasonic/PHCbi, and ARES Scientific—offer incubators within or near the required capacity range but do not offer a unit at exactly 750 liters.

2. Dual Heating and Cooling Functionality: The chamber must provide both active heating and active cooling within a single unit, enabling precise temperature control across the full operating range required for USP microbiological testing. This integrated dual-function capability is a distinguishing feature of the Heratherm series.

3. Temperature Uniformity and Stability: The system maintains temperature uniformity within ±0.1 to 0.5°C across an operating range of approximately 0°C to 70°C. This level of precision is essential for microbiological testing, pharmaceutical quality control, and stability studies conducted under USP Chapters <60> through <62> and <71>, where even minor temperature deviations can compromise analytical results and regulatory validity.

6. Salient Physical, Functional, and Performance Characteristics (FAR 11.104) To the extent an offeror proposes an equal item, the following salient characteristics must be met at a minimum. Any proposed equal item that does not meet all of the following characteristics will be considered technically unacceptable:

• Minimum Internal Capacity: 750 liters (nominal)

• Temperature Control Mode: Dual — active heating AND active cooling within a single integrated unit

• Operating Temperature Range: Approximately 0°C to 70°C

• Temperature Uniformity: ±0.5°C or better across the full operating range

• Temperature Stability: ±0.1°C or better

• Compliance: Suitable for use in microbiological testing per USP Chapters <60>, <61>, <62>, and <71>

• Power/Installation: Compatible with existing laboratory electrical and spatial infrastructure at NYMPL (158-15 Liberty Avenue)

7. Market Research (FAR Part 10) Market research was conducted to identify commercially available incubation chamber systems capable of meeting NYMPL's operational requirements. The research confirmed that incubator chambers with a 750-liter capacity and integrated dual heating and cooling functionality are not widely available from multiple established manufacturers at this exact specification.

The following vendors were evaluated:

• Binder (KB series) — Offers refrigerated incubators near the required capacity range but does not offer a unit at 750 liters with equivalent dual heating/cooling performance.

• Memmert (IPP/IPPeco series) — Offers Peltier-cooled incubators with good uniformity but not at the 750-liter capacity required.

• Panasonic/PHCbi — Offers large-format incubators but not with equivalent dual heating and cooling functionality at the 750-liter capacity.

• ARES Scientific — Offers incubators near the required capacity range but not at 750 liters with equivalent performance specifications.

Market research further confirms that mid- to large-sized manufacturers offering comparable performance specifications do not produce units at the exact 750-liter capacity, limiting the availability of small business or alternative sources for this specific requirement.

8. Efforts to Solicit Offers from Additional Sources Efforts to identify additional sources were undertaken as part of the market research described in Section 7. No alternative vendor was identified that offers a product meeting all of NYMPL's salient characteristics, particularly the 750-liter capacity with integrated dual heating and cooling functionality and required temperature uniformity.

This justification will be posted to SAM.gov concurrent with the solicitation in accordance with FAR 5.102(a)(6), providing an opportunity for any vendor that believes it can offer an equal item to respond.

9. Actions to Remove or Overcome Barriers to Competition For any subsequent acquisition of similar laboratory incubation equipment, the agency will broaden the performance-based specification to the extent practicable— focusing on functional requirements such as minimum capacity, temperature range, and uniformity tolerances—rather than specifying a brand name. This approach is intended to increase the pool of responsive vendors and promote full and open competition in future procurements.

10. Certifications and Approvals

a. Program Office Certification (COR / Requiring Activity POC)

I hereby certify that the information provided in this Brand Name Justification is accurate, complete, and to the best of my knowledge supports the rationale for the proposed single-source acquisition under FAR 13.106-1(b)(1)(i).

Signature / Date Printed Name / Title

REDACTED REDACTED

c. Contracting Officer Certification

This is to certify that the justification for the proposed acquisition has been reviewed and that, to the best of my knowledge and belief, the information and/or data provided to support the rationale and recommendation for approval is accurate and complete. This document will be posted to SAM.gov in accordance with FAR 5.102(a)(6).

Signature / Date Printed Name / Title REDACTED Jennifer Mun

Contracting Officer