A13. Brand Name SSJ_Redacted.pdf

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN MARKET OR GSA)

UNDER $250,000

Sole source acquisitions may be used on a limited basis and only when the Contracting Officer’s Representative (COR)/Program Official has provided sufficient justification and the Contracting Officer has determined that the circumstances warrant such action. The content for a justification must contain detailed facts and rationale to justify the sole source acquisition. Soliciting from a single source must be done in accordance with FAR 13.106-1(b) or 8.405-6. At a minimum, the following information must be included:

Identification of Program Office, Contracting Activity, and Proposed Requirement, Justification and Program Office Certification:

A. Program Office:

Division of Core Laboratory Services & Response (DCLSR) Office of Laboratory Systems and Response (OLSR) Centers for Disease Control and Prevention (CDC) Atlanta, GA

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch

C. Identification of Requirement:

1. Nature of Action to be Approved by Contracting Officer:

a. Sole source acquisition of: Mobile Cryogenic Transfer Operations Platform MVE Cryo Carts W/Temp Recorder and Plumbing

b. Procurement Request (PR) Number: 00HCANDD-2025-94879

2. Proposed Vendor and Estimated Procurement Amount:

a. Proposed Vendor: SELECT GASES

b. Estimated Procurement Amount: $

3. Is the requirement on GSA Schedule? Yes No If yes, provide schedule number: Click here to enter text.

Rev. 5/14/19

D. Justification:

1. The justification for this non-competitive action is:

In accordance with FAR 13.106-1(b)(1), “only one source [is] reasonably available” which states that, “For purchases not exceeding the simplified acquisition threshold. (i) Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). (ii) Where a single source is identified to provide a portion of a purchase because that portion of the purchase specifies a particular brand-name item, the documentation in paragraph (b)(1)(i) of this section only applies to the portion of the purchase requiring brand-name item. The documentation should state it is covering only the portion of the acquisition which is brand- name.”

Urgency

Exclusive licensing agreements/Proprietary data

Brand name required

Industrial mobilization

Other (e.g., compatibility, space issues, continuity, compatibility, etc.)

In accordance with FAR 8.405-6 “Limiting Sources” which states that, “the only circumstances that may justify the action are – (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays; (B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; or (C) In the interest of economy and efficiency, the new work is a logical follow-up to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original BPA must not have been previously issued under sole-source or limited-sources procedures.”

Urgency

Only One Source

Logical Follow Up

Brand name required

2. Other facts supporting sole source procurement:

a. What can this product/service do that other products/services cannot do?

The Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) support public health programs that include biorepository activities. The Preparedness, Response, and Outbreak Services Branch (PROSB) within the Division of Core Laboratory Services and Response (DCLSR) operates the CDC Biorepository (CBR) located in Lawrenceville, Georgia. CBR’s mission is to preserve CDC’s valuable samples and facilitate CDC program activities fundamental to public health surveillance, research, and outbreak response.

In alignment with its comprehensive Quality Management System (QMS), CBR operates as a facility accredited by the College of American Pathologists’ (CAP) Biorepository Accreditation Program (BAP). To maintain this accreditation, CBR must ensure continuous cold-chain integrity and sample preservation during all sample handling and disposition activities, including transport.

The criteria identified are mandatory requirements, not preferences. The cryogenic transfer platform must meet CDC Biorepository technical specifications, maintain uninterrupted cold-chain integrity, be compatible with existing liquid nitrogen (LN ) infrastructure, and support continued compliance with CAP BAP standards.