A13- Sole Source Justification - CO signed 30 Jul 2025_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:

NCEZID

1600 Clifton Rd NE Building 18, H18-1 Centers for Disease Control and Prevention Atlanta, GA 30333

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Office of Acqusition Services

C. Identification of Requirement:

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

a. Sole source acquisition of: Liquid chromatography tandem mass spectrography (LC- MS/MS) and Pharmacokinetic (PK) Sample Analysis for i) Alisporivir (Compound A) and ii) Cyclophilin Inhibitor (NIM811) (Compound B) in Mouse Plasma (K2EDTA) Samples from NorthEast BioAnalytical Laboratories LLC

b. Procurement Request (PR) Number (if available):

2. Proposed Vendor and Estimated Procurement Amount (if available):

a. Proposed Vendor: NorthEast BioAnalytical Laboratories LLC

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?

NorthEast BioLab can complete a LC-MS/MS and PK sample analysis for Alisporivir and NIM811 in mouse plasma samples, which is a quantitative analysis capability that we do not have here at our labs within Poxvirus and Rabies Branch (PRB). After contacting multiple vendors, it appears that this company is the only one that is capable/willing to develop an assay for the specific species or strains that PRB typically works with (i.e., black-tailed prairie dogs, Cast/EiJ mice (A mouse strain that was derived from wild mice and is often combined with the common laboratory strains to generate hybrids with high levels of heterozygosity)).

b. What other products/services were considered and why did they not meet the need?

Charles River Laboratories was contacted to complete a PK analysis under this animal protocol, and we were informed they do not have capabilities to develop an assay for that species. Auburn University was contacted since they have completed