Sole Source JA.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:

OFFICE OF LABORATORY SYSTEMS AND RESPONSES (OLSR)

PREPAREDNESS, RESPONSE AND OUTBREAK SERIVCES BRANCH (PROSB)

1600 CLIFTON RD NE

Centers for Disease Control and Prevention Atlanta, GA 30329

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch Click here to enter text.

C. Identification of Requirement:

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

a. Sole source acquisition of: Purchasing of Primer and Probe Kits

b. Procurement Request (PR) Number (if available): 00HCANDD-2025-90558

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

a. Proposed Vendor: BIOSEARCH TECHNOLOGIES, INC., 2199 SOUTH

MCDOWELL BLVD, PETALUMA, CA 94954

b. Estimated Procurement Amount: $249,997.00

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:

The Laboratory Response Network (LRN) and BioWatch laboratories use primer/probe kits provided by the CDC for clinical and environmental testing. These kits must meet the Food and Drug Administration's (FDA) Quality System Regulation (QSR) requirements due to federal regulations for clinical specimen testing. It is mandatory for the kits to utilize Black Hole Quenchers (BHQ) on probes. Biosearch is the sole licensed and authorized supplier for producing BHQ probes for clinical applications.

The primer and probe kits are only compatible with existing Laboratory Response Network (LRN) and Biowatch laboratories verification procedures. Without years of extensive comparison and validation studies, no other vendor can meet this critical need.

The BHQ probes used in FDA QSR-compliant testing of clinical specimens cannot legally be produced by any other vendor. Therefore, it is crucial to consider the timing of the budget's approval and access to funding.

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?

Rev. 5/14/19

The primer and probe kits are vital tools used in high-security laboratories authorized by the Centers for Disease Control and Prevention (CDC), such as Laboratory Response Network (LRN) and Biowatch laboratories, for the detection of potential bioterrorism agents. These kits must adhere to the Quality Systems Regulations (QSR) of the Food and Drug Administration (FDA) for real-time PCR primer and probe kits. They are specifically designed to identify bioterrorism agents such as Y. pestis, B. anthracis, Variola, F.

tularensis, Burkholderia, Brucella species, and others. Each kit is required to contain one or more unique signatures, utilize probes with Black Hole Quencher technology, and be manufactured in accordance with QSR requirements.

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

No other products were considered due to complaince and limitations.

3. Program Office efforts to seek potential offerors:

A Market Research Report (MRR) was completed and is attached.

E. Program Office Certification:

I have reviewed this sole source justification and certify that the justification is true and accurate to the best of my knowledge and adequate to support other than full and open competition.

Center/Institute/Office COR/Program Official Name/Title: OLSR/DCLSR/PROSB, Drenda Morrissette, PHA

Center/Institute/Office COR/Program Official Signature:

Certification Date: Click here to enter a date.

F. Contracting Office Certification:

I have fully relied on the information provided herein and hereby certify that this justification is accurate and complete to the best of my knowledge and belief:

Contracting Officer Name: Click here to enter text.

Contracting Officer Signature:

Certification Date: Click here to enter a date.

Matthew Nelson