A. 13. SSJ signed.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:

Centers for Disease Control and Prevention, National Centers for Immunization and Respiratory Diseases, Influenza Division 1600 Clifton Rd NE Roybal BLDG 24, 7th floor, MS A-20 Centers for Disease Control and Prevention Atlanta, GA 30333

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch 2920 Brandywine Road, Atlanta, GA 30341

C. Identification of Requirement:

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

a. Sole source acquisition of: Purchase of a BioMark X from Fluidigm

b. Procurement Request (PR) Number (if available): 67676

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

a. Proposed Vendor: Fluidigm

b. Estimated Procurement Amount: $122,480.34

3. Is the requirement on GSA Schedule? ☐ Yes ☒ No

If yes, provide schedule number: Click here to enter text.

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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?

We are collaborating with the Broad Institute to develop CRISPR-based diagnostics for influenza and other respiratory pathogens. We are setting up Combinatorial Arrayed Reactions for Multiplexed Evaluation of Nucleic acids (CARMEN), which is a technology where nanoliter droplets containing CRISPR-based nucleic acid detection are used for simultaneously testing many pathogens. The BioMark X contains the microfluidic technology necessary for this protocol.

The Biomark™ X system includes the optical, thermal cycling, and software components necessary to perform real-time PCR gene expression and genotyping, as well as endpoint analysis for genotyping applications. It also primes integrated fluidic circuits (IFCs) with control line fluid and then loads them with the assay and sample mixes. The Biomark X system provides orders of magnitude higher throughput for real-time PCR compared to conventional platforms using IFCs— nanofluidic circuits containing fluidic networks that automatically combine sets of samples with sets of assays. This innovative solution for real-time PCR provides experiment densities far beyond what is possible with microplate platforms, Rev. 5/14/19 significantly reducing the number of liquid-handling steps and volumes per reaction.

Fluidigm has the sole legal right to commercialize the Biomark X system utilizing Dynamic Array and/or Digital Array IFCs and Fluidigm is the only vendor of Biomark X, Dynamic Array and Digital Array technology.

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

The Fluidigm BioMark X was determined to be the optimum system to meet the needs requirements of the Influenza Division for the Combinatorial Arrayed Reactions for Multiplexed Evaluation of Nucleic acids (CARMEN), a platform for scalable, multiplexed pathogen detection and compatibility with collaborators at the Broad Institute performing similar testing. Fluidigm is the only supplier for the BioMark X system.

3. Program Office efforts to seek potential offerors:

Not applicable

E. Program Office Certification:

I have reviewed this sole source justification and certify 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: NCIRD/ID/VSDB; Charmaine V McKenzie;

Public Health Advisor

Center/Institute/Office COR/Program Official Signature:

Certification Date: April 30, 2024

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.