A13_SSJ_R.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:

OID/NCHHSTP/DHP/Lab Branch Roybal, 1600 Clifton Road NE Building 18, Room #2-134, MS H18-2 Centers for Disease Control and Prevention Atlanta, GA 30329

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch #2

2900 Woodcock Blvd

Atlanta, GA 30341

C. Identification of Requirement:

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

a. Sole source acquisition of: Procurement of lateral flow assay design using antibodies developed by the CDC to detect antiretroviral drugs

b. Procurement Request (PR) Number (if available): 00HCKBG-2024-84795

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

a. Proposed Vendor: NanoComposix, Inc. 4878 Ronson Ct., Suite J San Diego, CA

b. Estimated Procurement Amount: $120,000.00

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

Justification:

1. The justification for this non-competitive action is: (NOTE: Must select only ONE of the listed justifications for other than full and open competition and fully support the justification in the following paragraphs. Please delete this note prior to submitting the justification.)

☒ 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?

NanoComposix is a small company that develops lateral flow assays (LFAs) intended for clinical use. They have proprietary state of the art nanoparticle materials and have expertise in translating laboratory designed LFAs into clinical products through the entire Food and Drug Administration (FDA) licensing process. Additionally, NanoComposix has extensive experience with the design applications and specific needs for this particular LFA as they have worked on the previous PO #75D30122P15630 for the original conception and design. Continuing the work by NanoComposix will provide advantages in speed and knowledge that will not be possible using another source within the time frame required.

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

Rev. 5/14/19

Two other large companies considered were DCNdx and Sigma-Aldrich. These firms were evaluated for their ability to provide lateral flow devices under good manufacturing practices (GMP), their experience manufacturing and delivering clinical LFAs, and their experiences with shepherding an LFA product through FDA approval. Due to the intended use of the devices, we are limited to vendors that have the capacity to manufacture under GMP and have worked with the FDA on device approvals. NanoComposix is a small company and the only company that provides nanoparticle technology for LFA development, while also delivering clinical grade assays for evaluation, and providing strong support for the FDA application and approval process. The Migration of the project to a new vendor would require a significant investment of time and resources to re-configure the LFA device with the new vendor’s technology.

3. Program Office efforts to seek potential offerors:

The program has conducted extensive internet research on potential vendors for LFA design and manufacture. Having worked on a previous contract, NanoComposix is the only vendor that can continue the LFA development.

D. 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: Caryn Kim, COR, Division of HIV Prevention, Laboratory Branch

Caryn Kim

Center/Institute/Office COR/Program Official Signature:

Certification Date: March 6, 2024

E. 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: Ronnie Williams

Contracting Officer Signature:

Certification Date: April 3, 2024 kpz6 Highlight