SSJ for nanoparticles redacted 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:

NIOSH/HELD/ACIB

1095 Willowdale Road Mail Stop: Kelly Fraser (L3419) Morgantown, WV 26505 Click here to enter text.

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch #5

Identification of Requirement:

Nature of Action to be Approved by Contracting Officer:

Sole source acquisition of: This is a request to procure specialized research materials on a sole source basis from Lab261.

Procurement Request (PR) Number (if available): Click here to enter text.

Proposed Vendor and Estimated Procurement Amount (if available):

3. Is the requirement on GSA Schedule? Yes No

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

Proposed Vendor: Lab261

Estimated Procurement Amount: Redacted vwl8 Highlight

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?

Lab261 is the only known vendor capable of providing the required materials with the precise specifications necessary to meet the Government’s minimum requirements.

Specifically:

1. Unique Combination of Specifications: The study requires PVC and PET particles in occupationally relevant sizes (10 nm and 1 μm) with stable green fluorescent labeling. This exact combination of polymer type, particle size, and fluorescence is not commercially available from other vendors.

2. Scientific Necessity and Research Application: The study aims to investigate the toxicological effects of micro- and nanoplastics in vitro, including particle deposition and cellular translocation. Pre-labeled fluorescent particles are essential to efficiently and accurately monitor particle presence, significantly improving assay reliability and enabling real-time tracking.

3. Specialized Manufacturing Constraints: Producing nanoplastic particles at the 10 nm scale with consistent size distribution and stable fluorescent labeling requires specialized synthesis capabilities. At present, Lab261 is the only identified vendor capable of reliably producing these materials within the narrow specifications required.

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

Alternative sources were considered. Micro and nano plastic particles are available without fluorescent labeling or in larger size ranges. However, these particles are not suitable because larger particles are non-respirable and not representative of human respiratory exposures, making them inappropriate for the study’s objectives.

In-house production via milling was also considered. An alternative approach would be to produce particles by milling larger plastics into smaller sizes. However, this method is cost-prohibitive, requires specialized equipment not readily available, and produces heterogeneous particle sizes with low yield. Achieving a narrow size distribution (e.g., 10 nm) through milling and subsequent filtration is technically difficult and often unsuccessful. Additionally, certain polymers such as PVC are not well-suited for this process. As a result, this approach would not meet the study’s requirements for consistency, reproducibility, or scale. Furthermore, Lab261 has previously supplied four (4) similar particles currently in use for this study.

Maintaining consistency in particle source, synthesis methods, and labeling is critical to ensure comparability of results and preserve scientific validity across experiments. The inability to procure these specific materials would prevent completion of the current study, resulting in an incomplete assessment of micro-and nanoplastic toxicity and failure to adequately test the study hypothesis. Based on these factors, Lab261 is the only responsible source capable of meeting the Government’s requirements without unacceptable risk to the research objectives.

3. Program Office efforts to seek potential offerors:

Market research was conducted through literature review, scientific vendor catalogs, and online searches for micro- and nanoplastic particle suppliers. While limited alternatives exist, none meet the study’s minimum requirements.

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.

CIO Project Officer Name: Kelly Fraser, Associate Service Fellow, NIOSH/ACIB

CIO Project Officer Signature:

Approval Date: Click here to enter a date.

Program Management Officer: Yvette Bostic, Management and Program Analyst

Signature:

Approval Date: Click here to enter a date.

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.

KELLY E. FRASER

-S (Affiliate)

Digitally signed by KELLY E.

FRASER -S (Affiliate) Date: 2026.05.11 14:28:22 -04'00'

Yvette F. Bostic -S Digitally signed by Yvette F.

Bostic -S Date: 2026.05.11 16:16:11 -04'00'