A13 SSJ_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 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:

Division of Laboratory Sciences Chamblee Campus 4770 Buford Hwy Centers for Disease Control and Prevention Atlanta, GA 30341

B. Contracting Activity:

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

C. Identification of Requirement:

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

a. Sole source acquisition of: Affinisep AffiniMIP Filter Plates

b. Procurement Request (PR) Number (if available): 00HCNBI-2024-85592

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

a. Proposed Vendor: Affinisep USA,LLC

25 SE 2ND Ave. Suite 1016 Miami, FL 33131

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-

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-

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-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 proced

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?

Affinisep is the only company that produces an NNAL Molecular Imprinted Polymer (MIP) that meets the high recovery requirements for tobacco-specific nitrosamines (TSNA) method analysis. MIP filter plates are used for all TSNA studies as an essential consumable supply. These plates are necessary for the sample clean-up procedure and are vital for processing and analysis. These plates have been tested extensively and are critical to our on-going processing for TSNA analysis.

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

There are no current alternatives for this consumable. Previously, Sigma produced NNAL MIP filter plates but the company has since discontinued the product so Affinisep is the only available source for these custom filter plates. It has been tested and provided exceptional results on our validated method.

3. Program Office efforts to seek potential offerors:

Conducted internet searches for specific plates that would meet the needs of our research but did not find any that would suffice. Affiinsep has been found to be higher in recovey and better suited for TSNA assay.