A13_Justification Permitting Other Than Full and Open Competition pr85494 DJM.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:

NCHHSTP DVH

Roybal Bldg 18, Room 3-123, MS A-33 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: Purchase of Hepatitis C Seroconversion Panels

b. Procurement Request (PR) Number (if available): 000HCKED-2024-85494

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

a. Proposed Vendor: Zeptometrix

b. Estimated Procurement Amount: $113118.16

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:

X 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

☐ X - 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?

HCV seroconversion panels are limited in the market in the quantity that is required to evaluate multiple FDA cleared assays for their sensitivity in detecting window phase (RNA positivity prior to antibody positivity) infections. These panels are unique in that they include specimens with RNA positive samples both prior to and after antibody positivity. Fisher Scientific has 4 panels available, of which only two have samples in the panels with RNA positivity after antibody positivity.

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

Fisher Scientific has 4 panels available, however the number of members in the panel with RNA positivity after seroconversion are limited. Further, Fisher only has 4 seroconversion panels available while ZeptoMetrix has 20 panels available for purchase with pre- and post-seroconversion RNA samples. In order to do the evaluations of all FDA approved HCV RNA assays, we need large volumes of the same panels to compare assays and Zeptometrix is the only company with this diversity of panels and volumes.

Rev. 5/14/19

3. Program Office efforts to seek potential offerors:

Fisher has 4 seroconversion panels available, but only 2 of the panels have collection points with RNA positivity after antibody conversion. Zeptometrix is the only company that has this many panels available with the volumes that we need.

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:

----NCHHSTP/DVH/Youkyung Choi/Microbiologist and COR 1

Center/Institute/Office COR/Program Official Signature:

Certification Date: May 9, 2023

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.