A1b. SSJ 77199-79661 SSJ_Sedia_rev 8.21.2023 redacted.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:

Center for Disease Control & Prevention (CGH/DGHT/ILB) Roybal Campus Trudy Dobbs 1600 Clifton Rd.

Building 15,2101 Center for Disease Control and Prevention Atlanta, GA 30333

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch 1

C. Identification of Requirement:

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

a. Sole source acquisition of: Sedia Bioscience Asante Rapid Recency Test and HIV-1 LAg Avidity EIA Test Kits

b. Procurement Request (PR) Number (if available): Not available

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

a. Proposed Vendor: Sedia Biosciences Corporation 9590 SW Gemini Drive Beaverton, OR 97008 Phone: 503-459-4159

b. Estimated Procurement Amount: $82,263.00

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

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

D. Justification:

Rev. 5/14/19

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?

No other products were considered as the reagents and kits we are required to continue to use in ongoing projects is only available from Sedia Biosciences, no other company manufactures these specific kits. The Sedia Biosciences is the only commercial biotech company that supplies Asante HIV-1 Rapid Recency Assay and

HIV-1 LAg Avidity kits.

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

No other products were considered for this specific purchase because we need these specific reagent kits to continue supporting ongoing projects utilizing these reagent kits available from Sedia Biosciences.

3. Program Office efforts to seek potential offerors:

Did not seek any offers since Sedia is the only manufacturer of Asante HIV-1 Rapid Recency

Test kit and we already have in stock the other HIV-1 LAg Avidity kits.

Rev. 5/14/19

Program Office Certification:

I have reviewed this sole source justification and certify the justification is true, 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: Click here to enter text.

Center/Institute/Office COR/Program Official Signature:

Certification Date: Clic0k 8h.e2re1.t2o 0e2n3te r a date.

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: Click here to enter text.

Contracting Officer Signature:

Certification Date: Click here to enter a date.