A13_SSJ_000HCKBG-2024-84796.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 2-132, 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 matched biological specimens from people receiving antiretrovirals for HIV treatment or prevention –Emory University

b. Procurement Request (PR) Number (if available): HCKBG-2024-84796

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

a. Proposed Vendor: Emory University

201 Dowman Drive, Atlanta, GA 30322

b. Estimated Procurement Amount: $249,912.00

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: (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?

Emory University has previous track records of collecting clinical trial specimens under IRB-approved protocols while strictly following DHP SOPs for specimen collection (75D301-20-Q-72023, 75D30122C14484, 75D30121P11533). Their experience is required to provide continuity and consistency in data procurement and allow for direct comparisons to historical trial data. Additionally, Emory University is near in distance to the CDC DHP laboratory. The analysis of freshly collected specimens is essential to the success of this requirement, and Emory University’s proximity to CDC lab will ensure timely sample delivery.

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

Vendors in the metro Atlanta area that were considered included Emory University, Morehouse College of Medicine, and the VA Atlanta Health Care. These vendors being medical facilities have the potential to meet the procurement requirements. However, The VA Atlanta healthcare network focuses on veterans, which would likely limit

Rev. 5/14/19 recruitment and enrollment. Morehouse College of Medicine would likely be capable of enrolling and completing the trial. However, timely fresh sample delivery is integral to the trial’s success and Emory is the only vendor that can consistently provide the specimens timely which will also allow for a direct comparison with prior data.

3. Program Office efforts to seek potential offerors:

Emory is the only vendor that can fulfill this requirement based on the program’s need for the collection method, history, access to recruitment participants, and proximity to the CDC location.

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: Caryn Kim , COR, DHP, Lab Branch

Caryn Kim

Center/Institute/Office COR/Program Official Signature:

Certification Date: March 4, 2024

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: Ronnie Williams

Contracting Officer Signature:

Certification Date: May 15, 2024