A13_SSJ_CO Signed.pdf

Rev. 1/6/14

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:

DDID/NCHHSTP/DHAP/Lab Branch Roybal Campus, 1600 Clifton Road, NE Building 18, Room 2-132, Mailstop 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 Services, Branch 4, Team 2

2920 Woodcock Blvd, Mail stop TUC-4

Atlanta, GA 30341

C. Identification of Requirement:

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

a. Sole source acquisition of Procurement and Delivery of Lateral Flow Test Results from Persons

Administered Integrase Inhibitor-based Antiretroviral Therapy or Long-acting Pre-Exposure Prophylaxis (PrEP).

b. Procurement Request (PR) Number (if available): HCKBG-2024-86298

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

a. Proposed Vendor:

Fenway Institute, 1340 Boylston Street, Boston, Mass 02215

Email: KMayer@Fenwayhealth.org - Director Dr. Kenneth Mayer

b. Estimated Procurement Amount: $200,000

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

If yes, provide schedule number:

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) mailto:KMayer@Fenwayhealth.org 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, comparability, 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?

This contract requires an HIV care clinic with a clientele of at least 100 persons on injectable cabotegravir long-acting (CAB-LA) (Apretude) pre-exposure prophylaxis (PrEP) as well as a high proportion of patients on bictegravir-based treatment. CAB-LA uptake is very low in the US therefore having a sufficient number of participants on CAB-LA in one clinic to be able to successfully recruit at least 50 participants combined with being a highly resourced clinic that has a history of successfully supporting clinical studies is a rarity. Fenway Health has the number of clientele mentioned above and has a large team of care providers and recognized leaders in HIV preventative care who can support investigation of new CDC-developed assays and manage requested blood spot specimen collection during care visits.

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

Other providers do not have the combined capacity of recruiting persons with HIV or at increased risk of acquiring HIV, together with the high level of recognized expertise in long-acting PrEP care, and with experience in running Institutional Review Board (IRB) -approved protocols. The Fenway Principal Investigator was an investigator in the injectable CAB PrEP clinical trial and has unique perspective on CAB-LA adherence and pharmacokinetics. The Fenway clinicians and care providers have a combined 90+ years of HIV care research with an entire team on site to perform test evaluations and timely shipping of specimen to CDC. Fenway has evidence of successfully performing clinical studies to satisfy CDC task orders.

3. Program Office efforts to seek potential offerors:

Program has knowledge of CAB-LA administration prevalence and has taken into consideration past performance to allow for completion within required timeline. Fenway meets the above criteria to perform the work to inform a key CDC-developed test to assist in PrEP monitoring.

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, Lab Branch

Center/Institute/Office COR/Program Official Signature:

Certification Date: May 2, 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:

Contracting Officer Signature:

Certification Date: