A13. SAP-Sole-Source-Procurement RFO Part 8 and 12_CORsigned - Copy.pdf

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN MARKET OR GSA)

UNDER $350,000

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 12.102 or 8.401 (GSAR 538.7104-3). 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:

Mycotic Diseases Branch (MDB) Division of Foodborne, Waterborne, and Environmental Diseases National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) Centers for Disease Control and Prevention Atlanta, GA 30329 Centers for Disease Control and Prevention

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Office of Acquisition Services

C. Identification of Requirement:

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

a. Sole source acquisition of: Development and validation of diagnostic methods for coccidioidomycosis (Valley Fever), including biospecimen repository expansion, serologic assay development, and CLIA-compliant validation activities.

OR

b. Competitive acquisition of brand name only items: Click here to enter text.

c. Procurement Request (PR) Number (if available): 000HCRBG-2026-98810

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

a. Proposed Vendor: Click here to enter text.

b. Estimated Procurement Amount: $349,900

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

Rev. 5/28/26

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

D. Justification:

1. The justification for this non-competitive action is: Market research was conducted through:

internet research of organizations involved in fungal disease diagnostics and coccidioidomycosis research, review of scientific publications and federally funded Valley Fever research programs, evaluation of organizations with access to endemic patient populations and biospecimen repositories, review of commercial and academic laboratory capabilities relevant to diagnostic assay development and validation. Market research confirmed that the Valley Fever Center for Excellence (VFCE) is the only identified source with the combination of: wpecialized expertise in coccidioidomycosis, existing biospecimen repository infrastructure, Access to endemic patient populations, established IRB-approved protocols, laboratory and CLIA validation capabilities necessary to meet CDC’s requirements.

☒ In accordance with FAR 12.102, “only one source is available” in accordance with 41

USC 1901:

X Only one source available A brand-name product or service being required without allowing “equal” products The need for compatibility with existing systems, equipment, software, licenses, warranties, or support arrangements Unusual urgency Exclusive licensing or proprietary rights Continuity of operations Other: [briefly describe]

☐ In accordance with GSAM 538.7104-3 as required in FAR 8.401(b) I hereby determine that the circumstances of this acquisition deems only one source reasonably capable of providing this requirement on the basis that:

The need is of such unusual urgency that following the procedures would result in unacceptable delays in fulfilling that need;

Only one source is capable of providing the products, services, or solution required at the level of quality required because the products, services, or solutions are unique or highly specialized;

The order should be issued on a sole source basis in the interest of economy and efficiency because it is a logical follow-on to an FSS order already issued on a competitive basis;

It is necessary to place the order with a particular FSS contractor to satisfy a minimum guarantee established in the FSS BPA; or

A law expressly authorizes or requires that the purchase be made from a specified source.

Other: [briefly describe]

2. Market Research Conducted:

The Valley Fever Center for Excellence (VFCE) is uniquely qualified to perform this work due to its specialized expertise, established infrastructure, and longstanding focus on coccidioidomycosis research and diagnostics. The VFCE maintains: an existing biospecimen repository containing specimens from patients with coccidioidomycosis, established IRB-approved patient recruitment and specimen collection protocols, access to endemic patient populations through Banner Health System clinical partnerships in Arizona, laboratory infrastructure capable of performing serologic, immunologic, and flow cytometry-based diagnostic research, and experience conducting CLIA-related diagnostic development and validation activities. The VFCE has over 30 years of institutional experience focused specifically on coccidioidomycosis and is the only administratively constituted center in the United States dedicated to Valley Fever research, clinical care, and diagnostic advancement. This requirement depends upon immediate access to existing specimen repositories, endemic patient populations, specialized laboratory expertise, Rev. 5/14/19 and established clinical and research infrastructure. No other known organization possesses all of these capabilities within a single institution.

3. Facts supporting sole source procurement: What can this product/service do that other products/services cannot do? Include description of other products/services considered and why they did not meet the need.

Alternative academic institutions, commercial laboratories, and research organizations were considered through internet research and review of organizations involved in fungal disease diagnostics and infectious disease research. However, no alternative organization was identified that could provide equivalent expertise specifically in coccidioidomycosis, existing biospecimen repositories dedicated to Valley Fever, georgraphic proximity and access to sufficient endemic patient populations, existing IRB-approved protocols and clinical infrastructure, and combined BSL-2/BSL-3 laboratory and CLIA validation capabilities. Use of alternative vendors would require substantial time and cost to: establish new patient recruitment pipelines, develop specimen repositories, obtain new IRB approvals, and build specialized laboratory infrastructure and expertise. This would significantly delay project objectives and reduce the Government’s ability to rapidly advance diagnostic development for coccidioidomycosis.

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: Christina Ottis

Center/Institute/Office COR/Program Official Signature/Date

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: Brian Swann

Contracting Officer Signature/Date