Sole Source Justification_73735signed.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:

Centers for Disease Control and Prevention, National Centers for Immunization and Respiratory Diseases, Influenza Division 1600 Clifton Rd NE Roybal BLDG 24, 7th floor, MS A-20 Centers for Disease Control and Prevention Atlanta, GA 30333

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch 2920 Brandywine Road, Atlanta, GA 30341

C. Identification of Requirement:

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

a. Sole source acquisition of: Purchasing service of vialing and drying down the vials of primers and probes for the FDA-Approved CDC Influenza B Genotyping In Vitro Diagnostic (IVD) kit.

b. Procurement Request (PR) Number (if available): 73735

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

a. Proposed Vendor: Integrated DNA Technologies (IDT)

b. Estimated Procurement Amount:

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:

☒ 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?

The CDC Influenza B Genotyping IVD kit is an FDA-approved in vitro diagnostic test.

When manufacturing FDA-approved in vitro diagnostic tests, we must keep to the steps and processes that were used when creating test performance data for the FDA data submission, as per FDA guidelines. Integrated DNA Technologies is the only approved manufacturer for vialing and drying down of the primers and probes for the CDC Influenza B Genotyping IVD kit, and we cannot use a different external vendor for this process.

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

No other alternative companies were considered, as we must keep to the manufacturers approved during the FDA review process of this diagnostic test. We are manufacturing more CDC Influenza B Genotyping Kits for public health laboratories, and we must use Integrated DNA Technologies for the vialing/drying step to keep within the FDA-approved steps for manufacturing this kit.

Rev. 5/14/19

3. Program Office efforts to seek potential offerors:

Not applicable

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: NCIRD/ID/VSDB Public Health Advisor

Center/Institute/Office COR/Program Official Signature:

Certification Date: May 5, 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: Click here to enter text.

Contracting Officer Signature:

Certification Date: Click here to enter a date.