A13- Sole Source Justification_V2_ SL signed 6 Nov 24_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:

Jean Whichard Enteric Diseases Laboratory Branch, National Antimicrobial Resistance Surveillance Team MSG29; 1600 Clifton Road Centers for Disease Control and Prevention Atlanta, GA 30329

B. Contracting Activity:

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

C. Identification of Requirement:

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

a. Sole source acquisition of: We ask that items be received with maximum shelf life left. Surveillance for antimicrobial resistance among enteric bacteria in the United States is conducted by a tri-agency partnership among CDC, FDA and USDA, through the National Antimicrobial Resistance Monitoring System (NARMS), and the method required is Sensititre™ broth microdilution testing. The testing supplies, equipment and service agreement provisions are proprietary and only provided by Remel, Inc., a subsidiary of ThermoFisher. Continuity of the surveillance that has been performed in this standardized way since 1996 is very important. Other non-Sensititre antimicrobial susceptibility testing methods would require extensive validation and equivalency studies, and switching to a different method would undermine our ability to do timely, integrated surveillance and trend analysis, major goals of our surveillance program, and undermine our ability to achieve our mission in comparing data collected from humans with historical data collected by FDA and USDA on retail meat and food animals, respectively. This is a proprietary line of products. Supplies from other manufacturers cannot be used with the equipment that we have, so changing to another manufacturer's platform for performing susceptibility testing would require purchase of hundreds of thousands of dollars worth of new equipment to accommodate a new manufacturer's supplies. The current use of proprietary

Sensititre™ broth microdilution supplies, equipment and service agreement for the NARMS surveillance project is the only option that can provide continuity and comparability with our historical data and that of our federal partners in this surveillance.

b. Procurement Request (PR) Number (if available): Click here to enter text.

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

a. Proposed Vendor: ThermoFischer Scientific

b. Estimated Procurement Amount: $

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

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

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?

Please see the attached sole source manufacturer document (PDF file “20240110 Customer Communication - Sensititre sole source”). Surveillance for antimicrobial resistance among enteric bacteria in the United States is conducted by a tri-agency partnership among CDC, FDA and USDA, through the National Antimicrobial Resistance Monitoring System (NARMS), and the method required for primary testing or confirmation of DNA sequence-based approaches is Sensititre TM broth microdilution testing. The testing supplies, equipment and service agreement provisions are proprietary, only manufactured by Remel, Inc., a subsidiary of ThermoFisher, and in the US are only provided by Remel, Inc., a subsidiary of ThermoFisher. Continuity of the surveillance that has been performed in this standardized way since 1996 is very important. Other non- Sensititre antimicrobial susceptibility testing methods would require extensive validation and equivalency studies, and switching to a different method would undermine our ability to do integrated surveillance and conduct trend analysis, major goals of our surveillance program. Supplies from other manufacturers cannot be used with the equipment that we have, so changing to another manufacturer's platform for performing susceptibility testing would require purchase of hundreds of thousands of dollars worth of new equipment to accommodate a new manufacturer's supplies. The current use of proprietary Sensititre™ broth microdilution supplies, equipment and service agreement for the NARMS surveillance project is the only option that can provide continuity and comparability with our historical data and that of our federal partners in this surveillance.

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

No other products can be considered. The sensititre susceptibility testing equipment and supplies are proprietary and are the only ones we can use for our surveillance and the only ones compatible with current methods and equipment.

Other manufacturers' products cannot be used instead and do not meet requirements for historical comparisons and trend analysis.

3. Program Office efforts to seek potential offerors:

There are no other potential US vendors of known sources with the capability to provide the supplies required. Remel is the sole manufacturer of the Sensititre plates and ancillary supplies used for valid testing using Sensititre plates. The sensititre susceptibility testing equipment and supplies are the only ones compatible with our needs and other manufacturers' products cannot be interchanged with current surveillance testing workflows Jean Whichard confirmed with web searches on May 13, 2024 that no other US vendors sell Sensititre equipment and supplies, including Giles, Becton Dickinson, and Beckman who have other products for antimicrobial susceptibility testing. Keywords searched included “Sensititre”, “HiQ”, “ARIS”, “CMV5AGNF” and “CMVCAMPY”. Searches using these terms in the Acquisition Gateway Best In Class Solutions Finder yielded no matches for the equipment nor supplies. Thermo Fisher Scientific has provided a letter dated January 10, 2024 confirming they are the sole source manufacturer of the items we are purchasing.

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: Jean Whichard, Team Leader, National Antimicrobial Resistance Surveillance Team

Center/Institute/Office COR/Program Official Signature:

Certification Date: July 17, 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: Click here to enter a date.

signed: 6 Nov 2024