SSJ - Brand Name - 75D30123Q76674.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:

1. Program Office:

Project Officer/End User: Jonathan Button Division of Laboratory Sciences 4770 Buford Hwy, Bldg. 103, Rm 1010 MS S110-5 Centers for Disease Control and Prevention Atlanta, GA 30341-3717

2. Contracting Activity:

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

3. Identification of Requirement:

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

a. Sole source acquisition of: Radioactive source solutions

b. Procurement Request (PR) Number (if available): 78553

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

a. Proposed Vendor: Eckert and Ziegler Analytics, Inc.

b. Estimated Procurement Amount: $xx,xxx.xx

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

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

4. 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)

Rev. 5/14/19

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?

Eckert & Ziegler Analytics/Isotope Products is the only known manufacturer or commercial source in the United States of radionuclides in a liquid solution with customized activity levels and a certificate of activity traceable to the National Institute of Standards and Technology (NIST) standards for the basic measurement of radioactivity and produced to Health Physics Society and ANSI N42.22-1995 standards.

We use NIST traceable quality standards to develop and validate specialized radiological analytical methods for radiological terrorism response, which comply with CLIA regulations. Eckert and Ziegler Analytics is the only source in the US that will customize the solutions to the activity concentrations we request. They can also ensure that the material will be delivered in the timeline specified in the technical specifications.

b. What other products/services were considered and why did they not meet the need? National Physical Laboratory (NPL) in the United Kingdom functions similarly to NIST in the US and is a manufacturer of customized radionuclide solutions. However, when pursing the precision of laboratory work, the government must be exact and only consider single radionuclide standard reference materials directly from the National Institute of Standards and Technology (NIST). NIST materials are manufactured infrequently, not on demand. We are unable to request solutions at custom activity levels and volumes as is required for the analytical work performed by our laboratory.

Additionally, pursuing international vendors in this work is not in the public interest for security and supply chain considerations.

3. Program Office efforts to seek potential offerors:

Our research has identified only Eckert & Ziegler Analytics/Isotope Products as a vendor

Rev. 5/14/19 capable of providing the radioactive reference material solutions needed, based in part on prior procurements and similar sole source justifications. No comparable products were found. We have also gathered knowledge about available products by attending scientific and professional meetings and conferences and collaborating with subject matter experts from other radioanalytical labs. A Notice of Intent to Sole Source was posted in July 2023 and it produced a single company claiming they can resell Eckert & Ziegler and may meet the need. It is not clear that Eckert & Zieglar prohibit any resellers of their product. As a result, a brand name sole source justification is being pursued to allow potential offerors other than Eckert & Zieglar to provide a quote of their product and allow for the maximum possibility of competition.

4. 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: Jonathan Button/Lead Health Physicist

Signed by:

Center/Institute/Office COR/Program Official Signature:

Certification Date: Click here to enter a date.

5. 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: David Smythe

Contracting Officer Signature:

Certification Date: Click here to enter a date.