A13. Sole Source Justification EMD Millipore Signed.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:

NCIRD/DVD/VGB

Roybal 1600 Clifton Rd NE H18-7 Centers for Disease Control and Prevention Atlanta, GA 30329

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch 2

C. Identification of Requirement:

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

a. Sole source acquisition of: One Step RT-PCR Master Mix Kit

b. Procurement Request (PR) Number (if available): 88202

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

a. Proposed Vendor: EMD Millipore

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?

For our rotavirus surveillance qRT-PCR detection assay, NCIRD/DVD requires a single enzyme RT-PCR kit that uses rTth instead of reverse transcriptase and Taq polymerase (a two-step RT-PCR method is unacceptable). The EMD Millipore One- Step RT-PCR Master Mix Kit (Catalog # 71978-3) meets this requirement, and is the only available one-step RT-PCR kit that has been validated for use in our qRT-PCR rotavirus detection assay. Members of the Centers for Disease Control and Prevention’s Rotavirus Surveillance and Molecular Epidemiology Team (RSMET) developed the qRT-PCR rotavirus detection assay and validated this kit for use:

http://jcm.asm.org/content/early/2017/03/02/JCM.00126-17 In addition, RSMET serves as the Rotavirus Reference Laboratory for multiple international laboratories. These international laboratories are also required to use the EMD Millipore One Step RT-PCR Master Mix Kit in their molecular extraction assays due to this being the only validated reagent for surveillance monitoring.

http://jcm.asm.org/content/early/2017/03/02/JCM.00126-17

Rev. 5/14/19

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

The EMD Millipore One-Step RT-PCR Master Mix Kit (Catalog # 71978-3) is the only available single enzyme RT-PCR kit that uses rTth instead of reverse transcriptase and Taq polymerase. It is also the only available one-step RT-PCR kit that has been validated for use in our qRT-PCR rotavirus detection assay.

Other products on the market from ThermoFisher and Qiagen have not been validated for use with the program’s assay and are unlikely to be compatible because they use reverse transcriptase rather than rTth. Only a single enzyme RT- PCR kit that uses rTth is compatible with NCIRD/DVD’s rotovirus surveillance monitoring assay, so these products will not be able to meet the need.

3. Program Office efforts to seek potential offerors:

Market research was done through internet search, literature review, and phone calls with customer service representatives. EMD Millipore Corporation is the only vendor of this kit.

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/DVD/VGB/RSMET/Amy L Hopkins/Biologist

Center/Institute/Office COR/Program Official Signature:

Certification Date: June 14, 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.