SSJ_Roche_MagNA Pure 24signed.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:

Click here to enter text.

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: Roche MagNA Pure 24

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

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

a. Proposed Vendor: Roche

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: (NOTE: Must select only ONE of the listed justifications for other than full and open competition and fully support the justification in the following paragraphs. Please delete this note prior to submitting the justification.)

☒ 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 Roche MagNA Pure 24 is a fully automated clinical nucleic acid extraction system with scalable extraction of 1 to 24 samples. The MagNA Pure 24 system includes the MagNA Pure 24 instrument, software, consumables, and reagents. The MagNA Pure 24 system is intended for use by professional users for the purification of nucleic acids from biological samples for in vitro diagnostic purposes. The Influenza Division is purchasing the MagNA Pure 24 system specifically to evaluate its performance with our FDA-cleared and FDA-approved in vitro diagnostic assays for Influenza and SARS-CoV-2. Roche is the only company that produces the MagNA Pure 24 system.

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

Rev. 5/14/19

The Influenza Division is specifically purchasing the Roche MagNA Pure 24 extraction system to evaluate the performance of our FDA-cleared and FDA-approved in vitro diagnostic assays for influenza and SARS-CoV-2 on samples extracted with this instrument. Roche is the only company that produces the MagNA Pure 24 extraction system.

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; Charmaine V. McKenzie, PHA

Center/Institute/Office COR/Program Official Signature:

Certification Date: April 30, 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.