SSJ68478signedred.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/Division of Viral Diseases/Respiratory Viruses Branch (HCVGEB) 1600 Clifton Rd Bldg. 24, MS H24-5 Centers for Disease Control and Prevention Atlanta, GA 30329

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch Click here to enter text.

C. Identification of Requirement:

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

a. Sole source acquisition of 30 plates V-PLEX respiratory Panel 1 (IgG Kits).

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

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

a. Proposed Vendor: MSD

b. Estimated Procurement Amount: $28,982.00

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

If yes, provide schedule number:

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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 (Only One Source)

☐ 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. Meso Scale Discovery provides a proprietary platform for electrochemiluminescence assays. This platform provides the capability for increases dynamic range, improved sensitivity, reduced sample/reagent requirements and a streamlined workflow. Assay plates to be used on this platform are only made and sold by Meso Scale Discovery. These plates use a proprietary carbon electrode that when electricity is applied to the plate electrode light emission is generated by the proprietary SULFO-tag that is utilized in the assay. This procurement Respiratory syncytial virus antibody kits. These kits are quantitative, so can be used for examining decay that can be used to make decisions about timing of vaccine booster doses and vaccine efficacy.

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

We looked at RSV antibody kits made by Abcam and creative diagnostics.

The MSD assays are more sensitive, more quantitative, and more specimens can be run on one plate saving significantly on personnel time.

Rev. 5/14/19

3. Program Office efforts to seek potential offerors:

We looked for different distributors of the MSD RSV antibody kits, and they are the exclusive distributors. The SMEs advised that they looked at other commercial assays produced by abcam and creative diagnostics. They have stated those assays are not as sensitive, less quantitative, and because of the way the assays are run, will require significantly more staff time per sample.

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/Respiratory Viruses Branch

April Thornton, Program Specialist (COR) NCIRD/Division of Viral Diseases/Respiratory Viruses Branch (HCVGEB) Certification Date: October 15, 2012

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.