PR 68994 SSJ Signed_Redacted.pdf

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN

MARKET OR GSA) UNDER $150,000

Sole source acquisitions may be used on a limited basis and only when the 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:

Enteric Diseases Laboratory Branch Division of Foodborne, Waterborne, and Environmental Diseases National Center for Emerging, Zoonotic, and Infectious Diseases Centers for Disease Control and Prevention Atlanta, GA 30333

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch EDLB/PROST/NGS

C. Identification of Requirement:

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

a. Sole source acquisition of: Procurement of the Clear Labs DX service, installation, and reagents for EDLB/PROST/NGS use and overview of enteric organisms with validation for use in future outbreaks.

b. Procurement Request (PR) Number (if available): 202268919

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

a. Proposed Vendor: Clear Labs, Inc

b. Estimated Procurement Amount:

3. Is the requirement on GSA Schedule? Yes No

If yes, provide schedule number: n/a

D. Justification:

Rev. 5/15/17

1. The justification for this non-competitive action is:

In accordance with FAR 13.106-

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-

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-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 proced

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?

This proposed acquisition is for sequencing on the Clear Labs next generation prep and sequencing platform. Only reagents optimized for this machine can operate on this instrument, thus procurement of these particular reagents from Clear Labs is critical. Technical requirements are as follows: 1) Kits and parts must be the exact items required by the manufacturer. 2) No generic or other brand equivalents are acceptable (were they to exist) as they would require revalidation of our assays at a great expense of time and money. 3) Kits must be available rapidly (maximum 30 day wait on delivery).

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

Not considered, since there are preparation supplies available from other brand companies for this prep to sequencing platform.

3. Program Office efforts to seek potential offerors:

Search produced no viable alternatives.