PR_26374_-_BioDOT_signed_SSJ_for_FBO.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 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:

Centers for Disease Control and Prevention Division of Vector Borne Diseases 3156 Rampart Road Fort Collins, CO 80521

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch 4

C. Identification of Requirement:

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

a. Sole source acquisition of: Manufacturing equipment to produce lateral flow assays which include a dispensing platform, guillotine cutter and assembly roller.

b. Procurement Request (PR) Number (if available): 00HCVLJC-2018-26374

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

a. Proposed Vendor: BioDot, Inc. 2852 Alton Parkway, Irvine, CA 92606

b. Estimated Procurement Amount: $110,200.00

3. Is the requirement on GSA Schedule? Yes No

If yes, provide schedule number:

kpy3 Typewritten Text

XXXXXXXX

kpy3 Typewritten Text

XXXXXXXX

kpy3 Typewritten Text

XXXXXXX

kpy3 Typewritten Text

XXXXXXXX

kpy3 Typewritten Text

XXXXXXXXXXXXXXXX

kpy3 Typewritten Text

XXXXXXXXX

Rev. 5/15/17

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?

This laboratory has used the BioDot dispenser, cutter, and assembler for the past 10 years to manufacture the Plague Rapid Test (PRT). The equipment is now beyond their expected life and no longer eligible for preventative maintenance by the manufacturer. We require the same equipment from the same manufacturer to replace the three machines so that we can continue producing the PRT at the same level as in the past.

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

No other products were considered because we cannot change any of the manufacturing processes to ensure that future PRTs produced will match the performance of past PRTs. To change any of the manufacturing machines would require new procedures, validation, and could jeopardize the performance characteristics of the PRTs produced.

Rev. 5/15/17

3. Program Office efforts to seek potential offerors:

Market research was not conducted. This purchase is to replace the existing equipment from BioDot and no change in vendor will be considered. The replacement equipment must be the same and from the same vendor to ensure consistency in the manufactured diagnostic tests.

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: Cynthia Summerhawk

Center/Institute/Office COR/Program Official Signature:

Certification Date: July 31, 2018

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:

Contracting Officer Signature:

Certification Date:

Cynthia L.

Summerhawk -S

Digitally signed by Cynthia L.

Summerhawk -S

Date: 2018.07.31 08:37:23 -06'00'

Nathan R. Amador -

S Digitally signed by Nathan R. Amador -S

Date: 2018.08.03 08:52:40 -04'00'