A13 - 2022 08 30 - 2022-68204 - SSJ - redacted.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:

Centers for Disease Control and Prevention

1600 Clifton Rd. NE

Atlanta, GA 30329

B. Contracting Activity:

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

C. Identification of Requirement:

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

a. Sole source acquisition of: Sole source acquisition for the purchase of a new Dr.

Oligo 48 Medium Throughput Oligo synthesizer. This synthesizer will replace our 20+ year old ABI 3900 synthesizer which has become very unreliable and problematic.

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

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

a. Proposed Vendor: Biolytic Lab Performance, Inc.

5680 Stewart Ave. Fremont, California 94538 U.S.A.

Phone: +1 (510) 795-1149

b. Estimated Procurement Amount:

Rev. 5/14/19

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

If yes, provide schedule number:

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?

The purchase of this Synthesizer will allow us to synthesize oligos at a much higher capacity with a reduced turnaround time when trying to meet the demands of groups for large scale synthesis for manufacturing kits. It will also reduce our argon gas consumption by 30%-50% for synthesis. The Biolytic Dr. Oligo 48 Medium Throughput Oligo synthesizer has an increased performance with 4 drain stations which will help reduce the cycle time. This means that all reagents can be delivered and drained from all 4 banks of the machine at the same time, reducing synthesis time hence turnover time to the end-user will be reduced also. It also has a smaller chamber which will help reduce the argon gas consumption by 30%-50%. It has a new motion controller which helps communicate with a USB connection instead of the old PCB (Printed Circuit Board) which is more prone to failures and is expensive to replace. It also has new built flood control system which eliminates the reagents from spilling into the machine It also has extra optional bottle and bottle cap configurations and an updated lid with a pneumatic clamping system seals the chamber replacing the outdated screw knobs.

The specific characteristics unique to this design and the basis of our sole source request include:

1) New windows 7 / 8 software with many new features including shared reagents allowing for the use or up to 10 special amidites and 2 different Oxidizers.

2) 4 drain stations (old synthesizers have only 2). This allows the system to synthesize much faster (reduce cycle time) for 4 banks of oligos. All 4 banks receive reagent at the same time and then all 4 banks can drain at the same time. The original system delivers to 2 banks and then reacts and drains those 2 banks then the other 2 banks get reagent and then they react and drain.

3) New slow drain system allows for fine control over reagent movement through the columns. Includes 3 slow drain rates per bank.

4) Flood control system that eliminates the ability for reagents spill in the bowl to get into the transmission and motor.

5) Valve turn over to allow for the use of lower cost valves and eliminates leaking reagents from getting into the valve coils which have a bad effect on the valve controller.

6) New valve controller that does not burn up if a valve shorts.

7) New motion controller that does not need any special PCB in the PC.

Communication is via USB.

8 ) Special chemistry reagent bottles are located at the top decreasing the length of the tubing and hence reducing the amount of expensive reagent needed for coupling

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

We have looked at the following three vendors for buying new synthesizers: ABI 3900 DNA synthesizer, BioAutomation MM-48 synthesizer and Biolytic Dr. Oligo 48 Medium Throughput Synthesizer. ABI, the manufacturer of this DNA synthesizer, is no longer selling or supporting the 3900 synthesizers thus they cannot offer a quote. BioAutomation sold their rights to LG Biosearch who has the MM-48 which is almost a replica of the old ABI-3900 synthesizer but with only a few valve modifications and is highly overpriced .

Biolytic is offering the Dr. Oligo 48 Medium throughput Oligo synthesizer with lots of upgraded hardware features along with an upgraded software.

Yes, Biolytic is the only vendor available to provide the latest state of art machine for meeting our synthesis needs.

3. Program Office efforts to seek potential offerors:

As mentioned before, we did seek different vendors, however to the best of our knowledge Biolytic is the only vendor available to provide the latest state to the art machine for meeting our synthesis needs.

ABI, the manufacturer of this DNA synthesizer, is no longer selling or supporting the 3900 synthesizers thus they cannot offer a quote. BioAutomation sold their rights to LG Biosearch who has the MM-48 which is almost a replica of the old ABI-3900 synthesizer but with only a few valve modifications and is highly overpriced. Biolytic is offering the Dr. Oligo 48 Medium throughput Oligo synthesizer with lots of upgraded hardware features along with an upgraded software.

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:

Center/Institute/Office COR/Program Official Signature:

Certification Date: 08-16-2022

E. 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: 30 August 2022

Lee Catherine Kennedy