A13. SSJ- SAM.gov.pdf

Rev. 5/14/19

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 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 Advanced Diagnostics and Biotechnologies Branch

CDC/NCEZID/DCSLR/ADBB

1600 Clifton Rd NE, Mailstop G-36 Bldg 23, Room 12-435 Atlanta, GA 30333

B. Contracting Activity:

Centers for Disease Control and Prevention Procurement and Grants Office Acquisition Branch II

2920 Brandywine Road, Mail Stop K-69 Atlanta. GA 30341

C. Identification of Requirement:

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

a. Sole source acquisition of: The Sole source acquisition of Purchase of the CS136X fully automated CSBio peptide synthesizer.

b. Procurement Request (PR) Number (if available): 000HCRHB-2024-82863

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

a. Proposed Vendor:

CSBio Instrumentation Co.

915 Linda Vista Mountain View California 94043 Phone: 650-525-6200

b. Estimated Procurement Amount: $0.00

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-

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-

Urgency

Only One Source

Logical Follow Up

2. Other facts supporting sole source procurement:

a. What can this product/service do that other products/services cannot do?

CSBio is a leading automated peptide synthesizer manufacturing company worldwide.

The CS136X is an automated research scale peptide synthesizer with 180 degrees inversion mixing with nitrogen bubbling for complete solvent and resin contact. CS136X can perform unlimited couplings, fully automated synthesis of sequences 130-mer or more with no user interaction. The uniqueness of this system is, it also has jacketed reaction vessels, it can circulate chilled or heated water from 5 °C to 90° C around the reaction during the entire synthesis. This creates a uniform and regulated temperature environment with no localized spikes which can cause racemization in peptides. The other products like CEM Liberty B sels. We already have an older version of CS136X for 10 years, and this one will replace the older synthesizer.

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

The other products that were considered are the CEM Liberty Blue peptide synthesizer, the Gyros Protein Technologies PurePep Chorus 2RV Peptide synthesizer, and the Biotage Initiator+ Alstra peptide synthesizer. The CEM Liberty Blue peptide synthesizer uses microwave based heating, it doesn't have a jacketed reaction vessel, hence doesn't have well regulated temperature which can cause racemization. In addition, the Liberty Blue only uses nitrogen bubbling for mixing the resin during the synthesis which is a poorer mixing then when compared with the inversion mixing in the CSBio instrument. Also, the Liberty Blue instrument uses predissolved amino acids which is not as good as the CSBio instrument which dissolves the amino acids at the time of use. Previously, the lab had a Gyros Protein Technologies Tribute Peptide synthesizer in house. The unit was excessed because of several reasons. The unit was not user friendly and has high consumption of reagents and Nitrogen gas. The Tribute also despite numerous attempts at optimization produced peptides of poor quality. The Tribute is no longer sold by Gyros Protein Technologies. The replacement model, the PurePep Chorus 2RV, is a multiple reaction vessel unit (2 RV’s) that incorporates controlled induction heating with oscillation mixing and UV reaction monitoring. This is like the Tribute synthesizer that was previously used. PurePep Chorus like the Liberty Blue uses predissolved amino acids which is not the preferred method. Also, the induction heating is gentler than the microwave heating from the Liberty Blue but not as gentle as the CSBio instrument. Also, the oscillation mixing, while better than nitrogen mixing, is still not as good as the inversion mixing of the CSBio instrument.

Also, in general, the experience of using previous Protein Technologies instruments does not give great confidence that a new synthesizer will perform any better than previous instruments.

3. Program Office efforts to seek potential offerors:

We did thorough research on google.com and examining company websites and brochures.

There are other companies like CEM Corportation, Gyros Protein Technologies, and Biotage that make peptide synthesizers in market. As mentioned earlier, these peptide synthesizers are expensive and have high maintenance costs. CS Bio CS136X has low maintenance cost and lower usage of reagents for the same scale peptide synthesis. In addition, there are already several units of an older model in the lab, which means the lab staff already knows how to operate the instrument so no further training of personnel is required and there will be no delay in getting the new instrument operating.

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:

COR II

Center/Institute/Office COR/Program Official Signature:

Certification Date:

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: Gbolii H. Fumbah Wei

Contracting Officer Signature:

Certification Date: Click here to enter a date.