A13. SSJ SAM.gov.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 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 Core Laboratory Services and Response Advanced Diagnostics and Biotechnologies Branch

NCEZID/DCLSR/ADBB

1600 Clifton Rd. NE Building 23, 12th Floor, MS H23-12 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: Procurement of CEM Liberty Blue Peptide Synthesizer (SN

LB2236, N2911, DA3553, and DU8206) service and maintenance agreement. This agreement will include one scheduled on-site preventative maintenance visit, all parts and labor and any necessary software upgrades to keep the instruments in best working condition. This agreement also includes 24 hour telephone troubleshooting support and guaranteed response time within 36 business hours. The agreement will include support for both the liquid handling portion of the synthesizer and the microwave unit of the synthesizer.

b. Procurement Request (PR) Number (if available): 000HCRHB-2024-87126

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

a. Proposed Vendor: CEM

3100 Smith Farm Rd Matthew, NC 28106 Fax: 704-973-2499/Phone: 704-821-7015

Rev. 5/14/19

b. Estimated Procurement Amount:

3. Is the requirement on GSA Schedule? Yes No

If yes, provide schedule number: Click here to enter text.

D. Justification:

1. The justification for this non-competitive action is: (NOTE: Must select only ONE of the listed justifications for other than full and open competition and fully support the justification in the following paragraphs. Please delete this note prior to submitting the justification.)

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?

CEM Corporation is the leading provider for microwave assisted peptide synthesis in the world. It manufactures the Liberty blue peptide synthesizer and the Discover microwave instrument in this service contract. In order to maintain these CEM systems that uses CEM software and its technologies and, the engineers need to have constant CEM training and widespread experience and expertise of the specific instrumentation covered in the maintenance contract. The repair and maintenance of the system can be completed only by CEM technicians who are

Rev. 5/14/19 trained at the CEM factory and certified through the CEM service certification process. Also, the CEM engineer would be an ideal person to understand the internal problem with the instrument when it has errors. Though there are very few common individual parts such as inline filters, Falcon tubes, amino acids that can be purchased outside, but the specific fittings, Reaction vessels, valves, motors or other internal parts of this instrument needs to be purchased only by CEM because they are exclusively designed for this Liberty blue instrument.

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

The Liberty blue instrument has already being used for several years supporting CDC's research activities. This synthesizer has microwave assisted short coupling times (20 minutes) and also 90% solvent waste reduction compared to other Solid Phase peptide synthesizers. No other vendor can match up with the services that CEM provides. This vendor has a unique understanding of the instrument, its setup and operations. Hence, CEM is the only provider for its services, parts or software.

3. Program Office efforts to seek potential offerors:

An internet search was performed for companies which may be offering peptide synthesizers maintenance contracts, and we found ThermoFisher. They have different skills and software is not compatible with their instruments. We can only get a limited service. The CEM specific parts are not provided by other vendors like ThermoFisher.

And also, they do not have CEM certified engineers. Therefore, only CEM Corporation can only provide the required maintenance and expertise.

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:

Center/Institute/Office COR/Program Official Signature:

Certification Date: Click here to enter a 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: Click here to enter text.

Contracting Officer Signature:

Certification Date: Click here to enter a date.