SSJ_Redacted CO Signed.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:

Newborn Screening and Molecular Biology Branch CHAM Bldg. 109, Room 1301 S109-1 4770 Buford Highway Centers for Disease Control and Prevention Atlanta, GA 30341

B. Contracting Activity:

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

C. Identification of Requirement:

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

a. Sole source acquisition of: Sole source acquisition of the Sebia Capillarys 3 DBS Instrument.

b. Procurement Request (PR) Number (if available): Click here to enter text.

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

a. Proposed Vendor: Sebia, Inc. Norcross, GA

b. Estimated Procurement Amount: $

3. Is the requirement on GSA Schedule? Yes No

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

Rev. 5/14/19

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

1. The Agilent 4200 TapeStation System can only analyze DNA and RNA samples for next generation sequencing. This instrument cannot analyze hemoglobin proteins, nor can it test samples derived from dried blood spots.

2. ThermoFisher sells a manual protein gel electrophoresis system however this is not capillary electrophoresis technology, it is completely manual, it does not have a compatible barcoding system, and it is not FDA-approved for testing dried blood spot specimens for hemoglobin proteins.

3. Program Office efforts to seek potential offerors:

An internet search was conducted and no other vendors were found that could provide an instrument with the required accuracy for testing dried blood spot specimens containing abnormal hemoglobin proteins.

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: CDC/NCEH/DLS/NSMBB

Center/Institute/Office COR/Program Official Signature:

Certification Date: 8/28/2024

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.

Samantha L. Isenberg - S

Digitally signed by Samantha L.

Isenberg -S Date: 2024.08.28 15:02:24 -04'00'