Malvern JA SAP 20-004023 NanoSight JA_SAP_Form.pdf

Justification and Approval – Simplified Acquisition under $250,000

FACTS SUPPORTING A REQUEST TO ENTER INTO AN ACQUISITION USING OTHER THAN FULL

AND OPEN COMPETITION – SIMPLIFIED ACQUISITION (UNDER $250,000)

REQ no. Requestor: Stanislav Tomarev Office Code Phone no.: 301-496-8524

Introduction: Pursuant to Federal Acquisition Regulation 13.106-3(b)(3)(i), the following data is furnished to the Contracting Officer to support the requisitioning office’s request that the items/services identified on the above-mentioned Requisition be obtained using other than full and open competition. The requisitioning office understands that a contract may not be awarded on a sole source/brand name only basis unless the Contracting Officer approves Other than Full and Open Competition.

1. Identification of the Agency: HHS/NIH/NEI/LRCMB/SRGCB

2. Nature and or/Description of Action Being Approved.: sole source

3. Description of the supplies and services required to meet the Agency’s needs.

The NS300 instrument is required to estimate quality and concentration of small extracellular vesicles isolated from different cells. Small extracellular vesicles are used for retinal ganglion cell neuroprotection in different models of glaucoma, one of the main causes of blindness in the United States.

4. Proposed Contractor’s unique qualifications: Malvern Panalytical Inc. is the only company that produces instruments for required evaluation of small extracellular vesicles. These instruments are used in most publications that use extracellular vesicles.

A detailed characterization of extracellular vesicles is a requirement for publication in scientific journals.

5. Additional Supporting Facts: Manufacturer only sells directly and there are no resellers.

I hereby certify that the supporting data above forms the basis for this justification, is complete and accurate to the best of my knowledge and belief.

Certification by Requirements\Technical Personnel:

I concur and approve this justification for other than full and open competition.

Contracting Officer Date