JA_SAP_Form_250K_EHN_29APR20.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 $150,000)

REQ no. Requestor Kapil Bharti / Eric Nguyen Office Code Phone no.

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: National Eye Institute

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 requirement is for continuing bio-printing experiments that are critical lab goals. Bio-printing 3D in-vitro models of the RPE/Choroidal interface uses a thin poly(Lactic-co-Glycolic acid) membrane as a printing surface and structural support. As the membrane is delicate, and is used as the bioprinting surface, a laser-based means of determining the membrane height relative to the printhead is necessary to successfully print tissues. RegenHu has customized SHC (Substrate Height Calibration) settings on their equipment to detect the presence of the membranes. This will be included in an experimental bioprinter that we will be acquiring and testing in this order. Only RegenHu can manufacture a bioprinter that meets our specifications.

4. Proposed Contractor’s unique qualifications.

a. Replacement parts: RegenHU, Inc. manufactures and services bioprinters that meet the demands of our project. Competitive sources do not meet requirements such as piston-based extrusion, small volume syringe compatibility, and laser-based substrate detection and height calibration. Additionally, other manufacturers will NOT tailor their products to meet our specifications.

5. Additional Supporting Facts.

a. Manufacturer only sells directly and there are no licensed resellers to our knowledge.

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