Justification and Approval Eyecro.docx

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) Instructions to the requestor: Prepare this document and include it an attachment to the requisition. When received in OLAO, the contracting officer (CO) will review the data provided, and if it is concluded by the CO that the proposed sole source is justified they will proceed with the action. PLEASE DELETE ALL INSTRUCTIONS IN RED BEFORE SIGNING AND FORWARDING TO ACQUISITIONS.

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

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 Neurobiology Neurodegeneration & Repair Laboratory (NNRL), National Eye Institute (NEI) is seeking services for the analysis of the effect of a test agent (chemical compound) on a rat model of inherited retinal degeneration. Reports of these analyses will be used as a basis for assessing the suitability of these materials for use in biological activity studies, pharmacological studies, toxicological studies, and potentially clinical trials. Data provided in these analytical reports can further be supplied to the Food and Drug Administration (FDA) as part of the Investigational New Drug (IND) filings for new agents applicable for inherited retinal degeneration. The contractor shall be experienced in the analytical assessment of drug substances according to FDA regulations and guidelines and will be expected to have operational equipment and capabilities.

4. Proposed Contractor’s unique qualifications. (choose a letter below that makes the most sense for your requirement)

c. Proprietary data: The scientific team at EyeCRO has extensive experience in the application of preclinical models and utilization of novel formulations to advance ophthalmic therapeutics in development. They have been providing contracted research services to commercial and academic organizations since 2004 and routinely utilize the assays and models quoted. The EyeCRO facility is fully accredited by AAALAC and the project will be conducted under the review of the EyeCRO IACUC. Additionally, EyeCRO is an assured organization by the Office of Laboratory Animal Welfare (ID# D20-01086). IND filings through the FDA require research settings that are impractical to set up within a standard biological laboratory. Contracting with specialized services is highly encouraged by the FDA.

d. Additional Supporting Facts.

a. Technical data packages are too costly to obtain to support competition

b. Manufacturer only sells directly and there are no resellers.

c. The proposed action is a brand name only. Competition will be obtained through 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:

Charles Drinnan 06/08/2022_______________________________

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

Contracting Officer Date