JA SAP.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 Catherine Cukras MD, PhD Office Code Phone no. 301-6752397

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/DECA

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. Optical coherence tomography angiography imaging collected under the clinical protocols “Longitudinal Investigation of Dark Adaptation in Participants with Age-Related Macular Degeneration Protocol Number: 11-EI-0147” and the followup study “A Long-term Follow-up Study of Participants Enrolled in 11-EI-0147: Longitudinal Investigation of Dark Adaptation in Participants with Age-Related Macular Degeneration (DA_AMD) Protocol Number: 17EI0112” will be graded by the Boston Imaging Research Center (BIRC) which has domain expertise in quantifying the density of choroidal capillaris and larger choroidal layer vessel density.

OCTAs from Dark Adaptation in AMD studies

Boston Imaging Reading Center will:

• Provide access to site for uploading OCT images from NEI to BIRC

• Conduct Optical Coherence Tomography Angiography (OCTA) analysis of the choroidal layers

• Explore the analysis of retinal vasculature

• Quantify the drusen volume

• Provide Data Exports of quantified analyses

4. Proposed Contractor’s unique qualifications.

a. Replacement parts: NA

b. Equipment upgrade/repair: NA

c. Proprietary data: BIRC has developed expertise in measuring choroidal vasculature metrics using OCTA imaging modalities. Dr. Nadia Waheed is a world-wide expert in OCTA and is invited internationally to speak about the imaging modality and the analyses of the resulting data. She has co-authored more than 66 scientific peer-reviewed journal articles on this topic. BIRC has been hired as the reading center for many clinical trials analyzing OCTA imaging.

d. Urgency: NA

e. Brand Name only: NA

5. Additional Supporting Facts.

a. Casey Eye Institute reading center is involved in an ongoing study of RP sponsored by the foundation fighting blindness (Pro-EYS). Using the same domain expertise for the NEI’s study on RP would be important for validating outcome measures

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