Sole_Source_Justification_ _Approval.pdf

Sole Source Justification & Approval

Unusual and Compelling Urgency

The National Eye Institute (NEI) is initiating preclinical studies for our cell therapy project with the goal to file FDA approval application next year. For these preclinical studies, NEI will be performing testing on multiple animals every day. To accommodate for that, NEI will need two procedure rooms equipped with the ventilator equipment. If NEI does not get this equipment within the next couple of weeks, it will jeopardize all of our preclinical work. This will not only result in loss of federal resources but it also risk the loss of the entire FDA application and the clinical trial.

Kapil Bharti, PhD Earl Stadtman Tenure-Track Investigator Unit on Ocular and Stem Cell Translational Research National Eye Institute/National Institutes of Health 10 Center Drive Bldg10 Rm10B10 Bethesda, MD 20892 301-451-9372 (office) 240-274-8576 (cell)