36C24E21Q0064.docx

Contract Opportunity Special Notice

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AN43

508-21-2-1103-0148/ Prototype Development/ Atlanta CVNR

(VA-21-00039067)

15212-5319 36C24E21Q0064 N 339113 US Department of Veterans Affairs Veterans Health Administration Regional Procurement Office (RPO) East 323 North Shore Drive, Suite 500 Pittsburgh PA 15212-5319 The Veterans Administration Atlanta VA Research and Development Group intends to negotiate on a sole source basis with Global Center for Medical Innovation (GCMI) to provide services relating to the development of a prototype device that is wearable, non-invasive ERG diagnostic system to detect early stage diabetic retinopathy (DR) . GCMI will work with VA researchers to create a wearable frame, electronics, light stimulus encased in the device, and design a device interface. GCMI is located in the greater Atlanta area, which is important to enable them to work closely with the Atlanta VA researchers in the development of this product. GCMI has the regulatory specialists on staff to ensure all documentation, schematics, etc. meet regulatory requirements (such as FDA device requirements) and have the ability to produce the protype in a short time frame.

This notice of intent is not a request for competitive proposals; however, any responsible source who believes it is capable of meeting the requirement may submit a capability statement to the contracting office no later than Friday, February 26, 11AM, EST. Interest/capability statements may be sent to Elaine DiBucci at elaine.dibucci@va.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.