FDA Looking for new Ethics Filing Platform

The Food and Drug Administration (FDA) released a request for information (RFI) on Feb. 3 looking to modernize its Office of Ethics and Integrity’s (OEI) ethics filing platform.

The FDA is using the RFI to gather market research to aid in the development of strategies of a new Ethics E-Filing System that will “ensure compliance with government-wide and departmental ethics rules and regulations.”

The OIR is tasked with ensuring that all FDA employees are in compliance with Federal ethics laws and regulations. Currently, the FDA has five separate forms to manage general regulation requirements, submit ethics violations, and raise potential ethics concerns – each with their own requirements and workflows.

In the RFI, the FDA noted that OEI has to manually process more than 20,000 forms annually and “managing and tracking these submissions, ensuring that all employees have filed the appropriate forms manually has proven to be a difficult task.” With that in mind, the OEI is looking for an automated system that can handle submission, review/processing, tracking, and data reporting of forms received and processed.

The OEI is specifically looking for a system with eight main functionality areas:

• Notification and alerting capability;
• Status tracking;
• Reporting and analytics;
• System integration;
• Workflow and form management;
• Document and case management;
• User experience and user interface; and
• Artificial intelligence capabilities.

Initial responses are due no later than Feb. 17.