Monday, November 25, 2024

FDA RFI: Ethics Electronic Filing System

Solicitation Number:  FDA-RFI-20-1224212

“This RFI is being used to gather market research for the FDA to make decisions regarding development of strategies for a new Ethics E-Filing System that will ensure compliance with government-wide and departmental ethics rules and regulations.”

To provide programmatic oversight and ensuring the staff are in compliance with ethics requirements, the Office of Ethics and Integrity (OEI) has the responsibility to ensure all FDA employees are abiding by applicable federal ethics laws and regulations thereby protecting the integrity of FDA’s programs and operations. Currently there are 5 forms, each with their unique requirements and workflows. Managing and tracking these submissions, ensuring that all employees have filed the appropriate forms manually has proven to be a difficult task. Therefore, OEI needs an automated system that would allow for submission, review/processing, tracking, and data reporting of forms received and processed.

In the future, the new Ethics Systems Landscape would include new E-Filing System functionality that would first replace EFDS, support the electronic automation of HHS 717-2, HHS 520, HHS 521, and FDA 3539 forms, and potentially replace functionality within FDA’s Ethics Application (pending decision). The exhibit below illustrates the new Ethics System landscape that includes E-Filing System and the supporting applications and tools: SharePoint, FDAMail, EASE, eArrive, eDepart, and Integrity.gov.

Read more here.

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Jackie Gilbert
Jackie Gilbert
Jackie Gilbert is a Content Analyst for FedHealthIT and Author of 'Anything but COVID-19' on the Daily Take Newsletter for G2Xchange Health and FedCiv.

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