The Food and Drug Administration (FDA) is embarking on a significant modernization project, known as the ESG NextGen, which aims to transform the Electronic Submissions Gateway (ESG) by leveraging the latest cloud technologies and COTS software. In part, this project addresses the significant growth that the ESG has seen. In 2015, 3,100,970 submissions went through the ESG. In 2022, 8,350,467 submissions were processed.
This initiative seeks to establish a secure, cloud-based, and unified intake gateway to accommodate a diverse array of electronic submissions from industry stakeholders and government agencies. The enhanced ESG will be scalable, highly available, secure, more user-friendly, and designed to handle the full spectrum of electronic submissions efficiently.
FDA ESG NextGen Functional Enhancements and Process
The current plan is to improve performance in four key areas.
User Account Management – ESG NextGen will address slow account creation and management processes and security issues with a more comprehensive and efficient production account provisioning workflow. It will also implement an Identity, Credential, and Access Management (ICAM) cybersecurity framework that ensures that the right person with the right permissions is accessing the right information at the right time.
Package Preparation – Though the current ESG requires the installation of client-side software, the NextGen project envisions a web-based interface that supports step-by-step submission preparation, including submission workflows based on file size. The new system will also automatically update digital submission forms as they are changed, which is not possible in the current system.
File Submission – Currently, digital certificates are required during registration and submission. eSignatures will replace the need for digital certificates in the new system. A unified submission portal will enhance status tracking with a much improved and intuitive view. ESG NextGen will also support better file upload performance, larger files, and offer an Application Programming Interface (API).
Communication – One of the most exciting aspects of the NextGen approach is the support for secure, two-way communication channels and broadcast capabilities. In addition, the new system will have improved help desk support that includes intelligent chatbots that will replace the legacy support and help desk structure.
The ESG NextGen’s Unified Submission Portal will accommodate a four-step process to create an account, prepare a submission, upload files, and monitor and track the submission status.
Advanced API Specifications
To support industry partners, the ESG NextGen is introducing a comprehensive Application Programming Interface (API) platform. This will include functionalities for initial and subsequent submissions, status inquiries, and other functions integral to the file submission process. The API design adheres to the RESTful standard, ensuring ease of integration, and incorporates robust security enforcement to safeguard data exchanges. Currently, interested parties can request a pre-release copy of the API specification by emailing EsgNgSupport@fda.hhs.gov.
FDA ESG Timelines
The FDA’s timeline for the project depicts a proof of concept (POC) followed by three releases that stretch into the fourth quarter of FY2025. During the POC, the agency will identify testers, communicate high-level features and technical designs, and develop test plans and testing scenarios for the first release.
The first release will deploy the unified submission portal, the API, and identity/account management. The Unified Submission Portal will work with major Browsers such as Google Chrome, Microsoft Edge, Apple Safari, etc.
The second release will migrate eSubmitter features, address some self-service enhancements, and offer an improved dashboard with two-way communications.
The third release will handle large file sizes, deploy the support chatbots, and include additional portal features. During each release phase, lessons learned will be captured and incorporated, training and user guides will be updated, and test scenarios for the next phase will be developed.
The agency is currently in the POC Phase and is conducting webinars to provide a brief overview of the project and demonstrate portions of the new solution.
The timeline for industry testing is slated to start in Q2/ of FY24, allowing stakeholders to trial their submissions on the new platform. The FDA is looking for testing volunteers. If you are interested in participating, you can sign up by sending an email to esgngSupport@fda.hhs.gov by January 20, 2024. The NextGen team will work with testing volunteers to develop the testing strategy, test cases, schedules, and execution of the testing process.