FDA Electronic Submissions Gateway (ESG)

User Guide

February 9, 2010

1      Introduction

The business of the Food and Drug Administration (FDA) is extremely information intensive. In recognition of this fact and of the potential benefits offered by information technology for information management, the FDA has undertaken a number of projects supporting the electronic submission of text and data from the industries it regulates.

One of these projects entails the establishment of an Agency-wide solution for accepting electronic regulatory submissions, referred to as the FDA Electronic Submissions Gateway (FDA ESG). The FDA ESG enables the submission of regulatory information for review. The overall purpose of the FDA ESG is to provide a centralized, agency-wide communications point for securely receiving electronic regulatory submissions. The new Agency Gateway will enable the FDA to process regulatory information through automated mechanisms while it enables:

• A single point of entry for receiving and processing all electronic submissions in a highly secure environment.
• Automating current electronic processes such as the electronic acknowledgment of submissions.
• Supporting the electronic Common Technical Document (eCTD).

The electronic submission process is defined as the receipt, acknowledgment, routing, and notification to a receiving Center of the receipt of an electronic submission. In this definition,

• "Receipt" means transfer of a submission from a sender’s system to a temporary storage area in the FDA ESG.
• "Acknowledgment" to the sender that the submission was sent from the sender’s system and received by the Gateway.
• "Routing" refers to delivering a submission to a Center-level storage area and initiating a load process to place a submission into a Center receiving system
• "Notification" of a submission’s arrival is made to those individuals responsible for the Center’s receiving system.
• Each of these terms denotes a step in the process of electronic submission delivery, and together, these steps comprise the whole scope of electronic submission delivery.

The FDA ESG is the central transmission point for sending information electronically to the FDA. Within that context, the FDA ESG is a conduit, or "highway", along which submissions travel to reach their final destination. It does not open or review submissions; it merely routes them to the proper destination.

The FDA ESG uses a software application certified to comply with secure messaging standards. The screen graphics provided in the FDA ESG Web Interface sections of this User Guide are from the application.

1.1      Objective

The objective of this User Guide is to provide industry participants with information and guidance on how to prepare and send documents through the FDA ESG. See Table 2: Electronic Submissions Supported by the FDA ESG for a list of submissions that the FDA ESG will accept. This document provides a high-level description of the electronic submission process via the FDA ESG.