User Guide

Table of Contents

CHAPTER 1 – INTRODUCTION

• 1.1 Objective

CHAPTER 2 – OVERVIEW OF THE REGISTRATION PROCESS

• 2.1 Apply for a Test Account
• 2.2 Test Account Setup and Approval
• 2.3 Send a Test Submission
• 2.4 Set Up a Production Account 
• 2.5 Send Submissions to the Production System

CHAPTER 3 – PREPARATORY ACTIVITIES

• 3.1 Submit Letter of Non-Repudiation Agreement
• 3.2 Obtain Digital Certificate
• 3.3 Understand Submission Guidelines
• 3.4 Naming Conventions
• 3.5 Determine Submission Method
• 3.6 Connection Requirements
• 3.7 Help and Information

CHAPTER 4 – FDA ESG WEB INTERFACE ELECTRONIC SUBMISSIONS

• 4.1 Apply for a Test Account
• 4.2 Test Account Setup and Approval
• 4.3 Send a Test Submission
• 4.4 Apply for a Production System Account
• 4.5 Production System Account Setup and Approval
• 4.6 Send Submissions to the Production System
• 4.7 Tracking Submissions
• 4.8 WebTrader French Language Translation

CHAPTER 5 – AS2 GATEWAY-TO-GATEWAY ELECTRONIC SUBMISSIONS

• 5.1 Apply for a Test Account
• 5.2 Test Account Setup and Approval
• 5.3 Send a Test Submission
• 5.4 Apply for a Production System Account
• 5.5 Production System Account Setup and Approval
• 5.6 Send Submissions to the Production System
• 5.7 Sending Large (> 7.5 GB) Submissions
• 5.8 Common AS2 Errors

CHAPTER 6 – REFERENCES/RESOURCES

• 6 References/Resources

APPENDICES

• Appendix A: Troubleshooting the FDA ESG Web Interface
• Appendix B: Creating tar Files and Compressing Files for Submission
• Appendix C: Digital Certificates
• Appendix D: Glossary of Terms
• Appendix E: Acronyms
• Appendix F: AS2 Header Attributes
• Appendix G: Sample Letters of Non-Repudiation Agreement
• Appendix H: EDIFACT Message Structure
• Appendix I: Digital Signatures
• Appendix J: AS2 Routing IDs
• Appendix K: Sample Authorization Letter

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