FDA ELECTRONIC SUBMISSIONS GATEWAY (ESG)

Setting up an FDA ESG Account (Webtrade and AS2)

1. Before you begin
   
   
1. All electronic submissions must comply with published FDA guidelines and regulations. FDA ESG strongly recommends that you contact the appropriate Center representative Refer to Center-Specific Submission Preparation Guidelines for more information.
   
   
2. The Adverse Events Reporting System (AERS) pre-qualifies submitters of electronic AERS reports before they begin testing on the FDA ESG. Refer to the FDA AERS Electronic Submissions Web Site for more information about submitting AERS reports electronically.
   
   
2. Apply/request for a Test Account
   
   
1. Send email to esgprep@fda.hhs.gov; include your company name, your name, phone number and submission method (Webtrader or AS2; see Submission Method Options for details).
   
   
2. Send Letter of Non-Repudiation A letter of Non-Repudiation Agreement must be submitted to the FDA. The non- repudiation agreement allows the FDA to receive electronically signed submissions in compliance with 21 Code of Federal Regulations (CFR) Part 11.100. Refer to Sample Letters of Non-Repudiation Agreement for more information and sample letters. A copy of the letter must be sent to:
   
   Michael Fauntleroy
   Office of the Director (HFM-25)
   Center for Biologics Evaluation and Research
   Food and Drug Administration
   11400 Rockville Pike, Room 4119
   Rockville, MD 20857
   
   
3. FDA ESG confirms information supplied in the request and sends an email with information needed to register for a test account online.
   
   
3. Review Tutorials and User Guide ( PDF or HTML).
   
   
We strongly recommend that you read and understand the tutorials and user guide before continuing with the online registration.


4. Register online for a test account using registration information sent by FDA ESG.
   
   
1. FDA ESG confirms Letter of Non-Repudiation has been received by FDA
   
   
2. FDA ESG activates the test account and sends a notification email. A test account is not functional until the FDA ESG System Administrator has activated the account. The notification email provides information on preparing your client to send test submissions. The email also describes how to schedule a session with FDA ESG to test your client setup.
   
   
5. Establish connection to FDA ESG
   
   
1. Prepare client to send submissions
   
   
1. Webtrader
   The FDA web interface uses a Java Applet running within the Internet Explorer. This requires installation of the Java Runtime Edition and Java Cryptography Extensions (refer to Installing Java Runtime Edition for more information). The Java Applet communicates over port 3080 via HTTPS. Check with your IT network department to confirm that communications over port 3080 are allowed through your company's firewall.
   
   
2. AS2
   FDA ESG will provide the trading profile information and digital certificates necessary to configure your Gateway product. Refer to Section 6, AS2 Gateway-to-Gateway Electronic Submissions, of the user guide for detailed information. AS2 communications occur over port 4080 via HTTPS. Check with your IT network department to confirm that communications over port 4080 are allowed through your company's firewall.
   
   
2. Schedule a test session with FDA ESG to confirm your client setup works.
   
   
6. Send a Regulatory Compliant test submission.
   All electronic submissions must comply with published FDA guidelines and regulations. Refer to Center-Specific Submission Preparation Guidelines for more information.
   
   
7. Special Testing Requirements
   
   
1. Send a 7.5 GB submission. This test is performed to ensure that your network infrastructure can support the efficient transfer of submissions larger than 7.5 GB. This test is needed only if you plan to send submissions to CBER and CDER via Webtrader or AS2. Refer to Section 4, FDA ESG Web Interface Electronic Submissions, or Section 6, AS2 Gateway-to-Gateway Electronic Submissions, for detailed information.
   
   
2. AERS Testing with multiple submissions simultaneously Send a batch of 25 to 50 submissions all at once to the FDA ESG. During the pilot testing program, some external trading partners experienced problems with performance, such as slow response times and slow processing of submissions.
   
   
8. FDA ESG validates that test submissions comply with FDA guidelines.
   An email notification is sent when all tests have been completed successfully.
   
   
9. Create a Production Account
   
   
1. FDA ESG sends email with registration information for the production system.
   
   
2. Register online for the production account using registration information.
   
   
3. FDA ESG activates the production account and sends notification email.