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ESG NextGen AS2 Account Set-Up Steps

AS2 is legacy technology. ESG NextGen has the ability to submit via API to ensure implementation keeps pace with the modernization goals of ESG NextGen. We encourage you to review API submission details here: API User Guide

For assistance with ESG NextGen related items, please contact ESGNGsupport@fda.hhs.gov. 

 

1. Preparatory activities 
  1. Obtain a Digital Certificate
    1. A valid digital certificate is required per routing ID per profile.
  2. Prepare Guidance-Compliant Test Submissions
    1. Follow center-specific guidance for preparing compliant submissions. Refer to the appropriate FDA Center website for details.
  3. Review the User Guide and Tutorials
    1. Familiarize yourself with the ESG NextGen User Guide and tutorials to ensure readiness for submission. 
2. Register for an ESG NextGen account via the Unified Submission Portal (USP). 
  1. Navigate to Electronic Submissions Gateway | FDA.  
  2. Select the “Industry USP Log In” button.
  3. Select “Accept” on the FDA warning screen.
  4. Select the “Register now” link at the bottom of the sign in screen.  
  5. Complete all user profile registration screens.  
  6. Log in to ESG NextGen.
  7. Complete all ESG NextGen registration screens.  
  8. See Training Videos for more information about registration. 
3. Email ESGNGSupport@fda.hhs.gov with the following information 
  • Subject Line: AS2 Account Set-up for <insert company name>
  • Email address associated with profile registered on USP
  • Routing ID to associate with profile
  • Your Gateway HTTPS URL (only ports 443, 4080 are accepted)
  • User ID to connect to your HTTPS URL, if any
  • Password to connect to your HTTPS URL, if any
  • Upload Signing cert (public key)
  • Upload Encryption cert, if different than signing cert (public key) 
4. Support will reach out to confirm your AS2 profile is ready
  • You will receive an email from ESGNGSupport@fda.hhs.gov✉️ once your AS2 profile is ready to finalize setup and test. 
5. Set Up Your System for AS2 Usage
  • Once you receive the AS2 Test Account Activation Email, configure your system to transmit test submissions.
  • Refer to the “Electronic Submission Gate (ESG) NextGen AS2 Guide for Industry Users” for details of configuration.  
6. Send Test Submissions 
  • Initial Test Submission: To ensure you are properly configured prior to sending a test submission to a Center, you may send a test submission using the appropriate configuration indicated in the Guide with the following Center and Submission Type:
    • Center: "GWTEST"
    • Submission Type: "ConnectTest"
  • Center Test Submission: Once you have successfully received the MDN for the above initial test submission, you are able to send a test submission to the Center using the appropriate Center and Submission Type.
    • If your Center and Submission Type require a guidance-compliant test submission this will need to be completed first in order for production submissions to be subsequently submitted. Refer to Center Submission Types and the Test Submission Required for New ESG NextGen Users.
    • Review Timeline: Test submissions for a Center and Submission Type where a guidance-compliant submission is not required will not be reviewed by the Center. Guidance-compliant test submissions may take up to 1 week for review. You will receive an email from the ESGNGSupport@fda.hhs.gov✉️ regarding submission status for required guidance-compliant submissions. 
7. Set Up Your System for Production
  • Once you have received an MDN for the initial test submission and, if applicable, an approved guidance-compliant test submission, you are welcome to generate production submissions. Please note that production submissions for Center Submission Types which require guidance-compliant test submissions will fail until the test submission is approved by the Center.
  • To finalize the production submission configuration in your AS2 system and begin sending production submissions:
    • Install the FDA Public Production Certificate provided in the AS2 guide.
    • Utilize the production URL.
    • Update routing ID if applicable. 
8. Begin Sending Submissions 
  • You are now ready to send AS2 electronic submissions to the FDA using the ESG NextGen system.
  • For further assistance with ESG NextGen setup or submissions, please contact ESGNGsupport@fda.hhs.gov✉️. 
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