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  1. Vaccines, Blood & Biologics

Getting Started with ICSR Submission to FDA’s electronic Vaccine Adverse Event Reporting System (eVAERS)

Follow the steps below for submitting ICSRs to the FDA's electronic Vaccine Adverse Event Reporting System (eVAERS).

Step 1: Contact the CBER ICSR Submissions Coordinator (CBERICSRSubmissions@fda.hhs.gov) to inform FDA of your intent to begin submitting vaccine ICSRs electronically and to identify your chosen Sender ID.

Step 2: Review the relevant guidances and technical specifications that are posted at the CBER Vaccine ICSR Implementation web page

Questions pertaining to eVAERS submission requirements and process can be sent to the CBER ICSR Submissions Coordinator.

Step 3: FDA ESG Transaction Partner Registration

If you have an active ESG Partner Account, please skip Step 3 and go to Step 4.

Visit the FDA ESG Web Site: 

  • Complete and submit the Trading Partner Information Package for submissions to the FDA using the ESG Gateway (FDA ESG Partner Account Registration).
  • Complete FDA ESG Connectivity testing.    After Connectivity Testing is complete, ESG support will direct you to Step 4: Guidance-Compliant testing.

Step 4:  Guidance-Compliant Testing

Before submitting your guidance-compliant testing submission, notify the CBER ICSR Submissions Coordinator of a planned schedule for sending your guidance-compliant test submissions, and then follows the steps below:

  1. Provide the CBER ICSR Submissions Coordinator with the Sender ID you intend to use for your submissions to eVAERS (for more information, see the VAERS Technical Specifications).
  2. Create vaccine ICSR files using the FDA’s eSubmitter tool (which can be downloaded at eSubmitter Download and Installation) or other appropriate tool in accordance with eVAERS technical specification. Test files should collectively include:  all data elements; use of nullFlavors; use of parent/child case information;  an example of a nullification or amendment,  and inline document attachments. 
  3. Submit the test file to eVAERS via the FDA ESG test environment using the appropriate CBER gateway routing identifier (ID):
    • WebTrader Accounts: CBER VAERS
    • AS/2 B2B Accounts: CBER_VAERS
  4. Ensure that you receive an ESG MDN (ACK 1) and a CBER receipt acknowledgement (ACK 2), both of which usually occur within 24 hours of submission, and a third acknowledgment message (ACK 3) with eVAERS file validation results within 2 working days of submission. But:
    • If you do not receive ACK 1 and/or ACK 2, contact the FDA ESG Help Desk (ESGHelpDesk@fda.hhs.gov)
    • If you do not receive ACK 3, contact the CBER ICSR Submissions Coordinator.
  5. If any test ICSR fails validation (per ACK 3), make the necessary correction(s) and submit the corrected ICSR files to eVAERS (repeat of steps 2-4).
  6. Once your testing submission is complete, please email CBERICSRSubmissions@fda.hhs.gov with the following information:
    • CoreIDs of your test files (Core Ids are found in the second and third ACK messages)
    • Notification that the test files included all requested variations
    • Confirm the SenderID you plan to use for production submissions.

The testing submission will be reviewed by the ICSR Submissions Coordinator and you will be informed that you have passed the testing phase.

Step 4: Once you have passed the testing phase, an FDA ESG production account will be activated allowing you to send submissions to FDA using the FDA ESG production system.

Step 5: After obtaining a production account, you may submit ICSRs to the Agency on a regular basis in compliance with regulatory timelines and requirements.

 

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