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U.S. Department of Health and Human Services

For Industry

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CBER ICSR Implementation

CBER is implementing the updated ICH E2B(R3) specification to support electronic submission of vaccine Individual Case Safety Reports (ICSR)s to the Vaccine Adverse Event Reporting System (VAERS).  Industry participants interested in conducting pilot testing should submit a request to: CBER_eSubmitter_program@fda.hhs.gov  to register.

 

To assist industry with preparing for vaccine electronic submissions, the following resources are available:
 

 

 



 

*Note: this document is considered an informal working document to help inform VAERS pilot testing.  FDA will issue notice and process description for formal public consultation and comments in the Federal Register.