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Adverse Event Reporting - Industry Guidance for the AS2 Gateway

This page contains helpful information for veterinary biologics manufacturers submitting Adverse Event Reports to the Center for Veterinary Biologics (CVB) via the AS2 Gateway. Information provided is intended to be used in conjunction with the Guidance document on Individual Case Safety Report Format for Submission to USDA APHIS-CVB.

Section 1.5
Document number 6: USDA APHIS-CVB ICSR HL7 Vocabulary Lists

Section 2.11
In the table below are the example XML files provided for reference purposes in Section 2.11 of the Guidance document on Individual Case Safety Report Format for Submission to USDA APHIS-CVB.

Filename
Content
Sample_USDA_AER.xml
A single adverse event report
Sample_USDA_AER_PPR.xml
A single adverse event with associated product defect report
Sample_USDA_PPR.xml
A single product defect with no adverse event report
Sample_ack_USDA_Invalid.xml
An acknowledgement for an invalid report (xml that does not comply with the schema)
Sample_ack_USDA_Reject.xml
An acknowledgement for a report that was structurally valid but was rejected due to failing business rules
Sample_ack_USDA_Accept_warn.xml
An acknowledgement for a valid report that was accepted with a warning
Sample_ack_USDA_Accept.xml
An acknowledgement for a valid report that was accepted without warnings
Sample_ack_USDA_Mixed.xml
An acknowledgement for a valid batch report for ICSRs with a mixture of statuses (one accepted, one warning, one rejected)




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