CSMS# 17-000781 - FDA PN Refusal messages to be sent on related ACE Cargo Release Dec 16, 2017

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12/15/2017 05:02 PM EST

Rail Manifest

Beginning December 16, 2017, any entry with ACE Cargo Release that includes an FDA standalone prior notice confirmation number that has been refused by FDA will receive messaging via ACE Cargo Release Status Notification (SO) transaction. Prior to this change, the refusal information was not sent back to the entry filer on any SO transaction. Only the filer who initiated the filing of the Prior Notice via the ACE PE transaction or PNSI would know the refusal status.



This notification will be via the following codes within the SO transaction:

SO70 Status code - 08 Move to Secure Holding Facility

SO70 Reason code - 28 Prior Notice Refused - Inaccurate Prior Notice

SO70 Reason code - 29 Prior Notice Refused – Untimely Prior Notice

SO70 Reason code - 30 Prior Notice Refused – Prior Notice Not Submitted for All Foods

SO70 Reason code - 31 Prior Notice Refused – Registration Hold

SO71 Sub Reason code 133 - Inaccurate Manufacturer

SO71 Sub Reason code 134 - Inaccurate Ultimate Consignee

SO71 Sub Reason code 135 - Inaccurate Shipper

SO71 Sub Reason code 136 - Inaccurate Importer

SO71 Sub Reason code 137 - Inaccurate FDA Product Code

SO71 Sub Reason code 138 - Inaccurate Bill of Lading or Airway Bill

SO71 Sub Reason code 139 - Inaccurate Prior Notice - Other - Contact the FDA DFDT



The above information is also attached in a table format. The information is in the ACE Cargo Release Status Notification chapter of the ACE CATAIR, beginning on page SO-28. https://www.cbp.gov/document/technical-documentation/ace-cargo-release-status-notification-implementation-guide





Questions regarding prior notice compliance actions and policies should be presented to the FDA's Division of Food Defense Targeting 24/7 at (866) 521-2297.



FDA ACE Support can be contacted from 6:00 AM -10:00 PM Eastern, 7 days a week, at ACE_Support@fda.hhs.gov or 877-345-1101 for ACE inquiries.








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