| Title: | Entry Summary transaction ACE System Failure E90 or ACE Cargo SE with PGA Data Rejected |
|---|---|
| Date: | 2017-03-31 |
| To: | abi,partner |
| Links: | previous, original, next |
Entry Summary transaction ACE System Failure E90 or SE with PGA Data Rejected
Incorrect Error Messages for FDA Drug Entries
CBP has identified an issue where the correct PGA related error message isn’t being sent for certain entries when PGA data is not submitted correctly by the filer. This applies to both (ACE Entry Summary (AE) transaction Certified for ACE Cargo Release and ACE Cargo Release (SE) transaction.
The correct reject message is scheduled to be sent with the Production implementation on April 6. The ACE Certification environment was updated on March 30 to send the correct error message.
Instead of the correct PGA error message, the filers are receiving the following:
For ACE Entry Summary (AE), filer receives an AX with an ACE SYSTEM FAILURE and the code E90.
For ACE Cargo Release (SE), filer receives an SX with PGA DATA REJECTED, but no specific reject.
If you have reject with these conditions, check if there is PGA message set data for FDA for the DRUG program )Program code DRU in the PG01 record). If so, the underlying reason is one of the two below.
1. If the PROCESSING code is INV, and intended use code is 180.009, then there needs to be a PG23 with the Affirmation of Compliance Code IND and the Investigational New Drug Number. No other Affirmations of Compliance apply.
OR
2. If the PROCESSING code PRE or OTC is sent, and the intended use code is 080.012, 980.000, 130.000, 150.007, 150.013, 150.017 or 155.009, then there needs to be two PG23 records with at least one of each of the below Affirmations of Compliance:
REG Drug Registration Number
DLS Drug Listing Number
The DRUG chapter of the ACE CATAIR FDA Supplemental Guide starts on page 77. Affirmations of compliance for this chapter are covered on pages 96-97.
URL is
https://www.cbp.gov/document/guidance/fda-supplemental-guide-release-16
When the issue is resolved, the correct error message generated will be
PN9 MISSING AFFIRMATION OF COMPLIANCE CODE PER PGA
If you get any other ACE System Failure response on the Entry Summary Transaction, or the ACE Cargo Release response of PGA DATA REJECTED that is missing any specific error message, and it is not as described above, please email the entry number to your assigned CBP client rep.
Questions about the FDA ACE Supplemental Guidance can be sent to: ACE_Support@fda.hhs.gov