CBP Reports Issues With Connection to FDA System
The Food and Drug Administration wasn't getting ACE entries due to "connection problems between FDA and CBP’s systems," CBP said in a June 29 CSMS message. Filers that already submitted Prior Notice through ACE and received confirmation don't need to…
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take further action, CBP said. Filers that haven't received confirmation or have not yet submitted Prior Notice can "wait until the issue is resolved, unless this will cause the prior notice submission to be untimely," CBP said. "Filers who choose this option should understand that they remain responsible under section 801(m) of the Federal Food, Drug, and Cosmetic Act and under the prior notice final rule for filing timely prior notice." Filers can also provide CBP officers "with evidence to show prior notice was submitted via ACE (e.g. signed copy of the ABI/ACE transmission)" or provide a confirmation page from the Prior Notice System Interface that shows submission.