From July 13th, 11:00 PM to July14th 5:00 AM there will be a scheduled maintenance of multiple FDA computer systems including prior notice. FDA will not be processing inbound entries or outbound messages until the end of the maintenance period. In addition, the Prior Notice System Interface (PNSI) will be unavailable during this window.
During the maintenance window, the following instructions will be applicable.
If Prior Notice has been submitted via ACE and confirmation has been received:
No further action is required.
If Prior Notice has been submitted via PNSI and confirmation has been received:
Proceed with the Prior Notice using the PNSI confirmation number(s). The confirmation number(s) must accompany the article(s). Presenting the PNSI confirmation page(s) to CBP officers is recommended.
If Prior Notice has been submitted via ACE and confirmation has not been received:
- Please do not resubmit entries as this will cause additional delays.
- Filers have the options to:
- Wait until the issue is resolved, unless this will cause the prior notice submission to be untimely. 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.
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- Provide CBP officers with evidence to show prior notice was submitted via ACE (e.g. signed copy of the ABI/ACE transmission).
If Prior Notice has not been submitted:
- Filers have the options to:
- (Preferred) Wait until the issue is resolved, unless this will cause the prior notice submission to be untimely. 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.
- Submit Prior Notice via email:
- Link to submit the email submission form
- FDA will send a reply email with the prior notice confirmation number. A copy of the email should be provided to CBP.
- Submit Prior Notice via fax:
- Division of Food Defense Targeting’s fax number
- FDA will send a return fax with the confirmation number. A copy of the fax should be provided to CBP.
For additional details, see Prior Notice Contingency Scenario 6