CSMS Message: 09-000235

Title:FDA Prior Notice Contingency Plan for ABI Filers
Date:2009-05-28
To:abi
Links:previous, next

We are currently experiencing a system problem which prevents submitters who filed via ABI/ACS from receiving prior notice confirmation and would prevent CBP from auto-checking the prior notice confirmation for ABI/ACS filers.

If prior notice has not already been submitted, ABI filers may decide to wait out the ACS/OASIS downtime if users determine that the timeliness of prior notice will not be adversely affected. Filers who choose this option should understand they remain responsible under section 801(m) of the Act and under the prior notice interim final rule for filing timely final prior notice.

Alternatively, filers may submit prior notice via PNSI in which case the prior notice confirmation number must accompany the article of food (21 CFR 1.279(g).
If prior notice is submitted through PNSI, FDA and CBP recommend that the submitter present the PSNI confirmation page, including the prior notice confirmation number and time stamp, to CBP officers for cargo release. If the PNSI confirmation page is not presented, this may delay cargo release, while the CBP officer, without being able to access OASIS, contacts FDA for verification of the prior notice confirmation numer(s) and time of submission.

If prior otice has already been submitted via ABI/ACS prior to the interface outage and confirmation has already been received, the submitter may proceed with prior notice using the standard process. If prior notice has already been submitted via ABI/ACS and confirmation has not been received prior to the interface outage, FDA and CBP recommend that rather than resubmitting via PNSI, submitters should provide to CBP officers, at the time of cargo release, an endorsed (signed) copy of the ABI transmission or some other evidence adequate to show that prior notice has been submitted via ABI/ACS.

Upon restoration of the interface FDA intends to provide notice, via web page posting at http://www.cfsan.fda.gov~furls/fisstat.html, that normal processing has resumed.

Referenced By

CSMS #09-000236