CSMS Message: 10-000018

FDA's OASIS import system will be down for maintenance on Sunday, January 17, 2010, starting at approximately 1:00 AM (0100), and is not anticipated to be back up until 4:30 AM (0430). All times are Eastern Standard Time. As a result, FDA will be operating under the Prior Notice Scenario 2 Contingency. During this downtime ACS, PNSI and the link between ACS and OASIS are operational. However, the OASIS downtime will prevent submitters who filed via ABI from receiving Prior Notice confirmeation and would prevent CBP from auto-checking the Prior Notice confirmation for ABI filers.

If Prior Notice has not already been submitted, ABI filers may decide to wait out the OASIS downtime if they determine that the timeliness of Prior Notice will not be adversely affected. Filers who choose this option should understand that they remain responsible under section 801(M) of the Act and under the Prior Notice Final Rule for filing timely Prior Notice. ABI transmissions received by FDA during the downtime will be queued and processed once the maintenance is completed. Prior Notice (PN) confirmation numbers will not be transmitted back to the filers during the downtime.

Alternatively, filers may submit Prior Notice via PNSI, in which case the Prior Notcie confirmation article must accompany the article of foood (21 CFR 1.279(g)). If Prior Notice is submitted through PNSI, FDA and CBP recommend that the PNSI confirmation page, including the prior notice confirmation number and time stamp, be presented to CBP officers.

If the PNSI confirmation page is not presented, this may delay cargo release while the CBP officer contacts FDA for verification of the Prior Notice confirmation number(s) and the time of submission.

If Prior Notice has already been submitted via ABI 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 and confirmation has NOT been received prior to the interface downtime, 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.

If you have any questions during this downtime, please contact the FDA's Prior Notice Center at 866-521-2297.