| Title: | Scheduled FDA Import Systems Downtime on August 3, 2013 |
|---|---|
| Date: | 2013-07-30 |
| To: | abi |
| Links: | previous, original, next |
To: All Filers
From: Food & Drug Administration
Subject: Scheduled FDA Import Systems Downtime on August 3, 2013
Several of FDA's import systems, including OASIS, PREDICT and ITACS, will be down for maintenance on Saturday, August 3, 2013 starting at approximately 12:00 am ET (00:00) and are not anticipated to be back up until 12:00 pm ET (12:00). As a result, FDA will be operating under the Prior Notice Contingency - Scenario 2.
During this downtime ACS/ACE, PNSI and the link between ACS/ACE and OASIS are operational. However, the OASIS downtime will prevent submitters who filed via ABI from receiving Prior Notice confirmation 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 filers during the downtime.
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 PNSI confirmation page, including the Prior Notice confirmation number and time stamp, be presented 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 numbers(s) and time of submission.
If Prior Notice 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 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. If you have any questions during this downtime, please contact the FDA's Prior Notice Center at (866) 521-2297.
Due to the length of this downtime, it may take some extra time for FDA field staff to perform FDA entry review and make admissibility “801(a)” decisions once the systems become available. It is also possible that FDA field staff may need to rescind system "May Proceeds" issued right after the downtime is over. Notification of these "May Proceed" rescinds will be provided to filers. Please follow the instructions above for transmission of Prior Notice for food products. Filers may want to submit entries of FDA-regulated commodities as well as uploading documents in advance of this downtime.