CSMS Message: 11-000181

TO: ALL FILERS
FROM: FOOD & DRUG ADMINISTRATION
SUBJECT: SCHEDULED OASIS AND PNSI DOWNTIME ON AUGUST 13, 2011

FDA's OASIS import system AND Prior Notice System Interface(PNSI) will be down intermittently on Saturday August 13, 2011 to deploy updates being made to these systems in response to the Food Safety Modernization Act. The systems will be down starting at approximately 03:00 am (0300), and are not anticipated to be back up until 5:00 am (0500) EST. As a result,FDA will be operating under the prior notice scenario 3 contingency. However, it is expected that during the approximately half hour (1/2 hour) period when PNSI is down, ACS and the link between ACS and OASIS will be operational. Conversely, during the approximately half hour (1/2 hour) period when OASIS is down, PNSI and the link between ACS and OASIS will be operational.

The PNSI downtime will prevent filers from providing prior notice using the PNSI system. If prior notice has been submitted via PNSI prior to the outage, the confirmation number must accompany the article of food (21CFR 1.279(g)). In addition, FDA and CBP recommend that the submitter also provide the PNSI confirmation page, including the prior notice confirmation number and time stamp, to CBP officers for cargo release. If the PNSI confirmation page is not provided, this may delay cargo release while the CBP officer, without being able to access OASIS, contacts FDA for verification of the prior notice confirmation number(s)and time of submission. If prior notice has not been submitted prior to the PNSI outage, filers can chose to submit prior notice via ABI/ACS or wait out the PNSI downtime if they determine that the timeliness of prior notice will not be adversely affected. Filers who choose to wait 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.

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 already been submitted via ABI/ACS prior to the system outage, and a prior notice confirmation number has been received, the submitter may proceed with prior notice using the standard process. However, if prior notice is submitted via ABI/ACS and a prior notice confirmation number is not received prior to the outages, submitters should provide to CBP officers, at the time of cargo release, either an endorsed (signed) copy of the ABI transmission showing the prior notice submission, or some other evidence adequate to show that prior notice has been submitted via ABI/ACS. If prior notice has not already been submitted, ABI filers may submit prior notice via PNSI or decide to wait out the OASIS downtime if they determine that the timeliness of prior notice will not be adversely affected. Filers who choose to wait 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.

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