• 08-000068
• May 01, 2008

• To : Automated Broker Interface

TITLE: URGENT - FDA System Outage on Saturday, May 3, 2008 
DATE: May 1, 2008 
TO: All Filers 

                                                      
FDA’s import systems will experience periodic downtimes for maintenance this Saturday, May 03, 2008, between 01:00 am (0100) and 08:00 pm (2000) EDT.  FDA’s OASIS is expected to experience relatively little or no downtime during this period.  However, access to FDA's web-based Prior Notice System Interface (PNSI) will be affected during much of this time.  As such, filers may want to plan ahead and submit FDA prior notice submissions prior to or after the above stated downtime to avoid transmission and processing delays. If OASIS is down, ABI transmissions received by FDA during that time will be queued and processed once the maintenance is completed.  ABI filers also will not receive Prior Notice (PN) confirmation numbers for ABI PN submissions received during any OASIS downtimes until the system is restored.
  
Note - during the FDA import system downtime period, FDA and CBP will operate using Prior Notice Contingency Plan Scenario 4 if PNSI only is down or Scenario 3 if both OASIS and PNSI are down.
  
When FDA’s PNSI is unavailable during the maintenance period, FDA and CBP will operate using the declared contingency plans that allow prior notice submissions via e-mail and fax during the downtime (Scenarios 3 or 4; 21 CFR 1.280(c)).  In these cases, a paper copy of FDA’s e-mail receipt or fax acknowledgement report with the associated prior notice confirmation number should then be presented to the CBP officer for cargo release processing. CBP officers intend to enforce prior notice submission based on the e-mail and/or fax receipt confirmation time stamp.                                                
                                                      
If prior notice has already been submitted via ABI prior to the FDA system outage and confirmation has already been received, no further action is required. If prior notice has already been submitted via ABI prior to the FDA system outage and confirmation has not been received, FDA and CBP recommend that rather than resubmitting via e-mail or fax, submitters should provide to CBP officers, at the time of cargo release, an endorsed (signed) copy of the ABI transmission or other evidence adequate to show that prior notice has been submitted via ABI.

If you have any questions, please call the FDA Prior Notice Center at   
866) 521-2297.