CSMS Message: 08-000124

FDA’S IMPORT SYSTEMS WILL EXPERIENCE DOWNTIMES FOR MAINTENANCE THIS SATURDAY, JULY 26, 2008, BETWEEN 03:00 AM (0300) AND 06:00 AM (0600) EDT. FDA'S OASIS AND PRIOR NOTICE SYSTEM INTERFACE (PNSI) SYSTEMS WILL BE DOWN FOR THIS MAINTENANCE. ABI TRANSMISSION RECEIVED BY FDA DURING THAT TIME 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 PRIOR NOTICE HAS NOT ALREADY BEEN SUBMITTED, ABI FILERS MAY DECIDE TO WAIT OUT THE DOWNTIME IF THEY DETERMINE THAT TIMELINESS OF PN WILL NOT BE ADVERSELY AFFECTED.

ACCESS TO FDA'S WEB-BASED PRIOR NOTICE SYSTEM INTERFACE (PNSI) WILL ALSO BE AFFECTED DURING 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.

NOTE - DURING THE FDA IMPORT SYSTEM DOWNTIME PERIOD, FDA AND CBP WILL OPERATE USING PRIOR NOTICE CONTINGENCY PLAN SCENARIO 3 SINCE BOTH OASIS AND PNSI ARE DOWN. FDA AND CBP WILL OPERATE USING THE DECLARED CONTINGENCY PLANS THAT ALLOW PRIOR NOTICE SUBMISSIONS VIA E-MAIL AND FAX DURING THE DOWNTIME (SCENARIO 3; 21 CFR 1.280(C)). IN THIS CASE, A PAPER COPY OF FDA’S E-MAIL RECEIPT OR FAX ACKNOWLEDGEMENT REPORT WITH THE ASSOCIATED PRIOR NOTICE CONFIRMATION NUMBER SHOULD 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 OR PNSI PRIOR TO THE FDA SYSTEM OUTAGES 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.

Referenced By

CSMS #08-000126