CSMS Message: 05-000394

TO: ALL ABI FILER

FROM: THE FOOD & DRUG ADMINISTRATION

SUBJECT: FDA OAIS DOWNTIME SATURDAY, APRIL 9, 2005
FDA PNSI DOWNTIME SUNDAY, APRIL 10, 2005

FDA'S OASIS SYSTEM WILL BE DOWN FOR MAINTENANCE SATURDAY, APRIL 9, 2005,
BETWEEN 5:00 AM (0500) EDT - 8:00 AM (0800) EDT. ABI TRANSMISSIONS
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. ALTERNATIVELY, FILERS MAY SUBMIT PN VIA THE
PRIOR NOTICE SYSTEM INTERFACE (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 SUBMITTER PRESENT THE PNSI CONFIRMATION PAGE, INCLUDING THE PRIOR
NOTICE CONFIRMATION NUMBER AND TIME STAMP TO CBP OFFICERS FOR CARGO
RELEASE.

IF PRIOR NOTICE HAS ALREADY BEEN SUBMITTED VIA ABI PRIOR TO THE
OASIS OUTAGE AND CONFIRMATION HAS ALREADY BEEN RECEIVED, NO FURTHER
ACTION IS REQUIRED. IF PRIOR NOTICE HAS ALREADY BEEN SUBMITTED VIA
ABI AND CONFIRMATION HAS NOT BEEN RECEIVED PRIOR TO THE OASIS 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.
NOTE - DURING THE DOWNTIME PERIODS FDA AND CBP WILL BE OPERATING USING
CONTINGENCY PLAN - SCENARIO 2.

FDA'S PRIOR NOTICE SYSTEM INTERFACE (PNSI) WILL BE DOWN DUE TO AN FDA
ELECTRICAL POWER SYSTEM UPGRADE ON SUNDAY, APRIL 10, 2005 FROM
APPROXIMATELY 3:00 AM (0300) EDT - 5:30 AM (0530) EDT. PRIOR NOTICE
SUBMISSIONS THROUGH ABI WILL NOT BE AFFECTED BY THIS DOWNTIME. FILERS
WHO CANNOT SUBMIT PRIOR NOTICE VIA ABI SHOULD MAKE EVERY EFFORT TO
SUBMIT PRIOR NOTICE VIA PNSI PRIOR TO THE SCHEDULED DOWNTIME. FILERS
SHOULD CAREFULLY READ AND FOLLOW THE CONTINGENCY SUBMISSION PROCEDURES
WHICH ARE OUTLINES ON FDA'S WEBSITE AT WWW.CFSAN.FDA.GOV/~PN/PNGUID.
HTML. NOTE - DURING THE DOWNTIME PERIODS FDA AND CBP WILL BE
OPERATING USING CONTINGENCY PLAN - SCENARIO 4.

FDA WILL PUBLISH THE FAX TELEPHONE NUMBER FOR FDA'S PRIOR NOTICE CENTER
AT WWW.ACCESS.FDA.GOV, WWW.FDA.GOV, WWW.CFSAN.FDA.GOV/~FURLS/FISSTAT.
HTML AND WWW CFSAN.FDA.GOV/~PN/PNOVIEW.HTML )SEE 21 CFR 1.280(C)). IN
FAX TRANSMISSIONS, THE PRIOR NOTICE CENTER INTENDS TO RETURN A FAX
ACKNOWLEDGEMENT REPORT, INCLUDING THE PRIOR NOTICE CONFIRMATION NUMBER.
FILERS WHO INTEND TO FILE AN ABI ENTRY PRIOR TO ARRIVAL, USING THE
CONFIRMATION NUMBER(S) RECEIVED VIA FAX DO NOT NEED TO PROVIDE ANY
ADDITIONAL INFORMATION TO CBP AT TIME OF ARRIVAL. FILERS WHO INTEND TO
FILE NON-ABI (PAPER) ENTRIES FOR THESE PRIOR NOTICES SHOULD PRESENT
THE FAX ACKNOWLEDGEMENT REPORT RECEIVED TO THE CBP OFFICER FOR CARGO
RELEASE PROCESSING.

IF YOU HAVE ANY QUESTIONS, PLEASE CALL THE FDA PRIOR NOTICE CENTER
AT (866) 521-2297.

THE FOOD & DRUG ADMINISTRATION