CSMS Message: 06-000689

TO: ALL ABI FILER

FROM: THE FOOD & DRUG ADMINISTRATION

SUBJECT: FDA OASIS DOWNTIME SATURDAY, JUNE 16, 2006

FDA'S OASIS SYSTEM WILL BE DOWN FOR MAINTENANCE FRIDAY, JUNE 16, 2006
BETWEEN 6:00 AM (0600) EDT - 7:00 AM (0700) 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 PERIOD FDA AND CBP WILL BE OPERATING USING
CONTINGENCY PLAN - SCENARIO 2.

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

THE FOOD & DRUG ADMINISTRATION