CSMS Message: 07-000084

TO: ALL FILERS

FROM: FOOD & DRUG ADMINSTRATION

SUBJECT: OASIS DOWNTIME ON APRIL 11, 2007

FDA'S OASIS SYSTEM WILL BE DOWN BETWEEN THE HOURS OF 4:00 AM EASTERN
AND 6:00 AM EASTERN TIME ON WEDNESDAY, APRIL 11, 2007, FOR SCHEDULED
MAINTENANCE. DURING THIS DOWNTIME ACS, PNSI AND THE LINK BETWEEN ACS
AND OASIS ARE OPERATIONAL. HOWEVER, 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 NOT ALREADY BEEN SUBMITTED, ABI FILERS MAY DECIDE TO
WAIT OUT THE OASIS DOWNTIME IF THEY DETERMINE THAT THE TIMELINESS OF
PRIOR NOTICE WILL NOT BE ADVERSELY AFFECTED. FILERS WHO CHOOSE THIS
OPTION SHOULD UNDERSTAND THAT THEY REMAIN RESPONSIBLE UNDER SECTION
801(M) OF THE ACT AND UNDER THE PRIOR NOTICE INTERIM FINAL RULE FOR
FILING TIMELY PRIOR NOTICE.

ALTERNATIVELY, FILERS MAY SUBMIT PRIOR NOTICE VIA 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 PNSI CONFIRMATION PAGE, INCLUDING THE PRIOR
NOTICE CONFRIMATION NUMBER AND TIME STAMP, BE PRESENTED TO CBP OFFICERS
FOR CARGO RELEASE. IF THE PNSI CONFIRMATION PAGE IS NOT PRESENTED, THIS
MAY DELAY CARGO RELEASE WHILE THE CBP OFFICER, WITHOUT BEING ABLE TO
ACCESS OASIS, CONTACTS FDA FOR VERIFICATION OF THE PRIOR NOTICE
CONFIRMATION NUMBERS(S) AND TIME OF SUBMISSION.

IF PRIOR NOTICE HAS ALREADY BEEN SUBMITTED VIA ABI/ACS PRIOR TO THE
INTERFACE OUTAGE, AND CONFIRMATION HAS ALREADY BEEN RECEIVED, THE
SUBMITTER MAY PROCEED WITH PRIOR NOTIC USING THE STANDARD PROCESS. IF
PRIOR NOTICE HAS ALREADY BEEN SUBMITTED VIA ABI/ACE AND CONFIRMATION HAS
NOT BEEN RECEIVED PRIOR TO THE INTERFACE OUTAGE, FDA AND CBP RECOMMEND
THAT, RATHER THAN RESUBMITTING VIA PNSI, SUBMITTERS SHOUDL PROVIDE TO
CBP OFFICERS, AT THE TIME OF CARGO RELEASE, AN ENDORSED (SIGNED) COPY OF
THE ABIL TRANSMISSION OR SOME OTHER EVIDENCE ADEQUATE TO SHOW THAT PRIOR
NOTICE HAS BEEN SUBMITTED VIA ABI/ACS.

IF YOU HAVE ANY QUESTIONS DURING THIS DOWNTIME, PLEASE CONTACT THE FDA'S
PRIOR NOTICE CENTER AT (866) 521-2297.