CSMS Message: 07-000067

TO: ALL ABI FILERS

FROM: FOOD AND DRUG ADMINISTRATION

RE: DOWN TIME ON MAR 19, 2007

THE INTERFACE BETWEEN CBP'S ACS AND FDA'S OASIS SYSTEM WILL BE DOWN
BETWEEN THE HOURS OF 7:00 AM AND 8:00 AM ON MONDAY, MARCH 19, 2007,
FOR SCHEDULED MAINTENANCE. DURING THIS DOWNTIME ACS, OASIS, AND PNSI
WILL ALL BE OPERATIONAL. HOWEVER, THE INTERFACE DOWNTIME WOULD 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 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 REPORTING.

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 SUBMITTER PRESENT THE PNSI CONFIRMATION
PAGE, INCLUDING THE PRIOR NOTICE CONFIRMATION NUMBER AND TIME STAMP, 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 NUMBER(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
THE SUBMITTER MAY PROCEED WITH PRIOR NOTICE USING THE STANDARD PROCESS.
IF PRIOR NOTICE HAS ALREADY BEEN SUBMITTED VIA ABI/ACS AND
CONFIRMATION HAS NOT BEEN RECEIVED PRIOR TO THE INTERFACE 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/ACS.

CBP WILL QUEUE ALL PRIOR NOTICE SUBMITTED DATA FROM ACS DURING
THE SCHEDULED MAINTENANCE. UPON RESTORATION OF THE INTERFACE, CBP
WILL RELEASE ALL THE QUEUED DATA TO FDA AND FDA INTENDS TO PROVIDE
NOTICE.
QUESTIONS REGARDING THIS MESSAGE MAY BE DIRECTED TO THE FOOD AND DRUG
ADMINISTRATION OFFICE AT (301) 594-3873.