CSMS Message: 05-001438

THE INTERFACE BETWEEN CBP'S ACS SYSTEM AND FDA'S OASIS SYSTEM IS DOWN.
DUE TO THIS COMMUNICATION PROBLEM, PRIOR NOTIC CONTINGENCY SCENARIO 1 IS
IN EFFECT. THIS CONTINGENCY STATES:

SCENARIO 1: ACS, OASIS AND PNSI ARE ALL OPERATIONAL, BUT THE LINK
BETWEEN ACS AND OASIS IS DOWN ON FDA'S OR CBP'S SIDE OF THE SYSTEM
INTERFACE.

THE OUTAGE DESCRIBED IN THIS SCENARIO WOULD PREVENT SUBMITTERS WHO FILED
VIA ABI/ACS FROM RECEIVING PRIOR NOTICE CONFIRMATION AND WOULD PREVENT
CBP FROM AUTO-CHECKING THE PRIOR NOTICE CONFIRMATION FOR ABI/ACS FILERS.

FDA HAS POSTED A NOTICE AT HTTP://WWW.ACCESS.FDA.GOV, HTTP://WWW.FDA.GOV
HTTP:WWW.CFSAN.FDA.GOV/~FURLS/FISSTAT.HTML AND HTTP://WWW.CFSAN.FDA.GOV
/~PN/PNOVIEW.HTML, ADVISING OF ANY AVAILABLE DOWNTIME SPECIFICS. IF
PRIOR NOTICE HAS NOT ALREADY BEEN SUBMITTED, ABI FILERS MAY DECIDE TO
WAIT OUT THE ACS/OASIS INTERFACE 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 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
SUBMITTER MAY PROCEED WITH PRIOR NOTICE USING THE STANDARD PROCESS.
IF PRIOR NOTICE HAS ALREADY BEEN SUMITTED 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.

UPON RESTORATION OF THE INTERFACE, FDA INTENDS TO PROVIDE NOTICE, VIA
WEB PAGE POSTING AT HTTP://WWW.CFSAN.FDA.GOV/~FURLS/FISSTAT.HTML,
THAT NORMAL PROCESSING HAS RESUMERED.

Referenced By

CSMS #05-001440