| Title: | OGA-ACS-OASIS LINK DOWN 09/08-09/09 |
|---|---|
| Date: | 2009-09-09 |
| To: | abi |
| Links: | previous, next |
TO: ALL ABI FILERS
FROM: FOOD AND DRUG ADMINISTRATION
RE: OGA-ACS-OASIS LINK DOWN ON SEPTEMBER 8-9/2009
THE INTERFACE BETWEEN CBP'S ACS AND FDA'S OASIS SYSTEM IS EXPERIENCING PROBLEMS AND HAS BEEN DOWN SINCE APPROXIMATELY 7:00 PM, LAST NIGHT, SEPTEMBER 8, 2009. AS A RESULT, CBP AND FDA HAVE BEEN OPERATING UNDER THE PRIOR NOTICE SCENARIO 1 CONTINGENCY. ACS, OASIS, AND PNSI ALL REMAIN OPERATIONAL. HOWEVER, THE INTERFACE OUTAGE HAS PREVENTED SUBMITTERS WHO FILED VIA ABI FROM RECEIVING PRIOR NOTICE CONFIRMATION AND HAS PREVENTED 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 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.
UPON RESTORATION OF THE INTERFACE, CBP AND FDA WILL WORK TO RELEASE THE QUEUED DATA. IF YOU HAVE ANY QUESTIONS DURING THIS DOWNTIME, PLEASE CONTACT THE FDA'S PRIOR NOTICE CENTER AT (866) 521-2297.
CSMS #09-000304