| Title: | FDA SYSTEM MAINTENANCE OCTOBER 30, 2004 OASIS & PNSI |
|---|---|
| Date: | 2004-10-28 |
| To: | abi |
| Links: | previous, next |
TO: ALL ABI FILERS
FROM: FOOD & DRUG ADMINISTRATION
SUBJECT: FDA OASIS & PNSI SYSTEMS DOWN FOR MAINTENANCE OCTOBER 30, 2004
BOTH FDA'S OASIS SYSTEM AND PRIOR NOTICE SYSTEM INTERFACE (PNSI) WILL BE
DOWN FOR MAINTENANCE SATURDAY, OCTOBER 30, 2004. OASIS WILL BE DOWN
BETWEEN 5:00 AM AND 8:00 AM EDT (0500-0800 EDT). PNSI WILL BE DOWN
BETWEEN 3:00 AM AND 8:00 AM EDT (0300-0800 EDT). ABI TRANSMISSIONS
RECEIVED BY FDA DURING THIS 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 IS SUBMITTED VIA ABI PRIOR TO THE SYSTEM OUTAGE AND A
PN CONFIRMATION NUMBER HAS BEEN RECEIVED, THE SUBMITTER MAY PROCEED WITH
PRIOR NOTICE USING THE STANDARD PROCESS. HOWEVER, IF PRIOR NOTICE IS
SUBMITTED VIA ABI AND A PN CONFIRMATION NUMBER IS NOT RECEIVED PRIOR TO
THE OUTAGES, SUBMITTERS SHOULD PROVIDE TO CBP OFFICERS, AT THE TIME OF
CARGO RELEASE, EITHER AN ENDORSED (SIGNED) COPY OF THE ABI TRANSMISSION
SHOWING THE PRIOR NOTICE SUBMISSION, OR SOME OTHER EVIDENCE ADEQUATE
TO SHOW THAT PRIOR NOTICE HAS BEEN SUBMITTED VIA ABI.
IF PRIOR NOTICE IS SUBMITTED VIA PNSI PRIOR TO THE SYSTEM OUTAGE AND A
CONFIRMATION NUMBER HAS BEEN RECEIVED, THE CONFIRMATION NUMBER MUST
ACCOMPANY THE ARTICLE OF FOOD (21 CFR 1.279(G)). IN ADDITION, FDA AND
CBP RECOMMEND THE SUBMITTER PROVIDE THE PNSI CONFIRMATION PAGE,
INCLUDING THE PN CONFIRMATION NUMBER AND TIME STAMP. FOR CARGO RELEASE,
IF THE PN CONFIRMATION PAGE IS NOT PROVIDED,CARGO RELEASE MAY BE DELAYED
WHILE CBP CONTACTS FDA FOR VERIFICATION OF THE PN CONFIRMATION
NUMBER(S) AND TIME OF SUBMISSION.
OTHERWISE, IF PRIOR NOTICE HAS NOT BEEN SUBMITTED PRIOR TO THE SYSTEM
OUTAGES, IT MAY BE SUBMITTED BY EITHER E-MAIL OR FAX (21 CFR 1.280(C)).
FDA WILL NOT ACCEPT ANY PRIOR NOTICE SUBMITTED BY THESE METHODS OTHER
THAN DURING PNSI/OASIS DOWNTIMES (21 CFR 1.280(E)). PLEASE ACCESS
DIRECTIONS FOR E-MAIL OR FAX SUBMISSION IN THE "PRIOR NOTICE OF
IMPORTED FOOD CONTINGENCY PLAN FOR SYSTEM OUTAGES" LOCATED AT
WWW.CFSAN.FDA.GOV/~PN/PNDGUID.HTML
FOOD & DRUG ADMINISTRATION