CSMS Message: 11-000287

TO : ALL ABI FILERS WHO MAY ON OCCASION FILE PRIOR NOTICE USING THE
PRIOR NOTICE SYSTEM INTERFACE (PNSI)

FROM : FOOD AND DRUG ADMINISTRATION

SUBJECT: FDA PNSI DOWNTIME SATURDAY, November 19, 2011

FDA'S PNSI SYSTEM WILL BE DOWN FOR MAINTENANCE SATURDAY, NOVEMBER 19, 2011, BETWEEN 01:00 AM (0100) EST AND 12:00 PM(1200)EST. ACS, OASIS, AND THE LINK BETWEEN ACS AND OASIS WILL BE OPERATIONAL BUT PNSI WILL BE UNAVAILABLE DURING THIS TIME. PRIOR NOTICE MAY CONTINUE TO BE SUBMITTED THROUGH THE ABI/ACS SYSTEM.

IF BROKERS USE THE PNSI SYSTEM AND THEY SUBMITTED PRIOR NOTICE VIA PNSI PRIOR TO THE SYSTEM OUTAGE AND A CONFIRMATION NUMBER HAS ALREADY BEEN RECEIVED, THE CONFIRMATION NUMBER MUST ACCOMPANY THE ARTICLE OF FOOD (21 CFR 179 (G)). IN ADDITION, FDA AND CBP RECOMMEND THAT THE SUBMITTER ALSO PROVIDE THE PNSI CONFIRMATION PAGE, INCLUDING THE PRIOR NOTICE CONFIRMATION NUMBER AND TIME STAMP TO CBP OFFICERS FOR CARGO RELEASE. IF THE PRIOR NOTICE CONFIRMATION PAGE IS NOT PROVIDED, THIS MAY DELAY CARGO RELEASE WHILE THE CBP OFFICER CONTACTS FDA FOR VERIFICATION OF THE PRIOR NOTICE CONFIRMATION NUMBER(S) AND TIME OF SUBMISSION.

IF A BROKER NEEDS TO FILE A PRIOR NOTICE USING PNSI AND THE PRIOR NOTICE HAS NOT BEEN SUBMITTED PRIOR TO THE SYSTEM OUTAGE, IT MAY BE SUBMITTED BY EITHER E-MAIL OR FAX (21 CFR 1.280(C)). FDA DOES NOT INTEND TO ACCEPT ANY PRIOR NOTICE SUBMITTED BY THESE METHODS OTHER THAN DURING PNSI/OASIS DOWNTIMES (21 CFR 1.280 (E)).

1. E-MAIL SUBMISSION
FDA WILL PUBLISH A LOCATION (URL) LINKING TO THE EMAIL SUBMISSION FORM FOR THE PRIOR NOTICE CENTER AT http://www.access.fda.gov13, http://www.fda.gov14, http://www.cfsan.fda.gov/~furls/fisstat.html and http://www.cfsan.fda.gov/~pn/pnoview.html (see 21 CFR 1.280(c)). FOR E-MAIL SUBMISSIONS, THE FDA INTENDS TO TRANSMIT BACK TO THE EMAIL ADDRESS FROM WHICH THE PRIOR NOTICE WAS SUBMITTED, AN AUTOMATED RECEIPT RESPONSE, INCLUDING THE CONFIRMATION NUMBER. A PAPER COPY OF FDA’S E-MAIL RECEIPT CONFIRMATION SHOUL BE PRESENTED TO THE CBP OFFICER FOR CARGO RELEASE PROCESSING. CBP INTENDS TO ENFORECE PRIOR NOTICE SUBMISSION TIMEFRAMES BASED ON THE E-MAIL RECEIPT CONFIRMATION TIME STAMP.

2. FAX SUBMISSIONS
FDA WILL PUBLISH THE FAX TELEPHONE NUMBER FOR FDA’S PRIOR NOTICE CENTER http://www.access.fda.gov15, http://www.fda.gov16, http://www.cfsan.fda.gov/~furls/fisstat.html and http://www.cfsan.fda.gov/~pn/pnoview.html (see 21 CFR 1.280(c). IN CASES OF FAX TRANSMISSIONS, THE PRIOR NOTICE CENTER INTENDS TO RETURN A FAX ACKNOWLEDGEMENT REPORT, INCLUDING THE PRIOR NOTICE CONFIRMATION NUMBER. THIS FAX ACKNOWLEDGEMENT REPORT SHOULD BE PRESENTED TO THE CBP OFFICER FOR CARGO RELEASE PROCESSING. CBP OFFICERS INTEND TO ENFORCE PRIOR NOTICE SUBMISSION TIME FRAMES BASED ON THE FAX RECEIVED CONFIRMATION TIME STAMP.

UPON RESTORATION OF THE SYSTEM, FDA INTENDS TO ISSUE A NOTICE, VIA THE WEB PAGE POSTING AT http://www.cfsan.fda.gov/~furls/fisstat.html THAT NORMAL PROCESSING HAS RESUMED.

IF YOU HAVE ANY QUESTIONS, PLEASE CALL THE FDA PRIOR NOTICE CENTER AT
(866) 521-2297.