CSMS Message: 05-000050

FDA PNSI DOWNTIME FRIDAY JAN 14, 2005 5:00 PM - 11:30 PM; AND MONDAY
JANUARY 17, 2005 TIME TO BE DETERMINED.

ATTENTION ALL ABI FILERS:

THIS ADMINISTRATIVE MESSAGE IMPACTS ONLY FDA'S PRIOR NOTICE SYSTEM
INTERFACE (PNSI). CBP'S ABI/ACS AND FDA'S OASIS WILL BE OPERATIONAL
DURING THESE PERIODS AND THEREFORE FILERS WILL CONTINUE TO RECEIVE
PN CONFIRMATION NUMBERS FOR ABI PN SUBMISSIONS.

FDA'S PRIOR NOTICE SYSTEM INTERFACE WILL BE DOWN DUE TO AN FDA
ELECTRICAL POWER SYSTEM UPGRADE ON FRIDAY, JANUARY 14, 2005, FROM
APPROXIMATELY 5:00 PM (1700) TO 11:30 PM (2330) EASTERN TIME AND DURING
A PERIOD ON MONDAY, JANUARY 17, 2005, YET TO BE DETERMINED.
PRIOR NOTICE SUBMISSIONS THROUGH ABI/ACS WILL NOT BE AFFECTED BY THIS
DOWNTIME. FILERS WHO CANNOT SUBMIT PRIOR NOTICE VIA ABI SHOULD MAKE
EVERY EFFORT TO SUBMIT PRIOR NOTICE VIA PNSI PRIOR TO THE SCHEDULED
DOWNTIME. FILERS SHOULD CAREFULLY READ AND FOLLOW THE CONTINGENCY
SUBMISSION PROCEDURES WHICH ARE OUTLINED ON FDA'S WEBSITE AT:
WWW.CFSAN.FDA.GOV/~PN/PNDGUID.HTML. NOTE - DURING THE DOWNTIME PERIODS
FDA AND CBP WILL BE OPERATING USING A MODIFIED CONTINGENCY PLAN -
SCENARIO 4. ONLY FAX SUBMISSION WILL BE AVAILABLE DURING THE PNSI
DOWNTIMES.

FDA WILL PUBLISH THE FAX TELEPHONE NUMBER FOR FDA'S PRIOR NOTICE CENTER
AT WWW.ACCESS.FDA.GOV, WW.FDA.GOV, WWW.CFSAN.FDA.GOV/~FURLS/FISSTAT.HTML
AND 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.
FILERS WHO INTEND TO FILE AN ABI ENTRY PRIOR TO ARRIVAL, USING THE
CONFIRMATION NUMBER(S) RECEIVED VIA FAX, DO NOT NEED TO PROVIDE ANY
ADDITIONAL INFORMATION TO CBP AT TIME OF ARRIVAL. FILERS WHO INTEND TO
FILE NON-ABI (PAPER) ENTRIES FOR THESE PRIOR NOTICES SHOULD PRESENT THE
FAX ACKNOWLEDGEMENT REPORT RECEIVED TO THE CBP OFFICER FOR CARGO RELEASE
PROCESSING.

PLEASE MONITOR FDA'S WEB PAGE WWW.CFSAN.FDA.GOV/~PN/PNOVIEW.HTML TO
DETERMINE THE TIME AND DURATION OF THE PNSI DOWNTIME ON MONDAY JANUARY
17, 2005. FOLLOW THE SAME INSTRUCTIONS PROVIDED ABOVE FOR PN SUBMISSION
DURING THAT DOWNTIME.

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

THE FOOD AND DRUG ADMINISTRATION