| Title: | FDA OASIS IMPLEMENTATION |
|---|---|
| Date: | 1996-04-29 |
| To: | abi |
| Links: | previous, next |
THE FOOD AND DRUG ADMINISTRATION (FDA) HAS ANNOUNCED THE SCHEDULE FOR
IMPLEMENTING THE NEXT STAGE OF ITS AUTOMATED IMPORT SYSTEM. THE
OPERATIONAL AND ADMINISTRATIVE SYSTEM FOR IMPORT SUPPORT (OASIS)
VERSION 2 WILL EXPAND THE AVAILABILITY OF THE ADDITIONAL FEATURES OF
OASIS CURRENTLY AVAILABLE IN THE PORTS SERVICED BY FDA'S SEATTLE
DISTRICT TO FDA'S IMPORT OPERATIONS NATIONWIDE.
THE EXPANSION SCHEDULE IS AS FOLLOWS:
FDA DISTRICT IMPLEMENTATION DATE
SEATTLE AUGUST 1, 1996 (UPGRADE FROM OASIS VERSION 1)
PHILADELPHIA OCTOBER 16, 1996
BALTIMORE NOVEMBER 13, 1996
NEW ORLEANS NOVEMBER 13, 1996
ATLANTA JANUARY 22, 1997
SAN JUAN JANUARY 22, 1997
SAN FRANCISCO FEBRUARY 19, 1997
KANSAS CITY FEBRUARY 19, 1997
DETROIT MARCH 11, 1997
MINNEAPOLIS MARCH 11, 1997
NASHVILLE APRIL 29, 1997
FLORIDA APRIL 29, 1997
DALLAS MAY 28, 1997
DENVER MAY 28, 1997
CINCINNATI JUNE 24, 1997
CHICAGO JUNE 24, 1997
NEW YORK JULY 29, 1997
LOS ANGELES SEPTEMBER 3, 1997
BUFFALO SEPTEMBER 30, 1997
BOSTON SEPTEMBER 30, 1997
PRIOR TO THE IMPLEMENTATION DATE FOR EACH DISTRICT, THE LOCAL FDA
OFFICE WILL MEET WITH THE LOCAL FILER COMMUNITY TO ANSWER QUESTIONS
AND EXPLAIN CHANGES IN LOCAL PROCEDURES NECESSITATED BY THE
IMPLEMENTATION OF OASIS.
WHEN OASIS IS IMPLEMENTED IN THE ABOVE FDA DISTRICTS, ENTRY FILERS WILL
RECEIVE BOTH LINE LEVEL AND ENTRY LEVEL FDA RESULTS. FILERS SHOULD
ACSERTAIN THAT THEIR ABI SOFTWARE FULLY CONFORMS TO THE SPECIFICATIONS
STATED IN THE CATAIR, SPECIFICALLY REGARDING THE R6 OUTPUT RECORD, AS
DETAILED ON PAGES CRL-30, 31. THIS RECORD RETURNS BOTH ENTRY AND LINE
FDA RESULTS. FILERS SHOULD ALSO CONFIRM THAT THEIR SOFTWARE HAS OGA
CORRECTION CAPABILITY ("CP" TRANSACTION), FEI QUERY CAPABILITY, AND
THE ABILITY TO TRANSMIT FDA DATA FOR "UNFLAGGED" HTS NUMBERS.
FILERS SHOULD CONTACT THEIR SOFTWARE PROVIDERS TO CONFIRM THAT
ALL THE CAPABILITIES LISTED ABOVE ARE AVAILABLE AND PROPERLY
FUNCTIONING. (SEE ADMIN MESSAGE 96-0130 FOR A DETAILED EXPLANATION
OF THE R6 OUTPUT RECORD).
PLEASE CONTACT YOUR CLIENT REPRESENTATIVE IF YOU HAVE ANY QUESTIONS.