| Title: | FUTURE EXPANSION OF FDA FULL PROCESSING SYSTEM NATIONWIDE |
|---|---|
| Date: | 1996-02-27 |
| To: | abi |
| Links: | previous, next |
TO: ALL ABI FILERS AND ABI SOFTWARE PROVIDERS
SUBJECT: FUTURE EXPANSION OF FDA FULL PROCESSING SYSTEM NATIONWIDE
FDA PLANS TO IMPLEMENT THE NEXT STAGE IN ITS AUTOMATED IMPORT SYSTEM
BEGINNING IN LATE 1996. THIS SYSTEM (OPERATIONAL AND ADMINISTRATIVE
SYSTEM FOR IMPORT SUPPORT, KNOWN AS OASIS) WILL EXPAND THE AVAILABILITY
OF THE ADDITIONAL FEATURES OF OASIS,CURRENTLY FOUND ONLY IN THE SEATTLE
FDA DISTRICT, TO FDA'S IMPORT OPERATIONS NATIONWIDE. THESE FEATURES WILL
NOT REQUIRE ANY ADDITIONAL PROGRAMMING BEYOND THAT SPECIFIED IN THE
CATAIR. HOWEVER, FILERS SHOULD PAY SPECIAL ATTENTION TO THE R6 OUTPUT
RECORD, DETAILED ON PAGES CRL-30,31 OF THE CATAIR. THIS RECORD RETURNS
BOTH FDA ENTRY AND FDA LINE LEVEL RESULTS. CURRENTLY, ONLY FILERS IN
SEATTLE ARE RECEIVING LINE LEVEL FDA RESULTS AFTER FDA PROCESSES THE
ENTRY IN OASIS. WHEN THE OASIS SYSTEM EXPANDS NATIONWIDE FILERS MUST
HAVE THE CAPABILITY TO RECEIVE FDA LINE LEVEL MESSAGES. THE LATEST
UPDATE OF THE CATAIR DOES NOT LIST THE VALID DISPOSITION MESSAGE CODES
FOR THE FDA INTERFACE. THE FDA PROCESSING MESSAGES AT THE ENTRY LEVEL ARE
01 FDA REVIEW
02 FDA HOLD
03 FDA DO NOT DEVAN
04 FDA EXAM/SAMPLE
05 FDA RELEASE
06 FDA MAY PROCEED
FDA PROCESSING MESSAGES AT THE FDA LINE LEVEL ARE:
01 FDA EXAM
02 FDA EXAM, NOTIFY
05 FDA EXAM, DO NOT DEVAN
06 FDA EXAM, REDELIVER
07 FDA MAY PROCEED
08 FDA RELEASED
09 FDA RELEASED W/COMMENT
10 FDA DETAINED
11 FDA CANCEL DETENTION
12 FDA REFUSED
13 FDA PARTIAL RELEASE/REFUSE
14 FDA CANCEL REFUSAL
ONE MESSAGE WILL BE TRANSMITTED TO THE ABI FILER AS INDICATED ABOVE
FOR EACH ENTRY AND LINE ITEM TOGETHER WITH THE APPROPRIATE CUSTOMS ENTRY
PROCESSING MESSAGE. FOR EACH R6 MESSAGE THE CURRENT R5 CUSTOMS
PROCESSING MESSAGE WILL BE RETURNED.
THREE OTHER AREAS SHOULD BE REVIEWED BY FILERS AND PROGRAMMERS PRIOR
TO FULL OASIS IMPLEMENTATION. FILERS MUST HAVE THE OGA CORRECTION
CAPABILITY ( "CP" APPLICATION). IN OASIS PORTS SHIPMENTS ARE NOT
RELEASED BY FDA IF THEY ARE IN A "REJECT" STATUS. FILERS MUST BE ABLE TO
CORRECT REJECTS. FILERS MUST ALSO HAVE THE CAPABILITY TO VOLUNTARILY SEND
FDA DATA FOR "UNFLAGGED" HARMONIZED NUMBERS. FILERS MUST ALSO HAVE THE
CAPABILITY TO REQUEST AND USE FDA ESTABLISHMENT NUMBERS (FEI NUMBERS).
SPECIFICATIONS FOR THESE APPLICATIONS ARE DETAILED IN THE CATAIR.
FILERS SHOULD CONTACT THEIR SOFTWARE SUPPLIER TO CONFIRM THAT ALL
CAPABILITIES LISTED ABOVE ARE AVAILABLE AND ARE FUNCTIONING PROPERLY.
PLEASE CONTACT YOUR ABI CLIENT REPRESENTATIVE IF YOU HAVE ANY
QUESTIONS.
USER SUPPORT SERVICES DIVISION
CUSTOMER ASSISTANCE BRANCH
OTHER GOVERNMENT AGENCIES BRANCH
CSMS #96-000334