CSMS Message: 96-001004

FDA WISHES TO REMIND FILERS THAT, EFFECTIVE ECEMBER 2, 1996,
TRANSMISSION OF FDA DATA ELEMENTS WILL BE MANDATORY FOR ALL ABI
TRANSMISSIONS OF ENTRY DATA AND ENTRY SUMMARY DATA FOR LINE RELEASE
ENTRIES FOR FDA REGULATED PRODUCTS (I.E. PRODUCTS FLAGGED "FD2"
OR "FD1" IN THE ACS HARMONIZED TARIFF FILE.) FAILURE TO TRANSMIT FDA
DATA IN THE PROPER FORMAT WILL RESULT IN AN ENTRY REJECT BY THE ABI
EDITS. THE FOLLOWING INFORMATION IS PRIMARILY DIRECTED TO FILERS WHO
HAVE NOT YET ATTENDED FDA TRAINING ON ELECTRONICALLY TRANSMITING FDA
DATA THROUGH ABI. FILERS WHO HAVE COMPLETED TRAINING, AND CONTINUE
TO MAINTAIN FDA "PAPERLESS" STATUS, WILL CONTINUE TO RECEIVE OFFICIAL
FDA ENTRY DECISIONS ELECTRONICALLY THROUGH ABI AND ARE NOT REQUIRED
TO ROUTINELY SUBMIT PAPER ENTRY DOCUMENTS FOR ALL ENTRIES. FILERS
CURRENTLY IN "DUAL FILING" MODE REMAIN SO UNTIL NOTIFIED BY FDA THAT
THEY HAVE ACHIEVED "PAPERLESS" STATUS.

FILERS WHO HAVE NOT ATTENDED FDA ENTRY DATA TRAINING, AND WHO SUBMIT
ENTRY DATA ELECTRONICALLY THROUGH ABI BEGINNING DECEMBER 2, 1996 WILL
ALSO BE REQUIRED TO SUBMIT PAPER ENTRY DOCUMENTS (GENERALLY TWO
COPIES OF CF 3461, CF 3461/ALT, OR CF 7501, INVOICES, AND ANY
PRODUCT SPECIFIC DOCUMENTS SUCH AS FDA 2877, ETC.) TO FDA AT TIME OF
ENTRY.

NOTE: ALL FDA ENTRY STATUS MESSAGES I.E. "MAY PROCEED" OR "FDA
REVIEW" RETURNED VIA ABI TO FILERS NOT APPROVED FOR "PAPERLESS"
FDA FILING WILL NOT BE OFFICIAL FDA DETERMINATIONS ON THE ADMISSIBILITY
OF THOSE ENTRIES.

THOSE ADMISSIBILITY DETERMINATIONS WILL BE MADE BY FDA ONLY AFTER
REVIEWING THE PAPER ENTRY DOCUMENTS. THE RESULTS OF FDA'S REVIEW
WILL BE COMMUNICATED TO FILERS VIA THE USUAL FDA PAPER NOTICES.
FDA HAS OFFERED, AND CONTINUES TO OFFER, TRAINING TO FILERS IN
THE TRANSMISSION OF FDA DATA THROUGH ABI. UNTIL FILERS HAVE
COMPLETED SUCH TRAINING, THEIR ELECTRONIC ENTRIES WILL NOT BE
EVALUATED FOR ACCURACY, AND THEREFORE, THEY WILL REMAIN IN THE
"DUAL FILER MODE" INDEFINITELY. THIS WILL REQUIRE BOTH THE
FILING OF PAPER DOCUMENTS AND THE TRANSMISSION OF ELECTRONIC DATA
FOR EACH ENTRY. IN ORDER TO HELP FILERS REACH "PAPERLESS" STATUS
AS SOON AS POSSIBLE, FDA URGES FILERS TO CONTACT THEIR LOCAL FDA
OFFICE TO ARRANGE TO ATTEND FDA TRAINING IMMEDIATELY.

QUESTIONS SHOULD BE DIRECTED TO JOE MCCALLION, DIVISION OF IMPORT
OPERATIONS AND POLICY, FDA AT (301) 443-6553.