CSMS Message: 94-000378

THE INFORMATION BELOW PERTAINS TO FDA'S EXPANSION PROCESS TO THE
SCHEDULED PORTS LISTED RECENTLY IN ADMIN # 94-0350 DATED 4/8/94.

IT IS EVIDENT THAT THE ABI FILERS IN EACH FDA EXPANSION PORT ARE
PROVIDING AS MUCH FDA INFORMATION AS POSSIBLE TO ASSIST THE FOOD
AND DRUG ADMINISTRATION IN ACHIEVING A SUCCESSFUL EXPANSION OF
THEIR INTERFACE WITH CUSTOMS. AT THE PRESENT TIME, FDA HAS EXPANDED
TO SAVANNAH AND ATLANTA, MIAMI, AND MOST RECENTLY TO SAN FRANCISCO
ON APRIL 11. THE NEXT SCHEDULED PORT IS PHILADELPHIA, PA ON
APRIL 25TH. THESE PORTS ARE IN ADDITION TO THE FULLY OPERATIONAL
FDA INTERFACE IN SEATTLE, PORTLAND AND BLAINE, WA.

THERE ARE ONLY FIVE FDA DATA ELEMENTS WHICH ARE MANDATORY FOR THE
ABI FILER TO TRANSMIT. SEE ADMIN # 92-0423. IF THE FILER OPTS
TO SEND ADDITIONAL FDA DATA ELEMENTS, ABI WILL EDIT AND VALIDATE THOSE
ELEMENTS. IF INCORRECT OR INVALID, ABI WILL REJECT THEM. TWO OF
THE CONDITIONAL FDA DATA ELEMENTS THAT ARE CAUSING FILERS SOME
DIFFICULTY ARE THE "FDA UNIT OF MEASURE" AND THE "FDA ESTABLISHMENT
NUMBER". THEY ARE ADDRESSED BELOW:

1) "701: UOM INVALID/UNKNOWN" - IT IS IMPORTANT TO REALIZE THAT FDA
------------------------- AND CUSTOMS HAVE SIMILIAR UNITS OF
MEASURE (UOM). HOWEVER, THEY ARE NOT IDENTICAL. FDA ALSO
USES A STRUCTURED HIERARCHY IN REPORTING THESE UOM. IF ONLY
ONE FDA UOM IS USED, IT MUST BE ONE OF THE "BASE UNITS OF
MEASURE". ANY INVALID UOM WILL BE REJECTED BY ABI. IF YOU
ELECT TO TRANSMIT MORE THAN ONE UOM PER PRODUCT, VALID CONTAINER
CODES MUST BE REPORTED FIRST, WITH A "BASE UNIT OF MEASURE"
BEING REPORTED LAST. ONLY ONE "BASE UNIT OF MEASURE" CAN BE USED
PER FDA LINE ITEM.

BASE UNITS OF MEASURE *
---------------------------

UNIT TYPE CODE UNIT
------------ ---- ---------------------
VOLUME BBL BARRELS (42 GALLON EA)
DOSAGE BOL BOLUSES
DOSAGE CAP CAPSULES
WEIGHT CAR CARATS
VOLUME CFT CUBIC FEET
WEIGHT CG CENTIGRAMS
LENGTH CM CENTIMETERS
VOLUME CM3 CUBIC CENTIMETERS
VOLUME CYD CUBIC YARDS
COUNT DOZ DOZEN
COUNT DPC DOZEN PIECES
COUNT DPR DOZEN PAIRS
VOLUME FOZ OUNCES, FLUID
LENGTH FT FEET
WEIGHT G GRAMS
VOLUME GAL GALLONS (US)
COUNT GR GROSS
WEIGHT KG KILOGRAMS
LENGTH KM KILOMETERS
AREA KM2 1,000 SQUARE METERS
VOLUME KM3 1,000 CUBIC METERS
VOLUME L LITERS
WEIGHT LB POUNDS, WEIGHT (AVDP)
LENGTH LNM LINEAR METERS
LENGTH M METERS
AREA M2 SQUARE METERS
VOLUME M3 CUBIC METERS
WEIGHT MG MILLIGRAMS
VOLUME ML MILLILITERS
COUNT NO NUMBER
WEIGHT OZ OUNCES, WEIGHT (AVDP)
COUNT PCS PIECES
COUNT PRS PAIRS
VOLUME PTL PINTS, LIQUID (US)
VOLUME QTL QUARTS, LIQUID (US)
AREA SFT SQUARE FEET
AREA SQI SQUARE INCHES
WEIGHT STN SHORT TON (2000 LB)
DOSAGE SUP SUPPOSITORIES
AREA SYD SQUARE YARDS
WEIGHT T METRIC TON
DOSAGE TAB TABLETS
WEIGHT TON LONG TON (2240 LB)
WEIGHT TOZ OUNCES, TROY OR APOTH
LENGTH YD YARDS

* THIS INFORMATION WAS PROVIDED TO CUSTOMS BY THE FOOD AND DRUG
ADMINISTRATION. VALID CONTAINER CODES USED BY FDA ARE THE SAME
CODES LISTED IN APPENDIX B OF THE CATAIR UNDER THE HEADING OF
"SHIPPING/PACKAGING UNIT CODES", WITH TWO CHANGES. THEY ARE
CONTAINER CAGE = CAG AND THE CONTAINER KEG = KEG.
PLEASE NOTE: INVALID CONTAINER CODES WILL BE REJECTED BY THE SYSTEM.

2) FDA ESTABLISHMENT IDENTIFIER (FEI) - THIS DATA ELEMENT IS THE
---------------------------------- "SHIP TO" ADDRESS OF THE
FDA CONSIGNEE. THIS IS NOT A MANDATORY DATA ELEMENT. THIS
DATABASE IS RESIDENT IN FDA, NOT ACS. IF YOU NEED TO QUERY OR
ADD A NEW FEI #, THIS IS DONE BY TRANSMITTING THE NAME AND
ADDRESS TO ACS. ACS PASSES THIS INFORMATION TO FDA AND THEY
ASSIGN A NEW FEI NUMBER. ACS ONLY KEEPS THE VALID FEI NUMBER
ON FILE. FEI NUMBERS ARE ASSIGNED TO U.S. DOMESTIC FIRMS ONLY.

THE MOST COMMONLY REPORTED PROBLEM WHICH RELATES TO THE
FEI NUMBER IS WHEN THE FILER HAS TRANSMITTED AN ULTIMATE
CONSIGNEE NUMBER WHICH HAS A FOREIGN ADDRESS. FDA AUTOMATICALLY
REJECTS THESE ENTRIES WITH THE MESSAGE BEING RETURNED TO THE
FILER OF "FD DATA REJECTED". IF THIS OCCURS, THE FILER CAN USE
THE OTHER GOV'T AGENCY CORRECTION CAPABILITY (CP) TO TRANSMIT THE
FEI NUMBER FOR THE "SHIP TO" ADDRESS FOR THE DOMESTIC CONSIGNEE.
IF, PRIOR TO THE TRANSMISSION OF THE ENTRY, THE FILER IS AWARE THAT
THE ULTIMATE CONSIGNEE HAS A FOREIGN ADDRESS, THE FILER CAN INCLUDE
THE FEI NUMBER WITH HIS OR HER FDA DATA WHICH WILL ELIMINATE FDA'S
REJECTION OF THE ENTRY.

THE FEI NUMBER IS NOT A MANDATORY FDA DATA ELEMENT AND ONLY
NEEDS TO BE USED IN CERTAIN SITUATIONS.