CSMS Message: 95-000063

PROJECT: FDA PRODUCT CODE UPDATE QUERY

THIS PROJECT WILL ALLOW ABI FILERS TO RECEIVE UPDATES TO THEIR
FDA PRODUCT CODE BUILDER THROUGH ACS. THE PRODUCT CODE BUILDER
WAS CREATED BY FDA TO ASSIST ABI FILERS IN SUPPLYING THE CORRECT
FDA PRODUCT CODE IN THEIR ELECTRONIC TRANSMISSION. THE PRODUCT
CODE BUILDER RUNS ON A PERSONAL COMPUTER AND IS INDEPENDENT OF ABI.

THIS QUERY SHOULD NOT BE CONFUSED WITH THE ORIGINAL PRODUCT CODE
QUERY APPLICATION 'NP'. THE 'NP' QUERY CAPABILITY IS FOR A QUERY
OF THE PRODUCT CODE FILE RESIDENT IN ACS WHICH ONLY CONTAINS THE
PRODUCT CODE NUMBER AND A DESCRIPTION. ACS WILL CONTINUE TO
SUPPORT THE 'NP' QUERY. THE NEW ABI QUERY DESCRIBED IN THIS MESSAGE
IS BEING CREATED TO PERMIT ABI FILERS TO OBTAIN FDA PRODUCT CODE
"UPDATES" IN ORDER TO KEEP THEIR PRODUCT CODE BUILDER FILES CURRENT.

AT EVERY FDA PRODUCT CODE TRAINING SESSION HELD IN THE LOCAL PORTS,
FDA DISTRIBUTED THE PRODUCT CODE BUILDER PROGRAM DISKETTE TO
EACH ATTENDEE. DUE TO ADDITIONS, DELETIONS AND CHANGES
TO THE PRODUCT CODE SYSTEM, THE NEED TO UPDATE THIS DISK HAS
ARISEN. FROM A LOGISTICAL STANDPOINT, IT IS NOT PRUDENT FOR FDA
TO GENERATE A LIST AND MAIL UPDATED VERSIONS OF THE PRODUCT CODE
DISK TO ALL USERS. ACS WILL PROVIDE A NEW ABI QUERY WHICH
WILL ALLOW THE FILER TO RECEIVE FDA UPDATES TO THEIR PRODUCT CODE
BUILDER.

THE ACS/FDA PROJECT TO PROVIDE UPDATES TO THE FDA PRODUCT CODE
BUILDER IS VOLUNTARY FOR ALL PARTICIPATING ABI FILERS. IT IS
NOT MANDATORY. ONCE THE NEW PROGRAMMING IS IMPLEMENTED, FDA
INTERFACE FILERS MAY BEGIN USING THE NEW QUERY APPLICATION.

CUSTOMS AND FDA ANTICIPATE THAT THERE WILL BE APPROXIMATELY
ONE UPDATE PER MONTH, BUT THIS IS ONLY AN ESTIMATE. THIS QUERY
CAPABILITY SHOULD BE AVAILABLE ON OR ABOUT FEBRUARY 1, 1995.
AN ADMININISTRATIVE MESSAGE WILL BE ISSUED WHEN THIS PROJECT HAS
MOVED INTO ACS PRODUCTION AND FILERS MAY THEN BEGIN QUERYING THESE
PRODUCT CODE UPDATES FROM ABI.

IMPORTANT:
----------- FDA CREATED THE PRODUCT CODE BUILD SOFTWARE.
ACS WILL ACT STRICTLY AS A CONDUIT FOR FILERS
TO RECEIVE THIS UPDATE INFORMATION. THE DATA
CONTAINED IN THESE UPDATES IS FORMATTED BY FDA FOR THE
PURPOSE OF UPDATING THE PRODUCT CODE BUILDER PROGRAM.
FDA WILL PROVIDE THE UPDATES IN AN 80 CHARACTER DATA
FORMAT AND ACS WILL ALLOW THE FILERS TO QUERY AND RECEIVE
EACH UPDATE.

THE FOLLOWING INSTRUCTIONS ARE A COLLABORATION BETWEEN US CUSTOMS
AND FDA. THESE INSTRUCTIONS WILL ASSIST IN UPDATING THE FDA
PRODUCT CODE BUILDER FILES WITH THE NEW UPDATE INFORMATION RECEIVED
THRU ABI.

NOTE:

FILERS SHOULD BE AWARE THAT SOME OF THE FOLLOWING INSTRUCTIONS
ARE INTENDED FOR SOFTWARE VENDORS OR THOSE FILERS WHO DO THEIR
OWN IN-HOUSE SOFTWARE PROGRAMMING. CUSTOMS DOES NOT EXPECT
EVERY ABI FILER TO PERFORM THE FOLLOWING INSTRUCTIONS
UNLESS THEY HAVE THE NECESSARY PROGRAMMING BACKGROUND TO DO SO.
CUSTOMS EXPECTS THAT THE MAJORITY OF FILERS WILL REQUIRE THEIR
SOFTWARE VENDORS TO PROVIDE THE NECESSARY PROGRAMMING.

UPDATE INSTRUCTIONS
-------------------

- ACS WILL STORE ALL THE CHANGES, ADDITIONS AND DELETIONS MADE TO
FDA PRODUCT CODES SINCE MARCH OF 1994. ABI FILERS WILL USE THE
NEW 'MJ' APPLICATION QUERY TO RECEIVE THESE UPDATES. ONCE THE FILER
HAS QUERIED AN UPDATE BY A SPECIFIC DATE, THE UPDATE INFORMATION
WILL BE PROVIDED IN THE NEW OUTPUT RESPONSE OF 'ML'. SEE NEW
ABI SPECIFICATIONS BELOW. THE UPDATE INFORMATION IS IN 80
CHARACTER FORMAT AND HAS NOT BEEN ALTERED BY ABI. THE ABI FILER
SHOULD CAPTURE THIS DATA IN A TEXT FILE. IF POSSIBLE, THE A-B-Y-Z
RECORDS SHOULD BE STRIPPED. IF THIS IS NOT POSSIBLE, DO NOT BE
CONCERNED. THE FDA UPDATE PROGRAM IN THE PC WILL IGNORE THESE
RECORDS. THE TEXT FILE SHOULD BE NAMED WITH THE CALENDAR YEAR AND
DATE OF THE UPDATE WHICH WAS QUERIED, ALONG WITH THE EXTENSION OF
PCB. THE FILE NAME WILL CHANGE WITH EACH UPDATE RECEIVED.
(EXAMPLE: 19950125.PCB)

IT IS BEST IF THE PC FILE IS STORED IN THE SAME DIRECTORY AS THE
FDA PRODUCT CODE UPDATE SOFTWARE WAS ORIGINALLY INSTALLED.
IF THE PC FILE IS NOT IN THAT DIRECTORY, THEN EITHER MOVE THE FILE
TO THE INSTALLATION DIRECTORY OR IDENTIFY THE DRIVE AND
DIRECTORY ALONG WITH THE FILE NAME TO THE PRODUCT CODE
SOFTWARE. FOR EXAMPLE, USE C:\TEMP\19950125.PCB IF THE PRODUCT
CODE UPDATE FILE IS IN THE TEMP DIRECTORY OF THE C DRIVE.

TO UPDATE THE FDA PRODUCT CODE FILES, GO TO THE 'CONTROL'
MENU OPTION, CLICK ON THE 'UPDATE' OPTION. THERE ARE 2 TYPES OF
UPDATE OPTIONS:
(*) UPDATE ONLY
( ) COMPLETE DATABASE RELOAD

FILERS WILL USE THE 'UPDATE ONLY' OPTION FOR THE UPDATES FROM ABI.
THE 'COMPLETE DATABASE RELOAD' OPTION DELETES THE ENTIRE DATABASE
THEN RELOADS IT, SIMILIAR TO THE ORIGINAL INSTALLATION OF THE
PRODUCT CODE BUILDER. ALL THE PRODUCT CODE UPDATES WOULD THEN HAVE
TO BE QUERIED AGAIN. VERY SELDOM, IF EVER, SHOULD THE 'COMPLETE
DATABASE RELOAD' OPTION BE USED.

INPUT THE NEW TEXT FILE NAME INTO THE 'UPDATE FILE' FIELD AND HIT
ENTER. REMEMBER THAT YOU MUST INCLUDE THE DRIVE AND DIRECTORY
IF THE FILE IS NOT STORED IN THE SAME DIRECTORY AS THE SOFTWARE
WAS INSTALLED. THIS WILL UPDATE THE FDA PRODUCT CODE BUILDER FILES
WITH CURRENT INFORMATION.

(NEW) PRODUCT CODE UPDATE QUERY

APPLICATION IDENTIFIER = MJ (INPUT)
-----------------------------------

++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
+ DATA + LENGTH/+ + + +
+ ELEMENT + CLASS + POSITION + STATUS + DESCRIPTION +
====================================================================
+ CONTROL + + + + +
+ IDENTIFIER+ 2A + 1-2 + M + MUST ALWAYS EQUAL FD +
++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
+ RECORD + + + + +
+ TYPE + 2N + 3-4 + M + MUST ALWAYS EQUAL 61 +
++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
+ QUERY + + + + +
+ DATE + 8N + 5-12 + M + INPUT DATE - +
+ + + + + QUERY WILL RETURN ALL +
+ + + + + UPDATES FROM THE INPUT +
+ + + + + DATE TO THE PRESENT DATE+
+ + + + + DATE = YYYYMMDD +
+ + + + + TO RETRIEVE ALL UPDATES +
+ + + + + USE '00000000' +
+ + + + + +
++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
+ FILLER + 68AN + 13-80 + C + SPACE FILL +
+ + + + + +
+ + + + + +
+ + + + + +
+ + + + + +
+ + + + + +
+ + + + + +
+ + + + + +
+ + + + + +
+ + + + + +
++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

NOTE: THE NARRATIVE MESSAGE OF "NO RECORDS FOR QUERY DATE"
WILL BE GENERATED WHEN THE QUERY DATE IS:

1) GREATER THAN THE CURRENT DATE
2) THE CURRENT DATE
3) A DATE IN THE PAST BUT ONE WHERE THERE HAVE BEEN NO
UPDATES BETWEEN THAT DATE AND THE PRESENT DATE.

APPLICATION IDENTIFIER = ML (OUTPUT)
------------------------------------

++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
+ DATA + LENGTH/+ POSITION + STATUS +DESCRIPTION +
+ ELEMENT + CLASS + + + +
====================================================================
+ RECORD + + + + +
+ TYPE + 2AN + 1-2 + M + FDA RECORD UPDATE TYPES +
+ + + + + - THERE ARE 10 POSSIBLE +
+ + + + + RECORD TYPES +
+ + + + + +
+ + + + + * SEE NOTE 1 +
++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
+ FDA + + + + +
+ PRODUCT + 78X + 3-80 + M + FDA PRODUCT CODE UPDATE +
+ CODE + + + + INFORMATION; RECEIVED +
+ UPDATE + + + + FROM FDA IN CURRENT +
+ DATA + + + + FORMAT. SEE ABOVE +
+ + + + + INSTRUCTIONS FOR THE +
+ + + + + PROPER METHOD TO UPDATE +
+ + + + + THE FDA PRODUCT CODE +
+ + + + + BUILDER. +
+ + + + + +
+ + + + + +
+ + + + + +
++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

NOTES:
------- 1) OUTPUT DATA DOES NOT CONTAIN A CONTROL IDENTIFIER
IN POSITIONS 1-2. RECORD TYPE (POSITION 1-2) CAN
BE 1 OUT OF 10 POSSIBLE TYPES. THESE RECORD TYPES
ARE PART OF THE DATA USED TO UPDATE THE PRODUCT CODE
BUILDER. NO ACTION REQUIRED FOR RECORD TYPES.

POSSIBLE RECORD
TYPES => 1) C1 6) G2
2) D1 7) M1
3) EI 8) N1
4) F1 9) S1
5) G1 10) T1

POSSIBLE ERROR CODES FOR THE 'MJ' QUERY:

- 'AI8' = INPUT FIELDS ARE BLANK
- '1M5' = INVALID DATA ENTERED
- 'EC6' = INVALID DATE

POINTS TO REMEMBER:

1) AN ADMIN MESSAGE WILL BE ISSUED EVERY TIME FDA TRANSMITS A
PRODUCT CODE UPDATE TO ACS. THIS ADMIN WILL INFORM THE ABI
FILERS THAT AN UPDATE HAS BEEN ISSUED AND SHOULD BE QUERIED
THRU ABI BY THE DATE LISTED ON THE ADMIN MESSAGE. ALL FDA
PRODUCT CODE UPDATES WILL BE QUERIED BY A DATE FIELD.

2) IT IS IMPORTANT TO KEEP TRACK OF THE UPDATES ISSUED BY FDA.
IF A NUMBER OF UPDATES HAVE BEEN MISSED, FILERS HAVE THE OPTION
OF INPUTTING A DATE FIELD OF '00000000' TO RETRIEVE ALL UPDATES
WHICH HAVE BEEN ISSUED.

3) THE DATE FIELD USED IN THE 'MJ' QUERY WILL PROVIDE ALL FDA
UPDATES FROM THE DATE SELECTED, UP TO THE PRESENT DATE.

4) THESE ABI QUERIES WILL PROCESS ON DEFERRED TIME SCHEDULING,
WHICH MEANS THEY WILL RUN AT NIGHT AND RESULTS WILL BE PROVIDED
AT THAT TIME. NO IMMEDIATE RESULTS WILL BE GENERATED TO THE
ABI FILER UNLESS THE QUERY IS SUBMITTED TO ABI IMMEDIATELY
BEFORE DEFERRED QUERIES BEGIN PROCESSING.

5) THIS QUERY OF THE PRODUCT CODE UPDATE IS DIFFERENT FROM THE
CURRENT PRODUCT CODE QUERY (APPLICATION NP). THE 'NP' PRODUCT
CODE QUERY IS A QUERY OF THE PRODUCT CODE NUMBER AND DESCRIPTION
RESIDENT IN ACS.

6) USE THE CORRECT DATE(S) DESCRIBED ABOVE WHEN DOING THIS QUERY.
IT IS IMPORTANT TO KEEP TRACK OF ALL THE ANNOUNCED PRODUCT
CODE UPDATES. IF ONE OR MORE UPDATES ARE MISSED OR
NOT QUERIED, A QUERY DATE OF ONE DAY IN THE FUTURE FROM THE
LAST KNOWN UPDATE WILL PROVIDE ALL THE UPDATES WHICH HAVE BEEN
ISSUED FROM THAT POINT, TO THE PRESENT DATE. THIS SHOULD NOT
BECOME STANDARD PRACTICE, HOWEVER, SINCE IT WILL RESULT IN FILERS
CONSTANTLY RECEIVING DUPLICATE DATA (OLD UPDATES).

7) IF PROBLEMS ARISE ON THE ABI QUERY PORTION OF THIS PROCEDURE
PLEASE CONTACT YOUR CLIENT REP. IF PROBLEMS ARISE CAPTURING THE
FILE AND UPDATING YOUR PRODUCT CODE BUILDER, CONTACT EITHER YOUR
SOFTWARE VENDOR OR THE FDA CONTACT, ANNA COLANDREO (301)443-7466.

Referenced By

CSMS #96-000879, 95-000121