CSMS Message: 96-000532

THE FOLLOWING INFORMATION IS PROVIDED TO ABI FILERS FILING ENTRIES
USING THE FDA INTERFACE. ALL QUESTIONS SHOULD BE DIRECTED TO
DENNIS LINSLEY OF THE FDA, AT 301 443 6553.

*** SCHEDULED CANCELLATION OF AFFIRMATION OF COMPLIANCE
*** 'CCC' ON 7/15/96.

CCIB CERTIFICATES ARE NO LONGER REQUIRED BY THE FDA FOR
CERAMIC WARE ENTRIES. AFFIRMATION CODE 'CCC' WILL BE
CANCELLED AND DELETED FROM ACS RECORDS ON 7/15/96, THUS, THE
'CCC' CODE WILL NOT BE ACCEPTED BY ACS AFTER THAT DATE.

USE OF THE AFFIRMATION OF COMPLIANCE 'CCC' AFTER THIS DATE
WILL CAUSE THE ENTRY TO BE REJECTED BY CUSTOMS.

*** NEW AFFIRMATION OF COMPLIANCE CODES

THE FOLLOWING AFFIRMATION OF COMPLIANCE CODES ARE NOW
AVAILABLE FOR USE WITH THE FDA DATA SET:

ERR - ENTRY REVIEW RECOMMENDED - QUALIFIER REQUIRED

THIS AFFIRMATION, WITH A REQUIRED QUALIFIER, CAN BE USED
WHEN A FILER BECOMES AWARE, PRIOR TO TRANSMITTING ENTRY
DATA, THERE IS A LEGITIMATE NEED FOR FDA TO EXAMINE THE
COMMODITIES IN AN ENTRY E.G., THE FILER HAS BEEN NOTIFIED
THAT REFRIGERATION FAILURE IN A TRUCK OR SHIP HAS CAUSED
DAMAGE TO A PARTIAL OR TOTAL SHIPMENT. TRANSMISSION OF THIS
CODE WILL GENERATE A 'FDA REVIEW' ON SCREENING AND ELIMINATE
THE NEED TO RETURN A SHIPMENT FOR FDA SAMPLING. THIS CODE
CAN ALSO BE USED, AT FDA'S REQUEST, IF A FILER IS ASKED TO
WITHDRAW AND RETRANSMIT AN ENTRY TO CORRECT AN ERRONEOUS MAY
PROCEED.

THE QUALIFIER (UP TO 20 CHARACTERS) SHOULD INDICATE THE
REASON THE CODE IS BEING TRANSMITTED, E.G., 'DAMAGED IN
SHIPMENT'.

UFC - UNACCEPTABLE TO FOREIGN COUNTRY - QUALIFIER REQUIRED

THIS AFFIRMATION, WITH A REQUIRED QUALIFIER, CAN BE USED
WHEN A FILER BECOMES AWARE, PRIOR TO TRANSMITTING ENTRY
DATA, A SHIPMENT OR PORTION OF A SHIPMENT HAS BEEN REJECTED
BY ANOTHER COUNTRY'S GOVERNMENT AGENCY. FDA MAY BE NOTIFIED
OF THIS REJECT FOR APPROPRIATE ACTION. TRANSMISSION OF THIS
CODE WILL GENERATE A "FDA REVIEW" ON SCREENING AND ELIMINATE
THE NEED TO RETURN SHIPMENT TO FDA FOR SAMPLING. IN
ADDITION THE USE OF THIS CODE WILL PREVENT THE NEED TO
WITHDRAW AN ENTRY TRANSMISSION AND RETRANSMIT THE ENTRY AT
FDA'S REQUEST.

THE QUALIFIER REQUIRED SHOULD INCLUDE THE IDENTIFICATION
REPORT NUMBER OF THE FOREIGN COUNTRY'S REJECT REPORT (UP TO
20 CHARACTERS).

IFE - IMPORTED FOR EXPORT - NO QUALIFIER

THIS AFFIRMATION ALLOWS FOR IMPORTATION OF FDA REGULATED
PRODUCTS UNDER THE NEW IMPORT FOR EXPORT PROVISIONS OF THE
FD&C ACT. THE ARTICLE MUST BE INCORPORATED, BY THE INITIAL
OWNER OR CONSIGNEE, (WHICH CAN BE SOMEONE OTHER THAN THE
IMPORTER OF RECORD) INTO A PRODUCT FOR EXPORT BY SUCH OWNER
OR CONSIGNEE FROM THE UNITED STATES IN ACCORDANCE WITH THE
PROVISIONS OF SECTION 801(3), AND/OR OTHER PROVISIONS OF THE
FD&C ACT.

NO QUALIFIER IS REQUIRED BUT QUANTITY AND VALUE MUST BE
TRANSMITTED WHEN USING THIS AFFIRMATION OF COMPLIANCE CODE.

*** REVISION OF AFFIRMATION DESCRIPTION

NDA - NEW DRUG APPLICATION NUMBER - QUALIFIER REQUIRED

THIS AFFIRMATION AND QUALIFIER IS THE NEW DRUG APPLICATION
NUMBER ISSUED BY FDA/CDER FOR THE PRODUCT IDENTIFIED IN THE
FDA LINE. A DRUG MAY BE "NEW" IF (1) IT CONTAINS A NEWLY
DEVELOPED CHEMICAL; (2) IT CONTAINS A CHEMICAL OR SUBSTANCE
NOT PREVIOUSLY USED IN MEDICINE; (3) THE DRUG HAS
PREVIOUSLY BEEN USED IN MEDICINE BUT NOT IN THE DOSAGES OR
CONDITIONS FOR WHICH THE SPONSOR NOW RECOMMENDS ITS USE; OR
(4) THE DRUG HAS BECOME RECOGNIZED BY QUALIFIED EXPERTS AS
SAFE AND EFFECTIVE FOR ITS INTENDED USES AS A RESULT OF
INVESTIGATIONAL STUDIES BUT HAS NOT OTHERWISE BEEN USED TO A
MATERIAL EXTENT OR FOR A MATERIAL TIME. A NEW DRUG CAN NOT
BE COMMERCIALLY MARKETED IN THE U.S. UNLESS IT HAS BEEN
APPROVED AS SAFE AND EFFECTIVE BY THE FDA BASED ON A NEW
DRUG APPLICATION.

THE QUALIFIER REQUIRED IS THE NDA NUMBER ASSIGNED TO THE
PRODUCT BY FDA.