CSMS Message: 00-000007

Title:NEW FDA AFFIRMATIONS OF COMPLIANCE
Date:2000-01-06
To:abi
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FDA IS ISSUING TWO NEW AFFIRMATIONS OF COMPLIANCE WHICH CAN BE USED
IMMEDIATELY. USE OF THE NEW CODES WILL BECOME MANDATORY 30 DAYS AFTER
RECEIPT OF THIS ADMINISTRATIVE MESSAGE.

FILERS CAN BEGIN TRANSMITTING A NEW AFFIRMATION OF COMPLIANCE (A OF C)
CODE TO INDICATE THAT SHIPMENTS OF PRODUCTS SUBJECT TO FDA IMPORT ALERT
99-24 (DETENTION WITHOUT PHYSICAL EXAMINATION OF HUMAN FOOD PRODUCTS AND
ANIMAL FEEDS CONTAMINATED WITH DIOXIN AND/OR PCB) ARE ACCOMPANIED BY A
HEALTH CERTIFICATE FROM BELGIUM. THE NEW CODE IS "DHC" (DIOXIN HEALTH
CERTIFICATE CODE). NO QUALIFIER IS REQUIRED. USE OF THIS CODE WILL
EXPEDITE FDA RELEASE OF THE SHIPMENT.

FILERS CAN ALSO BEGIN TRANSMITTING A NEW AFFIRMATION OF COMPLIANCE
A OF C) CODE TO INDICATE THAT SHIPMENTS OF CERAMICWARE ARE PRODUCED BY A
MANUFACTURER CERTIFIED AS PART OF A FDA/PROC MEMORANDUM OF UNDERSTANDING
(MOU). THE NEW A OF C CODE IS "CCC" (CHINESE CERAMICWARE FACTORY CODE).
THE CODE REQUIRES A QUALIFIER CONSISTING OF THE FACTORY CODE ASSIGNED TO
THE INDIVIDUAL MANUFACTURER. THIS CODE WILL HAVE TO BE OBTAINED FROM THE
MANUFACTURER BY THE FILER OR IT'S CLIENT. USE OF THIS CODE WILL EXPEDITE
FDA RELEASE OF THE SHIPMENT. PAPER CERTIFICATES (CCIB) WILL NO LONGER BE
USED IN FDA'S EVALUATION OF THESE ENTRIES.

QUESTIONS ON THE USE OF THESE AFFIRMATIONS CAN BE DIRECTED TO YOUR LOCAL
FDA OFFICE OR TO ANY MEMBER OF THE OASIS NATIONAL OPERATIONS STAFF AT
301-443-6553.