CSMS Message: 04-002171

TO: ALL ABI FILERS OF PRIOR NOTICE DATA

FROM: THE FOOD & DRUG ADMINISTRATION

IN AUGUST FDA IMPLEMENTED ADDITIONAL PRIOR NOTICE EDITS AND
FILERS ARE EXPERIENCING AN INCREASED NUMBER OF REJECTS. THE LEADING
CAUSE OF REJECTS IS FAILURE TO SUBMIT PRIOR NOTICE (PN) DATA WHEN
REQUIRED. THE SECOND LEADING CAUSE IS INAPPROPRIATE DISCLAIM OF PRIOR
NOTICE WHEN THE FOOD PRODUCT REQUIRES PRIOR NOTICE.

PRIOR NOTICE CAN BE SUBMITTED IN ONE OF THE FOLLOWING WAYS:

FILERS CAN SUBMIT THE ADDITIONAL PN DATA ELEMENTS FOR EACH LINE WITHIN
A CONSUMPTION ENTRY THAT IS SUBJECT TO PRIOR NOTICE.

FILERS CAN SUBMIT IN-BOND ENTRIES VIA CBP'S ABI "WP" TRANSACTION. THEY
WILL RECEIVE A PRIOR NOTICE CONFIRMATION NUMBER AND THAT NUMBER CAN THEN
BE TRANSMITTED AS AN AFFIRMATION OF COMPLIANCE CODE WHEN SUBMITTING A
CONSUMPTION ENTRY FOR THE FOOD PRODUCT.

ANYONE CAN FILE PRIOR NOTICE VIA FDA'S WEB-BASED PRIOR NOTICE SYSTEM
INTERFACE (PNSI) AND THEY WILL RECEIVE A PRIOR NOTICE CONFIRMATION
NUMBER. THAT NUMBER CAN THEN BE TRANSMITTED AS AN AFFIRMATION OF
COMPLIANCE CODE WHEN SUBMITTING A CONSUMPTION ENTRY FOR THE ARTICLES
OF FOOD.

CBP (ABI/ACS) DETERMINES IF PRIOR NOTICE DATA IS REQUIRED BASED ON THE
OTHER GOVERNMENT AGENCY (OGA) FLAG ON THE HTS (HARMONIZED
TARIFF SCHEDULE). THE RULES ARE AS FOLLOWS:

FD4 PRIOR NOTICE (PN) DATA IS REQUIRED, FDA ADMISSIBILITY DATA (801(A))
IS REQUIRED.

FD3 PN MAY BE REQUIRED OR DISCLAIMED, 801(A) MAY BE REQUIRED OR
DISCLAIMED.

FD2 PN MAY BE REQUIRED , 801(A) IS REQUIRED.

FD1 PN MAY BE REQUIRED, 801(A) MAY BE REQUIRED OR DISCLAIMED.

FD0 NO 801(A) OR PN DATA ACCEPTED.

NO FLAG SHOULD SUBMIT 801(A) AND/OR PN IF APPROPRIATE.

SINCE THERE IS NOT ALWAYS A SIMPLE RELATIONSHIP BETWEEN PRODUCT
CODES AND HTS CODES, FDA'S OASIS SYSTEM IS PROGRAMMED TO EDIT FOR PRIOR
NOTICE REQUIREMENTS BASED ON THE PRODUCT CODE SUBMITTED. AS A RESULT
WE HAVE A NUMBER OF SITUATIONS WHERE FILERS ARE SUBMITTING AN ENTRY AND
ARE NOT PROVIDING PRIOR NOTICE DATA OR ARE TRANSMITTING A DISCLAIM "PND"
AFFIRMATION OF COMPLIANCE CODE BUT THE PRODUCT CODE REQUIRES PRIOR
NOTICE. IN THOSE CASES, FDA IS SENDING A REJECT BACK TO ABI AND
ULTIMATELY THE FILER RECEIVES A LINE LEVEL REJECT WITH A REASON CODE.
MOST PRODUCT CODES ARE STRAIGHTFORWARD HOWEVER THERE ARE SOME INDUSTRY
CODES WHERE CERTAIN PRODUCT CODES REQUIRE PN (AND WILL CAUSE A REJECT
IF NOT SENT) AND OTHERS DO NOT.

IN THE CASE OF INDUSTRY 50 THE PRIOR NOTICE REQUIREMENTS ARE ONLY
APPLICABLE TO TWO PRODUCT CODES:

50A--01 COLOR FOR FOODS, DRUGS AND COSMETICS (FD&C) (CERTIFIED)
50B--01 COLOR FOR FOOD (NOT CERTIFIED)

IN THE CASE OF INDUSTRY 54, THE PRIOR NOTICE REQUIREMENT IS DETERMINED
BY THE PRODUCT CODE SUBCLASS. THE FOLLOWING SUBCLASSES REQUIRE PN:

A ENRICHED HUMAN FOODS
B HUMAN FOOD DIETARY SUPPLEMENT 1 INGREDIENT
C HUMAN FOOD DIETARY SUPPLEMENT MULTI INGREDIENTS
L ENRICHED ANIMAL FOODS
M ANIMAL DIET SUPPLEMENTS
Y NOT ELSEWHERE CLASSIFIED (NEC)

THE FOLLOWING DO NOT REQUIRE PN:

D HUMAN N/RX 1 INGREDIENT
E HUMAN N/RX COMBINED INGREDIENT
F HUMAN RX 1 INGREDIENT
G HUMAN RX COMBINED INGREDIENT
I INVESTIGATIONAL
N ANIMAL N/RX DRUG
R ANIMAL RX DRUG

WE HAVE ALSO SEEN MANY REJECTS FOR NO PRIOR NOTICE SUBMITTED FOR
ARTICLES OF FOOD WITH U.S. GOODS RETURNED TARIFF CLASSIFICATIONS.
PLEASE REFER TO ABI ADMINISTRATIVE MESSAGE 04-2093, SEPTEMBER 27, 2004
FOR INFORMATION ON HTS 9801001097 (OTHER AMERICAN GOODS RETURNED). IF
PRODUCTS WHICH FALL UNDER THIS HTS ARE NOT SUBJECT TO PRIOR NOTICE,
THIS CODE REQUIRES A "PND" DISCLAIMER. IF THE PRODUCT REQUIRES PRIOR
NOTICE THE FDA COUNTRY OF PRODUCTION (US) DOES NOT CHANGE THIS
REQUIREMENT. FAILURE TO SEND PRIOR NOTICE DATA WILL RESULT IN
A FDA REJECT.

ANOTHER CAUSE OF FDA REJECTS IS THE USE OF AN EXPIRED OR CANCELLED
PRIOR NOTICE CONFIRMATION NUMBER (PNC). IF YOU RECEIVE THIS REJECT,
THE FILER MUST CONTACT THE SUBMITTER OF THE PRIOR NOTICE TO DETERMINE
WHY IT WAS EXPIRED OR CANCELLED. IN EITHER CASE NEW PRIOR NOTICE MUST
BE FILED. THE ENTRY THEN WOULD HAVE TO BE CORRECTED USING THE ABI
OTHER GOVERNMENT AGENCY CORRECTION (CP) TRANSACTION WITH THE CORRECT,
CURRENT PRIOR NOTICE CONFIRMATION NUMBERS.

THE FOOD & DRUG ADMINISTRATION