CSMS Message: 05-000098

TO: ALL ABI FILERS

FROM: FOOD & DRUG ADMINISTRATION

SUBJECT: END-DATE OF FME EXEMPTION QUALIFIER "Y" ON FEBRUARY 1, 2005

ON JULY 20, 2004, FILERS WERE NOTIFIED VIA ABI ADMINISTRATIVE MESSAGE
04-1667 THAT PRIOR NOTICE MANUFACTURER REGISTRATION "EXEMPTION" REASON
CODE "Y" WOULD BE END-DATED AND CONTINUED USE AFTER THAT END-DATE WOULD
CAUSE REJECTION OF PRIOR NOTICE SUBMISSIONS

THIS QUALIFIER TO THE FME AFFIRMATION OF COMPLIANCE CODE WILL BE
END-DATED EFFECTIVE FEBRUARY 1, 2005.

IF A MANUFACTURER'S REGISTRATION NUMBER IS NOT PROVIDED BECAUSE THE
MANUFACTURER IS EXEMPT FROM REGISTRATION OR THERE IS A VALID REASON WHY
A MANUFACTURER'S REGISTRATION NUMBER IS NOT BEING PROVIDED, ONE OF THE
FOLLOWING EXEMPTION OR REASON CODES MUST BE USED AS A QUALIFIER TO THE
FME AFFIRMATION OF COMPLIANCE CODE. AS PREVIOUSLY ANNOUNCED VIA ABI
ADMINISTRATIVE MESSAGE THE VALID FME QUALIFIER EXEMPTION/REASON CODES
INCLUDE:

FME QUALIFIER CODES

EXEMPTION CODES A - J

A. FACILITY IS OUT OF BUSINESS
B. FACILITY IS A PRIVATE RESIDENCE
C. FACILITY IS A RESTAURANT
D. FACILITY IS A RETAIL FOOD ESTABLISHMENT
E. FACILITY IS NONPROCESSING FISHING VESSEL
F. FACILITY IS NONBOTTLED DRINKING WATER COLLECTION AND DISTRIBUTION
ESTABLISHMENT
G. INDIVIDUAL GIFT LABEL NAME/ADDRESS IN LIEU OF REGISTRATION NUMBER
H. GROWER SATISFIES FARM EXEMPTION (21 CFR 1.226(B); 1.227(B)(3)
I. SAMPLES - QUALITY ASSURANCE, RESEARCH OR ANALYSIS PURPOSES ONLY
J. U.S. MANUFACTURING FACILITY THAT IS NOT REQUIRED TO REGISTER

REASON CODES K - O
K. UNABLE TO DETERMINE THE REGISTRATION NUMBER OF THE MANUFACTURER
L. UNABLE TO DETERMINE IDENTITY OF MANUFACTURER - PROVIDING IDENTITY
OF MANUFACTURER'S HEADQUARTERS
M. UNABLE TO DETERMINE IDENTITY OF MANUFACTURER OR HEADQUARTERS -
PROVIDING INVOICING FIRMS IDENTITY
O. GIFT PACK FOR NON-BUSINESS PURPOSES - PROVIDING SINGLE PRIOR
NOTICE AND IDENTITY OF PACKER

THE FOOD & DRUG ADMINISTRATION

Referenced By

CSMS #05-000110