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Subject: END-DATE OF FME EXEMPTION REASON CODE "Y" FEB 1, 2005
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