| Title: | FDA BTA PN FOOD FACILITY REGISTRATION EXEMPTION REASONS |
|---|---|
| Date: | 2004-07-20 |
| To: | abi |
| Links: | previous, next |
ATTN ALL ABI FILERS, BROKERS, AND SOFTWARE VENDORS.
THE PRIOR NOTICE INTERIM FINAL RULE REQUIRES SUBMISSION OF A
REGISTRATION NUMBER FOR THE PRODUCER OF THE ARICLE OF FOOD UNLESS THE
FACILITY IS EXEMPT FROM REGISTRATION OR IF THE ARTICLE OF FOOD WAS
IMPORTED FOR "TRANSHIPMENT OR OTHER EXPORT". IF THE FACILITY IS EXEMPT,
THE "FME" (FOOD FACILITY REGISTRATION EXEMPTION) AFFIRMATION OF
COMPLIANCE CODE AND QUALIFIER SHOULD BE TRANSMITTED.
THE FOOD AND DRUG ADMINISTRATION IS MODIFYING THE QUALIFIERS FOR "FME"
TO INDICATE THE REASON FOR EXEMPTION. FILERS CAN BEGIN TO TRANSMIT THE
NEW QUALIFIERS BEGINNING AUGUST 13, 2004. TRANSMISSION OF THE EXISTING
"Y" QUALIFIER CAN CONTINUE UNTIL FILERS HAVE BEEN NOTIFIED OF AN END-
DATE. FILERS MAY WANT TO PROGRAM FOR TRANSMITSSION OF ANY ONE-DIGIT
ALPHA CHARACTER TO ACCOMMODATE ADDITIONAL EXEMPTION REASONS.
QUALIFIER QUALIFIER DESCRIPTION
A FACILITY IS OUT OF BUSINESS
B FACILITY IS PRIVATE RESIDENCE (21 CFR 1.227(B)(2))
C FACILITY IS A RESTAURANT (21 CFR 1.226(D); 1.227(B)(10))
D FACILITY IS RETAIL FOOD ESTABLISHMENT (21 CFR 1.226(C); 1.22
7(B) (11))
E FACILITY IS NON-PROCESSING FISHING VESSEL
(21 CFR 1.226(F)
F FACILITY IS NON-BOTTLED DRINKING WATER COLLECTION
AND DISTRIBUTION ESTABLISHMENT (21 CFR 1.227(B)(2))
G INDIVIDUAL GIFT - LABEL NAME/ADDRESS IN LIEU OF
REGISTRATION NUMBER (21 CFR 1.281(A)(6),(B)(5) AND (C)(6))
H GROWER - SATISFIES FARM EXEMPTION (21 CFR 1.226(B); 1.22
7(B) (3))
CONTACT YOUR CLIENT REPRESENTATIVE IF YOU HAVE QUESTIONS.