| Title: | INVALID FDA FME INDICATORS "N" & "Y" |
|---|---|
| Date: | 2005-02-02 |
| To: | abi |
| Links: | previous, next |
TO: ALL ABI FILERS AND SOFTWARE VENDORS
FROM: THE FOOD & DRUG ADMINISTRATION
CUSTOMS & BORDER PROTECTION
SUBJECT: END-DATING OF FME QUALIFIER 'N' & 'Y'
REFERENCES: ADMINISTRATIVE MESSAGE 04-2355
ADMINISTRATIVE MESSAGE 05-0098
ABI FILERS, ABI SOFTWARE VENDORS AND ABI SELF-PROGRAMMERS WERE NOTIFIED
BY ADMINISTRATIVE MESSAGES 04-2355 AND 05-0098 THAT FME EXEMPTION CODES
"N" AND "Y" WERE BEING END-DATED ON FEBRUARY 1, 2005. IF THE FILER
IS SENDING THE MANUFACTURER REGISTRATION NUMBER IN AFFIRMATION OF
COMPLIANCE PFR THEN AFFIRMATION OF COMPLIANCE FME IS NOT SENT AT ALL.
IF THE FILER IS NOT SENDING A MANUFACTURER REGISTRATION NUMBER IN
AFFIRMATION OF COMPLIANCE PFR THEN THE AFFIRMATION OF COMPLIANCE FME
MUST BE SENT WITH ONE OF THE QUALIFIERS DESCRIBED IN ADMINISTRATIVE
MESSAGE 05-0098. "N" AND "Y" ARE NOT VALID QUALIFIERS AND WILL BE
REJECTED.
THE FOOD & DRUG ADMINISTRATION
CBP CLIENT REPRESENTATIVE BRANCH