| Title: | FDA PRIOR NOTICE (CORRECTION ON PHONE NUMBER) |
|---|---|
| Date: | 2003-12-23 |
| To: | abi |
| Links: | previous, next |
TO: ALL ABI FILERS
FROM: DIOP SYSTEMS BRANCH, FOOD & DRUG ADMINISTRATION
PLEASE NOTE THE CORRECTION ON PHONE NUMBER FROM THE ONE SENT IN
ADMINISTRATIVE MESSAGE 03-2962!!!
DURING THE FIRST PHASE OF THE PRIOR NOTICE DISCRETIONARY
ENFORCEMENT PERIOD (DEC 12 2003 - MARCH 12 2004), OR UNTIL FURTHER
NOTICE, THE FDA REQUESTS THAT:
1. IF YOU IDENTIFY AN HTS CODE FOR A PRODUCT SUBJECT TO PRIOR NOTICE
THAT DOES NOT HAVE AN OTHER GOVERNMENT AGENCY (OGA) FD3 OR FD4 FLAG,
PLEASE NOTIFY FDA, AT 301-443-6553.
2. IN THE SITUATION ABOVE, TRANSMIT THE DATA THROUGH ABI WITHOUT PRIOR
NOTICE DATA. PLEASE DO NOT SUBMIT THROUGH FDA'S PRIOR NOTICE SYSTEM
INTERFACE (PNSI) USING THE SAME ENTRY NUMBER.
3. IF THE PRODUCT YOU ARE TRYING TO SUBMIT HAS AN OGA FD3 FLAG AND THE
PRODUCT IS NOT SUBJECT TO PRIOR NOTICE, BUT IS SUBJECT TO FDA ENTRY
REVIEW FOR 801(A) ADMISSIBILITY PURPOSES, DO NOT DISCLAIM THE LINE.
UNTIL FURTHER NOTICE SUBMIT THE LINE WITHOUT PRIOR NOTICE DATA.
4. IF AN ENTRY CONTAINING PRIOR NOTICE DATA IS TRANSMITTED VIA ABI AND
REJECTED, CONTACT YOUR ASSIGNED ABI CLIENT REPRESENTATIVE FOR ADVICE IN
RESOLVING THE REJECT. DO NOT SUBMIT THE PRIOR NOTICE DATA THROUGH
FDA'S PNSI UNLESS YOU ARE CERTAIN THAT THE REJECTED ENTRY CANNOT BE
RETRANSMITTED THROUGH ABI. FDA'S OASIS SYSTEMS HAS A CONFLICT WHEN THE
SAME ENTRY NUMBER IS RECEIVED FROM BOTH PNSI AND ABI.
KELLE R. FRY, DIOP SYSTEMS BRANCH
FOOD & DRUG ADMINISTRATION
301-594-3873 (VOICE)
301-594-1413 (FAX)
KFRY@ORA.FDA.GOV (EMAIL)