CSMS Message: 03-002891

Title:ABI 'BN' RETURN MESSAGES - FDA/BTA PROCESSING
Date:2003-12-15
To:abi
Links:previous, next

AS YOU ARE AWARE, IN THE EDUCATIONAL PHASE OF FDA/BTA ENFORCEMENT, IF
PRIOR NOTICE DATA IS REQUIRED, BUT HAS NOT BEEN SUBMITTED, YOU ARE
RECEIVING ERROR MESSAGE CODE 'FDP' - "REQ'D PRIOR NOTICE NOT SUBMITTED".
THIS MESSAGE IS ONLY A WARNING IN THIS PHASE AND IS TO ADVISE FILERS
THAT THE MDSE IN QUESTION DOES, IN FACT, REQUIRE BTA PRIOR NOTICE.

PLEASE BE AWARE THAT WHENEVER THIS WARNING MESSAGE IS RETURNED, FILERS
WILL ALSO RECEIVE A 'BN' RETURN FOR THE RECORD INDICATING THAT PRIOR
NOTICE WAS RECEIVED. DURING THIS EDUCATIONAL PHASE, ALL RECORDS WHERE
PRIOR NOTICE WAS SUBMITTED, OR SHOULD HAVE BEEN SUBMITTED, ARE BEING
RETURNED BY FDA WITH A DEFAULT PRIOR NOTICE RECEIVED MESSAGE.