The DMF will be deemed not available for reference. Once the DMF fee becomes
due, no generic drug submission submitted referencing the DMF will be received
unless the fee is paid and the DMF is deemed available for reference.
ANDA applicants that reference a DMF for which a fee is due but has not been paid
will be provided notification of the DMF holder’s failure to satisfy the user fee
obligation. If the DMF fee is not paid within 20 calendar days after notification, the
ANDA referencing the DMF will not be received.