Change Request for FDA 3331a

UNITED STATES FOOD & DRUG ADMINISTRATION
Applications for FDA Approval to Market a New Drug
OMB Control No. 0910-0001
Request for Non-substantive, non-material change:

Changes to Form FDA 3331a: NDA/ANDA Field Alert Automated
As part of the FDA Adverse Event Reporting System (FAERS) II Modernization Priority, the
CDER/OPQ/Office of Surveillance/DQSA/QDAB is recommending an update to the FORM
FDA 3331a Field Alert Report (FARs). The revision of the form improves efficiency in
collecting and using the data and adds information to help identify, verify, and archive
documents in each appropriate FAR. (Draft attached). The form is available for electronic
submission. No database changes are required.
We believe these revisions allow for a more streamlined approach for accepting data.
Form Revisions:
This field currently exists in the form:
1. Box 8 (Lot numbers and expiration dates): Also include the Batch Size and number of
Consumer Complaints on Batch. This information assists with evaluating potential
risk with product quality defects.
New fields to be added:
1. Manufacturer Control Number (MCN) – a number assigned by the Manufacturer to
each initial individual case safety report submission. The same MCN is assigned by
the manufacturer and is used for the initial and any follow-up submissions. Use of
the same MCN standardizes the identification of serial reports for a single event.
2. Field # 12: Coded quality issue/defect: uses standard MedDRA terminology to
provide the most specific quality issue/defect description.
3. Field # 13: Reported specific quality issue/defect.
As a result of these limited adjustments/changes, we do not anticipate any adjustment will be
required to the cumulative burden for submission.
Submitted: February 2020