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## Guidance for Industry and Reviewers

How the Center for Veterinary Medicine Intends to Handle Deficient
Submissions Filed During the Investigation of a New Animal Drug

FINAL GUIDANCE

This final guidance announces the Center for Veterinary Medicine\'s
(CVM's) policy regarding the circumstances under which CVM intends to
not accept for review submissions filed during the investigation of a
new animal drug and notify the sponsor that CVM intends not to review
the submission.

Comments and suggestions regarding this document should be sent to
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630
Fisher's Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments
to <http://www.fda.gov/dockets/ecomments>. All comments should be
identified with the Docket No. 01D-0146.

For questions regarding this guidance document, contact Gail L.
Schmerfeld, Center for Veterinary Medicine (HFV-100), Food and Drug
Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-1796,
E-mail: <gschmer1@cvm.fda.gov>

**U.S. Department of Health and Human Services\
Food and Drug Administration\
Center for Veterinary Medicine\
August 29, 2002**

How the Center for Veterinary Medicine Intends to Handle Deficient
Submissions Filed During the Investigation of a New Animal Drug

***This final guidance represents the Agency's current thinking on the
circumstances under which CVM intends to not accept for review
submissions filed during the investigation of a new animal drug and
notify the sponsor that the submission will not be reviewed. It does not
create or confer any rights for or on any person and does not operate to
bind the Food and Drug Administration or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statute and regulations.***

**Introduction:**

CVM's Office of New Animal Drug Evaluation (ONADE) encourages sponsors
to submit data, study protocols, or other information for review at the
most appropriate and productive times in the drug development process
rather than submitting all data at one time in a New Animal Drug
Application (NADA). Thus, sponsors may submit data intended to support
an application for new animal drug approval during the investigation of
the new animal drug to an investigational new animal drug (INAD) file.
This final guidance announces CVM's policy regarding the circumstances
under which ONADE intends to notify the sponsor that its submission
relating to a new animal drug approval (filed to the INAD file) will not
be accepted for review and remove the submission from the review queue.

A significant backlog in the number of submissions pending review
prompted ONADE to look at its review process. In the interest of
improving the efficiency of the review process, ONADE examined the
causes of delay. ONADE found that one of the significant inefficient
uses of reviewer resources is the number of submissions received by
ONADE that require significant additional information or rehabilitation
for ONADE to conduct its review. ONADE's practice has been to keep a
submission "active" pending the submission of additional information
from sponsors.

Instead of keeping deficient submissions "active" pending the submission
of additional or revised information, ONADE intends to handle them under
the policy set out in this guidance. This policy will permit ONADE to
focus on reviewing quality submissions that contain all the information
necessary for ONADE to evaluate the submission, thereby facilitating
timely review of new animal drug applications.

**Refusal to review a submission**

Within 60 days of receiving a submission, the reviewer, Team Leader, or
designated ONADE staff member should determine whether the submission is
acceptable for review, using reasons similar to those for refusing to
file an application found in 21 CFR 514.110 for refusing to review a
submission. For example, ONADE should not review a submission if on its
face the information concerning the required matter is so inadequate
that the submission is clearly not reviewable. ONADE should consider a
submission to be inadequate if the number or type of errors in a
submission or flaws in the development plan cause the person making the
appraisal to question the quality of the entire submission and conclude
that the submission cannot reasonably be reviewed. [^1]

If the person making the appraisal finds that the submission is
insufficient on its face or otherwise of unacceptable quality for
review, the Division should notify the sponsor by letter of its decision
not to accept the submission for review. The letter to the sponsor
should state that the submission has not been accepted for review and
summarize in detail commensurate with the quality of the submission the
reasons the submission has not been accepted for review. The letter also
should remind the sponsor that the sponsor may request a meeting with
ONADE to discuss why the submission was not accepted for review and how
best to proceed with drug development and submission of data. Finally,
the letter should inform the sponsor that any resubmission of data or
information should go through a thorough review process by the sponsor
before it is resubmitted to make sure that all the information is both
accurate and complete.

[^1]: Examples of these types of errors could include missing data sets,
    missing components in the submission, lack of detail in a study
    protocol, discrepancies between electronic data sets and the paper
    copy, conflicting information between sections of the submission,
    and the absence of important information.