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119 
 
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 (CVMs) 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 the document should be submitted to Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm.  1061,  Rockville,  MD    20852.    Submit  electronic  comments  to 
http://www.regulations.gov.  All comments should be identified with the Docket No. 
01D-0146. 
 
For questions regarding this guidance document, contact Marty Schoenemann, Center for 
Veterinary,  Medicine (HFV-100), Food and Drug Administration, 7500 Standish Place, 
Rockville, MD  20855, 240-276-8302, email Herman.Schoenemann@fda.hhs.gov. 
  
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine 
August 29, 2002  
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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 Agencys 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: 
 
CVMs  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 CVMs 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. ONADEs 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. 
 
 
 
 
 
 
 
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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. 
  3