Appendix 1 
 
Person Making Submission  Is the Person an  The submission  Will the Animal Drug Sponsor Fee be Assessed? 
Animal  
Drug Sponsor? 
1.  The person has approved  Yes  A description of a  No. An answer regarding jurisdiction is an 
NADAs and INAD files  product under  administrative action and does not subject an animal 
development and a  drug sponsor to a fee. 
question whether it is a 
new animal drug 
regulated by FDA 
       
2.  The person has one INAD  Yes  A request to terminate  No.  This request for administrative action is not an 
file  the INAD file that is  investigational animal drug submission.  After CVM 
submitted after Sept. 1,  terminates the INAD files, the person will no longer be 
2003  an animal drug sponsor. 
       
3.  The person has an  Yes  A request to terminate  No.  The request for administrative action does not 
approved NADA and an  an INAD file is  trigger assessment of the animal drug sponsor fee. 
INAD file  submitted after Sept. 1, 
2003 
       
4.  The person has approved  Yes  An NADA,  Yes 
NADAs and/or INAD files  supplemental NADA, 
or an investigational 
animal drug submission 
submitted prior to, but 
still pending after, Sept. 
1, 2003 
 
  1 Person Making Submission  Is the Person an  The submission  Will the Animal Drug Sponsor Fee be Assessed? 
Animal  
Drug Sponsor? 
5.  The person has approved  Yes  An NADA,  Yes 
NADAs and/or INAD files  supplemental NADA, 
or an investigational 
animal drug submission 
submitted after Sept. 1, 
2003 
           
6.  The person does not have  No  A request for a meeting  No.  The person is not an animal drug sponsor and the 
any approved NADAs, does  solely to discuss FDAs  submission does not change the status. 
not have any INAD files, and  administrative 
has not conducted clinical  processes for 
trials  submitting 
investigational 
information, an NADA, 
or a supplemental 
NADA 
           
7.  The person does not have  No  A request for a meeting  Yes, when a person requests a meeting to discuss 
any approved NADAs, does  to discuss  investigational or submission requirements, they are 
not have any INAD files, and  investigational or  requesting presubmission conference and need to 
has not conducted clinical  submission  provide advance materials.  FDA will establish an 
studies  requirements  INAD file for these materials and the person will 
become an animal drug sponsor.  FDA reviewers will 
evaluate information submitted for the purpose of 
enabling FDA to evaluate safety or effectiveness if a 
new animal drug application is submitted. 
  2  
Person Making Submission  Is the Person an  The Submission   Will the animal Drug Sponsor Fee be Assessed? 
Animal Drug 
Sponsor? 
8.  The person does not have  No  A Notice of Claimed  Yes.  When the person files a claim for investigational 
any approved NADAs and  Investigational  exemption, FDA establishes an INAD file and the 
does not have any INAD files  Exemption (NCIE)  person becomes an animal drug sponsor subject to an 
submitted prior to  animal drug sponsor fee. 
shipping new animal 
drug for clinical tests 
in animals and after 
Sept. 1, 2003 
       
9.  The person submitted  Yes (see # 8)  A request for a  No.  A request only for administrative action will not 
NCIEs and started clinical  meeting solely to  trigger assessment of the animal drug sponsor fee. 
studies before September 1,  discuss FDAs 
2003, and currently has no  administrative 
submissions pending    processes for 
submitting 
investigational 
information, an 
NADA; the request is 
made after Sept. 1, 
2003 
           
  3  
Person Making Submission  Is the Person an  The Submission  Will the Animal Drug Sponsor Fee be Assessed? 
Animal Drug 
Sponsor?  
10. The person does not have  No  A request for a meeting  Qualified No.  If no new animal drug is shipped from 
any approved NADAs, does  to solely to discuss  the U.S. to conduct clinical studies, an INAD has not 
not have any INAD files, and  FDAs administrative  previously been established, and the meeting 
has begun foreign clinical  processes for submitting  requested is solely to discuss administrative 
studies to support approval in  investigational  processes, the person is not an animal drug sponsor 
the U.S.  information, and NADA,  and does not become a sponsor or subject to a fee by 
or a supplemental NADA   virtue of the request for a meeting.   
is submitted after Sept. 1,   
2003  It is, however, recommended that persons seeking 
approval of a new animal drug in the U.S. discuss 
with the FDA the applicability of foreign studies to 
support U.S. approval.  If a presubmission conference 
is requested to discuss investigational and submission 
requirements, the request for the presubmission 
conference would trigger assessment of an animal 
drug sponsor fee (see #7). 
        
11.  The person has only one  Yes  An NADA, supplemental  Yes.  Because this person has a submission pending 
approved new animal drug  NADA, or  after Sept. 1, 2003, FDA is required to assess an 
application for a new animal  investigational animal  animal drug sponsor fee.  The animal drug sponsor 
drug intended only for use in  drug submission for a  may, however, request a fee waiver or reduction (see 
minor species  new animal drug  Guidance #170.) 
intended only for use in 
minor species is pending 
as of, or submitted after 
9/1/03. 
  4  
  5