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Guidance for Industry 
Animal Drug Sponsor Fees under the Animal Drug 
User Fee Act (ADUFA) 
           
 
This guidance discusses how the Food and Drug Administration intends to implement the 
animal drug sponsor fee provision of ADUFA.   
 
Comments and suggestions regarding this document should be sent to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Room 1061, Rockville, MD 20852.  All comments should be identified with the Docket 
No. 2004D-0422.  Submit electronic comments to http://www.regulations.gov. 
 
For questions regarding this document, contact Steven Vaughn, Center for Veterinary 
Medicine (HFV-100), Food and Drug Administration, 7520 Standish Place, Rockville, 
MD 20855, 240-276-8300, e-mail: steven.vaughn@fda.hhs.gov. 
 
Additional copies of this guidance document may be requested from the Communications 
Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 
Standish Place, Rockville, MD  20855 and may be viewed on the Internet at 
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforInd
ustry/ucm042450.htm.   
 
According to the Paperwork Reduction Act of 1995, a collection of information should 
display a valid OMB control number.  This guidance contains no new collections of 
information. 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine (CVM)  
February 7, 2005   
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Guidance for Industry 
Animal Drug Sponsor Fees under the Animal Drug 
User Fee Act (ADUFA)1 
 
 
This guidance represents the agencys current thinking on the topic.  It does not 
create or confer any rights for or on any person and does not operate to bind FDA or 
the  public.    You  can  use  an  alternative  approach  if  the  approach  satisfies  the 
requirements of the applicable statutes and regulations.  If you want to discuss an 
alternative  approach,  contact  the  FDA  staff  responsible  for  implementing  this 
guidance.  If you cannot identify the appropriate FDA staff, call the contact number 
listed on the title page of this guidance.  
 
 
 
I.  INTRODUCTION 
 
The Animal Drug User Fee Act of 2003 (ADUFA), enacted on November 18, 2003,  
amends the Federal Food, Drug, and Cosmetic Act (the act) by adding Sections 739 and  
740 (21 U.S.C. 379j-11, and j-12) which require the Food and Drug Administration 
(FDA) to assess and collect user fees for certain applications, products, establishments, 
and sponsors.  This guidance represents the FDAs current thinking on how it intends to 
implement the animal drug sponsor fee provision of ADUFA. 
 
FDAs guidance documents, including this guidance, do not establish legally 
enforceable responsibilities.  Instead, guidances describe the Agencys current thinking 
on a topic and should be viewed only as recommendations, unless specific regulatory or 
statutory requirements are cited.  The use of the word "should" in Agency guidances 
means that something is suggested or recommended, but not required. 
 
II.  DETERMINING WHETHER YOU ARE SUBJECT TO THE ANIMAL 
DRUG SPONSOR FEE 
 
Section 740 of the act, as amended by ADUFA, requires FDA to assess and collect animal 
drug sponsor fees.  You are subject to sponsor fees if you: (1) meet the definition of an 
animal drug sponsor within a fiscal year; and (2) after September 1, 2003, had pending 
                                                 
1 This guidance has been prepared by the Office of New Animal Drug Evaluation in the Center for 
Veterinary Medicine, FDA. 
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before FDA an animal drug application, a supplemental animal drug application, or an 
investigational animal drug submission.  (Section 740(a)(4) of the act) (21 U.S.C. 379j-
12(a)(4)).  This two-part test is discussed in more detail below. 
 
1.  Determining whether you are an animal drug sponsor. 
 
You are an "animal drug sponsor" if you are either:  
  An applicant named in an animal drug application, except for an approved 
application for which all subject products have been removed from listing under 
section 510 of the act; or 
  A person who has submitted an investigational animal drug submission that has 
not been terminated or otherwise rendered inactive by FDA. 
(Section 739(6) of the act) (21 U.S.C. 379j-11(6)). 
 
An "animal drug application" is an application for approval of any new animal drug 
submitted under section 512(b)(1) of the act (21 U.S.C. 360b(b)(1)), and is commonly 
referred to as a new animal drug application (NADA).  It does not include a new animal 
drug application submitted under 512(b)(2) of the act (21 U.S.C. 360b(b)(2)), commonly 
referred to as an abbreviated new animal drug application (ANADA), or a supplemental 
animal drug application.  Thus, you are an animal drug sponsor if you are named as an 
applicant in any NADA.2 
 
An "investigational animal drug submission" is either: 
  The filing of a claim for an investigational exemption under 512(j) of the act for a 
new animal drug intended to be the subject of an animal drug application or a 
supplemental animal drug application, which means the submission of a "Notice of  
Claimed Investigational Exemption for a New Animal Drug" in accordance with 
21 CFR 511.1(b)(4); or 
  The submission of information for the purpose of enabling FDA to evaluate the 
safety or effectiveness of an animal drug application or supplemental animal drug 
application in the event of their filing. 
Section 739(5) of the act (21 U.S.C. 379j-11(5)). 
 
FDA will establish an INAD file no later than at the time a sponsor begins clinical studies 
and is required by 21 CFR 511.1(b)(4) to submit a Notice of Claimed Investigational 
Exemption.  But, as an administrative matter, FDA intends to establish an INAD file prior 
to the shipment of new animal drug for clinical tests if a sponsor submits any information 
that enables FDA to evaluate the safety or effectiveness of a new animal drug.  Thus, the 
                                                 
2 FDA believes that this includes products approved prior to 1962 and then found effective under the Drug 
Efficacy Study Implementation (DESI) review process. 
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existence of an INAD will enable FDA to identify those persons who meet the definition 
of an animal drug sponsor.  The existence of the INAD file will also help to make clear 
that the submitted information is subject to the confidentiality provisions of 21 CFR 
514.12.  
  
Not all submissions concerning an investigational product will meet the definition of an 
"investigational animal drug submission."  In general, submissions requesting only 
administrative actions are not investigational animal drug submissions.  For example, 
submissions asking whether a product under development is a new animal drug subject to 
FDA regulation and submissions asking about FDA's administrative process for 
submitting a "Notice of Claimed Investigational Exemption for a New Animal Drug", 
investigational information, or an NADA, by themselves, are not investigational animal 
drug submissions.  However, if you wish to discuss investigational or submission 
requirements and provide advance materials for FDA to review, FDA would likely 
establish an INAD file for these materials and you would be considered an animal drug 
sponsor.  
  
You will no longer be an animal drug sponsor if: 
  You withdraw all of your NADAs, which includes removing all subject products 
from listing under section 510 of the act (21 U.S.C. 360); and 
  All of your INAD files are either terminated, pursuant to 21 CFR 511.1(d), or are 
rendered inactive. 
FDA will consider an INAD file as being rendered inactive if it receives a request from 
the animal drug sponsor to close the INAD file and the request states that the sponsor has 
ceased all investigations and recalled or destroyed all unused supplies of the new animal 
drug.  FDA considers an INAD file that is rendered inactive to have the same status as an 
INAD file that has been terminated.  Therefore, FDA asks that your request to close an 
INAD file include a waiver to a right to a hearing regarding termination. 
 
Veterinary Master Files (VMFs) and Public Master Files (PMFs) are not considered 
animal drug applications or investigational animal drug submissions.  Creation of, and 
submissions to, VMFs or PMFs do not, by themselves, make a person an animal drug 
sponsor. 
 
2.  Determining whether you have an animal drug application, a supplemental 
animal drug application, or an investigational animal drug submission 
pending before FDA after September 1, 2003. 
 
The terms "animal drug application" and "investigational animal drug submission" are 
explained above.  A "supplemental animal drug application" is: 
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  A supplement, manufacturing or non-manufacturing, to an application approved 
under section 512(c)(1) of the act (21 U.S.C. 360b(c)(1)) (i.e., a supplement to an 
NADA), regardless of whether data with respect to safety or effectiveness are 
required for approval; or 
  A supplement, manufacturing or non-manufacturing, to an application approved 
under section 512(c)(2) of the act (21 U.S.C. 360b(c)(2)) (i.e., a supplement to an 
ANADA), provided that data with respect to safety or effectiveness are required 
for the supplement to be approved. 
 
An application was "pending after September 1, 2003," if: 
  It was accepted for filing after September 1, 2003; or  
  It was accepted for filing before September 1, 2003, and it had not been 
completely processed3 by that date. 
 
Likewise, an investigational animal drug submission was "pending after September 1, 
2003," if: 
  FDA established an INAD file for the animal drug sponsor after September 1, 
2003; 
  The animal drug sponsor filed, after September 1, 2003, information for the 
purpose of enabling FDA to evaluate the safety or effectiveness of an animal drug 
application or supplemental animal drug application in the event of their filing; or 
  The animal drug sponsor submitted, before September 1, 2003, information for the 
purpose of enabling FDA to evaluate the safety or effectiveness of an animal drug 
application or supplemental animal drug application in the event of their filing and 
the submission had not been completely processed4 prior to September 1, 2003.   
 
Thus, FDA will not consider an INAD file to be pending after September 1, 2003, if the 
sponsor did not have any data or information pending as of that date and has not submitted 
any data or information to the file since that date.  As discussed above, FDA does not 
intend to consider submissions that are unrelated to safety or effectiveness, such as a 
request to terminate the INAD file, to be investigational animal drug submissions.  
 
   
                                                 
3FDA considers an application or submission to be completely processed when FDA has completed its 
review, identified in its tracking system that the review is complete, mailed any related letters, and put the 
submission and related documentation in the administrative file. 
 
4 See footnote 3. 
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3. Animal Drug Sponsor Fee Implementation.  
 
Appendix 1 provides some illustrations of how FDA intends to implement  the animal drug 
sponsor fee.  The examples in the appendix are not all inclusive.  The answers in a row are 
specific to the facts in that row and assume there is no other information relevant to the 
person making the submission or the submission. 
 
III.  PAYMENT INFORMATION FOR THOSE SUBJECT TO THE ANIMAL 
DRUG SPONSOR FEE 
 
 
The animal drug sponsor fee is assessed annually and must be paid on or before January 
31 of each year.  (Section 740(a)(4) of the act) (21 U.S.C. 379j-12(a)(4)).  If you become 
subject to the animal drug sponsor fee for the first time after the invoices issue for the 
January 31st payment, you will be assessed the animal drug sponsor fee for that fiscal year 
the following October and thereafter be billed annually with payment due by January 31.  
Each animal drug sponsor is responsible for paying only one sponsor fee each fiscal year 
whether a sponsor has one INAD file or NADA or has multiple INAD files or NADAs. 
(Section 740(a)(4) of the act) (21 U.S.C. 379j-12(a)(4)).  FDA's invoices for sponsor fees 
will include complete payment instructions.  The invoices are based on fee rates 
established each year and the fee rates will be announced in the Federal  Register.  
(Section 740(c)(5) of the act) (21 U.S.C. 379j-12(c)(5)). 
 
A sponsor may submit a written request for a waiver or reduction of a sponsor or other 
user fee.  To qualify for consideration of a waiver or reduction, a person must submit the 
written request no later than 180 days after the fee is due.  (Section 740(i)) of the act) (21 
U.S.C. 379j-12(i)).  The conditions under which FDA must grant such a waiver or 
reduction are defined in section 740(d) of the act (21 U.S.C. 379j-12(d)).  Further 
guidance regarding fee waivers and reductions is provided in Guidance # 170: "Animal 
Drug User Fees and Fee Waivers and Reductions." 
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