#170 
  Animal Drug User Fees 
and Fee Waivers and Reductions 
  Revised 
Guidance for Industry 
This version of the guidance replaces the version made available in July 2017.  This revision of 
the guidance document updates hyperlinks, mailing, and contact information. 
Submit comments on this revised guidance at any time.  Submit electronic comments to 
https://www.regulations.gov.  Submit written comments to the Dockets Management Staff (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.  
Identify all comments with the Docket No. FDA-2004-D-0369. 
For further information regarding this document, contact cvmadufa@fda.hhs.gov. 
Additional copies of this revised guidance document may be requested from the Policy and 
Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 
Standish Place, Rockville, MD 20855, and may be viewed on the Internet at  
https://www.fda.gov/animal-veterinary, https://www.fda.gov/regulatory-information/search-fda-
guidance-documents, or http://www.regulations.gov. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine 
April 2023  Contains Non-Binding Recommendations 
2  Contains Non-Binding Recommendations 
 
Table of Contents 
 
I.  Introduction ............................................................................................................................. 1 
II.  Payment of Fees Pending a Decision on a Waiver/Reduction Request .............................. 1 
III. Types of Fees ............................................................................................................................ 2 
A.  Animal Drug Sponsor Fee ............................................................................................... 2 
B.  Animal Drug Application and Supplement Fee ............................................................ 2 
C.  Animal Drug Product Fee ............................................................................................... 3 
D.  Animal Drug Establishment Fee..................................................................................... 3 
IV.  Types of Fee Waivers and Reductions ................................................................................... 3 
A.  Significant Barrier to Innovation ................................................................................... 4 
B.  Fees Exceed Costs ............................................................................................................ 6 
C.  Free Choice Feeds ............................................................................................................ 7 
D.  Minor Use or Minor Species ........................................................................................... 8 
E.  Small Business .................................................................................................................. 8 
V.  Procedures and Timing for Requesting Fee Waivers or Reductions .................................. 9 
A.  Procedures Applicable To All Requests for Waivers or Reductions ........................... 9 
B.  Additional Procedures for Small Business Waiver Requests ..................................... 13 
C.  Additional Procedures for Significant Barrier to Innovation Waiver or Reduction 
Requests .......................................................................................................................... 14 
D.  Additional Procedures for Fees Exceed Costs Waiver or Reduction Requests ........ 14 
i 
  Contains Non-Binding Recommendations 
ii  Contains Non-Binding Recommendations 
 
Animal Drug User Fees and Fee Waivers and Reductions 
 
Revised Guidance for Industry 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on FDA 
or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA office 
responsible for this guidance as listed on the title page. 
 
I.  Introduction 
 
The purpose of this document is to provide guidance on the types of fees the Food and Drug 
Administration (FDA or the Agency) is authorized to collect under the Animal Drug User Fee Act 
of 2003 (ADUFA) and how to request waivers and reductions from these fees.  This revised 
guidance describes the types of fees and fee waivers and reductions; what information FDA 
recommends you submit in support of a request for a fee waiver or reduction; how to submit such 
a request; and FDA's process for reviewing requests. 
 
Enacted on November 18, 2003, ADUFA (Public Law 108-130) amended the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act) and requires the FDA to assess and collect user fees for certain 
applications, products, establishments, and sponsors.  It also authorizes the Agency to grant a 
waiver from or a reduction of those fees in certain circumstances. 
 
The Animal Drug User Fee Amendments of 2008 (ADUFA II) further amended the FD&C Act to 
revise and reauthorize the ADUFA program for fiscal years 2009 through 2013.  Revisions to the 
ADUFA provisions made by this legislation included refinements to the ADUFA fee structure.  In 
June 2013, the ADUFA program was reauthorized for an additional 5 years from fiscal year 2014 
through fiscal year 2018 by the Animal Drug User Fee Amendments of 2013 (ADUFA III). 
 
In general, FDAs guidance documents 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.  Payment of Fees Pending a Decision on a Waiver/Reduction Request 
 
An animal drug application or supplemental animal drug application submitted by a person 
subject to ADUFA fees is considered incomplete and will not be accepted for filing by FDA until 
all fees owed by such person have been paid.  Section 740(e) of the FD&C Act.  FDA considers 
fees to be due even if the person has a request for a fee waiver or reduction pending, meaning that 
either FDA has not yet granted or denied the request or the requestor has asked for agency 
reconsideration or review of a denial.  If FDA grants a waiver or reduction of a fee that has been 
paid, it will issue a refund as anticipated by section 740(i) of the FD&C Act.
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  Contains Non-Binding Recommendations 
 
III.  Types of Fees 
 
A.  Animal Drug Sponsor Fee 
 
An animal drug sponsor is defined in section 739(6) of the FD&C Act as either an applicant 
named in an animal drug application that has not been withdrawn by the applicant and for which 
approval has not been withdrawn by the Agency or a person who has submitted an investigational 
animal drug submission that has not been terminated or otherwise rendered inactive by the 
Agency.  A person who meets this definition within a fiscal year is assessed a sponsor fee in that 
fiscal year if, after September 1, 2003, the person had pending with FDA an animal drug 
application, a supplemental animal drug application, or an investigational animal drug 
submission.  Section 740(a)(4) of the FD&C Act.  ADUFA requires FDA to collect animal drug 
sponsor fees on an annual basis; each sponsor will pay only one such fee each fiscal year.  Section 
740(a)(4) of the FD&C Act.  Further guidance regarding animal drug sponsor fees is provided in 
Guidance for Industry #173, Animal Drug Sponsor Fees under the Animal Drug User Fee Act 
(ADUFA). 
 
B.  Animal Drug Application and Supplement Fee 
 
ADUFA requires FDA to collect fees from each person who submits certain animal drug 
applications or supplements on or after September 1, 2003.  Section 740(a)(1)(A) of the FD&C 
Act. 
 
All animal drug applications submitted under section 512(b)(1) of the FD&C Act are subject to 
fees.  Sections 739(1) and 740(a)(1)(A)(i) of the FD&C Act.  Animal drug applications subject to 
the criteria set forth in section 512(d)(4) of the FD&C Act, and supplemental animal drug 
applications that request a change for which safety or effectiveness data are required (whether 
the change is to an application that had been approved under section 512(c)(1) or 512(c)(2) of the 
FD&C Act), are subject to fees.  Sections 739(2) and 740(a)(1)(A)(ii) of the FD&C Act.  
Supplemental animal drug applications for which safety and effectiveness data are not required 
and abbreviated new animal drug applications, which are submitted under section 512(b)(2) of 
the FD&C Act, are not subject to application fees under ADUFA. 
 
If you have paid the fee for an application or supplement which was accepted for filing, but was 
either not approved or was withdrawn without a waiver or refund, then if you or your licensee, 
assignee, or successor submit an application or supplement for the same product (i.e., a 
reactivation), it will not be subject to an application fee.  Section 740(a)(1)(C) of the FD&C Act. 
 
An applicant may submit an amendment to an application or supplement.  If you amend a pending 
application or supplement, the unamended application may be considered as withdrawn and the 
amended application considered resubmitted.  21 CFR 514.6.  An amended application that FDA 
considers to be resubmitted will not result in a new application fee if the unamended application 
was not approved or was withdrawn without a waiver or refund.  FDA intends to accept minor 
changes without considering the amended application as resubmitted. 
 
2  Contains Non-Binding Recommendations 
C.  Animal Drug Product Fee 
 
Under specified circumstances, ADUFA requires FDA to collect an annual product fee for each 
drug product which has been submitted for listing under section 510 of the FD&C Act.  Section 
740(a)(2) of the FD&C Act.  This requirement applies to approved animal drug products that 
have been listed or submitted for listing.  ADUFA defines the term animal drug product1 to 
mean each specific strength or potency of a particular active ingredient or ingredients in final 
dosage form marketed by a particular manufacturer or distributor, which is uniquely identified 
by the labeler code and product code portions of the national drug code, and for which an 
animal drug application or a supplemental animal drug application has been approved.  Section 
739(3) of the FD&C Act.  The product fee is assessed to the person named as the applicant in an 
animal drug application or supplemental animal drug application for an animal drug product 
that has been submitted for listing and who, after September 1, 2003, had pending with FDA an 
animal drug application or supplemental animal drug application.  Section 740(a)(2) of the 
FD&C Act. 
 
D.  Animal Drug Establishment Fee 
 
ADUFA requires FDA to collect an annual establishment fee from each person who 1) owns or 
operates, directly or through an affiliate, an animal drug establishment; 2) is named as the 
applicant in an animal drug application or supplemental animal drug application for an animal 
drug product which has been submitted for listing under section 510 of the FD&C Act; and 3) 
after September 1, 2003, had pending with FDA an animal drug application or supplemental 
animal drug application.  Section 740(a)(3) of the FD&C Act.  The person is assessed an 
establishment fee for each animal drug establishment listed in its approved animal drug 
application as an establishment that manufactures that animal drug product.  Section 740(a)(3) of 
the FD&C Act.  If an animal drug establishment listed in an application does not engage in the 
manufacture of the animal drug product during a particular fiscal year, an annual establishment 
fee will not be assessed for that fiscal year on the basis of that product.  Section 740(a)(3) of the 
FD&C Act. 
 
If a single establishment manufactures both animal drug products and human prescription drug 
products as defined in section 735(3) of the FD&C Act, such establishment shall be assessed 
both the animal drug establishment fee (under ADUFA) and the prescription drug establishment 
fee (under PDUFA).  Section 740(a)(3) of the FD&C Act. 
 
IV.  Types of Fee Waivers and Reductions 
 
This section contains a summary of each of the specific provisions under which a waiver or 
reduction may be requested for each of the fees described above. 
 
1 For information on the term animal drug product as applied to intentionally altered genomic DNA in animals, 
including in genetically engineered animals, see Guidance for Industry #187, Regulation of Intentionally Altered 
Genomic DNA in Animals https://wayback.archive-
it.org/7993/20170111005939/http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/G
uidanceforIndustry/UCM113903.pdf 
3  Contains Non-Binding Recommendations 
 
A.  Significant Barrier to Innovation 
 
Section 740(d)(1)(A) of the FD&C Act provides that FDA shall grant a waiver from or a 
reduction of one or more of the fees where FDA finds that: 
 
the assessment of the fee would present a significant barrier to innovation because of 
limited resources available to such person or other circumstances. 
 
FDA interprets this provision to mean that a waiver or reduction is appropriate when: (1) the 
product for which the waiver is being requested is innovative, or the requestor is otherwise 
pursuing innovative animal drug products or technology; and (2) the fee would be a significant 
barrier to the requestor's ability to develop, manufacture, or market the innovative product or 
technology. 
 
To qualify for a waiver or reduction in user fees under this provision, an applicant must meet 
both criteria. 
 
1.  Is the product innovative? 
 
In evaluating whether a product is innovative, the Agency asks the following questions: 
 
a.  Is the product novel or does it represent a medical breakthrough?2 
 
i.  Does the product have a novel mechanism of action?  Is the biochemical 
interaction through which the drug substance produces its pharmacological 
effect different from other approved animal drug products, and does the 
difference represent advanced breakthrough technology (e.g., monoclonal 
antibodies, RNA inhibitors, gene vectors or altered DNA constructs)? 
 
ii.  Does the product have a novel formulation?  Does the drug products 
formulation demonstrate an advanced breakthrough technology (e.g., 
nanotechnology) that enhances safety or effectiveness of the drug product? 
 
iii. Does the product employ a novel delivery system?  Does the drug delivery 
system or drug vehicle demonstrate breakthrough technology to improve 
delivery of the drug (e.g., improves delivery to the target organ, improves bio-
distribution of the drug)?  Examples are drug carriers with ligandreceptor 
interactions for target organ delivery; drug-carrying polymers that respond to 
specific stimuli (e.g., exposure to light, changes in pH or temperature) for 
cyclic drug release. 
 
2 What constitutes novel or a medical breakthrough may change over time.  As new, emerging technology becomes 
more commonplace, FDA may no longer consider it novel or a medical breakthrough. 
4  Contains Non-Binding Recommendations 
 
 
b.  Is there sufficient information to suggest the product would likely have the 
proposed effect?  Is there sufficient information for proof of concept in a 
validated in vitro system or in the target animal or an animal model of the target 
animal (e.g., laboratory rodent species)? 
 
For the purposes of a Barrier to Innovation waiver, a product is not considered innovative 
if the proposed innovation relates to any of the following: 
 
1.  An incremental change in manufacturing, dosage form, or route of administration 
of an approved new animal drug.3 
 
2.  A drug where the only change is enhanced safety, enhanced efficacy, decreased 
dosing frequency, or a shorter residue withdrawal time where the same or similar 
active ingredient is approved, WITHOUT such change utilizing advanced, 
breakthrough technology. 
 
Additionally, in determining whether a product is innovative, FDA may consider as a 
factor whether another product using the same technology and for the same indication has 
been approved, even if the previously approved product is no longer on the market. 
 
2.  Does the fee create a significant barrier to the applicants ability to develop, 
manufacture, or market innovative products or to pursue innovative technology? 
 
Under section 740(d)(1)(A) of the FD&C Act, an applicant may qualify for a fee waiver if 
the fee would present a significant barrier to innovation for one of two reasons: because 
of limited resources available to the applicant or due to other circumstances. 
 
a.  Limited Resources 
 
To determine whether a fee would be a significant barrier to an applicants ability to 
develop, manufacture, or market innovative products or to pursue innovative technology, 
the Agency considers the relationship between the annual cost of user fees and the 
financial resources of the applicant and its affiliates as that term is defined in section 
735(11) of the FD&C Act.  Under the Act, the applicant is the person who is responsible 
for payment of the fees and the person who must qualify for a waiver or reduction of user 
fees.  Accordingly, the statute does not allow persons other than those legally subject to 
user fees, such as a distributor that is not an affiliate, to qualify for or receive waivers or 
reductions of user fees. 
 
FDA considers the working capital of the requestor and its affiliates in determining 
whether the requestor has limited financial resources.  Working capital is the capital that a 
 
3 For products related to intentionally altered genomic DNA in animals, an incremental change would include the 
same or similar genetic changes carrying the same claim (e.g., enhanced growth, different insertional events 
producing the same product).  Please consult the Center if you have questions on this point. 
5  Contains Non-Binding Recommendations 
company uses for its day-to-day operations, calculated as the current assets minus the 
current liabilities.  Working capital is frequently used to measure a companys ability to 
meet current, marketable securities, accounts receivable, and inventory.  Examples of 
current liabilities are accounts payable, accrued expenses (such as wages, interest, and 
taxes payable), and short-term notes payable.  When calculating working capital, FDA 
intends to deduct from current liabilities any that reflect marketing costs, including 
expenses in foreign markets, that are often incurred because of an applicants marketing 
decisions, and any dividends payable to investors. 
 
FDA does not intend to consider lack of profitability as evidence of limited resources, 
given that even a very large requestor may have operating losses. 
 
Beginning with fees assessed for FY 2017, the Agency expects to determine that an 
applicant with financial resources of less than $20 million (adjusted annually thereafter for 
inflation4), including the financial resources of the applicants affiliates, has limited 
resources available for purposes of determining whether to grant a barrier to innovation 
waiver or reduction of fees on financial grounds.  An applicant with $20 million or more in 
financial resources, including the financial resources of the applicants affiliates, generally 
will not be considered to have limited resources available for purposes of determining 
whether to grant a barrier to innovation waiver or reduction of fees on financial grounds.  
The Agency also does not intend to consider product sales figures to be evidence of 
limited resources, because even a large and profitable company can have low sales figures 
for an individual product, but not need a waiver on the basis that the ADUFA fees billed to 
that company would present a significant barrier to innovation. 
 
b.  Other Circumstances 
 
Section 740(d)(1)(A) of the FD&C Act authorizes FDA to grant a fee waiver or reduction 
on barrier to innovation grounds for financial reasons or because of other circumstances.  
Consistent with this provision, there are certain circumstances where FDA will consider 
granting a barrier to innovation waiver when an applicant does not qualify on financial 
grounds.  Those circumstances include, but are not necessarily limited to, the following: 
 
  Public policy or congressional intent.  FDA has granted waivers under an 
analogous provision for human drugs where Congress has indicated its intent to 
grant certain products or technology regulatory relief (see PET Drugs, 65 FR 
13004-5) or where public policy calls for such a waiver (see GFI: HIV Drug 
Waivers).  FDA expects to grant waivers where similar circumstances arise in the 
context of animal drugs. 
 
B.  Fees Exceed Costs 
 
Section 740(d)(1)(B) of the FD&C Act provides that FDA shall grant a waiver from or a 
 
4 FDA publishes user fee rates for each fiscal year in the Federal Register on or before August 1st of the preceding 
fiscal year.  FDA will announce the financial resource ceiling for the upcoming fiscal year in this Federal Register 
notice. 
6  Contains Non-Binding Recommendations 
reduction of one or more of the fees where FDA finds that: 
 
the fees to be paid by such person will exceed the anticipated present and future costs 
incurred by [FDA] in conducting the process for the review of animal drug applications 
for such person. 
 
In making this finding, FDA may use standard costs.  Section 740(d)(2) of the FD&C Act.  FDA 
interprets person in this provision to include the requestor's affiliates,5 as that term is defined 
in section 735(9) of the FD&C Act.  Therefore, when a person submits a request for a fee waiver 
or reduction based on the assertion that the Agency's costs associated with the process for 
review of animal drug applications for that person will be less than the fees, FDA intends to take 
into consideration all applications submitted by the entity and its affiliates.  The term process 
for the review of animal drug applications is defined in section 739(8) of the FD&C Act, and 
includes activities related to the review of animal drug applications, supplemental animal drug 
applications, and investigational animal drug submissions.  In determining whether the requestor 
qualifies for a fees exceed costs waiver or reduction, FDA intends to compare the fees paid with 
the actual and anticipated costs from September 1, 2003, through September 30 of the year for 
which the request is made. 
 
To evaluate a waiver request on the basis that fees assessed exceed FDAs costs, FDA will need 
information that will only be available after the end of the fiscal year for which the request is 
made, likely by the end of March following the close of the fiscal year. 
 
C.  Free Choice Feeds 
 
Section 740(d)(1)(C) of the FD&C Act provides that FDA shall grant a waiver from or a reduction 
of one or more of the fees where FDA finds that: 
 
the animal drug application or supplemental animal drug application is intended solely to 
provide for use of the animal drug in 
 
(i)  a Type B medicated feed (as defined in section 558.3(b)(3) of title 21, Code of 
Federal Regulations (or any successor regulation)) intended for use in the 
manufacture of Type C free-choice medicated feeds, or 
 
(ii) a Type C free-choice medicated feed (as defined in section 558.3(b)(4) of title 21, 
Code of Federal Regulations (or any successor regulation)). 
 
Thus, FDA will waive or reduce fees when an application or supplement is intended solely to 
provide for use of the animal drug in free-choice medicated feed.  For the purpose of this 
provision, FDA intends to define free-choice medicated feeds consistent with 21 CFR 510.455(a) 
as 
 
 
5 An affiliate is a business entity that has a relationship with a second business entity if, directly or indirectly  (a) one 
business entity controls, or has the power to control, the other business entity; or (b) a third party controls, or has 
power to control, both of the business entities. 
7  Contains Non-Binding Recommendations 
 
The free-choice administration of animal drugs in feeds involves feeds that are placed in 
feeding or grazing areas and are not intended to be consumed fully at a single feeding or to 
constitute the entire diet of the animal.  Such methods of administering drugs include, but are 
not limited to, medicated blocks (agglomerated feed compressed or rendered into a solid mass 
and cohesive enough to hold its form), mineral mixes, and liquid feed tank supplements (lick 
tank supplements) containing one or more animal drugs. 
 
D.  Minor Use or Minor Species 
 
Section 740(d)(1)(D) of the FD&C Act provides that FDA shall grant a waiver from or a 
reduction of one or more of the fees where FDA finds that: 
 
the animal drug application or supplemental animal drug application is intended solely to 
provide for a minor use or minor species indication. 
 
For the purpose of this provision, FDA uses the definition of the term "minor use" provided in 
21 CFR 516.3(b) which means the intended use of a drug in a major species for an indication 
that occurs infrequently and only in a small number of animals or in limited geographic areas 
and in only a small number of animals annually.  Small number of animals means equal to or 
less than:  50,000 horses; 70,000 dogs; 120,000 cats; 310,000 cattle; 1,450,000 pigs; 14,000,000 
turkeys; and 72,000,000 chickens. 
 
Likewise, for the purpose of this provision, FDA uses the definition of the term "minor species" 
that is provided in 21 CFR 516.3(b), which states that minor species are animals, other than 
humans, that are not major species; that is, animals other than cattle, horses, swine, chickens, 
turkeys, dogs, and cats. 
 
The Agency intends to waive or reduce the product fee only if the animal drug product is 
exclusively labeled for minor species or minor use indications.  The Agency intends to waive or 
reduce the establishment fee only if the establishment manufactures products exclusively for 
minor species or minor use indications. 
 
E.  Small Business 
 
Section 740(d)(1)(E) of the FD&C Act provides that FDA shall grant a waiver from or a 
reduction of one or more of the fees where FDA finds that: 
 
the sponsor involved is a small business submitting its first animal drug application to 
[FDA] for review. 
 
A "small business" is one that has fewer than 500 employees, including employees of affiliates.  
Section 740(d)(3)(A) of the FD&C Act.  Because section 740(d)(3)(B) states that FDA shall 
waive the application fee for the first animal drug application submitted, FDA believes that the 
provision requires a waiver of the entire application fee rather than a reduction, and that the 
provision pertains to application fees but not to any other type of animal drug user fee.  The 
8  Contains Non-Binding Recommendations 
waiver applies only to the first animal drug application that the small business or its affiliate 
submits for review.  Section 740(d)(3)(B) of the FD&C Act.  FDA believes this means the first 
application the small business ever submits, regardless of whether it was submitted before or 
after ADUFA was enacted. 
 
A person who applies for a waiver under this section must certify its qualification for the waiver.  
Section 704(d)(3)(C) of the FD&C Act.  ADUFA requires FDA to periodically publish in the 
Federal Register a list of persons making such certifications.  Section 740(d)(3)(C) of the FD&C 
Act. 
 
V.  Procedures and Timing for Requesting Fee Waivers or Reductions 
 
This section of the guidance document describes the procedures that FDA recommends for 
submitting a fee waiver or reduction request, and the information that the Agency believes it 
needs from a person to determine whether it can grant the request for a fee waiver or reduction.  
Adherence to these procedures will help to minimize time-consuming efforts by the Agency to 
obtain additional necessary information, and will enable the Agency to grant fee waivers or 
reductions to qualifying persons in a timely manner.  Please note that you must submit a 
written request to the Agency for a waiver or reduction no later than 180 days after the fee 
is due.  Section 740(i) of the FD&C Act.  FDA does not intend to consider any requests made 
later than 180 days after the fee is due. 
 
A.  Procedures Applicable To All Requests for Waivers or Reductions 
 
1.  Submitting a Waiver or Reduction Request 
 
Because waivers and reductions apply to specific fees due for a specific application or fiscal year, 
new requests should be submitted for each application or fiscal year.  The request must be 
submitted in writing and must be submitted to FDA by no later than 180 days after the fees are 
due.  Section 704(i) of the FD&C Act.  Requests for fee waivers and reductions, other than those 
made on the basis that fees exceed costs, will be reviewed and granted or denied by FDAs Center 
for Veterinary Medicine (CVM) ADUFA Waiver Officer.  Requests for waivers or reductions 
made on the basis that fees exceed costs will be evaluated by the ADUFA Waiver Officer and 
subsequently forwarded, with a recommended disposition, to FDAs Office of Financial 
Management.  The Director of FDAs Office of Financial Management will then review the 
request and make a decision about whether to grant or deny the request. 
 
To facilitate timely review and processing of requests for a waiver or reduction of one or more 
types of ADUFA fees, such requests should contain the following information: 
 
a.  The name and address of the entity requesting the waiver or reduction 
(requestor), including the company name and address if the requestor is an 
agent for the company. 
b.  The name, telephone number, and e-mail address of a contact person. 
c.  The specific type(s) of fees for which a waiver or reduction is requested, 
including: 
9  Contains Non-Binding Recommendations 
 
i.  For application or supplement fees: 
 
a)  the number of the NADA or supplemental NADA for which a fee 
waiver or reduction is being requested; 
b)  the trade and established names of animal drug products covered by the 
application; and 
c)  the date the application or supplement was submitted. 
 
ii.  For product fees: 
 
a)  the trade and established names of the animal drug product, its 
applicable National Drug Code (NDC) number, and the number of the 
NADA or supplemental NADA under which the product was approved; 
b)  the name of the person holding the approved application for the animal 
drug product; 
c)  the specific strength or potency of the product and its final dosage form; 
and 
d)  the product fee invoice number and invoice date, if available.  A 
photocopy of FDAs invoice to the person may be submitted to provide 
this information, though you should clearly state for which specific 
animal drug product the fee waiver or reduction is requested. 
 
iii. For establishment fees: 
 
a)  the name, address, and FEI/CFN number of the establishment for which 
the fee waiver or reduction is requested; 
b)  the establishment number as listed on the fee invoice, and the invoice 
number and date, if available.  A copy of the invoice is acceptable. 
 
iv. For sponsor fees: 
 
a)  the name and address of the animal drug sponsor requesting the waiver 
or reduction; 
b)  the invoice number and invoice date if available.  A copy of the invoice 
is acceptable. 
 
d.  If payment has been made, the date on which payment was made; 
 
e.  The particular grounds on which the waiver or reduction is requested (i.e., one 
or more of the provisions specified in section IV above);6 and 
 
 
6 The Agency intends to waive or reduce sponsor fees only if the sponsors entire portfolio of files and applications is 
eligible for a waiver based on one or more of the provisions specified in section IV. Types of Fee Waivers and 
Reductions. 
10  Contains Non-Binding Recommendations 
f.  Information and analyses showing why the requestor believes it qualifies for 
the waiver or reduction. 
 
If submitting a fee waiver or reduction request in advance of the date the fees are due, you should 
provide any new or updated information as soon as it becomes available. 
 
A request for a fee waiver or reduction should be sent to: 
 
Food & Drug Administration 
Center for Veterinary Medicine 
MPN 2, E150 
Attention: ADUFA Waiver Officer 
12225 Wilkins Avenue  
Rockville, MD 20852 
 
FDA will send a written acknowledgement of receipt of the fee waiver or reduction request to 
the requestor.  The acknowledgement letter will include the date on which the waiver or 
reduction request was received, and will request any additional information the FDA believes, 
at the time, will be necessary to evaluate the request.  The ADUFA Waiver Officer will evaluate 
the fees exceed costs waiver or reduction request and forward the recommendation to the 
Director of the Office of Financial Management. 
 
2.  Timing of a Fee Waiver or Reduction Request 
 
If you plan to request a fee waiver or reduction and wish to minimize the likelihood that you will 
have to pay the fee and then wait for a refund, FDA encourages you to submit your requests at 
least 90 days before the fees are due.  For animal drug application and supplemental animal drug 
application fees, this would be 90 days before the expected submission of the application or 
supplement.  For sponsor, product, and establishment fees, this would normally be by November 1 
of each fiscal year because these fees are generally due on or before January 31 of the fiscal year.  
This recommendation does not apply to "Fees Exceed Costs" waivers and reductions since FDA 
expects that it will not be able to make a decision on them until after the associated fees are due. 
 
3.  The Waiver Officer's or Office of Financial Management Directors Review of the 
Request 
 
The ADUFA Waiver Officer will review the waiver or reduction request and consult with 
relevant Agency officials as appropriate.  The Waiver Officer may request additional information 
from, or a meeting with, the requestor during the review period.  The Agency expects to notify 
the requestor of the Waiver Officers decision and the reasons for it within 90 days of the receipt 
of a waiver or reduction request, except for Fees Exceed Costs waiver or reduction requests, 
which will not be decided by the Director of FDAs Office of Financial Management until 
approximately 6 months after the end of the fiscal year for which the waiver or reduction is 
requested.  These time periods may vary depending on, among other things, the number of fee 
waiver or reduction requests submitted and whether the request contains sufficient supporting 
information. 
11  Contains Non-Binding Recommendations 
 
4.  Requesting Reconsideration of a Decision 
 
If the ADUFA Waiver Officer, or Director of FDAs Office of Financial Management in the case 
of fees exceed costs requests, fully or partially denies your request for a fee waiver or reduction, 
you may request reconsideration of that decision.  FDA encourages persons to make such 
requests for reconsideration promptly, and suggests that they be made within 15 days of receiving 
the decision.  A request for reconsideration should state the persons reasons for believing that 
the decision is in error, and should include any additional information necessary to support the 
persons position.  The ADUFA Waiver Officer or Office of Financial Management Director will 
issue a decision upon reconsideration, setting forth the reasons for it.  A request for 
reconsideration is decided by the original decision maker, and is different from a request for 
review under 21 CFR 10.75, which is described in the next two sections.  You may, but are not 
required to, request reconsideration of the initial decision by the ADUFA Waiver Officer or 
Office of Financial Management Director before seeking review of that decision. 
 
You should send the request for reconsideration to: 
 
Food & Drug Administration 
Center for Veterinary Medicine 
MPN 2, E150 
Attention: ADUFA Waiver Officer 
12225 Wilkins Avenue  
Rockville, MD 20852 
 
5.  Requesting Review of the ADUFA Waiver Officers Decision 
 
If the ADUFA Waiver Officer denies your waiver or reduction request or denies your request for 
reconsideration, you may seek review by CVMs ADUFA Appeals Officer in accordance with this 
agencys regulations at 21 CFR 10.75.  Please note that this procedure does not apply to fees 
exceed costs waiver or reduction requests.  The procedures that apply to such requests are 
described separately below.  Your request for review should contain a copy of the ADUFA 
Waiver Officers original decision, his or her decision upon reconsideration, if any, and the 
reasons you believe the decisions are in error.  The review will be based on information in the 
administrative file, which includes information and analyses already submitted to the Agency, as 
provided by 21 CFR 10.75(d). 
 
The request for review should be sent to: 
 
Food & Drug Administration 
Center for Veterinary Medicine 
MPN 2, E150 
Attention: CVM ADUFA Appeals Officer (HFV-1) 
12225 Wilkins Avenue  
Rockville, MD 20852
12  Contains Non-Binding Recommendations 
 
After reviewing the request, the CVM ADUFA Appeals Officer will issue a written decision. 
 
6.  Requesting Review of the CVM ADUFA Appeals Officers Decision or the Office of 
Financial Management Directors Decision 
 
If the Director of the Office of Financial Management denies your fees exceed costs waiver or 
reduction request or denies your request for reconsideration, you may seek review by FDA's User 
Fee Appeals Officer.  You may likewise seek review by FDA's User Fee Appeals Officer if the 
CVM ADUFA Appeals Officer upholds the ADUFA Waiver Officer's decision.  Your request for 
review should contain a copy of the original decision, any decisions upon reconsideration or 
review, and the reasons you believe those decisions are in error.  The review will be based only on 
information in the administrative file, which includes information and analyses already submitted 
to the Agency, as provided by 21 CFR 10.75(d). 
 
The request for review should be sent to: 
 
The Office of the Chief Scientist 
FDA White Oak Campus - Building 1 
10903 New Hampshire Ave 
Silver Spring, MD 20993 
 
After reviewing the request, FDAs User Fee Appeals Officer will issue a written decision. 
 
B.  Additional Procedures for Small Business Waiver Requests 
 
In addition to the information requested in section V(A)(1) of this document, a request for a 
waiver of the application fee on the grounds that the animal drug sponsor is a small business 
submitting its first new animal drug application to FDA for review must contain a certification 
that the requestor qualifies for the waiver.  Section 740(d)(3)(C) of the FD&C Act.  When 
applying for such a waiver, we recommend that a responsible officer of the entity certify: 
 
a)  that the entity has fewer than 500 employees, including employees of affiliates; 
and 
b)  that this is the first animal drug application the entity or any one of its affiliates 
has submitted to FDA for review. 
 
The request for a small business waiver should contain the following certification statement: 
 
I certify that to best of my knowledge that 1) [name of company] is a small business 
within the meaning of 21 U.S.C. 379j-12(d)(3) because [name of company] has fewer than 
500 employees, including employees of affiliates; and 2) this is the first animal drug 
application [name of company] or any of its affiliates has submitted to FDA for review.  I 
further certify that this is an accurate, true, and complete submission of information.  This 
statement is subject to criminal penalties for false statements as set forth in 18 U.S.C.  
1001. 
13  Contains Non-Binding Recommendations 
 
The Agency encourages requestors to time their small business waiver requests carefully to reduce 
the potential that the information provided as the basis of the request is no longer current when the 
animal drug application is submitted. 
 
C.  Additional Procedures for Significant Barrier to Innovation Waiver or Reduction 
Requests 
 
In addition to the information requested in section V(A)(1) of this document, a request for a fee 
waiver or reduction on the basis that the fee would present a significant barrier to innovation 
should contain the following information: 
 
1.  a statement of what the innovation is relating to the animal drug product for which the 
waiver is being requested, or other animal drug products or technologies the requestor 
is pursuing); 
2.  an explanation of why the requestor believes its product or technology is innovative 
(please see section IV (A)(1) above); 
3.  an analysis of why the fee or fees would present a significant barrier to the requestor's 
ability to develop, manufacture, or market the innovative product or technology; 
4.  A statement indicating whether the requestor has any affiliates, and if so, a list of those 
affiliates7; and 
5.  if the request is based on limited resources: 
a.  an estimate of the total fees that the requestor, including its affiliates, would be 
required to pay in the fiscal year; and 
b.  financial statements that show the resources available to the requestor, 
including its affiliates (please see section IV(A)(2)). 
 
D.  Additional Procedures for Fees Exceed Costs Waiver or Reduction Requests 
 
In addition to the information requested in section V(A)(1) of this document, a request for a fee 
waiver or reduction on the basis of fees exceeding costs should include a list of the requestors 
affiliates, as that term is defined in section 735(11) of the FD&C Act, from September 1, 2003, 
through September 30 of the year for which the request is made.  The information will be used to 
estimate the fees paid and the anticipated costs.  For each affiliate on the list, you should include 
the name, address, and phone number of the affiliates counsel or head of regulatory affairs so that 
FDA may contact the affiliate if necessary in reviewing the request. 
 
If a fee waiver or reduction is also requested under other provisions of ADUFA, then FDA intends 
to evaluate the other waiver or reduction requests first.  Only if it denies the other waiver or 
reduction request(s) would the Agency review the fees exceed costs request. 
 
7 What is an affiliate?  As defined at section 735(11) of the FD&C Act, an affiliate means a business entity that has a 
relationship with a second business entity if, directly or indirectly  a) one business entity controls, or has the power 
to control, the other business entity; or b) a third party controls, or has power to control, both of the business entities. 
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