**170**

**Guidance for Industry**

**Animal Drug User Fees**

**and Fee Waivers and Reductions**

**FINAL GUIDANCE**

This guidance provides industry the procedures that FDA recommends a
person to follow to request a fee waiver or reduction.

Comments and suggestions regarding this guidance 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-0124. Comments may also be
submitted electronically via the Internet at
<http://www.fda.gov/dockets/ecomments>. After bringing up this Internet
site, select "2004D-0124 Guidance for Industry Animal Drug User Fees and
Fee Waivers and Reductions" and follow the directions

For questions regarding this document, contact David Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Place, Rockville, MD 20855, 301-827-6967, e-mail:
<dnewkirk@cvm.fda.gov>.

Additional copies of this final guidance 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/cvm>*.*

**Paperwork Reduction Act Public Burden Statement**

According to the Paperwork Reduction Act of 1995, a collection of
information should display a valid OMB control number. The valid OMB
control number for this information collection is 0910-0540. It expires
September 30, 2004. The time required to complete this information
collection is estimated to average 2 hours per response, including the
time to review instructions, search existing data resources, and gather
the data needed, and complete and review the information collection.

**U.S. Department of Health and Human Services**

##### Food and Drug Administration

**Center for Veterinary Medicine (CVM)**

**March 15, 2004**

TABLE OF CONTENTS

[I. INTRODUCTION 3](#introduction)

II\. Payment of Fees Pending a Decision on a Waiver/Reduction
Request.....................\...\...3

[III. Types of Fees 4](#iii.-types-of-fees)

[A. Animal Drug Application and Supplement Fee
4](#a.-animal-drug-application-and-supplement-fee)

[B. Animal Drug Product Fee 4](#b.-animal-drug-product-fee)

[C. Animal Drug Establishment Fee 5](#c.-animal-drug-establishment-fee)

[D. Animal Drug Sponsor Fee 5](#d.-animal-drug-sponsor-fee)

[IV. Types of Fee Waivers and Reductions
5](#iv.-types-of-fee-waivers-and-reductions)

[A. Significant Barrier to Innovation
5](#a.-significant-barrier-to-innovation)

[B. Fees Exceed Costs 6](#b.-fees-exceed-costs)

[C. Free Choice Feeds 6](#c.-free-choice-feeds)

[D. Minor Use or Minor Species 7](#d.-minor-use-or-minor-species)

[E. Small Business 8](#e.-small-business)

[V. Procedures and Timing for Requesting Fee Waivers or Reductions
8](#v.-procedures-and-timing-for-requesting-fee-waivers-or-reductions)

[A. Procedures Applicable To All Requests for Waivers or Reductions
9](#a.-procedures-applicable-to-all-requests-for-waivers-or-reductions)

[B. Additional Procedures for Small Business Waiver Requests
13](#b.-additional-procedures-for-small-business-waiver-requests)

[C. Additional Procedures for Significant Barrier to Innovation Waiver
or Reduction
Requests.................................................................................................13](#c.-additional-procedures-for-significant-barrier-to-innovation-waiver-or-reduction-requests)

[D. Additional Procedures for Fees Exceed Costs Waiver or Reduction
Requests
14](#additional-procedures-for-fees-exceed-costs-waiver-or-reduction-requests)

**GUIDANCE FOR INDUSTRY**

Animal Drug User Fees and Fee Waivers and Reductions

**This guidance represents the Food and Drug Administration's (FDA's)
current thinking on this 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 appropriate number listed on the title page of this
guidance.**

# 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 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 requires the Agency to grant a
waiver from or a reduction of those fees in certain circumstances.

***FDA's guidance documents, including this guidance, do not establish
legally enforceable responsibilities. Instead, guidances describe the
Agency's 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 application 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.

# III. Types of Fees 

#  A. 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. Section 740(a)(1)(A)(i) of the FD&C Act. A
supplemental animal drug application is subject to fees if it requests 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. 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.

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. FDA intends to accept minor changes without
considering the amended application as resubmitted.

# B. 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.
FDA believes that this requirement applies to approved animal drug
products that have been listed or submitted for listing. ADUFA defines
the term "animal drug product" 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.

# C. 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.

# D. Animal Drug Sponsor Fee

ADUFA requires FDA to collect animal drug sponsor fees. 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, except for an approved
application for which all subject products have been removed from
listing under section 510 of the FD&C Act, 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 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. Each sponsor will pay only one such fee each fiscal year. Section
740(a)(4) 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.

# 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. If the
> request is based on limited resources, FDA believes that the most
> important considerations are likely to be the total ADUFA fees that
> the requestor would be required to pay in the fiscal year, the
> requestor\'s annual gross revenue, and all other resources available
> to the requestor. FDA interprets "person" in this provision to include
> the requestor\'s affiliates, as that term is defined in section 735(9)
> of the FD&C Act.

# B. Fees Exceed Costs

Section 740(d)(1)(B) 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 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, 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
FDA's 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:

> 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 interprets the term \"minor use\"
as it is defined in 21 CFR 514.1(d)(1)(i): the use of (a) new animal
drugs in minor animal species, or (b) new animal drugs in any animal
species for the control of a disease that occurs infrequently or occurs
in limited geographic areas.

Likewise, for the purpose of this provision, FDA interprets the term
\"minor species\" as it is defined in 21 CFR 514.1(d)(1)(ii): animals
other than cattle, horses, swine, chickens, turkeys, dogs and cats.

The Agency intends to waive or reduce sponsor and application fees only
if the application provides exclusively for a new minor species or minor
use indication. 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 waiver applies only to
the [first]{.underline} animal drug application that the small business
[or its affiliate]{.underline} 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 not 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. 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 FDA's Center for Veterinary
> Medicine (CVM) ADUFA Waiver Officer. Requests for waivers made on the
> basis that fees exceed costs will be reviewed and granted or denied by
> the Director of FDA's Office of Financial Management. To facilitate
> timely review and processing, these 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 fee or fees for which a waiver or reduction is
    requested, including:

    i.  *For application or supplement fees*:

        a.  the number of the NADA or supplemental NADA for which a
            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 FDA's 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 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);
    and

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:
>
> ADUFA Waiver Officer
>
> Office of New Animal Drug Evaluation, HFV-100
>
> 7500 Standish Place
>
> Rockville, MD 20855
>
> FDA will send a written acknowledgement of receipt of the 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
> Waiver Officer will forward fees exceed costs requests to the Director
> of the Office of Financial Management.
>
> 2\. Timing of a Fee Waiver Or Reduction Request
>
> If you plan to request a 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 after FY 2004 these fees are 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 Director's
> Review of the Request
>
> The 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 Officer's 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 FDA's 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.
>
> 4\. Requesting Reconsideration of a Decision
>
> If the Waiver Officer, or Director of FDA's 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 person's reasons for believing that
> the decision is in error, and should include any additional
> information necessary to support the person's position. The 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, which is described in the
> next two sections. You may, but are not required to, request
> reconsideration of the initial decision by the Waiver Officer or
> Office of Financial Management Director before seeking review of that
> decision.
>
> You should send the request for reconsideration to:
>
> CVM ADUFA Waiver Officer
>
> Office of New Animal Drug Evaluation, HFV-100
>
> 7500 Standish Place
>
> Rockville, MD 20855
>
> 5\. Requesting Review of the ADUFA Waiver Officer's Decision
>
> If the ADUFA Waiver Officer denies your waiver or reduction request or
> denies your request for reconsideration, you may seek review by CVM's
> ADUFA Appeals Officer. Please note that this does not apply to fees
> exceed costs waiver or reduction requests. Your request for review
> should contain a copy of the Waiver Officer's original decision; the
> Waiver Officer's 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:
>
> CVM ADUFA Appeals Officer (HFV-1)
>
> Center for Veterinary Medicine
>
> Food and Drug Administration
>
> 7519 Standish Place
>
> Rockville, MD 20855
>
> After reviewing the request, the CVM ADUFA Appeals Officer will issue
> a written decision.
>
> 6\. Requesting Review of the CVM ADUFA Appeals Officer's Decision or
> the Office of Financial Management Director's 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 FDA User Fee Appeals Officer (HF-3)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857

> After reviewing the request, FDA's User Fee Appeals Officer will issue
> a written decision.

# B. Additional Procedures for Small Business Waiver Requests

> 1\. Submitting the Waiver Request
>
> In addition to the information requested in section V (A)(1) of this
> document, a request for a small business waiver must contain a
> certification that the requestor qualifies for the waiver. Section
> 740(d)(3)(C) of the FD&C Act. For this, 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.

> 2\. FDA\'s Review of the Waiver Request
>
> In evaluating whether the entity meets the size criteria for the small
> business waiver, FDA intends to ask the Small Business Administration
> (SBA) to make a formal size determination under 13 CFR 121.1001(b)(6).
> The requestor will have to respond to information requested by the SBA
> in this process. If the requestor wishes to appeal SBA's
> determination, it should follow the procedures in 13 CFR 121.1101.
>
> 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 it is innovative;

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; and

4.  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.  the annual gross revenues and all other resources available to
        the requestor, including its affiliates.

# 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 affiliates, as defined in
section 735(9) of the FD&C Act. 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
affiliate's counsel or head of regulatory affairs so that FDA may
contact the affiliate if necessary in reviewing the request.

If a 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 requests
would the Agency review the fees exceed costs request.