#173

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.fda.gov/dockets/ecomments>.

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 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/cvm>.

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.

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**U.S. Department of Health and Human Services\
Food and Drug Administration**

**Center for Veterinary Medicine (CVM)\
February 7, 2005**

Guidance for Industry

**Animal Drug Sponsor Fees under the Animal Drug User Fee Act
(ADUFA)**[^1]

**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 FDA's current thinking on how it intends to
implement the animal drug sponsor fee provision of ADUFA.

***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. **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 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

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-   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 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:

-   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 processed[^3] 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 processed[^4] 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.

**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.\"

[^1]: This guidance has been prepared by the Office of New Animal Drug
    Evaluation in the Center for Veterinary Medicine, FDA.

[^2]: FDA believes that this includes products approved prior to 1962
    and then found effective under the Drug Efficacy Study
    Implementation (DESI) review process.

[^3]: FDA 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.