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Food and Drug Administration

Department of Health and Human Services

######### FY 2004 PERFORMANCE REPORT

######### TO THE CONGRESS

for the

**Animal Drug User Fee Act**

![](media/image2.png){width="2.1333333333333333in"
height="1.3583333333333334in"}

**Center for Veterinary Medicine**

# Commissioner's Report

I am pleased to present the Food and Drug Administration FY 2004
Performance Report to Congress for the Animal Drug User Fee Act (ADUFA)
of 2003. The ADUFA was enacted on November 18, 2003, and authorized the
Food and Drug Administration (FDA) to collect fees above base
appropriations needed to build and modernize the animal drug review
program. The Agency agreed, under this new Act, to meet a comprehensive
set of performance goals established to show significant improvement in
the timeliness and predictability of the new animal drug review process.
The report that follows presents the Agency's accomplishments for FY
2004, the first year operating under ADUFA. It is my pleasure to report
the FDA is meeting or exceeding each performance goal targeted for FY
2004.

As part of ADUFA implementation, the Agency has improved the new animal
drug review process, hired additional FDA staff, and prepared guidance
for the industry and staff. The Agency has also reached beyond the
established ADUFA performance goals to work collaboratively with the
industry to reduce the frequency of multiple review cycles in the new
animal drug application process.

While FDA's first year under ADUFA was highly productive and successful,
much work remains to complete the building process begun this year. In
FY 2005, FDA plans to do the following:

-   Continue hiring additional staff necessary to achieve the review
    capacity dictated by ADUFA.

-   Continue work already begun on management initiatives (including
    quality business systems and new information technology systems and
    solutions).

-   Develop improved standard operating procedures for review processes
    and develop scientific policies for review staff.

-   Issue guidance to the industry to clarify current Agency thinking.

-   Direct and target training and educational opportunities for staff
    and management to improve the knowledge base of the review
    organization.

The Agency is committed to improving the efficiency, quality, and
predictability of the new animal drug review process. We are dedicated
to exploring new approaches and technologies that offer high quality,
cost-effective improvements in FDA's review of new animal drug
applications and submissions. Under the leadership of the President and
in collaboration with the Congress and industry, the FDA looks forward
to the continued success and significant improvements in the animal drug
review process that ADUFA will make possible in the coming years.

> Lester M. Crawford, D.V.M., Ph.D.
>
> Acting Commissioner of Food and Drugs

**Executive Summary**

On November 18, 2003, the President signed the Animal Drug User Fee Act
of 2003 (ADUFA) into law. ADUFA amends the Federal Food, Drug, and
Cosmetic Act to authorize FDA to collect user fees from new animal drug
sponsors. In exchange for this authority, ADUFA requires FDA to pursue a
comprehensive set of review performance goals and commitments to improve
the timeliness and predictability of the review of new animal drug
applications (NADAs) and investigational new animal drug (INAD)
submissions. This report describes FDA's accomplishments in FY 2004
toward meeting the performance goals prescribed under ADUFA.

**FY 2004 Activities and Accomplishments**

**FY 2004 ADUFA Performance.** FDA met or exceeded all the review time
frames defined under ADUFA for FY 2004 for applications and submissions
that have been acted on as of September 30, 2004. Additional
applications and submissions received in FY 2004 are pending review and
action, but are still within ADUFA time frames.

FY 2004 performance will be updated in FY 2005 to reflect these pending
actions.

**FDA Backlog.** The 833 submissions not associated with abbreviated new
animal drug applications (ANADAs) that were pending before September 30,
2003, have been reviewed and acted upon**.** FDA was required to review
and act on pending NADAs, supplemental NADAs, and INAD submissions
within 24 months after user fee payments were initiated.

**FDA Hiring.** FDA has made substantial progress in recruiting for its
review staff and will meet its goal of having 50 percent of additional
FDA review staff recruited and on-board by the first quarter of FY 2006.

**Guidance Development.** On March 15, 2004, the Agency published
*Guidance for Industry #170 Animal Drug User Fees and Fee Waivers and
Reductions* to help industry understand the ADUFA fee structure and the
options available to individuals who qualify for a fee waiver or
reduction. On September 28, 2004, the Agency published *Guidance for
Industry #173 Animal Drug Sponsor Fees under the Animal Drug User Fee
Act (Draft Guidance).*

**Implementation Plans for FY 2005**

During FY 2005, FDA will expand its efforts, through employee hiring,
training, and guidance development to improve the timeliness and
efficiency of animal drug review programs and build FDA's capacity to
meet the more challenging goals set for later years.

-   **Employee Hiring.** FDA plans to hire the remaining review staff
    allocated to help meet the ADUFA performance goals by the end of the
    fiscal year and for project managers to guide the animal drug review
    process more efficiently. Higher levels of professional development
    will be offered to review scientists to maintain and further develop
    the cutting edge knowledge base they need to review emerging
    technologies in drug development.

-   **Management Initiatives.** FDA will continue to develop standard
    operating procedures for review processes, scientific policies for
    review staff, and procedures for expedient resolution of scientific
    issues. FDA will continue to implement a quality business system
    using an activity-based model to demonstrate better
    performance-to-budget efficiency and to explore, and propose as
    needed, new IT systems and solutions for electronic receipt, review,
    and standardization of NADA submissions.

-   **Guidance Development.** FDA will continue to develop and issue
    guidance to the industry clarifying current Agency thinking.

-   **Staff Training.** FDA will direct and target training and
    educational opportunities for staff and management to improve the
    knowledge base of the review organization.

# Table of Contents

**Introduction [1](#introduction)**

##### 

##### Overview of ADUFA [2](#overview-of-adufa) 

**ADUFA Implementation \... [4](#adufa-implementation)**

##  FY 2004 Activities and Accomplishments [4](#section-2) 

####  Implementation Plans for FY 2005 [4](#section-4) 

**Report on FY 2004 ADUFA Performance
[6](#report-on-fy-2004-adufa-performance)**

**Original NADAs and Reactivations
[7](#original-nadas-and-reactivations)**

#######  Non-Manufacturing Supplemental NADAs and Reactivations [9](#non-manufacturing-supplemental-nadas-and-reactivations) 

**Manufacturing Supplemental NADAs and Reactivations**
**[11](#manufacturing-supplemental-nadas-and-reactivations)**

**INAD Study Submissions [13](#inad-study-submissions)**

**INAD Study Protocol Submissions
[15](#inad-study-protocol-submissions)**

**Administrative NADAs and Reactivations
[17](#administrative-nadas-and-reactivations)**

**Abbreviated New Animal Drug Applications 19**

**Appendices:**

> **Appendix A: Secretary Thompson's Letter to Congress**

Appendix B: ADUFA Performance Goals

# Introduction

The Animal Drug User Fee Act of 2003 (ADUFA) was enacted on November 18,
2003. This statute authorized FDA to collect user fees for certain
applications and supplements, establishments, products, and sponsors to
support the review of new animal drugs. The Consolidated Appropriations
Act of 2004, enacted on January 23, 2004, contained a required
appropriations action enabling FDA's implementation of ADUFA. In return
for stable appropriations and user fees, FDA must meet certain
performance goals for the review of certain submissions over the next 5
years. Information about ADUFA, including the text of Secretary
Thompson's November 13, 2003, letter to Congress are located in Appendix
A and can also be found at <http://www.fda.gov./oc/adufa>.

This year's report summarizes FDA's progress in implementing ADUFA in FY
2004 and in meeting quantifiable ADUFA review goals for FY 2004. The
report also describes FDA's implementation plans for FY 2005.

ADUFA requires the Secretary to submit two annual reports to Congress
for each fiscal year fees are collected: 1) a performance report due
within 60 days of the end of the fiscal year, and 2) a financial report
within 120 days of the end of the fiscal year. This document fulfills
the first of these requirements for FY 2004.

# Overview of ADUFA

The ADUFA was signed into law on November 18, 2003, amending the Federal
Food, Drug, and Cosmetic Act to provide FDA important new
responsibilities, resources, and challenges. The goal of ADUFA is to
better serve animal health and public health by providing additional
funds to augment the FDA resources devoted to "the process for review of
new animal drug applications."

ADUFA established review performance goals for the Agency. These goals
aim to expedite the review of NADAs, supplemental NADAs, and INAD
submissions.

This program is similar to the Prescription Drug User Fee Act (PDUFA)
program for human drugs that has been in place for over 10 years and the
recently enacted Medical Device User Fee and Modernization Act (MDUFMA).
It is expected that ADUFA, like PDUFA and MDUFMA, will help FDA expedite
and improve its review of applications for new animal drugs so that safe
and effective new products will be available more quickly. The
guidelines and definitions below apply to FDA's implementation of ADUFA.
Further information can be found in Appendix A and can also be found at
<http://www.fda.gov./oc/adufa>

> **Review and Act On Applications and Submissions.** The term \"review
> and act on\" is understood to mean the issuance of a complete action
> letter after the complete review of an animal drug application,
> supplemental animal drug application, or investigational drug
> submission which either (1) approves an animal drug application or
> supplemental application or notifies a sponsor that an investigational
> new animal drug submission is complete or (2) sets forth in detail the
> specific deficiencies in such animal drug application, supplemental
> animal drug application, or investigational animal drug submission in
> condition for approval.
>
> **Refuse to File Applications and Refuse to Review Submissions.**
> Within 30 days of submission, FDA shall "refuse to file" an animal
> drug application, supplemental animal drug application, or their
> reactivation, which is determined to be insufficient on its face or
> otherwise of unacceptable quality for review upon initial inspection
> as per 21 CFR 514.110. Thus, the Agency will refuse to file an
> application containing numbers or types of errors, or flaws in the
> development plan, sufficient to cause the quality of the entire
> submission to be questioned to the extent that it cannot reasonably be
> reviewed. Within 60 days of submission, FDA will refuse to review an
> investigational animal drug submission which is determined to be
> insufficient on its face or otherwise of unacceptable quality upon
> initial inspection using criteria and procedures similar to those
> found in
>
> 21 CFR 514.110. A decision to refuse to file an application or to
> refuse to review a submission as described above will result in the
> application or submission not being entered into the cohort upon which
> the relevant user fee goal is based. The Agency will keep a record of
> the numbers and types of such refusals and include them in its annual
> performance report.

**Progressive Goal Setting Over Five Years**

The ADUFA performance goals are progressive over a 5-year period with
each year requiring FDA to review and act in shorter periods of time.
The fifth year of ADUFA will end on September 30, 2008. In that fifth
year, FDA will be required to review and act on 90 percent of the
following submissions within the following specified times:

-   Complete NADAs and reactivations of such applications within 180
    days after submission date.

-   Non-manufacturing supplemental NADAs (i.e., supplemental NADAs for
    which safety or effectiveness data are required) and reactivations
    of such supplemental applications within 180 days after submission
    date.

-   Manufacturing supplemental NADAs and reactivations of such
    supplemental applications within 120 days after submission date.

-   INAD study submissions within 180 days after submission date.

-   INAD submissions consisting of protocols, that the Agency and the
    sponsor consider to be an essential part of the basis for making the
    decision to approve or not approve an animal drug application or
    supplemental animal drug application, without substantial data
    within 50 days after submission date.

-   Administrative NADAs submitted after all scientific decisions have
    been made in the investigational animal drug process, (i.e., prior
    to submission of the NADA) within 60 days after submission date.

The five-year progression of these goals is presented in Appendix B.

**Fiscal Year Receipt Cohorts**

All FDA review performance statistics are based on a fiscal year receipt
cohort. This methodology calculates performance statistics for
submissions for the fiscal year FDA received them, regardless of when
FDA ultimately acted on or approved the submissions. A consequence of
this approach is that the statistics shown for a particular year may
change from one report to the next. This is because as time passes, FDA
completes work on more and more submissions in a receipt cohort. As more
submissions are completed, the statistics for that year of receipt must
be adjusted to reflect the new completions. Until all submissions in a
cohort are completed, only a preliminary performance assessment can be
provided for that cohort. With the exception of this report, where only
information for the first reporting year (FY 2004) is available, FDA
will report, in subsequent years on two performance years for ADUFA
performance. Starting with the FY 2005 report, the status of the current
year and an update on the previous year will be included.

# ADUFA Implementation

# 

FDA is taking action, as part of its ADUFA implementation, to address
backlogs and hire new employees. These actions are intended to position
FDA to meet the progressively challenging performance goals of ADUFA.
Concurrently, FDA is also addressing more immediate needs.

# 

# FY 2004 Activities and Accomplishments

# 

FDA has met or exceeded all of the interim goals for FY 2004.

-   **Interim Backlog Goal.** On September 30, 2003, FDA had 833 pending
    submissions not associated with ANADAs. All submissions not
    associated with ANADAs that were pending before September 30, 2003,
    have been reviewed.

-   **Employee Hiring**. FDA has made substantial progress in recruiting
    for its review staff and will meet its goal of having 50 percent of
    additional FDA review staff recruited and on-board by the first
    quarter of FY 2006.

-   **Interim Application/Submission Review Goals.** FDA has met or
    exceeded all the interim review time frames for FY 2004.

-   **Guidance Development.** On March 15, 2004, the Agency published a
    guidance document on animal drug user fees, fee waivers, and fee
    reductions (*Guidance for Industry #170 Animal Drug User Fees and
    Fee Waivers and Reductions*) to help industry understand the ADUFA
    fee structure and what options are available to those individuals
    who may quality for a fee waiver or reduction. On September 28,
    2004, the Agency published a guidance document, *Guidance for
    Industry #173 Animal Drug Sponsor Fees under the Animal Drug User
    Fee Act (Draft Guidance),* that discusses how the Agency intends to
    implement the animal drug sponsor fee provision of ADUFA.

# 

# Implementation Plans for FY 2005

During FY 2005, FDA will expand its efforts, through employee hiring,
training, and guidance development, to improve the timeliness and
efficiency of animal drug review programs and build FDA's capacity to
meet the more challenging goals set for later years.

-   **Employee Hiring.** FDA plans to hire the remaining review staff
    allocated to help meet the ADUFA performance goals by the end of the
    fiscal year. Project managers will be hired to guide the animal drug
    review process more efficiently. Higher levels of professional
    development will be offered to review scientists to help them
    maintain and further develop the cutting edge knowledge base they
    need to review emerging technologies in drug development.

-   **Management Initiatives.** FDA will continue to develop standard
    operating procedures for review processes, scientific policies for
    review staff, and procedures for expedient resolution of scientific
    issues. FDA will continue to implement a quality business system
    using an activity-based model to demonstrate better
    performance-to-budget efficiency and to explore, and propose as
    needed, new IT systems and solutions for electronic receipt, review,
    and standardization of NADA submissions.

-   **Guidance Development.** FDA will continue to issue guidance to the
    industry clarifying current Agency thinking.

-   **Staff Training.** FDA will direct and target training and
    educational opportunities for staff and management to improve the
    knowledge base of the review organization, including core curricula
    for new reviewers, policy and procedure competency, and expansion of
    the scientific knowledge base.

#  

# Report on FY 2004 ADUFA Performance 

This report presents the Agency's review performance as related to ADUFA
performance goals and commitments in FY 2004. Only a preliminary
performance assessment on applications submitted during FY 2004 is
possible now. For submission categories with a longer review goal (e.g.,
320 days), early review performance data is limited. For those
submission categories with a review goal that is shorter (e.g., 90 days)
performance on submissions received early in the fiscal year provides an
early indicator of final review performance. Unless otherwise noted, all
performance data in this section are as of September 30, 2004.

# Original NADAs and Reactivations

**[Goal]{.underline} - Review and act on original NADAs and
reactivations**

The ADUFA goal for applications received in FY 2004 requires FDA to
review and act on 90 percent of complete NADAs and reactivations of such
applications within 295 days after the submission date. Under ADUFA, FDA
will gradually reduce the target review time from 295 days for
submissions received in FY 2004 to 180 days for submissions received in
FY 2008. The table below summarizes the review time goals for original
NADAs and reactivations of such applications.

+----------------+-----+------+---+-----+-----+------+---+------------------+
| **Original     | **  |      |   |     |     |      | * |                  |
| Application    | Rev |      |   |     |     |      | * |                  |
| Type**         | iew |      |   |     |     |      | P |                  |
|                | T   |      |   |     |     |      | e |                  |
|                | ime |      |   |     |     |      | r |                  |
|                | Goa |      |   |     |     |      | f |                  |
|                | l** |      |   |     |     |      | o |                  |
|                |     |      |   |     |     |      | r |                  |
|                |     |      |   |     |     |      | m |                  |
|                |     |      |   |     |     |      | a |                  |
|                |     |      |   |     |     |      | n |                  |
|                |     |      |   |     |     |      | c |                  |
|                |     |      |   |     |     |      | e |                  |
|                |     |      |   |     |     |      | G |                  |
|                |     |      |   |     |     |      | o |                  |
|                |     |      |   |     |     |      | a |                  |
|                |     |      |   |     |     |      | l |                  |
|                |     |      |   |     |     |      | * |                  |
|                |     |      |   |     |     |      | * |                  |
|                |     |      |   |     |     |      |   |                  |
|                |     |      |   |     |     |      | * |                  |
|                |     |      |   |     |     |      | * |                  |
|                |     |      |   |     |     |      | F |                  |
|                |     |      |   |     |     |      | Y |                  |
|                |     |      |   |     |     |      | 0 |                  |
|                |     |      |   |     |     |      | 4 |                  |
|                |     |      |   |     |     |      | - |                  |
|                |     |      |   |     |     |      | - |                  |
|                |     |      |   |     |     |      | F |                  |
|                |     |      |   |     |     |      | Y |                  |
|                |     |      |   |     |     |      | 0 |                  |
|                |     |      |   |     |     |      | 8 |                  |
|                |     |      |   |     |     |      | * |                  |
|                |     |      |   |     |     |      | * |                  |
|                |     |      |   |     |     |      |   |                  |
|                |     |      |   |     |     |      | * |                  |
|                |     |      |   |     |     |      | * |                  |
|                |     |      |   |     |     |      | S |                  |
|                |     |      |   |     |     |      | u |                  |
|                |     |      |   |     |     |      | b |                  |
|                |     |      |   |     |     |      | m |                  |
|                |     |      |   |     |     |      | i |                  |
|                |     |      |   |     |     |      | s |                  |
|                |     |      |   |     |     |      | s |                  |
|                |     |      |   |     |     |      | i |                  |
|                |     |      |   |     |     |      | o |                  |
|                |     |      |   |     |     |      | n |                  |
|                |     |      |   |     |     |      | s |                  |
|                |     |      |   |     |     |      | * |                  |
|                |     |      |   |     |     |      | * |                  |
+----------------+-----+------+---+-----+-----+------+---+------------------+
|                | *   | **FY |   | *   | *   | **FY |   |                  |
|                | *FY | 05** |   | *FY | *FY | 08** |   |                  |
|                | 0   |      |   | 0   | 0   |      |   |                  |
|                | 4** |      |   | 6** | 7** |      |   |                  |
+----------------+-----+------+---+-----+-----+------+---+------------------+
| NADAs and      | 295 | 270  | 2 |     | 200 | 180  |   | 90% on time      |
| Reactivations  |     |      | 3 |     |     |      |   |                  |
|                | d   | days | 0 |     | d   | days |   |                  |
|                | ays |      |   |     | ays |      |   |                  |
|                |     |      | d |     |     |      |   |                  |
|                |     |      | a |     |     |      |   |                  |
|                |     |      | y |     |     |      |   |                  |
|                |     |      | s |     |     |      |   |                  |
+----------------+-----+------+---+-----+-----+------+---+------------------+

![](media/image3.wmf)**[Workload]{.underline}**

During FY 2004, seven original NADAs and reactivations were submitted to
FDA and accepted for filing.[^1] One original NADA received a "refuse to
file" notification.

  ------------------- ---------- ---------- ---------- ---------- ----------
  **Original                                                      
  Applications                                                    
  Filed**                                                         

  **Filed**           **FY 04**  **FY 05**  **FY 06**  **FY 07**  **FY 08**

  NADAs and           7          \--        \--        \--        \--
  Reactivations                                                   
  ------------------- ---------- ---------- ---------- ---------- ----------

#  

# Original NADAs and Reactivations

**[Performance]{.underline}**

**FY 2004 Submissions**

As of September 30, 2004, approximately 71 percent (5 of 7) of the
original NADAs and reactivations were reviewed and acted on within 295
days. With 2 submissions still pending and not overdue, it is too early
to make a final performance determination for FY 2004. The table below
reflects FDA's performance for these submissions that were reviewed and
acted on in FY 2004.

+---------------+--------+---------+--------+------------+-----------+
| ###### FY 200 |        |         |        |            |           |
| 4 Submissions |        |         |        |            |           |
+---------------+--------+---------+--------+------------+-----------+
| **Original**  | **     | **R     | **     | **ADUFA    | **        |
|               | Review | eviewed | Number | P          | Percent** |
| **            | Wi     | and**   | On     | erformance |           |
| Application** | thin** |         | Time** | Goal**     | **on      |
|               |        | **Acted |        |            | Time**    |
| **Type**      |        | On**    |        |            |           |
+---------------+--------+---------+--------+------------+-----------+
| NADAs and     | 295    | 5       | 5      | 90%        | 100%      |
| Reactivations | days   |         |        |            |           |
+---------------+--------+---------+--------+------------+-----------+

# Non-Manufacturing Supplemental NADAs and Reactivations

**[Goal]{.underline} - Review and act on non-manufacturing supplemental
NADAs and reactivations**

The ADUFA goal for applications received in FY 2004 requires FDA to
review and act on 90 percent of the non-manufacturing supplemental NADAs
(i.e., supplemental animal drug applications for which safety or
effectiveness data are required) and reactivations of such supplemental
applications within 320 days after the submission date. Under ADUFA, FDA
will gradually reduce the target review time from 320 days for
submissions received in FY 2004 to 180 days for submissions received in
FY 2008. The table below summarizes the review time goals for
non-manufacturing supplemental NADAs and reactivations of such
supplemental NADAs.

<table>
<colgroup>
<col style="width: 26%" />
<col style="width: 9%" />
<col style="width: 10%" />
<col style="width: 0%" />
<col style="width: 9%" />
<col style="width: 0%" />
<col style="width: 9%" />
<col style="width: 0%" />
<col style="width: 8%" />
<col style="width: 27%" />
</colgroup>
<tbody>
<tr class="odd">
<td rowspan="2"><strong>Non-Manufacturing Submission Type</strong></td>
<td colspan="8"><strong>Review Time Goal</strong></td>
<td rowspan="2"><p><strong>Performance Goal</strong></p>
<p><strong>FY 04 – FY 08</strong></p>
<p><strong>Submissions</strong></p></td>
</tr>
<tr class="even">
<td><strong>FY 04</strong></td>
<td colspan="2"><strong>FY 05</strong></td>
<td colspan="2"><strong>FY 06</strong></td>
<td colspan="2"><strong>FY 07</strong></td>
<td><strong>FY 08</strong></td>
</tr>
<tr class="odd">
<td>Supplemental NADAs and Reactivations</td>
<td><p>320</p>
<p>days</p></td>
<td><p>285</p>
<p>days</p></td>
<td colspan="2"><p>235</p>
<p>days</p></td>
<td colspan="2"><p>200</p>
<p>days</p></td>
<td colspan="2"><p>180</p>
<p>days</p></td>
<td>90% on time</td>
</tr>
</tbody>
</table>

![](media/image4.wmf)**[Workload]{.underline}**

During FY 2004, 14 non-manufacturing supplemental NADAs and
reactivations were submitted to FDA.

+--------------------------+-------+-------+-------+-------+-------+
| **Non-Manufacturing      |       |       |       |       |       |
| Submissions**            |       |       |       |       |       |
+--------------------------+-------+-------+-------+-------+-------+
| **Type**                 | **FY  | **FY  | **FY  | **FY  | **FY  |
|                          | 04**  | 05**  | 06**  | 07**  | 08**  |
+--------------------------+-------+-------+-------+-------+-------+
| Supplemental NADAs       | 14    | \--   | \--   | \--   | \--   |
|                          |       |       |       |       |       |
| and Reactivations        |       |       |       |       |       |
+--------------------------+-------+-------+-------+-------+-------+

#  

# Non-Manufacturing Supplemental NADAs and Reactivations

**[Performance]{.underline}**

**FY 2004 Submissions**

As of September 30, 2004, approximately 57 percent (8 of 14) of the
non-manufacturing supplemental NADAs and reactivations had been reviewed
and acted on within the 320 days. With six submissions still pending and
not overdue, it is too early to make a final performance determination
for FY 2004. The table below reflects FDA's performance for these
submissions that were reviewed and acted on in FY 2004. The FY 2005
ADUFA report will provide an update for FY 2004 submissions and report
on FY 2005 submissions.

+----------------+--------+---------+--------+-----------+-----------+
| ###### FY 20   |        |         |        |           |           |
| 04 Submissions |        |         |        |           |           |
+----------------+--------+---------+--------+-----------+-----------+
| **Non-M        | **     | **R     | **     | **ADUFA   | **Percent |
| anufacturing** | Review | eviewed | Number | Pe        | on Time** |
| **Submission** | Wi     | and**   | On     | rformance |           |
|                | thin** |         | Time** | Goal**    |           |
| **Type**       |        | **Acted |        |           |           |
|                |        | On**    |        |           |           |
+----------------+--------+---------+--------+-----------+-----------+
| Supplemental   | 320    | 8       | 8      | 90%       | 100%      |
| NADAs and      | days   |         |        |           |           |
| Reactivations  |        |         |        |           |           |
+----------------+--------+---------+--------+-----------+-----------+

# Manufacturing Supplemental NADAs and Reactivations

**[Goal]{.underline} - Review and act on manufacturing supplemental
NADAs and reactivations**

The ADUFA goal for applications received in FY 2004 requires FDA to
review and act on 90 percent of the manufacturing supplemental NADAs
(i.e., supplemental animal drug applications for which safety or
effectiveness data are required) and reactivations of such supplemental
applications within 225 days after submission date. Under ADUFA, FDA
will gradually reduce the target review time from 225 days for
submissions received in FY 2004 to 120 days for submissions received in
FY 2007 and FY 2008. The table below summarizes the review time goals
for manufacturing supplemental NADAs and reactivations of such
supplemental NADAs.

+-----------------+-----+-----+-----+-----+-----+------------------+
| **Manufacturing | **  |     |     |     |     | **Performance    |
| Submission      | Rev |     |     |     |     | Goal**           |
| Type**          | iew |     |     |     |     |                  |
|                 | T   |     |     |     |     | **FY 04 -- FY    |
|                 | ime |     |     |     |     | 08**             |
|                 | Goa |     |     |     |     |                  |
|                 | l** |     |     |     |     | **Submissions**  |
+-----------------+-----+-----+-----+-----+-----+------------------+
|                 | *   | *   | *   | *   | *   |                  |
|                 | *FY | *FY | *FY | *FY | *FY |                  |
|                 | 0   | 0   | 0   | 0   | 0   |                  |
|                 | 4** | 5** | 6** | 7** | 8** |                  |
+-----------------+-----+-----+-----+-----+-----+------------------+
| Supplemental    | 225 | 190 | 140 | 120 | 120 | 90% on time      |
| NADAs and       |     |     |     |     |     |                  |
| Reactivations   | d   | d   | d   | d   | d   |                  |
|                 | ays | ays | ays | ays | ays |                  |
+-----------------+-----+-----+-----+-----+-----+------------------+

![](media/image5.wmf)**[Workload]{.underline}**

During FY 2004, 357 manufacturing supplemental NADAs and reactivations
were submitted to FDA and accepted for filing. Two manufacturing
supplemental NADAs received a "refuse to file" notification.

+--------------------------+-------+-------+-------+-------+-------+
| **Manufacturing          |       |       |       |       |       |
| Submissions**            |       |       |       |       |       |
+--------------------------+-------+-------+-------+-------+-------+
| **Type**                 | **FY  | **FY  | **FY  | **FY  | **FY  |
|                          | 04**  | 05**  | 06**  | 07**  | 08**  |
+--------------------------+-------+-------+-------+-------+-------+
| Supplemental NADAs       | 357   | \--   | \--   | \--   | \--   |
|                          |       |       |       |       |       |
| and Reactivations        |       |       |       |       |       |
+--------------------------+-------+-------+-------+-------+-------+

#  

# Manufacturing Supplemental NADAs and Reactivations

**[Performance]{.underline}**

**FY 2004 Submissions**

As of September 30, 2004, approximately 64 percent (230 of 357) of the
manufacturing supplemental NADAs and reactivations were reviewed and
acted on within the 225 days. With 127 submissions still pending and not
overdue, it is too early to make a final performance determination for
FY 2004. The table below reflects FDA's performance for these
submissions that were reviewed and acted on in FY 2004. The FY 2005
ADUFA report will provide an update for FY 2004 submissions and report
on FY 2005 submissions.

+---------------+--------+---------+--------+-----------+-----------+
| ###### FY 200 |        |         |        |           |           |
| 4 Submissions |        |         |        |           |           |
+---------------+--------+---------+--------+-----------+-----------+
| **Ma          | **     | **R     | **     | **ADUFA   | **Percent |
| nufacturing** | Review | eviewed | Number | Perf      | On Time** |
| *             | Wi     | and**   | On     | ormance** |           |
| *Submission** | thin** |         | Time** |           |           |
|               |        | **Acted |        | **Goal**  |           |
| **Type**      |        | On**    |        |           |           |
+---------------+--------+---------+--------+-----------+-----------+
| Supplemental  | 225    | 230     | 230    | 90%       | 100%      |
| NADAs and     | days   |         |        |           |           |
| Reactivations |        |         |        |           |           |
+---------------+--------+---------+--------+-----------+-----------+

# INAD Study Submissions

**[Goal]{.underline} - Review and act on INAD study submissions**

The ADUFA goal for submissions received in FY 2004 requires FDA to
review and act on 90 percent of the INAD study submissions within 320
days after the submission date. Under ADUFA, FDA will gradually reduce
the target review time from 320 days for submissions received in FY 2004
to 180 days for submissions received in FY 2008. The table below
summarizes the review time goals for INAD study submissions.

<table style="width:100%;">
<colgroup>
<col style="width: 26%" />
<col style="width: 9%" />
<col style="width: 10%" />
<col style="width: 0%" />
<col style="width: 9%" />
<col style="width: 0%" />
<col style="width: 9%" />
<col style="width: 0%" />
<col style="width: 8%" />
<col style="width: 27%" />
</colgroup>
<tbody>
<tr class="odd">
<td rowspan="2"><strong>Submission Type</strong></td>
<td colspan="8"><strong>Review Time Goal</strong></td>
<td rowspan="2"><p><strong>Performance Goal</strong></p>
<p><strong>FY 04 – FY 08</strong></p>
<p><strong>Submissions</strong></p></td>
</tr>
<tr class="even">
<td><strong>FY 04</strong></td>
<td colspan="2"><strong>FY 05</strong></td>
<td colspan="2"><strong>FY 06</strong></td>
<td colspan="2"><strong>FY 07</strong></td>
<td><strong>FY 08</strong></td>
</tr>
<tr class="odd">
<td>INAD Studies</td>
<td><p>320</p>
<p>days</p></td>
<td><p>285</p>
<p>days</p></td>
<td colspan="2"><p>235</p>
<p>days</p></td>
<td colspan="2"><p>200</p>
<p>days</p></td>
<td colspan="2"><p>180</p>
<p>days</p></td>
<td>90% on time</td>
</tr>
</tbody>
</table>

![](media/image6.wmf)**[Workload]{.underline}**

During FY 2004, 251 INAD study submissions were submitted to FDA and
accepted for filing. One INAD study submission received a "refuse to
review" notification.

  -------------------------- -------- -------- -------- -------- --------
  **INAD Study Submissions**                                     

  **Type**                   **FY     **FY     **FY     **FY     **FY
                             04**     05**     06**     07**     08**

  INAD Studies               251      \--      \--      \--      \--
  -------------------------- -------- -------- -------- -------- --------

# INAD Study Submissions

**[Performance]{.underline}**

**FY 2004 Submissions**

As of September 30, 2004, approximately 43 percent (107 of 251) of the
INAD study submissions had been reviewed and acted on within 320 days.
With 144 submissions still pending and not overdue, it is too early to
report final review performance determination for FY 2004. The table
below reflects FDA's performance for these submissions that were
reviewed and acted on in FY 2004. The FY 2005 ADUFA report will provide
an update for FY 2004 submissions and report on FY 2005 submissions.

+---------------+--------+---------+--------+------------+-----------+
| ###### FY 200 |        |         |        |            |           |
| 4 Submissions |        |         |        |            |           |
+---------------+--------+---------+--------+------------+-----------+
| *             | **     | **R     | **     | **ADUFA    | **Percent |
| *Submission** | Review | eviewed | Number | Per        | on Time** |
|               | Wi     | and**   | On     | formance** |           |
| **Type**      | thin** |         | Time** |            |           |
|               |        | **Acted |        | **Goal**   |           |
|               |        | On**    |        |            |           |
+---------------+--------+---------+--------+------------+-----------+
| INAD Studies  | 320    | 107     | 107    | 90%        | 100%      |
|               | days   |         |        |            |           |
+---------------+--------+---------+--------+------------+-----------+

# INAD Study Protocol Submissions

**[Goal]{.underline} - Review and act on INAD study protocol
submissions**

The ADUFA goal for submissions received in FY 2004 requires FDA to
review and act on 90 percent of INAD study protocol submissions within
125 days after the submission date. Under ADUFA, FDA will gradually
reduce the target review time from 125 days for submissions received in
FY 2004 to 50 days for submissions received in FY 2008. The table below
summarizes the review time goals for INAD study protocol submissions.

<table style="width:100%;">
<colgroup>
<col style="width: 26%" />
<col style="width: 9%" />
<col style="width: 10%" />
<col style="width: 0%" />
<col style="width: 9%" />
<col style="width: 0%" />
<col style="width: 9%" />
<col style="width: 0%" />
<col style="width: 8%" />
<col style="width: 27%" />
</colgroup>
<tbody>
<tr class="odd">
<td rowspan="2"><strong>Submission Type</strong></td>
<td colspan="8"><strong>Review Time Goal</strong></td>
<td rowspan="2"><p><strong>Performance Goal</strong></p>
<p><strong>FY 04 – FY 08</strong></p>
<p><strong>Submissions</strong></p></td>
</tr>
<tr class="even">
<td><strong>FY 04</strong></td>
<td colspan="2"><strong>FY 05</strong></td>
<td colspan="2"><strong>FY 06</strong></td>
<td colspan="2"><strong>FY 07</strong></td>
<td><strong>FY 08</strong></td>
</tr>
<tr class="odd">
<td>INAD Protocols</td>
<td><p>125</p>
<p>days</p></td>
<td><p>100</p>
<p>days</p></td>
<td colspan="2"><p>80</p>
<p>days</p></td>
<td colspan="2"><p>60</p>
<p>days</p></td>
<td colspan="2"><p>50</p>
<p>days</p></td>
<td>90% on time</td>
</tr>
</tbody>
</table>

![](media/image7.wmf)**[Workload]{.underline}**

During FY 2004, 224 INAD protocols were submitted to FDA and accepted
for filing. Four INAD protocols received a "refuse to review"
notification.

  -------------------------- -------- -------- -------- -------- --------
  **INAD Protocol                                                
  Submissions**                                                  

  **Type**                   **FY     **FY     **FY     **FY     **FY
                             04**     05**     06**     07**     08**

  INAD Protocols             224      \--      \--      \--      \--
  -------------------------- -------- -------- -------- -------- --------

# 

# 

# INAD Study Protocol Submissions

**[Performance]{.underline}**

**FY 2004 Submissions**

As of September 30, 2004, approximately 66 percent (147 of 224) of the
INAD study protocols had been reviewed and acted on within 125 days.
With 77 submissions still pending and not overdue, it is too early to
report final review performance determinations for FY 2004. The table
below reflects FDA's performance for these submissions that were
reviewed and acted on in FY 2004. The FY 2005 ADUFA report will provide
an update for FY 2004 submissions and report on FY 2005 submissions.

+---------------+--------+---------+--------+------------+-----------+
| ###### FY 200 |        |         |        |            |           |
| 4 Submissions |        |         |        |            |           |
+---------------+--------+---------+--------+------------+-----------+
| *             | **     | **R     | **     | **ADUFA    | **Percent |
| *Submission** | Review | eviewed | Number | Per        | on Time** |
|               | Wi     | and**   | On     | formance** |           |
| **Type**      | thin** |         | Time** |            |           |
|               |        | **Acted |        | **Goal**   |           |
|               |        | On**    |        |            |           |
+---------------+--------+---------+--------+------------+-----------+
| INAD          | 125    | 147     | 147    | 90%        | 100%      |
| Protocols     | days   |         |        |            |           |
+---------------+--------+---------+--------+------------+-----------+

# Administrative NADAs and Reactivations

# 

**[Goal]{.underline} - Review and act on administrative NADAs and
reactivations**

The ADUFA goal for applications received in FY 2004 requires FDA to
review and act on 90 percent of administrative NADAs and reactivations
of such applications within 90 days after the submission date. Under
ADUFA, FDA will gradually reduce the target review time from 90 days for
submissions received in FY 2004 to 60 days for submissions received in
FY 2008. The table below summarizes the review time goals for
administrative NADAs and reactivations of such applications.

<table style="width:100%;">
<colgroup>
<col style="width: 26%" />
<col style="width: 9%" />
<col style="width: 10%" />
<col style="width: 0%" />
<col style="width: 9%" />
<col style="width: 0%" />
<col style="width: 9%" />
<col style="width: 0%" />
<col style="width: 8%" />
<col style="width: 27%" />
</colgroup>
<tbody>
<tr class="odd">
<td rowspan="2"><p><strong>Submission</strong></p>
<p><strong>Type</strong></p></td>
<td colspan="8"><strong>Review Time Goal</strong></td>
<td rowspan="2"><p><strong>Performance Goal</strong></p>
<p><strong>FY 04 – FY 08</strong></p>
<p><strong>Submissions</strong></p></td>
</tr>
<tr class="even">
<td><strong>FY 04</strong></td>
<td colspan="2"><strong>FY 05</strong></td>
<td colspan="2"><strong>FY 06</strong></td>
<td colspan="2"><strong>FY 07</strong></td>
<td><strong>FY 08</strong></td>
</tr>
<tr class="odd">
<td><p>Administrative</p>
<p>NADAs and Reactivations</p></td>
<td><p>90</p>
<p>days</p></td>
<td><p>85</p>
<p>days</p></td>
<td colspan="2"><p>80</p>
<p>days</p></td>
<td colspan="2"><p>70</p>
<p>days</p></td>
<td colspan="2"><p>60</p>
<p>days</p></td>
<td>90% on time</td>
</tr>
</tbody>
</table>

![](media/image8.wmf)**[Workload]{.underline}**

During FY 2004, 10 administrative NADAs and reactivations were submitted
to FDA.

+--------------------------+-------+-------+-------+-------+-------+
| **Administrative         |       |       |       |       |       |
| Submissions**            |       |       |       |       |       |
+--------------------------+-------+-------+-------+-------+-------+
| **Type**                 | **FY  | **FY  | **FY  | **FY  | **FY  |
|                          | 04**  | 05**  | 06**  | 07**  | 08**  |
+--------------------------+-------+-------+-------+-------+-------+
| Administrative NADAs     | 10    | \--   | \--   | \--   | \--   |
|                          |       |       |       |       |       |
| and Reactivations        |       |       |       |       |       |
+--------------------------+-------+-------+-------+-------+-------+

# 

# 

#  

# Administrative NADAs and Reactivations

**[Performance]{.underline}**

**FY 2004 Submissions**

As of September 30, 2004, 80 percent (8 of 10) of the administrative
NADAs and reactivations had been reviewed and acted on within 90 days.
With 2 applications pending and not overdue, it is too early to make a
final performance determination for FY 2004. The table below reflects
FDA's performance for these applications that were reviewed and acted on
in FY 2004. The FY 2005 ADUFA report will provide an update for FY 2004
submissions and report on FY 2005 submissions.

+---------------+--------+---------+--------+------------+-----------+
| ###### FY 200 |        |         |        |            |           |
| 4 Submissions |        |         |        |            |           |
+---------------+--------+---------+--------+------------+-----------+
| *             | **     | **R     | **     | **ADUFA    | **Percent |
| *Submission** | Review | eviewed | Number | P          | on Time** |
|               | Wi     | and**   | On     | erformance |           |
| **Type**      | thin** |         | Time** | Goal**     |           |
|               |        | **Acted |        |            |           |
|               |        | On**    |        |            |           |
+---------------+--------+---------+--------+------------+-----------+
| A             | 90     | 8       | 8      | 90%        | 100%      |
| dministrative | days   |         |        |            |           |
| NADAs and     |        |         |        |            |           |
| Reactivations |        |         |        |            |           |
+---------------+--------+---------+--------+------------+-----------+

# Abbreviated New Animal Drug Applications

**[Section 740(k) Abbreviated New Animal Drug
Applications]{.underline}** of the ADUFA provides**:**

The Secretary shall---

''(1) to the extent practicable, segregate the review of abbreviated new
animal drug applications from the process for the review of animal drug
applications, and

''(2) adopt other administrative procedures to ensure that review times
of abbreviated new animal drug applications do not increase from their
current level due to activities under the user fee program.''

**[Performance]{.underline}**

CVM had already established within its Office of New Animal Drug
Evaluation (ONADE) a separate staff, the Generic Animal Drug Team,
dedicated specifically to the review of Abbreviated New Animal Drug
Applications (ANADAs) and submissions. This staff was brought up to full
pre-ADUFA capacity by filling existing vacancies during 2004. In
addition, a specific team was established within ONADE's Division of
Manufacturing Technologies to handle related ANADA chemistry reviews.

CVM administers a totally separate review queue for ANADAs. It is
important to emphasize that this queue is independent from the queue
maintained for the process to review NADAs under ADUFA. This also
ensures that ANADAs are reviewed independently of applications under
ADUFA by dedicated staff. In addition, application management processes
and adherence to them are being re-examined and continue to be worked on
and improved within the Generic Animal Drug Team.

To ensure that review times for ANADAs and submissions do not increase
due to activities under the user fee program, ONADE has established a
baseline of sentinel submission review times averaged over the previous
3 fiscal years (2001 -- 2003). The document and submission types chosen
for monitoring were those that represented analogous submission types to
the ADUFA sentinel submission types. The office monitors on a continuous
basis current year completed review times for these submissions. We are
pleased to report that review times for completed sentinel submissions
during FY 2004 did not increase, compared to the baseline.

***Appendix A: DHHS Secretary Thompson's Commitment Letter to
Congress***

On November 13, 2003, the Department of Health and Human Services (DHHS)
Secretary Thompson sent identical commitment letters to the following
four members of Congress:

> The Honorable Judd Gregg
>
> Chairman
>
> Committee on Health, Education, Labor and Pensions
>
> United States Senate
>
>  
>
> The Honorable Edward Kennedy
>
> Ranking Minority Member
>
> Committee on Health, Education, Labor and Pensions
>
> United States Senate
>
>  
>
> The Honorable W. J. (Billy) Tauzin
>
> Chairman
>
> Committee on Energy and Commerce
>
> U.S. House of Representatives
>
>  
>
> The Honorable John Dingell
>
> Ranking Minority Member
>
> Committee on Energy and Commerce
>
> U.S. House of Representatives

This appendix provides one copy of the four identical letters and a
summary of the goals and procedures of the FDA Center for Veterinary
Medicine (CVM) as agreed to under the \"Animal Drug User Fee Act of
2003.\"

**THE SECRETARY OF HEALTH AND HUMAN SERVICES**

Washington, DC, November 13, 2003

The Honorable Judd Gregg\
Chairman\
Committee on Health, Education, Labor and Pensions\
United States Senate\
Washington, DC 20510\
\
Dear Mr. Chairman:

As you are aware, the Food and Drug Administration has been working with
representatives of the veterinary pharmaceutical industry and staff of
your Committee to design a new animal drug \"user fee\" proposal. Under
this proposal, the additional revenues generated from fees paid by this
industry would be dedicated for use in expediting the process for the
review of animal drug applications, in accordance with performance goals
that have been developed by FDA in consultation with the industry.
S.313, the \"Animal Drug User Fee Act of 2003\" reflects the fee
mechanisms developed in these discussions. The performance goals are
specific in the enclosure to this letter entitled, \"Animal Drug User
Fee Act Performance Goals and Procedures.\" I believe they represent a
realistic projection of what FDA can accomplish with industry
cooperation and the additional resources that would be provided by the
bill and annual FDA appropriations that fully cover the costs of pay and
inflation increases for the animal drug review process each year.

I appreciate the support of you and your staff, and the assistance of
other Members of the Committee.

Sincerely,

TOMMY G. THOMPSON

***The goals and procedures of the FDA Center for Veterinary Medicine
(CVM) as agreed to under the \"Animal Drug Fee Act 2003\" are summarized
as follows**:*

**[Five-Year Goals (to be implemented by September 30,
2008)]{.underline}**

1.  *Review and act on 90 percent of complete animal drug applications
    (NADAs) and reactivations of such applications within 180 days after
    submission date.*

2.  *Review and act on 90 percent of non-manufacturing supplemental
    animal drug applications (i.e. supplemental animal drug applications
    for which safety or effectiveness data are required) and
    reactivations of such supplemental applications within 180 days
    after submission date.*

3.  *Review and act on 90 percent of manufacturing supplemental animal
    drug applications and reactivations of such supplemental
    applications within 120 days after submissions date.*

4.  *Review and act on 90 percent of investigational animal drug study
    submissions within 180 days after submission date.*

5.  *Review and act on 90 percent of investigational animal drug
    submissions consisting of protocols, that the Agency and the sponsor
    consider to be an essential part of the basis for making the
    decision to approve or not approve an animal drug application or
    supplemental animal drug applications, without substantial data
    within 50 days after submission date.*

6.  *Review and act on 90 percent of administrative animal drug
    applications (NADAs submitted after all scientific decisions have
    been made in the investigational animal drug process, i.e., prior to
    the submission of the NADA) within 60 days after the submission
    date.*

*The term \"review and act on\" is understood to mean the issuance of a
complete action letter after the complete review of an animal drug
application, supplemental animal drug application, or investigational
drug submission which either (1) approves an animal drug application or
supplemental application of notifies a sponsor that an investigational
new animal drug submission is complete or (2) sets forth in detail the
specific deficiencies in such animal drug application, supplemental
animal drug application, or investigational animal drug submission in
condition for approval. Within 30 days of submission, FDA shall refuse
to file and animal drug application, supplemental animal drug
application, or their reactivation, which is determined to be
insufficient on its face or otherwise of unacceptable quality for review
upon initial inspection as per 21 CFR 514.110. Thus, the agency will
refuse to file an application containing numbers or types of errors, or
flaws in the development plan, sufficient to cause the quality of the
entire submission to be questioned to the extent that it cannot
reasonably be reviewed. Within 60 days of submission, FDA will refuse to
review an investigational animal drug submission which is determined to
be insufficient on its face or otherwise of unacceptable quality upon
initial inspection using criteria and procedures similar to those found
in 21 CFR 514.110. A decision to refuse to file an application or to
refuse to review a submission as describe above will result in the
application or submission not being entered into the cohort upon which
the relevant user fee goal is based. The agency will keep a record of
the numbers and types of such refusals and include them in its annual
performance report.*

*FDA may request minor amendments to animals drug applications,
supplemental animal drug applications, and investigational animal drug
submissions. At its discretion, the Agency may extend an internal due
date (but not a user fee goal) to allow for the complete review of an
application or submission for which a minor amendment is requested. If a
pending application is amended with significant changes, the amended
application may be considered resubmitted, thereby effectively resetting
the clock to the date FDA received the amendment. The Agency intends to
establish the same policy for investigational animal drug submissions.*

*Sponsors are not required to submit study protocols for review.
However, for each voluntarily submitted protocol for a study that the
Agency and the sponsor considered to be an essential part of the basis
for making the decision to approve or not approve an animal drug
application or supplemental animal drug application, the Agency will
issue an acknowledgment letter providing comments resulting from a
complete review of the protocol. The acknowledgement letter will be as
detailed as possible considering the quality and level of detail of the
protocol submission; will include a succinct assessment of the protocol;
and will state whether the Agency agrees, disagrees, or lacks sufficient
information to reach a decision that the protocol design, execution
plans and data analyses are adequate to achieve the objectives of the
study. If the Agency determines that a protocol is acceptable, this
represents an agreement that the data generated by the protocol can be
used to support a safety or effectiveness decision regarding the subject
animal drug. The fundamental agreement is that having agreed to the
design, execution, or analyses proposed in protocols reviewed under this
process, the Agency will not later alter its perspectives on the issues
of design, execution or analyses unless public or animal health concerns
unrecognized at the time of protocol assessment under this process are
evident.*

**[Interim Backlog Goals]{.underline}**

1.  *Review and act on pending animal drug applications, supplemental
    animal drug applications, and investigational animal drug
    submissions within 24 months of initiation of user fee payments.*

    **[Additional Interim Goals]{.underline}**

```{=html}
<!-- -->
```
1.  *Fifty percent of FDA incremental review staff recruited and
    on-board by first quarter of FY 2006. Total staff increment on-board
    by end of FY 2008.*

2.  *FDA will review all submissions in accordance with procedures for
    working within a queue. An Application/submission that is not
    reviewed within the applicable interim Application/Submission Goal
    time frame (noted below) will be reviewed with the highest possible
    priority among those pending.*

    **[Interim Application/Submission Goals]{.underline}**

    **FY 2004 \--** *Review and Act on 90 percent of:*

-   *Animal drug applications (NADAs) and reactivations of such
    applications received during FY 2004 are reviewed within 295 days.*

-   *Non-manufacturing supplement animal drug application and
    reactivations of such supplemental Manufacturing supplemental animal
    drug applications and reactivations of such supplemental
    applications received during FY 2004 are reviewed within 225 days.*

-   *Manufacturing supplemental animal drug applications and
    reactivations of such supplemental applications received
    applications received during FY 2004 are reviewed within 320 days.*

-   *Investigational animal drug study submissions received during FY
    2004 are reviewed within 320 days.*

-   *Investigational animal drug submissions consisting of protocols,
    that the Agency and the sponsor consider to be an essential part of
    the basis for making the decision to approve or not approve an
    animal drug application or supplemental animal drug application,
    without substantial data received during FY 2004 are reviewed within
    125 days.*

-   *Administrative animal drug applications (administrative NADAs)
    received during FY 2004 are reviewed within 90 days.*

    **FY 05** *\-- Review and Act on 90 percent of:*

-   *NADAs and reactivations of NADAs received during FY 2005 are
    reviewed within 270 days.*

-   *Non-manufacturing supplemental animal drug applications and
    reactivations of such supplemental applications received during FY
    2005 are reviewed within 285 days.*

-   *Manufacturing supplemental animal drug applications and
    reactivations of such supplemental applications received during FY
    2005 are reviewed within 190 days.*

-   *Investigational animal drug study submissions received during FY
    2005 are reviewed within 285 days.*

-   *Investigational animal submissions consisting of protocols, that
    the Agency and the sponsor consider to be an essential part of the
    basis for making the decision to approve or not approve an animal
    drug applications or supplemental animal drug application, without
    substantial data submissions received during FY 2005 are reviewed
    within 100 days.*

-   *Administrative NADAs received during FY 2005 are reviewed within 85
    days.*

    **FY 06** \-- *Review and Act on 90 percent of:*

```{=html}
<!-- -->
```
-   *NADAs and reactivations of NADAs received during FY 2006 are
    reviewed within 230 days.*

-   *Non-manufacturing supplemental animal drug applications and
    reactivations of such supplemental applications received during FY
    2006 are reviewed within 235 days.*

-   *Manufacturing supplemental animal drug applications and
    reactivations of such supplemental applications received during 2006
    are reviewed within 140 days.*

-   *Investigational animal drug study submissions received during FY
    2006 are reviewed with in 235 days.*

-   *Investigational animal drug submissions consisting of protocols,
    that the Agency and the sponsor consider to be an essential part of
    the basis for making the decision to approve or not approve an
    animal drug application or supplemental animal drug application,
    without substantial data submissions received during FY 2006 are
    reviewed within 80 days.*

-   *Administrative NADAs received during FY 2006 are reviewed within 80
    days.*

    **FY 07 \--** *Review and Act on 90 percent of*

-   *NADAs and reactivations of NADAs received during FY 2007 are
    reviewed within 200 days.*

-   *Non-manufacturing supplemental animal drug applications and
    reactivations of such supplemental applications received during FY
    2007 are reviewed within 200 days.*

-   *Manufacturing supplemental animal drug applications and
    reactivations of such supplemental applications received during FY
    2007 are reviewed within 120 days.*

-   *Investigational animal drug study submissions received during FY
    2007 are reviewed within 200 days.*

-   *Investigational animal drug submissions consisting of protocols,
    that the Agency and the sponsor consider to be an essential part of
    the basis for making the decision to approve or not approve an
    animal drug application or supplemental animal drug application,
    without substantial data submissions received during FY 2007 are
    reviewed within 60 days.*

-   *Administrative NADAs received during FY 2007 are reviewed within 70
    days.*

    **FY 08 \--** *Review and Act on 90 percent of*

-   *NADAs and reactivations of NADAs received during FY 2008 are
    reviewed within 180 days.*

-   *Non-manufacturing supplemental animal drug applications and
    reactivations of such supplemental applications received during FY
    2008 are reviewed within 180 days.*

-   *Manufacturing supplemental animal drug applications and
    reactivations of such supplemental applications received during FY
    2008 are reviewed within 120 days.*

-   *Investigational animal drug study submissions received during FY
    2008 are reviewed within 180 days.*

-   *Investigational animal drug submissions consisting of protocols,
    that the Agency and the sponsor consider to be an essential part of
    the basis for making the decision to approve or not approve an
    animal drug application or supplemental animal drug application,
    without substantial data submissions received during FY 2008 are
    reviewed within 50 days.*

-   *Administrative NADAs received during FY 2008 are reviewed within 60
    days.*

***Appendix B: Summary of ADUFA's Performance Goals***

+-------------------------+---------+-----+-----+-----+-----+------+
| **Activity**            | **Perf  | **  |     |     |     |      |
|                         | ormance | FDA |     |     |     |      |
|                         | Level** | Rev |     |     |     |      |
|                         |         | iew |     |     |     |      |
|                         |         | Tim |     |     |     |      |
|                         |         | e** |     |     |     |      |
|                         |         |     |     |     |     |      |
|                         |         | **  |     |     |     |      |
|                         |         | (in |     |     |     |      |
|                         |         | d   |     |     |     |      |
|                         |         | ays |     |     |     |      |
|                         |         | )** |     |     |     |      |
+-------------------------+---------+-----+-----+-----+-----+------+
|                         |         | *   | *   | *   | *   | **FY |
|                         |         | *FY | *FY | *FY | *FY | 08** |
|                         |         | 0   | 0   | 0   | 0   |      |
|                         |         | 4** | 5** | 6** | 7** |      |
+-------------------------+---------+-----+-----+-----+-----+------+
| *                       |         |     |     |     |     |      |
| *Application/Submission |         |     |     |     |     |      |
| Goals**                 |         |     |     |     |     |      |
+-------------------------+---------+-----+-----+-----+-----+------+
| Animal drug             | 90%     | 295 | 270 | 230 | 200 | 180  |
| applications (NADAs)    |         |     |     |     |     |      |
| and reactivations of    |         |     |     |     |     |      |
| such applications       |         |     |     |     |     |      |
+-------------------------+---------+-----+-----+-----+-----+------+
| Non-manufacturing       | 90%     | 320 | 285 | 235 | 200 | 180  |
| supplemental animal     |         |     |     |     |     |      |
| drug applications and   |         |     |     |     |     |      |
| reactivations of such   |         |     |     |     |     |      |
| supplemental            |         |     |     |     |     |      |
| applications            |         |     |     |     |     |      |
+-------------------------+---------+-----+-----+-----+-----+------+
| Manufacturing           | 90%     | 225 | 190 | 140 | 120 | 120  |
| supplemental animal     |         |     |     |     |     |      |
| drug applications and   |         |     |     |     |     |      |
| reactivation of such    |         |     |     |     |     |      |
| supplemental            |         |     |     |     |     |      |
| applications            |         |     |     |     |     |      |
+-------------------------+---------+-----+-----+-----+-----+------+
| Investigational animal  | 90%     | 320 | 285 | 235 | 200 | 180  |
| drug study submissions  |         |     |     |     |     |      |
+-------------------------+---------+-----+-----+-----+-----+------+
| Investigational animal  | 90%     | 125 | 100 | 80  | 60  | 50   |
| drug submissions        |         |     |     |     |     |      |
| consisting of           |         |     |     |     |     |      |
| protocols, that the     |         |     |     |     |     |      |
| agency and the sponsor  |         |     |     |     |     |      |
| consider to be an       |         |     |     |     |     |      |
| essential part of the   |         |     |     |     |     |      |
| basis for making the    |         |     |     |     |     |      |
| decision to approve or  |         |     |     |     |     |      |
| not approve an animal   |         |     |     |     |     |      |
| drug application or     |         |     |     |     |     |      |
| supplemental animal     |         |     |     |     |     |      |
| drug application,       |         |     |     |     |     |      |
| without substantial     |         |     |     |     |     |      |
| data                    |         |     |     |     |     |      |
+-------------------------+---------+-----+-----+-----+-----+------+
| Administrative animal   | 90%     | 90  | 85  | 80  | 70  | 60   |
| drug applications       |         |     |     |     |     |      |
| (administrative NADAs)  |         |     |     |     |     |      |
+-------------------------+---------+-----+-----+-----+-----+------+
| **Interim Backlog       |         |     |     |     |     |      |
| Goals**                 |         |     |     |     |     |      |
+-------------------------+---------+-----+-----+-----+-----+------+
| Review and act on       |         |     |     |     |     |      |
| pending animal drug     |         |     |     |     |     |      |
| applications,           |         |     |     |     |     |      |
| supplemental animal     |         |     |     |     |     |      |
| drug applications, and  |         |     |     |     |     |      |
| investigational animal  |         |     |     |     |     |      |
| drug submissions within |         |     |     |     |     |      |
| 24 months of initiation |         |     |     |     |     |      |
| of user fee payments.   |         |     |     |     |     |      |
+-------------------------+---------+-----+-----+-----+-----+------+
| **Additional Interim    |         |     |     |     |     |      |
| Goals**                 |         |     |     |     |     |      |
+-------------------------+---------+-----+-----+-----+-----+------+
| Fifty percent of FDA    |         |     |     |     |     |      |
| incremental review      |         |     |     |     |     |      |
| staff recruited and     |         |     |     |     |     |      |
| on-board by first       |         |     |     |     |     |      |
| quarter of FY 2006.     |         |     |     |     |     |      |
| Total staff increment   |         |     |     |     |     |      |
| on-board by end of FY   |         |     |     |     |     |      |
| 2008.                   |         |     |     |     |     |      |
+-------------------------+---------+-----+-----+-----+-----+------+
| FDA will review all     |         |     |     |     |     |      |
| submissions in          |         |     |     |     |     |      |
| accordance with         |         |     |     |     |     |      |
| procedures for working  |         |     |     |     |     |      |
| within a queue. An      |         |     |     |     |     |      |
| application/submission  |         |     |     |     |     |      |
| that is not reviewed    |         |     |     |     |     |      |
| within the applicable   |         |     |     |     |     |      |
| Interim                 |         |     |     |     |     |      |
| Application/Submission  |         |     |     |     |     |      |
| Goal timeframe will be  |         |     |     |     |     |      |
| reviewed with the       |         |     |     |     |     |      |
| highest possible        |         |     |     |     |     |      |
| priority among those    |         |     |     |     |     |      |
| pending.                |         |     |     |     |     |      |
+-------------------------+---------+-----+-----+-----+-----+------+

+-----------------------------------------------------------------------+
| This report was prepared by FDA\'s Center for Veterinary Medicine in  |
| collaboration with the Office of Planning. For information on         |
| obtaining additional copies, please contact:                          |
|                                                                       |
| Office of Planning (HFP-10)                                           |
|                                                                       |
| Food and Drug Administration                                          |
|                                                                       |
| 5600 Fishers Lane                                                     |
|                                                                       |
| Rockville, Maryland 20857                                             |
|                                                                       |
| Phone: 301-827-5270                                                   |
|                                                                       |
| FAX: 301-827-5260                                                     |
|                                                                       |
| This report is available on the FDA Home Page at http://www.fda.gov   |
+-----------------------------------------------------------------------+

# 

# 

[^1]: The count of FY 2004 submissions assumes that all submissions
    received in the last month of FY 2004 are filed. When FDA files a
    submission, it is deemed "complete" by ADUFA definition. FDA makes a
    filing decision within 30 days of an original application's receipt.
    All calculations of ADUFA review times are made, however, from the
    original receipt date of the filed application.