

[Federal Register: February 21, 2008 (Volume 73, Number 35)]
[Notices]               
[Page 9571-9575]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21fe08-68]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0082]

 
Animal Drug User Fee Act; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the agency) is 
publishing proposed recommendations for the reauthorization of the 
Animal Drug User Fee Act of 2003 (ADUFA) for fiscal years (FY) 2009 to 
2013. These proposed recommendations were developed after a public 
meeting with stakeholders and discussions with regulated industry. 
ADUFA, enacted November 18, 2003, directs FDA to publish these proposed 
recommendations in the Federal Register; hold a meeting at which the 
public may present its views on such recommendations; and provide a 
period of 30 days for the public to provide written comments on such 
recommendations.
    Dates and Time: The public meeting will be held on March 11, 2008, 
from 1 p.m. to 3:30 p.m.
    Location: The public meeting will be held at 7519 Standish Pl., 
third floor, rm. A, Rockville, MD 20855. There is parking near the 
building. Photo identification is required to clear building security.
    Contact Person: Roxanne Schweitzer, Center for Veterinary Medicine 
(HFV-10), Food and Drug Administration, 7529 Standish Pl., Rockville, 
MD 20855, 240-276-9705, FAX: 240-276-9744, e-mail: 
Roxanne.Schweitzer@fda.hhs.gov.

    Registration: To ensure there is sufficient room we ask that you 
pre-register. Furthermore, to assist us in scheduling, we ask that you 
notify us through the registration process if you wish to make a public 
comment at the meeting. To register, please send an electronic mail 
message to roxanne.schweitzer@fda.hhs.gov by March 4, 2008. Your e-mail 
should include the following information: Name, Company, Company 
Address, Company Telephone Number, and E-mail Address. You will receive 
a confirmation within 2 business days.
    FDA also will accept walk-in registration at the meeting site, but 
space is limited, and the agency will close registration when maximum 
seating capacity (approximately 500) is reached. FDA will try to 
accommodate all persons who wish to make a public comment at the 
meeting, including those who register at the meeting site, however, the 
time allotted for public comments may depend on the number of persons 
who wish to speak.
    Additionally, please notify FDA (see Contact Person) if you need 
any special accommodations (such as wheelchair access or a sign 
language interpreter) at least 7 days in advance.
    Comments: To ensure consideration of your comments regarding these 
proposed recommendations, you should

[[Page 9572]]

submit comments by April 14, 2008. Interested persons may submit 
written or electronic comments to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.
 Submit a single copy of electronic comments or two 

paper copies of any mailed comments, except that individuals may submit 
one paper copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

SUPPLEMENTARY INFORMATION:

I. Introduction

    Section 4 of ADUFA, enacted in 2003 (Public Law 108-130, November 
18, 2003), authorized FDA to collect user fees from regulated industry 
that were to be dedicated to expediting the review of animal drug 
applications in accordance with certain performance goals identified in 
letters dated November 13, 2003, from the Secretary of Health and Human 
Services to the Chairman and Ranking Minority Member of the Energy and 
Commerce Committee of the House of Representatives and the Chairman and 
Ranking Minority Member of the Health, Education, Labor and Pensions 
Committee of the Senate.
    Before ADUFA, FDA's animal drug review process was unpredictable 
and slow. Since the implementation of ADUFA there has been a 
significant improvement in FDA funding for the process for review of 
new animal drug applications (NADA), including significant investments 
in infrastructure and support. ADUFA has enabled FDA to increase the 
staff dedicated to the process of reviewing animal drug applications 
since 2003 by about 30 percent. As a result, the process for review of 
NADAs has become more predictable and faster.
    Under ADUFA, the industry provides user fees that are available to 
FDA, in addition to appropriated funds, to spend on the animal drug 
review process. Moreover, FDA authority to collect user fees is 
``triggered'' only when a base amount of appropriated funds, adjusted 
for inflation, is spent.
    As part of ADUFA, FDA established review performance goals that 
have been phased in over a 5 year period. These performance goals run 
from FY 2004 through FY 2008 and are intended to achieve progressive, 
yearly improvements in the time for review of animal drug applications. 
FDA agreed to review and act on submissions within shorter periods of 
time each fiscal year. With the fifth and final year of ADUFA ending on 
September 30, 2008, FDA has agreed to review and act on 90 percent of 
the following submission types within specified times:
     Animal drug applications and reactivations of such 
applications within 180 days after submission date.
     Non-manufacturing supplemental animal drug applications 
(that is, supplemental animal drug applications for which safety or 
effectiveness data are required) and reactivations of such supplemental 
applications within 180 days after submission date.
     Manufacturing supplemental animal drug applications and 
reactivations of such supplemental applications within 120 days after 
submission date.
     Investigational animal drug study submissions within 180 
days after submission date.
     Investigational animal drug submissions consisting of 
protocols, that FDA and the sponsor consider to be an essential part of 
making the decision to approve or not approve an animal drug 
application or supplemental animal drug application, without 
substantial data, within 60 days after submission date.
     Administrative animal drug applications submitted after 
all scientific decisions have been made in the investigational animal 
drug process (that is, prior to submission of the animal drug 
application) within 60 days after submission date.
    We began public consultation on ADUFA reauthorization with a public 
meeting held on April 24, 2007. The meeting included presentations by 
FDA and four speakers from the public. FDA presented information on 
ADUFA's successful performance and financial outcomes. The public 
participants represented different stakeholder groups, including 
consumer groups and regulated industry. The stakeholders were asked to 
respond to the following questions: (1) What is your assessment of the 
overall performance of the ADUFA program thus far and (2) What 
suggestions or changes would you make relative to the reauthorization 
of ADUFA? There was general agreement among the responding stakeholders 
that ADUFA should be reauthorized. In preparing proposed 
recommendations for ADUFA reauthorization (ADUFA II), FDA has also 
conducted technical discussions with regulated industry.
    Congress also directed FDA to: (1) Publish in the Federal Register 
the proposed recommendations developed through this process after 
negotiations with the regulated industry, (2) present the proposed 
recommendations to the congressional committees specified in the 
statute, (3) hold a public meeting at which the public can present its 
views on the proposed recommendations, and (4) provide a period of 30 
days for the public to provide written comment on the proposed 
recommendations.
    We have now concluded discussions with industry and other 
stakeholders regarding reauthorization of ADUFA. The purpose of this 
document is to publish the recommendations FDA intends to propose to 
Congress and announce the dates for the upcoming public meeting and 
written comment period. After the public meeting and the close of the 
30-day comment period, FDA plans to undertake a careful review of all 
public comments on these proposed recommendations.

II. What FDA is Proposing to Recommend for ADUFA II

    For ADUFA II, as described in the following paragraphs, FDA plans 
to carry forward the performance goals from ADUFA and to propose 
additional goals related to proposed enhancements to the program. 
Proposed recommendations fall into three categories:
    A. Proposals to Ensure Sound Financial Footing for the Animal Drug 
Review Program
    B. Proposals to Enhance the Process for Review of Animal Drug 
Applications and
    C. Improving the Information Technology (IT) Infrastructure for 
Animal Drug Review

A. Proposed Recommendations to Ensure Sound Financial Footing

    Although user fees have provided substantial resources to FDA since 
the beginning of the program, user fees have not kept up with the 
increasing costs of the program associated with inflation in pay and 
benefit costs to the agency, and rent and rent-related costs. FDA has 
experienced an increase in costs of pay and benefits averaging 5.9 
percent per year over the most recent 5 years. Non-salary costs, 
including the costs of rent and contract support, have also increased 
at the same rate. FDA is proposing changes to the financial provisions 
of ADUFA to address these shortcomings and place the program on sound 
financial footing so FDA can

[[Page 9573]]

continue with the program and enhance it.
1. The Proposals Set the Total Fee Revenue Amounts in Section 740(b) of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379j-
12(b)) to Assure That the Amounts Grow Sufficiently Each Year to Cover 
FDA's Anticipated Change in Costs Each Year
    Based on an analysis of FDA's recent costs history and anticipated 
costs over the next 5 years, FDA expects the trend of increasing costs 
to continue. FDA's proposed recommendation to Congress, after 
consultation with regulated industry, is that the total fee revenue 
estimate for each of the 5 fiscal years of ADUFA II be the amounts set 
out in table 1 of this document.

                                         Table 1.-- ADUFA II Fee Revenue Targets for Each Year Beginning FY 2009
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            Fiscal Year                     2009                2010                 2011               2012               2013              Total
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Total Revenue Target                       $15,260,000           $17,280,000        $19,448,000        $21,768,000        $24,244,000        $98,000,000
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    With this level of proposed funding, FDA can have confidence that 
it will have a stable review workforce over the 5 years to be covered 
by ADUFA II. That assurance of a stable animal drug review workforce 
enables FDA to commit to a continuation of the FY 2008 performance 
goals, and to some additional performance goals.
2. Proposed Elimination of the Inflation Adjustment Applied to User 
Fees
    Because the proposed total fee revenue amounts already have the 
costs of inflation built into them, there is no need for the inflation 
adjustment that was applied to the total revenue amounts that were in 
ADUFA. Accordingly, FDA proposes to eliminate the inflation adjustment 
provisions for the fee revenue amounts.
3. Technical Changes to Increase Administrative Efficiency of the User 
Fee Program
    FDA is proposing several technical changes to ADUFA to clarify the 
original intent of several ADUFA definitions and to remove potential 
ambiguity. FDA's analysis of the impact of these changes indicates that 
they would be revenue-neutral and would have a minimal impact on 
industry fee-payers. These technical proposals include the following:
     Change the date for the calculation of the inflationary 
adjustment factor so it can be calculated before the President's budget 
is sent to Congress;
     Amend the definition of ``animal drug sponsor'' to clarify 
that it includes a holder of an approved application for an animal drug 
that is not marketed but the application has not been withdrawn;
     Add the definition of ``person'' to include affiliates, 
which continues the current interpretation of the act and parallels 
recent changes made to Prescription Drug User Fee Act;
     Change the application fee rate for combination 
applications subject to the criteria of section 512(d)(4) of act (21 
U.S.C. 360b(d)(4)) (Animal Drug Availability Act combinations) to one-
half the full application fee rate;
     Delay offsets for collections in excess of appropriations 
in any year to the final year of the ADUFA program and make offsetting 
reductions only if cumulative fees collected over the first 4 years 
exceed cumulative appropriations for fees over the same period; and
     Revise the authorization of appropriations in the act to 
match the total fee revenue amounts being proposed.
4. Triggers
    ADUFA has three triggers. One is tied to appropriations for the 
process for review of new animal drug applications and two are tied to 
agency appropriations. FDA is proposing to leave the current triggers 
unchanged through ADUFA II. The three triggers are as follows:
    (1) Fees may not be assessed for a FY beginning after FY 2003 
unless appropriations for salaries and expenses of FDA for such FY 
(excluding the amount of fees appropriated for such FY) are equal to or 
greater than the amount of appropriations for the salaries and expenses 
of FDA for FY 2003 (excluding the amount of fees appropriated for such 
FY) multiplied by the adjustment factor applicable to the FY involved.
    (2) The fees authorized shall only be collected and available to 
defray increases in the cost of the resources allocated for the process 
for the review of animal drug applications (including increases in such 
costs for an additional number of full-time equivalent positions in the 
Department of Health and Human Services to be engaged in such process) 
over such costs, excluding costs paid from fees collected for FY 2003 
multiplied by the adjustment factor.
    (3) The fees authorized by this section shall be retained in each 
FY in an amount not to exceed the amount specified in appropriation 
acts, or otherwise made available for obligations for such FY.

B. Enhancing the Process for Premarket Review

    We are proposing changes to the performance goals that ADUFA 
established to enhance the process for review of animal drug 
applications. In addition to the performance goals established by ADUFA 
for the review of administrative animal drug applications submitted 
after all scientific decisions have been made in the investigational 
animal drug process (that is, prior to submission of the animal drug 
application) and the review of manufacturing supplemental animal drug 
applications and reactivations of such supplemental applications, FDA 
has agreed to revised performance goals for the following submission 
types:
    (1) The agency will review and act on 90 percent of non-
administrative animal drug applications and reactivations of such 
applications within:
     180 days after the submission date (Day 180) if the agency 
determines that the application is complete or incomplete. An 
application is incomplete if it would require substantial data or 
information to enable the agency to complete a comprehensive review of 
the application and reach a decision on the approvability of the 
application; or
     220 days after the submission date if the agency 
determines that the submission of additional non-substantial data or 
information would likely complete the application and electronically 
requests an end-review amendment

[[Page 9574]]

to the application on or before Day 180, but the sponsor fails to file 
such amendment on or before Day 210. If a sponsor files an amendment 
after Day 210, then the amendment is ineligible for consideration as an 
end-review amendment, the extended performance goal (345 days) will not 
apply, and a complete action letter will be issued by Day 220 for the 
original application; or
     345 days after the submission date if the agency 
electronically requests an end-review amendment to the application on 
or before Day 180 and the sponsor files an end-review amendment on or 
before Day 210.
    (2) The agency will 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 the submission date (Day 180) if the agency 
determines that the application is complete or incomplete. An 
application is incomplete if it would require substantial data or 
information to enable the agency to complete a comprehensive review of 
the application and reach a decision on the approvability of the 
application; or
     220 days after the submission date if the agency 
determines that the submission of additional non-substantial data or 
information would likely complete the application and electronically 
requests an end-review amendment to the application on or before Day 
180, but the sponsor fails to file such amendment on or before Day 210. 
If a sponsor files an amendment after Day 210, then the amendment is 
ineligible for consideration as an end-review amendment, the extended 
performance goal (345 days) will not apply, and a complete action 
letter will be issued by Day 220 for the original application; or
     345 days after the submission date if the agency 
electronically requests an end-review amendment to the application on 
or before Day 180 and the sponsor files an end-review amendment on or 
before Day 210.
    (3) The agency will review and act on 90 percent of investigational 
animal drug study submissions within:
     180 days after the submission date (Day 180) if the agency 
determines that the submission is complete or incomplete. A submission 
is incomplete if it would require substantial data or information to 
enable the agency to complete a comprehensive review of the study 
submission and reach a decision on the issue(s) presented in the 
submission; or
     220 days after the submission date if the agency 
determines that the submission of additional non-substantial data or 
information would likely complete the submission and electronically 
requests an end-review amendment to the submission on or before Day 
180, but the sponsor fails to submit such amendment on or before Day 
210. If a sponsor submits an amendment after Day 210, then the 
amendment is ineligible for consideration as an end-review amendment, 
the extended performance goal (270 days) will not apply, and a complete 
action letter will be issued by Day 220 for the original submission; or
     270 days after the submission date if the agency 
electronically requests an end-review amendment to the submission on or 
before Day 180 and the sponsor submits an end-review amendment on or 
before Day 210.
    (4) Review and act on 90 percent of investigational animal drug 
submissions consisting of protocols without substantial data, 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, within:
     60 days after the submission date (Day 60) if the agency 
does not request an end-review amendment to the protocol and the agency 
determines that the protocol is acceptable, the agency will notify the 
sponsor of this decision electronically on or before Day 50, followed 
by a complete action letter; or
     60 days after the submission date (Day 60) if the agency 
does not request an end-review amendment to the protocol and the agency 
determines that a protocol is not acceptable, the agency will notify 
the sponsor of this decision electronically, providing preliminary 
broad areas of protocol deficiency, on or before Day 50, with the 
subsequently issued complete action letter providing the detailed 
protocol assessment. The sponsor may contact the agency for a brief 
clarification of these areas of deficiency prior to the issuance of the 
complete action letter; or
     75 days after the submission date if the agency 
electronically requests an end-review amendment to the protocol on or 
before Day 50, but the sponsor fails to submit such amendment within 10 
days of the amendment request date. If a sponsor files an amendment 
more than 10 days after the amendment request date, then the amendment 
is ineligible for consideration as an end-review amendment, the 
extended performance goal (refer to the following paragraph) will not 
apply, and a complete action letter will be issued by Day 75 for the 
original submission; or
     The greater of 60 days after the original protocol is 
received by the agency or 20 days after the amended protocol is 
received by the agency if the agency electronically requests an end-
review amendment on or before Day 50 and the sponsor submits such 
amendment within 10 days of the date the amendment is requested.
    (5) The following are additional efforts related to the performance 
goals for all submission types being proposed for ADUFA II to enhance 
the premarket review of animal drug applications:
     The agency and regulated industry agree to participate in 
10 public workshops by the end of FY 2013 on mutually agreed-upon 
topics;
     To improve the timeliness and predictability of foreign 
preapproval inspections (PAIs), sponsors may voluntarily submit at the 
beginning of the calendar year, a list of foreign manufacturing 
facilities that are subjects of animal drug applications, supplemental 
animal drug applications, or investigational animal drug submissions 
and may be subject to foreign PAIs for the following fiscal year;
     If such a list is voluntarily submitted the sponsor should 
submit a notification 30 days prior to submitting an animal drug 
application, a supplemental animal drug application, or investigational 
animal drug submission that informs the agency that the application 
includes a foreign manufacturing facility; (should any changes to the 
annual list occur after its submission to the agency, the sponsor may 
provide the updated information to the agency);
     The agency and the regulated industry agree to explore and 
discuss the applicable use of pharmacokinetic/pharmacodynamic data in 
the development and evaluation of new animal drugs

[[Page 9575]]

submitted for approval;
     The agency and the regulated industry agree to explore 
opportunities for exchange of information regarding the characteristics 
of a new animal drug, and to identify safety and effectiveness issues 
as early as possible in the drug development process; and
     The agency and regulated industry commit to work together 
to explore shorter timeframes commensurate with the magnitude of 
submitted pharmacokinetic/pharmacodynamic and other new animal drug 
characteristic data/information.

C. Improving the Information Technology (IT) Infrastructure for Animal 
Drug Review

    In the recommended IT performance goals for ADUFA II, FDA will 
develop an electronic submission tool for industry submissions and 
online review capability within 24 months of appropriated ADUFA funds 
for FY 2009. The agency will consult with the sponsors in the 
development of this tool.

III. What Information Should You Know About the Meeting?

A. When and Where Will the Meeting Occur? What Format Will FDA Use?

    Through this document, FDA is announcing the convening of a public 
meeting to hear stakeholder views on the recommendations we propose to 
provide to Congress on the reauthorization of ADUFA.
    FDA will conduct the meeting at 1 p.m. on March 11, 2008, at 7519 
Standish Pl., third floor, rm. A, Rockville, MD 20855. In general, the 
meeting format will include presentations by FDA and an open comment 
period for the public. FDA will also give organizations and individuals 
an opportunity to submit written comments to the docket after the 
meeting.

B. Will Meeting Transcripts Be Available?

    FDA will prepare a meeting transcript and make it available on the 
agency's Web site (http://www.fda.gov) after the meeting. FDA anticipates that 

transcripts will be available approximately 30 business days after the 
meeting.The transcript will also be available for public examination at 
the Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: February 14, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-3267 Filed 2-20-08; 8:45 am]

BILLING CODE 4160-01-S
