[Federal Register Volume 73, Number 35 (Thursday, February 21, 2008)]
[Notices]
[Pages 9571-9575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-3267]
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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:
[email protected].
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 [email protected] 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
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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
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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
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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
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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 (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