[Federal Register Volume 77, Number 234 (Wednesday, December 5, 2012)]
[Notices]
[Pages 72356-72359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-29498]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0656]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting; request for comments.

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    The Food and Drug Administration (FDA) is announcing the following 
meeting: Animal Drug User Fee Act. The topic to be discussed is 
proposed recommendations for the reauthorization of the Animal Drug 
User Fee Act (ADUFA III).
    Date and Time: The meeting will be held on December 18, 2012, from 
9 a.m. to 12 p.m.
    Location: The meeting will be held at FDA's Metro Park North 
Campus, 7519 Standish Pl., third floor, Meeting Room A, Rockville, MD 
20855. There is parking near the building.
    Contact: Jacqueline Farmer, Center for Veterinary Medicine (HFV-
10), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 
20855, 240-276-8695, FAX: 240-276-9744, email: 
[email protected].
    Registration and Requests for Oral Presentations: Send registration 
information (including name, title, firm name, address, telephone, and 
fax number), and written material and requests to make oral 
presentations, to the contact person by December 11, 2012.
    If you need special accommodations due to a disability, please 
contact Jacqueline Farmer at least 7 days in advance.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
be viewed at the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to the Division of Freedom of Information (ELEM-1029), 
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857.
    Comments: Interested persons may submit either written comments 
regarding this meeting to the Division of Dockets Management (see 
Transcripts) or electronic comments to http://www.regulations.gov. It 
is only necessary to send one set of comments. Identify comments 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, and will be posted to 
the docket at http://www.regulations.gov. So that FDA can consider 
comments and revise the recommendations as necessary, we request that 
comments be submitted to the docket by January 4, 2013.

SUPPLEMENTARY INFORMATION:

[[Page 72357]]

I. The ADUFA Program

A. What is ADUFA? What does it do?

    FDA considers the timely review of the safety and effectiveness of 
new animal drug applications (NADAs) to be central to the Agency's 
mission to protect and promote the public health. Prior to 2004, the 
timeliness and predictability of the new animal drug review program was 
a concern. The Animal Drug User Fee Act enacted in 2003 (Pub. L. 108-
130; hereinafter referred to as ``ADUFA I''), authorized FDA to collect 
user fees that were to be dedicated to expediting the review of new 
animal drug applications in accordance with certain performance goals 
and to expand and modernize the new 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 implementation of ADUFA I provided a significant funding increase 
that enabled FDA to increase the number of staff dedicated to the new 
animal drug application review process by 30 percent since 2003.
    In 2008, before ADUFA I expired, Congress passed the Animal Drug 
User Fee Amendments of 2008 (Pub. L. 110-316; hereinafter referred to 
as ``ADUFA II'') which included an extension of ADUFA for an additional 
5 years--fiscal year (FY) 2009 to FY 2013. ADUFA II performance goals 
were established based on ADUFA I FY 2008 review timeframes. In 
addition, FDA provided program enhancements to reduce review cycles and 
improve communications during reviews. The ADUFA programs have enabled 
FDA to speed up the application review process for new animal drugs 
without compromising the quality of the Agency's review.

B. ADUFA Achievements

    As part of ADUFA I, FDA established review performance goals that 
were phased in over a 5-year period. These performance goals, set from 
FY 2004 through FY 2008, enabled FDA to achieve progressive, yearly 
improvements in the time allotted for review of new animal drug 
applications. By the final year of ADUFA I ending on September 30, 
2008, FDA reviewed and acted on 90 percent of the following submission 
types within the times specified:
     New animal drug applications and reactivations of such 
applications within 180 days after submission date.
     Non-manufacturing supplemental new animal drug 
applications and reactivations of such supplemental applications within 
180 days after submission date.
     Manufacturing supplemental new animal drug applications 
and reactivations of such supplemental applications within 120 days 
after submission date.
     Investigational new animal drug study submissions within 
180 days after submission date.
     Investigational new animal drug submissions consisting of 
protocols without substantial data within 60 days after submission 
date.
     Administrative new animal drug applications within 60 days 
after submission date.
    With the reauthorization of ADUFA for an additional 5 years under 
ADUFA II (FY 2009 to FY 2013), FDA agreed to enhance and further 
improve the review process via the following changes.
    A key improvement under ADUFA II is the ``end-review amendment'' 
(ERA) process that allows FDA reviewers to work with the drug sponsor 
to amend certain pending submissions. The ERA process allows us to 
decrease the number of review cycles, which ultimately leads to a 
shorter time to approval. Improved communication early in the process 
has the greatest potential of reducing review cycles. The greatest 
impact of this new tool in the first 3 years under ADUFA II has been 
with submissions of investigational new animal drug (INAD) studies and 
study protocols, which are the earliest review processes impacted by 
ADUFA performance goals.
    The development of an electronic submission tool has enabled 
sponsors to submit applications and submissions electronically, and has 
provided FDA reviewers with the ability to evaluate submissions online.
    The joint participation of FDA and the regulated industry in 10 
public workshops by the end of FY 2013 on mutually agreed-upon topics 
has enhanced communication and transparency on topics critical to the 
animal drug review and approval process. To date, FDA and the regulated 
industry have participated in eight workshops with the final two 
planned for FY 2013.
    FDA is committed to improving the animal drug review and business 
processes to facilitate the timely scheduling and conducting of foreign 
preapproval inspections. Because of processes developed under ADUFA II, 
sponsors are now able to voluntarily submit an annual facilities list 
and notification 30 days prior to submitting an NADA, a supplemental 
NADA, or an INAD submission to inform FDA that the application or 
submission includes a foreign manufacturing facility.
    FDA has published a number of reports that provide useful 
background on ADUFA I and ADUFA II. ADUFA-related Federal Register 
notices, guidances, legislation, performance reports, and financial 
reports can be found at: http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm.

II. Proposed ADUFA III Recommendations

A. Enhancing the Process for Premarket Review

    We are proposing changes to the performance goals that ADUFA II 
established to further enhance the process for review of animal drug 
applications.
    The ERA procedure implemented as part of ADUFA II resulted in an 
increase in the number of one-cycle reviews; however, certain 
challenges associated with the process restricted its full utilization. 
We are proposing, among other changes, to further improve the review 
process by replacing the ERA with shorter review times for certain 
resubmissions and reactivations. To allow time for the programming and 
system changes required to make this and other changes, we are 
proposing to maintain the ADUFA II ERA process and associated review 
performance goals for FY 2014 for non-administrative animal drug 
applications, non-manufacturing supplemental animal drug applications, 
investigational animal drug study submissions, and investigational 
animal drug submissions consisting of protocols without substantial 
data.
    Starting on October 1, 2014 (for FYs 2015 to 2018), we are 
proposing to discontinue the ERA procedures and replace them with the 
process for shorter review times for reactivations and resubmissions. 
The performance goals listed below for the shorter reactivation and 
resubmission times only apply when the sponsor provides submissions for 
the NADA and the INAD through the use of the eSubmitter electronic 
submission tool.
    The Agency will review and act on 90 percent of non-administrative 
NADAs within 180 days after the submission date. An application is 
incomplete if it would require additional data or information to enable 
the Agency to complete a comprehensive review of the application and 
reach a decision on the issue(s) presented in the application.
    The Agency will review and act on 90 percent of reactivated 
applications:

[[Page 72358]]

     Within 180 days after the reactivated NADA submission date 
if the Agency determines and notifies the sponsor that the deficiencies 
are substantial;
     Within 135 days after the reactivated NADA submission date 
if the Agency determines and notifies the sponsor that the deficiencies 
are not substantial; and the NADA reactivation must be submitted no 
more than 120 days after the Agency's dated incomplete letter to 
qualify for the shorter review time; and
     Within 180 days after the reactivated NADA submission date 
if the NADA reactivation is submitted after 120 days of the Agency's 
dated incomplete letter or new substantial information is provided in 
the reactivated application.
    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) 
within 180 days after the submission date. A supplemental application 
is incomplete if it would require additional data or information to 
enable the Agency to complete a comprehensive review of the supplement 
and reach a decision on the issue(s) presented in the supplement.
     The Agency will review and act on 90 percent of 
reactivated supplements:
     Within 180 days after the resubmission date if the Agency 
determines and notifies the sponsor that the deficiencies are 
substantial.
     Within 135 days after the resubmission date if the Agency 
determines and notifies the sponsor that the deficiencies are not 
substantial; and the resubmission to the supplemental application must 
be submitted no more than 120 days after the Agency's dated incomplete 
letter to qualify for the shorter review time; and
     Within 180 days after the resubmission date if the 
resubmission to the supplemental application is submitted after 120 
days of the Agency's dated incomplete letter or new substantial 
information is provided in the resubmission.
    The Agency will review and act on 90 percent of INAD study 
submissions within 180 days after the submission date. An INAD study 
submission is incomplete if it would require additional data or 
information to enable the Agency to complete a comprehensive review of 
the submission and reach a decision on the issue(s) presented in the 
submission.
    The Agency will review and act on 90 percent of resubmitted INAD 
study submissions:
     Within 180 days after the resubmitted INAD study 
submission date if the Agency determines and notifies the sponsor that 
the deficiencies are substantial;
     Within 60 days after the resubmitted INAD study submission 
date if the Agency determines and notifies the sponsor that the 
deficiencies are not substantial; and the resubmission must be 
submitted no more than 120 days after the Agency's dated incomplete 
letter to qualify for the shorter review time; and
     Within 180 days after the resubmitted INAD study 
submission date if the resubmission is submitted after 120 days of the 
Agency's dated incomplete letter or new substantial information is 
provided in the resubmission.
    The Agency will review and act on 90 percent of INAD submissions 
consisting of protocols without 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 50 days after the submission date. An 
INAD protocol without data submission is incomplete if it would require 
additional information to enable the Agency to complete a comprehensive 
review of the protocol and reach a decision on the issue(s) presented 
in the protocol.
    The Agency will review and act on 90 percent of resubmitted INAD 
protocol without data submissions:
     Within 50 days after the resubmission date if the Agency 
determines and notifies the sponsor that the deficiencies are 
substantial;
     Within 20 days after the resubmitted INAD protocol without 
data submission date if the Agency determines and notifies the sponsor 
that the deficiencies are not substantial; and the resubmission must be 
submitted no more than 120 days after the Agency's dated nonconcurrence 
letter to qualify for the shorter review time; and
     Within 50 days after the resubmission date if the 
resubmission is submitted after 120 days of the Agency's dated 
nonconcurrence letter or new substantial information is provided in the 
resubmission.

B. Additional Review Enhancements Proposal for FYs 2015 to 2018

    The Agency will review and act on 90 percent of microbial food 
safety hazard characterization submissions within 100 days after the 
submission date.
    The Agency will review and act on 90 percent of qualifying labeling 
supplements as described in 21 CFR 514.8(c)(2)(i)(A) and (D) within 60 
days after the submission date. Qualifying labeling supplements are 
defined as those submitted through the use of the eSubmitter electronic 
submission tool, for which the sponsor provides and certifies a 
complete list of label changes made in the application and that CVM can 
determine upon initial review do not decrease the safety of drug use.
    The Agency will review and act on 90 percent of non-qualifying 
supplemental applications within 180 days after the submission date.

C. Performance Goals Proposal Affecting All Fiscal Years of ADUFA III 
(2014 to 2018)

    The Agency will maintain the ADUFA II goals regarding work queue 
procedures, timely meetings with industry, review of administrative 
NADAs, and preapproval foreign inspections.
    The Agency will review and act on 90 percent of manufacturing 
supplemental animal drug applications within 120 days after the 
submission date. A submission is incomplete if it would require 
additional data or information to enable the Agency to complete a 
comprehensive review of the submission and reach a decision on the 
issue(s) presented in the submission.
     If the Agency determines and notifies the sponsor that the 
deficiencies are not substantial for manufacturing supplements 
requiring prior approval according to Sec.  514.8(b), the Agency will 
permit the manufacturing supplements to be resubmitted as 
``Supplement--Changes Being Effected in 30 Days'' as described in Sec.  
514.8(b)(3).
     If the Agency determines and notifies the sponsor that the 
deficiencies are substantial or new substantial information is provided 
in the resubmission, the Agency will review and act on 90 percent of 
reactivated manufacturing supplements within 120 days after the 
resubmission date.
    The Agency will permit comparability protocols as described in 
Sec.  514.8(b)(2)(v) to be submitted as protocols without substantial 
data in an INAD file. The Agency will review and act on 90 percent of 
INAD submissions consisting of protocols without substantial data 
within 50 days after the submission date of the protocol.
    The Agency will develop guidance for a two-phased Chemistry, 
Manufacturing, and Controls (CMC) technical section submission and 
review process under the INAD file by the end of FY 2014.
    The Agency and the regulated industry agree that data and/or 
information which uniquely describes

[[Page 72359]]

the general attributes of the new animal drug (e.g., the known 
characteristics of the drug that can impact safety, effectiveness, and/
or quality) needs to be submitted early in the new animal drug 
development process in order to enable the parties to reach agreement 
at a presubmission conference or to begin review of a protocol. 
Predicated on submission of this information:
     The Agency will allow short justifications within INAD 
protocols without data submissions that are limited in scope.
     The Agency will allow for the concurrent submission of 
supporting data and protocols provided that the protocol is not 
submitted until the supporting data has been in the Agency's queue for 
at least 50 days.
    The Agency will allow for the inclusion of this data and/or 
information in presubmission conferences, however it would not preclude 
holding a presubmission conference without such data. Presubmission 
conferences will be held approximately 100 days after the submission of 
the data supporting the request.
    The Agency and the regulated industry agree that dosage 
characterization is part of the effectiveness technical section of an 
investigational new animal drug file. In instances where data and/or 
information about the dosage is integral to the review of a protocol, 
the Agency and the regulated industry agree that this data and/or 
information should be submitted as supporting data well in advance of 
the protocol submission.
    The Agency agrees to explore the feasibility of pursuing statutory 
revisions, consistent with the Agency's mission to protect and promote 
the public health, that may expand the use of conditional approvals to 
other appropriate categories of new animal drug applications and that 
may modify the current requirement that the use of multiple new animal 
drugs in the same medicated feed be subject to an approved application.

D. ADUFA III Enhancements for a Modified Inflation Adjuster and 
Workload Adjuster

    ADUFA III financial enhancements include a new statutory inflation 
adjuster provision that accounts for changes in FDA's costs related to 
payroll compensation and benefits as well as changes in nonpayroll 
costs through use of the Consumer Price Index. ADUFA III also modifies 
the base years for calculating the workload adjuster, as specified in 
the ADUFA III performance goals letter, to ensure that it adequately 
captures changes in FDA's workload during ADUFA III.

E. Impact of ADUFA III Enhancements on User Fee Revenue

    The following table summarizes the FY 2014 baseline and added 
funding to support ADUFA III program:

------------------------------------------------------------------------
                     Financial baseline                        Dollars
------------------------------------------------------------------------
FY 2014 Base Revenue \1\...................................   21,600,000
One-Time Information Technology (IT) Funding...............    2,000,000
Total Statutory Revenue for FY 2014........................   23,600,000
------------------------------------------------------------------------
\1\ For each year in FY 2015 to FY 2018, the annual fee revenue will be
  further adjusted according to the new statutory provision for the
  inflation adjuster and may be further adjusted by the workload
  adjuster. In fiscal years 2016 to 2018, if applicable, the annual fee
  revenue is subject to a number of possible adjustments, including for
  inflation and collection shortfalls.

    The statutory revenue for 2009, the first year of ADUFA II, was 
$15,260,000. The statutory revenue for the first year of ADUFA III will 
be $23,600,000, which includes one-time IT funding in the amount of 
$2,000,000 for FY 2014. The statute specifies annual revenue of 
$21,600,000 for each of the FY 2015 through FY 2018, however this 
amount is subject to a number of possible adjustments, including for 
inflation and collection shortfalls.
    Additionally, ADUFA III offers the following financial 
recommendations:
     A new provision for recovering collection shortfalls is 
being offered to ensure adequate funding for the animal drug review 
process. For example, when FDA sets fees for FY 2016, it may add to the 
fee revenue the amount of any shortfall in fees collected in FY 2014. 
This process would follow in subsequent years through the final year 
adjustment, as specified in the statute.
     FDA has modified the fee revenue distribution from 25 
percent for each fee type in ADUFA II to 20 percent in application, 27 
percent in product, 27 percent in sponsor, and 26 percent in 
establishment fees in ADUFA III. The purpose of changing the fee 
distribution is to increase the revenue stream stability, reduce 
application fee costs, and minimize the potential for collection 
shortfalls.

III. What information should you know about the meeting?

    We will convene a public meeting to hear the public's views on the 
proposed recommendations for reauthorization of the ADUFA program. We 
will conduct the meeting on December 18, 2012, at FDA's Metro Park 
North Campus (see Location). The meeting will include a presentation by 
FDA and we will provide an opportunity for other organizations and 
individuals to make presentations at the meeting or to submit written 
comments to the docket. So that FDA can consider comments and revise 
the recommendations as necessary, we request that comments be submitted 
to the docket by January 4, 2013.

    Dated: December 3, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29498 Filed 12-3-12; 4:15 pm]
BILLING CODE 4160-01-P