[Federal Register Volume 77, Number 234 (Wednesday, December 5, 2012)]
[Notices]
[Pages 72359-72361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-29499]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0655]


Animal Generic 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 Generic Drug User Fee Act. The topic to be discussed is 
proposed recommendations for the reauthorization of the Animal Generic 
Drug User Fee Act (AGDUFA II).
    Date and Time: The meeting will be held on December 18, 2012, from 
1 p.m. to 4 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

[[Page 72360]]

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:

I. The AGDUFA Program

A. What is AGDUFA? What does it do?

    FDA considers the timely review of abbreviated new animal drug 
applications (ANADAs) to be central to the Agency's mission to protect 
and promote the public health. Prior to 2009, the timeliness and 
predictability of the generic animal drug review program was a concern. 
The Animal Generic Drug User Fee Act enacted in 2008 (Pub. L. 110-316; 
hereinafter referred to as ``AGDUFA I'') amended the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) to authorize the FDA's first-ever 
generic animal drug user fee program. AGDUFA I provides FDA with 
additional funds to enhance the performance of the generic animal drug 
review process. Furthermore, the authorization of AGDUFA I enabled 
FDA's continued assurance that generic animal drug products are safe 
and effective, and enabled FDA's continued support for lower cost 
alternatives to brand name drugs for consumers.
    Under AGDUFA I, FDA agreed to meet review performance goals for 
certain submissions over 5 years from fiscal year (FY) 2009 through FY 
2013. The purpose of establishing these review performance goals was to 
expedite the review of ANADAs and reactivations, supplemental ANADAs, 
and generic investigational new animal drug (JINAD) submissions and to 
enable FDA to speed up the application review process for generic new 
animal drugs without compromising the quality of the Agency's review.

B. AGDUFA Achievements

    AGDUFA I established increasingly stringent review performance 
goals over a 5-year period from FY 2009 through FY 2013. Based on those 
performance goals, in the final year of AGDUFA I (FY 2013) FDA has 
agreed to review and act on 90 percent of the following submission 
types within the specified timeframes:
     Original ANADAs and reactivations within 270 days after 
the submission date.
     Administrative ANADAs within 100 days after the submission 
date.
     Manufacturing supplemental ANADAs and reactivations within 
270 days after the submission date.
     JINAD study submissions within 270 days after the 
submission date.
     JINAD protocol submissions within 100 days after 
submission date.
    In the 3 years of AGDUFA I review performance evaluated to date (FY 
2009 to FY 2011) FDA has exceeded all performance goals for ANADAs, 
manufacturing supplements, JINAD data submissions, and administrative 
ANADAs. FDA did not meet the FY 2009 performance goal for JINAD 
protocol submissions, with 86 percent reviewed by the goal for that 
year but has exceeded the performance goal for JINAD protocol 
submissions in FY 2010 and FY 2011. The additional resources provided 
under AGDUFA I enabled FDA to completely eliminate the backlog of ANADA 
and JINAD submissions by August 2010.
    FDA has published a number of reports that provide useful 
background on AGDUFA I. AGDUFA-related Federal Register notices, 
guidances, legislation, performance reports, and financial reports can 
be found at: http://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/default.htm.

II. Proposed AGDUFA II Recommendations

A. Enhancing the Process for Premarket Review

    We are proposing to maintain the AGDUFA I goals regarding work 
queue procedures, timely meetings with industry, review of 
administrative ANADAs, review of protocols without substantial data, 
and amending similar applications and submissions. We are proposing the 
following changes to the performance goals that AGDUFA I established to 
further enhance the process for review of generic animal drug 
applications.
    The Agency will review and act on 90 percent of non-administrative 
ANADAs within 270 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:
     Within 190 days after the reactivated ANADA submission 
date if the Agency determines that the deficiencies are not 
substantial;
     Within 270 days after the reactivated ANADA submission 
date if the Agency determines that the deficiencies are substantial or 
new substantial information is provided.
    The Agency will review and act on 90 percent of manufacturing 
supplemental ANADAs within 270 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 that the deficiencies are not 
substantial for manufacturing supplements requiring prior approval 
according to 21 CFR 514.8(b), the Agency will permit the manufacturing 
supplements to be resubmitted as ``Supplement-Changes Being Effected in 
30 Days'' as described in 21 CFR 514.8(b)(3).
     If the Agency determines 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 270 days after the 
resubmission date.
    The Agency will review and act on 90 percent of JINAD study 
submissions within 270 days after the submission date. A JINAD 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 JINAD 
study submissions:
     Within 90 days after the JINAD study resubmission date if 
the Agency determines that the deficiencies are not substantial;
     Within 270 days after the JINAD study resubmission date if 
the Agency

[[Page 72361]]

determines that the deficiencies are substantial or new substantial 
information is provided in the resubmission.
    The Agency will permit comparability protocols as described in 21 
CFR 514.8(b)(2)(v) to be submitted as protocols without substantial 
data in a JINAD file. The Agency will continue to review and act on 90 
percent of JINAD submissions consisting of protocols without 
substantial data within 100 days after the submission date.
    The Agency will develop guidance for a two-phased Chemistry, 
Manufacturing, and Controls technical section submission and review 
process under the JINAD file by the end of FY 2014.
    The Agency will develop and implement a question based review 
process for bioequivalence submissions by the end of FY 2016. At its 
discretion, the Agency may extend the timeline for completion if 
necessary, depending on available resources.
    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 included in abbreviated 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 abbreviated animal drug 
application, an abbreviated supplemental animal drug application, or 
generic 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.

B. AGDUFA II Enhancements for a Modified Inflation Adjuster and 
Workload Adjuster

    Similar to AGDUFA I, we agreed to a fixed inflation adjuster over 
the 5-year period that results in the statutory revenues specified in 
sections 741(b) and 741(g)(3) of FD&C Act (21 U.S.C. 379j-21(b) and 
379-21(g)(3)).
    AGDUFA II also modifies the base years for calculating the workload 
adjuster, as specified in the AGDUFA II performance goals letter, to 
ensure that it adequately captures changes in FDA's workload during 
AGDUFA II.

C. Impact of AGDUFA II Enhancements on User Fee Revenue

    The following table summarizes FY 2014 baseline and added funding 
to support AGDUFA II program, as well as the AGDUFA II total 5-year 
revenue:

------------------------------------------------------------------------
                     Financial baseline                        Dollars
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FY 2014 Base Revenue \1\...................................    6,478,000
One-Time Information Technology (IT) Funding...............      850,000
                                                            ------------
    Total Statutory Revenue for FY 2014....................    7,328,000
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                         Total Financial Funding
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Total 5-Year Revenue.......................................   38,100,000
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\1\ For each year in FY 2015 to FY 2018, the annual statutory revenue
  amounts established in section 741(b) of the FD&C Act may be further
  adjusted by the workload adjuster for FY 2015 to FY 2018 user fee
  revenues.

    The total 5-year revenue for AGDUFA I was $27,100,000. The total 5-
year revenue for AGDUFA II will be $38,100,000, which also includes 
one-time IT funding in the amount of $850,000 for FY 2014.
    Additionally, the fee revenue distribution has been modified from 
30 percent in application fees, 35 percent in product fees, and 35 
percent in sponsor fees under AGDUFA I to 25 percent in application 
fees, 37.5 percent in product fees, and 37.5 percent in sponsor fees 
under AGDUFA II. The purpose of changing the fee distribution is to 
increase the revenue stream stability and reduce application fee costs.

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 AGDUFA I. The public 
meeting will be held on December 18, 2012, at FDA's Metro Park North 
Campus (see Location). The meeting will include a presentation by FDA, 
and we will also 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. 2012-29499 Filed 11-26-12; 4:15 pm]
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