[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)]
[Notices]
[Pages 23311-23313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09150]


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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 public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting on the Animal Generic Drug User Fee Act (AGDUFA). FDA invites 
public comment on the AGDUFA program and suggestions regarding the 
features FDA should propose for the next AGDUFA program.

DATES: The meeting will be held on May 16, 2016, from 1 p.m. to 4 p.m. 
In order to be taken into consideration before the public meeting, 
submit either electronic or written comments to the docket by May 4, 
2016. To permit the widest possible opportunity to obtain comments on 
all aspects of the public meeting, the docket will remain open for 
comment through December 1, 2017. In addition to being publicly 
viewable at http://www.regulations.gov, comments received by June 16, 
2016, suggesting changes to the program, will also be published on 
http://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm270232.htm. See the SUPPLEMENTARY 
INFORMATION section for registration date and information.

ADDRESSES: The meeting will be held at the Food and Drug 
Administration, 7519 Standish Pl., 3rd floor, Rm. A, Rockville, MD 
20855.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-N-0655 for ``Animal Generic Drug User Fee Act; Public Meeting; 
Request for Comments.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Cassie Ravo, Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855, 240-402-6866, FAX: 240-276-9744, [email protected].

SUPPLEMENTARY INFORMATION: 

[[Page 23312]]

I. Introduction

    The authority for AGDUFA expires September 30, 2018. Without new 
legislation, FDA will no longer have the authority to collect user fees 
to fund the generic new animal drug review process. Prior to beginning 
negotiations with the regulated industry on AGDUFA reauthorization, 
section 740A(d)(2) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 379j-13(d)(2)) requires FDA to: (1) Publish a 
notice in the Federal Register requesting public input on the 
reauthorization; (2) hold a public meeting at which the public may 
present its views on the reauthorization including specific suggestions 
for changes to the goals referred in section 740A(a) of FD&C Act; (3) 
provide a period of 30 days after the public meeting to obtain written 
comments from the public suggesting changes; and (4) publish the 
comments on FDA's Web site. FDA is holding a public meeting to gather 
information on what FDA should consider including in the 
reauthorization of AGDUFA. FDA is interested in responses from the 
public on the following two general questions and welcomes other 
pertinent information that stakeholders would like to share:
    1. What is your assessment of the overall performance of the AGDUFA 
program thus far?
    2. What aspects of AGDUFA should be retained, changed, or 
discontinued to further strengthen and improve the program?
    The following information is provided to help potential meeting 
participants better understand the history and evolution of AGDUFA and 
its current status.

II. Background

    The Animal Generic Drug User Fee Act enacted in 2008 (Pub. L. 110-
316; hereinafter referred to as ``AGDUFA I'') amended the FD&C Act to 
authorize FDA's first ever generic new animal drug user fee program. 
AGDUFA I provided FDA with additional funds to enhance the performance 
of the generic new animal drug review process. Furthermore, the 
authorization of AGDUFA I enabled FDA's continued assurance that 
generic new animal drug products are safe and effective, and enabled 
FDA's continued support for lower-cost alternatives to brand 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. These review performance goals strive to expedite the review 
of abbreviated new animal drug applications (ANADAs) and reactivations, 
supplemental ANADAs, and generic investigational new animal drug 
(JINAD) submissions.
    Under AGDUFA I, the industry agreed to pay user fees that are 
available to FDA, in addition to appropriated funds, to spend on the 
generic new animal drug review process. Moreover, FDA's authority to 
collect user fees is contingent on a certain level of spending from 
appropriated funds, as adjusted for inflation.
    AGDUFA I established increasingly stringent review performance 
goals over a 5-year period from FY 2009 through FY 2013. By the 5th and 
final year of AGDUFA I, FDA agreed to review and act on 90 percent of 
the following submission types within the specified timeframes:
     Original ANADAs and reactivations within 270 days of the 
submission date.
     Administrative ANADAs (ANADAs submitted after all 
scientific decisions have been made during the JINAD process, i.e., 
prior to the submission of the original 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. JINAD protocol submissions consist of protocols 
without substantial data that FDA and the sponsor consider to be an 
essential part of the basis to make the decision to approve or not 
approve an ANADA or supplemental ANADA.
    The additional resources provided under AGDUFA I enabled FDA to 
completely eliminate the backlog of ANADA and JINAD submissions by 
August 2010.
    In 2013, before AGDUFA I expired, Congress passed the Animal 
Generic Drug User Fee Amendments of 2013 (Pub. L. 113-14; hereinafter 
referred to as ``AGDUFA II'') which included an extension of AGDUFA for 
an additional 5 years (FY 2014 to FY 2018). AGDUFA II is maintaining 
the AGDUFA I performance 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. In addition, FDA agreed to the following program 
enhancements to further improve review processes:
     Developing a shortened review time process for certain 
ANADA and JINAD submissions.
     Permitting certain prior approval manufacturing 
supplements to be resubmitted as ``Supplement-Changes Being Effected in 
30 days.''
     Developing guidance for a two-phased Chemistry 
Manufacturing and Controls technical section submission and review 
process under the JINAD file.
     Permitting comparability protocols to be submitted as 
protocols without substantial data in a JINAD file.
     Improving timeliness and predictability of foreign pre-
approval inspections.
     Developing and implementing a question-based review 
process for the bioequivalence submissions.
    FDA has published a number of reports that provide useful 
background on AGDUFA I and AGDUFA II. AGDUFA-related Federal Register 
notices, guidances, legislation, performance reports, and financial 
reports and plans can be found at: http://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/default.htm.

III. Meeting Information

A. Meeting Format

    In general, the meeting format will include presentations by FDA 
followed by an open public comment period. Registered speakers for the 
open public comments will be grouped and scheduled in advance of the 
meeting based on their affiliation (scientific and academic experts/
veterinary professionals, representatives of consumer advocacy groups, 
and the regulated industry) and timing of their registration. FDA 
presentations are planned from 1 p.m. until 2 p.m. The open public 
comment portion of the meeting for registered and scheduled speakers is 
planned to begin at 2 p.m. An opportunity for additional open public 
comments from meeting attendees will commence following the registered 
presentations, if time permits.
    FDA policy issues are beyond the scope of these reauthorization 
discussions. Accordingly, the presentations should focus on process 
enhancements and funding issues, not on policy issues.

B. Meeting Questions

    Please consider the following questions for this meeting:
    1. What is your assessment of the overall performance of the AGDUFA 
program thus far?
    2. What aspects of AGDUFA should be retained, changed, or 
discontinued to further strengthen and improve the program?

[[Page 23313]]

C. Registration

    If you wish to attend and/or present at the meeting, please 
register by email to [email protected] by May 4, 2016. Your email 
should contain complete contact information for each attendee, 
including name, title, affiliation, address, email, and telephone 
number. Also, please self-identify as a member of one of the following 
stakeholder categories: Scientific or academic experts; veterinary 
professionals; patients and consumer advocacy groups; or the regulated 
industry and whether you are requesting a scheduled presentation. 
Registration is free and available on a first-come, first-served basis. 
Early registration is recommended since seating is limited. FDA may 
limit the number of participants from each organization based on space 
constraints. Registrants will receive confirmation once their 
registrations are accepted. Onsite registration on the day of the 
public meeting will be based on space availability. FDA will try to 
accommodate all persons who wish to make a presentation. The time 
allotted for presentations may depend on the number of persons who wish 
to speak.
    If you need special accommodations due to a disability, please 
contact Cassie Ravo (see FOR FURTHER INFORMATION CONTACT) at least 7 
days before the meeting.

D. Transcripts

    Please be advised that as soon as the transcript is available, it 
will be accessible at http://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm270232.htm. It may be viewed at 
the Division of Dockets Management (see ADDRESSES). A transcript will 
also be made available in either hard copy or on CD-ROM, after 
submission of a Freedom of Information request. The Freedom of 
Information office address is available on the Agency's Web site at 
http://www.fda.gov.

    Dated: April 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09150 Filed 4-19-16; 8:45 am]
 BILLING CODE 4164-01-P