[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)]
[Notices]
[Pages 23313-23315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09148]


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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 public meeting; request for comments.

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

DATES: The meeting will be held on May 16, 2016, from 9 a.m. to 12 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 throughout the reauthorization of ADUFA, until 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/AnimalDrugUserFeeActADUFA/ucm042891.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-0656 for the ``Animal Drug User Fee Act; Public Meeting.'' 
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

[[Page 23314]]

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: 

I. Introduction

    The authority for ADUFA expires September 30, 2018. Without new 
legislation, FDA will no longer have the authority to collect user fees 
to fund the new animal drug review process. Prior to beginning 
negotiations with the regulated industry on ADUFA 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 ADUFA. 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 ADUFA 
program thus far?
    2. What aspects of ADUFA 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 ADUFA and 
its current status.

II. Background

    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 dedicated to expediting the review of animal drug 
applications in accordance with certain performance goals. The 
implementation of ADUFA I provided a significant funding increase for 
new animal drug application review process, and enabled FDA to increase 
the number of staff dedicated to the new animal drug application review 
process by 30 percent from 2003 through 2008.
    Under ADUFA I, the industry agreed to pay user fees that are 
available to FDA, in addition to appropriated funds, to spend on the 
new animal drug application 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.
    As part of ADUFA I, FDA established review performance goals that 
have been phased in over a 5-year period. These performance goals set 
from FY 2004 to FY 2008 were intended to achieve progressive, yearly 
improvements in the time for review of new animal drug applications. By 
the 5th and final year of ADUFA ending on September 30, 2008, FDA 
agreed to review and act on 90 percent of the following submission 
types within the specified timeframes:
     New animal drug applications (NADAs) and reactivations of 
such applications within 180 days after submission date.
     Nonmanufacturing supplemental NADAs (that is supplemental 
NADAs for which safety or effectiveness data are required) and 
reactivations of such supplemental applications within 180 days after 
submission date.
     Manufacturing supplemental NADAs and reactivations of such 
supplemental applications within 120 days after submission date.
     Investigational new animal drug (INAD) study submissions 
within 180 days after submission date.
     INAD submissions consisting of protocols, that FDA and the 
sponsor consider to be an essential part of making the decision to 
approve or not approve a NADA or supplemental NADA, without substantial 
data, within 60 days after submission date.
     Administrative NADAs submitted after all scientific 
decisions have been made in the INAD process (that is, prior to 
submission of the animal drug application) within 60 days after 
submission date.
    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 (FY 2009 to FY 2013). ADUFA II performance goals were 
established based on ADUFA I FY 2008 review timeframes. In addition, 
FDA agreed to the following program enhancements to reduce review 
cycles and improve communications during reviews:
     Incorporating an ``end-review amendment'' process to amend 
pending submissions to achieve a complete review decision sooner and 
reduce the number of review cycles.
     Developing an electronic submission tool that allows 
industry to submit drug applications electronically.
     Participating with industry in public workshops on 
mutually agreed upon topics.
     Improving communications by enhancing the timeliness and 
predictability of foreign pre-approval inspections.
    In 2013, before ADUFA II expired, Congress passed the Animal Drug 
User Fee Amendments of 2013 (Pub. L. 113-14; hereinafter referred to as 
``ADUFA III'') which included an extension of ADUFA for an additional 5 
years (FY 2014 to FY 2018). ADUFA III is maintaining the ADUFA II 
performance goals regarding work queue procedures, timely meetings with 
industry, preapproval foreign inspections, and review of NADAs 
(including administrative NADAs), supplemental NADAs, INAD protocol 
submissions, and INAD study submissions. In addition, FDA agreed to the 
following program enhancements to further improve the review process:
     Discontinuing the end-review amendment procedures and 
replacing them with a shorter review time process for sponsors 
providing certain NADA and INAD submissions through the eSubmitter 
electronic submission tool.
     Implementing a new sentinel submission type and decreasing 
review time for certain labeling supplements.
     Decreasing the review time for microbial food safety 
hazard characterization submissions.
     Developing guidance for a two-phased Chemistry, 
Manufacturing, and Controls technical section submission and review 
process under the INAD file.

[[Page 23315]]

     Permitting certain prior approval manufacturing 
supplements to be resubmitted as ``Supplement--Changes Being Effected 
in 30 days.''
     Permitting comparability protocols to be submitted as 
protocols without substantial data in an INAD file.
     Developing a process where supporting information for pre-
submission conferences and INAD protocols without data submissions can 
be submitted early.
     Exploring the feasibility of pursuing statutory revisions 
that may modify the current requirements that the use of multiple new 
animal drugs in the same medicated feed be subject to an approved 
application.
     Exploring the feasibility of pursuing statutory revisions 
that may expand the use of conditional approvals to other appropriate 
categories of new animal drug applications.
    FDA has published a number of reports that provide useful 
background on ADUFA I, ADUFA II, and ADUFA III. ADUFA-related Federal 
Register notices, guidances, legislation, performance reports, and 
financial reports and plans can be found at: http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/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 registration. FDA 
presentations are planned from 9 a.m. until 10 a.m. The open public 
comment portion of the meeting for registered and scheduled speakers is 
planned to begin at 10 a.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 ADUFA 
III program thus far?
    2. What aspects of ADUFA should be retained, changed, or 
discontinued to further strengthen and improve the program?

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 phone 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/AnimalDrugUserFeeActADUFA/ucm042891.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 www.fda.gov.

    Dated: April 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09148 Filed 4-19-16; 8:45 am]
BILLING CODE 4164-01-P