[Federal Register Volume 82, Number 192 (Thursday, October 5, 2017)]
[Notices]
[Pages 46503-46505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21439]


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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, the Agency, or we) is 
announcing a forthcoming public meeting entitled ``Animal Drug User Fee 
Act.'' The topic to be discussed is proposed recommendations for the 
reauthorization of the Animal Drug User Fee Act (ADUFA IV). The meeting 
will be open to the public.

DATES: The public meeting will be held on November 2, 2017, from 9 a.m. 
to 12 noon. Submit either electronic or written comments on this public 
meeting to the docket by November 17, 2017. See the SUPPLEMENTARY 
INFORMATION section for registration date and information.

ADDRESSES: The public meeting will be held at 7500 Standish Pl., Room 
N149 (first floor), Rockville, MD 20855. Free parking is available 
onsite. Attendees must provide a valid government issued photo ID 
(driver's license, identification card, or passport) to enter the 
facility. Entrance for the public meeting participants (non-FDA 
employees) is through the front of the building where routine security 
check procedures will be performed.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Comments must be submitted on or 
before November 17, 2017.\1\ The https://www.regulations.gov electronic 
filing system will accept comments until midnight Eastern Time at the 
end of November 17, 2017. Comments received by mail/hand delivery/
courier (for written/paper submissions) will be considered timely if 
they are postmarked or the delivery service acceptance receipt is on or 
before that date.
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    \1\ This date corrects the comment closing date of December 1, 
2017, stated in the Federal Register notice announcing the initial 
ADUFA reauthorization public meeting held on May 16, 2016 (81 FR 
23313, April 20, 2016).
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Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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

[[Page 46504]]

identifies you in the body of your comments, that information will be 
posted on https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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 ``Animal Drug User Fee Act; Public Meeting; Request 
for Comments.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management 
Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    In addition to being publicly viewable at https://www.regulations.gov, comments will also be published on https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042891.htm.

FOR FURTHER INFORMATION CONTACT: Cassie Ravo, Center for Veterinary 
Medicine (HFV-10), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-6866, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a public meeting to discuss proposed 
recommendations for the reauthorization of ADUFA, which authorizes FDA 
to collect user fees and use them for the process of reviewing new 
animal drug applications and associated submissions. 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 for future fiscal years. Section 740A(d)(4) of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379j-
13(d)(4)) requires that, after holding negotiations with regulated 
industry and periodic consultations with stakeholder, and before 
transmitting the Agency's final recommendation to Congress for the 
reauthorized program (ADUFA IV), we do the following: (1) Present the 
recommendation to the relevant Congressional committees, (2) publish 
such recommendations in the Federal Register, (3) provide for a period 
of 30 days for the public to provide written comments on such 
recommendations, (4) hold a meeting at which the public may present its 
views on such recommendations, and (5) consider such public views and 
comments and revise such recommendations as necessary. This notice, the 
30-day comment period, and the public meeting will satisfy certain of 
these requirements. After the public meeting, we will revise the draft 
recommendations as necessary. In addition, the Agency will present the 
draft recommendations to the Congressional committees.
    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 human and animal 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 dedicated to the timely 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 ADUFA I, 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 in ADUFA I.
    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 through FY 2013). ADUFA II performance 
goals were established based on ADUFA I FY 2008 review time frames. In 
addition, FDA provided program enhancements to reduce review cycles and 
improve communications during reviews. The ADUFA programs have enabled 
FDA to meet performance timeframes for application review for new 
animal drugs without compromising the quality of the Agency's review.
    In 2013, Congress passed the Animal Drug and Animal Generic Drug 
User Fee Reauthorization Act of 2013, reauthorizing ADUFA (Pub. L. 113-
14; hereinafter referred to as ``ADUFA III''). ADUFA II was set to 
expire September 30, 2013, and the new reauthorization extends ADUFA 
until 2018.
    ADUFA III reauthorization maintained the FY 2013 review timeframes 
for key submissions in addition to enhancements to the program. 
Enhancements included: Replacing the End Review Amendment with a short, 
second-round review; reducing time for microbial food safety hazard 
characterization submissions to

[[Page 46505]]

100 days; and adding a variable inflation adjuster to account for 
changes in the Center for Veterinary Medicine's costs using the 
Consumer Price Index as a guide. Also, the proportion of revenue 
collected from fees was redistributed as follows: Application fees from 
25 percent to 20 percent; product fees from 25 percent to 27 percent; 
establishment fees from 25 percent to 26 percent; and sponsor fees from 
25 percent to 27 percent.
    Additionally, there were chemistry, manufacturing, and controls 
(CMC) enhancements, including: Permitting the manufacturing supplements 
to be resubmitted as ``Supplement-Changes Being Effected in 30 Days'' 
if deficiencies are not substantial for manufacturing supplements 
requiring prior approval according to 21 CFR 514.8(b); permitting 
comparability protocols as described in 21 CFR 514.8(b)(2)(v) to be 
submitted as protocols without substantial data in an investigational 
new animal drug (INAD) file; and developing guidance for a two-phased 
CMC technical section submission and review process under the INAD 
file. The Agency agreed to explore the feasibility of pursuing expanded 
conditional approvals and of modifying the current requirement that the 
use of multiple new animal drugs in the same medicated feed 
(combination medicated feed) be subject to an approved application. The 
reauthorization of ADUFA is targeted to generate $114,000,000 in user 
fees over 5 years (FY 2014 through FY 2018).
    FDA has published a number of reports that provide useful 
background on ADUFA I, II, and III. ADUFA-related Federal Register 
notices, guidances, legislation, performance reports, and financial 
reports can be found at: https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm.

II. Topics for Discussion at the Public Meeting

    In preparing the proposed recommendations to Congress for ADUFA 
reauthorization (ADUFA IV), we have conducted discussions with the 
regulated industry, and we have consulted with stakeholders as required 
by the law. We began the ADUFA reauthorization process with a public 
meeting held on May 16, 2016 (81 FR 23313, April 20, 2016). Following 
the May 2016 public meeting, FDA conducted negotiations with regulated 
industry and continued regular consultations with public stakeholders 
from October 2016 through April 2017. As directed by Congress, FDA 
posted minutes of these discussions on its Web site at https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042891.htm.
    The proposed enhancements from ADUFA IV address many of the top 
priorities identified by public stakeholders, the top concerns 
identified by regulated industry, and the most important challenges 
identified within FDA. The full descriptions of these proposed 
recommendations can be found in the proposed ADUFA IV Performance Goals 
and Procedures Letter. FDA intends to publish in the Federal Register 
the full text of the proposed ADUFA IV Performance Goals and Procedures 
Letter and a summary of proposed statutory changes, as well as post 
them at https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm before the public meeting and 
will provide for a period of 30 days for the public to provide written 
comments.
    FDA will post the agenda approximately 5 days before the meeting at 
https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please contact 
Cassie Ravo (see FOR FURTHER INFORMATION CONTACT). Please provide 
complete contact information for each attendee, including name, title, 
affiliation, address, email, and telephone. 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 based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
meeting must register by October 26, 2017, midnight Eastern Time. Early 
registration is recommended because seating is limited; therefore, FDA 
may limit the number of participants from each organization. 
Registrants will receive confirmation when they have been accepted. If 
time and space permit, onsite registration on the day of the public 
meeting will be provided beginning at 8:30 a.m. We will let registrants 
know if registration closes before the day of the public meeting. If 
you need special accommodations due to a disability, please contact 
Cassie Ravo (see FOR FURTHER INFORMATION CONTACT) no later than October 
26, 2017.
    Requests for Oral Presentations: When registering, you may indicate 
if you wish to present during a public comment session or participate 
in a specific session, and which topic(s) you wish to address. We will 
do our best to accommodate requests to make public comments. 
Individuals and organizations with common interests are urged to 
consolidate or coordinate their presentations, and request time for a 
joint presentation, or submit requests for designated representatives 
to participate in the focused sessions. Following the close of 
registration, we will determine the amount of time allotted to each 
presenter and the approximate time each oral presentation is to begin, 
and will select and notify participants by October 27, 2017. All 
requests to make oral presentations must be received by the close of 
registration on October 26, 2017. If selected for presentation, any 
presentation materials must be emailed to the Cassie Ravo (see FOR 
FURTHER INFORMATION CONTACT) no later than October 31, 2017. No 
commercial or promotional material will be permitted to be presented or 
distributed at the public meeting.
    Streaming Webcast of the public meeting: This public meeting will 
also be webcast.
    Event: ADUFA IV Public Meeting. Event address for attendees: 
https://fda.webex.com/fda/onstage/g.php?MTID=e9adcd215b7dba5d99361b002663e51fe. Date and time: Thursday, 
November 2, 2017, 9 a.m. Eastern Daylight Time (New York, GMT-4). 
Duration: 3 hours. Event number: 812 395 634. Event password: 110217. 
Teleconference: Provide your number when you join the event to receive 
a call back. (1) Call one of the following numbers: Local: 1-301-796-
7777; toll free: 1-855-828-1770. (2) Follow the instructions that you 
hear on the phone. Cisco Unified MeetingPlace meeting ID: 812 395 634.
    FDA has verified the Web site addresses in this document, as of the 
date this document publishes in the Federal Register, but Web sites are 
subject to change over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
internet at: https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042891.htm.

    Dated: September 29, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21439 Filed 10-4-17; 8:45 am]
BILLING CODE 4164-01-P