82 FR 46506 - Animal Generic Drug User Fee Act; Public Meeting; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 192 (October 5, 2017)

Page Range		46506-46508
FR Document		2017-21438
The Food and Drug Administration (FDA, the Agency, or we) is announcing the forthcoming public meeting entitled ``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 III). The meeting will be open to the public.
Federal Register, Volume 82 Issue 192 (Thursday, October 5, 2017)
[Federal Register Volume 82, Number 192 (Thursday, October 5, 2017)]
[Notices]
[Pages 46506-46508]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-21438]



[[Page 46506]]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the forthcoming public meeting entitled ``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 III). The meeting will be open to the public.

DATES: The public meeting will be held on November 2, 2017, from 1 p.m. 
to 4 p.m. Submit either electronic or written comments on this public 
meeting 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., Rm. 
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.
---------------------------------------------------------------------------

    \1\ This date corrects the comment closing date of December 1, 
2017, stated in the Federal Register notice announcing the initial 
AGDUFA reauthorization public meeting held on May 16, 2016 (81 FR 
23311, April 20, 2016).
---------------------------------------------------------------------------

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 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-0655 for ``Animal Generic 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.thefederalregister.org/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/AnimalGenericDrugUserFeeActAGDUFA/ucm270232.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 AGDUFA, which authorizes FDA 
to collect user fees and use them for the process of reviewing new 
animal generic drug applications and associated submissions. 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 new animal generic drug review process for future fiscal 
years. Section 742(d)(4) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 379j-22(d)(4)) requires that, after holding 
negotiations with regulated industry and periodic consultations with 
stakeholders, and before transmitting the Agency's final

[[Page 46507]]

recommendation to Congress for the reauthorized program (AGDUFA III), 
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 abbreviated new animal drug 
applications (ANADAs) to be central to the Agency's mission to protect 
and promote human and animal health. Prior to 2009, the timeliness and 
predictability of the generic new 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 FD&C Act 
to authorize the FDA's first-ever generic animal drug user fee program. 
AGDUFA I provided FDA with additional funds to enhance the performance 
and predictability 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.
    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 
ensure the timely review of ANADAs and reactivations, supplemental 
ANADAs, and generic investigational new animal drug (JINAD) 
submissions, and as a result FDA has been able to reduce the time for 
the application review process for generic new animal drugs without 
compromising the quality of the Agency's review.
    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 agreed 
to review and act on 90 percent of the following submission types 
within the specified time frames:
     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.
    With the reauthorization of AGDUFA for an additional 5 years under 
AGDUFA II (FY 2014 to FY 2018), FDA agreed to further enhance and 
improve the review process.
    The AGDUFA II reauthorization enhancements included developing 
Question Based Review Process for Bioequivalence Submissions and 
shortening review time for key submission types. Additionally, there 
were chemistry, manufacturing, and controls (CMC) enhancements, 
including: Permitting 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 a JINAD file; and developing guidance for a two-
phased CMC technical section submission and review process under the 
JINAD file. Finally, the proportion of revenue collected from user fees 
was redistributed as follows: Application fees from 30 percent to 25 
percent; product fees from 35 percent to 37.5 percent; and sponsor fees 
from 35 percent to 37.5 percent.
    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 can be found at: https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/default.htm.

II. Topics for Discussion at the Public Meeting

    In preparing the proposed recommendations to Congress for AGDUFA 
reauthorization (AGDUFA III), we have conducted discussions with the 
regulated industry, and we have consulted with stakeholders as required 
by the law. We began the AGDUFA reauthorization process with a public 
meeting held on May 16, 2016 (81 FR 23311, April 20, 2016). Following 
the May 2016 public meeting, FDA conducted negotiations with regulated 
industry and continued regular consultations with public stakeholders 
from August 2016 through January 2017. As directed by Congress, FDA 
posted minutes of these discussions on its Web site at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm270232.htm. The proposed enhancements from AGDUFA III 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 AGDUFA III 
Performance Goals and Procedures Letter. FDA intends to publish in the 
Federal Register the full text of the proposed AGDUFA III Performance 
Goals and Procedures Letter and a summary of proposed statutory 
changes, as well as post them at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm270232.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/AnimalGenericDrugUserFeeActAGDUFA/ucm270232.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 12:30 p.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

[[Page 46508]]

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 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: AGDUFA III Public Meeting. Event address for attendees: 
https://fda.webex.com/fda/onstage/g.php?MTID=ec1c356734bcf010b59e0b885726ccad0. Date and time: Thursday, 
November 2, 2017, 1 p.m. Eastern Daylight Time (New York, GMT-4). 
Duration: 3 hours. Event number: 817 527 611. 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: 817 527 611.
    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/AnimalGenericDrugUserFeeActAGDUFA/ucm270232.htm.

    Dated: September 29, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21438 Filed 10-4-17; 8:45 am]
BILLING CODE 4164-01-P
Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices 46507

recommendation to Congress for the • Administrative ANADAs within from August 2016 through January 2017.
reauthorized program (AGDUFA III), we 100 days after the submission date. As directed by Congress, FDA posted
do the following: (1) Present the • Manufacturing supplemental minutes of these discussions on its Web
recommendation to the relevant ANADAs and reactivations within 270 site at https://www.fda.gov/ForIndustry/
Congressional committees, (2) publish days after the submission date. UserFees/AnimalGenericDrugUserFee
such recommendations in the Federal • JINAD study submissions within ActAGDUFA/ucm270232.htm. The
Register, (3) provide for a period of 30 270 days after the submission date. proposed enhancements from AGDUFA
days for the public to provide written • JINAD protocol submissions within III address many of the top priorities
comments on such recommendations, 100 days after submission date. identified by public stakeholders, the
(4) hold a meeting at which the public With the reauthorization of AGDUFA top concerns identified by regulated
may present its views on such for an additional 5 years under industry, and the most important
recommendations, and (5) consider such AGDUFA II (FY 2014 to FY 2018), FDA challenges identified within FDA. The
public views and comments and revise agreed to further enhance and improve full descriptions of these proposed
such recommendations as necessary. the review process. recommendations can be found in the
This notice, the 30-day comment period, The AGDUFA II reauthorization
proposed AGDUFA III Performance
and the public meeting will satisfy enhancements included developing
Goals and Procedures Letter. FDA
certain of these requirements. After the Question Based Review Process for
intends to publish in the Federal
public meeting, we will revise the draft Bioequivalence Submissions and
Register the full text of the proposed
recommendations as necessary. In shortening review time for key
AGDUFA III Performance Goals and
addition, the Agency will present the submission types. Additionally, there
Procedures Letter and a summary of
draft recommendations to the were chemistry, manufacturing, and
proposed statutory changes, as well as
Congressional committees. controls (CMC) enhancements,
post them at https://www.fda.gov/
FDA considers the timely review of including: Permitting manufacturing
ForIndustry/UserFees/AnimalGeneric
abbreviated new animal drug supplements to be resubmitted as
DrugUserFeeActAGDUFA/
applications (ANADAs) to be central to ‘‘Supplement-Changes Being Effected in
ucm270232.htm, before the public
the Agency’s mission to protect and 30 Days’’ if deficiencies are not
meeting, and will provide for a period
promote human and animal health. substantial for manufacturing
of 30 days for the public to provide
Prior to 2009, the timeliness and supplements requiring prior approval
written comments.
predictability of the generic new animal according to 21 CFR 514.8(b); permitting
comparability protocols as described in FDA will post the agenda
drug review program was a concern. approximately 5 days before the meeting
The Animal Generic Drug User Fee Act 21 CFR 514.8(b)(2)(v) to be submitted as
protocols without substantial data in a at https://www.fda.gov/ForIndustry/
enacted in 2008 (Pub. L. 110–316; UserFees/AnimalGenericDrugUserFee
hereinafter referred to as ‘‘AGDUFA I’’) JINAD file; and developing guidance for
a two-phased CMC technical section ActAGDUFA/ucm270232.htm.
amended the FD&C Act to authorize the
FDA’s first-ever generic animal drug submission and review process under III. Participating in the Public Meeting
user fee program. AGDUFA I provided the JINAD file. Finally, the proportion of
revenue collected from user fees was Registration: To register for the public
FDA with additional funds to enhance
redistributed as follows: Application meeting, please contact Cassie Ravo (see
the performance and predictability of
FOR FURTHER INFORMATION CONTACT).
the generic new animal drug review fees from 30 percent to 25 percent;
product fees from 35 percent to 37.5 Please provide complete contact
process. Furthermore, the authorization
percent; and sponsor fees from 35 information for each attendee, including
of AGDUFA I enabled FDA’s continued
percent to 37.5 percent. name, title, affiliation, address, email,
assurance that generic new animal drug
FDA has published a number of and telephone. Also, please self-identify
products are safe and effective.
Under AGDUFA I, FDA agreed to reports that provide useful background as a member of one of the following
meet review performance goals for on AGDUFA I and AGDUFA II. stakeholder categories: Scientific or
certain submissions over 5 years from AGDUFA-related Federal Register academic experts; veterinary
fiscal year (FY) 2009 through FY 2013. notices, guidances, legislation, professionals; patients and consumer
The purpose of establishing these performance reports, and financial advocacy groups; or the regulated
review performance goals was to ensure reports can be found at: https:// industry, and whether you are
the timely review of ANADAs and www.fda.gov/ForIndustry/UserFees/ requesting a scheduled presentation.
reactivations, supplemental ANADAs, AnimalGenericDrugUserFeeAct Registration is free and based on
and generic investigational new animal AGDUFA/default.htm. space availability, with priority given to
drug (JINAD) submissions, and as a early registrants. Persons interested in
II. Topics for Discussion at the Public attending this public meeting must
result FDA has been able to reduce the
Meeting register by October 26, 2017, midnight
time for the application review process
for generic new animal drugs without In preparing the proposed Eastern Time. Early registration is
compromising the quality of the recommendations to Congress for recommended because seating is
Agency’s review. AGDUFA reauthorization (AGDUFA III), limited; therefore, FDA may limit the
AGDUFA I established increasingly we have conducted discussions with the number of participants from each
stringent review performance goals over regulated industry, and we have organization. Registrants will receive
a 5-year period from FY 2009 through consulted with stakeholders as required confirmation when they have been
FY 2013. Based on those performance by the law. We began the AGDUFA accepted. If time and space permit,
ethrower on DSK3G9T082PROD with NOTICES

goals, in the final year of AGDUFA I (FY reauthorization process with a public onsite registration on the day of the
2013) FDA agreed to review and act on meeting held on May 16, 2016 (81 FR public meeting will be provided
90 percent of the following submission 23311, April 20, 2016). Following the beginning at 12:30 p.m. We will let
types within the specified time frames: May 2016 public meeting, FDA registrants know if registration closes
• Original ANADAs and reactivations conducted negotiations with regulated before the day of the public meeting.
within 270 days after the submission industry and continued regular If you need special accommodations
date. consultations with public stakeholders due to a disability, please contact Cassie

VerDate Sep<11>2014 19:52 Oct 04, 2017 Jkt 244001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\05OCN1.SGM 05OCN1
Document Created: 2017-10-05 00:53:32
Document Modified: 2017-10-05 00:53:32
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of public meeting; request for comments.
Dates		The public meeting will be held on November 2, 2017, from 1 p.m. to 4 p.m. Submit either electronic or written comments on this public meeting by November 17, 2017. See the SUPPLEMENTARY INFORMATION section for registration date and 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]
FR Citation		82 FR 46506
82 FR 46506 - Animal Generic Drug User Fee Act; Public Meeting; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 192 (October 5, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
