[Federal Register Volume 89, Number 118 (Tuesday, June 18, 2024)]
[Notices]
[Pages 51531-51533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13303]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2602]


First Annual Animal Drug User Fee Educational Conference; Public 
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following educational conference (public meeting) 
entitled ``First Annual Animal Drug User Fee Educational Conference.'' 
This is the first of five annual educational conferences FDA will host 
as described in the ``Animal Drug User Fee Act Reauthorization 
Performance Goals and Procedures Fiscal Years 2024 Through 2028.'' The 
purpose of this series of conferences is to provide educational 
sessions for stakeholders who are interested in the new animal drug 
approval process.

DATES: The first educational conference will be held on July 17, 2024, 
from 9 a.m. to 5 p.m. Eastern Time. See the SUPPLEMENTARY INFORMATION 
section for registration date and information. You may submit comments 
at any time for this series of educational conferences. We request that 
you submit either electronic or written comments by 90 days after each 
annual educational conference to ensure that the Agency considers your 
comment on a topic discussed at that conference.

[[Page 51532]]


ADDRESSES: The first educational conference will be available in person 
and virtually. The in-person conference will be held at the FDA White 
Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Great Room Conference 
Center, Silver Spring, MD 20993-0002. Entrance for conference 
participants (non-FDA employees) is through Building 1 where routine 
security check procedures will be performed. For parking and security 
information, please refer to https://www.fda.gov/about-fda/visitor-information. Persons interested in attending this educational 
conference must register at: https://fda.zoomgov.com/webinar/register/WN_cSFEyfDpQK6RuGrwPznG9A.
    You may submit comments as follows.

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-2024-N-2602 for ``First Annual Animal Drug User Fee Educational 
Conference.'' Received comments 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Walter Ellenberg, Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-796-0885, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The Animal Drug User Fee Act (Pub. L. 108-130) (ADUFA or the Act) 
was originally signed into law in 2003 and was subsequently 
reauthorized by Congress in 2008, 2013, 2018, and 2023. ADUFA 
authorizes FDA to collect fees for certain new animal drug 
applications, products, establishments, and sponsors. Resources 
generated under ADUFA supplement the Agency's funding to enhance the 
performance of the drug review process, ensuring that new animal drug 
products are safe and effective for animals, and that food derived from 
treated animals will be safe for consumption. FDA considers the timely 
review of the safety and effectiveness of new animal drug applications 
to be central to the Agency's mission to protect and promote human and 
animal health.
    The Animal Drug User Fee Amendments of 2023 (ADUFA V), the most 
recent reauthorization of the Act, authorizes FDA to collect user fees 
through fiscal year 2028. ``The Animal Drug User Fee Act 
Reauthorization Performance Goals and Procedures Fiscal Years 2024 
Through 2028'' (Performance Goals Letter) sets forth the Agency's 
performance goals for the period covered by ADUFA V. Among other goals, 
the document commits the Agency to hosting triannual meetings (three 
meetings per calendar year) with Animal Health Institute (AHI) members. 
Each year, during one of these meetings, the Agency will commit up to 8 
hours for an educational conference intended for the animal drug 
industry. This notice announces the first of these annual Animal Drug 
User Fee Educational Conferences. These conferences are open to the 
public. The educational conference being announced in this notice is 
the first annual conference of this series.

II. Topics for Discussion at the Educational Conference

    As described in the Performance Goals Letter, FDA will plan a 
series of topics for the educational conferences during the 5 years of 
ADUFA V. While the agenda for each educational conference is determined 
by the Agency with input from AHI, all stakeholders are welcome to 
submit comments to the docket requesting topics to be included for 
future educational conferences (see ADDRESSES).
    This initial conference will provide a high-level overview in the 
following areas:

(1) Overview of the Approval Process
(2) Communication Pathways with the Center for Veterinary Medicine

[[Page 51533]]

(3) Best Practices in the Approval Process
(4) Target Animal Safety Technical Section Overview
(5) Effectiveness Technical Section Overview
(6) Chemistry, Manufacturing, and Controls Technical Section Overview
(7) Human Food Safety Technical Section Overview
(8) Environmental Impact Technical Section Overview
(9) Minor Technical Sections Overview

    The conference will also contain Q&A sessions during which FDA will 
address specific questions from the in-person and virtual audience as 
time allows. Future educational conferences will take a more in-depth 
approach to these and other topics based on questions and comments 
received during this conference, as well as questions and comments 
submitted to the docket.

III. Participating in the Educational Conference

    Registration: This educational conference is open to the public and 
will be available virtually and in-person. When registering, please 
provide complete contact information for each attendee, including name, 
title, affiliation (if any), address, email, and telephone number. 
Also, please self-identify as a member of one of the stakeholder 
categories: regulated industry, scientific or academic experts, 
veterinary professionals, consumer advocacy groups, press/media 
relations, FDA, other government/congress, or other.
    Early registration is recommended for persons who wish to attend 
the conference. Registrants will receive confirmation when their 
registration has been received and they will be provided the webcast 
link. Persons interested in attending this conference virtually may 
register until the start time of the conference. Persons interested in 
attending this conference in person are encouraged to register online 
at https://fda.zoomgov.com/webinar/register/WN_cSFEyfDpQK6RuGrwPznG9A 
no later than July 10, 2024. Onsite registration will be provided on 
the day of the conference on a first-come, first-served basis, until 
the room capacity is reached. Onsite registration will open at the 
conference site at 8 a.m. on July 17, 2024. If room capacity is 
reached, individuals will be offered the opportunity to observe the 
conference from an overflow room located at the conference site.
    If you need special accommodations due to a disability, please 
contact Walter Ellenberg (see FOR FURTHER INFORMATION CONTACT) no later 
than July 10, 2024.
    Transcript: Transcripts of the educational conference will be 
available on FDA's website at https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings approximately 30 days after the 
conference. Please be advised that as soon as a transcript of the 
educational conference is available, it will be accessible at https://www.regulations.gov, and may also be viewed at the Dockets Management 
Staff (see ADDRESSES). A link to the transcript will also be available 
at https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings.
    Recording of Conference: Please be advised that as soon as a 
recording of this conference is available, it will be accessible at 
https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings.

    Dated: June 11, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13303 Filed 6-17-24; 8:45 am]
BILLING CODE 4164-01-P