Notice2024-13303
First Annual Animal Drug User Fee Educational Conference; Public Meeting
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 18, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 118 (Tuesday, June 18, 2024)</title>
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[Federal Register Volume 89, Number 118 (Tuesday, June 18, 2024)]
[Notices]
[Pages 51531-51533]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-13303]
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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.
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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 <a href="https://www.fda.gov/about-fda/visitor-information">https://www.fda.gov/about-fda/visitor-information</a>. Persons interested in attending this educational
conference must register at: <a href="https://fda.zoomgov.com/webinar/register/WN_cSFEyfDpQK6RuGrwPznG9A">https://fda.zoomgov.com/webinar/register/WN_cSFEyfDpQK6RuGrwPznG9A</a>.
You may submit comments as follows.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#0a6b6e7f6c6b557c556f6e7f556965646c6f786f64696f4a6c6e6b24626279246d657c"><span class="__cf_email__" data-cfemail="3c5d58495a5d634a63595849635f53525a594e59525f597c5a585d1254544f125b534a">[email protected]</span></a>.
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 <a href="https://fda.zoomgov.com/webinar/register/WN_cSFEyfDpQK6RuGrwPznG9A">https://fda.zoomgov.com/webinar/register/WN_cSFEyfDpQK6RuGrwPznG9A</a>
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 <a href="https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings">https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>, and may also be viewed at the Dockets Management
Staff (see ADDRESSES). A link to the transcript will also be available
at <a href="https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings">https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings</a>.
Recording of Conference: Please be advised that as soon as a
recording of this conference is available, it will be accessible at
<a href="https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings">https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings</a>.
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
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