First Annual Animal Drug User Fee Educational Conference; Public Meeting, 51531-51533 [2024-13303]
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Federal Register / Vol. 89, No. 118 / Tuesday, June 18, 2024 / Notices
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-201509-18/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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Karen Takahashi, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm, 6686,
Silver Spring, MD 20993–0002, 301–
796–3191.
SUPPLEMENTARY INFORMATION:
lotter on DSK11XQN23PROD with NOTICES1
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Facility Readiness: Goal Date Decisions
Under GDUFA.’’ This guidance provides
information to applicants on how FDA
intends to assign a goal date based on
a facility’s readiness for inspection as
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Jkt 262001
certified on Form FDA 356h submitted
as part of an original ANDA under
section 505(j) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(j)).
This guidance explains how FDA
incorporates a performance
enhancement in the GDUFA III
commitment letter as part of its goal
date assignments.
Under the commitment letter related
to the GDUFA authorization for fiscal
years 2018 through 2022 (under the
Generic Drug User Fee Amendments of
2017), a goal date was assigned without
regard to facility readiness for
inspection. In contrast, under the
GDUFA III commitment letter, FDA
agreed to assign a longer goal date if a
facility is not ready for an inspection at
the time of application submission. An
application containing a facility not
ready for inspection is more likely to
require more than one assessment cycle,
extending the time required for possible
approval and potentially delaying
patient access to quality generic drugs.
This change in goal date assignment
will help FDA to focus resources on
applications with facilities ready for
inspection.
This guidance finalizes the draft
guidance of the same title issued on
October 7, 2022 (87 FR 61039). No
public comments were received on the
draft guidance. Only minor editorial
changes were made.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
This guidance represents the current
thinking of FDA on ‘‘Facility Readiness:
Goal Date Decisions Under GDUFA.’’ It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in 21 CFR part 314 for
ANDAs have been approved under OMB
control number 0910–0001. The
collections of information in Form FDA
356h have been approved under OMB
control number 0910–0338. The
collections of information in 21 CFR
part 11 for electronic records and
electronic signatures have been
approved under OMB control number
PO 00000
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51531
0910–0303. The collections of
information in 21 CFR parts 210 and
211 pertaining to current good
manufacturing practice have been
approved under OMB control number
0910–0139. The collections of
information pertaining to the GDUFA III
commitment letter have been approved
under OMB control number 0910–0727.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: June 13, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–13391 Filed 6–17–24; 8:45 am]
BILLING CODE 4164–01–P
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.
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.
SUMMARY:
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Federal Register / Vol. 89, No. 118 / Tuesday, June 18, 2024 / Notices
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.zoom
gov.com/webinar/register/WN_
cSFEyfDpQK6RuGrwPznG9A.
You may submit comments as
follows.
ADDRESSES:
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’’).
lotter on DSK11XQN23PROD with NOTICES1
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.’’
VerDate Sep<11>2014
17:57 Jun 17, 2024
Jkt 262001
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-201509-18/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,
adufa_v_edu_conference@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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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
E:\FR\FM\18JNN1.SGM
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Federal Register / Vol. 89, No. 118 / Tuesday, June 18, 2024 / Notices
(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.
lotter on DSK11XQN23PROD with NOTICES1
III. Participating in the Educational
Conference
Registration: This educational
conference is open to the public and
will be available virtually and inperson. When registering, please
provide complete contact information
for each attendee, including name, title,
affiliation (if any), address, email, and
telephone number. Also, please selfidentify 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
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17:57 Jun 17, 2024
Jkt 262001
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-druguser-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-druguser-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-actadufa/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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–5656]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; State Enforcement
Notifications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
SUMMARY:
PO 00000
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51533
collection of information by July 18,
2024.
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0275. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
State Enforcement Notifications—21
CFR 100.2(d)
OMB Control Number 0910–0275—
Extension
This information collection supports
Agency regulations. Specifically, section
310(b) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
337(b)) authorizes a State to enforce
certain sections of the FD&C Act in their
own name and within their own
jurisdiction. However, before doing so,
a State must provide notice to FDA
according to § 100.2 (21 CFR 100.2). The
information required in a letter of
notification under § 100.2(d) enables us
to identify the food against which a
State intends to take action and to
advise that State whether Federal
enforcement action against the food has
been taken or is in process. With certain
narrow exceptions, Federal enforcement
action precludes State action under the
FD&C Act.
In the Federal Register of January 23,
2024 (89 FR 4315), we published a 60day notice soliciting comment on the
proposed collection of information. No
comments were received.
We estimate the burden of this
collection of information as follows:
E:\FR\FM\18JNN1.SGM
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]]>Agencies
[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
