Agency Information Collection Activities; Proposed Collection; Risk/Safety Considerations and Motivations for Purchase and Use of Kratom and Psychedelics Alone and in Combination With Other Substances; Withdrawal of Notice, 65635 [2024-17793]
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Federal Register / Vol. 89, No. 155 / Monday, August 12, 2024 / Notices
II. Topics for Discussion at the Public
Meeting
The public meeting will address a
variety of topics related to development
of an enhanced systematic process for
FDA’s post-market assessment of
chemicals in food, including:
• Principles for the post-market
assessment process,
• Steps in the post-market assessment
process,
• Prioritizing chemicals for postmarket assessment, and
• Engaging stakeholders throughout
the post-market assessment process.
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III. Participating in the Public Meeting
Registration: This public meeting is a
hybrid meeting offering both online and
in-person attendance. Registration is
free and open for virtual attendance. Inperson attendance is free, but seating is
limited. Please note that in-person
registration will be accepted in the order
of registration. We encourage
organizations to consider attendance
numbers to help accommodate as many
groups as possible for in-person
attendance. To register to attend the
public meeting on the ‘‘Development of
an Enhanced Systematic Process for
FDA’s Post-Market Assessment of
Chemicals in Food,’’ please register at
https://www.fda.gov/food/workshopsmeetings-webinars-food-and-dietarysupplements/public-meetingdevelopment-enhanced-systematicprocess-fdas-post-market-assessmentchemicals-food for in-person attendance
by September 20, 2024, and for webcast
attendance by September 24, 2024, at
11:59 p.m. Eastern Time. Registrants
will receive confirmation when they
have been accepted and will be
provided the webcast link for those who
plan to attend virtually.
Request to Provide Open Public
Comment: During online registration,
you may indicate if you wish to make
open public comments during the
public meeting and which topic(s) you
would like to address. All requests to
make public comments must be
received by September 3, 2024, at 11:59
p.m. Eastern Time. We will do our best
to accommodate requests to make public
comments. We are seeking to have a
broad representation of ideas and issues
presented at the meeting. Individuals
and organizations with common
interests are urged to consolidate or
coordinate their comments. We will
determine the amount of time for each
public comment and will notify all
registrants who requested an
opportunity to make an open public
comment.
VerDate Sep<11>2014
17:30 Aug 09, 2024
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Streaming Webcast of the Public
Meeting: This public meeting will be
broadcast via Zoom.
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
meeting website page at https://
www.fda.gov/food/workshops-meetingswebinars-food-and-dietarysupplements/public-meetingdevelopment-enhanced-systematicprocess-fdas-post-market-assessmentchemicals-food.
For more meeting specifics, please see
https://www.fda.gov/food/workshopsmeetings-webinars-food-and-dietarysupplements/public-meetingdevelopment-enhanced-systematicprocess-fdas-post-market-assessmentchemicals-food. FDA will post an
agenda and other meeting materials on
this web page in advance of the meeting.
Dated: August 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–17791 Filed 8–9–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
65635
Information Collection Activities;
Proposed Collection; Comment Request:
Risk/Safety Considerations and
Motivations for Purchase and Use of
Kratom and Psychedelics Alone and in
Combination With Other Substances,’’
FDA requested comment on the
information collection associated with
the proposed study entitled ‘‘Risk/
Safety Considerations and Motivations
for Purchase and Use of Kratom and
Psychedelics Alone and in Combination
With Other Substances.’’
Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice.
In the August 2, 2024, Federal
Register notice, FDA proposed a new
collection of information. However,
FDA no longer intends to proceed with
the proposed study as described because
circumstances occurred necessitating
changes to the scope of the study.
Therefore, we are withdrawing the
August 2, 2024, notice.
Dated: August 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–17793 Filed 8–9–24; 8:45 am]
BILLING CODE 4164–01–P
[Docket No. FDA–2024–N–1532]
Agency Information Collection
Activities; Proposed Collection; Risk/
Safety Considerations and Motivations
for Purchase and Use of Kratom and
Psychedelics Alone and in
Combination With Other Substances;
Withdrawal of Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; withdrawal.
The Food and Drug
Administration (FDA) is announcing the
withdrawal of a notice that was
published in the Federal Register of
August 2, 2024.
DATES: The notice is withdrawn on
August 12, 2024.
FOR FURTHER INFORMATION CONTACT:
Darren Eicken, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6206,
Silver Spring, MD 20993–0002, 240–
402–0978.
SUPPLEMENTARY INFORMATION: In a notice
published in the Federal Register of
August 2, 2024 (89 FR 63202), ‘‘Agency
SUMMARY:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–3569]
Gastrointestinal Drugs Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments—Supplemental
New Drug Application 207999 S–011
for OCALIVA (obeticholic acid) Oral
Tablets
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Gastrointestinal Drugs
Advisory Committee (the Committee).
The general function of the Committee
is to provide advice and
recommendations to FDA on regulatory
issues. The meeting will be open to the
public. FDA is establishing a docket for
public comment on this document.
SUMMARY:
E:\FR\FM\12AUN1.SGM
12AUN1
]]>Agencies
[Federal Register Volume 89, Number 155 (Monday, August 12, 2024)]
[Notices]
[Page 65635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17793]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-1532]
Agency Information Collection Activities; Proposed Collection;
Risk/Safety Considerations and Motivations for Purchase and Use of
Kratom and Psychedelics Alone and in Combination With Other Substances;
Withdrawal of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal of a notice that was published in the Federal Register of
August 2, 2024.
DATES: The notice is withdrawn on August 12, 2024.
FOR FURTHER INFORMATION CONTACT: Darren Eicken, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 240-
402-0978.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of August 2, 2024 (89 FR 63202), ``Agency Information
Collection Activities; Proposed Collection; Comment Request: Risk/
Safety Considerations and Motivations for Purchase and Use of Kratom
and Psychedelics Alone and in Combination With Other Substances,'' FDA
requested comment on the information collection associated with the
proposed study entitled ``Risk/Safety Considerations and Motivations
for Purchase and Use of Kratom and Psychedelics Alone and in
Combination With Other Substances.''
Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies
are required to publish notice in the Federal Register concerning each
proposed collection of information, including each proposed extension
of an existing collection of information, and to allow 60 days for
public comment in response to the notice.
In the August 2, 2024, Federal Register notice, FDA proposed a new
collection of information. However, FDA no longer intends to proceed
with the proposed study as described because circumstances occurred
necessitating changes to the scope of the study. Therefore, we are
withdrawing the August 2, 2024, notice.
Dated: August 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-17793 Filed 8-9-24; 8:45 am]
BILLING CODE 4164-01-P
