Notice2024-17102
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
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Published
August 2, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish a notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed study entitled "Risk/Safety Considerations and Motivations for Purchase and Use of Kratom and Psychedelics Alone and in Combination With Other Substances."
Full Text
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<title>Federal Register, Volume 89 Issue 149 (Friday, August 2, 2024)</title>
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[Federal Register Volume 89, Number 149 (Friday, August 2, 2024)]
[Notices]
[Pages 63202-63205]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-17102]
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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;
Comment Request: Risk/Safety Considerations and Motivations for
Purchase and Use of Kratom and Psychedelics Alone and in Combination
With Other Substances
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish a notice in the Federal
Register concerning each proposed collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on a proposed study entitled ``Risk/Safety
Considerations and Motivations for Purchase and Use of Kratom and
Psychedelics Alone and in Combination With Other Substances.''
DATES: Either electronic or written comments on the collection of
information must be submitted by October 1, 2024.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 1, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
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-1532 for ``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.'' 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 <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 in 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: 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.
For copies of the questionnaire: Please contact the CDER Controlled
Substances Program (CDER/CSP) at <a href="/cdn-cgi/l/email-protection#dcbfb8b9aebfafac9cbab8bdf2b4b4aff2bbb3aa"><span class="__cf_email__" data-cfemail="2142454453425251614745400f4949520f464e57">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information
[[Page 63203]]
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Risk/Safety Considerations and Motivations for Purchase and Use of
Kratom and Psychedelics Alone and in Combination With Other Substances
OMB Control Number 0910-NEW
This information collection supports scientific research, as
authorized by section 1701(a)(4) of the Public Health Service Act (42
U.S.C. 300u(a)(4)), and section 1003(d)(2)(C) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)). Emerging
data on kratom and psychedelics suggest increasing use of these
substances in certain populations, and is accompanied by reports noting
risk and safety concerns with their use. Understanding the social,
behavioral, and environmental contexts and motivations for use is
included in our need to protect the public's health, through data-
informed strategic initiatives.
This study seeks to capture information on how consumers make
decisions about how, where, and why they buy these substances; what, if
any risk/safety considerations and tradeoffs they take into account in
the decision-making process; and the behavioral considerations in
assessing the quality of the product and perceived harm to self.
This study will collect data that will enable the Agency, through
the market research vendor (Brightfield Group) awarded this contract,
to collect and analyze data on supply and demand characteristics;
perceived product quality, pricing, and product labeling; and the
consumer's perceived health outcome expectations for purchase and use
of kratom and psychedelics, and concurrent use of both and other drug
products.
The key study objectives include:
<bullet> Understand the temporal relationships and correlate of
purchase decisions and behaviors among consumers' segments.
<bullet> Understand how marketing strategies nudge purchase and
affect use demand.
<bullet> Develop predictive insights on potential future use
(behavior) patterns based on analysis of the quantitative data.
<bullet> Identify other products often purchased and used along
with these two substances.
As part of its key priorities in preventing access to substances
with potential risk/safety concerns or that could be abused or misused,
the Center for Drug Evaluation and Research/Controlled Substances
Program/Controlled Substances Initiative (CDER/CSP/CSI), proactively
works to identify: (1) emerging new substances that may pose potential
public health risk; and (2) unmet needs regarding these emerging
substances (including scientific knowledge gaps on use and risk/safety
patterns among U.S. populations). These efforts support other
scientific initiatives by CDER to meet the Agency's public health
mandate to develop public health strategies, as appropriate, in
response to risk to the health of populations.
The program achieves these objectives by actively: (1) monitoring
the policy landscape for shifts in policies that may have implications
on substance or drug use and access in U.S. populations, (2) convening
stakeholders for a strategic and timely response, and (3) identifying
and leading special research projects, including funding exploratory
studies to address knowledge gaps and through other strategic
initiatives. These exploratory research projects include behavioral and
social science research studies allowing CDER to capture data on real-
world experiences with use, behavioral and environmental (including
economic or supply and demand factors) motivations or reinforcements
for use, or that influence purchase and use. Exploratory research
projects, such as the current study on kratom and psychedelics can
identify new or expanded areas for additional scientific
investigations. Similarly, exploratory social and behavioral research
studies improve CDER's ability to quantify motivations for use,
characterize patterns of use and access, identify individual-perceived
risks and health outcome expectations, and individual risk-aversion
behaviors when making a decision to buy and use these substances,
better enabling the Agency to anticipate and predict future risks among
U.S. populations. Notably, the Agency's proactive and preventive
efforts, in combination with other scientific investigations options,
can support the consideration of, or the development of, policy
guardrails to prevent abuse and misuse.
This exploratory study is intended as a strategic response to
understand and characterize emergent risk/safety and perceived benefits
reportedly linked to kratom and psychedelics. CDER/CSP/CSI behavioral
and social science exploratory research studies do not change the FDA's
practice of relying on randomized controlled trials (RCTs) in
regulatory decision-making, nor do they seek to be the only source of
scientific information that inform policies. Strategic studies
recognize the dynamic environment and systems in which drugs are used,
misused, or lead to addiction. This is especially the case with
unapproved, unregulated substances like kratom and controlled
substances like psychedelics, which remain unapproved by FDA for the
treatment of any medical condition. These types of studies advance the
Agency's understanding of the real-world uses of drugs and unapproved
and unregulated substances through exploration of the multidimensional
factors (including behavioral and social motivations for use) that
contribute to abuse and misuse.
Strategic exploratory research, such as this one, are also
consistent with FDA's Overdose Prevention Framework of: (1) encouraging
harm reduction through innovation and education; and (2) protecting the
public from unapproved, diverted, or counterfeit drugs presenting
overdose risk. Kratom is one of the substances that make up the opioid
ecosystem, suggesting that it can potentially present the risks of
abuse, addiction, and misuse. It is noteworthy that FDA has not
approved any prescription or over-the-counter drug products containing
kratom or its two main chemical components, mitragynine and 7-
hydroxymitragynine (7-OH-mitragynine). Hence, while the Agency actively
encourages interested researchers to study kratom to address the
knowledge gap about its full risk/safety effects when ingested by
humans by conducting rigorous randomized clinical studies, currently,
there are no FDA approved drug products containing kratom or its two
main chemical components legally marketed in the United States.
Notably, kratom's unapproved status does not appear to have
diminished its
[[Page 63204]]
growing popularity, with people using kratom to reportedly ``treat''
certain health conditions. Its chemical affinity with opioid and use
among patients with opioids use disorder as a ``treatment'' is of
public health concern for the Agency. An estimated 1.7 million
Americans 14 years and older reportedly used the substance in 2021
according to the Substance Abuse and Mental Health Services
Administration's National Survey on Drug Use and Health data. Further,
if the thousands of comments posted by the public in response to the
Agency's publication of a Federal Register notice on August 16, 2021,
entitled ``International Drug Scheduling; Convention on Psychotropic
Substances; Single Convention on Narcotic Drugs; 4F-MDMB-BICA (4F-MDMB-
BUTICA); Brorphine; Metonitazene; Eutylone (bk-EBDB); BMDP (3,4-
Methylenedioxy-N-benzylcathinone); Kratom (mitragynine, 7-
hydroxymitragynine); Phenibut; Reopening Comment Period'' (<a href="https://www.federalregister.gov/documents/2021/08/16/2021-17498/international-drug-scheduling-convention-on-psychotropic-substances-single-convention-on-narcotic">https://www.federalregister.gov/documents/2021/08/16/2021-17498/international-drug-scheduling-convention-on-psychotropic-substances-single-convention-on-narcotic</a>), is an indication of its popularity, the use of
this substance, that has yet to be tested and determined safe for use
in human population by the Agency, is a significant concern. Moreover,
unapproved drug products are one of the most challenging areas for the
Agency, including concerns with the quality of kratom products supplies
that enter the country illegally and warning consumers of the risks
from adulterated products. This challenge is in part due to the complex
and fragmented supply chain networks that includes distributors,
wholesalers, retailers, and user communities.
Psychedelics, although a Schedule 1 controlled substance under the
Controlled Substances Act administered by the Drug Enforcement Agency
(DEA), have recently seen a rapid resurgence with the growing interest
in its use as a potential treatment for some mental health disorders.
Further, the increasing social acceptance of psychedelics use among
certain communities in the United States may also present public health
risks. Although a Schedule 1 substance, there is no FDA-approved
psychedelic drug, which does not appear to have diminished the growing
interest in their use. The rapid pace of interest in psychedelics is
evidenced by the number of research investigations and investigational
new drug applications from certain groups. Psychedelics such as LSD,
MDMA, and psilocybin are especially of interest. In the backdrop of
shifting State policies to either decriminalize or legalize
psychedelics, suggests a potential future in which these drugs are
abused or people who use them are abused because of their vulnerable
state of consciousness while under the influence of the drug.
Presently, there is little to no study on the co-occurrence of use
of kratom and psychedelics. Further, our review of public databases of
peer reviewed journals did not reveal any previous studies using
behavioral economics and health outcome expectations theoretical
framework to study the purchase and use of these two substances in U.S.
populations. Consequently, we anticipate this study filling a key
knowledge gap in our understanding of the behavioral and social drivers
for purchase and use, with the potential for identifying areas for
further scientific investigation.
The proposed research will use a mixed-methods design, involving
in-depth interviews and survey of kratom and psychedelics consumers and
a survey of non-users of these products as a comparison group. Our
methodological approach will involve non-probabilistic samples. The
design recognizes that non-probabilistic sampling approach has its
limitations for generalizability due to inherent sampling bias.
However, we feel confident that this limitation will be controlled and
minimized through the analysis plan (economic modeling) proposed for
this study. The proposed vendor for this sole source contract is a
market research firm, Brightfield Group, that owns proprietary rights
to a large database of over 5,000 comparable consumers of drug products
and dietary supplements. In-depth (N = 36) interview participants will
be recruited from this database. In-depth interview respondents will
receive a $75 gift card for their time as a gift for the 60 minutes
estimated for each person to complete the interview. In-depth
interviews will be conducted online through video recording.
Survey respondents (N = 400 for group 1; i.e., users of kratom and
psychedelics) and N = 400 as a comparison group of non-kratom and
psychedelics products (group 2). Both groups will be recruited and
screened by a survey panel company, EMI Research Solutions (<a href="https://emi-rs.com/">https://emi-rs.com/</a> com/), sub-contracted by the vendor to conduct this online
survey. EMI plans to use double-opt-in, market research panels to
identify and survey participants. They will also submit two back-up
sources for compliance in the instance that changing incidence rate or
other unforeseen fielding difficulties necessitate utilizing additional
resources. The company will pass a respondent-level panel-specific
variable through the survey link so that it is contained in the study
team's final survey data. Survey respondents will receive a cash
incentive of no more than $4.50 based on the estimated 15 minutes to
complete the online questionnaire. Incentive amount will be
transparently disclosed to survey respondents prior to participation.
This will be done via the recruitment outreach email invitation clearly
displayed on the self-service portal. Interview respondents and the
survey groups (i.e., group 1 and group 2) will be screened for
inclusion through a set of screening questions that ensures respondents
meet inclusion criteria, such as recent use (within the last 6 months)
of either drug. Efforts will also be made to include a diverse group of
respondents based on age, geographic setting, intention to use the
substance in the immediate future, and residency in the Unites States.
Description of Respondents:
In-depth interview respondents: The hour-long in-depth interview
respondents will include a total of 36 consumers recruited from the
vendor's proprietary market research database--<a href="https://www.Evergi.com">https://www.Evergi.com</a>.
The platform includes data from consumers who have previously purchased
and reported using drug products such as kratom or psychedelics in the
past and have previously expressed interest in being contacted to
participate in research studies.
Survey respondents: A combined of 400 kratom and psychedelics users
(group 1) will be recruited for the study, as well as a comparison
group (group 2) of 400 people who report that they have never used
either kratom or psychedelics in the past. The inclusion criteria for
participation in the survey will include:
<bullet> Age 18 years and older
<bullet> Have used kratom, psilocybin, MDMA, or LSD in the past 6
months. (The vendor plans to recruit 9 users of each substance.)
<bullet> Have used the substance at least two times in their life
and say they will use it in the future.
<bullet> Live in the Unites States.
We estimate the burden of this collection of information as
follows:
[[Page 63205]]
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden per response \2\ Total hours
respondents respondent responses
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Survey Group #1 (Target Group) (Consumers of Kratom or Psychedelics)
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In-depth interview........................... 36 1 36 1........................................ 36
Questionnaire completion..................... 400 1 400 0.17 (10 minutes)........................ 68
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Survey Group #2 (Comparison Group)
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Questionnaire completion (non-use of 400 1 400 0.08 (5 minutes)......................... 32
substances).
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Total.................................... .............. .............. .............. ......................................... 136
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.
Dated: July 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-17102 Filed 8-1-24; 8:45 am]
BILLING CODE 4164-01-P
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