Schedules of Controlled Substances: Placement of 4-hydroxy-N,N, 2376-2383 [2022-00713]
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Federal Register / Vol. 87, No. 10 / Friday, January 14, 2022 / Proposed Rules
Availability and Summary of
Documents for Incorporation by
Reference
This document proposes to amend
FAA Order JO 7400.11F, Airspace
Designations and Reporting Points,
dated August 10, 2021, and effective
September 15, 2021. FAA Order JO
7400.11F is publicly available as listed
in the ADDRESSES section of this
document. FAA Order JO 7400.11F lists
Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting
points.
Background
In August, 2021, the FAA revoked
VOR Federal airway V–242 within the
U.S. to mirror similar action taken by
NAV CANADA within Canadian
airspace due to the decommissioning of
the Atikokan, ON, Canada, NDB in
support of Canada’s Airspace
Modernization Program. Upon
revocation of V–242, NAV CANADA
initiated action to replace V–242 with
an RNAV route designated T–768. T–
768 has been established within
Canadian airspace; however, the route is
currently charted as T–786 and being
corrected to reflect T–768.
The FAA is proposing this action to
provide routing across the U.S./Canada
border by connecting to NAV
CANADA’s T–768 at the border. The
proposed T–768 within U.S. airspace
would extend between the International
Falls, MN, VOR/Tactical Air Navigation
(VORTAC) NAVAID and the U.S./
Canada border located approximately 16
nautical miles northeast of International
Falls, MN.
Additionally, the proposed T–768
would support FAA NextGen efforts to
transition the NAS from a ground-based
navigation system to a satellite-based
navigation system. The proposed route
would provide positive course guidance
into and out of Canadian airspace;
support enroute structure in an area of
limited or no radar coverage; reduce air
traffic control sector workload and
complexity; reduce pilot and controller
communications; and increase NAS
efficiency and capacity in the
International Falls, MN, area.
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The Proposal
The FAA is proposing an amendment
to 14 CFR part 71 to establish RNAV
route T–768. The proposed new T-route
is described below.
T–768: T–768 is a new RNAV route
proposed to extend between the
International Falls, MN, VORTAC and
the ARBBY, MN, waypoint (WP). This
proposed T-route would provide routing
between the International Falls
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VORTAC and the U.S./Canada border;
connecting to NAV CANADA’s existing
T–768 within Canadian airspace.
Canadian RNAV T-routes are
published in paragraph 6013 of FAA
Order JO 7400.11F, dated August 10,
2021, and effective September 15, 2021,
which is incorporated by reference in 14
CFR 71.1. The RNAV T-route listed in
this document would be published
subsequently in FAA Order JO 7400.11.
FAA Order JO 7400.11, Airspace
Designations and Reporting Points, is
published yearly and effective on
September 15.
Regulatory Notices and Analyses
The FAA has determined that this
proposed regulation only involves an
established body of technical
regulations for which frequent and
routine amendments are necessary to
keep them operationally current. It,
therefore: (1) Is not a ‘‘significant
regulatory action’’ under Executive
Order 12866; (2) is not a ‘‘significant
rule’’ under Department of
Transportation (DOT) Regulatory
Policies and Procedures (44 FR 11034;
February 26, 1979); and (3) does not
warrant preparation of a regulatory
evaluation as the anticipated impact is
so minimal. Since this is a routine
matter that will only affect air traffic
procedures and air navigation, it is
certified that this proposed rule, when
promulgated, will not have a significant
economic impact on a substantial
number of small entities under the
criteria of the Regulatory Flexibility Act.
Environmental Review
This proposal will be subject to an
environmental analysis in accordance
with FAA Order 1050.1F,
‘‘Environmental Impacts: Policies and
Procedures’’ prior to any FAA final
regulatory action.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order JO 7400.11F,
Airspace Designations and Reporting
Points, dated August 10, 2021, and
effective September 15, 2021, is
amended as follows:
■
Paragraph 6013
Routes.
Canadian Area Navigation
*
*
*
*
*
T–768 International Falls, MN (INL) to
ARBBY, MN [New]
International Falls, MN, (INL) VORTAC
(Lat. 48°33′56.87″ N, long. 093°24′20.44″
W)
ARBBY, MN WP
(Lat. 48°37′29.35″ N, long. 093°00′31.59″
W)
*
*
*
*
*
Issued in Washington, DC, on January 6,
2022.
Michael R. Beckles,
Manager, Rules and Regulations Group.
[FR Doc. 2022–00459 Filed 1–13–22; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–623]
Schedules of Controlled Substances:
Placement of 4-hydroxy-N,Ndiisopropyltryptamine (4-OH-DiPT), 5methoxy-alpha-methyltryptamine (5MeO-AMT), 5-methoxy-N-methyl-Nisopropyltryptamine (5-MeO-MiPT), 5methoxy-N,N-diethyltryptamine (5MeO-DET), and N,Ndiisopropyltryptamine (DiPT) in
Schedule I
Airspace, Incorporation by reference,
Navigation (air).
Drug Enforcement
Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
The Proposed Amendment
SUMMARY:
List of Subjects in 14 CFR Part 71
In consideration of the foregoing, the
Federal Aviation Administration
proposes to amend 14 CFR part 71 as
follows:
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for part 71
continues to read as follows:
■
Authority: 49 U.S.C. 106(f), 106(g); 40103,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,
1959–1963 Comp., p. 389.
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AGENCY:
The Drug Enforcement
Administration proposes placing five
tryptamine hallucinogens, as identified
in this proposed rule, in schedule I of
the Controlled Substances Act. If
finalized, this action would impose the
regulatory controls and administrative,
civil, and criminal sanctions applicable
to schedule I controlled substances on
persons who handle (manufacture,
distribute, reverse distribute, import,
export, engage in research, conduct
instructional activities or chemical
analysis with, or possess), or propose to
handle these five specific controlled
substances.
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Federal Register / Vol. 87, No. 10 / Friday, January 14, 2022 / Proposed Rules
Comments must be submitted
electronically or postmarked on or
before February 14, 2022.
Requests for hearing and waivers of
an opportunity for a hearing or to
participate in a hearing must be
received on or before February 14, 2022.
ADDRESSES: Interested persons may file
written comments on this proposal in
accordance with 21 CFR 1308.43(g). The
electronic Federal Docket Management
System will not accept comments after
11:59 p.m. Eastern Time on the last day
of the comment period. To ensure
proper handling of comments, please
reference ‘‘Docket No. DEA–623’’ on all
electronic and written correspondence,
including any attachments.
• Electronic comments: DEA
encourages commenters to submit all
comments electronically through the
Federal eRulemaking Portal, which
provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the on-line instructions at that site for
submitting comments. Upon completion
of your submission, you will receive a
Comment Tracking Number. Submitted
comments are not instantaneously
available for public view on
regulations.gov. If you have received a
Comment Tracking Number, you have
submitted your comment successfully
and there is no need to resubmit the
same comment. Commenters should be
aware that the electronic Federal Docket
Management System will not accept
comments after 11:59 p.m. Eastern Time
on the last day of the comment period.
• Paper comments: Paper comments
that duplicate electronic submissions
are not necessary and are discouraged.
Should you wish to mail a paper
comment in lieu of an electronic
comment, it should be sent via regular
or express mail to: Drug Enforcement
Administration, Attn: DEA FR
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
• Hearing requests: All requests for a
hearing and waivers of participation,
together with a written statement of
position on the matters of fact and law
asserted in the hearing, must be sent to:
Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive,
Springfield, Virginia 22152. All requests
for hearing and waivers of participation
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA FR Representative/DPW,
8701 Morrissette Drive, Springfield,
Virginia 22152.
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DATES:
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FOR FURTHER INFORMATION CONTACT:
Terrence L. Boos, Drug & Chemical
Evaluation Section, Diversion Control
Division, Drug Enforcement
Administration; Telephone: (571) 362–
3249.
In this
proposed rule, the Drug Enforcement
Administration (DEA) proposes to
schedule the following five controlled
substances in schedule I of the
Controlled Substances Act (CSA),
including their salts, isomers, and salts
of isomers whenever the existence of
such salts, isomers, and salts of isomers
is possible within the specific chemical
designation:
• 4-Hydroxy-N,Ndiisopropyltryptamine (4-OH-DiPT),
• 5-Methoxy-alphamethyltryptamine
(5-MeO-AMT),
• N-Isopropyl-5-Methoxy-NMethyltryptamine (5-MeO-MiPT),
• N,N-Diethyl-5-methoxytryptamine
(5-MeO-DET), and
• N,N-Diisopropyltryptamine (DiPT).
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
All comments received in response to
this docket are considered part of the
public record. DEA will make comments
available, unless reasonable cause is
given, for public inspection online at
https://www.regulations.gov. Such
information includes personal
identifying information (such as your
name, address, etc.) voluntarily
submitted by the commenter. The
Freedom of Information Act applies to
all comments received. If you want to
submit personal identifying information
(such as your name, address, etc.) as
part of your comment, but do not want
DEA to make it publicly available, you
must include the phrase ‘‘PERSONAL
IDENTIFYING INFORMATION’’ in the
first paragraph of your comment. You
must also place all of the personal
identifying information you do not want
made publicly available in the first
paragraph of your comment and identify
what information you want redacted.
If you want to submit confidential
business information as part of your
comment, but do not want DEA to make
it publicly available, you must include
the phrase ‘‘CONFIDENTIAL BUSINESS
INFORMATION’’ in the first paragraph
of your comment. You must also
prominently identify the confidential
business information to be redacted
within the comment.
DEA will generally make available in
publicly redacted from comments
containing personal identifying
information and confidential business
information identified, as directed
above. If a comment has so much
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confidential business information that
DEA cannot effectively redact it, DEA
may not make available publicly all or
part of that comment. Comments posted
to https://www.regulations.gov may
include any personal identifying
information (such as name, address, and
phone number) included in the text of
your electronic submission that is not
identified as confidential as directed
above.
An electronic copy of this document
and supplemental information to this
proposed rule are available at https://
www.regulations.gov for easy reference.
Request for Hearing or Appearance;
Waiver
Pursuant to 21 U.S.C. 811(a), this
action is a formal rulemaking ‘‘on the
record after opportunity for a hearing.’’
Such proceedings are conducted
pursuant to the provisions of the
Administrative Procedure Act, 5 U.S.C.
551–59. 21 CFR 1308.41 through
1308.45; 21 CFR part 1316, subpart D.
Interested persons may file requests for
a hearing or notices of intent to
participate in a hearing in conformity
with the requirements of 21 CFR
1308.44(a) or (b), and such requests
must include a statement of interest in
the proceeding and the objections or
issues, if any, concerning which the
person desires to be heard. 21 CFR
1316.47(a). Any interested person may
file a waiver of an opportunity for a
hearing or to participate in a hearing
together with a written statement
regarding the interested person’s
position on the matters of fact and law
involved in any hearing as set forth in
21 CFR 1308.44(c).
All requests for hearing and waivers
of participation, together with a written
statement of position on the matters of
fact and law involved in such hearing,
must be sent to DEA using the address
information provided above.
Legal Authority
The CSA provides that proceedings
for the issuance, amendment, or repeal
of the scheduling of any drug or other
substance may be initiated by the
Attorney General on his own motion. 21
U.S.C. 811(a). This proposed action was
initiated on the Attorney General’s own
motion, as delegated to the
Administrator of DEA (Administrator),
and is supported by, inter alia, a
recommendation from the former
Assistant Secretary for Health of the
Department of Health and Human
Services (former Assistant Secretary of
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Federal Register / Vol. 87, No. 10 / Friday, January 14, 2022 / Proposed Rules
HHS or former Assistant Secretary) 1
and an evaluation of all relevant data by
DEA. If finalized, this action would
impose the regulatory controls and
administrative, civil, and criminal
sanctions applicable to controlled
substances, including those specific to
schedule I controlled substances, on
persons who handle or propose to
handle 4-OH-DiPT, 5-MeO-AMT, 5MeO-MiPT, 5-MeO-DET, and DiPT.
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Background
4-OH-DiPT, 5-MeO-AMT, 5-MeOMiPT, 5-MeO-DET, and DiPT are
tryptamine hallucinogens. They share
structural and pharmacological
similarities with several schedule I
tryptamine hallucinogens, such as
alpha-methyltryptamine (AMT), N,Ndimethyltryptamine (DMT), 5-methoxyN,N-diisopropyltryptamine (5-MeODiPT), and psilocyn. They have no
approved medical use in the United
States.
Proposed Determination To Schedule 4OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5MeO-DET, and DiPT
Pursuant to 21 U.S.C. 811(b), DEA
gathered the necessary data on 4-OHDiPT, 5-MeO-AMT, 5-MeO-MiPT, 5MeO-DET, and DiPT, and on December
19, 2008, submitted it to the former
Assistant Secretary with a request for a
scientific and medical evaluation of
available information and a scheduling
recommendation for 4-OH-DiPT, 5MeO-AMT, 5-MeO-MiPT, 5-MeO-DET,
and DiPT.
On March 29, 2012, May 17, 2012,
and August 14, 2012, HHS provided to
DEA scientific and medical evaluations
for the above mentioned five
tryptamines and a scheduling
recommendation for each. The
evaluations were entitled: (1) ‘‘Basis for
the Recommendation to Control 4Hydroxy-N,N-diisopropyltryptamine (4OH-DIPT) and its Salts in Schedule I of
the Controlled Substances Act (CSA);’’
(2) ‘‘Basis for the Recommendation to
Control 5-Methoxyalphamethyltryptamine (5-MeO-AMT)
and its Salts in Schedule I of the
Controlled Substances Act (CSA);’’ (3)
‘‘Basis for the Recommendation to
Control N-Isopropyl-5-Methoxy-NMethyltryptamine (5-MeO-MIPT) and its
Salts in Schedule I of the Controlled
Substances Act (CSA);’’ (4) ‘‘Basis for
the Recommendation to Control N,NDiethyl-5-methoxytryptamine (5-MeODET) and its Salts in Schedule I of the
Controlled Substances Act (CSA);’’ and
1 The
Secretary of HHS has delegated to the
Assistant Secretary for Health the authority to make
domestic drug scheduling recommendations.
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(5) ‘‘Basis for the Recommendation to
Control N,N-Diisopropyltryptamine
(DIPT) and its Salts in Schedule I of the
Controlled Substances Act (CSA).’’
Following consideration of the eight
factors and findings related to each of
the substances’ abuse potential,
legitimate medical use, and dependence
liability, HHS recommended that 4-OHDiPT, 5-MeO-AMT, 5-MeO-MiPT, 5MeO-DET, and DiPT and their
respective salts be controlled in
schedule I of the CSA under 21 U.S.C.
812(b).
In response, DEA reviewed the
scientific and medical evaluation and
scheduling recommendation provided
by HHS and all other relevant data, and
completed its own eight-factor review
pursuant to 21 U.S.C. 811(c). Included
below is a brief summary of each factor
as analyzed by HHS and DEA in their
respective eight-factor analyses, and as
considered by DEA in this proposed
scheduling determination. Please note
that both DEA and HHS analyses are
available in their entirety under
‘‘Supporting Documents’’ of the public
docket for this proposed rule at https://
www.regulations.gov under docket
number ‘‘DEA–623.’’
1. The Drugs’ Actual or Relative
Potential for Abuse
In addition to considering the
information HHS provided in its
scientific and medical evaluation
documents for 4-OH-DiPT, 5-MeO-AMT,
5-MeO-MiPT, 5-MeO-DET, and DiPT,
DEA also considered all other relevant
data regarding actual or relative
potential for abuse of each substance.
The term ‘‘abuse’’ is not defined in the
CSA, however the legislative history of
the CSA suggests the following four
prongs in determining whether a
particular drug or substance has a
potential for abuse: 2
a. Individuals are taking the drug or
other substance in amounts sufficient to
create a hazard to their health or to the
safety of other individuals or to the
community; or
b. There is a significant diversion of
the drug or other substance from
legitimate drug channels; or
c. Individuals are taking the drug or
other substance on their own initiative
rather than on the basis of medical
advice from a practitioner licensed by
law to administer such drugs; or
d. The drug is so related in its action
to a drug or other substance already
listed as having a potential for abuse to
2 Comprehensive Drug Abuse Prevention and
Control Act of 1970, H.R. Rep. No. 91–1444, 91st
Cong., 2nd Sess. (1970) reprinted in 1970
U.S.C.C.A.N. 4566, 4603.
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make it likely that it will have the same
potential for abuse as such substance,
thus making it reasonable to assume
that there may be significant diversions
from legitimate channels, significant use
contrary to or without medical advice,
or that it has a substantial capability of
creating hazards to the health of the
user or to the safety of the community.
DEA reviewed the scientific and
medical evaluation provided by HHS
and all other data relevant to the abuse
potential of 4-OH-DiPT, 5-MeO-AMT, 5MeO-MiPT, 5-MeO-DET, and DiPT.
These data as presented below
demonstrate that 4-OH-DiPT, 5-MeOAMT, 5-MeO-MiPT, 5-MeO-DET, and
DiPT have a high potential for abuse.
a. There is evidence that individuals
are taking the drug or other substance
in amounts sufficient to create a hazard
to their health or to the safety of other
individuals or to the community.
According to HHS 2012 review, and
more current DEA findings, data show
that 4-OH-DiPT, 5-MeO-AMT, 5-MeOMiPT, 5-MeO-DET, and DiPT have been
encountered by law enforcement (Factor
5). Based on published case reports in
the medical literature and anecdotal
reports (Factor 2), HHS states that these
substances are being abused for their
hallucinogenic properties. HHS has
determined that consumption of these
five tryptamines due to their
hallucinogenic properties poses a safety
hazard to the public health. There were
hospital emergency room admissions
related to the abuse of 5-MeO-AMT and
5-MeO-MiPT. One confirmed death was
reported in 2004 from the abuse of 5MeO-AMT, taken in combination with
alcohol and the antidepressant
bupropion; however, it is unclear what
role 5-MeO-AMT played in the death.
b. There is significant diversion of the
drug or substance from legitimate drug
channels.
HHS, in its 2012 review, stated that 4OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5MeO-DET, and DiPT are not Food and
Drug Administration (FDA)-approved
drug products for treatment in the
United States and that it is unaware of
any country in which their use is legal.
DEA has confirmed with HHS that their
2012 statements are still applicable. In
addition, HHS’ 2012 review stated that
there appear to be no legitimate sources
for 4-OH-DiPT, 5-MeO-AMT, 5-MeOMiPT, 5-MeO-DET, and DiPT as
marketed drugs. DEA notes that these
substances are available for purchase
from legitimate suppliers for scientific
research. However, there is no evidence
of significant diversion of 4-OH-DiPT, 5MeO-AMT, 5-MeO-MiPT, 5-MeO-DET,
and DiPT from legitimate suppliers.
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c. Individuals are taking the
substance on their own initiative rather
than on the basis of medical advice
from a practitioner licensed by law to
administer such substance.
4-OH-DiPT, 5-MeO-AMT, 5-MeOMiPT, 5-MeO-DET, and DiPT are not
approved for medical use and are not
formulated or available for clinical use.
Therefore, individuals are taking 4-OHDiPT, 5-MeO-AMT, 5-MeO-MiPT, 5MeO-DET, and DiPT on their own
initiative, rather than based on medical
advice from a practitioner licensed by
law to administer drugs. This is
consistent with the data from law
enforcement seizures and case reports
suggesting that individuals are taking
these substances for similar
hallucinogenic effects produced by
lysergic acid diethylamide (LSD) and
N,N-diethyltryptamine (DET), while
possibly simultaneously attempting to
circumvent criminal prosecution since
these are explicitly scheduled
substances (see Factor 5 for more
detailed information).
d. The drug is a new drug so related
in its action to a drug or other substance
already listed as having a potential for
abuse to make it likely that the drug
substance will have the same potential
for abuse as such drugs, thus making it
reasonable to assume that there may be
significant diversion from legitimate
channels, significant use contrary to or
without medical advice, or that it has a
substantial capability of creating
hazards to the health of the user or to
the safety of the community.
After scientific evaluation, HHS states
that 4-OH-DiPT, 5-MeO-AMT, 5-MeOMiPT, 5-MeO-DET, and DiPT are
structural analogs of schedule I
hallucinogens (4-OH-DiPT of 5-MeODiPT, 5-MeO-AMT of AMT, 5-MeOMiPT of DMT, 5-MeO-DET of 5-MeODMT and DMT, and DiPT of 5-MeODiPT) and produce similar
pharmacological effects to natural and
synthetic schedule I hallucinogens.
4-OH-DiPT
4-OH-DiPT elicits pharmacological
responses similar to the schedule I
substances 4-methyl-2,5-dimethoxyamphetamine (DOM) and LSD, which
have no accepted medical use and have
high abuse potential. In animal drug
discrimination studies, 4-OH-DiPT fully
generalizes for the discriminative
stimulus effects of DOM and LSD in
rats. Additionally, 4-OH-DiPT produces
classic hallucinogenic effects such as
perceptual distortions and pleasurable
physical effects. Risks and effects of 4OH-DiPT include: Hallucinations,
euphoria, fatigue, headache,
gastrointestinal distress, insomnia, and
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anxiety. HHS states that these effects are
like those of schedule I hallucinogens
and concludes that based on the
psychological and cognitive
disturbances associated with effects of
4-OH-DiPT, it is reasonable to assume
that this substance has a substantial
capability to cause a hazard to public
health, both to the user and to the
community.
5-MeO-AMT
According to HHS, 5-MeO-AMT
elicits pharmacological responses
similar to the schedule I substances LSD
and DET which have no accepted
medical use and have high abuse
potential. Drug discrimination data
demonstrate that 5-MeO-AMT produces
partial generalization for the
discriminative stimulus effects of LSD
in rats. In humans, 5-MeO-AMT
produces hallucinogenic effects similar
to those produced by LSD and DET,
including euphoria and visual and
auditory hallucinations. Adverse effects
caused by 5-MeO-AMT are similar to
those of schedule I hallucinogens
including: Fatigue, headache,
gastrointestinal distress, insomnia, and
anxiety. Based on the hallucinogenic
and other effects caused by 5-MeOAMT, HHS states that it is reasonable to
assume that this substance has
substantial capability to cause a hazard
to public health, both to the user and to
the community.
5-MeO-MiPT
According to HHS, 5-MeO-MiPT
elicits pharmacological responses
similar to the schedule I substances LSD
and DMT, which have no accepted
medical use and have high abuse
potential. Drug discrimination studies
showed that 5-MeO-MiPT fully
generalizes to the discriminative
stimulus effects of DOM in rats, and
partially generalizes to the
discrimination stimulus effects of LSD,
DMT, and 3,4-methylenedioxymethamphetamine (MDMA, schedule I).
In humans it has been reported that 5MeO-MiPT is 15-fold more potent than
DMT when comparing doses that
produce hallucinogenic effects. Thus,
HHS concluded that it is reasonable to
assume that 5-MeO-MiPT has
substantial capability to cause a hazard
to public health, both to the user and to
the community.
5-MeO-DET
According to HHS, 5-MeO-DET elicits
pharmacological responses similar to
the schedule I substances DMT and
DOM, which have no accepted medical
use and have high abuse potential. In
animal drug discrimination studies, 5-
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2379
MeO-DET fully generalizes for the
discriminative stimulus effect of DMT
in rats. 5-MeO-DET partially generalizes
to the discriminative stimulus cues of
DOM and MDMA. The reports from
users describe the effects of 5-MeO-DET
as being similar to those produced by
DMT and LSD. Adverse health risks
associated with 5-MeO-DET use
include: Bizarre behavior,
hallucinations, and sympathomimetic
effects, such as increased heart rate.
These adverse effects are similar to
those of schedule I hallucinogens. Based
on available information, it is
reasonable to assume that 5-MeO-DET
has substantial capability to cause a
hazard to public health, both to the user
and to the community.
DiPT
According to HHS, DiPT elicits
pharmacological responses similar to
the schedule I substances DOM and
DMT, which have no accepted medical
use and have high abuse potential. Drug
discrimination studies showed that
DiPT fully substitutes for the
discriminative stimulus effects of DOM
and DMT in rats. The reports from users
describe the effects of DiPT as being
similar to those produced by 4-bromo2,5-dimethoxyphenethylamine (2C-B),
2-(2,5-dimethoxy-4methylphenyl)ethanamine (2C-D), and
2,5-dimethoxy-4-ethylamphetamine
(DOET), all of which are classified as
schedule I substances. Risks associated
with DiPT use are based on the
perceptual changes in the auditory
experience. Like schedule I
hallucinogens, DiPT produces adverse
effects such as: Auditory and other
sensory distortions, lethargy, nausea,
hyperreflexia, and mydriasis. Based on
the adverse effects associated with
DiPT, it is reasonable to assume that this
substance has substantial capability to
cause a hazard to public health, both to
the user and to the community.
2. Scientific Evidence of the Drugs’
Pharmacological Effects, If Known
As stated by HHS (HHS reviews,
2012a–e), the neurochemical effects of
4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT,
5-MeO-DET, and DiPT mainly involve
serotonergic system in the central
nervous system (CNS). Tryptamine
hallucinogens are believed to produce
their characteristic effects primarily
through stimulation of the 2A subtype
of serotonin (5-HT) receptors (5-HT2A).
DEA further notes that the 5-HT2A
receptor has also been shown to mediate
the in vivo behavioral effects and
discriminative stimulus effects of the
three classes of classic hallucinogens,
ergotamines (e.g., LSD),
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phenethylamines (e.g., DOM), and
tryptamines (e.g., DMT).
Animal testing data in rats show that
stimulus properties of 4-OH-DiPT are
similar to DOM and LSD, and partially
similar to DMT; 5-MeO-AMT
substantially overlaps with LSD; 5-MeOMiPT substantially overlaps with DOM,
LSD, and MDMA; 5-MeO-DMT are
similar to DMT, DOM, and MDMA; and
DiPT are similar to DOM and DMT, and
are partially similar to LSD. Thus, 4-OHDiPT, 5-MeO-AMT, 5-MeO-MiPT, 5MeO-DET, and DiPT produce
psychopharmacologic effects similar to
those produced by serotonin-mediated
hallucinogens in an animal model,
which are predictive of its abuse in
humans.
In humans, users of 4-OH-DiPT, 5MeO-AMT, 5-MeO-MiPT, 5-MeO-DET,
and DiPT report hallucinogenic effects
similar to LSD and DET including:
Euphoria, hallucinations involving
various senses, perceptual distortions
and pleasant intensification of sensory
experiences. Physiological and
psychological effects have been reported
to be frightening or disturbing and can
include: Dizziness, fatigue, headache,
trembling, anxiety, insomnia,
restlessness, cold sweats, and
gastrointestinal disturbances (i.e.,
nausea, vomiting, and diarrhea), among
others. One death was reported in 2004
with the use of 5-MeO-AMT, however
alcohol and bupropion (an
antidepressant) were also detected in
post mortem toxicology analyses.
3. The State of Current Scientific
Knowledge Regarding the Drugs or
Other Substances
Chemistry
4-OH-DiPT, 5-MeO-AMT, 5-MeOMiPT, 5-MeO-DET, and DiPT are part of
the tryptamine family and share the core
tryptamine structure with substitutions
at the a-position, 4-position, 5-position,
and on the nitrogen (N) atom. All of
these substances contain an indole ring
with a substituted ethylamino
sidechain. 4-OH-DiPT, 5-MeO-AMT, 5MeO-MiPT, 5-MeO-DET, and DiPT
share structural similarities with
schedule I tryptamine hallucinogens
such as DMT, DET, AMT, and psilocyn.
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Pharmacokinetics
Metabolism studies have not been
conducted for 4-OH-DiPT, 5-MeO-AMT,
5-MeO-DET, and DiPT. However,
metabolism has been reported for 5MeO-MiPT. Similar to other structurally
related tryptamines, 5-MeO-MiPT has
been reported to undergo metabolism
through oxidative deamination, Ndemethylation, O-demethylation, and N-
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oxidation with N-oxides as the major
metabolites. Thus, it is highly likely that
4-OH-DiPT, 5-MeO-AMT, 5-MeO-DET,
and DiPT will be metabolized in a
similar manner.
4. Its History and Current Pattern of
Abuse
In the U.S., law enforcement entities
have initially encountered 5-MeO-AMT
and DiPT in 2003, 5-MeO-MiPT in 2004,
5-MeO-DET in 2006, and 4-OH-DiPT in
2009, according to the National Forensic
Laboratory Information System
(NFLIS).3 Each of these tryptamines has
been encountered in one or more of the
following forms: Powder, tablets,
capsules, liquid, or on blotter paper.
These substances are generally
purchased from internet-based
companies in addition to being
purchased from dealers. These
tryptamines are often misrepresented as
LSD to users due to their similarities in
producing hallucinogenic effects.
4-OH-DiPT, 5-MeO-AMT, 5-MeOMiPT, 5-MeO-DET, and DiPT do not
have an approved medical indication in
the U.S. and therefore have no
legitimate medical use in the U.S.
Anecdotal reports from users of these
substances indicate that these
substances produce classical
hallucinogenic properties, such as
perceptual distortions and pleasurable
physical effects. Users report oral
administration as the most common
route of administration. Other routes of
administration such as insufflation,
smoking, and rectal administration have
been reported.
5. The Scope, Duration, and
Significance of Abuse
Tryptamine hallucinogens, both
natural and synthetic, have been
popular among the attendees of rave
parties, music concerts, and other large
or social venues, as well as in intimate
and smaller settings since the 1990s in
the U.S. and Europe. Often these
substances are promoted as substitutes
for LSD. Synthetic hallucinogens and
stimulants are known as ‘‘club drugs.’’
In addition to sales in raves and
nightclubs, internet sales have become
one of the main outlets for the sale and
distribution of tryptamine
hallucinogens.
In the U.S., there has been significant
availability, trafficking and abuse of a
3 NFLIS is a national drug forensic laboratory
reporting system that systematically collects results
from drug chemistry analyses conducted by state
and local forensic laboratories across the country.
The NFLIS participation rate, defined as the
percentage of the national drug caseload
represented by laboratories that have joined NFLIS,
is over 97 percent. NFLIS includes drug chemistry
results from completed analyses only.
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number of tryptamines including 4-OHDiPT, 5-MeO-AMT, 5-MeO-MiPT, 5MeO-DET, and DiPT. This is evidenced
by large numbers of encounters of one
or more of these tryptamines by U.S.
law enforcement in 47 states and the
District of Columbia.
According to NFLIS, there have been
5 reports of 4-OH-DiPT (first reported in
2009), 92 reports of 5-MeO-AMT (first
reported in 2003), 348 reports of 5-MeOMiPT (first reported in 2004), 17 reports
of 5-MeO-DET (first reported in 2006),
and 25 reports of DiPT (first reported in
2003).4
6. What, if Any, Risk There Is to the
Public Health
HHS indicates that 4-OH-DiPT, 5MeO-AMT, 5-MeO-MiPT, 5-MeO-DET,
and DiPT pose a risk to public health
due to their hallucinogenic properties
that usually occur quickly (often
between 5–15 minutes, dependent on
the route of administration) after
ingestion and may cause impairing
effects on the user’s judgment and lead
to dangerous behavior. The risks could
be to the individual user or to the
community, especially when the user is
operating a motor vehicle. Several
adverse effects were reported in animal
studies and in humans from internet
forums for all five tryptamines (see
Factor 2). HHS also cited published and
anecdotal reports that described the
adverse effects of these five
hallucinogens including agitation,
confusion, psychological distress for all
five substances, and death in the case of
5-MeO-AMT. It is unclear what role 5MeO-AMT played in the death. The
toxicology report also reported alcohol
and the presence of an antidepressant,
bupropion. Users of 4-OH-DiPT reported
that the hallucinations were intense and
the psychological and physiological
effects were frightening or disturbing. A
non-lethal poisoning was reported in an
adolescent after ingesting an alleged
combination of 5-MeO-MiPT and
harmaline, a CNS stimulant.
7. Its Psychic or Physiological
Dependence Liability
According to HHS, hallucinogens are
not usually associated with physical
dependence and the physiological
dependence liability in animals or
humans has not been reported in
scientific and medical literature for
these five substances. Thus, it is not
possible at this time to determine
whether 4-OH-DiPT, 5-MeO-AMT, 5MeO-MiPT, 5-MeO-DET, and DiPT
produce physiological dependence
4 NFLIS data were queried August 17, 2021, by
date of submission.
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following acute or chronic
administration. However, hallucinogen
abusers may develop psychological
dependence to these substances as
evidenced by the continued use of these
substances despite knowledge of the
potential toxic and adverse effects.
The data on the drug discrimination
studies conducted by the National
Institute on Drug Abuse, cited in HHS
reviews and later published, show that
4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT,
5-MeO-DET, and DiPT share
discriminative stimulus effects with
other schedule I hallucinogens: 4-OHDiPT fully substitutes for DOM and
LSD; 5-MeO-AMT partially substitutes
for LSD and DMT; 5-MeO-MiPT fully
substitutes for DOM; 5-MeO-DET fully
substitutes for DMT; and DiPT fully
substitutes for DOM and DMT. DEA
adds that LSD, DOM, and MDMA fully
substitute for DiPT-trained
discriminative stimulus effects,
confirming that DiPT has hallucinogenic
effects similar to other schedule I
hallucinogens.
8. Whether the Substance Is an
Immediate Precursor of a Substance
Already Controlled Under the CSA
4-OH-DiPT, 5-MeO-AMT, 5-MeOMiPT, 5-MeO-DET, and DiPT are not
immediate precursors of a substance
already controlled under the CSA as
defined by 21 U.S.C. 802(23).
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Conclusion
Based on consideration of the
scientific and medical evaluation and
accompanying recommendations of
HHS, and on DEA’s consideration of its
own eight-factor analysis, DEA finds
that these facts and all relevant data
constitute substantial evidence of
potential for abuse of 4-OH-DiPT, 5MeO-AMT, 5-MeO-MiPT, 5-MeO-DET,
and DiPT. As such, DEA hereby
proposes to schedule 4-OH-DiPT, 5MeO-AMT, 5-MeO-MiPT, 5-MeO-DET,
and DiPT as controlled substances
under the CSA.
Proposed Determination of Appropriate
Schedule
The CSA establishes five schedules of
controlled substances known as
schedules I, II, III, IV, and V. The CSA
also outlines the findings required to
place a drug or other substance in any
particular schedule. 21 U.S.C. 812(b).
After consideration of the analysis and
recommendation of the former Assistant
Secretary and review of all other
available data, the Administrator,
pursuant to 21 U.S.C. 812(b)(1), finds
that:
(1) 4-OH-DiPT, 5-MeO-AMT, 5-MeOMiPT, 5-MeO-DET, and DiPT elicit
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pharmacological effects qualitatively
similar to those of schedule I
hallucinogens (e.g., DOM, LSD, DMT,
DET). These effects are marked by
hallucinations and CNS stimulation.
Law enforcement reported a number of
encounters of 5-MeO-AMT and DiPT
beginning in 2003, 5-MeO-MiPT
beginning in 2004, 5-MeO-DET
beginning in 2006, and 4-OH-DiPT
beginning in 2009.
The available data indicate that 4-OHDiPT, 5-MeO-AMT, 5-MeO-MiPT, 5MeO-DET, and DiPT have high potential
for abuse that is similar to that of other
schedule I tryptamine hallucinogens
DET (5-MeO-AMT) and DMT (5-MeODET, 5-MeO-MiPT, and DiPT), the
phenethylamine hallucinogen DOM (4OH-DiPT, 5-MeO-DET, 5-MeO-MiPT,
and DiPT), and the ergotamine
hallucinogen LSD (5-MeO-AMT, 4-OHDiPT, 5-MeO-DET, 5-MeO-MiPT).
(2) 4-OH-DiPT, 5-MeO-AMT, 5-MeOMiPT, 5-MeO-DET, and DiPT are not
legally marketed in the U.S. They lack
current marketing approval under new
drug applications, abbreviated new drug
applications, or investigational use
under an active investigational new
drug application. There is no evidence
that 4-OH-DiPT, 5-MeO-AMT, 5-MeOMiPT, 5-MeO-DET, and DiPT have a
currently accepted medical use in
treatment in the U.S.5
(3) Because 4-OH-DiPT, 5-MeO-AMT,
5-MeO-MiPT, 5-MeO-DET, and DiPT
have no approved medical use and have
not been thoroughly investigated as new
drugs, their safety for use under medical
supervision is not determined. Thus,
there is a lack of accepted safety for use
of these substances under medical
supervision.
Based on these findings, the
Administrator concludes that 4-OHDiPT, 5-MeO-AMT, 5-MeO-MiPT, 5MeO-DET, and DiPT warrant control in
schedule I of the CSA. More precisely,
because of their hallucinogenic effects,
and because they may produce
hallucinogenic-like tolerance and
5 Although there is no evidence suggesting that 4OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET,
and DiPT have a currently accepted medical use in
treatment in the United States, it bears noting that
a drug cannot be found to have such medical use
unless DEA concludes that it satisfies a five-part
test. Specifically, with respect to a drug that has not
been approved by FDA, to have a currently
accepted medical use in treatment in the United
States, all of the following must be demonstrated:
i. the drug’s chemistry must be known and
reproducible; ii. there must be adequate safety
studies; iii. there must be adequate and wellcontrolled studies proving efficacy; iv. the drug
must be accepted by qualified experts; and v. the
scientific evidence must be widely available. 57 FR
10499 (1992), pet. for rev. denied, Alliance for
Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135
(D.C. Cir. 1994).
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dependence in humans, DEA proposes
to place 4-OH-DiPT, 5-MeO-AMT, 5MeO-MiPT, 5-MeO-DET, and DiPT,
including their salts, isomers, and salts
of isomers whenever the existence of
such salts, isomers, and salts of isomers
is possible within the specific chemical
description, in 21 CFR 1308.11(d) (the
hallucinogenic substances category of
schedule I).
Requirements for Handling 4-OH-DiPT,
5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET,
and DiPT
If this rule is finalized as proposed, 4OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5MeO-DET, and DiPT would be subject to
the CSA’s schedule I regulatory controls
and administrative, civil, and criminal
sanctions applicable to the manufacture,
distribution, reverse distribution,
import, export, research, conduct of
instructional activities or chemical
analysis with, and possession of
schedule I controlled substances,
including the following:
1. Registration. Any person who
handles (manufactures, distributes,
reverse distributes, imports, exports,
engages in research, or conducts
instructional activities or chemical
analysis with, or possesses), or who
desires to handle, 4-OH-DiPT, 5-MeOAMT, 5-MeO-MiPT, 5-MeO-DET, or
DiPT would be required to be registered
with DEA to conduct such activities
pursuant to 21 U.S.C. 822, 823, 957, and
958, and in accordance with 21 CFR
parts 1301 and 1312, as of the effective
date of a final scheduling action. Any
person who currently handles 4-OHDiPT, 5-MeO-AMT, 5-MeO-MiPT, 5MeO-DET, or DiPT, and is not registered
with DEA, would need to submit an
application for registration and may not
continue to handle 4-OH-DiPT, 5-MeOAMT, 5-MeO-MiPT, 5-MeO-DET, or
DiPT as of the effective date of a final
scheduling action, unless DEA has
approved that application for
registration pursuant to 21 U.S.C. 822,
823, 957, 958, and in accordance with
21 CFR parts 1301 and 1312.
2. Disposal of stocks. Any person
unwilling or unable to obtain a schedule
I registration would be required to
surrender or transfer all quantities of
currently held 4-OH-DiPT, 5-MeO-AMT,
5-MeO-MiPT, 5-MeO-DET, and DiPT to
a person registered with DEA before the
effective date of a final scheduling
action, in accordance with all applicable
Federal, State, local, and tribal laws. As
of the effective date of a final scheduling
action, 4-OH-DiPT, 5-MeO-AMT, 5MeO-MiPT, 5-MeO-DET, and DiPT
would be required to be disposed of in
accordance with 21 CFR part 1317, in
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addition to all other applicable Federal,
State, local, and tribal laws.
3. Security. 4-OH-DiPT, 5-MeO-AMT,
5-MeO-MiPT, 5-MeO-DET, and DiPT
would be subject to schedule I security
requirements for DEA registrants and
would need to be handled and stored
pursuant to 21 U.S.C. 823 and in
accordance with 21 CFR 1301.71
through 1301.76 as of the effective date
of a final scheduling action. Nonpractitioners handling 4-OH-DiPT, 5MeO-AMT, 5-MeO-MiPT, 5-MeO-DET,
and DiPT would also need to comply
with the employee screening
requirements of 21 CFR 1301.90 through
1301.93.
4. Labeling and Packaging. All labels
and labeling for commercial containers
of 4-OH-DiPT, 5-MeO-AMT, 5-MeOMiPT, 5-MeO-DET, or DiPT would need
to be in compliance with 21 U.S.C. 825,
and be in accordance with 21 CFR part
1302, as of the effective date of a final
scheduling action.
5. Quota. Only registered
manufacturers would be permitted to
manufacture 4-OH-DiPT, 5-MeO-AMT,
5-MeO-MiPT, 5-MeO-DET, and DiPT in
accordance with a quota assigned
pursuant to 21 U.S.C. 826 and in
accordance with 21 CFR part 1303, as of
the effective date of a final scheduling
action.
6. Inventory. Every DEA registrant
who possesses any quantity of 4-OHDiPT, 5-MeO-AMT, 5-MeO-MiPT, 5MeO-DET, and DiPT on the effective
date of the final rule would need to take
an inventory of 4-OH-DiPT, 5-MeOAMT, 5-MeO-MiPT, 5-MeO-DET, and/or
DiPT on hand at that time, pursuant to
21 U.S.C. 827 and in accordance with 21
CFR 1304.03, 1304.04, and 1304.11(a)
and (d).
Any person who registers with DEA
on or after the effective date of the final
scheduling action would be required to
take an initial inventory of all stocks of
controlled substances (including 4-OHDiPT, 5-MeO-AMT, 5-MeO-MiPT, 5MeO-DET, and/or DiPT) on hand on the
date the registrant first engages in the
handling of controlled substances,
pursuant to 21 U.S.C. 827 and in
accordance with 21 CFR 1304.03,
1304.04, and 1304.11(a) and (b).
After the initial inventory, every DEA
registrant would be required to take a
new inventory of controlled substances
(including 4-OH-DiPT, 5-MeO-AMT, 5MeO-MiPT, 5-MeO-DET, and/or DiPT)
on hand every two years, pursuant to 21
U.S.C. 827 and in accordance with 21
CFR 1304.03, 1304.04, and 1304.11.
7. Records and Reports. Every DEA
registrant would be required to maintain
records and submit reports with respect
to 4-OH-DiPT, 5-MeO-AMT, 5-MeO-
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MiPT, 5-MeO-DET, DiPT, or products
containing 4-OH-DiPT, 5-MeO-AMT, 5MeO-MiPT, 5-MeO-DET, and/or DiPT
pursuant to 21 U.S.C. 827 and in
accordance with 21 CFR 1301.74(b) and
(c) and parts 1304, 1312, and 1317, as
of the effective date of a final scheduling
action. Manufacturers and distributors
would need to submit reports regarding
these substances to the Automation of
Reports and Consolidated Order System
pursuant to 21 U.S.C. 827 and in
accordance with 21 CFR parts 1304 and
1312, as of the effective date of a final
scheduling action.
8. Order Forms. Every DEA registrant
who distributes 4-OH-DiPT, 5-MeOAMT, 5-MeO-MiPT, 5-MeO-DET, or
DiPT would be required to comply with
the order form requirements, pursuant
to 21 U.S.C. 828, and 21 CFR part 1305,
as of the effective date of a final
scheduling action.
9. Importation and Exportation. All
importation and exportation of 4-OHDiPT, 5-MeO-AMT, 5-MeO-MiPT, 5MeO-DET, or DiPT would need to be in
compliance with 21 U.S.C. 952, 953,
957, and 958, and in accordance with 21
CFR part 1312, as of the effective date
of a final scheduling action.
10. Liability. Any activity involving 4OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5MeO-DET, or DiPT not authorized by, or
in violation of, the CSA or its
implementing regulations would be
unlawful, and could subject the person
to administrative, civil, and/or criminal
sanctions.
Regulatory Analyses
Executive Orders 12866 and 13563
(Regulatory Planning and Review;
Improving Regulation and Regulatory
Review)
In accordance with 21 U.S.C. 811(a),
this proposed scheduling action is
subject to formal rulemaking procedures
performed ‘‘on the record after
opportunity for a hearing,’’ which are
conducted pursuant to the provisions of
5 U.S.C. 556 and 557. The CSA sets
forth procedures and criteria for
scheduling a drug or other substance.
Such actions are exempt from review by
the Office of Management and Budget
pursuant to section 3(d)(1) of Executive
Order (E.O.) 12866 and the principles
reaffirmed in E.O. 13563.
Executive Order 12988, Civil Justice
Reform
This proposed regulation meets the
applicable standards set forth in
sections 3(a) and 3(b)(2) of E.O. 12988,
to eliminate drafting errors and
ambiguity, minimize litigation, provide
a clear legal standard for affected
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conduct, and promote simplification
and burden reduction.
Executive Order 13132, Federalism
This proposed rulemaking does not
have federalism implications warranting
the application of E.O. 13132. The
proposed rule does not have substantial
direct effects on the States, on the
relationship between the National
Government and the States, or the
distribution of power and
responsibilities among the various
levels of government.
Executive Order 13175, Consultation
and Coordination With Indian Tribal
Governments
This proposed rule does not have
tribal implications warranting the
application of E.O. 13175. It does not
have substantial direct effects on one or
more Indian tribes, on the relationship
between the Federal Government and
Indian tribes, or on the distribution of
power and responsibilities between the
Federal Government and Indian tribes.
Paperwork Reduction Act of 1995
This proposed action does not impose
a new collection of information
requirement under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3521).
Regulatory Flexibility Act
The Administrator, in accordance
with the Regulatory Flexibility Act (5
U.S.C. 601–612), has reviewed this
proposed rule, and by approving it,
certifies that it will not have a
significant economic impact on a
substantial number of small entities.
DEA proposes placing the substances
4-hydroxy-N,N-diisopropyltryptamine
(4-OH-DiPT), 5-methoxy-alphamethyltryptamine (5-MeO-AMT), 5methoxy-N-methyl-Nisopropyltryptamine (5-MeO-MiPT), 5methoxy-N,N-diethyltryptamine (5MeO-DET), and N,Ndiisopropyltryptamine (DiPT), including
their salts, isomers, and salts of isomers
whenever the existence of such salts,
isomers, and salts of isomers is possible
within the specific chemical
designation, in schedule I of the CSA. If
finalized, this action would impose
regulatory controls and administrative,
civil, and/or criminal sanctions
applicable to schedule I controlled
substances on persons who handle
(manufacture, distribute, reverse
distribute, import, export, engage in
research, conduct instructional
activities, or chemical analysis with, or
possess), or propose to handle 4-OHDiPT, 5-MeO-AMT, 5-MeO-MiPT, 5MeO-DET, or DiPT.
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There appear to be no legitimate
sources for 4-OH-DiPT, 5-MeO-AMT, 5MeO-MiPT, 5-MeO-DET, and DiPT as
marketed drugs and no accepted
medical use in the United States, but
DEA notes that these substances are
available for purchase from legitimate
suppliers for scientific research. There
is no evidence of significant diversion of
4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT,
5-MeO-DET, and DiPT from legitimate
suppliers.
DEA has identified 31 domestic
suppliers of one or more of the
following substances: 4-hydroxy-N,Ndiisopropyltryptamine (4-OH-DiPT), 5methoxy-alpha-methyltryptamine (5MeO-AMT), 5-methoxy-N-methyl-Nisopropyltryptamine (5-MeO-MiPT), 5methoxy-N,N-diethyltryptamine (5MeO-DET), and N,Ndiisopropyltryptamine (DiPT). Thirty
(30) of the 31 domestic suppliers are not
registered with DEA to handle
controlled substances. The one
registered supplier is already registered
with DEA and has all security and other
handling processes in place, resulting in
minimal impact to this supplier.
Therefore, the remaining 30 nonregistered domestic suppliers are
affected. Since the vast majority of DEA
registrants are small entities or are
employed by small entities, all 30
affected suppliers are assumed to be
small entities. It is impossible to know
how much 4-hydroxy-N,Ndiisopropyltryptamine (4-OH-DiPT), 5methoxy-alpha-methyltryptamine (5MeO-AMT), 5-methoxy-N-methyl-Nisopropyltryptamine (5-MeO-MiPT), 5methoxy-N,N-diethyltryptamine (5MeO-DET), and N,Ndiisopropyltryptamine (DiPT) are
distributed by these suppliers. It is
common for suppliers to have items on
their catalog while not actually having
any material level of sales. Based on the
discussion above, DEA believes any
quantity of sales from these distributors
for legitimate purposes is minimal.
Therefore, these suppliers are expected
to remove the product from their catalog
rather than incur the cost of obtaining
a DEA registration and physical security
for products with minimal sales.
Therefore, DEA estimates the cost of this
rule, in form of lost sales, if any, on the
affected small entities is minimal. DEA
welcomes any public comment
regarding this estimate.
Because of these facts, this proposed
rule will not, if promulgated, result in
a significant economic impact on a
substantial number of small entities.
Unfunded Mandates Reform Act of 1995
On the basis of information contained
in the ‘‘Regulatory Flexibility Act’’
VerDate Sep<11>2014
16:36 Jan 13, 2022
Jkt 256001
section above, DEA has determined
pursuant to the Unfunded Mandates
Reform Act (UMRA) of 1995 (2 U.S.C.
1501 et seq.) that this proposed action
would not result in any Federal
mandate that may result ‘‘in the
expenditure by State, local, and tribal
governments, in the aggregate, or by the
private sector, of $100,000,000 or more
(adjusted annually for inflation) in any
1 year . . . .’’ Therefore, neither a Small
Government Agency Plan nor any other
action is required under UMRA of 1995.
List of Subjects in 21 CFR Part 1308
Administrative practice and
procedure, Drug traffic control,
Reporting and recordkeeping
requirements.
For the reasons set out above, DEA
proposes to amend 21 CFR part 1308 as
follows:
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
1. The authority citation for 21 CFR
part 1308 continues to read as follows:
■
Authority: 21 U.S.C. 811, 812, 871(b),
956(b), unless otherwise noted.
2. In § 1308.11, as proposed to be
amended at 86 FR 16553 (March 30,
2021), 86 FR 37719 (July 16, 2021), and
86 FR 69187 (December 7, 2021), add
paragraphs (d)(101) through (105) to
read as follows:
■
§ 1308.11
Schedule I.
*
*
*
*
*
(d) * * *
(101) 4-hydroxy-N,Ndiisopropyltryptamine (other names: 4OH-DiPT; 3-(2(diisopropylamino)ethyl)-1H-indol-4-ol)
7516.
(102) 5-methoxy-alphamethyltryptamine (Other names: 5MeO-AMT; 1-(5-methoxy-1H-indol-3yl)propan-2-amine) 7506.
(103) 5-methoxy-N-methyl-Nisopropyltryptamine (Other names: 5MeO-MiPT; N-(2-(5-methoxy-1H-indol3-yl)ethyl)-N-methylpropan-2-amine)
7512.
(104) 5-methoxy-N,Ndiethyltryptamine (Other names: 5MeO-DET; N,N-diethyl-2-(5-methoxy1H-indol-3-yl)ethanamine) 7525.
(105) N,N-diisopropyltryptamine
(Other names: DiPT; N-(2-(1H-indol-3yl)ethyl)-N-isopropylpropan-2-amine)
7522.
*
*
*
*
*
Anne Milgram,
Administrator.
[FR Doc. 2022–00713 Filed 1–13–22; 8:45 am]
BILLING CODE 4410–09–P
PO 00000
Frm 00025
Fmt 4702
Sfmt 4702
2383
DEPARTMENT OF THE INTERIOR
National Indian Gaming Commission
25 CFR Part 537
RIN 3141–AA58
Background Investigations for Persons
or Entities With a Financial Interest in
or Having a Management
Responsibility for a Management
Contract; Correction
National Indian Gaming
Commission, Department of the Interior.
ACTION: Proposed rule; correction.
AGENCY:
This document corrects the
preamble to a proposed rule published
in the Federal Register of December 2,
2021, regarding Background
Investigations for Persons or Entities
with a Financial Interest in or Having a
Management Responsibility for a
Management Contract. The document
contained incorrect dates for submitting
comments. This correction clarifies that
comments are due January 31, 2022.
FOR FURTHER INFORMATION CONTACT:
Michael Hoenig, 202–632–7003.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Correction
In the Federal Register of December 2,
2021, in proposed rule FR Doc. 2021–
25844, on page 68446, in the second
column, change the DATES caption to
read:
DATES: Written comments on this
proposed rule must be received on or
before January 31, 2022.
Dated: January 6, 2022.
Michael Hoenig,
General Counsel.
[FR Doc. 2022–00631 Filed 1–13–22; 8:45 am]
BILLING CODE 7565–01–P
DEPARTMENT OF THE INTERIOR
National Indian Gaming Commission
25 CFR Part 537
RIN 3141–AA77
Fees; Correction
National Indian Gaming
Commission, Department of the Interior.
ACTION: Proposed rule; correction.
AGENCY:
This document corrects the
preamble to a proposed rule published
in the Federal Register of December 2,
2021, regarding Fees. The document
contained incorrect dates for submitting
comments. This correction clarifies that
comments are due January 31, 2022.
SUMMARY:
E:\FR\FM\14JAP1.SGM
14JAP1
]]>Agencies
[Federal Register Volume 87, Number 10 (Friday, January 14, 2022)]
[Proposed Rules]
[Pages 2376-2383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00713]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-623]
Schedules of Controlled Substances: Placement of 4-hydroxy-N,N-
diisopropyltryptamine (4-OH-DiPT), 5-methoxy-alpha-methyltryptamine (5-
MeO-AMT), 5-methoxy-N-methyl-N-isopropyltryptamine (5-MeO-MiPT), 5-
methoxy-N,N-diethyltryptamine (5-MeO-DET), and N,N-
diisopropyltryptamine (DiPT) in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Drug Enforcement Administration proposes placing five
tryptamine hallucinogens, as identified in this proposed rule, in
schedule I of the Controlled Substances Act. If finalized, this action
would impose the regulatory controls and administrative, civil, and
criminal sanctions applicable to schedule I controlled substances on
persons who handle (manufacture, distribute, reverse distribute,
import, export, engage in research, conduct instructional activities or
chemical analysis with, or possess), or propose to handle these five
specific controlled substances.
[[Page 2377]]
DATES: Comments must be submitted electronically or postmarked on or
before February 14, 2022.
Requests for hearing and waivers of an opportunity for a hearing or
to participate in a hearing must be received on or before February 14,
2022.
ADDRESSES: Interested persons may file written comments on this
proposal in accordance with 21 CFR 1308.43(g). The electronic Federal
Docket Management System will not accept comments after 11:59 p.m.
Eastern Time on the last day of the comment period. To ensure proper
handling of comments, please reference ``Docket No. DEA-623'' on all
electronic and written correspondence, including any attachments.
Electronic comments: DEA encourages commenters to submit
all comments electronically through the Federal eRulemaking Portal,
which provides the ability to type short comments directly into the
comment field on the web page or attach a file for lengthier comments.
Please go to https://www.regulations.gov and follow the on-line
instructions at that site for submitting comments. Upon completion of
your submission, you will receive a Comment Tracking Number. Submitted
comments are not instantaneously available for public view on
regulations.gov. If you have received a Comment Tracking Number, you
have submitted your comment successfully and there is no need to
resubmit the same comment. Commenters should be aware that the
electronic Federal Docket Management System will not accept comments
after 11:59 p.m. Eastern Time on the last day of the comment period.
Paper comments: Paper comments that duplicate electronic
submissions are not necessary and are discouraged. Should you wish to
mail a paper comment in lieu of an electronic comment, it should be
sent via regular or express mail to: Drug Enforcement Administration,
Attn: DEA FR Representative/DPW, 8701 Morrissette Drive, Springfield,
Virginia 22152.
Hearing requests: All requests for a hearing and waivers
of participation, together with a written statement of position on the
matters of fact and law asserted in the hearing, must be sent to: Drug
Enforcement Administration, Attn: Administrator, 8701 Morrissette
Drive, Springfield, Virginia 22152. All requests for hearing and
waivers of participation should also be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA FR Representative/DPW, 8701 Morrissette Drive, Springfield,
Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug & Chemical
Evaluation Section, Diversion Control Division, Drug Enforcement
Administration; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION: In this proposed rule, the Drug Enforcement
Administration (DEA) proposes to schedule the following five controlled
substances in schedule I of the Controlled Substances Act (CSA),
including their salts, isomers, and salts of isomers whenever the
existence of such salts, isomers, and salts of isomers is possible
within the specific chemical designation:
4-Hydroxy-N,N-diisopropyltryptamine (4-OH-DiPT),
5-Methoxy-alphamethyltryptamine (5-MeO-AMT),
N-Isopropyl-5-Methoxy-N-Methyltryptamine (5-MeO-MiPT),
N,N-Diethyl-5-methoxytryptamine (5-MeO-DET), and
N,N-Diisopropyltryptamine (DiPT).
Posting of Public Comments
All comments received in response to this docket are considered
part of the public record. DEA will make comments available, unless
reasonable cause is given, for public inspection online at https://www.regulations.gov. Such information includes personal identifying
information (such as your name, address, etc.) voluntarily submitted by
the commenter. The Freedom of Information Act applies to all comments
received. If you want to submit personal identifying information (such
as your name, address, etc.) as part of your comment, but do not want
DEA to make it publicly available, you must include the phrase
``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your
comment. You must also place all of the personal identifying
information you do not want made publicly available in the first
paragraph of your comment and identify what information you want
redacted.
If you want to submit confidential business information as part of
your comment, but do not want DEA to make it publicly available, you
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the
first paragraph of your comment. You must also prominently identify the
confidential business information to be redacted within the comment.
DEA will generally make available in publicly redacted from
comments containing personal identifying information and confidential
business information identified, as directed above. If a comment has so
much confidential business information that DEA cannot effectively
redact it, DEA may not make available publicly all or part of that
comment. Comments posted to https://www.regulations.gov may include any
personal identifying information (such as name, address, and phone
number) included in the text of your electronic submission that is not
identified as confidential as directed above.
An electronic copy of this document and supplemental information to
this proposed rule are available at https://www.regulations.gov for
easy reference.
Request for Hearing or Appearance; Waiver
Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking
``on the record after opportunity for a hearing.'' Such proceedings are
conducted pursuant to the provisions of the Administrative Procedure
Act, 5 U.S.C. 551-59. 21 CFR 1308.41 through 1308.45; 21 CFR part 1316,
subpart D. Interested persons may file requests for a hearing or
notices of intent to participate in a hearing in conformity with the
requirements of 21 CFR 1308.44(a) or (b), and such requests must
include a statement of interest in the proceeding and the objections or
issues, if any, concerning which the person desires to be heard. 21 CFR
1316.47(a). Any interested person may file a waiver of an opportunity
for a hearing or to participate in a hearing together with a written
statement regarding the interested person's position on the matters of
fact and law involved in any hearing as set forth in 21 CFR 1308.44(c).
All requests for hearing and waivers of participation, together
with a written statement of position on the matters of fact and law
involved in such hearing, must be sent to DEA using the address
information provided above.
Legal Authority
The CSA provides that proceedings for the issuance, amendment, or
repeal of the scheduling of any drug or other substance may be
initiated by the Attorney General on his own motion. 21 U.S.C. 811(a).
This proposed action was initiated on the Attorney General's own
motion, as delegated to the Administrator of DEA (Administrator), and
is supported by, inter alia, a recommendation from the former Assistant
Secretary for Health of the Department of Health and Human Services
(former Assistant Secretary of
[[Page 2378]]
HHS or former Assistant Secretary) \1\ and an evaluation of all
relevant data by DEA. If finalized, this action would impose the
regulatory controls and administrative, civil, and criminal sanctions
applicable to controlled substances, including those specific to
schedule I controlled substances, on persons who handle or propose to
handle 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT.
---------------------------------------------------------------------------
\1\ The Secretary of HHS has delegated to the Assistant
Secretary for Health the authority to make domestic drug scheduling
recommendations.
---------------------------------------------------------------------------
Background
4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT are
tryptamine hallucinogens. They share structural and pharmacological
similarities with several schedule I tryptamine hallucinogens, such as
alpha-methyltryptamine (AMT), N,N-dimethyltryptamine (DMT), 5-methoxy-
N,N-diisopropyltryptamine (5-MeO-DiPT), and psilocyn. They have no
approved medical use in the United States.
Proposed Determination To Schedule 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-
MeO-DET, and DiPT
Pursuant to 21 U.S.C. 811(b), DEA gathered the necessary data on 4-
OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT, and on December
19, 2008, submitted it to the former Assistant Secretary with a request
for a scientific and medical evaluation of available information and a
scheduling recommendation for 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-
DET, and DiPT.
On March 29, 2012, May 17, 2012, and August 14, 2012, HHS provided
to DEA scientific and medical evaluations for the above mentioned five
tryptamines and a scheduling recommendation for each. The evaluations
were entitled: (1) ``Basis for the Recommendation to Control 4-Hydroxy-
N,N-diisopropyltryptamine (4-OH-DIPT) and its Salts in Schedule I of
the Controlled Substances Act (CSA);'' (2) ``Basis for the
Recommendation to Control 5-Methoxy-alphamethyltryptamine (5-MeO-AMT)
and its Salts in Schedule I of the Controlled Substances Act (CSA);''
(3) ``Basis for the Recommendation to Control N-Isopropyl-5-Methoxy-N-
Methyltryptamine (5-MeO-MIPT) and its Salts in Schedule I of the
Controlled Substances Act (CSA);'' (4) ``Basis for the Recommendation
to Control N,N-Diethyl-5-methoxytryptamine (5-MeO-DET) and its Salts in
Schedule I of the Controlled Substances Act (CSA);'' and (5) ``Basis
for the Recommendation to Control N,N-Diisopropyltryptamine (DIPT) and
its Salts in Schedule I of the Controlled Substances Act (CSA).''
Following consideration of the eight factors and findings related to
each of the substances' abuse potential, legitimate medical use, and
dependence liability, HHS recommended that 4-OH-DiPT, 5-MeO-AMT, 5-MeO-
MiPT, 5-MeO-DET, and DiPT and their respective salts be controlled in
schedule I of the CSA under 21 U.S.C. 812(b).
In response, DEA reviewed the scientific and medical evaluation and
scheduling recommendation provided by HHS and all other relevant data,
and completed its own eight-factor review pursuant to 21 U.S.C. 811(c).
Included below is a brief summary of each factor as analyzed by HHS and
DEA in their respective eight-factor analyses, and as considered by DEA
in this proposed scheduling determination. Please note that both DEA
and HHS analyses are available in their entirety under ``Supporting
Documents'' of the public docket for this proposed rule at https://www.regulations.gov under docket number ``DEA-623.''
1. The Drugs' Actual or Relative Potential for Abuse
In addition to considering the information HHS provided in its
scientific and medical evaluation documents for 4-OH-DiPT, 5-MeO-AMT,
5-MeO-MiPT, 5-MeO-DET, and DiPT, DEA also considered all other relevant
data regarding actual or relative potential for abuse of each
substance. The term ``abuse'' is not defined in the CSA, however the
legislative history of the CSA suggests the following four prongs in
determining whether a particular drug or substance has a potential for
abuse: \2\
---------------------------------------------------------------------------
\2\ Comprehensive Drug Abuse Prevention and Control Act of 1970,
H.R. Rep. No. 91-1444, 91st Cong., 2nd Sess. (1970) reprinted in
1970 U.S.C.C.A.N. 4566, 4603.
---------------------------------------------------------------------------
a. Individuals are taking the drug or other substance in amounts
sufficient to create a hazard to their health or to the safety of other
individuals or to the community; or
b. There is a significant diversion of the drug or other substance
from legitimate drug channels; or
c. Individuals are taking the drug or other substance on their own
initiative rather than on the basis of medical advice from a
practitioner licensed by law to administer such drugs; or
d. The drug is so related in its action to a drug or other
substance already listed as having a potential for abuse to make it
likely that it will have the same potential for abuse as such
substance, thus making it reasonable to assume that there may be
significant diversions from legitimate channels, significant use
contrary to or without medical advice, or that it has a substantial
capability of creating hazards to the health of the user or to the
safety of the community.
DEA reviewed the scientific and medical evaluation provided by HHS
and all other data relevant to the abuse potential of 4-OH-DiPT, 5-MeO-
AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT. These data as presented below
demonstrate that 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT
have a high potential for abuse.
a. There is evidence that individuals are taking the drug or other
substance in amounts sufficient to create a hazard to their health or
to the safety of other individuals or to the community.
According to HHS 2012 review, and more current DEA findings, data
show that 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT have
been encountered by law enforcement (Factor 5). Based on published case
reports in the medical literature and anecdotal reports (Factor 2), HHS
states that these substances are being abused for their hallucinogenic
properties. HHS has determined that consumption of these five
tryptamines due to their hallucinogenic properties poses a safety
hazard to the public health. There were hospital emergency room
admissions related to the abuse of 5-MeO-AMT and 5-MeO-MiPT. One
confirmed death was reported in 2004 from the abuse of 5-MeO-AMT, taken
in combination with alcohol and the antidepressant bupropion; however,
it is unclear what role 5-MeO-AMT played in the death.
b. There is significant diversion of the drug or substance from
legitimate drug channels.
HHS, in its 2012 review, stated that 4-OH-DiPT, 5-MeO-AMT, 5-MeO-
MiPT, 5-MeO-DET, and DiPT are not Food and Drug Administration (FDA)-
approved drug products for treatment in the United States and that it
is unaware of any country in which their use is legal. DEA has
confirmed with HHS that their 2012 statements are still applicable. In
addition, HHS' 2012 review stated that there appear to be no legitimate
sources for 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT as
marketed drugs. DEA notes that these substances are available for
purchase from legitimate suppliers for scientific research. However,
there is no evidence of significant diversion of 4-OH-DiPT, 5-MeO-AMT,
5-MeO-MiPT, 5-MeO-DET, and DiPT from legitimate suppliers.
[[Page 2379]]
c. Individuals are taking the substance on their own initiative
rather than on the basis of medical advice from a practitioner licensed
by law to administer such substance.
4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT are not
approved for medical use and are not formulated or available for
clinical use. Therefore, individuals are taking 4-OH-DiPT, 5-MeO-AMT,
5-MeO-MiPT, 5-MeO-DET, and DiPT on their own initiative, rather than
based on medical advice from a practitioner licensed by law to
administer drugs. This is consistent with the data from law enforcement
seizures and case reports suggesting that individuals are taking these
substances for similar hallucinogenic effects produced by lysergic acid
diethylamide (LSD) and N,N-diethyltryptamine (DET), while possibly
simultaneously attempting to circumvent criminal prosecution since
these are explicitly scheduled substances (see Factor 5 for more
detailed information).
d. The drug is a new drug so related in its action to a drug or
other substance already listed as having a potential for abuse to make
it likely that the drug substance will have the same potential for
abuse as such drugs, thus making it reasonable to assume that there may
be significant diversion from legitimate channels, significant use
contrary to or without medical advice, or that it has a substantial
capability of creating hazards to the health of the user or to the
safety of the community.
After scientific evaluation, HHS states that 4-OH-DiPT, 5-MeO-AMT,
5-MeO-MiPT, 5-MeO-DET, and DiPT are structural analogs of schedule I
hallucinogens (4-OH-DiPT of 5-MeO-DiPT, 5-MeO-AMT of AMT, 5-MeO-MiPT of
DMT, 5-MeO-DET of 5-MeO-DMT and DMT, and DiPT of 5-MeO-DiPT) and
produce similar pharmacological effects to natural and synthetic
schedule I hallucinogens.
4-OH-DiPT
4-OH-DiPT elicits pharmacological responses similar to the schedule
I substances 4-methyl-2,5-dimethoxy-amphetamine (DOM) and LSD, which
have no accepted medical use and have high abuse potential. In animal
drug discrimination studies, 4-OH-DiPT fully generalizes for the
discriminative stimulus effects of DOM and LSD in rats. Additionally,
4-OH-DiPT produces classic hallucinogenic effects such as perceptual
distortions and pleasurable physical effects. Risks and effects of 4-
OH-DiPT include: Hallucinations, euphoria, fatigue, headache,
gastrointestinal distress, insomnia, and anxiety. HHS states that these
effects are like those of schedule I hallucinogens and concludes that
based on the psychological and cognitive disturbances associated with
effects of 4-OH-DiPT, it is reasonable to assume that this substance
has a substantial capability to cause a hazard to public health, both
to the user and to the community.
5-MeO-AMT
According to HHS, 5-MeO-AMT elicits pharmacological responses
similar to the schedule I substances LSD and DET which have no accepted
medical use and have high abuse potential. Drug discrimination data
demonstrate that 5-MeO-AMT produces partial generalization for the
discriminative stimulus effects of LSD in rats. In humans, 5-MeO-AMT
produces hallucinogenic effects similar to those produced by LSD and
DET, including euphoria and visual and auditory hallucinations. Adverse
effects caused by 5-MeO-AMT are similar to those of schedule I
hallucinogens including: Fatigue, headache, gastrointestinal distress,
insomnia, and anxiety. Based on the hallucinogenic and other effects
caused by 5-MeO-AMT, HHS states that it is reasonable to assume that
this substance has substantial capability to cause a hazard to public
health, both to the user and to the community.
5-MeO-MiPT
According to HHS, 5-MeO-MiPT elicits pharmacological responses
similar to the schedule I substances LSD and DMT, which have no
accepted medical use and have high abuse potential. Drug discrimination
studies showed that 5-MeO-MiPT fully generalizes to the discriminative
stimulus effects of DOM in rats, and partially generalizes to the
discrimination stimulus effects of LSD, DMT, and 3,4-methylenedioxy-
methamphetamine (MDMA, schedule I). In humans it has been reported that
5-MeO-MiPT is 15-fold more potent than DMT when comparing doses that
produce hallucinogenic effects. Thus, HHS concluded that it is
reasonable to assume that 5-MeO-MiPT has substantial capability to
cause a hazard to public health, both to the user and to the community.
5-MeO-DET
According to HHS, 5-MeO-DET elicits pharmacological responses
similar to the schedule I substances DMT and DOM, which have no
accepted medical use and have high abuse potential. In animal drug
discrimination studies, 5-MeO-DET fully generalizes for the
discriminative stimulus effect of DMT in rats. 5-MeO-DET partially
generalizes to the discriminative stimulus cues of DOM and MDMA. The
reports from users describe the effects of 5-MeO-DET as being similar
to those produced by DMT and LSD. Adverse health risks associated with
5-MeO-DET use include: Bizarre behavior, hallucinations, and
sympathomimetic effects, such as increased heart rate. These adverse
effects are similar to those of schedule I hallucinogens. Based on
available information, it is reasonable to assume that 5-MeO-DET has
substantial capability to cause a hazard to public health, both to the
user and to the community.
DiPT
According to HHS, DiPT elicits pharmacological responses similar to
the schedule I substances DOM and DMT, which have no accepted medical
use and have high abuse potential. Drug discrimination studies showed
that DiPT fully substitutes for the discriminative stimulus effects of
DOM and DMT in rats. The reports from users describe the effects of
DiPT as being similar to those produced by 4-bromo-2,5-
dimethoxyphenethylamine (2C-B), 2-(2,5-dimethoxy-4-
methylphenyl)ethanamine (2C-D), and 2,5-dimethoxy-4-ethylamphetamine
(DOET), all of which are classified as schedule I substances. Risks
associated with DiPT use are based on the perceptual changes in the
auditory experience. Like schedule I hallucinogens, DiPT produces
adverse effects such as: Auditory and other sensory distortions,
lethargy, nausea, hyperreflexia, and mydriasis. Based on the adverse
effects associated with DiPT, it is reasonable to assume that this
substance has substantial capability to cause a hazard to public
health, both to the user and to the community.
2. Scientific Evidence of the Drugs' Pharmacological Effects, If Known
As stated by HHS (HHS reviews, 2012a-e), the neurochemical effects
of 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT mainly involve
serotonergic system in the central nervous system (CNS). Tryptamine
hallucinogens are believed to produce their characteristic effects
primarily through stimulation of the 2A subtype of serotonin (5-HT)
receptors (5-HT2A). DEA further notes that the 5-
HT2A receptor has also been shown to mediate the in vivo
behavioral effects and discriminative stimulus effects of the three
classes of classic hallucinogens, ergotamines (e.g., LSD),
[[Page 2380]]
phenethylamines (e.g., DOM), and tryptamines (e.g., DMT).
Animal testing data in rats show that stimulus properties of 4-OH-
DiPT are similar to DOM and LSD, and partially similar to DMT; 5-MeO-
AMT substantially overlaps with LSD; 5-MeO-MiPT substantially overlaps
with DOM, LSD, and MDMA; 5-MeO-DMT are similar to DMT, DOM, and MDMA;
and DiPT are similar to DOM and DMT, and are partially similar to LSD.
Thus, 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT produce
psychopharmacologic effects similar to those produced by serotonin-
mediated hallucinogens in an animal model, which are predictive of its
abuse in humans.
In humans, users of 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET,
and DiPT report hallucinogenic effects similar to LSD and DET
including: Euphoria, hallucinations involving various senses,
perceptual distortions and pleasant intensification of sensory
experiences. Physiological and psychological effects have been reported
to be frightening or disturbing and can include: Dizziness, fatigue,
headache, trembling, anxiety, insomnia, restlessness, cold sweats, and
gastrointestinal disturbances (i.e., nausea, vomiting, and diarrhea),
among others. One death was reported in 2004 with the use of 5-MeO-AMT,
however alcohol and bupropion (an antidepressant) were also detected in
post mortem toxicology analyses.
3. The State of Current Scientific Knowledge Regarding the Drugs or
Other Substances
Chemistry
4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT are part of
the tryptamine family and share the core tryptamine structure with
substitutions at the [alpha]-position, 4-position, 5-position, and on
the nitrogen (N) atom. All of these substances contain an indole ring
with a substituted ethylamino sidechain. 4-OH-DiPT, 5-MeO-AMT, 5-MeO-
MiPT, 5-MeO-DET, and DiPT share structural similarities with schedule I
tryptamine hallucinogens such as DMT, DET, AMT, and psilocyn.
Pharmacokinetics
Metabolism studies have not been conducted for 4-OH-DiPT, 5-MeO-
AMT, 5-MeO-DET, and DiPT. However, metabolism has been reported for 5-
MeO-MiPT. Similar to other structurally related tryptamines, 5-MeO-MiPT
has been reported to undergo metabolism through oxidative deamination,
N-demethylation, O-demethylation, and N-oxidation with N-oxides as the
major metabolites. Thus, it is highly likely that 4-OH-DiPT, 5-MeO-AMT,
5-MeO-DET, and DiPT will be metabolized in a similar manner.
4. Its History and Current Pattern of Abuse
In the U.S., law enforcement entities have initially encountered 5-
MeO-AMT and DiPT in 2003, 5-MeO-MiPT in 2004, 5-MeO-DET in 2006, and 4-
OH-DiPT in 2009, according to the National Forensic Laboratory
Information System (NFLIS).\3\ Each of these tryptamines has been
encountered in one or more of the following forms: Powder, tablets,
capsules, liquid, or on blotter paper. These substances are generally
purchased from internet-based companies in addition to being purchased
from dealers. These tryptamines are often misrepresented as LSD to
users due to their similarities in producing hallucinogenic effects.
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\3\ NFLIS is a national drug forensic laboratory reporting
system that systematically collects results from drug chemistry
analyses conducted by state and local forensic laboratories across
the country. The NFLIS participation rate, defined as the percentage
of the national drug caseload represented by laboratories that have
joined NFLIS, is over 97 percent. NFLIS includes drug chemistry
results from completed analyses only.
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4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT do not have
an approved medical indication in the U.S. and therefore have no
legitimate medical use in the U.S. Anecdotal reports from users of
these substances indicate that these substances produce classical
hallucinogenic properties, such as perceptual distortions and
pleasurable physical effects. Users report oral administration as the
most common route of administration. Other routes of administration
such as insufflation, smoking, and rectal administration have been
reported.
5. The Scope, Duration, and Significance of Abuse
Tryptamine hallucinogens, both natural and synthetic, have been
popular among the attendees of rave parties, music concerts, and other
large or social venues, as well as in intimate and smaller settings
since the 1990s in the U.S. and Europe. Often these substances are
promoted as substitutes for LSD. Synthetic hallucinogens and stimulants
are known as ``club drugs.'' In addition to sales in raves and
nightclubs, internet sales have become one of the main outlets for the
sale and distribution of tryptamine hallucinogens.
In the U.S., there has been significant availability, trafficking
and abuse of a number of tryptamines including 4-OH-DiPT, 5-MeO-AMT, 5-
MeO-MiPT, 5-MeO-DET, and DiPT. This is evidenced by large numbers of
encounters of one or more of these tryptamines by U.S. law enforcement
in 47 states and the District of Columbia.
According to NFLIS, there have been 5 reports of 4-OH-DiPT (first
reported in 2009), 92 reports of 5-MeO-AMT (first reported in 2003),
348 reports of 5-MeO-MiPT (first reported in 2004), 17 reports of 5-
MeO-DET (first reported in 2006), and 25 reports of DiPT (first
reported in 2003).\4\
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\4\ NFLIS data were queried August 17, 2021, by date of
submission.
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6. What, if Any, Risk There Is to the Public Health
HHS indicates that 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and
DiPT pose a risk to public health due to their hallucinogenic
properties that usually occur quickly (often between 5-15 minutes,
dependent on the route of administration) after ingestion and may cause
impairing effects on the user's judgment and lead to dangerous
behavior. The risks could be to the individual user or to the
community, especially when the user is operating a motor vehicle.
Several adverse effects were reported in animal studies and in humans
from internet forums for all five tryptamines (see Factor 2). HHS also
cited published and anecdotal reports that described the adverse
effects of these five hallucinogens including agitation, confusion,
psychological distress for all five substances, and death in the case
of 5-MeO-AMT. It is unclear what role 5-MeO-AMT played in the death.
The toxicology report also reported alcohol and the presence of an
antidepressant, bupropion. Users of 4-OH-DiPT reported that the
hallucinations were intense and the psychological and physiological
effects were frightening or disturbing. A non-lethal poisoning was
reported in an adolescent after ingesting an alleged combination of 5-
MeO-MiPT and harmaline, a CNS stimulant.
7. Its Psychic or Physiological Dependence Liability
According to HHS, hallucinogens are not usually associated with
physical dependence and the physiological dependence liability in
animals or humans has not been reported in scientific and medical
literature for these five substances. Thus, it is not possible at this
time to determine whether 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET,
and DiPT produce physiological dependence
[[Page 2381]]
following acute or chronic administration. However, hallucinogen
abusers may develop psychological dependence to these substances as
evidenced by the continued use of these substances despite knowledge of
the potential toxic and adverse effects.
The data on the drug discrimination studies conducted by the
National Institute on Drug Abuse, cited in HHS reviews and later
published, show that 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and
DiPT share discriminative stimulus effects with other schedule I
hallucinogens: 4-OH-DiPT fully substitutes for DOM and LSD; 5-MeO-AMT
partially substitutes for LSD and DMT; 5-MeO-MiPT fully substitutes for
DOM; 5-MeO-DET fully substitutes for DMT; and DiPT fully substitutes
for DOM and DMT. DEA adds that LSD, DOM, and MDMA fully substitute for
DiPT-trained discriminative stimulus effects, confirming that DiPT has
hallucinogenic effects similar to other schedule I hallucinogens.
8. Whether the Substance Is an Immediate Precursor of a Substance
Already Controlled Under the CSA
4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT are not
immediate precursors of a substance already controlled under the CSA as
defined by 21 U.S.C. 802(23).
Conclusion
Based on consideration of the scientific and medical evaluation and
accompanying recommendations of HHS, and on DEA's consideration of its
own eight-factor analysis, DEA finds that these facts and all relevant
data constitute substantial evidence of potential for abuse of 4-OH-
DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT. As such, DEA hereby
proposes to schedule 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and
DiPT as controlled substances under the CSA.
Proposed Determination of Appropriate Schedule
The CSA establishes five schedules of controlled substances known
as schedules I, II, III, IV, and V. The CSA also outlines the findings
required to place a drug or other substance in any particular schedule.
21 U.S.C. 812(b). After consideration of the analysis and
recommendation of the former Assistant Secretary and review of all
other available data, the Administrator, pursuant to 21 U.S.C.
812(b)(1), finds that:
(1) 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT elicit
pharmacological effects qualitatively similar to those of schedule I
hallucinogens (e.g., DOM, LSD, DMT, DET). These effects are marked by
hallucinations and CNS stimulation. Law enforcement reported a number
of encounters of 5-MeO-AMT and DiPT beginning in 2003, 5-MeO-MiPT
beginning in 2004, 5-MeO-DET beginning in 2006, and 4-OH-DiPT beginning
in 2009.
The available data indicate that 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT,
5-MeO-DET, and DiPT have high potential for abuse that is similar to
that of other schedule I tryptamine hallucinogens DET (5-MeO-AMT) and
DMT (5-MeO-DET, 5-MeO-MiPT, and DiPT), the phenethylamine hallucinogen
DOM (4-OH-DiPT, 5-MeO-DET, 5-MeO-MiPT, and DiPT), and the ergotamine
hallucinogen LSD (5-MeO-AMT, 4-OH-DiPT, 5-MeO-DET, 5-MeO-MiPT).
(2) 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT are not
legally marketed in the U.S. They lack current marketing approval under
new drug applications, abbreviated new drug applications, or
investigational use under an active investigational new drug
application. There is no evidence that 4-OH-DiPT, 5-MeO-AMT, 5-MeO-
MiPT, 5-MeO-DET, and DiPT have a currently accepted medical use in
treatment in the U.S.\5\
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\5\ Although there is no evidence suggesting that 4-OH-DiPT, 5-
MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT have a currently accepted
medical use in treatment in the United States, it bears noting that
a drug cannot be found to have such medical use unless DEA concludes
that it satisfies a five-part test. Specifically, with respect to a
drug that has not been approved by FDA, to have a currently accepted
medical use in treatment in the United States, all of the following
must be demonstrated: i. the drug's chemistry must be known and
reproducible; ii. there must be adequate safety studies; iii. there
must be adequate and well-controlled studies proving efficacy; iv.
the drug must be accepted by qualified experts; and v. the
scientific evidence must be widely available. 57 FR 10499 (1992),
pet. for rev. denied, Alliance for Cannabis Therapeutics v. DEA, 15
F.3d 1131, 1135 (D.C. Cir. 1994).
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(3) Because 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT
have no approved medical use and have not been thoroughly investigated
as new drugs, their safety for use under medical supervision is not
determined. Thus, there is a lack of accepted safety for use of these
substances under medical supervision.
Based on these findings, the Administrator concludes that 4-OH-
DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT warrant control in
schedule I of the CSA. More precisely, because of their hallucinogenic
effects, and because they may produce hallucinogenic-like tolerance and
dependence in humans, DEA proposes to place 4-OH-DiPT, 5-MeO-AMT, 5-
MeO-MiPT, 5-MeO-DET, and DiPT, including their salts, isomers, and
salts of isomers whenever the existence of such salts, isomers, and
salts of isomers is possible within the specific chemical description,
in 21 CFR 1308.11(d) (the hallucinogenic substances category of
schedule I).
Requirements for Handling 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET,
and DiPT
If this rule is finalized as proposed, 4-OH-DiPT, 5-MeO-AMT, 5-MeO-
MiPT, 5-MeO-DET, and DiPT would be subject to the CSA's schedule I
regulatory controls and administrative, civil, and criminal sanctions
applicable to the manufacture, distribution, reverse distribution,
import, export, research, conduct of instructional activities or
chemical analysis with, and possession of schedule I controlled
substances, including the following:
1. Registration. Any person who handles (manufactures, distributes,
reverse distributes, imports, exports, engages in research, or conducts
instructional activities or chemical analysis with, or possesses), or
who desires to handle, 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or
DiPT would be required to be registered with DEA to conduct such
activities pursuant to 21 U.S.C. 822, 823, 957, and 958, and in
accordance with 21 CFR parts 1301 and 1312, as of the effective date of
a final scheduling action. Any person who currently handles 4-OH-DiPT,
5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or DiPT, and is not registered with
DEA, would need to submit an application for registration and may not
continue to handle 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or DiPT
as of the effective date of a final scheduling action, unless DEA has
approved that application for registration pursuant to 21 U.S.C. 822,
823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312.
2. Disposal of stocks. Any person unwilling or unable to obtain a
schedule I registration would be required to surrender or transfer all
quantities of currently held 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-
DET, and DiPT to a person registered with DEA before the effective date
of a final scheduling action, in accordance with all applicable
Federal, State, local, and tribal laws. As of the effective date of a
final scheduling action, 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET,
and DiPT would be required to be disposed of in accordance with 21 CFR
part 1317, in
[[Page 2382]]
addition to all other applicable Federal, State, local, and tribal
laws.
3. Security. 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT
would be subject to schedule I security requirements for DEA
registrants and would need to be handled and stored pursuant to 21
U.S.C. 823 and in accordance with 21 CFR 1301.71 through 1301.76 as of
the effective date of a final scheduling action. Non-practitioners
handling 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT would
also need to comply with the employee screening requirements of 21 CFR
1301.90 through 1301.93.
4. Labeling and Packaging. All labels and labeling for commercial
containers of 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or DiPT
would need to be in compliance with 21 U.S.C. 825, and be in accordance
with 21 CFR part 1302, as of the effective date of a final scheduling
action.
5. Quota. Only registered manufacturers would be permitted to
manufacture 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT in
accordance with a quota assigned pursuant to 21 U.S.C. 826 and in
accordance with 21 CFR part 1303, as of the effective date of a final
scheduling action.
6. Inventory. Every DEA registrant who possesses any quantity of 4-
OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT on the effective
date of the final rule would need to take an inventory of 4-OH-DiPT, 5-
MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and/or DiPT on hand at that time,
pursuant to 21 U.S.C. 827 and in accordance with 21 CFR 1304.03,
1304.04, and 1304.11(a) and (d).
Any person who registers with DEA on or after the effective date of
the final scheduling action would be required to take an initial
inventory of all stocks of controlled substances (including 4-OH-DiPT,
5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and/or DiPT) on hand on the date the
registrant first engages in the handling of controlled substances,
pursuant to 21 U.S.C. 827 and in accordance with 21 CFR 1304.03,
1304.04, and 1304.11(a) and (b).
After the initial inventory, every DEA registrant would be required
to take a new inventory of controlled substances (including 4-OH-DiPT,
5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and/or DiPT) on hand every two years,
pursuant to 21 U.S.C. 827 and in accordance with 21 CFR 1304.03,
1304.04, and 1304.11.
7. Records and Reports. Every DEA registrant would be required to
maintain records and submit reports with respect to 4-OH-DiPT, 5-MeO-
AMT, 5-MeO-MiPT, 5-MeO-DET, DiPT, or products containing 4-OH-DiPT, 5-
MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and/or DiPT pursuant to 21 U.S.C. 827
and in accordance with 21 CFR 1301.74(b) and (c) and parts 1304, 1312,
and 1317, as of the effective date of a final scheduling action.
Manufacturers and distributors would need to submit reports regarding
these substances to the Automation of Reports and Consolidated Order
System pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts
1304 and 1312, as of the effective date of a final scheduling action.
8. Order Forms. Every DEA registrant who distributes 4-OH-DiPT, 5-
MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or DiPT would be required to comply
with the order form requirements, pursuant to 21 U.S.C. 828, and 21 CFR
part 1305, as of the effective date of a final scheduling action.
9. Importation and Exportation. All importation and exportation of
4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or DiPT would need to be
in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance
with 21 CFR part 1312, as of the effective date of a final scheduling
action.
10. Liability. Any activity involving 4-OH-DiPT, 5-MeO-AMT, 5-MeO-
MiPT, 5-MeO-DET, or DiPT not authorized by, or in violation of, the CSA
or its implementing regulations would be unlawful, and could subject
the person to administrative, civil, and/or criminal sanctions.
Regulatory Analyses
Executive Orders 12866 and 13563 (Regulatory Planning and Review;
Improving Regulation and Regulatory Review)
In accordance with 21 U.S.C. 811(a), this proposed scheduling
action is subject to formal rulemaking procedures performed ``on the
record after opportunity for a hearing,'' which are conducted pursuant
to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth
procedures and criteria for scheduling a drug or other substance. Such
actions are exempt from review by the Office of Management and Budget
pursuant to section 3(d)(1) of Executive Order (E.O.) 12866 and the
principles reaffirmed in E.O. 13563.
Executive Order 12988, Civil Justice Reform
This proposed regulation meets the applicable standards set forth
in sections 3(a) and 3(b)(2) of E.O. 12988, to eliminate drafting
errors and ambiguity, minimize litigation, provide a clear legal
standard for affected conduct, and promote simplification and burden
reduction.
Executive Order 13132, Federalism
This proposed rulemaking does not have federalism implications
warranting the application of E.O. 13132. The proposed rule does not
have substantial direct effects on the States, on the relationship
between the National Government and the States, or the distribution of
power and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This proposed rule does not have tribal implications warranting the
application of E.O. 13175. It does not have substantial direct effects
on one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.
Paperwork Reduction Act of 1995
This proposed action does not impose a new collection of
information requirement under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3521).
Regulatory Flexibility Act
The Administrator, in accordance with the Regulatory Flexibility
Act (5 U.S.C. 601-612), has reviewed this proposed rule, and by
approving it, certifies that it will not have a significant economic
impact on a substantial number of small entities.
DEA proposes placing the substances 4-hydroxy-N,N-
diisopropyltryptamine (4-OH-DiPT), 5-methoxy-alpha-methyltryptamine (5-
MeO-AMT), 5-methoxy-N-methyl-N-isopropyltryptamine (5-MeO-MiPT), 5-
methoxy-N,N-diethyltryptamine (5-MeO-DET), and N,N-
diisopropyltryptamine (DiPT), including their salts, isomers, and salts
of isomers whenever the existence of such salts, isomers, and salts of
isomers is possible within the specific chemical designation, in
schedule I of the CSA. If finalized, this action would impose
regulatory controls and administrative, civil, and/or criminal
sanctions applicable to schedule I controlled substances on persons who
handle (manufacture, distribute, reverse distribute, import, export,
engage in research, conduct instructional activities, or chemical
analysis with, or possess), or propose to handle 4-OH-DiPT, 5-MeO-AMT,
5-MeO-MiPT, 5-MeO-DET, or DiPT.
[[Page 2383]]
There appear to be no legitimate sources for 4-OH-DiPT, 5-MeO-AMT,
5-MeO-MiPT, 5-MeO-DET, and DiPT as marketed drugs and no accepted
medical use in the United States, but DEA notes that these substances
are available for purchase from legitimate suppliers for scientific
research. There is no evidence of significant diversion of 4-OH-DiPT,
5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT from legitimate suppliers.
DEA has identified 31 domestic suppliers of one or more of the
following substances: 4-hydroxy-N,N-diisopropyltryptamine (4-OH-DiPT),
5-methoxy-alpha-methyltryptamine (5-MeO-AMT), 5-methoxy-N-methyl-N-
isopropyltryptamine (5-MeO-MiPT), 5-methoxy-N,N-diethyltryptamine (5-
MeO-DET), and N,N-diisopropyltryptamine (DiPT). Thirty (30) of the 31
domestic suppliers are not registered with DEA to handle controlled
substances. The one registered supplier is already registered with DEA
and has all security and other handling processes in place, resulting
in minimal impact to this supplier. Therefore, the remaining 30 non-
registered domestic suppliers are affected. Since the vast majority of
DEA registrants are small entities or are employed by small entities,
all 30 affected suppliers are assumed to be small entities. It is
impossible to know how much 4-hydroxy-N,N-diisopropyltryptamine (4-OH-
DiPT), 5-methoxy-alpha-methyltryptamine (5-MeO-AMT), 5-methoxy-N-
methyl-N-isopropyltryptamine (5-MeO-MiPT), 5-methoxy-N,N-
diethyltryptamine (5-MeO-DET), and N,N-diisopropyltryptamine (DiPT) are
distributed by these suppliers. It is common for suppliers to have
items on their catalog while not actually having any material level of
sales. Based on the discussion above, DEA believes any quantity of
sales from these distributors for legitimate purposes is minimal.
Therefore, these suppliers are expected to remove the product from
their catalog rather than incur the cost of obtaining a DEA
registration and physical security for products with minimal sales.
Therefore, DEA estimates the cost of this rule, in form of lost sales,
if any, on the affected small entities is minimal. DEA welcomes any
public comment regarding this estimate.
Because of these facts, this proposed rule will not, if
promulgated, result in a significant economic impact on a substantial
number of small entities.
Unfunded Mandates Reform Act of 1995
On the basis of information contained in the ``Regulatory
Flexibility Act'' section above, DEA has determined pursuant to the
Unfunded Mandates Reform Act (UMRA) of 1995 (2 U.S.C. 1501 et seq.)
that this proposed action would not result in any Federal mandate that
may result ``in the expenditure by State, local, and tribal
governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any 1 year .
. . .'' Therefore, neither a Small Government Agency Plan nor any other
action is required under UMRA of 1995.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
For the reasons set out above, DEA proposes to amend 21 CFR part
1308 as follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for 21 CFR part 1308 continues to read as
follows:
Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise
noted.
0
2. In Sec. 1308.11, as proposed to be amended at 86 FR 16553 (March
30, 2021), 86 FR 37719 (July 16, 2021), and 86 FR 69187 (December 7,
2021), add paragraphs (d)(101) through (105) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
(101) 4-hydroxy-N,N-diisopropyltryptamine (other names: 4-OH-DiPT;
3-(2-(diisopropylamino)ethyl)-1H-indol-4-ol) 7516.
(102) 5-methoxy-alpha-methyltryptamine (Other names: 5-MeO-AMT; 1-
(5-methoxy-1H-indol-3-yl)propan-2-amine) 7506.
(103) 5-methoxy-N-methyl-N-isopropyltryptamine (Other names: 5-MeO-
MiPT; N-(2-(5-methoxy-1H-indol-3-yl)ethyl)-N-methylpropan-2-amine)
7512.
(104) 5-methoxy-N,N-diethyltryptamine (Other names: 5-MeO-DET; N,N-
diethyl-2-(5-methoxy-1H-indol-3-yl)ethanamine) 7525.
(105) N,N-diisopropyltryptamine (Other names: DiPT; N-(2-(1H-indol-
3-yl)ethyl)-N-isopropylpropan-2-amine) 7522.
* * * * *
Anne Milgram,
Administrator.
[FR Doc. 2022-00713 Filed 1-13-22; 8:45 am]
BILLING CODE 4410-09-P
