2376 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. 

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 

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. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

The Proposed Amendment 

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. 

§ 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 Canadian Area Navigation 

Routes. 

* * * * * 

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), 5- 

methoxy-alpha-methyltryptamine (5- 

MeO-AMT), 5-methoxy-N-methyl-Nisopropyltryptamine (5-MeO-MiPT), 5- 

methoxy-N,N-diethyltryptamine (5- 

MeO-DET), and N,Ndiisopropyltryptamine (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. 


lotter on DSK11XQN23PROD with PROPOSALS1
Federal Register / Vol. 87, No. 10 / Friday, January 14, 2022 / Proposed Rules 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,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). 

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 


lotter on DSK11XQN23PROD with PROPOSALS1
2378 Federal Register / Vol. 87, No. 10 / Friday, January 14, 2022 / Proposed Rules 

1The Secretary of HHS has delegated to the 

Assistant Secretary for Health the authority to make 

domestic drug scheduling recommendations. 

2Comprehensive 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. 

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. 

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 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-OHDiPT, 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-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 

(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, 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

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-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 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-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, 5- 

MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, 

and DiPT from legitimate suppliers. 


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Federal Register / Vol. 87, No. 10 / Friday, January 14, 2022 / Proposed Rules 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-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, 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-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 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-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 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-bromo2,5-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), 


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3NFLIS 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. 

4NFLIS data were queried August 17, 2021, by 

date of submission. 

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, 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-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, 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, Ndemethylation, O-demethylation, and Noxidation 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 

number of tryptamines including 4-OHDiPT, 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-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, 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 


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5Although 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 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). 

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). 

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-MeOMiPT, 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-OHDiPT, 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-MeODET, 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-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, 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-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, 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-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, 5- 

MeO-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, 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-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, 5- 

MeO-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, 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-MeOMiPT, 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-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, 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-alphamethyltryptamine (5-MeO-AMT), 5- 

methoxy-N-methyl-Nisopropyltryptamine (5-MeO-MiPT), 5- 

methoxy-N,N-diethyltryptamine (5- 

MeO-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, 5- 

MeO-DET, or DiPT. 


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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,Ndiisopropyltryptamine (4-OH-DiPT), 5- 

methoxy-alpha-methyltryptamine (5- 

MeO-AMT), 5-methoxy-N-methyl-Nisopropyltryptamine (5-MeO-MiPT), 5- 

methoxy-N,N-diethyltryptamine (5- 

MeO-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), 5- 

methoxy-alpha-methyltryptamine (5- 

MeO-AMT), 5-methoxy-N-methyl-Nisopropyltryptamine (5-MeO-MiPT), 5- 

methoxy-N,N-diethyltryptamine (5- 

MeO-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’’ 

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: 4- 

OH-DiPT; 3-(2- 

(diisopropylamino)ethyl)-1H-indol-4-ol) 

7516. 

(102) 5-methoxy-alphamethyltryptamine (Other names: 5- 

MeO-AMT; 1-(5-methoxy-1H-indol-3- 

yl)propan-2-amine) 7506. 

(103) 5-methoxy-N-methyl-Nisopropyltryptamine (Other names: 5- 

MeO-MiPT; N-(2-(5-methoxy-1H-indol3-yl)ethyl)-N-methylpropan-2-amine) 

7512. 

(104) 5-methoxy-N,Ndiethyltryptamine (Other names: 5- 

MeO-DET; N,N-diethyl-2-(5-methoxy1H-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 

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 

AGENCY: National Indian Gaming 

Commission, Department of the Interior. 

ACTION: Proposed rule; correction. 

SUMMARY: 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: 

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 

AGENCY: National Indian Gaming 

Commission, Department of the Interior. 

ACTION: Proposed rule; correction. 

SUMMARY: 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. 


lotter on DSK11XQN23PROD with PROPOSALS1