86278 Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Proposed Rules 

main deck except with regard to special 

condition (j) for smoke detection. 

(r) When a crew rest compartment is 

installed or enclosed as a removable 

module in part of a cargo compartment 

or is located directly adjacent to a cargo 

compartment without an intervening 

cargo compartment wall, the following 

applies: 

(1) Any wall of the module (container) 

forming part of the boundary of the 

reduced cargo compartment, subject to 

direct flame impingement from a fire in 

the cargo compartment and including 

any interface item between the module 

(container), and the airplane structure or 

systems, must meet the applicable 

requirements of § 25.855 at Amendment 

25–60. 

(2) Means must be provided so that 

the fire protection level of the cargo 

compartment meets the applicable 

requirements of §§ 25.855 at amendment 

25–60, 25.857 at amendment 25–60 and 

25.858 at amendment 25–54 when the 

module (container) is not installed. 

(3) Use of each emergency evacuation 

route must not require occupants of the 

crew rest compartment to enter the 

cargo compartment in order to return to 

the passenger compartment. 

(4) The aural warning in special 

condition (g) must sound in the crew 

rest compartment in the event of a fire 

in the cargo compartment. 

(s) Means must be provided to prevent 

access into the Class C cargo 

compartment during all airplane 

operations and to ensure that the 

maintenance door is closed during all 

airplane flight operations. 

(t) All enclosed stowage 

compartments within the crew rest that 

are not limited to stowage of emergency 

equipment or airplane-supplied 

equipment (e.g., bedding) must meet the 

design criteria given in the table below. 

As indicated by the table below, this 

special condition does not address 

enclosed stowage compartments greater 

than 200 ft3 in interior volume. The inflight accessibility of very large, 

enclosed stowage compartments and the 

subsequent impact on the 

crewmember’s ability to effectively 

reach any part of the compartment with 

the contents of a hand fire extinguisher 

will require additional fire protection 

considerations similar to those required 

for inaccessible compartments such as 

Class C cargo compartments. 

STOWAGE COMPARTMENT INTERIOR VOLUMES

Fire protection features Less than 25 ft3 25 ft3 to 57 ft3 57 ft3 to 200 ft3

Materials of Construction 1 ................................................................. Yes .............................. Yes .............................. Yes. 

Detectors 2 .......................................................................................... No ................................ Yes .............................. Yes. 

Liner 3 .................................................................................................. No ................................ No ................................ Yes. 

Locating Device 4 ................................................................................ No ................................ Yes .............................. Yes. 

1 Materials of Construction: The material used to construct each enclosed stowage compartment must at least be fire resistant and must meet 

the flammability standards established for interior components per the requirements of § 25.853. For compartments less than 25 ft3 in interior volume, the design must ensure the ability to contain a fire likely to occur within the compartment under normal use. 2 Detectors: Enclosed stowage compartments equal to or exceeding 25 ft3 in interior volume must be provided with a smoke or fire detection 

system to ensure that a fire can be detected within a one-minute detection time. Flight tests must be conducted to show compliance with this requirement. Each system (or systems) must provide: 

(a) A visual indication in the flight deck within one minute after the start of a fire; 

(b) An aural warning in the crew rest compartment; and 

(c) A warning in the main passenger cabin. This warning must be readily detectable by a flight attendant, taking into consideration the positioning of flight attendants throughout the main passenger compartment during various phases of flight. 3 Liner: If it can be shown that the material used to construct the stowage compartment meets the flammability requirements of a liner for a 

Class B cargo compartment, then no liner would be required for enclosed stowage compartments equal to or greater than 25 ft3 in interior volume but less than 57 ft3 in interior volume. For all enclosed stowage compartments equal to or greater than 57 ft3 in interior volume but less than 

or equal to 200 ft3, a liner must be provided that meets the requirements of § 25.855 at Amendment 25–60 for a class B cargo compartment. 4 Location Detector: Crew rest areas which contain enclosed stowage compartments exceeding 25 ft3 interior volume and which are located 

away from one central location such as the entry to the crew rest area or a common area within the crew rest area would require additional fire 

protection features and/or devices to assist the firefighter in determining the location of a fire. 

Issued in in Kansas City, Missouri, on 

December 8, 2023. 

Patrick R. Mullen, 

Manager, Technical Policy Branch, Policy and 

Standards Division, Aircraft Certification 

Service. 

[FR Doc. 2023–27396 Filed 12–12–23; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA1156] 

Schedules of Controlled Substances: 

Placement of 2,5-dimethoxy-4- 

iodoamphetamine (DOI) and 2,5- 

dimethoxy-4-chloroamphetamine 

(DOC) in Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Drug Enforcement 

Administration proposes placing two 

phenethylamine hallucinogens, as 

identified in this proposed rule, in 

schedule I of the Controlled Substances 

Act. This action is being taken, in part, 

to enable the United States to meet its 

obligations under the 1971 Convention 

on Psychotropic Substances for one of 

these substances 2,5-dimethoxy-4- 

chloroamphetamine. 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 two specific controlled 

substances. 

DATES: Comments must be submitted 

electronically or postmarked on or 

before January 12, 2024. 

Interested persons may file a request 

for a hearing or waiver of hearing 

pursuant to 21 CFR 1308.44 and in 

accordance with 21 CFR 1316.47 and/or 

1316.49, as applicable. Requests for a 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Proposed Rules 86279 

hearing, and waivers of an opportunity 

for a hearing or to participate in a 

hearing, must be received or postmarked 

on or before January 12, 2024. 

To be considered by DEA as part of 

this rulemaking, comments and requests 

for a hearing must be submitted in 

response to this proposed rule within 

the timeframe specified above, 

regardless of whether the person 

previously submitted a comment or 

hearing request in response to the notice 

of proposed rulemaking that DEA 

published in the Federal Register on 

April 11, 2022 (87 FR 21069), and 

subsequently withdrew on August 29, 

2022 (87 FR 52712), under docket 

number DEA824. 

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. DEA1156’’ 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, your 

comment has been successfully 

submitted 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 filed 

with the DEA Administrator, who will 

make the determination of whether a 

hearing will be needed to address such 

matters of fact and law in the 

rulemaking. Such requests must be sent 

to: Drug Enforcement Administration, 

Attn: Administrator, 8701 Morrissette 

Drive, Springfield, Virginia 22152. For 

informational purposes, a courtesy copy 

of 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 Federal Register 

Representative/DPW, 8701 Morrissette 

Drive, Springfield, Virginia 22152. 

FOR FURTHER INFORMATION CONTACT: 

Terrence L. Boos, Drug and 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 two 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: 

• 2,5-dimethoxy-4-iodoamphetamine 

(DOI) and 

• 2,5-dimethoxy-4- 

chloroamphetamine (DOC). 

This proposed rule supersedes the 

April 11, 2022 notice of proposed 

rulemaking (NPRM) that DEA published 

in the Federal Register (87 FR 21069), 

to place DOI and DOC in schedule I of 

the CSA, which DEA withdrew on 

August 29, 2022 (87 FR 52712) in order 

to provide additional clarity on the 

process for submitting hearing requests. 

The scientific, medical, and other bases 

for the proposed placement of DOI and 

DOC in schedule I remain the same in 

this proposed rule as they were 

described in the April 2022 proposed 

rule, except for minor updates to certain 

data. 

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 it to be made 

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 form 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 (APA), 5 

U.S.C. 551–559. 21 CFR 1308.41– 

1308.45; 21 CFR part 1316, subpart D. 

Interested persons may file requests for 

a hearing in conformity with the 

requirements of 21 CFR 1308.44(a) and 

1316.47(a), and such requests must: 

(1) state with particularity the interest 

of the person in the proceeding; 

(2) state with particularity the 

objections or issues concerning which 

the person desires to be heard; and 

(3) state briefly the position of the 

person with regarding to the objections 

or issues. 


khammond on DSKJM1Z7X2PROD with PROPOSALS
86280 Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Proposed Rules 

1As discussed in a memorandum of 

understanding entered into by the Food and Drug 

Administration (FDA) and the National Institute on 

Drug Abuse (NIDA), FDA acts as the lead agency 

within HHS in carrying out the Secretary’s 

scheduling responsibilities under the CSA, with the 

concurrence of NIDA. 50 FR 9518 (March 8, 1985). 

The Secretary has delegated to the Assistant 

Secretary for Health of HHS the authority to make 

domestic drug scheduling recommendations. 58 FR 

35460 (July 1, 1993). 

2 21 U.S.C. 811(d)(3). 

Any interested person may file a 

waiver of an opportunity for a hearing 

or to participate in a hearing in 

conformity with the requirements of 21 

CFR 1308.44(c), together with a written 

statement of position on the matters of 

fact and law involved in any hearing. 21 

CFR 1316.49. 

All requests for a 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. The 

decision whether a hearing will be 

needed to address such matters of fact 

and law in the rulemaking will be made 

by the Administrator. If a hearing is 

needed, DEA will publish a notice of 

hearing on the proposed rulemaking in 

the Federal Register. 21 CFR 1308.44(b), 

1316.53. Further, once the 

Administrator determines a hearing is 

needed to address such matters of fact 

and law in rulemaking, she will then 

designate an Administrative Law Judge 

(ALJ) to preside over the hearing. The 

ALJ’s functions shall commence upon 

designation, as provided in 21 CFR 

1316.52. 

In accordance with 21 U.S.C. 811 and 

812, the purpose of a hearing would be 

to determine whether DOI and/or DOC 

meet the statutory criteria for placement 

in schedule I, as proposed in this rule. 

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 is 

supported by a recommendation from 

the then-Assistant Secretary for Health 

of the Department of Health and Human 

Services (HHS). 

In addition, regarding the placement 

of DOC in the Controlled Substances 

Act (CSA), the United States is a party 

to the 1971 United Nations Convention 

on Psychotropic Substances (1971 

Convention), February 21, 1971, 32 

U.S.T. 543, 1019 U.N.T.S. 175, as 

amended. Procedures respecting 

changes in drug schedules under the 

1971 Convention are governed 

domestically by 21 U.S.C. 811(d)(2)–(4). 

When the United States receives 

notification of a scheduling decision 

pursuant to Article 2 of the 1971 

Convention indicating that a drug or 

other substance has been added to a 

schedule specified in the notification, 

the Secretary of HHS (Secretary),1 after 

consultation with the Attorney General, 

shall first determine whether existing 

legal controls under subchapter I of the 

CSA and the Federal Food, Drug, and 

Cosmetic Act meet the requirements of 

the schedule specified in the 

notification with respect to the specific 

drug or substance.2 In the event that the 

Secretary did not consult with the 

Attorney General, and the Attorney 

General did not issue a temporary order, 

as provided under 21 U.S.C. 811(d)(4), 

the procedures for permanent 

scheduling set forth in 21 U.S.C. 811(a) 

and (b) control. Pursuant to 21 U.S.C. 

811(a)(1) and (2), the Attorney General 

(as delegated to the Administrator of 

DEA), by rule, and upon the 

recommendation of the Secretary, may 

add to such a schedule or transfer 

between such schedules any drug or 

other substance, if he finds that such 

drug or other substance has a potential 

for abuse, and makes with respect to 

such drug or other substance the 

findings prescribed by 21 U.S.C. 812(b) 

for the schedule in which such drug or 

other substance is to be placed. 

Background 

DOI and DOC belong to the 

phenethylamine class of drugs with 

hallucinogenic properties, similar to 

2,5-dimethoxy-4-methamphetamine 

(DOM), a schedule I hallucinogen. DOI 

and DOC have no approved medical use 

in the United States. 

On September 26, 2018, DEA, in 

accordance with the provisions of 21 

U.S.C. 811(b), requested HHS provide a 

scientific and medical evaluation as 

well as a scheduling recommendation 

for DOI and DOC. Additionally, on May 

7, 2020, the Secretary-General of the 

United Nations advised the Secretary of 

State of the United States that the 

Commission on Narcotic Drugs (CND), 

during its 63rd Session in March 2020, 

voted to place DOC in Schedule I of the 

1971 Convention (CND Dec/63/4). As a 

signatory to this international treaty, the 

United States is required, by scheduling 

under the CSA, to place appropriate 

controls on DOC to meet the minimum 

requirements of the treaty. 

Article 2, paragraph 7(a), of the 1971 

Convention sets forth the minimum 

requirements that the United States 

must meet when a substance has been 

added to Schedule I of the 1971 

Convention. The United States must 

adhere to specific export and import 

provisions that are provided in the 1971 

Convention. This requirement is 

accomplished by the CSA with the 

export and import provisions 

established in 21 U.S.C. 952, 953, 957, 

and 958, and in accordance with 21 CFR 

part 1312. Under Article 16, paragraph 

4, of the 1971 Convention, the United 

States is required to provide annual 

statistical reports to the International 

Narcotics Control Board (INCB). Using 

INCB Form P, the United States shall 

provide the following information: (1) In 

regard to each substance in Schedule I 

and II of the 1971 Convention, 

quantities manufactured, exported to 

and imported from each country or 

region as well as stocks held by 

manufacturers; (2) in regard to each 

substance in Schedule III and IV of the 

1971 Convention, quantities 

manufactured, as well as quantities 

exported and imported; (3) in regard to 

each substance in Schedule II and III of 

the 1971 Convention, quantities used in 

the manufacture of exempt preparations; 

and (4) in regard to each substance in 

Schedule II–IV of the 1971 Convention, 

quantities used for the manufacture of 

non-psychotropic substances or 

products. Lastly, under Article 2, 

paragraph 7(a)(vi) of the 1971 

Convention, the United States must 

adopt measures in accordance with 

Article 22 to address violations of any 

statutes or regulations that are adopted 

pursuant to its obligations under the 

1971 Convention. The United States 

complies with this provision as persons 

acting outside the legal framework 

established by the CSA are subject to 

administrative, civil, and/or criminal 

action. 

Proposed Determination To Schedule 

DOI and DOC 

Pursuant to 21 U.S.C. 811(b), DEA 

gathered the necessary data on DOI and 

DOC and on September 26, 2018, 

submitted it to the then-Assistant 

Secretary for Health of HHS with a 

request for a scientific and medical 

evaluation of available information and 

a scheduling recommendation for DOI 

and DOC. On September 28, 2020, HHS 

provided to DEA a scientific and 

medical evaluation entitled ‘‘Basis for 

the Recommendation to Control 2,5- 

dimethoxy-4-iodoamphetamine (DOI) 

and 2,5-dimethoxy-4- 

chloroamphetamine (DOC) and their 

Salts in Schedule I of the Controlled 

Substances Act (CSA)’’ and a scheduling 

recommendation. Following 

consideration of the eight factors and 

findings related to these substances’ 

abuse potential, legitimate medical use, 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Proposed Rules 86281 

3Comprehensive 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. 

and dependence liability, HHS 

recommended that DOI and DOC and 

their 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). 

After a review of the available data, 

including the scientific and medical 

evaluation and scheduling 

recommendation provided by HHS, the 

Administrator published an NPRM in 

the Federal Register on April 11, 2022 

(87 FR 21069), to place DOI and DOC in 

schedule I of the CSA. DEA withdrew 

that proposed rule on August 29, 2022 

(87 FR 52712). This proposed rule 

supersedes the April 2022 proposed 

rule, to provide additional clarity on the 

process for submitting hearing requests. 

The bases for the proposed placement of 

DOI and DOC in schedule I remain the 

same in this proposed rule as they were 

described in the April 2022 proposed 

rule. 

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 

the April 2022 proposed rule and 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 ‘‘DEA1156.’’ 

1. The Drug’s Actual or Relative 

Potential for Abuse 

In addition to considering the 

information HHS provided in its 

scientific and medical evaluation 

document for DOI and DOC, DEA also 

considered all other relevant data 

regarding actual or relative potential for 

abuse of DOI and DOC. 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: 3

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 DOI and DOC. These data as 

presented below demonstrate that DOI 

and DOC 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. 

Data show that DOI and DOC have 

been encountered by law enforcement 

in the United States (see Factor 5), 

indicating DOI and DOC availability for 

abuse. According to HHS, individuals 

are using DOI and DOC for their 

hallucinogenic effects and taking them 

in amounts sufficient to create a hazard 

to their health. 

b. There is significant diversion of the 

drug or substance from legitimate drug 

channels. 

HHS states that DOI and DOC are not 

Food and Drug Administration (FDA)- 

approved drugs for treatment in the 

United States and is unaware of any 

country in which their use is legal. DOI 

and DOC are available for purchase from 

legitimate chemical synthesis 

companies because they are used in 

scientific research. There is no evidence 

of diversion from these companies. 

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. 

DOI and DOC are not found in FDAapproved drug products and 

practitioners may neither legally 

prescribe nor dispense these substances. 

Therefore, individuals are taking DOI 

and DOC on their own initiative, rather 

than based on medical advice from 

practitioners licensed by law to 

administer drugs. This is consistent 

with the data from law enforcement 

seizures and case reports indicating that 

individuals are taking DOI and DOC on 

their own initiative rather than on the 

medical advice of licensed practitioners. 

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. 

Chemically, DOI and DOC are analogs 

of the schedule I hallucinogen DOM. 

The effects and pharmacological action 

of DOI and DOC are similar to those of 

other schedule I hallucinogens, such as 

DOM and lysergic acid diethylamide 

(LSD), which have no accepted medical 

use and a high abuse potential. 

In drug discrimination studies (an in 

vivo test to assess drug abuse liability of 

test drugs in comparison to known 

drugs of abuse), DOI and DOC produce 

full substitution for the discriminative 

stimulus effects of DOM, LSD, and N,Ndimethyltryptamine (DMT, schedule I). 

In humans, anecdotal reports suggest 

that DOI and DOC produce classic 

hallucinogenic effects that are similar to 

DOM, including visual and auditory 

hallucinations, fatigue, headache, 

gastrointestinal distress, insomnia and 

anxiety. HHS notes that use of DOC in 

combination with other drugs is 

associated with emergency department 

admissions and one death. 

Due to the psychological and 

cognitive disturbances associated with 

DOI and DOC, as with other schedule I 

hallucinogens, it is reasonable to 

assume that DOI and DOC have 

substantial capability to be a hazard to 

the health of the user and to the safety 

of the community. 

2. Scientific Evidence of the Drug’s 

Pharmacological Effects, If Known 

In vitro testing shows that DOI and 

DOC bind to and act as agonists at 

serotonin (5–HT) 2A (5–HT2A) receptors. 

In rats, DOI administration induced an 

increase in wet dog shakes and back 

muscle contractions. These effects were 

attributed to 5–HT2A receptor activation, 

since pretreatment with a 5–HT2A

receptor inverse agonist blocked the 

effect. Agonism of the 5–HT2A receptor 

is the primary mechanism of action of 

typical hallucinogenic responses, 

suggesting that DOI and DOC have 

hallucinogenic effects. Additionally, 

animal testing data in rats show that 

DOI and DOC fully substitute for DOM, 

LSD, and DMT discriminative stimulus 

effects in drug discrimination tests. 


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86282 Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Proposed Rules 

4World Health Organization (WHO). 2019a. 

Critical Review Report: DOC (4-Chloro-2,5- 

dimethoxyamfetamine) Expert Committee on Drug 

Dependence, Forty-second Meeting. Geneva. 

5NFLIS-Drug is a national forensic laboratory 

reporting system that systematically collects results 

from drug chemistry analyses conducted by state 

and local forensic laboratories in the United States. 

NFLIS-Drug data were queried on October 27, 2023. 

In humans, HHS reported that 

anecdotal reports of hallucinogenic 

experiences with DOI and DOC are 

available on online drug forums such as 

www.erowid.org, in which recreational 

drug users report on their experiences 

with all classes of substances. In these 

reports, DOI and DOC are reported to 

induce hallucinogenic effects, including 

prominent visual effects. 

Additionally, a World Health 

Organization (WHO) critical review of 

DOC4 mentions its hallucinogenic 

effects reported by those that selfexperimented with DOC and notes the 

duration of action may last 12 to 24 

hours. WHO notes that the long 

duration of effects is shared by other 

structurally related schedule I 

hallucinogens including DOI, 2,5- 

dimethoxy-4-bromoamphetamine 

(DOB), and DOM. DOI and DOC are 

commonly administered orally and/or 

sublingually when encountered in the 

form of blotters. 

3. The State of Current Scientific 

Knowledge Regarding the Drug or Other 

Substance 

DOI and DOC are centrally-acting 

hallucinogens and part of the 

phenethylamine hallucinogen family 

and share structural similarities with 

schedule I phenethylamine 

hallucinogens such as DOM. DOI (CAS 

42203–78–1) has a molecular formula of 

C11H16INO2 and a molecular weight of 

321.16 g/mol. The hydrochloride salt of 

DOI has a melting point of 201 °C. DOC 

(CAS 123431–31–2) has a molecular 

formula of C11H16ClNO2 and a molecular 

weight of 229.70 g/mol. The 

hydrochloride salt of DOC has a melting 

point of 193–194.5 °C. DOI and DOC are 

white, odorless, and crystalline solids. 

4. Its History and Current Pattern of 

Abuse 

The history and current pattern of 

abuse of DOI and DOC are described in 

law enforcement reports and anecdotal 

reports by drug abusers. In the United 

States, law enforcement entities initially 

encountered DOI and DOC in 2005, 

according to the National Forensic 

Laboratory Information System (NFLIS)- 

Drug 5 database. See Factor 5 for 

additional information. DOI and DOC 

are encountered in various forms (e.g., 

powder, tablets, capsules, liquid, or on 

blotter paper). 

Anecdotal reports on the internet 

indicate that individuals are using 

substances they identified as DOI and 

DOC for their hallucinogenic effects. 

Importantly, it is impossible to know if 

the street drugs sold to an individual as 

DOI or DOC are actually the substances 

they are marketed as in the absence of 

chemical analysis or evaluation of 

biological fluids following ingestion. 

However, in animal drug discrimination 

studies, DOI and DOC produced effects 

that are similar to the effects elicited by 

schedule I hallucinogens such as DOM, 

LSD, and DMT. 

Regarding DOC, a July 2019 report 

from the European Monitoring Centre 

for Drugs and Drug Addiction included 

data from their toxicology portal, and 

indicated that 16 non-fatal intoxications 

associated with DOC had been reported 

internationally between 2008 and 2017. 

In 2019, the United Nations Office on 

Drugs and Crime reported three deaths 

associated with DOC (one each in 2015 

and 2018; information about the third is 

unknown). 

5. The Scope, Duration, and 

Significance of Abuse 

Data from NFLIS-Drug indicate that 

DOI and DOC were found in samples 

starting in 2005, in the United States. 

Specifically, there were 40 NFLIS-Drug 

reports for DOI from 2005 through 

December 2022, and 790 NFLIS-Drug 

reports for DOC during the same period. 

DOI has been encountered in 15 states, 

whereas DOC has been encountered in 

39 states. In response to abuse and 

safety concerns, DOI has been 

controlled in Florida. 

Abuse of DOI and DOC has been 

characterized as causing acute public 

health and safety issues worldwide. In 

particular, WHO reports that DOC has 

been available in Europe since 2001. 

Based on available abuse data, public 

health risk, and drug trafficking data, 

the WHO recommended to the United 

Nations (UN) that DOC be controlled 

internationally. In March 2020, the UN 

Commission on Narcotic Drugs voted to 

place DOC into Schedule I of the 1971 

Convention. 

6. What, if Any, Risk There Is to the 

Public Health 

DOI and DOC share similar 

mechanisms of action with and produce 

similar physiological and subjective 

effects (see Factor 2 for more 

information) as other schedule I 

hallucinogens, such as DOM, DMT, and 

LSD. Thus, DOI and DOC pose the same 

risks to public health as similar 

hallucinogens. Predominantly, the risks 

to public health are borne by users (i.e., 

hallucinogenic effects, sensory 

distortion, impaired judgment, strange 

or dangerous behaviors), but they can 

affect the general public, as with driving 

under the influence. To date, there are 

no reports of distressing responses or 

death associated with DOI in medical 

literature. There have been three 

published reports, in 2008, 2014, and 

2015, of adverse events associated with 

DOC including, but not limited to, 

seizures, agitation, tachycardia, 

hypertension, and death of one 

individual. Since DOI is structurally 

similar to DOC and produces similar 

effects to DOC, it is likely to produce 

serious adverse effects similar to DOC. 

Thus, serious adverse events that may 

include death represent a risk to the 

individual drug users and to public 

health. 

7. Its Psychic or Physiological 

Dependence Liability 

According to HHS, the physiological 

dependence liability of DOI and DOC in 

animals and humans is not reported in 

scientific and medical literature. Thus, 

it is not possible to determine whether 

DOI and DOC produce physiological 

dependence following acute or chronic 

administration. 

According to HHS, DOI, DOC, and 

other related phenethylamine 

hallucinogens (such as the schedule I 

substance DOM) are highly abusable 

substances. Drug discrimination studies 

in animals indicate that DOI and DOC 

fully substitute to the discriminative 

stimulus effects of schedule I 

hallucinogens DOM, LSD, and DMT. 

HHS notes that hallucinogens are not 

usually associated with physical 

dependence, likely due to the rapid 

development of tolerance precluding 

daily administration. Hallucinogen 

abusers may develop psychological 

dependence as evidenced by the 

continued use of these substances 

despite knowledge of their potential 

toxic and adverse effects. 

8. Whether the Substance Is an 

Immediate Precursor of a Substance 

Already Controlled Under the CSA 

DOI and DOC are not immediate 

precursors of any controlled substance 

of the CSA as defined by 21 U.S.C. 

802(23). 

Conclusion 

Based on consideration of the 

scientific and medical evaluation and 

accompanying recommendation of HHS, 

and on DEA’s own eight-factor analysis, 

DEA finds that these facts and all 

relevant data constitute substantial 

evidence of potential for abuse of DOI 


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Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Proposed Rules 86283 

6Although there is no evidence suggesting that 

DOI and DOC 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). 

and DOC. As such, DEA proposes to 

schedule DOI and DOC 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, per 21 U.S.C. 

812(b). After consideration of the 

analysis and recommendation of the 

then-Assistant Secretary for Health of 

HHS to place DOI and DOC in schedule 

I and review of all other available data, 

the Administrator of DEA, pursuant to 

21 U.S.C. 812(b)(1), finds that: 

(1) DOI and DOC have a high 

potential for abuse that is comparable to 

other schedule I substances, such as the 

phenethylamine hallucinogen DOM; 

(2) DOI and DOC have no currently 

accepted medical use in treatment in the 

United States. FDA has not approved a 

marketing application for a drug 

product containing DOI or DOC for any 

therapeutic indication, and DEA and 

HHS know of no clinical studies or 

petitioners claiming an accepted 

medical use in the United States.6

(3) There is a lack of accepted safety 

for use of DOI and DOC under medical 

supervision. The use of DOC is 

associated with serious adverse 

consequences including deaths. Since 

DOI is structurally similar to DOC and 

produces effects similar to DOC, it is 

likely that DOI may produce serious 

adverse events similar to DOC. Because 

DOI and DOC have no approved 

medical use and have not been 

investigated as new drugs, their safety 

for use under medical supervision has 

not been determined. 

Based on these findings, the 

Administrator of DEA concludes that 

DOI and DOC 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 DOI and DOC, 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 DOI and 

DOC 

If this rule is finalized as proposed, 

DOI and DOC would be subject to the 

CSA’s schedule I regulatory controls 

and administrative, civil, and criminal 

sanctions applicable to the manufacture, 

distributing, dispensing, importing, 

exporting, research, and conduct of 

instructional activities, including the 

following: 

1. Registration. Any person who 

handles (manufactures, distributes, 

dispenses, imports, exports, engages in 

research, or conducts instructional 

activities or chemical analysis with, or 

possesses) would need 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. 

2. Security. DOI and DOC would be 

subject to schedule I security 

requirements and would need to be 

handled and stored pursuant to 21 

U.S.C. 821, 823, and in accordance with 

21 CFR 1301.71–1301.76. Nonpractitioners handling DOI and DOC 

also would need to comply with the 

screening requirements of 21 CFR 

1301.90–1301.93. 

3. Labeling and Packaging. All labels 

and packaging for commercial 

containers of DOI and DOC would need 

to comply with 21 U.S.C. 825, and be in 

accordance with 21 CFR part 1302. 

4. Quota. Only registered 

manufacturers would be permitted to 

manufacture DOI and DOC in 

accordance with quota assigned 

pursuant to 21 U.S.C. 826 and in 

accordance with 21 CFR part 1303. 

5. Inventory. Every DEA registrant 

who possesses any quantity of DOI and 

DOC would need to have an initial 

inventory of all stocks of controlled 

substances (including DOI and DOC) 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. 

After the initial inventory, every DEA 

registrant would need to take inventory 

of all controlled substances (including 

DOI and DOC) 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. 

6. Records and Reports. Every DEA 

registrant would need to maintain 

records and submit reports for DOI and 

DOC, pursuant to 21 U.S.C. 827 and 

832(a), and in accordance with 21 CFR 

1301.74(b) and (c) and parts 1304, 1312, 

and 1317 

7. Order Forms. Every DEA registrant 

who distributes DOI and DOC would 

need to comply with the order form 

requirements, pursuant to 21 U.S.C. 828 

and 21 CFR part 1305. 

8. Importation and Exportation. All 

importation and exportation of DOI and 

DOC would need to be in compliance 

with 21 U.S.C. 952, 953, 957, and 958, 

and in accordance with 21 CFR part 

1312. 

9. Liability. Any activity involving 

DOI and DOC not authorized by, or in 

violation of, the CSA or its 

implementing regulations would be 

unlawful, and may subject the person to 

administrative, civil, and/or criminal 

sanctions. 

Regulatory Analyses 

Executive Orders 12866 and 13563, 

Regulatory Planning and Review, and 

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 the 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 on the 

distribution of power and 

responsibilities among the various 

levels of government. 


khammond on DSKJM1Z7X2PROD with PROPOSALS
86284 Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Proposed Rules 

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 

This proposed action does not impose 

a new collection of information 

requirement under the Paperwork 

Reduction Act, 44 U.S.C. 3501–3521. 

Regulatory Flexibility Act 

The Administrator of DEA, 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 

DOI and DOC (chemical names: 2,5- 

dimethoxy-4-iodoamphetamine [DOI] 

and 2,5-dimethoxy-4- 

chloroamphetamine [DOC]), 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. 

This action is being taken, in part, to 

enable the United States to meet its 

obligations under the 1971 Convention 

for DOC. 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 DOI and 

DOC. 

According to HHS, and also by DEA’s 

findings in this proposed rule, DOI and 

DOC have a high potential for abuse, 

have no currently accepted medical use 

in treatment in the United States, and 

lack accepted safety for use under 

medical supervision. There appear to be 

no legitimate sources for DOI and DOC 

as marketed drugs 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 

DOI and DOC from legitimate suppliers. 

As such, the proposed rule, if finalized, 

is not expected to 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. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on December 7, 2023, by Administrator 

Anne Milgram. That document with the 

original signature and date is 

maintained by DEA. For administrative 

purposes only, and in compliance with 

requirements of the Office of the Federal 

Register, the undersigned DEA Federal 

Register Liaison Officer has been 

authorized to sign and submit the 

document in electronic format for 

publication, as an official document of 

DEA. This administrative process in no 

way alters the legal effect of this 

document upon publication in the 

Federal Register. 

Scott Brinks, 

Federal Register Liaison Officer, Drug 

Enforcement Administration. 

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, 21 CFR 

part 1308 is proposed to be amended to 

read 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 88 FR 22388 (April 13, 

2023), add paragraphs (d)(104) and 

(d)(105) to read as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(d) * * * 

*******

(104) 2,5-dimethoxy-4-iodoamphetamine (Other name: DOI) ......................................................................................................................... 7447 

(105) 2,5-dimethoxy-4-chloroamphetamine (Other name: DOC) ..................................................................................................................... 7448 

*******

* * * * * 

[FR Doc. 2023–27289 Filed 12–12–23; 8:45 am] 

BILLING CODE 4410–09–P 


khammond on DSKJM1Z7X2PROD with PROPOSALS