This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

61991 

Vol. 78, No. 197 

Thursday, October 10, 2013 

1Because the Secretary of the HHS has delegated 

to the Assistant Secretary for Health of the HHS the 

authority to make domestic drug scheduling 

recommendations, for purposes of this Notice of 

Intent, all subsequent references to ‘‘Secretary’’ 

have been replaced with ‘‘Assistant Secretary.’’ As 

set forth in a memorandum of understanding 

entered into by HHS, 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 Assistant 

Secretary’s scheduling responsibilities under the 

CSA, with the concurrence of NIDA. 50 FR 9518, 

Mar. 8, 1985. 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–382] 

Schedules of Controlled Substances: 

Temporary Placement of Three 

Synthetic Phenethylamines Into 

Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Notice of Intent. 

SUMMARY: The Deputy Administrator of 

the Drug Enforcement Administration 

(DEA) is issuing this notice of intent to 

temporarily schedule three synthetic 

phenethylamines into the Controlled 

Substances Act (CSA) pursuant to the 

temporary scheduling provisions of 21 

U.S.C. 811(h). The substances are 2-(4- 

iodo-2,5-dimethoxyphenyl)-N-(2- 

methoxybenzyl)ethanamine (25INBOMe; 2C-I-NBOMe; 25I; Cimbi-5), 2- 

(4-chloro-2,5-dimethoxyphenyl)-N-(2- 

methoxybenzyl)ethanamine (25CNBOMe; 2C-C-NBOMe; 25C; Cimbi-82), 

and 2-(4-bromo-2,5-dimethoxyphenyl)- 

N-(2-methoxybenzyl)ethanamine (25BNBOMe; 2C-B-NBOMe; 25B; Cimbi-36) 

[hereinafter 25I-NBOMe, 25C-NBOMe, 

and 25B-NBOMe]. This action is based 

on a finding by the Deputy 

Administrator that the placement of 

these synthetic phenethylamines into 

Schedule I of the CSA is necessary to 

avoid an imminent hazard to the public 

safety. Any final order will be published 

in the Federal Register and may not be 

issued prior to November 12, 2013. Any 

final order will impose the 

administrative, civil, and criminal 

sanctions and regulatory controls 

applicable to Schedule I substances 

under the CSA on the manufacture, 

distribution, possession, importation, 

exportation, research, and conduct of 

instructional activities of these synthetic 

phenethylamines. 

FOR FURTHER INFORMATION CONTACT: 

Ruth A. Carter, Chief, Policy Evaluation 

and Analysis Section, Office of 

Diversion Control, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152, Telephone (202) 598–6812. 

SUPPLEMENTARY INFORMATION: 

Background 

Section 201 of the CSA, 21 U.S.C. 811, 

provides the Attorney General with the 

authority to temporarily place a 

substance into Schedule I of the CSA for 

two years without regard to the 

requirements of 21 U.S.C. 811(b) if he 

finds that such action is necessary to 

avoid imminent hazard to the public 

safety. 21 U.S.C. 811(h). In addition, if 

proceedings to control a substance are 

initiated under 21 U.S.C. 811(a)(1), the 

Attorney General may extend the 

temporary scheduling for up to one 

year. 21 U.S.C. 811(h)(2). 

Where the necessary findings are 

made, a substance may be temporarily 

scheduled if it is not listed in any other 

schedule under section 202 of the CSA, 

21 U.S.C. 812, or if there is no 

exemption or approval in effect under 

section 505 of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act), 21 U.S.C. 

355, for the substance. 21 U.S.C. 

811(h)(1). The Attorney General has 

delegated his authority under 21 U.S.C. 

811 to the Administrator of the DEA, 

who in turn has delegated her authority 

to the Deputy Administrator of the DEA. 

28 CFR 0.100, 0.104. 

Section 201(h)(4) of the CSA, 21 

U.S.C. 811(h)(4), requires the Deputy 

Administrator to notify the Secretary of 

the Department of Health and Human 

Services (HHS) of his intention to 

temporarily place a substance into 

Schedule I of the CSA.1 As 25I-NBOMe, 

25C-NBOMe, and 25B-NBOMe are not 

currently listed in any schedule under 

the CSA, the DEA believes that the 

conditions of 21 U.S.C. 811(h)(1) have 

been satisfied. Any comments submitted 

by the Assistant Secretary in response to 

this notification shall be taken into 

consideration before a final order is 

published. 21 U.S.C. 811(h)(4). 

To make a finding that placing a 

substance temporarily into Schedule I of 

the CSA is necessary to avoid an 

imminent hazard to the public safety, 

the Deputy Administrator is required to 

consider three of the eight factors set 

forth in section 201(c) of the CSA, 21 

U.S.C. 811(c): The substance’s history 

and current pattern of abuse; the scope, 

duration and significance of abuse; and 

what, if any, risk there is to the public 

health. 21 U.S.C. 811(c)(4)–(6). 

Consideration of these factors includes 

actual abuse, diversion from legitimate 

channels, and clandestine importation, 

manufacture, or distribution. 21 U.S.C. 

811(h)(3). 

A substance meeting the statutory 

requirements for temporary scheduling 

may only be placed in Schedule I. 21 

U.S.C. 811(h)(1). Substances in 

Schedule I are those that have a high 

potential for abuse, no currently 

accepted medical use in treatment in the 

United States, and a lack of accepted 

safety for use under medical 

supervision. 21 U.S.C. 812(b)(1). 

Available data and information for 25INBOMe, 25C-NBOMe, and 25B-NBOMe 

indicate that these three synthetic 

phenethylamines have a high potential 

for abuse, no currently accepted medical 

use in treatment in the United States, 

and a lack of accepted safety for use 

under medical supervision. 

Synthetic Phenethylamines 

The 2-methoxybenzyl series of 2C 

phenethylamine substances, such as 

25I-NBOMe, 25C-NBOMe, and 25BNBOMe, has been developed over the 

last 10 years for use in mapping and 

investigating the serotonin receptors in 

the mammalian brain. 25I-NBOMe and 

25B-NBOMe were first described by 

legitimate research laboratories in 2003. 

Subsequent studies involving these two 

substances appeared in the scientific 

literature starting in 2006. 25C-NBOMe 

first appeared in the scientific literature 

in 2011. No approved medical use has 

been identified for these synthetic 

phenethylamines, nor have they been 

approved by the FDA for human 

consumption. Synthetic 2C 

phenethylamine substances, of which 

25I-NBOMe, 25C-NBOMe, and 25BNBOMe are representative, are sotermed for the two-carbon ethylene 


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61992 Federal Register / Vol. 78, No. 197 / Thursday, October 10, 2013 / Proposed Rules 

2STRIDE includes data on analyzed samples from 

DEA laboratories. 

3NFLIS is a database that collects scientifically 

verified data on analyzed samples in state and local 

forensic laboratories. 

group between the phenyl ring and the 

amino group of the phenethylamine and 

are substituted with methoxy groups at 

the 2 and 5 positions of the phenyl ring. 

Numerous blotter papers and food items 

have been analyzed, and combinations 

of one or more of 25I-NBOMe, 25CNBOMe, and 25B-NBOMe have been 

identified as adulterants. Bulk 

quantities of these substances have been 

encountered as powders and liquid 

solutions. 

From November 2011 through June 

2013, according to the System to 

Retrieve Information from Drug 

Evidence 2 (STRIDE) data, there are 54 

exhibits involving 27 cases for 25INBOMe; 27 exhibits involving 12 cases 

for 25C-NBOMe; and 3 exhibits 

involving 3 cases for 25B-NBOMe. From 

June 2011 through March 2013, the 

National Forensic Laboratory 

Information System 3 (NFLIS) registered 

689 reports containing these synthetic 

phenethylamines (25I-NBOMe-582 

reports; 25C-NBOMe-94 reports; 25BNBOMe-13 reports) across 33 states. No 

instances involving 25I-NBOMe, 25CNBOMe, or 25B-NBOMe were reported 

in NFLIS prior to June 2011. 

Factor 4. History and Current Pattern of 

Abuse 

One or more 2-methoxybenzyl 

analogues of the 2C compounds 

described here have been available over 

the Internet since 2010. The first 

identified domestic law enforcement 

encounter with 25I-NBOMe occurred in 

June 2011 in Milwaukee, Wisconsin. 

Information from published studies 

and law enforcement reports, 

supplemented with discussions on 

Internet Web sites and personal 

communications, document abuse of 

25I-NBOMe, 25C-NBOMe, and 25BNBOMe by nasal insufflation of 

powders, intravenous injection or nasal 

absorption of liquid solutions, 

sublingual or buccal administration of 

blotter papers, and consumption of food 

items laced with these substances. 

These sources also report that 25INBOMe, 25C-NBOMe, and 25B-NBOMe 

are often purported to be Schedule I 

hallucinogens like lysergic acid 

diethylamide (LSD). Reports document 

that the abuse of these substances can 

cause severe toxic reactions, including 

death. 

According to United States Customs 

and Border Protection data, bulk 

quantities of powdered 25I-NBOMe, 

25C-NBOMe, and 25B-NBOMe have 

been seized from shipments originating 

overseas, particularly from Asia. Given 

the relatively small quantity of these 

substances predicted to produce a 

hallucinogenic effect in humans, single 

seizures of these substances are capable 

of producing hundreds of thousands to 

millions of dosage units. Large seizures 

of these substances prepared on blotter 

papers have also been reported. Abuse 

of 25I-NBOMe, 25C-NBOMe, and 25BNBOMe has been characterized with 

acute public health and safety issues 

domestically and abroad. In response, a 

number of states and foreign 

governments have controlled these 

substances. 

Factor 5. Scope, Duration and 

Significance of Abuse 

According to forensic laboratory 

reports, the first law enforcement 

encounter with 25I-NBOMe in the 

United States occurred in June 2011. 

According to NFLIS, 689 exhibits 

involving 25I-NBOMe, 25C-NBOMe, 

and 25B-NBOMe were submitted to 

forensic laboratories between June 2011 

and March 2013 from a number of states 

including Alabama, Arkansas, 

California, Colorado, Connecticut, 

Florida, Georgia, Iowa, Indiana, Illinois, 

Kansas, Kentucky, Louisiana, Maryland, 

Maine, Minnesota, Missouri, New 

Hampshire, New Jersey, New Mexico, 

North Dakota, Nebraska, Nevada, Ohio, 

Oklahoma, Pennsylvania, South 

Carolina, Tennessee, Texas, Utah, 

Virginia, Wisconsin, and Wyoming. The 

number of reports submitted to NFLIS 

involving 25I-NBOMe, 25C-NBOMe, 

and 25B-NBOMe has increased in each 

of the last five quarters where data is 

available. According to STRIDE, there 

are 84 records that identify 25I-NBOMe, 

25C-NBOMe, and 25B-NBOMe in 

evidence submitted to DEA laboratories 

between November 2011 and June 2013. 

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

the Public Health 

In 2012 and 2013, emergency 

department physicians and toxicologists 

published and presented numerous case 

reports of patients treated for exposure 

to 25I-NBOMe. The adverse health 

effects reported include tachycardia, 

hypertension, agitation, aggression, 

visual and auditory hallucinations, 

seizures, hyperpyrexia, clonus, elevated 

white cell count, elevated creatine 

kinase, metabolic acidosis, 

rhabdomyolysis, and acute kidney 

injury. 

Medical examiner and postmortem 

toxicology reports from 11 states 

implicate some combination of 25INBOMe, 25C-NBOMe, and 25B-NBOMe 

in the death of at least 14 individuals. 

These reports suggest that 11 

individuals died of acute toxicity, and 3 

individuals died of unpredictable or 

violent behavior due to 25I-NBOMe 

toxicity. 25I-NBOMe, 25C-NBOMe, and 

25B-NBOMe have each been detected in 

postmortem blood toxicology for cases 

of acute toxicity. 

Since abusers obtain these drugs 

through unknown sources, the identity, 

purity, and quantity of these substances 

is uncertain and inconsistent, thus 

posing significant adverse health risks 

to users. There are no recognized 

therapeutic uses of these substances in 

the United States and possible deadly 

drug interactions between 25I-NBOMe 

and FDA approved medications have 

been noted. 

Finding of Necessity of Schedule I 

Placement To Avoid Imminent Hazard 

to Public Safety 

Based on the above data and 

information, the continued uncontrolled 

manufacture, distribution, importation, 

exportation, and abuse of 25I-NBOMe, 

25C-NBOMe, and 25B-NBOMe pose an 

imminent hazard to the public safety. 

The DEA is not aware of any currently 

accepted medical uses for these 

synthetic phenethylamines in the 

United States. A substance meeting the 

statutory requirements for temporary 

scheduling, 21 U.S.C. 811(h)(1), may 

only be placed in Schedule I. 

Substances in Schedule I are those that 

have a high potential for abuse, no 

currently accepted medical use in 

treatment in the United States, and a 

lack of accepted safety for use under 

medical supervision. Available data and 

information for 25I-NBOMe, 25CNBOMe, and 25B-NBOMe indicate that 

these three synthetic phenethylamines 

have a high potential for abuse, no 

currently accepted medical use in 

treatment in the United States, and a 

lack of accepted safety for use under 

medical supervision. As required by 

section 201(h)(4) of the CSA, 21 U.S.C. 

811(h), the Deputy Administrator 

through a letter dated September 3, 

2013, notified the Assistant Secretary of 

the intention to temporarily place these 

three synthetic phenethylamines in 

Schedule I. 

Conclusion 

This notice of intent initiates an 

expedited temporary scheduling action 

and provides the 30-day notice pursuant 

to section 201(h) of the CSA, 21 U.S.C. 

811(h). In accordance with the 

provisions of section 201(h) of the CSA, 

21 U.S.C. 811(h), the Deputy 

Administrator considered available data 

and information, herein set forth the 

grounds for his determination that it is 


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Federal Register / Vol. 78, No. 197 / Thursday, October 10, 2013 / Proposed Rules 61993 

necessary to temporarily schedule three 

synthetic phenethylamines, 2-(4-iodo2,5-dimethoxyphenyl)-N-(2- 

methoxybenzyl)ethanamine (25INBOMe; 2C-I-NBOMe; 25I; Cimbi-5), 2- 

(4-chloro-2,5-dimethoxyphenyl)-N-(2- 

methoxybenzyl)ethanamine (25CNBOMe; 2C-C-NBOMe; 25C; Cimbi-82) 

and 2-(4-bromo-2,5-dimethoxyphenyl)- 

N-(2-methoxybenzyl)ethanamine (25BNBOMe; 2C-B-NBOMe; 25B; Cimbi-36), 

in Schedule I of the CSA, and finds that 

placement of these synthetic 

phenethylamines into Schedule I of the 

CSA is warranted in order to avoid an 

imminent hazard to the public safety. 

Because the Deputy Administrator 

hereby finds that it is necessary to 

temporarily place these synthetic 

phenethylamines into Schedule I to 

avoid an imminent hazard to the public 

safety, any subsequent final order 

temporarily scheduling these substances 

will be effective on the date of 

publication in the Federal Register, and 

will be in effect for a period of two 

years, with a possible extension of one 

additional year, pending completion of 

the permanent or regular scheduling 

process. 21 U.S.C. 811(h)(1) and (2). It 

is the intention of the Deputy 

Administrator to issue such a final order 

as soon as possible after the expiration 

of 30 days from the date of publication 

of this notice. 25I-NBOMe, 25C-NBOMe, 

and 25B-NBOMe will then be subject to 

the regulatory controls and 

administrative, civil, and criminal 

sanctions applicable to the manufacture, 

distribution, possession, importation, 

exportation, research, and conduct of 

instructional activities of a Schedule I 

controlled substance under the CSA. 

The CSA sets forth specific criteria for 

scheduling a drug or other substance. 

Regular scheduling actions in 

accordance with 21 U.S.C. 811(a) are 

subject to formal rulemaking procedures 

done ‘‘on the record after opportunity 

for a hearing’’ conducted pursuant to 

the provisions of 5 U.S.C. 556 and 557. 

21 U.S.C. 811. The regular scheduling 

process of formal rulemaking affords 

interested parties with appropriate 

process and the government with any 

additional relevant information needed 

to make a determination. Final 

decisions that conclude the regular 

scheduling process of formal 

rulemaking are subject to judicial 

review. 21 U.S.C. 877. Temporary 

scheduling orders are not subject to 

judicial review. 21 U.S.C. 811(h)(6). 

Regulatory Matters 

Section 201(h) of the CSA, 21 U.S.C. 

811(h), provides for an expedited 

temporary scheduling action where 

such action is necessary to avoid an 

imminent hazard to the public safety. 

As provided in this subsection, the 

Attorney General may, by order, 

schedule a substance in Schedule I on 

a temporary basis. Such an order may 

not be issued before the expiration of 30 

days from (1) the publication of a notice 

in the Federal Register of the intention 

to issue such order and the grounds 

upon which such order is to be issued, 

and (2) the date that notice of a 

proposed temporary scheduling order is 

transmitted to the Assistant Secretary of 

HHS. 21 U.S.C. 811(h)(1). 

Inasmuch as section 201(h) of the 

CSA directs that temporary scheduling 

actions be issued by order and sets forth 

the procedures by which such orders are 

to be issued, the DEA believes that the 

notice and comment requirements of 

section 553 of the Administrative 

Procedure Act (APA), 5 U.S.C. 553, do 

not apply to this notice of intent. In the 

alternative, even assuming that this 

notice of intent might be subject to 

section 553 of the APA, the Deputy 

Administrator finds that there is good 

cause to forgo the notice and comment 

requirements of section 553, as any 

further delays in the process for 

issuance of temporary scheduling orders 

would be impracticable and contrary to 

the public interest in view of the 

manifest urgency to avoid an imminent 

hazard to the public safety. 

Although the DEA believes this notice 

of intent to issue a temporary 

scheduling order is not subject to the 

notice and comment requirements of 

section 553 of the APA, the DEA notes 

that in accordance with 21 U.S.C. 

811(h)(4), the Deputy Administrator will 

be taking into consideration any 

comments submitted by the Assistant 

Secretary with regard to the proposed 

temporary scheduling order. 

Further, the DEA believes that this 

temporary scheduling action is not a 

‘‘rule’’ as defined by 5 U.S.C. 601(2), 

and, accordingly, is not subject to the 

requirements of the Regulatory 

Flexibility Act (RFA). The requirements 

for the preparation of an initial 

regulatory flexibility analysis in 5 U.S.C. 

603(a) are not applicable where, as here, 

the DEA is not required by section 553 

of the APA or any other law to publish 

a general notice of proposed 

rulemaking. 

Additionally, this action is not a 

significant regulatory action as defined 

by Executive Order 12866 (Regulatory 

Planning and Review), section 3(f), and, 

accordingly, this action has not been 

reviewed by the Office of Management 

and Budget (OMB). 

This action will 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. Therefore, in 

accordance with Executive Order 13132 

(Federalism) it is determined that this 

action does not have sufficient 

federalism implications to warrant the 

preparation of a Federalism Assessment. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

Under the authority vested in the 

Attorney General by section 201(h) of 

the CSA, 21 U.S.C. 811(h), and 

delegated to the Deputy Administrator 

of the DEA by Department of Justice 

regulations (28 CFR 0.100, Appendix to 

Subpart R), the Deputy Administrator 

hereby intends to order that 21 CFR Part 

1308 be amended as follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for Part 1308 

continues to read as follows: 

Authority: 21 U.S.C. 811, 812, 871(b), 

unless otherwise noted. 

■ 2. Section 1308.11 is amended by 

adding new paragraphs (h)(12), (13), and 

(14) to read as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(h) * * * 

(12) 2-(4-iodo-2,5-dimethoxyphenyl)- 

N-(2-methoxybenzyl)ethanamine, its 

optical, positional, and geometric 

isomers, salts and salts of isomers— 

7538 (Other names: 25I-NBOMe; 2C-INBOMe; 25I; Cimbi-5) 

(13) 2-(4-chloro-2,5- 

dimethoxyphenyl)-N-(2-methoxybenzyl)

ethanamine, its optical, positional, and 

geometric isomers, salts and salts of 

isomers—7537 (Other names: 25CNBOMe; 2C-C-NBOMe; 25C; Cimbi-82) 

(14) 2-(4-bromo-2,5- 

dimethoxyphenyl)-N-(2-methoxybenzyl)

ethanamine, its optical, positional, and 

geometric isomers, salts and salts of 

isomers—7536 (Other names: 25BNBOMe; 2C-B-NBOMe; 25B; Cimbi-36) 

Dated: October 4, 2013. 

Thomas M. Harrigan, 

Deputy Administrator. 

[FR Doc. 2013–24432 Filed 10–9–13; 8:45 am] 

BILLING CODE 4410–09–P 


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