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[Federal Register Volume 78, Number 197 (Thursday, October 10, 2013)]
[Proposed Rules]
[Pages 61991-61993]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24432]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

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.

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

[[Page 61991]]

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.

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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 (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5), 2-(4-
chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 
2C-C-NBOMe; 25C; Cimbi-82), and 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-
methoxybenzyl)ethanamine (25B-NBOMe; 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).
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    \1\ Because 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.
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    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 
25I-NBOMe, 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 25B-NBOMe, 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 25B-NBOMe are representative, are so-termed for 
the two-carbon ethylene

[[Page 61992]]

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, 25C-NBOMe, 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 25I-NBOMe; 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; 
25B-NBOMe-13 reports) across 33 states. No instances involving 25I-
NBOMe, 25C-NBOMe, or 25B-NBOMe were reported in NFLIS prior to June 
2011.
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    \2\ STRIDE includes data on analyzed samples from DEA 
laboratories.
    \3\ NFLIS is a database that collects scientifically verified 
data on analyzed samples in state and local forensic laboratories.
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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 25B-NBOMe 
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 25I-NBOMe, 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 25B-
NBOMe 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 25I-NBOMe, 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, 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. 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

[[Page 61993]]

necessary to temporarily schedule three synthetic phenethylamines, 2-
(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 
2C-I-NBOMe; 25I; Cimbi-5), 2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-
methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82) and 2-
(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 
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

0
1. The authority citation for Part 1308 continues to read as follows:

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

0
2. Section 1308.11 is amended by adding new paragraphs (h)(12), (13), 
and (14) to read as follows:

Sec.  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-I-NBOMe; 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: 25C-NBOMe; 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: 25B-NBOMe; 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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