Schedules of Controlled Substances: Temporary Placement of Three Synthetic Phenethylamines Into Schedule I, 68716-68719 [2013-27315]
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Federal Register / Vol. 78, No. 221 / Friday, November 15, 2013 / Rules and Regulations
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
Drug Enforcement
Administration, Department of Justice.
ACTION: Final order.
AGENCY:
The Deputy Administrator of
the Drug Enforcement Administration
(DEA) is issuing this final order 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-(4iodo-2,5-dimethoxyphenyl)-N-(2methoxybenzyl)ethanamine (25I–
NBOMe; 2C–I–NBOMe; 25I; Cimbi-5), 2(4-chloro-2,5-dimethoxyphenyl)-N-(2methoxybenzyl)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 and
their optical, positional, and geometric
isomers, salts and salts of isomers in
schedule I of the CSA is necessary to
avoid an imminent hazard to the public
safety. As a result of this order, the
regulatory controls and administrative,
civil, and criminal sanctions applicable
to schedule I controlled substances will
be imposed on persons who handle
(manufacture, distribute, dispense,
import, export, engage in research,
conduct instructional activities, and
possess), or propose to handle these
synthetic phenethylamines.
DATES: This final order is effective
November 15, 2013.
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:
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SUMMARY:
Legal Authority
The DEA implements and enforces
titles II and III of the Comprehensive
Drug Abuse Prevention and Control Act
of 1970, as amended. Titles II and III are
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referred to as the ‘‘Controlled
Substances Act’’ and the ‘‘Controlled
Substances Import and Export Act,’’
respectively, but they are collectively
referred to as the ‘‘Controlled
Substances Act’’ or the ‘‘CSA’’ for the
purpose of this action. 21 U.S.C. 801–
971. The DEA publishes the
implementing regulations for these
statutes in title 21 of the Code of Federal
Regulations (CFR), parts 1300 to 1321.
The CSA and its implementing
regulations are designed to prevent,
detect, and eliminate the diversion of
controlled substances and listed
chemicals into the illicit market while
providing for legitimate medical,
scientific, research, and industrial needs
of the United States. Controlled
substances have the potential for abuse
and dependence and are controlled to
protect the public health and safety.
Under the CSA, controlled substances
are classified into one of five schedules
based upon their potential for abuse,
their currently accepted medical use,
and the degree of dependence the
substance may cause. 21 U.S.C. 812. The
initial schedules of controlled
substances established by Congress are
found at 21 U.S.C. 812(c), and the
current list of all scheduled substances
is published at 21 CFR part 1308.
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 an 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). Pursuant to 21 U.S.C. 871(a),
the Attorney General has delegated his
scheduling 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.
Background
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
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Services (HHS) of his intention to
temporarily place a substance in
schedule I of the CSA.1 The Deputy
Administrator transmitted notice of his
intent to place 25I–NBOMe, 25C–
NBOMe, and 25B–NBOMe in schedule
I on a temporary basis to the Assistant
Secretary by letter dated September 3,
2013. The Assistant Secretary
responded to this notice by letter dated
October 1, 2013 (received by the DEA on
October 8, 2013), and advised that based
on review by the FDA, there are
currently no investigational new drug
applications or approved new drug
applications for 25I–NBOMe, 25C–
NBOMe, or 25B–NBOMe. The Assistant
Secretary also stated that the HHS has
no objection to the temporary placement
of 25I–NBOMe, 25C–NBOMe, or 25B–
NBOMe in schedule I of the CSA. The
DEA has taken into consideration the
Assistant Secretary’s comments as
required by 21 U.S.C. 811(h)(4). As 25I–
NBOMe, 25C–NBOMe, and 25B–
NBOMe are not currently listed in any
schedule under the CSA, and as no
exemptions or approvals are in effect for
25I–NBOMe, 25C–NBOMe, and 25B–
NBOMe under section 505 of the FD&C
Act, 21 U.S.C. 355, the conditions of 21
U.S.C. 811(h)(1) have been satisfied. As
required by 21 U.S.C. 811(h)(1)(a), a
notice of intent to temporarily schedule
these three synthetic phenethylamines
was published in the Federal Register
on October 10, 2013. 78 FR 61991.
To make a finding that placing a
substance temporarily in 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
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 Final Order,
all subsequent references to ‘‘Secretary’’ have been
replaced with ‘‘Assistant Secretary.’’ As set forth in
a memorandum of understanding entered into by
the HHS, the Food and Drug Administration (FDA),
and the National Institute on Drug Abuse (NIDA),
the FDA acts as the lead agency within the HHS in
carrying out the Assistant Secretary’s scheduling
responsibilities under the CSA, with the
concurrence of the NIDA. 50 FR 9518, Mar. 8, 1985.
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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 sotermed for the two-carbon ethylene
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 4 exhibits
involving 4 cases for 25B–NBOMe.
From June 2011 through June 2013, the
National Forensic Laboratory
Information System 3 (NFLIS) registered
959 reports containing these synthetic
phenethylamines (25I–NBOMe—795
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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reports; 25C–NBOMe—144 reports;
25B–NBOMe—20 reports) across 35
States. No instances involving 25I–
NBOMe, 25C–NBOMe, 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 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, 959 exhibits
involving 25I–NBOMe, 25C–NBOMe,
and 25B–NBOMe were submitted to
forensic laboratories between June 2011
and June 2013 from a number of States
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including Alabama, Arizona, Arkansas,
California, Colorado, Connecticut,
Florida, Georgia, Illinois, Indiana, Iowa,
Kansas, Kentucky, Louisiana, Maine,
Maryland, Michigan, Minnesota,
Missouri, Nebraska, Nevada, New
Hampshire, New Jersey, New Mexico,
North Dakota, 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 complete data is
available. According to STRIDE, there
are 85 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 17
individuals. These reports suggest that
14 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 for 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
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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)(4), 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
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
necessary to temporarily schedule three
synthetic phenethylamines, 2-(4-iodo2,5-dimethoxyphenyl)-N-(2methoxybenzyl)ethanamine (25I–
NBOMe; 2C–I–NBOMe; 25I; Cimbi-5), 2(4-chloro-2,5-dimethoxyphenyl)-N-(2methoxybenzyl)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 in schedule I of the
CSA is necessary to avoid an imminent
hazard to the public safety.
Because the Deputy Administrator
hereby finds it necessary to temporarily
place these synthetic phenethylamines
in schedule I to avoid an imminent
hazard to the public safety, the 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)–(2).
The CSA sets forth specific criteria for
scheduling a drug or other substance.
Regular scheduling actions in
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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 Requirements
Upon the effective date of this Final
Order, 25I–NBOMe, 25C–NBOMe, and
25B–NBOMe will become subject to the
CSA’s schedule I regulatory controls
and administrative, civil, and criminal
sanctions applicable to the manufacture,
distribution, importation, exportation,
research, conduct of instructional
activities, and possession including the
following:
1. Registration. Any person who
handles (manufactures, distributes,
dispenses, imports, exports, engages in
research, conducts instructional
activities, or possesses), or desires to
handle, 25I–NBOMe, 25C–NBOMe, or
25B–NBOMe must be registered with
the 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. Any person who
currently handles 25I–NBOMe, 25C–
NBOMe, or 25B–NBOMe, and is not
registered with the DEA must submit an
application for registration and may not
continue his/her activities until the DEA
has approved that application. Retail
sales of schedule I controlled substances
to the general public are not allowed
under the CSA.
2. Security. 25I–NBOMe, 25C–
NBOMe, and 25B–NBOMe are subject to
schedule I security requirements and
must be handled and stored in
accordance with 21 CFR 1301.71–
1301.93, pursuant to 21 U.S.C. 821, 823,
871(b), as of November 15, 2013.
3. Labeling and packaging. All
labeling and packaging requirements for
controlled substances set forth in part
1302 of title 21 of the CFR shall apply
to commercial containers of 25I–
NBOMe, 25C–NBOMe, and 25B–
NBOMe. Current DEA registrants shall
have 30 calendar days from November
15, 2013 to comply with all labeling and
packaging requirements.
4. Quotas. Quotas for 25I–NBOMe,
25C–NBOMe, and 25B–NBOMe will be
established based on registrations
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granted and quota applications received
pursuant to part 1303 of title 21 of the
CFR.
5. Inventory. Every DEA registrant
who possesses any quantity of 25I–
NBOMe, 25C–NBOMe, or 25B–NBOMe
on the effective date of this order will
be required to take an inventory of all
stocks of these substances on hand as of
the effective date of this order, pursuant
to 21 U.S.C. 827, 958(e), and in
accordance with 21 CFR 1304.03,
1304.04, and 1304.11. Current DEA
registrants shall have 30 calendar days
from the effective date of this order to
be in compliance with all inventory
requirements.
6. Records. All registrants who are
authorized to handle 25I–NBOMe, 25C–
NBOMe, or 25B–NBOMe are required to
keep records pursuant to 1304.03,
1304.04, 1304.21, 1304.22, and 1304.23
of title 21 of the CFR. Current DEA
registrants authorized to handle 25I–
NBOMe, 25C–NBOMe, or 25B–NBOMe
shall have 30 calendar days from the
effective date of this order to be in
compliance with all recordkeeping
requirements.
7. Reports. All registrants are required
to submit reports in accordance with
1304.33 of title 21 of the CFR. DEA
registrants who manufacture or
distribute 25I–NBOMe, 25C–NBOMe, or
25B–NBOMe are required to comply
with these reporting requirements and
shall do so as of November 15, 2013.
8. Order Forms. All registrants
involved in the distribution of 25I–
NBOMe, 25C–NBOMe, or 25B–NBOMe
must comply with order form
requirements of part 1305 of title 21 of
the CFR as of November 15, 2013.
9. Importation and Exportation. All
importation and exportation of 25I–
NBOMe, 25C–NBOMe, or 25B–NBOMe
must be conducted by appropriately
registered DEA registrants in
compliance with part 1312 of title 21 of
the CFR, pursuant to 21 U.S.C. 952, 953,
957, and 958, on or after November 15,
2013.
10. Criminal Liability. Any activity
involving 25I–NBOMe, 25C–NBOMe, or
25B–NBOMe not authorized by, or in
violation of the CSA, occurring as of
November 15, 2013 is unlawful, and
may subject the person to
administrative, civil, and criminal
proceedings.
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,
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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 temporary scheduling
action. In the alternative, even assuming
that this action 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.
Further, the DEA believes that this
temporary scheduling action final order
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.
Pursuant to section 808(2) of the
Congressional Review Act (CRA), ‘‘any
rule for which an agency for good cause
finds…that notice and public procedure
thereon are impracticable, unnecessary,
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or contrary to the public interest, shall
take effect at such time as the Federal
agency promulgating the rule
determines.’’ It is in the public interest
to schedule these substances
immediately because they pose a public
health risk. This temporary scheduling
action is taken pursuant to section
811(h), which is specifically designed to
enable the DEA to act in an expeditious
manner to avoid an imminent hazard to
the public safety from new or designer
drugs or abuse of those drugs. Section
811(h) exempts the temporary
scheduling order from standard notice
and comment rulemaking procedures to
ensure that the process moves swiftly.
For the same reasons that underlie
section 811(h), that is, the DEA’s need
to move quickly to place these
substances into schedule I because they
pose a threat to public health, it would
be contrary to the public interest to
delay implementation of the temporary
scheduling order. Therefore, in
accordance with section 808(2) of the
CRA, this order shall take effect
immediately upon its publication.
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 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–I–
NBOMe; 25I; Cimbi-5)
(13) 2-(4-chloro-2,5dimethoxyphenyl)-N-(2methoxybenzyl)ethanamine, its optical,
positional, and geometric isomers, salts
and salts of isomers—7537 (Other
PO 00000
*
Frm 00033
Fmt 4700
Sfmt 4700
68719
names: 25C–NBOMe; 2C–C–NBOMe;
25C; Cimbi-82)
(14) 2-(4-bromo-2,5dimethoxyphenyl)-N-(2methoxybenzyl)ethanamine, its optical,
positional, and geometric isomers, salts
and salts of isomers—7536
(Other names: 25B–NBOMe; 2C–B–
NBOMe; 25B; Cimbi-36)
Dated: November 7, 2013.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2013–27315 Filed 11–14–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
24 CFR Parts 50, 55, and 58
[Docket No. FR–5423–F–02]
RIN 2501–AD51
Floodplain Management and
Protection of Wetlands
Office of the Secretary, HUD.
Final rule.
AGENCY:
ACTION:
This final rule revises HUD’s
regulations governing the protection of
wetlands and floodplains. With respect
to wetlands, the rule codifies existing
procedures for Executive Order 11990
(E.O. 11990), Protection of Wetlands.
HUD’s policy has been to require the
use of the 8-Step Process for floodplains
for wetlands actions performed by HUD
or actions performed with HUD
financial assistance. This rule codifies
this wetlands policy and improves
consistency and increases transparency
by placing the E.O. 11990 requirements
in regulation. In certain instances, the
new wetlands procedures will allow
recipients of HUD assistance to use
individual permits issued under section
404 of the Clean Water Act (Section 404
permits) in lieu of 5 steps of the E.O.
11990’s 8-Step Process, streamlining the
wetlands decisionmaking processes.
With respect to floodplains, with some
exceptions, the rule prohibits HUD
funding (e.g., Community Development
Block Grants, HOME Investment
Partnerships Program, Choice
Neighborhoods, and others) or Federal
Housing Administration (FHA)
mortgage insurance for construction in
Coastal High Hazard Areas. In order to
ensure maximum protection for
communities and wise investment of
Federal resources in the face of current
and future risk, this final rule also
requires the use of preliminary flood
maps and advisory base flood elevations
where the Federal Emergency
SUMMARY:
E:\FR\FM\15NOR1.SGM
15NOR1
Agencies
[Federal Register Volume 78, Number 221 (Friday, November 15, 2013)]
[Rules and Regulations]
[Pages 68716-68719]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27315]
[[Page 68716]]
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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: Final order.
-----------------------------------------------------------------------
SUMMARY: The Deputy Administrator of the Drug Enforcement
Administration (DEA) is issuing this final order 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 and their optical, positional, and geometric
isomers, salts and salts of isomers in schedule I of the CSA is
necessary to avoid an imminent hazard to the public safety. As a result
of this order, the regulatory controls and administrative, civil, and
criminal sanctions applicable to schedule I controlled substances will
be imposed on persons who handle (manufacture, distribute, dispense,
import, export, engage in research, conduct instructional activities,
and possess), or propose to handle these synthetic phenethylamines.
DATES: This final order is effective November 15, 2013.
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:
Legal Authority
The DEA implements and enforces titles II and III of the
Comprehensive Drug Abuse Prevention and Control Act of 1970, as
amended. Titles II and III are referred to as the ``Controlled
Substances Act'' and the ``Controlled Substances Import and Export
Act,'' respectively, but they are collectively referred to as the
``Controlled Substances Act'' or the ``CSA'' for the purpose of this
action. 21 U.S.C. 801-971. The DEA publishes the implementing
regulations for these statutes in title 21 of the Code of Federal
Regulations (CFR), parts 1300 to 1321. The CSA and its implementing
regulations are designed to prevent, detect, and eliminate the
diversion of controlled substances and listed chemicals into the
illicit market while providing for legitimate medical, scientific,
research, and industrial needs of the United States. Controlled
substances have the potential for abuse and dependence and are
controlled to protect the public health and safety.
Under the CSA, controlled substances are classified into one of
five schedules based upon their potential for abuse, their currently
accepted medical use, and the degree of dependence the substance may
cause. 21 U.S.C. 812. The initial schedules of controlled substances
established by Congress are found at 21 U.S.C. 812(c), and the current
list of all scheduled substances is published at 21 CFR part 1308.
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
an 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). Pursuant to 21 U.S.C. 871(a), the Attorney General has
delegated his scheduling 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.
Background
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 in schedule I of the CSA.\1\ The Deputy Administrator
transmitted notice of his intent to place 25I-NBOMe, 25C-NBOMe, and
25B-NBOMe in schedule I on a temporary basis to the Assistant Secretary
by letter dated September 3, 2013. The Assistant Secretary responded to
this notice by letter dated October 1, 2013 (received by the DEA on
October 8, 2013), and advised that based on review by the FDA, there
are currently no investigational new drug applications or approved new
drug applications for 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe. The Assistant
Secretary also stated that the HHS has no objection to the temporary
placement of 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe in schedule I of the
CSA. The DEA has taken into consideration the Assistant Secretary's
comments as required by 21 U.S.C. 811(h)(4). As 25I-NBOMe, 25C-NBOMe,
and 25B-NBOMe are not currently listed in any schedule under the CSA,
and as no exemptions or approvals are in effect for 25I-NBOMe, 25C-
NBOMe, and 25B-NBOMe under section 505 of the FD&C Act, 21 U.S.C. 355,
the conditions of 21 U.S.C. 811(h)(1) have been satisfied. As required
by 21 U.S.C. 811(h)(1)(a), a notice of intent to temporarily schedule
these three synthetic phenethylamines was published in the Federal
Register on October 10, 2013. 78 FR 61991.
---------------------------------------------------------------------------
\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 Final
Order, all subsequent references to ``Secretary'' have been replaced
with ``Assistant Secretary.'' As set forth in a memorandum of
understanding entered into by the HHS, the Food and Drug
Administration (FDA), and the National Institute on Drug Abuse
(NIDA), the FDA acts as the lead agency within the HHS in carrying
out the Assistant Secretary's scheduling responsibilities under the
CSA, with the concurrence of the NIDA. 50 FR 9518, Mar. 8, 1985.
---------------------------------------------------------------------------
To make a finding that placing a substance temporarily in 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
[[Page 68717]]
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 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 4 exhibits involving 4 cases for 25B-NBOMe.
From June 2011 through June 2013, the National Forensic Laboratory
Information System \3\ (NFLIS) registered 959 reports containing these
synthetic phenethylamines (25I-NBOMe--795 reports; 25C-NBOMe--144
reports; 25B-NBOMe--20 reports) across 35 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.
---------------------------------------------------------------------------
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, 959 exhibits involving 25I-NBOMe, 25C-NBOMe, and
25B-NBOMe were submitted to forensic laboratories between June 2011 and
June 2013 from a number of States including Alabama, Arizona, Arkansas,
California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana,
Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan,
Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New
Mexico, North Dakota, 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 complete
data is available. According to STRIDE, there are 85 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 17 individuals. These reports suggest that 14
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 for 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
[[Page 68718]]
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)(4), 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
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 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 in schedule I of the
CSA is necessary to avoid an imminent hazard to the public safety.
Because the Deputy Administrator hereby finds it necessary to
temporarily place these synthetic phenethylamines in schedule I to
avoid an imminent hazard to the public safety, the 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)-(2).
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 Requirements
Upon the effective date of this Final Order, 25I-NBOMe, 25C-NBOMe,
and 25B-NBOMe will become subject to the CSA's schedule I regulatory
controls and administrative, civil, and criminal sanctions applicable
to the manufacture, distribution, importation, exportation, research,
conduct of instructional activities, and possession including the
following:
1. Registration. Any person who handles (manufactures, distributes,
dispenses, imports, exports, engages in research, conducts
instructional activities, or possesses), or desires to handle, 25I-
NBOMe, 25C-NBOMe, or 25B-NBOMe must be registered with the 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. Any person who
currently handles 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe, and is not
registered with the DEA must submit an application for registration and
may not continue his/her activities until the DEA has approved that
application. Retail sales of schedule I controlled substances to the
general public are not allowed under the CSA.
2. Security. 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe are subject to
schedule I security requirements and must be handled and stored in
accordance with 21 CFR 1301.71-1301.93, pursuant to 21 U.S.C. 821, 823,
871(b), as of November 15, 2013.
3. Labeling and packaging. All labeling and packaging requirements
for controlled substances set forth in part 1302 of title 21 of the CFR
shall apply to commercial containers of 25I-NBOMe, 25C-NBOMe, and 25B-
NBOMe. Current DEA registrants shall have 30 calendar days from
November 15, 2013 to comply with all labeling and packaging
requirements.
4. Quotas. Quotas for 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe will be
established based on registrations granted and quota applications
received pursuant to part 1303 of title 21 of the CFR.
5. Inventory. Every DEA registrant who possesses any quantity of
25I-NBOMe, 25C-NBOMe, or 25B-NBOMe on the effective date of this order
will be required to take an inventory of all stocks of these substances
on hand as of the effective date of this order, pursuant to 21 U.S.C.
827, 958(e), and in accordance with 21 CFR 1304.03, 1304.04, and
1304.11. Current DEA registrants shall have 30 calendar days from the
effective date of this order to be in compliance with all inventory
requirements.
6. Records. All registrants who are authorized to handle 25I-NBOMe,
25C-NBOMe, or 25B-NBOMe are required to keep records pursuant to
1304.03, 1304.04, 1304.21, 1304.22, and 1304.23 of title 21 of the CFR.
Current DEA registrants authorized to handle 25I-NBOMe, 25C-NBOMe, or
25B-NBOMe shall have 30 calendar days from the effective date of this
order to be in compliance with all recordkeeping requirements.
7. Reports. All registrants are required to submit reports in
accordance with 1304.33 of title 21 of the CFR. DEA registrants who
manufacture or distribute 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe are
required to comply with these reporting requirements and shall do so as
of November 15, 2013.
8. Order Forms. All registrants involved in the distribution of
25I-NBOMe, 25C-NBOMe, or 25B-NBOMe must comply with order form
requirements of part 1305 of title 21 of the CFR as of November 15,
2013.
9. Importation and Exportation. All importation and exportation of
25I-NBOMe, 25C-NBOMe, or 25B-NBOMe must be conducted by appropriately
registered DEA registrants in compliance with part 1312 of title 21 of
the CFR, pursuant to 21 U.S.C. 952, 953, 957, and 958, on or after
November 15, 2013.
10. Criminal Liability. Any activity involving 25I-NBOMe, 25C-
NBOMe, or 25B-NBOMe not authorized by, or in violation of the CSA,
occurring as of November 15, 2013 is unlawful, and may subject the
person to administrative, civil, and criminal proceedings.
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,
[[Page 68719]]
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 temporary scheduling
action. In the alternative, even assuming that this action 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.
Further, the DEA believes that this temporary scheduling action
final order 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.
Pursuant to section 808(2) of the Congressional Review Act (CRA),
``any rule for which an agency for good cause finds[hellip]that notice
and public procedure thereon are impracticable, unnecessary, or
contrary to the public interest, shall take effect at such time as the
Federal agency promulgating the rule determines.'' It is in the public
interest to schedule these substances immediately because they pose a
public health risk. This temporary scheduling action is taken pursuant
to section 811(h), which is specifically designed to enable the DEA to
act in an expeditious manner to avoid an imminent hazard to the public
safety from new or designer drugs or abuse of those drugs. Section
811(h) exempts the temporary scheduling order from standard notice and
comment rulemaking procedures to ensure that the process moves swiftly.
For the same reasons that underlie section 811(h), that is, the DEA's
need to move quickly to place these substances into schedule I because
they pose a threat to public health, it would be contrary to the public
interest to delay implementation of the temporary scheduling order.
Therefore, in accordance with section 808(2) of the CRA, this order
shall take effect immediately upon its publication.
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.
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2. Section 1308.11 is amended by adding 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: November 7, 2013.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2013-27315 Filed 11-14-13; 8:45 am]
BILLING CODE 4410-09-P