Schedules of Controlled Substances: Temporary Placement of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA Into Schedule I, 31877-31883 [2018-14718]
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Federal Register / Vol. 83, No. 132 / Tuesday, July 10, 2018 / Rules and Regulations
reported with respect to a Fund’s Highly
Liquid Investment Minimum (Item B.7),
derivatives transactions (Item B.8),
country of risk and economic exposure
(Item C.5.b), delta (Items C.9.f.v,
C.11.c.vii, or C.11.g.iv), liquidity
classification for portfolio investments
(Item C.7), or miscellaneous securities
(Part D), or explanatory notes related to
any of those topics (Part E) that is
identifiable to any particular fund or
adviser. However, the SEC may use
information reported on this Form in its
regulatory programs, including
examinations, investigations, and
enforcement actions.
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Part B: Information About the Fund
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Item B.2.f. Cash and cash equivalents
not reported in Parts C and D.
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Item B.8 Derivatives Transactions. For
portfolio investments of open-end
management investment companies,
provide the percentage of the Fund’s
Highly Liquid Investments that it has
segregated to cover or pledged to satisfy
margin requirements in connection with
derivatives transactions that are
classified among the following
categories as specified in rule 22e–4 [17
CFR 270.22e–4]:
1. Moderately Liquid Investments
2. Less Liquid Investments
3. Illiquid Investments
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amozie on DSK3GDR082PROD with RULES
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Item C.7.a Liquidity classification
information.
For portfolio investments of open-end
management investment companies,
provide the liquidity classification(s) for
each portfolio investment among the
following categories as specified in rule
22e–4 [17 CFR 270.22e–4]. For portfolio
investments with multiple liquidity
classifications, indicate the percentage
amount attributable to each
classification.
i. Highly Liquid Investments
ii. Moderately Liquid Investments
iii. Less Liquid Investments
iv. Illiquid Investments
Item C.7.b. If attributing multiple
classification categories to the holding,
indicate which of the three
circumstances listed in the Instructions
to Item C.7 is applicable.
Instructions to Item C. 7 Funds may
choose to indicate the percentage
amount of a holding attributable to
multiple classification categories only in
the following circumstances: (1) If
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Part F: Exhibits
For reports filed for the end of the
first and third quarters of the Fund’s
fiscal year, attach no later than 60 days
after the end of the reporting period the
Fund’s complete portfolio holdings as of
the close of the period covered by the
report. These portfolio holdings must be
presented in accordance with the
schedules set forth in §§ 210.12–12—
210.12–14 of Regulation S–X [17 CFR
210.12–12—210.12–14].
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By the Commission.
Dated: June 28, 2018.
Brent J. Fields,
Secretary.
[FR Doc. 2018–14366 Filed 7–9–18; 8:45 am]
BILLING CODE 8011–01–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Part C: Schedule of Portfolio
Investments
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portions of the position have differing
liquidity features that justify treating the
portions separately; (2) if a fund has
multiple sub-advisers with differing
liquidity views; or (3) if the fund
chooses to classify the position through
evaluation of how long it would take to
liquidate the entire position (rather than
basing it on the sizes it would
reasonably anticipated trading). In (1)
and (2), a fund would classify using the
reasonably anticipated trade size for
each portion of the position.
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21 CFR Part 1308
[Docket No. DEA–479]
Schedules of Controlled Substances:
Temporary Placement of NM2201, 5FAB-PINACA, 4-CN-CUMYL-BUTINACA,
MMB-CHMICA and 5F-CUMYL-P7AICA
Into Schedule I
Drug Enforcement
Administration, Department of Justice.
ACTION: Temporary amendment;
temporary scheduling order.
AGENCY:
The Acting Administrator of
the Drug Enforcement Administration is
issuing this temporary scheduling order
to schedule the synthetic cannabinoids,
Naphthalen-1-yl 1-(5-fluoropentyl)-1Hindole-3-carboxylate (trivial name:
NM2201; CBL2201); N-(1-amino-3methyl-1-oxobutan-2-yl)-1-(5fluoropentyl)-1H-indazole-3carboxamide (trivial name: 5F-ABPINACA); 1-(4-cyanobutyl)-N-(2phenylpropan-2-yl)-1H-indazole-3carboxamide (trivial name: 4-CNCUMYL-BUTINACA; 4-cyano-CUMYL-
SUMMARY:
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31877
BUTINACA; 4-CN-CUMYL BINACA;
CUMYL-4CN-BINACA; SGT-78); methyl
2-(1-(cyclohexylmethyl)-1H-indole-3carboxamido)-3-methylbutanoate (trivial
names: MMB-CHMICA, AMB-CHMICA);
and 1-(5-fluoropentyl)-N-(2phenylpropan-2-yl)-1H-pyrrolo[2,3b]pyridine-3-carboxamide (trivial name:
5F-CUMYL-P7AICA), and their optical,
positional, and geometric isomers, salts,
and salts of isomers in schedule I. This
action is based on a finding by the
Acting Administrator that the placement
of these synthetic cannabinoids in
schedule I of the Controlled Substances
Act 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, reverse distribute, import,
export, engage in research, conduct
instructional activities or chemical
analysis, or possess), or propose to
handle, NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA
and 5F-CUMYL-P7AICA.
DATES: This temporary scheduling order
is effective July 10, 2018, until July 10,
2020. If this order is extended or made
permanent, the DEA will publish a
document in the Federal Register.
FOR FURTHER INFORMATION CONTACT:
Michael J. Lewis, Diversion Control
Division, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone: (202) 598–6812.
SUPPLEMENTARY INFORMATION:
Legal Authority
Section 201 of the Controlled
Substances Act (CSA), 21 U.S.C. 811,
provides the Attorney General with the
authority to temporarily place a
substance in 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)(1). 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 1 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,
1 Though DEA has used the term ‘‘final order’’
with respect to temporary scheduling orders in the
past, this document adheres to the statutory
language of 21 U.S.C. 811(h), which refers to a
‘‘temporary scheduling order.’’ No substantive
change is intended.
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21 U.S.C. 812, or if there is no
exemption or approval in effect for the
substance under section 505 of the
Federal Food, Drug, and Cosmetic Act
(FDCA), 21 U.S.C. 355. 21 U.S.C.
811(h)(1). The Attorney General has
delegated scheduling authority under 21
U.S.C. 811 to the Administrator of the
DEA. 28 CFR 0.100.
811(h)(1)(A), a notice of intent to
temporarily schedule NM2201, 5F-ABPINACA, 4-CN-CUMYL-BUTINACA,
MMB-CHMICA and 5F-CUMYL-P7AICA
was published in the Federal Register
on May 30, 2018. 83 FR 24696.
To find that placing a substance
temporarily in schedule I of the CSA is
necessary to avoid an imminent hazard
to the public safety, the Administrator is
Background
required to consider three of the eight
Section 201(h)(4) of the CSA 21 U.S.C. factors set forth in section 201(c) of the
811(h)(4), requires the Administrator to
CSA, 21 U.S.C. 811(c): The substance’s
notify the Secretary of the Department
history and current pattern of abuse; the
of Health and Human Services (HHS) of scope, duration and significance of
his intention to temporarily place a
abuse; and what, if any, risk there is to
substance in schedule I of the CSA.2 The the public health. 21 U.S.C. 811(h)(3).
Acting Administrator transmitted notice Consideration of these factors includes
of his intent to place NM2201, 5F-ABactual abuse, diversion from legitimate
PINACA, 4-CN-CUMYL-BUTINACA,
channels, and clandestine importation,
MMB-CHMICA and 5F-CUMYL-P7AICA manufacture, or distribution. 21 U.S.C.
in schedule I on a temporary basis to the 811(h)(3).
Assistant Secretary for Health of HHS by
A substance meeting the statutory
letter dated March 9, 2018. The
requirements for temporary scheduling
Assistant Secretary responded to this
may only be placed in schedule I. 21
notice by letter dated March 27, 2018,
U.S.C. 811(h)(1). Substances in schedule
and advised that based on a review by
I are those that have a high potential for
the Food and Drug Administration
abuse, no currently accepted medical
(FDA), there are currently no active
use in treatment in the United States,
investigational new drug applications or and a lack of accepted safety for use
approved new drug applications for
under medical supervision. 21 U.S.C.
NM2201, 5F-AB-PINACA, 4-CN812(b)(1).
Available data and information for
CUMYL-BUTINACA, MMB-CHMICA
NM2201, 5F-AB-PINACA, 4-CNand 5F-CUMYL-P7AICA. The Assistant
CUMYL-BUTINACA, MMB-CHMICA
Secretary also stated that the HHS has
no objection to the temporary placement and 5F-CUMYL-P7AICA, summarized
of NM2201, 5F-AB-PINACA, 4-CNbelow, indicate that these synthetic
CUMYL-BUTINACA, MMB-CHMICA
cannabinoids (SCs) have a high
and 5F-CUMYL-P7AICA in schedule I of potential for abuse, no currently
the CSA. The DEA has taken into
accepted medical use in treatment in the
consideration the Assistant Secretary’s
United States, and a lack of accepted
comments as required by 21 U.S.C.
safety for use under medical
811(h)(4). NM2201, 5F-AB-PINACA, 4supervision. The DEA’s three-factor
CN-CUMYL-BUTINACA, MMBanalysis and the Assistant Secretary’s
CHMICA and 5F-CUMYL-P7AICA are
March 27, 2018 letter are available in
not currently listed in any schedule
their entirety under the tab ‘‘Supporting
under the CSA, and no exemptions or
Documents’’ of the public docket of this
approvals are in effect for NM2201, 5Faction at www.regulations.gov under
AB-PINACA, 4-CN-CUMYLFDMS Docket ID: DEA–2018–0010–0001
BUTINACA, MMB-CHMICA or 5F(Docket Number DEA–479).
CUMYL-P7AICA under section 505 of
Synthetic Cannabinoids
the FDCA, 21 U.S.C. 355. The DEA has
The illicit use of the synthetic
found that the control of NM2201, 5Fcannabinoids (SCs) has continued
AB-PINACA, 4-CN-CUMYLthroughout the United States, resulting
BUTINACA, MMB-CHMICA and 5Fin severe adverse effects, overdoses and
CUMYL-P7AICA in schedule I on a
temporary basis is necessary to avoid an deaths. While new SCs continue to
imminent hazard to the public safety,
emerge on the illicit market, some
and as required by 21 U.S.C.
substances identified at their peak in
previous years have continued to be
2 As discussed in a memorandum of
abused by the user population.
understanding entered into by the Food and Drug
SCs are substances synthesized in
Administration (FDA) and the National Institute on
laboratories that mimic the biological
Drug Abuse (NIDA), the FDA acts as the lead agency
effects of delta-9-tetrahydrocannabinol
within the HHS in carrying out the Secretary’s
scheduling responsibilities under the CSA, with the (THC), the main psychoactive ingredient
concurrence of NIDA. 50 FR 9518, Mar. 8, 1985.
in marijuana. SCs were introduced on
The Secretary of the HHS has delegated to the
the designer drug market in several
Assistant Secretary for Health of the HHS the
European countries as ‘‘herbal incense’’
authority to make domestic drug scheduling
recommendations. 58 FR 35460, July 1, 1993.
before the initial encounter in the
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United States by U.S. Customs and
Border Protection (CBP) in November
2008. From 2009 to the present, misuse
of SCs has increased in the United
States with law enforcement encounters
describing SCs applied onto plant
material and in other designer drug
products intended for human
consumption. Hospital reports,
scientific publications and/or law
enforcement reports demonstrate that
NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA
and 5F-CUMYL-P7AICA and their
associated designer drug products are
abused for their psychoactive
properties. As with many generations of
SCs encountered since 2009, the abuse
of NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA
and 5F-CUMYL-P7AICA is impacting or
will negatively impact communities.
As observed by the DEA and CBP, SCs
originate from foreign sources, such as
China. Bulk powder substances are
smuggled via common carrier into the
United States and find their way to
clandestine designer drug product
manufacturing operations located in
residential neighborhoods, garages,
warehouses, and other similar
destinations throughout the country.
According to online discussion boards
and law enforcement encounters,
spraying or mixing the SCs with plant
material provides a vehicle for the most
common route of administration—
smoking (using a pipe, a water pipe, or
rolling the drug-laced plant material in
cigarette papers).
NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA
and 5F-CUMYL-P7AICA have no
accepted medical use in the United
States. Use of NM2201, 5F-AB-PINACA
and 4-CN-CUMYL-BUTINACA has been
reported to result in adverse effects in
humans in the United States. In
addition, within the United States, there
have been numerous law enforcement
seizures of NM2201, 5F-AB-PINACA, 4CN-CUMYL-BUTINACA, and MMBCHMICA during 2013 to 2018, as well
as one law enforcement seizure of 5FCUMYL-P7AICA in 2018. There have
been multiple international seizures of
5F-CUMYL-P7AICA, and its use has
been reported to result in serious
adverse events, including death, in
other countries. Use of other SCs has
resulted in signs of addiction and
withdrawal. Based on the
pharmacological similarities between
NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA
and 5F-CUMYL-P7AICA and other SCs,
they are likely to produce signs of
addiction and withdrawal similar to
those produced by other SCs.
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NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA
and 5F-CUMYL-P7AICA are SCs that
have pharmacological effects similar to
the schedule I hallucinogen THC and
other temporarily and permanently
controlled schedule I SCs. In addition,
the misuse of NM2201, 5F-AB-PINACA
and 4-CN-CUMYL-BUTINACA has been
associated with multiple overdoses
requiring emergency medical
intervention in the United States. With
no approved medical use and limited
safety or toxicological information,
NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA
and 5F-CUMYL-P7AICA have emerged
on the designer drug market, and the
abuse or trafficking of these substances
for their psychoactive properties is
concerning.
Factor 4. History and Current Pattern of
Abuse
Synthetic cannabinoids have been
developed by researchers over the last
30 years as tools for investigating the
endocannabinoid system (e.g.
determining CB1 and CB2 receptor
activity). The first encounter of SCs
intended for illicit use within the
United States occurred in November
2008 by CBP. Since then, the popularity
of SCs as product adulterants and
objects of abuse has increased as
evidenced by law enforcement seizures,
public health information, and media
reports.
Numerous SCs have been identified as
product adulterants, and law
enforcement has seized bulk amounts of
these substances. As successive
generations of SCs have been identified
and included within schedule I, illicit
distributors have developed new SC
substances that vary only by slight
modifications to their chemical
structure while retaining
pharmacological effects related to their
abuse potential. These substances and
products laced with these substances
are marketed under the guise of ‘‘herbal
incense’’ and promoted as a ‘‘legal high’’
with a disclaimer that they are ‘‘not for
human consumption.’’ Thus, after
section 1152 of the Food and Drug
Administration Safety and Innovation
Act (FDASIA), Public Law 112–144,
placed cannabimimetic agents and 26
specific substances in schedule I, law
enforcement documented the emergence
of new SCs, including UR-144, XLR11,
AKB48, PB-22, 5F-PB-22, ABFUBINACA, and ADB-PINACA. After
these substances were temporarily
scheduled (78 FR 28735, 79 FR 7577),
another generation of SCs appeared,
including AB-CHMINACA, ABPINACA, and THJ-2201. These
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substances were also temporarily, and
then permanently, scheduled in
schedule I (80 FR 5042, 82 FR 8593).
NM2201 was first identified in
November 2012 in seized drug evidence,
followed by 5F-AB-PINACA (August,
2013), MMB-CHMICA (December,
2015), 4-CN-CUMYL BUTINACA
(January, 2016) and most recently 5FCUMYL-P7AICA (February, 2018).
Following their manufacture in China,
SCs are often encountered in countries
including New Zealand, Australia and
Russia before appearing throughout
Europe and eventually the US.
European Monitoring Centre for Drugs
and Drug Addiction (EMCDDA)
reported that 50 kg’s of 4-CN-CUMYLBUTINACA were seized in Europe in
2016. While the National Forensic
Laboratory Information System (NFLIS)
(see factor 5) reported the first US
encounter of 4-CN-CUMYL-BUTINACA
in January 2016, the recent increase in
encounters did not occur until later in
2017. Similarly, prior to the first US
encounter of 5F-CUMYL-P7AICA in
February 2018, the use of this substance
has resulted in adverse events that have
been documented in Europe (See factor
6). These data further support that based
upon trends, SCs originate in China
before being abused in countries
including those in Europe often before
being trafficked in the US. Based upon
the similarity between the trafficking
patterns, distribution and use of 5FCUMYL-P7AICA versus other illicit
SCs, 5F-CUMYL-P7AICA poses
significant risk for continued emergence
in illicit drug markets in the United
States. Recent law enforcement seizures
are demonstrating that some SCs whose
popularity peaked in 2014 and 2015
have remained popular within the illicit
market (i.e. NM2201 and 5F-ABPINACA). The misuse of NM2201, 5FAB-PINACA, 4-CN-CUMYLBUTINACA, MMB-CHMICA and 5FCUMYL-P7AICA has been associated
with either law enforcement seizures or
overdoses requiring emergency medical
intervention. Reports of overdoses
involving the ingestion of products
containing NM2201, 5F-AB-PINACA
and 4-CN-CUMYL-BUTINACA, similar
to other SCs available on the illicit
market, have recently been published in
the scientific literature (See factor 4).
The powder form of SCs is typically
dissolved in solvents (e.g., acetone)
before being applied to plant material or
dissolved in a propellant intended for
use in electronic cigarette devices. In
addition, 4-CN-CUMYL BUTINACA was
identified as an adulterant on pieces of
paper that were then smuggled into a
detention facility and later found
partially burned. Law enforcement
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personnel have encountered various
application methods including buckets
or cement mixers in which plant
material and one or more SCs are mixed
together, as well as large areas where the
plant material is spread out so that a
dissolved SC mixture can be applied
directly. Once mixed, the SC plant
material is then allowed to dry before
manufacturers package the product for
distribution, ignoring any control
mechanisms to prevent contamination
or to ensure a consistent, uniform
concentration of the substance in each
package. Adverse health consequences
may also occur from directly ingesting
the drug during the manufacturing
process. The failure to adhere to any
manufacturing standards with regard to
amounts, the substance(s) included,
purity, or contamination may increase
the risk of adverse events. However, it
is important to note that adherence to
manufacturing standards would not
eliminate their potential to produce
adverse effects because the toxicity and
safety profile of these SCs have not been
studied.
NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA
and 5F-CUMYL-P7AICA, similar to
other SCs, have been found in powder
form or mixed with dried leaves or
herbal blends that were marketed for
human use. Presentations at emergency
departments directly linked to the abuse
of NM2201, 5F-AB-PINACA or 4-CNCUMYL-BUTINACA have resulted in
adverse symptoms, including
diaphoresis, tachycardia, hypertension,
seizures, agitation, violence, nausea and
memory impairment.
Factor 5. Scope, Duration and
Significance of Abuse
SCs continue to be encountered on
the illicit market despite scheduling
actions that attempt to safeguard the
public from the adverse effects and
safety issues associated with these
substances (see factor 5 in supporting
documentation). Novel substances
continue to be encountered, differing
only by small chemical structural
modifications intended to avoid
prosecution while maintaining the
pharmacological effects. Law
enforcement and health care
professionals continue to report the
abuse of these substances and their
associated products.
As described by the National Institute
on Drug Abuse (NIDA), many
substances being encountered in the
illicit market, specifically SCs, have
been available for years but have
reentered the marketplace due to a
renewed popularity. This is especially
true for substances like NM2201 and 5F-
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AB-PINACA, SCs that were popular in
2014 and have remained popular on the
illicit market. The threat of serious
injury to the individual and the
imminent threat to public safety
following the ingestion of NM2201, 5FAB-PINACA, 4-CN-CUMYLBUTINACA, MMB-CHMICA, 5FCUMYL-P7AICA and other SCs persist.
Full reports of information obtained
through STARLiMS,3 STRIDE,4 and
NFLIS for the past five years are
available under Factor 5 of the DEA 3Factor Analysis. According to NFLIS
data, state and local forensic
laboratories have detected the following
information about the SCs in question:
NM2201: 2,830 NFLIS reports from 30
states since 2012,5 282 STRIDE/
STARLiMS reports from 21 states plus
DC and Puerto Rico since 2014.
5F-AB-PINACA: 1,180 NFLIS reports
from 36 states since 2013, 188 STRIDE/
STARLiMS reports from 17 states plus
DC and Guam since 2013.
4-CN-CUMYL-BUTINACA: 493 NFLIS
reports from 3 states since 2016.
MMB-CHMICA: 254 NFLIS reports
from 17 states since 2015, 96
STARLiMS reports from 8 states plus
DC since 2015.
5F-CUMYL-P7AICA: 1 NFLIS report
from 1 state since 2018. As described
previously, based on the similarity
between trafficking patterns,
distribution and the use of 5F-CUMYLP7AICA versus other illicit SCs, 5FCUMYL-P7AICA poses significant risk
for continued emergence in illicit drug
markets in the United States.
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Factor 6. What, if Any, Risk There Is to
the Public Health
Since first being identified in the U.S.
in 2008, the ingestion of SCs continues
to result in serious adverse effects and
encounters. Details of these events in
the U.S. and/or abroad involving
NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA and 5F-CUMYLP7AICA are summarized below and
detailed in the DEA 3-Factor Analysis.
While no adverse event information is
currently available for MMB-CHMICA,
increasing law enforcement seizures,
scientific publications regarding its
abuse and the pharmacological
similarity of MMB-CHMICA to other
3 STARLiMS is a laboratory information
management system that systematically collects
results from drug chemistry analyses conducted by
DEA laboratories. On October 1, 2014, STARLiMS
replaced STRIDE as the DEA laboratory drug
evidence data system of record.
4 STRIDE is a database of drug exhibits sent to
DEA laboratories for analysis. Exhibits from the
database are from the DEA, other federal agencies,
and some local law enforcement agencies.
5 At the time of query, 2018 data were still
reporting.
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currently controlled schedule I SCs with
known risks to public health (i.e. ABCHMINACA, AB-FUBINACA, JWH-018)
demonstrate an imminent hazard to
public safety (see factor 5 in supporting
documentation).
1. A previously well 25-year-old man
in the United Kingdom presented with
agitation, double incontinence and leftsided incoordination. His symptoms
started after smoking a synthetic
cannabinoid (black mamba) 5 days
earlier. Over 48 hours, he developed
aphasia, generalized hypertonia, hyperreflexia and dense left hemiparesis. This
progressed to profuse diaphoresis, fever,
tachycardia, hypertension and a
possible seizure necessitating admission
to the intensive care unit. An
electroencephalogram showed
widespread brain wave slowing,
indicating diffuse cerebral dysfunction.
Toxicology analysis of the substance
confirmed a potent synthetic
cannabinoid NM2201.
2. In December 2015, 25–30 people in
Ocala, FL who used a synthetic
cannabinoid product were taken to local
hospitals following episodes of
violence, fighting and experiencing
seizures. Local laboratory analysis
confirmed drug evidence seized from
the overdose cluster as NM2201.
3. In June 2014, a 37 year old male in
Japan drove a car from a busy
downtown street onto a wide sidewalk
for 30 meters and hit many pedestrians
one after another until it was stopped by
collision with a telephone booth. A
woman was killed and seven persons
were injured. The driver lost
consciousness and was drooling. He had
no memory of what occurred after
smoking. 5F-AMB and AB-CHMINACA
were detected in the herbal mixture. In
addition, 5F-AB-PINACA was detected
in the urine sample.
4. Between December 2017 and
January 2018, at least 37 confirmed or
suspected cases of intoxication occurred
in Utah following ingestion of products
labeled either ‘‘CBD Oil’’ or ‘‘YOLO.’’
The products were liquids intended to
be used in a vaping device or directly
ingested sublingually. Further testing of
these products determined that they
contained the synthetic cannabinoid 4CN-CUMYL-BUTINACA. As per the
Utah Department of Health, adverse
reactions included altered mental status,
hallucinations, seizures, confusion, loss
of consciousness, tachycardia or slurred
speech.
5. In January 2018, 13 correctional
facility workers were treated for
overdose symptoms including
diaphoresis, hypertension and
tachycardia following ingestion of an
airborne substance while conducting
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cell searches for contraband. In response
to the overdose events, evidence
retrieved from the searches tested
positive for the synthetic cannabinoids
5F-ADB, 5F-EDMB-PINACA and 4-CNCUMYL-BUTINACA.
6. Eight countries within Europe have
reported just over 50 detections of 5FCUMYL-P7AICA to the European
Monitoring Centre for Drugs and Drug
Addiction (EMCDDA). 5F-CUMYLP7AICA was typically detected in plant
material or as a powder. The biggest
detections included a 5 kg seizure
(December 2014) and 7 kg seizure
(January 2015) of white powder believed
to originate from China.
7. Two deaths with confirmed
exposure to 5F-CUMYL-P7AICA
(detected along with other substances)
have been reported to the EMCDDA.
These occurred in November 2016 and
December 2016. In one of the cases, 5FCUMYL-P7AICA was reported as the
cause of death.
8. In February 2018, 5F-CUMYLP7AICA was confirmed in a seizure of
powder-material in Bay County, Florida.
Because they share pharmacological
similarities with schedule I substances
(D9-THC, JWH-018 and other
temporarily and permanently controlled
schedule I SCs), NM2201, 5F-ABPINACA, 4-CN-CUMYL-BUTINACA,
MMB-CHMICA and 5F-CUMYL-P7AICA
pose serious risk to an abuser. Tolerance
to SCs may develop fairly rapidly with
larger doses being required to achieve
the desired effect. Acute and chronic
abuse of SCs in general have been
linked to adverse health effects
including signs of addiction and
withdrawal, numerous reports of
emergency department admissions
resulting from their abuse, overall
toxicity and deaths. Psychiatric case
reports have been reported in the
scientific literature detailing the SC
abuse and associated psychoses. As
abusers obtain these drugs through
unknown sources, the identity and
purity of these substances is uncertain
and inconsistent, thus posing significant
adverse health risks to users.
NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA
and 5F-CUMYL-P7AICA are being
encountered on the illicit drug market
in the US and/or Europe and have no
accepted medical use in the United
States. Regardless, these products
continue to be easily available and
abused by diverse populations.
Finding of Necessity of Schedule I
Placement To Avoid Imminent Hazard
to Public Safety
In accordance with 21 U.S.C.
811(h)(3), based on the available data
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and information summarized above, the
continued uncontrolled manufacture,
distribution, reverse distribution,
importation, exportation, conduct of
research and chemical analysis,
possession, and abuse of NM2201, 5FAB-PINACA, 4-CN-CUMYLBUTINACA, MMB-CHMICA and 5FCUMYL-P7AICA pose an imminent
hazard to the public safety. The DEA is
not aware of any currently accepted
medical uses for NM2201, 5F-ABPINACA, 4-CN-CUMYL-BUTINACA,
MMB-CHMICA and 5F-CUMYL-P7AICA
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 NM2201, 5FAB-PINACA, 4-CN-CUMYLBUTINACA, MMB-CHMICA and 5FCUMYL-P7AICA indicate that these SCs
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 Acting Administrator,
through a letter dated March 9, 2018,
notified the Assistant Secretary of the
DEA’s intention to temporarily place
NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA
and 5F-CUMYL-P7AICA in schedule I.
A notice of intent was subsequently
published in the Federal Register on
May 30, 2018. 83 FR 24696.
Conclusion
In accordance with the provisions of
section 201(h) of the CSA, 21 U.S.C.
811(h), the Acting Administrator
considered available data and
information, and herein sets forth the
grounds for his determination that it is
necessary to temporarily schedule
Naphthalen-1-yl 1-(5-fluoropentyl)-1Hindole-3-carboxylate (trivial name:
NM2201; CBL2201); N-(1-amino-3methyl-1-oxobutan-2-yl)-1-(5fluoropentyl)-1H-indazole-3carboxamide (trivial name: 5F-ABPINACA); 1-(4-cyanobutyl)-N-(2phenylpropan-2-yl)-1H-indazole-3carboxamide (trivial name: 4-CNCUMYL-BUTINACA; 4-cyano-CUMYLBUTINACA; 4-CN-CUMYL BINACA;
CUMYL-4CN-BINACA; SGT-78); methyl
2-(1-(cyclohexylmethyl)-1H-indole-3carboxamido)-3-methylbutanoate (trivial
names: MMB-CHMICA, AMB-CHMICA);
and 1-(5-fluoropentyl)-N-(2-
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phenylpropan-2-yl)-1H-pyrrolo[2,3b]pyridine-3-carboxamide (trivial name:
5F-CUMYL-P7AICA) in schedule I of
the CSA to avoid an imminent hazard to
the public safety.
Because the Acting Administrator
hereby finds it necessary to temporarily
place NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA
and 5F-CUMYL-P7AICA in schedule I to
avoid an imminent hazard to the public
safety, this temporary order scheduling
these substances is effective on the date
of publication in the Federal Register,
and is in effect for a period of two years,
with a possible extension of one
additional year, pending completion of
the regular (permanent) scheduling
process. 21 U.S.C. 811(h)(1) and (2).
The CSA sets forth specific criteria for
scheduling a drug or other substance.
Permanent 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 permanent
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 permanent 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).
Requirements for Handling
Upon the effective date of this
temporary order, NM2201, 5F-ABPINACA, 4-CN-CUMYL-BUTINACA,
MMB-CHMICA and 5F-CUMYL-P7AICA
will be subject to the regulatory controls
and administrative, civil, and criminal
sanctions applicable to the manufacture,
distribution, reverse distribution,
importation, exportation, engagement in
research, and conduct of instructional
activities or chemical analysis with, and
possession of schedule I controlled
substances including the following:
1. Registration. Any person who
handles (manufactures, distributes,
reverse distributes, imports, exports,
engages in research, or conducts
instructional activities or chemical
analysis with, or possesses), or who
desires to handle, NM2201, 5F-ABPINACA, 4-CN-CUMYL-BUTINACA,
MMB-CHMICA and 5F-CUMYL-P7AICA
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, as of July 10, 2018. Any person
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31881
who currently handles NM2201, 5F-ABPINACA, 4-CN-CUMYL-BUTINACA,
MMB-CHMICA and 5F-CUMYLP7AICA, and is not registered with the
DEA, must submit an application for
registration and may not continue to
handle NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA
and 5F-CUMYL-P7AICA as of July 10,
2018, unless the DEA has approved that
application for registration pursuant to
21 U.S.C. 822, 823, 957, and 958, and
in accordance with 21 CFR parts 1301
and 1312. Retail sales of schedule I
controlled substances to the general
public are not allowed under the CSA.
Possession of any quantity of these
substances in a manner not authorized
by the CSA on or after July 10, 2018 is
unlawful and those in possession of any
quantity of these substances may be
subject to prosecution pursuant to the
CSA.
2. Disposal of stocks. Any person who
does not desire or is not able to obtain
a schedule I registration to handle
NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA
and 5F-CUMYL-P7AICA must surrender
all currently held quantities of NM2201,
5F-AB-PINACA, 4-CN-CUMYLBUTINACA, MMB-CHMICA and 5FCUMYL-P7AICA.
3. Security. NM2201, 5F-AB-PINACA,
4-CN-CUMYL-BUTINACA, MMBCHMICA and 5F-CUMYL-P7AICA are
subject to schedule I security
requirements and must be handled and
stored pursuant to 21 U.S.C. 821, 823,
871(b), and in accordance with 21 CFR
1301.71–1301.93, as of July 10, 2018.
4. Labeling and Packaging. All labels,
labeling, and packaging for commercial
containers of NM2201, 5F-AB-PINACA,
4-CN-CUMYL-BUTINACA, MMBCHMICA and 5F-CUMYL-P7AICA must
be in compliance with 21 U.S.C. 825,
958(e), and be in accordance with 21
CFR part 1302. Current DEA registrants
shall have 30 calendar days from July
10, 2018, to comply with all labeling
and packaging requirements.
5. Inventory. Every DEA registrant
who possesses any quantity of NM2201,
5F-AB-PINACA, 4-CN-CUMYLBUTINACA, MMB-CHMICA and 5FCUMYL-P7AICA on the effective date of
this order must take an inventory of all
stocks of these substances on hand,
pursuant to 21 U.S.C. 827 and 958, 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. After the initial
inventory, every DEA registrant must
take an inventory of all controlled
substances (including NM2201, 5F-AB-
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PINACA, 4-CN-CUMYL-BUTINACA,
MMB-CHMICA and 5F-CUMYLP7AICA) on hand on a biennial basis,
pursuant to 21 U.S.C. 827 and 958, and
in accordance with 21 CFR 1304.03,
1304.04, and 1304.11.
6. Records. All DEA registrants must
maintain records with respect to
NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA
and 5F-CUMYL-P7AICA pursuant to 21
U.S.C. 827 and 958(e), and in
accordance with 21 CFR parts 1304,
1312, 1317 and § 1307.11. Current DEA
registrants authorized to handle
NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA
and 5F-CUMYL-P7AICA shall have 30
calendar days from the effective date of
this order to be in compliance with all
recordkeeping requirements.
7. Reports. All DEA registrants who
manufacture or distribute NM2201, 5FAB-PINACA, 4-CN-CUMYLBUTINACA, MMB-CHMICA and 5FCUMYL-P7AICA must submit reports
pursuant to 21 U.S.C. 827 and in
accordance with 21 CFR 1304 and 1312
as of July 10, 2018.
8. Order Forms. All DEA registrants
who distribute NM2201, 5F-ABPINACA, 4-CN-CUMYL-BUTINACA,
MMB-CHMICA and 5F-CUMYL-P7AICA
must comply with order form
requirements pursuant to 21 U.S.C. 828
and in accordance with 21 CFR part
1305 as of July 10, 2018.
9. Importation and Exportation. All
importation and exportation of NM2201,
5F-AB-PINACA, 4-CN-CUMYLBUTINACA, MMB-CHMICA and 5FCUMYL-P7AICA must be in compliance
with 21 U.S.C. 952, 953, 957, 958, and
in accordance with 21 CFR part 1312 as
of July 10, 2018.
10. Quota. Only DEA registered
manufacturers may manufacture
NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA
and 5F-CUMYL-P7AICA in accordance
with a quota assigned pursuant to 21
U.S.C. 826 and in accordance with 21
CFR part 1303 as of July 10, 2018.
11. Liability. Any activity involving
NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA
and 5F-CUMYL-P7AICA not authorized
by, or in violation of the CSA, occurring
as of July 10, 2018, is unlawful, and may
subject the person to administrative,
civil, and/or criminal sanctions.
Regulatory Matters
Section 201(h) of the CSA, 21 U.S.C.
811(h), provides for a temporary
scheduling action where such action is
necessary to avoid an imminent hazard
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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 the proposed temporary
scheduling order is transmitted to the
Assistant Secretary. 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 the
Administrative Procedure Act (APA) at
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 5 U.S.C. 553,
the 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 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. 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 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.
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.
As noted above, this action is an
order, not a rule. Accordingly, the
Congressional Review Act (CRA) is
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inapplicable, as it applies only to rules.
However, if this were a rule, pursuant
to the CRA, ‘‘any rule for which an
agency for good cause finds 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.’’ 5
U.S.C. 808(2). It is in the public interest
to schedule these substances
immediately to avoid an imminent
hazard to the public safety. This
temporary scheduling action is taken
pursuant to 21 U.S.C. 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.
21 U.S.C. 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 21
U.S.C. 811(h), that is, the DEA’s need to
move quickly to place these substances
in schedule I because they pose an
imminent hazard to the public safety, it
would be contrary to the public interest
to delay implementation of the
temporary scheduling order. Therefore,
this order shall take effect immediately
upon its publication. The DEA has
submitted a copy of this temporary
order to both Houses of Congress and to
the Comptroller General, although such
filing is not required under the Small
Business Regulatory Enforcement
Fairness Act of 1996 (Congressional
Review Act), 5 U.S.C. 801–808 because,
as noted above, this action is an order,
not a rule.
List of Subjects in 21 CFR Part 1308
Administrative practice and
procedure, Drug traffic control,
Reporting and recordkeeping
requirements.
For the reasons set out above, the DEA
amends 21 CFR part 1308 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),
956(b), unless otherwise noted.
2. In § 1308.11, add paragraphs (h)(31)
to (35) to read as follows:
■
§ 1308.11
*
*
Schedule I.
*
(h) * * *
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(31) Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate, its optical, positional, and geometric isomers, salts and
salts of isomers (Other names: NM2201; CBL2201) .....................................................................................................................
(32) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: 5F-AB-PINACA) ................................................................................
(33) 1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxamide, its optical, positional, and geometric isomers,
salts and salts of isomers (Other names: 4-CN-CUMYL-BUTINACA; 4-cyano-CUMYL-BUTINACA; 4-CN-CUMYL
BINACA; CUMYL-4CN-BINACA; SGT-78) ....................................................................................................................................
(34) methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate, its optical, positional, and geometric
isomers, salts and salts of isomers (Other names: MMB-CHMICA, AMB-CHMICA) .................................................................
(35) 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboxamide, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: 5F-CUMYL-P7AICA) .........................................................................
Dated: June 30, 2018.
Robert W. Patterson,
Acting Administrator.
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
§ Section
U.S.C. United States Code
[FR Doc. 2018–14718 Filed 7–9–18; 8:45 am]
BILLING CODE 4410–09–P
II. Background Information and
Regulatory History
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket Number USCG–2018–0178]
RIN 1625–AA08
Special Local Regulation; Choptank
River, Cambridge, MD
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing special local regulations for
certain waters of the Choptank River.
This action is necessary to provide for
the safety of life on the navigable waters
located in Cambridge, MD, during a
power boat racing event on July 28,
2018, and July 29, 2018. This regulation
prohibits persons and vessels from
entering the regulated area unless
authorized by the Captain of the Port
Maryland-National Capital Region or the
Coast Guard Patrol Commander.
DATES: This rule is effective from 8:30
a.m. on July 28, 2018 through 6:30 p.m.
on July 29, 2018.
ADDRESSES: To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2018–
0178 in the ‘‘SEARCH’’ box and click
‘‘SEARCH.’’ Click on Open Docket
Folder on the line associated with this
rule.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, call or
email Mr. Ronald Houck, U.S. Coast
Guard Sector Maryland-National Capital
Region; telephone 410–576–2674, email
Ronald.L.Houck@uscg.mil.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
I. Table of Abbreviations
CFR
Code of Federal Regulations
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On February 18, 2018, The Kent
Narrows Racing Association of Chester,
MD, notified the Coast Guard that from
10 a.m. until 6 p.m. on July 28, 2018,
and July 29, 2018, it will be conducting
power boat races in the Choptank River
in a cove located between Hambrooks
Bar and the shoreline at Cambridge, MD.
Details of the proposed event were
provided to the Coast Guard at a
meeting on April 10, 2018, where the
sponsor changed the start time to 9 a.m.
to allow for additional races. In
response, on May 21, 2018, the Coast
Guard published a notice of proposed
rulemaking (NPRM) entitled ‘‘Special
Local Regulation; Choptank River,
Cambridge, MD’’ (83 FR 23395). There
we stated why we issued the NPRM,
and invited comments on our proposed
regulatory action related to this highspeed power boat racing event. During
the comment period that ended June 20,
2018, we received no comments.
Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for
making this rule effective less than 30
days after publication in the Federal
Register. Due to the date of the event,
it would be impracticable and contrary
to the public interest to make the
regulation effective 30 days after
publication in the Federal Register. The
regulation must be in place by June 28th
in order to protect the public from the
hazards associated with this power boat
racing event. Therefore, the Coast Guard
is making this rule effective
immediately.
III. Legal Authority and Need for Rule
The Coast Guard is issuing this rule
under authority in 33 U.S.C. 1233. The
Captain of the Port (COTP) MarylandNational Capital Region has determined
that potential hazards associated with
the power boat racing event will be a
safety concern for anyone intending to
participate in this event or for vessels
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(7221)
(7025)
(7089)
(7044)
(7085)
that operate within specified waters of
the Choptank River at Cambridge, MD.
The purpose of this rule is to protect
marine event participants, spectators
and transiting vessels on specified
waters of the Choptank River before,
during, and after the scheduled event.
IV. Discussion of Comments, Changes,
and the Rule
As noted above, we received no
comments on our NPRM published May
21, 2018. There are no substantive
changes in the regulatory text of this
rule from the proposed rule in the
NPRM.
This rule establishes a special local
regulation to be enforced from 8:30 a.m.
until 6:30 p.m. on July 28, 2018 and July
29, 2018. The regulated area covers all
navigable waters of the Choptank River
and Hambrooks Bay bounded by a line
connecting the following coordinates:
Commencing at the shoreline at Long
Wharf Park, Cambridge, MD, at position
latitude 38°34′30″ N, longitude
076°04′16″ W; thence east to latitude
38°34′20″ N, longitude 076°03′46″ W;
thence north across the Choptank River
along the Senator Frederick C. Malkus,
Jr. (US–50) Memorial Bridge, at mile
15.5, to latitude 38°35′30″ N, longitude
076°02′52″ W; thence west along the
shoreline to latitude 38°35′38″ N,
longitude 076°03′09″ W; thence north
and west along the shoreline to latitude
38°36′42″ N, longitude 076°04′15″ W;
thence southwest across the Choptank
River to latitude 38°35′31″ N, longitude
076°04′57″ W terminating at the
Hambrooks Bay breakwall. This rule
provides additional information about
designated areas within the regulated
area, including a ‘‘Race Area,’’
‘‘Spectator Area’’ and ‘‘Buffer Zone,’’
and the restrictions that apply to
mariners. The duration and enforcement
of the regulated area is intended to
insure the safety of vessels and these
navigable waters before, during, and
after the scheduled 9 a.m. through 6
p.m. high-speed power boat racing
event. Persons and vessels desiring to
transit, moor, or anchor within the
regulated area must obtain authorization
from COTP Maryland-National Capital
Region or Coast Guard Patrol
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]]>Agencies
[Federal Register Volume 83, Number 132 (Tuesday, July 10, 2018)]
[Rules and Regulations]
[Pages 31877-31883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14718]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-479]
Schedules of Controlled Substances: Temporary Placement of
NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-
P7AICA Into Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Temporary amendment; temporary scheduling order.
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SUMMARY: The Acting Administrator of the Drug Enforcement
Administration is issuing this temporary scheduling order to schedule
the synthetic cannabinoids, Naphthalen-1-yl 1-(5-fluoropentyl)-1H-
indole-3-carboxylate (trivial name: NM2201; CBL2201); N-(1-amino-3-
methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide
(trivial name: 5F-AB-PINACA); 1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-
1H-indazole-3-carboxamide (trivial name: 4-CN-CUMYL-BUTINACA; 4-cyano-
CUMYL-BUTINACA; 4-CN-CUMYL BINACA; CUMYL-4CN-BINACA; SGT-78); methyl 2-
(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate
(trivial names: MMB-CHMICA, AMB-CHMICA); and 1-(5-fluoropentyl)-N-(2-
phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboxamide (trivial
name: 5F-CUMYL-P7AICA), and their optical, positional, and geometric
isomers, salts, and salts of isomers in schedule I. This action is
based on a finding by the Acting Administrator that the placement of
these synthetic cannabinoids in schedule I of the Controlled Substances
Act 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, reverse distribute, import, export, engage in research,
conduct instructional activities or chemical analysis, or possess), or
propose to handle, NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-
CHMICA and 5F-CUMYL-P7AICA.
DATES: This temporary scheduling order is effective July 10, 2018,
until July 10, 2020. If this order is extended or made permanent, the
DEA will publish a document in the Federal Register.
FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control
Division, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.
SUPPLEMENTARY INFORMATION:
Legal Authority
Section 201 of the Controlled Substances Act (CSA), 21 U.S.C. 811,
provides the Attorney General with the authority to temporarily place a
substance in 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)(1). 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 \1\ for up to one year. 21 U.S.C. 811(h)(2).
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\1\ Though DEA has used the term ``final order'' with respect to
temporary scheduling orders in the past, this document adheres to
the statutory language of 21 U.S.C. 811(h), which refers to a
``temporary scheduling order.'' No substantive change is intended.
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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,
[[Page 31878]]
21 U.S.C. 812, or if there is no exemption or approval in effect for
the substance under section 505 of the Federal Food, Drug, and Cosmetic
Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 811(h)(1). The Attorney General
has delegated scheduling authority under 21 U.S.C. 811 to the
Administrator of the DEA. 28 CFR 0.100.
Background
Section 201(h)(4) of the CSA 21 U.S.C. 811(h)(4), requires the
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.\2\ The Acting Administrator transmitted
notice of his intent to place NM2201, 5F-AB-PINACA, 4-CN-CUMYL-
BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA in schedule I on a temporary
basis to the Assistant Secretary for Health of HHS by letter dated
March 9, 2018. The Assistant Secretary responded to this notice by
letter dated March 27, 2018, and advised that based on a review by the
Food and Drug Administration (FDA), there are currently no active
investigational new drug applications or approved new drug applications
for NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-
P7AICA. The Assistant Secretary also stated that the HHS has no
objection to the temporary placement of NM2201, 5F-AB-PINACA, 4-CN-
CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA 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). NM2201, 5F-AB-PINACA, 4-
CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA are not currently
listed in any schedule under the CSA, and no exemptions or approvals
are in effect for NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA
or 5F-CUMYL-P7AICA under section 505 of the FDCA, 21 U.S.C. 355. The
DEA has found that the control of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-
BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA in schedule I on a temporary
basis is necessary to avoid an imminent hazard to the public safety,
and as required by 21 U.S.C. 811(h)(1)(A), a notice of intent to
temporarily schedule NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-
CHMICA and 5F-CUMYL-P7AICA was published in the Federal Register on May
30, 2018. 83 FR 24696.
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\2\ As discussed in a memorandum of understanding entered into
by 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 Secretary's scheduling responsibilities under
the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The
Secretary of the HHS has delegated to the Assistant Secretary for
Health of the HHS the authority to make domestic drug scheduling
recommendations. 58 FR 35460, July 1, 1993.
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To find that placing a substance temporarily in schedule I of the
CSA is necessary to avoid an imminent hazard to the public safety, the
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(h)(3). 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 NM2201, 5F-AB-PINACA, 4-CN-
CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA, summarized below,
indicate that these synthetic cannabinoids (SCs) 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. The DEA's three-factor analysis and the Assistant
Secretary's March 27, 2018 letter are available in their entirety under
the tab ``Supporting Documents'' of the public docket of this action at
www.regulations.gov under FDMS Docket ID: DEA-2018-0010-0001 (Docket
Number DEA-479).
Synthetic Cannabinoids
The illicit use of the synthetic cannabinoids (SCs) has continued
throughout the United States, resulting in severe adverse effects,
overdoses and deaths. While new SCs continue to emerge on the illicit
market, some substances identified at their peak in previous years have
continued to be abused by the user population.
SCs are substances synthesized in laboratories that mimic the
biological effects of delta-9-tetrahydrocannabinol (THC), the main
psychoactive ingredient in marijuana. SCs were introduced on the
designer drug market in several European countries as ``herbal
incense'' before the initial encounter in the United States by U.S.
Customs and Border Protection (CBP) in November 2008. From 2009 to the
present, misuse of SCs has increased in the United States with law
enforcement encounters describing SCs applied onto plant material and
in other designer drug products intended for human consumption.
Hospital reports, scientific publications and/or law enforcement
reports demonstrate that NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA,
MMB-CHMICA and 5F-CUMYL-P7AICA and their associated designer drug
products are abused for their psychoactive properties. As with many
generations of SCs encountered since 2009, the abuse of NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA is
impacting or will negatively impact communities.
As observed by the DEA and CBP, SCs originate from foreign sources,
such as China. Bulk powder substances are smuggled via common carrier
into the United States and find their way to clandestine designer drug
product manufacturing operations located in residential neighborhoods,
garages, warehouses, and other similar destinations throughout the
country. According to online discussion boards and law enforcement
encounters, spraying or mixing the SCs with plant material provides a
vehicle for the most common route of administration--smoking (using a
pipe, a water pipe, or rolling the drug-laced plant material in
cigarette papers).
NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-
P7AICA have no accepted medical use in the United States. Use of
NM2201, 5F-AB-PINACA and 4-CN-CUMYL-BUTINACA has been reported to
result in adverse effects in humans in the United States. In addition,
within the United States, there have been numerous law enforcement
seizures of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, and MMB-CHMICA
during 2013 to 2018, as well as one law enforcement seizure of 5F-
CUMYL-P7AICA in 2018. There have been multiple international seizures
of 5F-CUMYL-P7AICA, and its use has been reported to result in serious
adverse events, including death, in other countries. Use of other SCs
has resulted in signs of addiction and withdrawal. Based on the
pharmacological similarities between NM2201, 5F-AB-PINACA, 4-CN-CUMYL-
BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA and other SCs, they are likely
to produce signs of addiction and withdrawal similar to those produced
by other SCs.
[[Page 31879]]
NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-
P7AICA are SCs that have pharmacological effects similar to the
schedule I hallucinogen THC and other temporarily and permanently
controlled schedule I SCs. In addition, the misuse of NM2201, 5F-AB-
PINACA and 4-CN-CUMYL-BUTINACA has been associated with multiple
overdoses requiring emergency medical intervention in the United
States. With no approved medical use and limited safety or
toxicological information, NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA,
MMB-CHMICA and 5F-CUMYL-P7AICA have emerged on the designer drug
market, and the abuse or trafficking of these substances for their
psychoactive properties is concerning.
Factor 4. History and Current Pattern of Abuse
Synthetic cannabinoids have been developed by researchers over the
last 30 years as tools for investigating the endocannabinoid system
(e.g. determining CB1 and CB2 receptor activity). The first encounter
of SCs intended for illicit use within the United States occurred in
November 2008 by CBP. Since then, the popularity of SCs as product
adulterants and objects of abuse has increased as evidenced by law
enforcement seizures, public health information, and media reports.
Numerous SCs have been identified as product adulterants, and law
enforcement has seized bulk amounts of these substances. As successive
generations of SCs have been identified and included within schedule I,
illicit distributors have developed new SC substances that vary only by
slight modifications to their chemical structure while retaining
pharmacological effects related to their abuse potential. These
substances and products laced with these substances are marketed under
the guise of ``herbal incense'' and promoted as a ``legal high'' with a
disclaimer that they are ``not for human consumption.'' Thus, after
section 1152 of the Food and Drug Administration Safety and Innovation
Act (FDASIA), Public Law 112-144, placed cannabimimetic agents and 26
specific substances in schedule I, law enforcement documented the
emergence of new SCs, including UR-144, XLR11, AKB48, PB-22, 5F-PB-22,
AB-FUBINACA, and ADB-PINACA. After these substances were temporarily
scheduled (78 FR 28735, 79 FR 7577), another generation of SCs
appeared, including AB-CHMINACA, AB-PINACA, and THJ-2201. These
substances were also temporarily, and then permanently, scheduled in
schedule I (80 FR 5042, 82 FR 8593).
NM2201 was first identified in November 2012 in seized drug
evidence, followed by 5F-AB-PINACA (August, 2013), MMB-CHMICA
(December, 2015), 4-CN-CUMYL BUTINACA (January, 2016) and most recently
5F-CUMYL-P7AICA (February, 2018). Following their manufacture in China,
SCs are often encountered in countries including New Zealand, Australia
and Russia before appearing throughout Europe and eventually the US.
European Monitoring Centre for Drugs and Drug Addiction (EMCDDA)
reported that 50 kg's of 4-CN-CUMYL-BUTINACA were seized in Europe in
2016. While the National Forensic Laboratory Information System (NFLIS)
(see factor 5) reported the first US encounter of 4-CN-CUMYL-BUTINACA
in January 2016, the recent increase in encounters did not occur until
later in 2017. Similarly, prior to the first US encounter of 5F-CUMYL-
P7AICA in February 2018, the use of this substance has resulted in
adverse events that have been documented in Europe (See factor 6).
These data further support that based upon trends, SCs originate in
China before being abused in countries including those in Europe often
before being trafficked in the US. Based upon the similarity between
the trafficking patterns, distribution and use of 5F-CUMYL-P7AICA
versus other illicit SCs, 5F-CUMYL-P7AICA poses significant risk for
continued emergence in illicit drug markets in the United States.
Recent law enforcement seizures are demonstrating that some SCs whose
popularity peaked in 2014 and 2015 have remained popular within the
illicit market (i.e. NM2201 and 5F-AB-PINACA). The misuse of NM2201,
5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA has
been associated with either law enforcement seizures or overdoses
requiring emergency medical intervention. Reports of overdoses
involving the ingestion of products containing NM2201, 5F-AB-PINACA and
4-CN-CUMYL-BUTINACA, similar to other SCs available on the illicit
market, have recently been published in the scientific literature (See
factor 4).
The powder form of SCs is typically dissolved in solvents (e.g.,
acetone) before being applied to plant material or dissolved in a
propellant intended for use in electronic cigarette devices. In
addition, 4-CN-CUMYL BUTINACA was identified as an adulterant on pieces
of paper that were then smuggled into a detention facility and later
found partially burned. Law enforcement personnel have encountered
various application methods including buckets or cement mixers in which
plant material and one or more SCs are mixed together, as well as large
areas where the plant material is spread out so that a dissolved SC
mixture can be applied directly. Once mixed, the SC plant material is
then allowed to dry before manufacturers package the product for
distribution, ignoring any control mechanisms to prevent contamination
or to ensure a consistent, uniform concentration of the substance in
each package. Adverse health consequences may also occur from directly
ingesting the drug during the manufacturing process. The failure to
adhere to any manufacturing standards with regard to amounts, the
substance(s) included, purity, or contamination may increase the risk
of adverse events. However, it is important to note that adherence to
manufacturing standards would not eliminate their potential to produce
adverse effects because the toxicity and safety profile of these SCs
have not been studied.
NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-
P7AICA, similar to other SCs, have been found in powder form or mixed
with dried leaves or herbal blends that were marketed for human use.
Presentations at emergency departments directly linked to the abuse of
NM2201, 5F-AB-PINACA or 4-CN-CUMYL-BUTINACA have resulted in adverse
symptoms, including diaphoresis, tachycardia, hypertension, seizures,
agitation, violence, nausea and memory impairment.
Factor 5. Scope, Duration and Significance of Abuse
SCs continue to be encountered on the illicit market despite
scheduling actions that attempt to safeguard the public from the
adverse effects and safety issues associated with these substances (see
factor 5 in supporting documentation). Novel substances continue to be
encountered, differing only by small chemical structural modifications
intended to avoid prosecution while maintaining the pharmacological
effects. Law enforcement and health care professionals continue to
report the abuse of these substances and their associated products.
As described by the National Institute on Drug Abuse (NIDA), many
substances being encountered in the illicit market, specifically SCs,
have been available for years but have reentered the marketplace due to
a renewed popularity. This is especially true for substances like
NM2201 and 5F-
[[Page 31880]]
AB-PINACA, SCs that were popular in 2014 and have remained popular on
the illicit market. The threat of serious injury to the individual and
the imminent threat to public safety following the ingestion of NM2201,
5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, 5F-CUMYL-P7AICA and
other SCs persist.
Full reports of information obtained through STARLiMS,\3\
STRIDE,\4\ and NFLIS for the past five years are available under Factor
5 of the DEA 3-Factor Analysis. According to NFLIS data, state and
local forensic laboratories have detected the following information
about the SCs in question:
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\3\ STARLiMS is a laboratory information management system that
systematically collects results from drug chemistry analyses
conducted by DEA laboratories. On October 1, 2014, STARLiMS replaced
STRIDE as the DEA laboratory drug evidence data system of record.
\4\ STRIDE is a database of drug exhibits sent to DEA
laboratories for analysis. Exhibits from the database are from the
DEA, other federal agencies, and some local law enforcement
agencies.
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NM2201: 2,830 NFLIS reports from 30 states since 2012,\5\ 282
STRIDE/STARLiMS reports from 21 states plus DC and Puerto Rico since
2014.
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\5\ At the time of query, 2018 data were still reporting.
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5F-AB-PINACA: 1,180 NFLIS reports from 36 states since 2013, 188
STRIDE/STARLiMS reports from 17 states plus DC and Guam since 2013.
4-CN-CUMYL-BUTINACA: 493 NFLIS reports from 3 states since 2016.
MMB-CHMICA: 254 NFLIS reports from 17 states since 2015, 96
STARLiMS reports from 8 states plus DC since 2015.
5F-CUMYL-P7AICA: 1 NFLIS report from 1 state since 2018. As
described previously, based on the similarity between trafficking
patterns, distribution and the use of 5F-CUMYL-P7AICA versus other
illicit SCs, 5F-CUMYL-P7AICA poses significant risk for continued
emergence in illicit drug markets in the United States.
Factor 6. What, if Any, Risk There Is to the Public Health
Since first being identified in the U.S. in 2008, the ingestion of
SCs continues to result in serious adverse effects and encounters.
Details of these events in the U.S. and/or abroad involving NM2201, 5F-
AB-PINACA, 4-CN-CUMYL-BUTINACA and 5F-CUMYL-P7AICA are summarized below
and detailed in the DEA 3-Factor Analysis. While no adverse event
information is currently available for MMB-CHMICA, increasing law
enforcement seizures, scientific publications regarding its abuse and
the pharmacological similarity of MMB-CHMICA to other currently
controlled schedule I SCs with known risks to public health (i.e. AB-
CHMINACA, AB-FUBINACA, JWH-018) demonstrate an imminent hazard to
public safety (see factor 5 in supporting documentation).
1. A previously well 25-year-old man in the United Kingdom
presented with agitation, double incontinence and left-sided
incoordination. His symptoms started after smoking a synthetic
cannabinoid (black mamba) 5 days earlier. Over 48 hours, he developed
aphasia, generalized hypertonia, hyper-reflexia and dense left
hemiparesis. This progressed to profuse diaphoresis, fever,
tachycardia, hypertension and a possible seizure necessitating
admission to the intensive care unit. An electroencephalogram showed
widespread brain wave slowing, indicating diffuse cerebral dysfunction.
Toxicology analysis of the substance confirmed a potent synthetic
cannabinoid NM2201.
2. In December 2015, 25-30 people in Ocala, FL who used a synthetic
cannabinoid product were taken to local hospitals following episodes of
violence, fighting and experiencing seizures. Local laboratory analysis
confirmed drug evidence seized from the overdose cluster as NM2201.
3. In June 2014, a 37 year old male in Japan drove a car from a
busy downtown street onto a wide sidewalk for 30 meters and hit many
pedestrians one after another until it was stopped by collision with a
telephone booth. A woman was killed and seven persons were injured. The
driver lost consciousness and was drooling. He had no memory of what
occurred after smoking. 5F-AMB and AB-CHMINACA were detected in the
herbal mixture. In addition, 5F-AB-PINACA was detected in the urine
sample.
4. Between December 2017 and January 2018, at least 37 confirmed or
suspected cases of intoxication occurred in Utah following ingestion of
products labeled either ``CBD Oil'' or ``YOLO.'' The products were
liquids intended to be used in a vaping device or directly ingested
sublingually. Further testing of these products determined that they
contained the synthetic cannabinoid 4-CN-CUMYL-BUTINACA. As per the
Utah Department of Health, adverse reactions included altered mental
status, hallucinations, seizures, confusion, loss of consciousness,
tachycardia or slurred speech.
5. In January 2018, 13 correctional facility workers were treated
for overdose symptoms including diaphoresis, hypertension and
tachycardia following ingestion of an airborne substance while
conducting cell searches for contraband. In response to the overdose
events, evidence retrieved from the searches tested positive for the
synthetic cannabinoids 5F-ADB, 5F-EDMB-PINACA and 4-CN-CUMYL-BUTINACA.
6. Eight countries within Europe have reported just over 50
detections of 5F-CUMYL-P7AICA to the European Monitoring Centre for
Drugs and Drug Addiction (EMCDDA). 5F-CUMYL-P7AICA was typically
detected in plant material or as a powder. The biggest detections
included a 5 kg seizure (December 2014) and 7 kg seizure (January 2015)
of white powder believed to originate from China.
7. Two deaths with confirmed exposure to 5F-CUMYL-P7AICA (detected
along with other substances) have been reported to the EMCDDA. These
occurred in November 2016 and December 2016. In one of the cases, 5F-
CUMYL-P7AICA was reported as the cause of death.
8. In February 2018, 5F-CUMYL-P7AICA was confirmed in a seizure of
powder-material in Bay County, Florida.
Because they share pharmacological similarities with schedule I
substances ([Delta]\9\-THC, JWH-018 and other temporarily and
permanently controlled schedule I SCs), NM2201, 5F-AB-PINACA, 4-CN-
CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA pose serious risk to an
abuser. Tolerance to SCs may develop fairly rapidly with larger doses
being required to achieve the desired effect. Acute and chronic abuse
of SCs in general have been linked to adverse health effects including
signs of addiction and withdrawal, numerous reports of emergency
department admissions resulting from their abuse, overall toxicity and
deaths. Psychiatric case reports have been reported in the scientific
literature detailing the SC abuse and associated psychoses. As abusers
obtain these drugs through unknown sources, the identity and purity of
these substances is uncertain and inconsistent, thus posing significant
adverse health risks to users.
NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-
P7AICA are being encountered on the illicit drug market in the US and/
or Europe and have no accepted medical use in the United States.
Regardless, these products continue to be easily available and abused
by diverse populations.
Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard
to Public Safety
In accordance with 21 U.S.C. 811(h)(3), based on the available data
[[Page 31881]]
and information summarized above, the continued uncontrolled
manufacture, distribution, reverse distribution, importation,
exportation, conduct of research and chemical analysis, possession, and
abuse of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-
CUMYL-P7AICA pose an imminent hazard to the public safety. The DEA is
not aware of any currently accepted medical uses for NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA 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 NM2201, 5F-AB-PINACA,
4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA indicate that these
SCs 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 Acting Administrator, through a letter
dated March 9, 2018, notified the Assistant Secretary of the DEA's
intention to temporarily place NM2201, 5F-AB-PINACA, 4-CN-CUMYL-
BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA in schedule I. A notice of
intent was subsequently published in the Federal Register on May 30,
2018. 83 FR 24696.
Conclusion
In accordance with the provisions of section 201(h) of the CSA, 21
U.S.C. 811(h), the Acting Administrator considered available data and
information, and herein sets forth the grounds for his determination
that it is necessary to temporarily schedule Naphthalen-1-yl 1-(5-
fluoropentyl)-1H-indole-3-carboxylate (trivial name: NM2201; CBL2201);
N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-
carboxamide (trivial name: 5F-AB-PINACA); 1-(4-cyanobutyl)-N-(2-
phenylpropan-2-yl)-1H-indazole-3-carboxamide (trivial name: 4-CN-CUMYL-
BUTINACA; 4-cyano-CUMYL-BUTINACA; 4-CN-CUMYL BINACA; CUMYL-4CN-BINACA;
SGT-78); methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-
methylbutanoate (trivial names: MMB-CHMICA, AMB-CHMICA); and 1-(5-
fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-
carboxamide (trivial name: 5F-CUMYL-P7AICA) in schedule I of the CSA to
avoid an imminent hazard to the public safety.
Because the Acting Administrator hereby finds it necessary to
temporarily place NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA
and 5F-CUMYL-P7AICA in schedule I to avoid an imminent hazard to the
public safety, this temporary order scheduling these substances is
effective on the date of publication in the Federal Register, and is in
effect for a period of two years, with a possible extension of one
additional year, pending completion of the regular (permanent)
scheduling process. 21 U.S.C. 811(h)(1) and (2).
The CSA sets forth specific criteria for scheduling a drug or other
substance. Permanent 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 permanent 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 permanent 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).
Requirements for Handling
Upon the effective date of this temporary order, NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA will be
subject to the regulatory controls and administrative, civil, and
criminal sanctions applicable to the manufacture, distribution, reverse
distribution, importation, exportation, engagement in research, and
conduct of instructional activities or chemical analysis with, and
possession of schedule I controlled substances including the following:
1. Registration. Any person who handles (manufactures, distributes,
reverse distributes, imports, exports, engages in research, or conducts
instructional activities or chemical analysis with, or possesses), or
who desires to handle, NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-
CHMICA and 5F-CUMYL-P7AICA 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, as of July 10, 2018. Any
person who currently handles NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA,
MMB-CHMICA and 5F-CUMYL-P7AICA, and is not registered with the DEA,
must submit an application for registration and may not continue to
handle NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-
CUMYL-P7AICA as of July 10, 2018, unless the DEA has approved that
application for registration pursuant to 21 U.S.C. 822, 823, 957, and
958, and in accordance with 21 CFR parts 1301 and 1312. Retail sales of
schedule I controlled substances to the general public are not allowed
under the CSA. Possession of any quantity of these substances in a
manner not authorized by the CSA on or after July 10, 2018 is unlawful
and those in possession of any quantity of these substances may be
subject to prosecution pursuant to the CSA.
2. Disposal of stocks. Any person who does not desire or is not
able to obtain a schedule I registration to handle NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA must
surrender all currently held quantities of NM2201, 5F-AB-PINACA, 4-CN-
CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA.
3. Security. NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA
and 5F-CUMYL-P7AICA are subject to schedule I security requirements and
must be handled and stored pursuant to 21 U.S.C. 821, 823, 871(b), and
in accordance with 21 CFR 1301.71-1301.93, as of July 10, 2018.
4. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA,
MMB-CHMICA and 5F-CUMYL-P7AICA must be in compliance with 21 U.S.C.
825, 958(e), and be in accordance with 21 CFR part 1302. Current DEA
registrants shall have 30 calendar days from July 10, 2018, to comply
with all labeling and packaging requirements.
5. Inventory. Every DEA registrant who possesses any quantity of
NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-
P7AICA on the effective date of this order must take an inventory of
all stocks of these substances on hand, pursuant to 21 U.S.C. 827 and
958, 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.
After the initial inventory, every DEA registrant must take an
inventory of all controlled substances (including NM2201, 5F-AB-
[[Page 31882]]
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA) on hand on
a biennial basis, pursuant to 21 U.S.C. 827 and 958, and in accordance
with 21 CFR 1304.03, 1304.04, and 1304.11.
6. Records. All DEA registrants must maintain records with respect
to NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-
P7AICA pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21
CFR parts 1304, 1312, 1317 and Sec. 1307.11. Current DEA registrants
authorized to handle NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-
CHMICA and 5F-CUMYL-P7AICA shall have 30 calendar days from the
effective date of this order to be in compliance with all recordkeeping
requirements.
7. Reports. All DEA registrants who manufacture or distribute
NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-
P7AICA must submit reports pursuant to 21 U.S.C. 827 and in accordance
with 21 CFR 1304 and 1312 as of July 10, 2018.
8. Order Forms. All DEA registrants who distribute NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA must comply
with order form requirements pursuant to 21 U.S.C. 828 and in
accordance with 21 CFR part 1305 as of July 10, 2018.
9. Importation and Exportation. All importation and exportation of
NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-
P7AICA must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in
accordance with 21 CFR part 1312 as of July 10, 2018.
10. Quota. Only DEA registered manufacturers may manufacture
NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-
P7AICA in accordance with a quota assigned pursuant to 21 U.S.C. 826
and in accordance with 21 CFR part 1303 as of July 10, 2018.
11. Liability. Any activity involving NM2201, 5F-AB-PINACA, 4-CN-
CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA not authorized by, or in
violation of the CSA, occurring as of July 10, 2018, is unlawful, and
may subject the person to administrative, civil, and/or criminal
sanctions.
Regulatory Matters
Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for a
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
the proposed temporary scheduling order is transmitted to the Assistant
Secretary. 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 the Administrative Procedure Act (APA) at 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 5
U.S.C. 553, the 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 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. 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 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.
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.
As noted above, this action is an order, not a rule. Accordingly,
the Congressional Review Act (CRA) is inapplicable, as it applies only
to rules. However, if this were a rule, pursuant to the CRA, ``any rule
for which an agency for good cause finds 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.'' 5 U.S.C. 808(2). It is in the
public interest to schedule these substances immediately to avoid an
imminent hazard to the public safety. This temporary scheduling action
is taken pursuant to 21 U.S.C. 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. 21 U.S.C. 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 21 U.S.C. 811(h), that is, the DEA's need to move quickly to
place these substances in schedule I because they pose an imminent
hazard to the public safety, it would be contrary to the public
interest to delay implementation of the temporary scheduling order.
Therefore, this order shall take effect immediately upon its
publication. The DEA has submitted a copy of this temporary order to
both Houses of Congress and to the Comptroller General, although such
filing is not required under the Small Business Regulatory Enforcement
Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801-808
because, as noted above, this action is an order, not a rule.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
For the reasons set out above, the DEA amends 21 CFR part 1308 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), 956(b), unless otherwise
noted.
0
2. In Sec. 1308.11, add paragraphs (h)(31) to (35) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(h) * * *
[[Page 31883]]
(31) Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3- (7221)
carboxylate, its optical, positional, and geometric
isomers, salts and salts of isomers (Other names:
NM2201; CBL2201).......................................
(32) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5- (7025)
fluoropentyl)-1H-indazole-3-carboxamide, its optical,
positional, and geometric isomers, salts and salts of
isomers (Other names: 5F-AB-PINACA)....................
(33) 1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H- (7089)
indazole-3-carboxamide, its optical, positional, and
geometric isomers, salts and salts of isomers (Other
names: 4-CN-CUMYL-BUTINACA; 4-cyano-CUMYL-BUTINACA; 4-
CN-CUMYL BINACA; CUMYL-4CN-BINACA; SGT-78).............
(34) methyl 2-(1-(cyclohexylmethyl)-1H-indole-3- (7044)
carboxamido)-3-methylbutanoate, its optical,
positional, and geometric isomers, salts and salts of
isomers (Other names: MMB-CHMICA, AMB-CHMICA)..........
(35) 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H- (7085)
pyrrolo[2,3-b]pyridine-3-carboxamide, its optical,
positional, and geometric isomers, salts and salts of
isomers (Other names: 5F-CUMYL-P7AICA).................
Dated: June 30, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-14718 Filed 7-9-18; 8:45 am]
BILLING CODE 4410-09-P
