[Federal Register Volume 83, Number 104 (Wednesday, May 30, 2018)]
[Proposed Rules]
[Pages 24696-24701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11531]
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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: Proposed amendment; notice of intent.
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SUMMARY: The Acting Administrator of the Drug Enforcement
Administration is issuing this notice of intent to publish a temporary
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), 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 (CSA) is necessary to avoid an
[[Page 24697]]
imminent hazard to the public safety. When it is issued, the temporary
scheduling order will impose regulatory requirements under the CSA on
the manufacture, distribution, reverse distribution, possession,
importation, exportation, research, and conduct of instructional
activities, and chemical analysis of these synthetic cannabinoids, as
well as administrative, civil, and criminal remedies with respect to
persons who fail to comply with such requirements or otherwise violate
the CSA with respect to these substances.
DATES: May 30, 2018.
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: This notice of intent contained in this
document is issued pursuant to the temporary scheduling provisions of
21 U.S.C. 811(h). The Drug Enforcement Administration (DEA) intends to
issue a temporary scheduling order (in the form of a temporary
amendment) placing NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-
CHMICA and 5F-CUMYL-P7AICA in schedule I of the Controlled Substances
Act.\1\ The temporary scheduling order will be published in the Federal
Register on or after June 29, 2018.
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\1\ Though DEA has used the term ``final order'' with respect to
temporary scheduling orders in the past, this notice of intent
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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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
permanently are initiated under 21 U.S.C. 811(a)(1) while the substance
is temporarily controlled under section 811(h), 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 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); 21 CFR part 1308. 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 of
intent by letter dated March 27, 2018, and advised that based on a
review by the Food and Drug Administration (FDA), there are currently
no approved new drug applications or active investigational 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. 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 and 5F-CUMYL-P7AICA under section 505
of the FDCA, 21 U.S.C. 355.
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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 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).
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,
[[Page 24698]]
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,
NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA and MMB-CHMICA have been
seized by law enforcement in the United States. Use of 5F-CUMYL-P7AICA
has not been documented in the United States yet, but 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.
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-PINCA (August, 2013), MMB-CHMICA (December,
2015) and most recently 4-CN-CUMYL BUTINACA (January, 2016). While 5F-
CUMYL-P7AICA has not been encountered within the U.S. yet, the use of
this substance and resulting adverse events have been documented in
Europe. Based on the similarity between trafficking patterns,
distribution and use of 5F-CUMYL-P7AICA versus other illicit SCs, 5F-
CUMYL-P7AICA poses significant risk for emergence in illicit drug
markets in the United States. Following their manufacture in China, SCs
are often encountered in countries including New Zealand, Australia and
Russia before appearing throughout Europe and eventually the U.S.
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.
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
[[Page 24699]]
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-AB-PINACA, SCs that were popular in 2014 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 and
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: 2,705 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, 2017 data were still reporting.
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5F-AB-PINACA: 1,141 NFLIS reports from 36 states since 2013, 188
STRIDE/STARLiMS reports from 17 states plus DC and Guam since 2013.
4-CN-CUMYL-BUTINACA: 59 NFLIS reports from 3 states since 2016.
MMB-CHMICA: 201 NFLIS reports from 17 states since 2015, 96
STARLiMS reports from 8 states plus DC since 2015.
5F-CUMYL-P7AICA: Currently international seizures only.
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
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. 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.
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.
[[Page 24700]]
NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-
P7AICA are being encountered on the illicit drug market in the U.S.
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
and information summarized above, the continued uncontrolled
manufacture, distribution, reverse distribution, importation,
exportation, conduct of research and chemical analysis, possession,
and/or abuse of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA
and 5F-CUMYL-P7AICA, resulting from the lack of control of these
substances, 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.
Conclusion
This notice of intent provides the 30-day notice pursuant to
section 201(h) of the CSA, 21 U.S.C. 811(h), of the DEA's intent to
issue a temporary scheduling order. 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, herein set
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, and finds that
placement of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and
5F-CUMYL-P7AICA in schedule I of the CSA on a temporary basis is
necessary to avoid an imminent hazard to the public safety.
The temporary placement of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-
BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA in schedule I of the CSA will
take effect pursuant to a temporary scheduling order, which will not be
issued before June 29, 2018. Because the Acting Administrator hereby
finds that it is 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, the temporary order
scheduling these substances will be effective on the date that order is
published 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 regular (permanent) scheduling process. 21 U.S.C.
811(h)(1) and (2). It is the intention of the Acting Administrator to
issue a temporary scheduling order as soon as possible after the
expiration of 30 days from the date of publication of this notice. Upon
publication of the 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, research, conduct of instructional activities
and chemical analysis, and possession of a schedule I controlled
substance.
The CSA sets forth specific criteria for scheduling a drug or other
substance. Regular scheduling actions in accordance with 21 U.S.C.
811(a) are subject to formal rulemaking procedures done ``on the record
after opportunity for a hearing'' conducted pursuant to the provisions
of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The regular scheduling process
of formal rulemaking affords interested parties with appropriate
process and the government with any additional relevant information
needed to make a determination. Final decisions that conclude the
regular scheduling process of formal rulemaking are subject to judicial
review. 21 U.S.C. 877. Temporary scheduling orders are not subject to
judicial review. 21 U.S.C. 811(h)(6).
Regulatory Matters
Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for 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 of HHS. 21 U.S.C. 811(h)(1).
Inasmuch as section 201(h) of the CSA directs that temporary
scheduling actions be issued by order and sets forth the procedures by
which such orders are to be issued, the DEA believes that the notice
and comment requirements of section 553 of the Administrative Procedure
Act (APA), 5 U.S.C. 553, do not apply to this notice of intent. In the
alternative, even assuming that this notice of intent might be subject
to section 553 of the APA, the Acting Administrator finds that there is
good cause to forgo the notice and comment requirements of section 553,
as any further delays in the process for issuance of temporary
scheduling orders would be impracticable and contrary to the public
interest in view of the manifest urgency to avoid an imminent hazard to
the public safety.
Although the DEA believes this notice of intent to issue a
temporary scheduling order is not subject to the notice and comment
requirements of section 553 of the APA, the DEA notes that in
accordance with 21 U.S.C. 811(h)(4), the Acting Administrator took into
consideration comments submitted by the Assistant Secretary in response
to the notice that DEA transmitted to the
[[Page 24701]]
Assistant Secretary pursuant to section 811(h)(4).
Further, the DEA believes that this temporary scheduling action is
not a ``rule'' as defined by 5 U.S.C. 601(2), and, accordingly, is not
subject to the requirements of the Regulatory Flexibility Act (RFA).
The requirements for the preparation of an initial regulatory
flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as
here, the DEA is not required by section 553 of the APA or any other
law to publish a general notice of proposed rulemaking.
Additionally, this action is not a significant regulatory action as
defined by Executive Order 12866 (Regulatory Planning and Review),
section 3(f), and, accordingly, this action has not been reviewed by
the Office of Management and Budget.
This action will not have substantial direct effects on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government. Therefore, in accordance with Executive Order
13132 (Federalism) it is determined that this action does not have
sufficient federalism implications to warrant the preparation of a
Federalism Assessment.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
For the reasons set out above, the DEA proposes to amend 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 paragraph (h)(31) to (35) to read as follows:
11, add paragraphs (h)(31) through (35) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(h) * * *
(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-indazole-3- (7089)
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: May 23, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-11531 Filed 5-29-18; 8:45 am]
BILLING CODE 4410-09-P