[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]


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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: 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