[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