[Federal Register Volume 83, Number 248 (Friday, December 28, 2018)]
[Proposed Rules]
[Pages 67166-67171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-28110]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-491]
Schedules of Controlled Substances: Temporary Placement of 5F-
EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 in
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 (SCs), ethyl 2-(1-(5-
fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate (trivial
name: 5F-EDMB-PINACA); methyl 2-(1-(5-fluoropentyl)-1H-indole-3-
carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-MDMB-PICA); N-
(adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (trivial
name: FUB-AKB48; FUB-APINACA; AKB48 N-(4-FLUOROBENZYL)); 1-(5-
fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxamide
(trivial names: 5F-CUMYL-PINACA; SGT-25); and (1-(4-fluorobenzyl)-1H-
indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)
[[Page 67167]]
methanone (trivial name: FUB-144), in schedule I. This action is based
on a finding by the Acting Administrator that the placement of these
SCs in schedule I of the Controlled Substances Act (CSA) is necessary
to avoid an 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 SCs, 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: December 28, 2018.
FOR FURTHER INFORMATION CONTACT: Kathy L. Federico, Regulatory Drafting
and Policy Support Section (DPW), 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 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-
PINACA and FUB-144 in schedule I of the Controlled Substances Act
(CSA).\1\ The temporary scheduling order will be published in the
Federal Register on or after January 28, 2019.
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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 CSA 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.\2\ 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.\3\
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\2\ 21 U.S.C. 811(h)(1).
\3\ Id. at 811(h)(2).
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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,\4\ 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).\5\ The Attorney General has delegated
scheduling authority under 21 U.S.C. 811 to the Administrator of the
DEA.\6\
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\4\ 21 U.S.C. 812.
\5\ 21 U.S.C. 811(h)(1); 21 CFR part 1308(h).
\6\ 28 CFR 0.100.
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Background
Section 201(h)(4) of the CSA 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.\7\ The Acting Administrator transmitted notice of his intent to
place 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-
144 in schedule I on a temporary basis to the Assistant Secretary for
Health of HHS by letter dated August 24, 2018. The Assistant Secretary
responded to this notice of intent by letter dated September 6, 2018,
and advised that based on a review by the Food and Drug Administration
(FDA), there are currently no approved new drug applications or
investigational new drug applications for 5F-EDMB-PINACA, 5F-MDMB-PICA,
FUB-AKB48, 5F-CUMYL-PINACA and FUB-144. The Assistant Secretary also
stated that HHS has no objection to the temporary placement of 5F-EDMB-
PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA or FUB-144 in schedule
I of the CSA. 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA
or FUB-144 are not currently listed in any schedule under the CSA, and
no exemptions or approvals are in effect for 5F-EDMB-PINACA, 5F-MDMB-
PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 under section 505 of the
FDCA.\8\
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\7\ 21 U.S.C. 811(h)(4); As discussed in a memorandum of
understanding entered into by the 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).
\8\ 21 U.S.C. 355.
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In order to place a substance temporarily in schedule I of the CSA
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): (1) The substance's history and current pattern of abuse; (2)
the scope, duration and significance of abuse; and (3) what, if any,
risk there is to the public health.\9\ Consideration of these factors
includes actual abuse, diversion from legitimate channels, and
clandestine importation, manufacture, or distribution.\10\
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\9\ 21 U.S.C. 811(h)(3).
\10\ Id.
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A substance meeting the statutory requirements for temporary
scheduling may only be placed in schedule I.\11\ Substances in schedule
I are those that have a high potential for abuse, no currently accepted
medical use for treatment in the United States, and a lack of accepted
safety for use under medical supervision.\12\
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\11\ 21 U.S.C. 811(h)(1).
\12\ 21 U.S.C. 812(b)(1).
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Synthetic Cannabinoids
The illicit use of SCs continues to cause severe adverse effects,
overdoses and deaths in the United States. 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 to 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, misuse of SCs has escalated in the United
States as evidenced by large numbers of law enforcement encounters of
SCs applied onto plant material and in other designer drug products
intended for human consumption. Recent hospital reports, scientific
publications, and/or law enforcement reports demonstrate that 5F-EDMB-
PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, FUB-144, and their
associated designer drug products are being abused for their
psychoactive properties (see DEA 3-Factor Analysis). As with many
generations of SCs encountered since 2009, the abuse of 5F-EDMB-PINACA,
5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 is negatively
impacting communities in the United States.
As noted 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,
[[Page 67168]]
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).
5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-
144 have no accepted medical use in the United States. Use of 5F-MDMB-
PICA, 5F-EDMB-PINACA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 has been
reported to result in adverse effects in humans in the United States
(see DEA 3-Factor Analysis). In addition, there have been multiple law
enforcement seizures of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-
CUMYL-PINACA and FUB-144 in the United States. Use of other SCs has
resulted in signs of addiction and withdrawal. Based on the
pharmacological similarities between 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-
AKB48, 5F-CUMYL-PINACA and FUB-144 and other SCs, these five SCs are
likely to produce signs of addiction and withdrawal similar to those
produced by other SCs.
5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-
144 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 5F-CUMYL-PINACA, 5F-EDMB-
PINACA and FUB-144 has been associated with multiple overdoses
requiring emergency medical intervention (see DEA 3-Factor Analysis)
while deaths have been reported that involved FUB-AKB48. With no
approved medical use and limited safety or toxicological information,
5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144
have emerged in the designer drug market, and the abuse of these
substances for their psychoactive properties is concerning.
Factor 4. History and Current Pattern of Abuse
SCs 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 controlled as schedule I
substances, 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 (15 of these
are SCs) into 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, May 16, 2013; 79 FR 7577, February 10, 2014) other
generations of SCs appeared and were temporarily controlled, including
AB-CHMINACA, AB-PINACA, THJ-2201 (80 FR 5042, January 30, 2015), MAB-
CHMINACA (81 FR 6171, February 5, 2016), 5F-ADB, 5F-AMB, 5F-ABK48, ADB-
FUBINACA, MDMB-CHMICA, MDMB-FUBINACA (82 FR 17119, April 10, 2017),
FUB-AMB (82 FR 51154, November 3, 2017) NM2201, 5F-AB-PINACA, 4-CN-
CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA (83 FR 31877, July 10,
2018).
FUB-AKB48 was first identified in seized drug evidence in October
2013, followed by FUB-144 (January 2014), 5F-MDMB-PICA (October 2016),
5F-EDMB-PINACA (October 2017) and 5F-CUMYL-PINACA (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 in the United States. 5F-CUMYL-PINACA
was first reported in the German and Swiss illicit drug market in 2015
but didn't show up in the United States until February 2018; 5F-EDMB-
PINACA was reported in China in 2016 but didn't appear in the United
States until October 2017; and 5F-MDMB-PICA was reported in Germany in
August 2016 and November 2016 in Belgium, a few months before showing
up in the United States. These data further support that based upon
trends, SCs appear in the illicit drug markets of other countries
including those in Europe, often before being trafficked in the United
States. The misuse of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-
CUMYL-PINACA and FUB-144 has been associated with law enforcement
seizures, overdoses requiring emergency medical intervention, or both
(see DEA 3-Factor Analysis).
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, 5F-EDMB-PINACA was identified as an adulterant on pieces of
paper that were smuggled into a detention facility and later found
partially burned (see DEA 3- Factor Analysis). 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, or in 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 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.
5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-
144, 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
5F-EDMB-PINACA and FUB-144 have included seizures, agitation, vomiting,
tachycardia and elevated blood pressure (see DEA 3-Factor Analysis).
Factor 5. Scope, Duration and Significance of Abuse
SCs continue to be encountered in the illicit market despite
scheduling actions that attempt to safeguard the public from the
adverse effects and safety issues associated with these substances
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(see DEA 3-Factor Analysis). 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 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. The threat
of serious injury to the individual and the imminent threat to public
safety following the ingestion of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-
AKB48, 5F-CUMYL-PINACA and FUB-144 and other SCs persist.
Full reports of information obtained through STARLiMS,\13\
STRIDE,\14\ and NFLIS \15\ for the past five years may be found in 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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\13\ 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
System to Retrieve Information from Drug Evidence (STRIDE) as the
DEA laboratory drug evidence data system of record.
\14\ 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.
\15\ The National Forensic Laboratory Information System (NFLIS)
is a national forensic laboratory reporting system that
systematically collects results from drug chemistry analyses
conducted by State and local forensic laboratories in the United
States.
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5F-EDMB-PINACA was identified in 205 different NFLIS
reports from five states since 2017,\16\ and 16 STRIDE/STARLiMS reports
from one state since 2017.
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\16\ At the time of query, 2017 data were still reporting.
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5F-MDMB-PICA was identified in 115 NFLIS reports from 18
states since 2016.
FUB-AKB48 was identified in 342 NFLIS reports from 20
states since 2014, and 36 STRIDE/STARLiMS reports from eight states
since 2013.
5F-CUMYL-PINACA was identified in three NFLIS reports from
two states since 2018.
FUB-144 was identified in 346 NFLIS reports from 26 states
since 2014, 71 STARLiMS reports from 13 states plus Washington, DC
since 2014.
Factor 6. What, if Any, Risk There Is to the Public Health
Since first being identified in the United States in 2008, the
ingestion of SCs continues to result in serious adverse effects.
Details of these events involving 5F-CUMYL-PINACA, 5F-EDMB-PINACA, FUB-
144, FUB-AKB48, and 5F-MDMB-PICA are summarized below.
1. In 2015, in London (United Kingdom), a 34 year-old male was
hospitalized after ingesting a synthetic cannabinoid product.
Toxicological analysis identified 5F-AKB48 and 5F-CUMYL-PINACA in
biological samples.
2. In September 2018, law enforcement in Georgia seized multiple
electronic cigarettes with various colored viscous liquids following
the reports of overdoses. Laboratory analysis on the seized evidence
determined the substance to be 5F-CUMYL-PINACA.
3. In late November and early December 2015, in Jackson, MS, five
individuals presented at local emergency facilities following ingestion
of a synthetic cannabinoid-containing product. Evidence collected from
the individuals tested positive for THC, MAB-CHMINACA and FUB-144.
Toxicological analysis of biological samples in all five patients
identified THC, MAB-CHMINACA, and FUB-144.
4. In March 2017, in Chaves, NM, a 14 year-old female was found in
the bathroom of her home with seizure-like activity. Following
transport to a local hospital by family members, she was pronounced
dead approximately 20 minutes later. Toxicological analysis upon
autopsy identified three SCs: FUB-AKB48, AB-CHMINACA, and ADB-CHMINACA
(MAB-CHMINACA). The cause of death was determined to be toxic effects
of synthetic cannabinoids (FUB-AKB48, AB-CHMINACA, and ADB-CHMINACA).
5. In January 2018, in Pittsburgh, PA, 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. In March 2018, in Chicago, IL, a 22 year-old male expired at a
local hospital. Toxicological analysis confirmed buprenorphine,
brodifacoum, bromadiolone, FUB-AMB and FUB-AKB48 in biological samples
of this decedent.
7. In April 2018, in Harrisburg, PA, a 38-year old male presented
at a local hospital due to repeated nosebleeds, gastrointestinal
bleeding with anemia and bruising on his arms. Toxicological analysis
confirmed brodifacoum, FUB-AMB, and FUB-AKB48 in biological samples.
8. In April 2018, in Harrisburg, PA, another patient presented at a
local hospital due to significant bleeding and anemia requiring a
transfusion. Toxicological analysis confirmed brodifacoum, FUB-AMB, and
FUB-AKB48 in biological samples.
9. In June 2018, in Chicago, IL, a 25-year old male expired at a
local hospital. Toxicological analysis confirmed brodifacoum,
bromadiolone, FUB-AMB and FUB-AKB48 in biological samples of this
decedent.
10. In July 2018, in Washington, DC, in excess of 260 overdoses and
four deaths were reported following use of a synthetic cannabinoid
product. Analysis of drug evidence from the overdose event confirmed
the presence of the synthetic cannabinoids FUB-AMB, EMB-FUBINACA and
FUB-144.
11. In August 2018, in New Haven, CT, in excess of 47 overdoses
were reported following the use of a synthetic cannabinoid product.
Analysis of drug evidence from the overdose event confirmed the
presence of the synthetic cannabinoids 5F-ADB, FUB-AMB and 5F-MDMB-
PICA.
12. From September 10-16, 2018, in Washington, DC, at least 244
overdoses were reported following use of a synthetic cannabinoid
product. Analysis of drug evidence from the overdose event confirmed
the presence of the synthetic cannabinoids FUB-AMB and 5F-MDMB-PICA.
Because they share pharmacological similarities with schedule I
substances ([Delta]\9\-THC, JWH-018 and other temporarily and
permanently controlled schedule I SCs), 5F-EDMB-PINACA, 5F-MDMB-PICA,
FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 pose serious risks 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, and 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
[[Page 67170]]
posing significant adverse health risks to users.
5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-
144 are being encountered on the illicit drug market 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) and based on the 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 5F-EDMB-
PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144,
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 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-
AKB48, 5F-CUMYL-PINACA, and FUB-144 in the United States. A substance
meeting the statutory requirements for temporary scheduling may only be
placed in schedule I.\17\ 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.\18\ Available data and information for 5F-
EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144
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,\19\ the Acting Administrator, through a
letter dated August 24, 2018, notified the Assistant Secretary for
Health of the DEA's intention to temporarily place 5F-EDMB-PINACA, 5F-
MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 in schedule I and
considered the Assistant Secretary's response.
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\17\ 21 U.S.C. 811(h)(1).
\18\ 21 U.S.C. 812(b)(1).
\19\ 21 U.S.C. 811(h)(4).
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Conclusion
This notice of intent provides the 30-day notice, pursuant to
section 201(h) of the CSA,\20\ of the DEA's intent to issue a temporary
scheduling order. In accordance with the provisions of section 201(h)
of the CSA, the Acting Administrator considered available data and
information, and herein sets forth the grounds for his determination
that it is necessary to temporarily schedule ethyl 2-(1-(5-
fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate (trivial
name: 5F-EDMB-PINACA); methyl 2-(1-(5-fluoropentyl)-1H-indole-3-
carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-MDMB-PICA); N-
(adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (trivial
name: FUB-AKB48; FUB-APINACA; AKB48 N-(4-FLUOROBENZYL)); 1-(5-
fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxamide
(trivial names: 5F-CUMYL-PINACA; SGT-25); and (1-(4-fluorobenzyl)-1H-
indol-3-yl)(2,2,3,3-tetramethylcyclopropyl) methanone (trivial name:
FUB-144) in schedule I of the CSA and finds that placement of 5F-EDMB-
PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 in
schedule I of the CSA on a temporary basis is necessary to avoid an
imminent hazard to the public safety.
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\20\ 21 U.S.C. 811(h).
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The temporary placement of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48,
5F-CUMYL-PINACA, and FUB-144 in schedule I of the CSA will take effect
pursuant to a temporary scheduling order, which will not be issued
before January 28, 2019. Because the Acting Administrator hereby finds
that it is necessary to temporarily place 5F-EDMB-PINACA, 5F-MDMB-PICA,
FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 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\ 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 document. Upon publication of the temporary
order, 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and
FUB-144 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.
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\21\ 21 U.S.C. 811(h)(1) and (2).
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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.\22\ 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.\23\ Temporary scheduling orders are not subject to judicial
review.\24\
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\22\ 21 U.S.C. 811.
\23\ 21 U.S.C. 877.
\24\ 21 U.S.C. 811(h)(6).
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Regulatory Matters
Section 201(h) of the CSA 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.\25\
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\25\ 21 U.S.C. 811(h)(1).
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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) \26\ 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.
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\26\ 5 U.S.C. 553.
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Although the DEA believes this notice of intent to issue a
temporary
[[Page 67171]]
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 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 paragraphs (h)(37) through (41) to read as
follows:
Sec. 1308.11 Schedule I
* * * * *
(h) * * *
(37) thyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-
dimethylbutanoate, its optical, positional, and geometric isomers,
salts and salts of isomers (trivial name: 5F-EDMB-PINACA)-(7036)
(38) methyl 2-(1-(5-fluoropentyl)-1H-indole-3-carboxamido)-3,3-
dimethylbutanoate, its optical, positional, and geometric isomers,
salts and salts of isomers (trivial name: 5F-MDMB-PICA)-(7041)
(39) N-(adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole-3-
carboxamide, its optical, positional, and geometric isomers, salts and
salts of isomers (trivial name: FUB-AKB48; FUB-APINACA; AKB48 N-(4-
FLUOROBENZYL))-(7047)
(40) 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-
carboxamide, its optical, positional, and geometric isomers, salts and
salts of isomers (trivial names: 5F-CUMYL-PINACA; SGT-25)-(7083)
(41) (1-(4-fluorobenzyl)-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone, its optical, positional, and
geometric isomers, salts and salts of isomers (trivial name: FUB-144)-
(7014)
Dated: December 20, 2018.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2018-28110 Filed 12-27-18; 8:45 am]
BILLING CODE 4410-09-P