[Federal Register Volume 80, Number 20 (Friday, January 30, 2015)]
[Rules and Regulations]
[Pages 5042-5047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01776]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-402]
Schedules of Controlled Substances: Temporary Placement of Three
Synthetic Cannabinoids Into Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final order.
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SUMMARY: The Administrator of the Drug Enforcement Administration is
issuing this final order to temporarily schedule three synthetic
cannabinoids (SCs) into schedule I pursuant to the temporary scheduling
provisions of the Controlled Substances Act (CSA). The substances are:
(1) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-
indazole-3-carboxamide (``AB-CHMINACA''); (2) N-(1-amino-3-methyl-1-
oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (``AB-PINACA''); and
(3) [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone
(``THJ-2201''). This action is based on a finding by the Administrator
that the placement of these synthetic cannabinoids and their optical,
positional, and geometric isomers, salts, and salts of isomers into
schedule I of the CSA 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, import, export, engage in research, or
possess), or propose to handle these SCs.
DATES: This final order is effective January 30, 2015.
FOR FURTHER INFORMATION CONTACT: Imelda L. Paredes, Office of Diversion
Control, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.
SUPPLEMENTARY INFORMATION:
Legal Authority
The Drug Enforcement Administration (DEA) implements and enforces
titles II and III of the Comprehensive Drug Abuse Prevention and
Control Act of 1970, as amended. Titles II and III are referred to as
the ``Controlled Substances Act'' and the ``Controlled Substances
Import and Export Act,'' respectively, and are collectively referred to
as the ``Controlled Substances Act'' or the ``CSA'' for the purpose of
this action. 21 U.S.C. 801-971. The DEA publishes the implementing
regulations for these statutes in title 21 of the Code of Federal
Regulations (CFR), chapter II. The CSA and its implementing regulations
are designed to prevent, detect, and eliminate the diversion of
controlled substances and listed chemicals into the illicit market
while providing for the legitimate medical, scientific, research, and
industrial needs of the United States. Controlled substances have the
potential for abuse and dependence and are controlled to protect the
public health and safety.
Under the CSA, each controlled substance is classified into one of
five schedules based upon its potential for abuse, its currently
accepted medical use, and the degree of dependence the drug or other
substance may cause. 21 U.S.C. 812. The initial schedules of controlled
substances established by Congress are found at 21 U.S.C. 812(c), and
the current list of all scheduled substances is published at 21 CFR
part 1308.
Section 201 of the CSA, 21 U.S.C. 811, provides the Attorney
General with the authority to temporarily place a
[[Page 5043]]
substance into 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). 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 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 his
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 DEA
to notify the Department of Health and Human Services (HHS) of the
intent to temporarily place a substance into schedule I of the CSA.\1\
The DEA transmitted notice of the intent to place AB-CHMINACA, AB-
PINACA, and THJ-2201 in schedule I on a temporary basis to the
Assistant Secretary by letter dated September 17, 2014. The Assistant
Secretary responded to this notice by letter dated September 30, 2014,
and advised that based on a review by the Food and Drug Administration
(FDA), there are currently no investigational new drug applications or
approved new drug applications for AB-CHMINACA, AB-PINACA, or THJ-2201.
The Assistant Secretary also stated that HHS has no objection to the
temporary placement of AB-CHMINACA, AB-PINACA, and THJ-2201 into
schedule I of the CSA.
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\1\ Because the Secretary of the HHS has delegated to the
Assistant Secretary for Health of the HHS the authority to make
domestic drug scheduling recommendations, for purposes of this Final
Order, all subsequent references to ``Secretary'' have been replaced
with ``Assistant Secretary.'' As set forth 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 Assistant Secretary's
scheduling responsibilities under the CSA, with the concurrence of
NIDA. 50 FR 9518, March 8, 1985.
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The DEA has taken into consideration the Assistant Secretary's
comments as required by 21 U.S.C. 811(h)(4). AB-CHMINACA, AB-PINACA,
and THJ-2201 are not currently listed in any schedule under the CSA,
and no exemptions or approvals are in effect for AB-CHMINACA, AB-
PINACA, or THJ-2201 under section 505 of the FDCA, 21 U.S.C. 355. The
DEA has found that the scheduling of AB-CHMINACA, AB-PINACA, and THJ-
2201 in schedule I on a temporary basis is necessary to avoid an
imminent hazard to public safety, and as required by 21 U.S.C.
811(h)(1)(A), a notice of intent to temporarily schedule these three
synthetic cannabinoids (SCs) was published in the Federal Register on
December 19, 2014. 79 FR 75767.
To find that placing a substance temporarily into 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). Available data and information for
AB-CHMINACA, AB-PINACA, and THJ-2201 indicate that these three 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.
Synthetic Cannabinoids
SCs are chemicals synthesized in laboratories and mimic the
biological effects of delta-9-tetrahydrocannabinol (THC), the main
psychoactive ingredient in marijuana. These chemicals, such as CP-
47,497 and cannabicyclohexanol (both designed in the 1980s and
currently controlled pursuant to the Food and Drug Administration
Safety and Innovation Act (FDASIA), Pub. L. 112-144), were initially
used as research tools to investigate the biological mechanisms in the
cannabinoid system and to develop novel therapies for various clinical
conditions. Other SCs including JWH-018, JWH-073, and JWH-200 (all
permanently controlled pursuant to FDASIA) were synthesized in the mid-
1990s and studied to advance the understanding of drug-receptor
interactions in the cannabinoid system.
SCs were marketed 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. In 2009, their
use began increasing in the United States, with law enforcement
encounters describing SCs laced on plant material and being abused for
their psychoactive properties. Forensic analyses by the DEA and other
Federal, State, and local laboratories have identified multiple
variations in both the type and amount of SCs applied to the plant
material.
As observed by the DEA and CBP, SCs originate from foreign sources,
including China and other countries in Southeast Asia. Bulk substances
are smuggled via common carrier into the United States and find their
way to clandestine manufacturing operations located in residential
neighborhoods, garages, warehouses, and other similar destinations
throughout the country. The powder form of SCs is typically dissolved
in solvents (e.g., acetone) before being applied to a green plant
material or dissolved in a propellant intended for use in e-cigarette
devices.
SCs are marketed under hundreds of different brand names, including
``Spice,'' ``K2,'' ``Blaze,'' ``Red X Dawn,'' ``Paradise,'' ``Demon,''
``Black Magic,'' ``Spike,'' ``Mr. Nice Guy,'' ``Ninja,'' ``Zohai,''
``Yucatan,'' ``Fire,'' ``Crazy Clown,'' ``Mojo,'' ``Black Mamba,''
``Black Voodoo,'' ``Scooby Snax,'' ``Bizzaro,'' and many others. In
addition, various ``new generations'' of SCs reflect the same or
similar product labels while yielding a higher intensity and longer-
lasting highs while the user remains unaware of the package's exact
contents.
The drug products laced with SCs are often sold under the guise of
``herbal incense,'' ``potpourri,'' etc., using various product names
and routinely labeled ``not for human consumption.'' Additionally,
these products are marketed as a ``legal high'' or ``legal alternative
to marijuana'' and are readily available over the Internet, in head
shops, and in convenience stores. There is an incorrect assumption that
these products are safe and further, that mislabeling these products as
``not for human consumption'' is a legal defense to criminal
prosecution.
These substances have no accepted medical use in the United States
and have been reported to produce adverse health effects in humans
while having a negative effect on communities. Acute and chronic abuse
of SCs in general have been linked to adverse health
[[Page 5044]]
effects including signs of addiction and withdrawal, numerous reports
of emergency room admissions resulting from their abuse, overall
toxicity, and death.
AB-CHMINACA, AB-PINACA, and THJ-2201 are SCs that have
pharmacological effects similar to the schedule I hallucinogen THC and
other temporarily and permanently controlled schedule I substances.
With no approved medical use in treatment in the United States and
limited safety or toxicological information, AB-CHMINACA, AB-PINACA,
and THJ-2201 have emerged on the illicit drug market and are being
abused for their psychoactive properties. The DEA's analysis is
available in its entirety under ``Supporting and Related Material'' of
the public docket for this action at www.regulations.gov under docket
number DEA-402.
Factor 4. History and Current Pattern of Abuse
SCs were initially developed over the last 30 years as part of
research efforts to investigate the cannabinoid system. SCs intended
for illicit use were first reported in the United States in a November
2008 encounter, when a shipment of ``Spice'' was seized and analyzed by
CBP in Dayton, Ohio, and later identified as containing JWH-018. At
approximately the same time, in December 2008, JWH-018 and
cannabicyclohexanol (CP-47,497 C8 homologue) were identified by German
forensic laboratories. Since then, many other SCs have been found
applied on plant material and encountered as drug products. Beginning
in January 2010, the popularity of these cannabinoids and their
associated products appears to have increased in the United States as
evidenced by seizure exhibits and public health and media reports.
Numerous SCs have previously been identified as product
adulterants, and law enforcement officials have seized bulk amounts of
these substances.\2\ The first SCs identified as being abused include
JWH-018, JWH-073, JWH-200, CP-47,497, and CP-47,497 C8 homologue,
followed shortly thereafter by new generations of SCs including UR-144,
XLR11, AKB48, PB-22, 5F-PB-22, AB-FUBINACA, ADB-PINACA, and numerous
others that vary only slightly in chemical structure. JWH-018, JWH-073,
JWH-200, CP-47,497, and CP-47,497 C8 homologue were temporarily
scheduled on March 1, 2011, 76 FR 11075, and later permanently placed
into schedule I by section 1152 of FDASIA on July 9, 2012. Section 1152
of FDASIA amended the CSA by placing cannabimimetic agents and 26
specific substances (including 15 SCs, 2 synthetic cathinones, and 9
synthetic phenethylamines of the 2C- series) into schedule I. UR-144,
XLR11, and AKB48 were temporarily scheduled on May 16, 2013. 78 FR
28735. PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA were temporarily
scheduled on February 10, 2014. 79 FR 7577.
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\2\ While seizure evidence is not direct evidence of abuse, it
can lead to an inference that a drug has been diverted and abused.
See 76 FR 77330, 77332, December 12, 2011.
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Recently, another generation of SCs including AB-CHMINACA, AB-
PINACA, and THJ-2201 has been encountered. AB-CHMINACA, AB-PINACA, and
THJ-2201 are not included among the 15 SCs that are specifically
controlled under FDASIA, and do not fall under the definition of
``cannabimimetic agents'' as provided under FDASIA. Furthermore, as
detailed in reports, law enforcement and public health officials are
encountering the abuse of these substances and products laced with
these substances, which are commonly marketed under the guise of being
a ``legal high'' with a disclaimer that the products are ``not for
human consumption.''
As with the older generation of SCs, the major concern of public
health officials and medical professionals regarding these new products
is the targeting and direct marketing toward adolescents and youth.
This is supported by law enforcement encounters and reports from
emergency rooms (see Factor 6 of Background Information and Evaluation
of ``Three Factor Analysis'' (Factors 4, 5, and 6) for Temporary
Scheduling). However, media reports indicate that all age groups abuse
these substances and related products. Additionally, law enforcement
has been encountering new variations of SCs in liquid form. The liquids
contain one or more SCs, including AB-CHMINACA and AB-PINACA. Users
have been identified applying the liquid to hookahs (an instrument for
vaporizing and smoking a given material whereby the smoke or vapor
passes through a water basin prior to inhalation), vaporizers (also
known as ``vaping'' or using an ``e-cigarette,'' which allows the user
to administer a liquid to be aerosolized and then inhaled), and hookah
pens (a type of vaporizer, often much smaller and intended for
increased discretion while smoking). As with conventional illicit
manufacturing of SC products, liquid preparations of these substances
do not adhere to any manufacturing standards with regard to dosage, the
substance(s) included, purity, or contamination. It is therefore
important to note that following manufacturing principles or standards
would not eliminate the adverse effects observed with SC products and
SCs would still be considered a threat to public safety.
Factor 5. Scope, Duration and Significance of Abuse
Despite multiple scheduling actions undertaken by the DEA in an
attempt to safeguard the public from the adverse effects and safety
issues associated with SCs, encounters by law enforcement and health
care professionals demonstrate the continued abuse of these substances
and their associated products. With the passing of each Federal control
action, clandestine drug manufacturers and suppliers are adapting at an
alarmingly quick pace to switch the ingredients to new, non-controlled
variations of SCs. Exposure incidents involving SCs continue to be
documented by poison control centers in the United States as the abuse
of these substances remain a threat to both the short- and long-term
public health and safety. Exposures to SCs were first reported to the
American Association of Poison Control Centers (AAPCC) in 2011.
Recently, the number of AAPCC exposure reports has begun to increase,
demonstrating the dangerous health effects observed involving these
chemicals. Exposures for August 2014 (442) were the highest received in
a monthly period by the AAPCC since July 2012 (when there were 459). As
of November 30, 2014, the AAPCC has received approximately 3,359 calls
involving exposure to SCs for 2014.
The following information details information obtained through
STRIDE \3\ and NFLIS,\4\ including the number of exhibits/reports,
dates of first encounter, and locations of those encounters where
available: \5\
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\3\ System to Retrieve Information from Drug Evidence (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 law enforcement agencies. STRIDE was last queried on
October 1, 2014. Note that reporting via STRIDE ceased on September
30, 2014.
\4\ National Forensic Laboratory Information System (NFLIS) is a
national drug forensic laboratory reporting system that
systematically collects results from drug chemistry analyses
conducted by state and local forensic laboratories in the United
States. NFLIS was last queried on November 25, 2014.
\5\ Supra note 2.
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For AB-CHMINACA, STRIDE contained 21 exhibits, with the first
encounter in March 2014. NFLIS contained 586 reports, with the first
encounter in February 2014, and locations of all encounters spanning
Arkansas, Arizona, California, Colorado, Georgia, Iowa, Indiana,
Kansas,
[[Page 5045]]
Kentucky, Louisiana, Missouri, North Dakota, New Jersey, Ohio,
Oklahoma, Pennsylvania, Tennessee, Texas, and Wisconsin.
For AB-PINACA, STRIDE contained 245 exhibits, with the first
encounter in June 2013. NFLIS contained 3,783 reports, with the first
encounter in March 2013, and locations of all encounters spanning
Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida,
Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana,
Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North
Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio,
Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah,
Virginia, Washington, Wisconsin, West Virginia, and Wyoming.
For THJ-2201, STRIDE contained 65 exhibits, with the first
encounter in September 2013. NFLIS contained 220 reports, with the
first encounter in January 2014, and locations of all encounters
spanning Arkansas, Arizona, Connecticut, Georgia, Iowa, Illinois,
Indiana, Kansas, Kentucky, Minnesota, Missouri, North Dakota, Nebraska,
New Hampshire, New Jersey, Ohio, Pennsylvania, Tennessee, and
Wisconsin.
Factor 6. What, if Any, Risk There is to the Public Health
AB-PINACA has been for sale on the illicit drug market as early as
March 2013. Meanwhile, THJ-2201 was first observed in September 2013,
and AB-CHMINACA was first observed in February 2014. From December 2013
through September 2014, CBP reported select encounters of these
substances with most shipments originating in China and intended for
destinations within the United States. Specifically, there were 17
seizures of AB-CHMINACA involving 15.825 kilograms total; 4 seizures of
AB-PINACA 6 kilograms total; and 6 seizures of THJ-2201 involving 5.5
kilograms total (see Three Factor Analysis). Additionally, the DEA has
reported multiple encounters of large quantities of AB-CHMINACA, AB-
PINACA and THJ-2201 that have been confirmed by forensic laboratories
(STRIDE and/or NFLIS).
From October 2013 to September 2014, multiple deaths and severe
overdoses occurred involving AB-CHMINACA and AB-PINACA. Adverse effects
reported from these incidences have included: Seizures, coma, severe
agitation, loss of motor control, loss of consciousness, difficulty
breathing, altered mental status, and convulsions that in some cases
resulted in death. There have been multiple overdose reports involving
AB-CHMINACA, AB-PINACA, or a combination of both substances. In
addition, there have been at least four documented deaths involving AB-
CHMINACA and three documented deaths involving AB-PINACA.
Since 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. Because the
three SCs share pharmacological similarities with schedule I substances
such as [Delta]9-THC, JWH-018, and other temporarily and permanently
controlled schedule I substances, AB-CHMINACA, AB-PINACA, and THJ-2201
pose a risk to the abuser. Furthermore, despite being encountered on
the illicit drug market and having no accepted medical use in treatment
within the United States, these products continue to be easily
available and abused across age groups.
Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard
to Public Safety
Based on the data and information summarized above, the continued
uncontrolled manufacturing, distribution, importation, exportation, and
abuse of AB-CHMINACA, AB-PINACA, and THJ-2201 pose an imminent hazard
to the public safety. Furthermore, the DEA is not aware of any
currently accepted medical uses for these SCs in the United States.
A substance meeting the statutory requirements for temporary
scheduling under 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 AB-CHMINACA, AB-PINACA,
and THJ-2201 indicate that these three 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 DEA, through a letter dated September 17, 2014, notified
the Assistant Secretary of the DEA's intention to temporarily place
these three SCs in schedule I.
Conclusion
In accordance with the provisions of section 201(h) of the CSA, 21
U.S.C. 811(h), the Administrator considered available data and
information, herein set forth the grounds for her determination that it
is necessary to temporarily place three synthetic cannabinoids, AB-
CHMINACA, AB-PINACA, and THJ-2201 into schedule I of the CSA, and
hereby finds that placement of these synthetic cannabinoids into
schedule I of the CSA is warranted in order to avoid an imminent hazard
to the public safety.
Because the Administrator hereby finds that it is necessary to
temporarily place these synthetic cannabinoids into schedule I to avoid
an imminent hazard to the public safety, the final order temporarily
scheduling these substances will be effective on the date of
publication 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).
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).
Requirements for Handling
Upon the effective date of this final order, AB-CHMINACA, AB-
PINACA, and THJ-2201 are subject to the regulatory controls and
administrative, civil, and criminal sanctions applicable to the
manufacture, distribution, importation, exportation, conduct of
instructional activities, and possession of schedule I controlled
substances including the following:
1. Registration. Any person who handles (manufactures, distributes,
imports, exports, engages in research, conducts instructional
activities with, or possesses), or desires to handle, AB-CHMINACA, AB-
PINACA, or THJ-2201, 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 January 30, 2015. Any
person who currently handles AB-CHMINACA, AB-PINACA, or THJ-2201, and
is not
[[Page 5046]]
registered with the DEA, must submit an application for registration
and may not continue to handle AB-CHMINACA, AB-PINACA, or THJ-2201 as
of January 30, 2015, unless the DEA has approved that application for
registration, pursuant to 21 U.S.C. 822, 823, 957, 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.
2. Security. AB-CHMINACA, AB-PINACA, and THJ-2201are 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 January 30, 2015.
3. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of AB-CHMINACA, AB-PINACA, and THJ-2201 must be
in compliance with 21 U.S.C. 825, 958(e), and be in accordance with 21
CFR part 1302 as of January 30, 2015. Current DEA registrants shall
have 30 calendar days from January 30, 2015, to comply with all
labeling and packaging requirements.
4. Inventory. Every DEA registrant who possesses any quantity of
AB-CHMINACA, AB-PINACA, or THJ-2201 on the effective date of this
order, must take an inventory of all stocks of these substances on hand
as of January 30, 2015, pursuant to 21 U.S.C. 827 and 958, and in
accordance with 21 CFR 1304.03, 1304.04, and 1304.11 (a) and (d).
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 AB-CHMINACA, AB-
PINACA, and THJ-2201) 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.
5. Records. All DEA registrants must maintain records with respect
to AB-CHMINACA, AB-PINACA, or THJ-2201 pursuant to 21 U.S.C. 827 and
958, and in accordance with 21 CFR parts 1304, 1307, and 1312 as of
January 30, 2015. Current DEA registrants authorized to handle AB-
CHMINACA, AB-PINACA, or THJ-2201 shall have 30 calendar days from the
effective date of this order to be in compliance with all recordkeeping
requirements.
6. Reports. All DEA registrants who manufacture or distribute AB-
CHMINACA, AB-PINACA, or THJ-2201must submit reports pursuant to 21
U.S.C. 827 and in accordance with 21 CFR 1304, 1307, and 1312 as of
January 30, 2015.
7. Order Forms. All registrants who distribute AB-CHMINACA, AB-
PINACA, or THJ-2201must comply with order form requirements pursuant to
21 U.S.C. 828 and in accordance with 21 CFR part 1305 as of January 30,
2015.
8. Importation and Exportation. All importation and exportation of
AB-CHMINACA, AB-PINACA, or THJ-2201must be in compliance with 21 U.S.C.
952, 953, 957, 958, and in accordance with 21 CFR part 1312 as of
January 30, 2015.
9. Quota. Only registered manufacturers may manufacture AB-
CHMINACA, AB-PINACA, or THJ-2201 in accordance with a quota assigned
pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.
10. Liability. Any activity involving AB-CHMINACA, AB-PINACA, or
THJ-2201 not authorized by, or in violation of the CSA, occurring as of
January 30, 2015, 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 an
expedited 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 section 553 of the Administrative Procedure
Act (APA), 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 section 553 of the APA, 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 final order 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 (OMB).
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.
Pursuant to section 808(2) of the Congressional Review Act (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
because they pose a public health risk. 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 into schedule I because they pose an
imminent hazard to public safety, it would be contrary to the public
interest to delay implementation of the temporary scheduling order.
Therefore, in accordance with section 808(2) of the CRA, this order
shall take effect immediately upon its publication.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
[[Page 5047]]
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), unless otherwise noted.
0
2. Amend Sec. 1308.11, by adding paragraphs (h)(29) through (31) to
read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(h) * * *
(29) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-
indazole-3-carboxamide, its optical, positional, and geometric isomers,
salts, and salts of isomers--7031 (Other names: AB-CHMINACA).
(30) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-
carboxamide, its optical, positional, and geometric isomers, salts, and
salts of isomers--7023 (Other names: AB-PINACA).
(31) [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-
yl)methanone, its optical, positional, and geometric isomers, salts,
and salts of isomers--7024 (Other names: THJ-2201).
Dated: January 23, 2015.
Michele M. Leonhart,
Administrator.
[FR Doc. 2015-01776 Filed 1-29-15; 8:45 am]
BILLING CODE 4410-09-P