```

[Federal Register Volume 80, Number 20 (Friday, January 30, 2015)]
[Rules and Regulations]
[Pages 5042-5047]
From the Federal Register Online via the Government Printing 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
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