[Federal Register Volume 79, Number 244 (Friday, December 19, 2014)]
[Proposed Rules]
[Pages 75767-75771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29651]
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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: Notice of intent.
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SUMMARY: The Deputy Administrator of the Drug Enforcement
Administration is issuing this notice of intent to temporarily schedule
three synthetic cannabinoids into schedule I pursuant to the temporary
scheduling provisions of the Controlled Substances Act. The substances
are: N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-
indazole-3-carboxamide (common name: AB-CHMINACA), N-(1-amino-3-methyl-
1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (common name: AB-
PINACA) and [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-
yl)methanone (common name: THJ-2201). This action is based on a finding
by the Deputy Administrator that the placement of these synthetic
cannabinoids into schedule I of the CSA is necessary to avoid an
imminent hazard to the public safety. Any final order will impose the
administrative, civil, and criminal sanctions and regulatory controls
applicable to schedule I substances under the CSA on the manufacture,
distribution, possession, importation, exportation, research, and
conduct of instructional activities of these synthetic cannabinoids.
DATES: December 19, 2014.
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: Any final order will be published in the
Federal Register and may not be effective prior to January 20, 2015.
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. 21 U.S.C. 801-971. 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. The DEA publishes the
implementing regulations for these statutes in title 21 of the Code of
Federal Regulations (CFR), parts 1300 to 1321. 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, every controlled substance is classified into one of
five schedules based upon its potential for abuse, its currently
accepted medical use in treatment in the United States, 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. 21 U.S.C. 812(a).
Section 201 of the CSA, 21 U.S.C. 811, provides the Attorney
General with the authority to temporarily place a 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
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
scheduling authority under 21 U.S.C. 811 to the Administrator of the
DEA, 28 CFR 0.100, who in turn has redelegated that authority to the
Deputy Administrator of the DEA, 28 CFR part 0, appendix to subpart R.
Background
Section 201(h)(4) of the CSA (21 U.S.C. 811(h)(4)) requires the
Deputy Administrator to notify the Secretary of the Department of
Health and Human Services (HHS) of his intention to temporarily place a
substance into schedule I of the CSA.\1\ The Deputy Administrator
transmitted notice of his 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. AB-CHMINACA, AB-PINACA, and THJ-2201 are not currently listed
in any schedule under the CSA, a condition of 21 U.S.C. 811(h)(1).
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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
notice of intent, all subsequent references to ``Secretary'' have
been replaced with ``Assistant Secretary.'' As set forth in a
memorandum of understanding entered into by the HHS, 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, Mar. 8, 1985.
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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
Deputy 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
[[Page 75768]]
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
synthetic cannabinoids (SCs) have a high potential for abuse, no
currently accepted medical use in treatment in the United States, and a
lack of accepted safety for use under medical supervision.
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. In addition, forensic analyses by the
DEA and other Federal, State, and local laboratories have identified
multiple variations in both the type and amount of SC 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 designer drug product manufacturing operations
located in residential neighborhoods, garages, warehouses, and other
similar destinations throughout the country. The powder form of SCs are
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, but with the user still being deprived of knowledge as
to exactly what is contained inside the packaging.
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, or sold 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 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 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 have been developed over the last 30 years as tools for
investigating the cannabinoid system. Synthetic cannabinoids intended
for illicit use were first reported in the United States in a November
2008 encounter, where a shipment of ``Spice'' was seized and analyzed
by CBP in Dayton, Ohio. At approximately the same time, in December
2008, JWH-018 and cannabicyclohexanol (CP-47,497 C8 homologue) were
identified by German forensic laboratories. Since the initial
identification of JWH-018 (November 2008), many other SCs have been
found applied on plant material and encountered as drug products. The
popularity of these cannabinoids and their associated products appears
to have increased since January 2010 in the United States based on
seizure exhibits and public health and media reports.
Numerous SCs have been identified as product adulterants, and law
enforcement has seized bulk amounts of these substances. 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 drugs such as UR-144, XLR11, AKB48, PB-22,
5F-PB-22, AB-FUBINACA, ADB-PINACA, and numerous other SCs varying only
by slight modifications to their 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
in 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 synthetic cannabinoids, 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).
Another generation of SCs including AB-CHMINACA, AB-PINACA, and
THJ-2201 has recently been encountered. AB-CHMINACA, AB-PINACA, and
THJ-2201 are not included among the 15 SCs that are specifically named
under FDASIA, and do not fall under the legal definition of
cannabimimetic agents as provided under FDASIA. These substances and
products laced with these substances are commonly marketed under the
guise of being a ``legal high'' with a disclaimer of ``not for human
consumption.'' As detailed in reports, law enforcement and public
health officials are encountering the abuse of these substances.
A major concern as reiterated by public health officials and
medical professionals remains the targeting and direct marketing of SCs
and SC-
[[Page 75769]]
containing products to 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, all age
groups have been reported by media as abusing these substances and
related products. Recently, 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 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). Similar to 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 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 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, AAPCC
exposure reports have begun to increase. The number of exposures
reported demonstrates 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 (459). As of
October 31, 2014, the AAPCC has received approximately 2,996 calls
involving exposure to SCs for 2014.
The following information details information obtained through
STRIDE \2\ and NFLIS \3\ (queried on October 1, 2014 (STRIDE); November
25, 2014 (NFLIS)), including dates of first encounter, exhibits/
reports, and locations.
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\2\ 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.
\3\ 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.
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AB-CHMINACA: STRIDE -21 exhibits, first encountered in March 2014;
NFLIS-586 reports, first encountered in February 2014, locations
include Arkansas, Arizona, California, Colorado, Georgia, Iowa,
Indiana, Kansas, Kentucky, Louisiana, Missouri, North Dakota, New
Jersey, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Wisconsin.
AB-PINACA: STRIDE-245 exhibits, first encountered in June 2013;
NFLIS-3,783 reports, first encountered in March 2013, locations include
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.
THJ-2201: STRIDE-65 exhibits, first encountered in September 2013;
NFLIS-220 reports, first encountered in January 2014, locations include
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
THJ-2201 was first observed in September 2013 while AB-CHMINACA was
first observed in February 2014. AB-PINACA has been for sale on the
illicit drug market as early as March 2013. 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: AB-CHMINACA-17 seizures involving 15.825 kg;
AB-PINACA-4 seizures involving 6 kg; THJ-2201-6 seizures involving 5.5
kg (see Three Factor Analysis). 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 the present, multiple deaths and severe
overdoses have occurred involving AB-CHMINACA and AB-PINACA. Adverse
effects reported from these incidences have included a variety of the
following effects: 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. By sharing
pharmacological similarities with schedule I substances ([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. AB-CHMINACA, AB-PINACA, and THJ-2201 are being encountered on
the illicit drug market and have no accepted medical use within 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
Based on the above summarized data and information, the continued
uncontrolled manufacture, distribution, importation, exportation, and
abuse of AB-CHMINACA, AB-PINACA, and THJ-2201 pose an imminent hazard
to the public safety. 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, 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,
[[Page 75770]]
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 Deputy
Administrator, 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
This notice of intent initiates an expedited temporary scheduling
action and provides the 30-day notice pursuant to section 201(h) of the
CSA, 21 U.S.C. 811(h). In accordance with the provisions of section
201(h) of the CSA, 21 U.S.C. 811(h), the Deputy Administrator
considered available data and information, herein set forth the grounds
for his determination that it is necessary to temporarily schedule
three SCs, N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-
1H-indazole-3-carboxamide (AB-CHMINACA), N-(1-amino-3-methyl-1-
oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA) and [1-
(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201)
in schedule I of the CSA, and finds that placement of these SCs into
schedule I of the CSA is necessary to avoid an imminent hazard to the
public safety.
Because the Deputy Administrator hereby finds that it is necessary
to temporarily place these SCs into schedule I to avoid an imminent
hazard to the public safety, any subsequent 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). It is the intention of the Deputy Administrator to
issue such a final order as soon as possible after the expiration of 30
days from the date of publication of this notice. AB-CHMINACA, AB-
PINACA, and THJ-2201 will then be subject to the regulatory controls
and administrative, civil, and criminal sanctions applicable to the
manufacture, distribution, possession, importation, exportation,
research, and conduct of instructional activities of a schedule I
controlled substance.
The CSA sets forth specific criteria for scheduling a drug or other
substance. Regular scheduling actions in accordance with 21 U.S.C.
811(a) are subject to formal rulemaking procedures done ``on the record
after opportunity for a hearing'' conducted pursuant to the provisions
of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The regular scheduling process
of formal rulemaking affords interested parties with appropriate
process and the government with any additional relevant information
needed to make a determination. Final decisions that conclude the
regular scheduling process of formal rulemaking are subject to judicial
review. 21 U.S.C. 877. Temporary scheduling orders are not subject to
judicial review. 21 U.S.C. 811(h)(6).
Regulatory Matters
Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for 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).
In as much as section 201(h) of the CSA directs that temporary
scheduling actions be issued by order and sets forth the procedures by
which such orders are to be issued, the DEA believes that the notice
and comment requirements of section 553 of the Administrative Procedure
Act (APA), 5 U.S.C. 553, do not apply to this notice of intent. In the
alternative, even assuming that this notice of intent might be subject
to section 553 of the APA, the Deputy Administrator finds that there is
good cause to forgo the notice and comment requirements of section 553,
as any further delays in the process for issuance of temporary
scheduling orders would be impracticable and contrary to the public
interest in view of the manifest urgency to avoid an imminent hazard to
the public safety.
Although the DEA believes this notice of intent to issue a
temporary scheduling order is not subject to the notice and comment
requirements of section 553 of the APA, the DEA notes that in
accordance with 21 U.S.C. 811(h)(4), the Deputy Administrator will take
into consideration any comments submitted by the Assistant Secretary
with regard to the proposed temporary scheduling order.
Further, the DEA believes that this temporary scheduling action is
not a ``rule'' as defined by 5 U.S.C. 601(2), and, accordingly, is not
subject to the requirements of the Regulatory Flexibility Act. The
requirements for the preparation of an initial regulatory flexibility
analysis in 5 U.S.C. 603(a) are not applicable where, as here, the DEA
is not required by 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), unless otherwise noted.
0
2. In Sec. 1308.11, add 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)
[[Page 75771]]
(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: December 12, 2014.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2014-29651 Filed 12-18-14; 8:45 am]
BILLING CODE 4410-09-P