[Federal Register Volume 78, Number 71 (Friday, April 12, 2013)]
[Proposed Rules]
[Pages 21858-21861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08671]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-373]
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 (DEA) is issuing this notice of intent to temporarily
schedule three synthetic cannabinoids into the Controlled Substances
Act (CSA) pursuant to the temporary scheduling provisions of 21 U.S.C.
811(h). The substances are 1-pentyl-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone (UR-144), 1-(5-fluoro-pentyl)-1H-
indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-fluoro-UR-144;
XLR11) and N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA,
AKB48). 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 be published in the Federal Register and may not
be issued prior to May 13, 2013. Any final order will impose the
administrative, civil, and criminal sanctions and regulatory controls
of Schedule I substances under the CSA on the manufacture,
distribution, possession, importation, and exportation of these
synthetic cannabinoids.
FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive
Assistant, Office of Diversion Control, Drug Enforcement
Administration; Mailing Address: 8701 Morrissette Drive, Springfield,
Virginia 22152, telephone (202) 307-7165.
SUPPLEMENTARY INFORMATION:
Background
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 up
to one year.
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 under section 505 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 355) for the substance. The Attorney
General has delegated his authority under 21 U.S.C. 811 to the
Administrator of DEA, who in turn has delegated her authority to the
Deputy Administrator of DEA. 28 CFR 0.100, Appendix to Subpart R.
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 has
transmitted notice of his intent to place UR-144, XLR11, and AKB48 in
Schedule I on a temporary basis to the Assistant Secretary by letter
dated February 14, 2013. The Assistant Secretary responded to this
notice by letter dated March 14, 2013 (received by DEA on March 21,
2013), and advised that based on review by the Food and Drug
Administration (FDA), there are currently no investigational new drug
applications or approved new drug applications for UR-144, XLR11, or
AKB48. The Assistant Secretary also stated that HHS has no objection to
the temporary placement of UR-144, XLR11 or AKB48 into Schedule I of
the CSA. DEA has taken into consideration the Assistant Secretary's
comments. As UR-144, XLR11, and AKB48 are not currently listed in any
schedule under the CSA, and as no exemptions or approvals are in effect
for UR-144, XLR11, and AKB48 under Section 505 of the FD&C Act (21
U.S.C. 355), DEA believes that the conditions of 21 U.S.C. 811(h)(1)
have been satisfied. Any additional comments submitted by the Assistant
Secretary in response to this notification shall also be taken into
consideration before a final order is published. 21 U.S.C. 811(h)(4).
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\1\ Because the Secretary of the Department of Health and Human
Services (HHS) has delegated to the Assistant Secretary for Health
the Department of Health and Human Services 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 HHS, the Food and Drug
Administration (FDA), and the National Institute on Drug Abuse
(NIDA), FDA acts as the lead agency within HHS in carrying out the
Secretary's scheduling responsibilities under the Controlled
Substance Act (CSA), with the concurrence of NIDA. 50 FR 9518.
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To make a finding 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 section 201(c) of the CSA (21 U.S.C.
811(c)). These factors are as follows: 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(c)(4)-(6). 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 (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 (U.S.), and a lack of accepted safety for use under medical
supervision. 21 U.S.C. 812(b)(1). Available data and information for
UR-144, XLR11, and AKB48 indicate that these three synthetic
cannabinoids have a high potential for abuse, no currently accepted
medical use in treatment in the U.S., and a lack of accepted safety for
use under medical supervision.
Synthetic Cannabinoids
While synthetic cannabinoids have been developed over the last 30
years for research purposes to investigate the cannabinoid system, no
scientific literature referring to UR-144, XLR11 or AKB48 was available
prior to these drugs identification in the illicit market. In addition,
no legitimate non-research uses have been identified for these
synthetic cannabinoids nor have they been approved by FDA for human
consumption. These synthetic cannabinoids, of which 1-pentyl-1H-indol-
3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144), 1-(5-fluoro-
pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-
fluoro-UR-144; XLR11), and N-(1-adamantyl)-1-pentyl-1H-indazole-3-
carboxamide (APINACA, AKB48) are representative, are so-termed for
their [Delta]\9\-tetrahydrocannabinol (THC)--like
[[Page 21859]]
pharmacological properties. Numerous herbal products have been
analyzed, and UR-144, XLR11, and AKB48 have been identified, in varying
mixture profiles and amounts, spiked on plant material.
From January 2009 through January 24, 2013, according to the System
to Retrieve Information from Drug Evidence (STRIDE) data, there are
1,074 reports involving 137 cases for UR-144, 773 reports involving 134
cases for XLR11, and 66 reports involving 25 cases for AKB48. From
March 2010 to January 29, 2013, the National Forensic Laboratory
Information System (NFLIS) registered 9,346 reports containing these
synthetic cannabinoids (UR-144--4,387 reports; XLR11--4,516 reports;
AKB48--443 reports) across 32 states. No instances regarding UR-144,
XLR11 or AKB48 were reported in NFLIS prior to March of 2010.
Collectively, reports from NFLIS and (STRIDE) \2\ (11,259 reports total
through January 29, 2013) for UR-144, XLR11 and AKB48 have exceeded the
number of reports for the five synthetic cannabinoid substances (JWH-
018, JWH-200, JWH-073, CP-47,497 and CP-47,497 C8 homologue
[cannabicyclohexanol]) (7,340 total reports through December 31, 2012).
JWH-018, JWH-200, JWH-073, CP-47,497 and CP-47,497 C8 homologue were
temporarily scheduled on March 1, 2011, and later placed in Schedule I
by Section 1152 of Food and Drug Administration Safety and Innovation
Act (FDASIA), Pub. L. 112-144, on July 9, 2012. Section 1152 of the
FDASIA \3\ amended the CSA by placing cannabimimetic agents and 26
specific substances (including 15 synthetic cannabinoids, 2 synthetic
cathinones, and 9 phenethylamines of the 2C-series) in Schedule I. UR-
144, XLR11, and AKB48 were not included among the 15 specific named
synthetic cannabinoids, and do not fall under the definition of
cannabimimetic agents, under FDASIA.
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\2\ National Forensic Laboratory Information System (NFLIS) is a
program sponsored by Drug Enforcement Administration's (DEA) Office
of Diversion Control which compiles information on exhibits analyzed
in State and local law enforcement laboratories. System to Retrieve
Information from Drug Evidence (STRIDE) is a DEA database which
compiles information on exhibits analyzed in DEA laboratories.
\3\ Subtitle D of Title XI of the Food and Drug Administration
Safety and Innovation Act (FDASIA), which includes Sections 1151-
1153 of Pub. L. 112-144, is also known as the ``Synthetic Drug Abuse
Prevention Act of 2012,'' or ``SDAPA.''
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Factor 4. History and Current Pattern of Abuse
Synthetic cannabinoids laced on plant material were first reported
in the U.S. in December 2008, when a shipment of `Spice' was seized and
analyzed by U.S. Customs and Border Patrol in Dayton, Ohio. Also in
December 2008, JWH-018 and cannabicyclohexanol were identified by
German forensic laboratories.
Since the initial identification of JWH-018 (December 2008), many
additional synthetic cannabinoids with purported psychotropic effects
have been found laced on plant material or related products. The
popularity of these synthetic cannabinoids and their associated
products appears to have increased since January 2010 in the U.S. based
on seizure exhibits and media reports. This trend appears to mirror
that experienced in Europe since 2008. Synthetic cannabinoids are being
encountered in several regions of the U.S. with the substances
primarily found as adulterants on plant material products as self-
reported on internet discussion boards. Since then, numerous other
synthetic cannabinoids including UR-144, XLR11 and AKB48 have been
identified as product adulterants.
Data gathered from published studies, supplemented by discussions
on Internet discussion Web sites and personal communications with
toxicological testing laboratories, demonstrate that products laced
with UR-144, XLR11 and/or AKB48 are being abused mainly by smoking for
their psychoactive properties. The adulterated products are marketed as
`legal' alternatives to marijuana. This characterization, along with
their reputation as potent herbal intoxicants, has increased their
popularity. Several synthetic cannabinoids have been shown to display
higher potency in vitro when compared to THC. Smoking mixtures of these
substances for the purpose of achieving intoxication has been
identified as a reason for numerous emergency room visits and calls to
poison control centers. Abuse of these synthetic cannabinoids and their
products has been characterized with both acute and long term public
health and safety issues. In addition, numerous states, local
jurisdictions, and the international community have controlled these
substances.
Factor 5. Scope, Duration and Significance of Abuse
According to forensic laboratory reports, the first appearance of
synthetic cannabinoids in the U.S. occurred in November 2008, when U.S.
Customs and Border Protection analyzed ``Spice'' products. NFLIS has
reported 9,346 exhibits (March 2010 to January 29, 2013) related to UR-
144, XLR11 and AKB48 from various states including Alaska, Alabama,
Arkansas, California, Colorado, Florida, Georgia, Iowa, Indiana,
Illinois, Kansas, Kentucky, Louisiana, Maryland, Minnesota, Missouri,
New Hampshire, New Jersey, New Mexico, North Dakota, Nebraska, Nevada,
Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah,
Virginia, Wisconsin and Wyoming. STRIDE has reported 1,913 records
involving UR-144, XLR11 and AKB48 from January 2009 through January 24,
2013. From January 1 through December 31, 2012, the American
Association of Poison Control Centers \4\ has reported receiving in
excess of 5,200 calls relating to products purportedly laced with
synthetic cannabinoids. Although the center does not identify specific
cannabinoid substances, the data does indicate the magnitude of
exposure to synthetic cannabinoids.
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\4\ American Association of Poison Control Centers (AAPCC) is a
non-profit, national organization that represents the poison centers
of the United States.
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Factor 6. What, If Any, Risk There Is to the Public Health
UR-144, XLR11 and AKB48 are pharmacologically similar to Schedule I
substances THC and JWH-018, as well as other synthetic cannabinoids. By
sharing pharmacological similarities with the Schedule I substances
(THC and JWH-018), synthetic cannabinoids pose a risk to the abuser. In
addition, the chronic abuse of products laced with synthetic
cannabinoids has also been linked to addiction and withdrawal. Law
enforcement, military, and public health officials have reported
exposure incidents that demonstrate the dangers associated with abuse
of synthetic cannabinoids to both the individual abusers and other
affected individuals since these substances were never intended for
human use. Warnings regarding the dangers associated with abuse of
synthetic cannabinoids and their products have been issued by numerous
state public health departments and poison control centers and private
organizations. In a 2012 report, the Substance Abuse and Mental Health
Services Administration \5\ reported 11,406 emergency department visits
involving a synthetic cannabinoid product during 2010.
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\5\ Substance Abuse and Mental Health Services Administration
(SAMHSA) is a branch of the U.S. Department of Health and Human
Services (HHS). It is charged with improving the quality and
availability of prevention, treatment, and rehabilitative services
in order to reduce illness, death, disability, and cost to society
resulting from substance abuse and mental illnesses.
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Detailed product analyses have detected variations in the amount
and type of synthetic cannabinoid laced on plant material even within
samplings of
[[Page 21860]]
the same product. Since abusers obtain these drugs through unknown
sources, purity of these drugs is uncertain, thus posing significant
adverse health risk to these users. Submissions to DEA laboratories
from January 2012 through February 11, 2013, have documented over 142
distinct packaging examples containing a mixture of UR-144, XLR11 and/
or AKB48. These unknown factors present a significant risk of danger to
the abuser. Some of the adverse health effects reported in response to
the abuse of synthetic cannabinoids include vomiting, anxiety,
agitation, irritability, seizures, hallucinations, tachycardia,
elevated blood pressure, and loss of consciousness. As mentioned above,
there are reported instances of emergency department admissions in
association with the abuse of these THC-like substances. There are no
recognized therapeutic uses of these substances in the U.S.
In February 2013, the Centers for Disease Control and Prevention
published a report by Murphy et al. describing unexplained cases of
acute kidney injury in 16 patients, all of whom had reported recent
smoking of synthetic cannabinoids. Upon further investigation, it was
determined that of the 16 patients, 7 of the subjects had smoked
substances that were positive for XLR11 or its metabolite. Cases were
reported from Wyoming (4 cases), Rhode Island (1 case), New York (2
cases), Oregon (6 cases), Kansas (1 case) and Oklahoma (2 cases).
Finding of Necessity of Schedule I Scheduling To Avoid Imminent Hazard
to Public Safety
Based on the above data and information, the continued uncontrolled
manufacture, distribution, importation, exportation, and abuse of UR-
144, XLR11, and AKB48 pose an imminent hazard to the public safety. DEA
is not aware of any currently accepted medical uses for these synthetic
cannabinoids in the U.S. 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 U.S., and a lack of accepted safety for use under medical
supervision. Available data and information for UR-144, XLR11, and
AKB48 indicate that these three synthetic cannabinoids have a high
potential for abuse, no currently accepted medical use in treatment in
the U.S., 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)), the Deputy Administrator through a letter dated February 14,
2013, notified the Assistant Secretary of Health of the intention to
temporarily place these three synthetic cannabinoids in Schedule I.
Conclusion
This notice of intent initiates 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 has
considered available data and information and has set forth herein the
grounds for his determination that it is necessary to temporarily
schedule three synthetic cannabinoids, 1-pentyl-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl) methanone (UR-144), 1-(5-fluoro-pentyl)-1H-
indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-fluoro-UR-144;
XLR11), and N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide
(APINACA, AKB48) in Schedule I of the CSA and 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 Deputy 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, 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 up to three years pending completion of the permanent or
regular scheduling process. 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. UR-
144, XLR11, and AKB48 will then be subject to the regulatory controls
and administrative, civil, and criminal sanctions applicable to the
manufacture, distribution, possession, importing and exporting of a
Schedule I controlled substance under the CSA.
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. The CSA sets forth specific criteria for scheduling
a drug or other substance. While temporary scheduling orders are not
subject to judicial review (21 U.S.C. 811(h)(6)), 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 which
conclude the regular scheduling process of formal rulemaking are
subject to judicial review. 21 U.S.C. 877.
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
a proposed temporary scheduling order is transmitted to the Secretary
of HHS. 21 U.S.C. 811(h)(1).
Inasmuch as section 201(h) of the CSA directs that temporary
scheduling actions be issued by order and sets forth the procedures by
which such orders are to be issued, 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 deemed
to 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 of the temporary
scheduling action to avoid an imminent hazard to the public safety.
Although 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, DEA notes that in accordance with 21 U.S.C. 811(h)(4),
the Deputy Administrator will be taking into consideration any comments
submitted by the Secretary of HHS with regard to the proposed temporary
scheduling order. Further, DEA believes that this temporary scheduling
action is not a ``rule'' as defined by 5 U.S.C. 601(2), and,
accordingly, 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 agency is not required by section 553 of
[[Page 21861]]
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 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.
Under the authority vested in the Attorney General by section
201(h) of the CSA (21 U.S.C. 811(h)), and delegated to the Deputy
Administrator of the DEA by Department of Justice regulations (28 CFR
0.100, Appendix to Subpart R), the Deputy Administrator hereby intends
to order that 21 CFR Part 1308 be amended 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. Section 1308.11 is amended by adding new paragraphs (h)(9), (10),
and (11) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(h) * * *
(9) 1-pentyl-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone, its optical, positional, and
geometric isomers, salts and salts of isomers--7144 (Other names: UR-
144, 1-pentyl-3-(2,2,3,3-tetramethylcyclopropoyl)indole)
(10) 1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-
tetramethylcyclopropyl)methanone, its optical, positional, and
geometric isomers, salts and salts of isomers--7011 (Other names: 5-
fluoro-UR-144, 5-F-UR-144, XLR11, 1-(5-fluoro-pentyl)-3-(2,2,3,3-
tetramethylcyclopropoyl)indole)
(11) N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide, its
optical, positional, and geometric isomers, salts and salts of
isomers--7048 (Other names: APINACA, AKB48)
Dated: April 5, 2013.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2013-08671 Filed 4-11-13; 8:45 am]
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