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[Federal Register Volume 78, Number 71 (Friday, April 12, 2013)]
[Proposed Rules]
[Pages 21858-21861]
From the Federal Register Online via the Government Printing 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]
BILLING CODE 4410-09-P
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