[Federal Register Volume 80, Number 179 (Wednesday, September 16, 2015)]
[Proposed Rules]
[Pages 55565-55568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23198]



[[Page 55565]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-421N]


Schedules of Controlled Substances: Temporary Placement of the 
Synthetic Cannabinoid MAB-CHMINACA Into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of intent.

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SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this notice of intent to temporarily schedule the synthetic 
cannabinoid N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-
(cyclohexylmethyl)-1H-indazole-3-carboxamide (common names, MAB-
CHMINACA and ADB-CHMINACA) into schedule I pursuant to the temporary 
scheduling provisions of the Controlled Substances Act. This action is 
based on a finding by the Administrator that the placement of this 
synthetic cannabinoid into schedule I of the Controlled Substances Act 
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 controlled 
substances under the Controlled Substances Act on the manufacture, 
distribution, possession, importation, exportation, research, and 
conduct of instructional activities of this synthetic cannabinoid.

DATES: September 16, 2015.

FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, 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 October 16, 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. 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), 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 ensuring an adequate supply is 
available 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.
    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 she finds that such action is necessary to avoid 
imminent hazard to the public safety. 21 U.S.C. 811(h)(1). 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). The Attorney General has delegated her scheduling 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 
Administrator to notify the Secretary of the Department of Health and 
Human Services (HHS) of the Administrator's intention to temporarily 
place a substance into schedule I of the CSA.\1\ The Administrator 
transmitted notice of intent to place N-(1-amino-3,3-dimethyl-1-
oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide 
(hereinafter referred to as MAB-CHMINACA) into schedule I on a 
temporary basis to the Assistant Secretary by letter dated May 14, 
2015. The Assistant Secretary responded to this notice by letter dated 
June 3, 2015, 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 MAB-CHMINACA. The 
Assistant Secretary also stated that HHS has no objection to the 
temporary placement of MAB-CHMINACA into schedule I of the CSA. The DEA 
has taken into consideration the Assistant Secretary's comments. MAB-
CHMINACA is not currently listed in any schedule under the CSA, and no 
exemptions or approvals are in effect for MAB-CHMINACA under section 
505 of the FDCA, 21 U.S.C. 355. The DEA has found that the control of 
MAB-CHMINACA in schedule I on a temporary basis is necessary to avoid 
an imminent hazard to public safety.
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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 
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): 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).

MAB-CHMINACA

    Available data and information for MAB-CHMINACA, summarized below,

[[Page 55566]]

indicate that this synthetic cannabinoid (SC) has 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. The DEA analysis is available in its entirety under the 
tab ``Supporting and Related Material'' of the public docket of this 
action at www.regulations.gov under Docket Number DEA-421N.

Synthetic Cannabinoids

    Synthetic cannabinoids are substances synthesized in laboratories 
that mimic the biological effects of delta-9-tetrahydrocannabinol 
(THC), the main psychoactive ingredient in marijuana. It is believed 
SCs were first introduced on the designer drug market 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. From 2009 to present, misuse of SCs has increased in the 
United States with law enforcement encounters describing plant material 
laced with SCs intended for human consumption. It has been demonstrated 
that the substances and the associated designer products are abused for 
their psychoactive properties. With many generations of SCs being 
encountered since 2009, MAB-CHMINACA is one of the latest, and based 
upon reports from public health and law enforcement, the misuse and 
abuse of this substance is negatively impacting the public health and 
communities.
    The designer drug products laced with SCs, including MAB-CHMINACA, 
are often sold under the guise of ``herbal incense'' or ``potpourri,'' 
use various product names, and are 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 that 
labeling these products as ``not for human consumption'' is a legal 
defense to criminal prosecution.
    MAB-CHMINACA is a SC that has pharmacological effects similar to 
the schedule I hallucinogen THC and other temporarily and permanently 
controlled schedule I substances. MAB-CHMINACA has been shown to cause 
severe toxicity and adverse health effects following ingestion, 
including seizures, excited delirium, cardiotoxicity and death. With no 
approved medical use and limited safety or toxicological information, 
MAB-CHMINACA has emerged on the illicit drug market and is being abused 
for its psychoactive properties.

Factor 4. History and Current Pattern of Abuse

    SCs have been developed over the last 30 years as tools for 
investigating the cannabinoid system. SCs were first encountered by CBP 
within the United States in November 2008. Since then, the popularity 
of SCs and their associated products has increased steadily as 
evidenced by law enforcement seizures, public health information, and 
media reports. Amidst multiple administrative and legislative actions 
to place SCs found on the illicit market into schedule I of the CSA, 
new versions of SCs intended to circumvent current law continue to be 
encountered. MAB-CHMINACA is a SC that was encountered following the 
hospitalization of 125 individuals around the Baton Rouge, Louisiana 
area in October 2014 (see factor 6 of supporting materials). Since that 
time, multiple overdoses and deaths involving MAB-CHMINACA have been 
reported. For example, overdose clusters attributed to MAB-CHMINACA 
have been reported in Shreveport, Louisiana; Bryan, Texas; Beaumont, 
Texas; multiple cities in the State of Mississippi; Hampton, Virginia; 
and Hagerstown, Maryland (see factor 6 of supporting materials). 
Specifically, in April 2015, the largest nationwide outbreak involving 
SCs was reported by multiple news outlets. In addition, State public 
health entities have collectively reported over 2,000 overdoses and at 
least 33 deaths across at least 11 States attributed to the misuse of 
SCs. Of these overdoses and deaths, currently available toxicology 
results have determined that a number of overdoses from this most 
recent cluster were connected to ingestion of MAB-CHMINACA (see factor 
6 of supporting materials).
    On April 29, 2015, the European Monitoring Centre for Drugs and 
Drug Addiction (EMCDDA) reported multiple outbreaks of intoxications 
within the United States resulting from the ingestion of products 
believed to contain SCs. EMCDDA further reported that MAB-CHMINACA had 
been implicated in at least some of those cases. EMCDDA also reported 
on two deaths involving MAB-CHMINACA, one in Hungary and the other in 
Japan.
    A major concern, as reiterated by public health officials and 
medical professionals, remains the targeting and direct marketing of 
SCs and SC-containing products to adolescents and youth. This is 
supported by law enforcement encounters and reports from emergency 
departments: however, all age groups have been reported by the media as 
abusing these substances and related products. Individuals, including 
minors, are purchasing SCs from the Internet, gas stations, convenience 
stores, and head shops.
    Smoking mixtures of these substances for the purpose of achieving 
intoxication have resulted in numerous emergency department visits and 
calls to poison control centers. As reported by the American 
Association of Poison Control Centers (AAPCC), adverse effects 
including severe agitation, anxiety, racing heartbeat, high blood 
pressure, nausea, vomiting, seizures, tremors, intense hallucinations, 
psychotic episodes, suicide, and other harmful thoughts and/or actions 
can occur following ingestion of SCs. Presentations at emergency 
departments directly linked to the abuse of MAB-CHMINACA have resulted 
in similar symptoms, including severe agitation, seizures and/or death 
(see factor 6).
    As discussed previously, it is believed most abusers of SCs or SC-
related products smoke the product following application to plant 
material. Until recently, this was the preferred route of 
administration. Law enforcement has also begun to encounter new 
variations of SCs in liquid form. It is believed abusers have been 
applying the liquid to hookahs or ``e-cigarettes,'' which allows the 
user to administer a vaporized liquid that can be inhaled.

Factor 5. Scope, Duration and Significance of Abuse

    Following multiple scheduling actions designed to safeguard the 
public from the adverse effects and safety issues associated with SCs, 
encounters by law enforcement and health care professionals indicate 
the continued abuse of these substances and their associated products. 
With each action to control SCs, drug manufacturers and suppliers are 
adapting at an alarmingly quick pace to design new SCs that circumvent 
regulatory controls. Even before DEA temporarily controlled the latest 
group of SCs, AB-CHMINACA, AB-PINACA, and THJ-2201, on January 30, 
2015, MAB-CHMINACA was already available on the illicit market and 
responsible for overdoses and deaths (see factor 6 of supporting 
materials). From October 2014 to the present, multiple overdoses and 
deaths have been attributed to the abuse of MAB-CHMINACA.
    On October 29, 2014, the State of Louisiana issued an emergency 
rule adding N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-
(cyclohexylmethyl)-1H-indazole-3-carboxamide (MAB-

[[Page 55567]]

CHMINACA) to the list of schedule I Controlled Dangerous Substances 
section of the Louisiana Administrative Code (La. Admin. Code tit. 46, 
section 2704 (2014)), upon the determination that it had a high 
potential for abuse and should be scheduled as a controlled substance 
to avoid an imminent peril to the public health, safety, and welfare.
    Poison control centers continue to report the abuse of SCs and 
their associated products. These substances remain a threat to both the 
short- and long-term public health and safety. Exposures to SCs were 
first reported to the AAPCC in 2011. The most alarming report via the 
AAPCC was published on April 23, 2015. The AAPCC reported a dramatic 
spike in poison center exposure calls throughout the United States in 
2015. The AAPCC reported 1,512 exposure calls in April 2015, 
representing an almost three-fold increase in exposures to SCs as 
compared to the previous largest monthly tally (657 exposures in 
January 2012) since reporting began in 2011. It is likely that many of 
the calls are directly attributable to the abuse of MAB-CHMINACA based 
on its high prevalence in drug seizure reports and specimen test 
reports (see factor 6 and table 3 of supporting materials). Further, 
exposure calls to the AAPCC from within the first five months of 2015 
(January 1 to June 1) are greater than the total exposure calls 
involving SCs from all of 2014. In addition, a majority of exposure 
incidents from 2011 to the present resulted in individuals seeking 
medical attention at health care facilities.
    The following information regarding MAB-CHMINACA was obtained 
through NFLIS \2\ (queried on May 27, 2015):
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    \2\ 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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    MAB-CHMINACA: NFLIS-451 reports; first encountered in September 
2014; locations include Arkansas, Indiana, Kansas, Louisiana, Missouri, 
Oklahoma, Texas, Virginia, and Wisconsin.

Factor 6. What, if Any, Risk There Is to the Public Health

    MAB-CHMINACA was identified in a cluster of 125 subjects that 
presented to emergency facilities within the Baton Rouge and 
Shreveport, Louisiana areas in October 2014. On October 29, 2014, the 
Louisiana Secretary of the Department of Health and Hospitals announced 
the addition of MAB-CHMINACA into schedule I of the Controlled 
Dangerous Substances section of the Louisiana Administrative Code (La. 
Admin. Code tit. 46, section 2704 (2014)). From October 2014 to the 
present, multiple clusters of overdoses involving MAB-CHMINACA and at 
least four deaths attributed to the misuse and abuse of MAB-CHMINACA 
have been reported. (see factor 6 and table 3 of supporting materials). 
Adverse health effects reported from use of MAB-CHMINACA 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.
    Since abusers obtain these drugs through unknown sources, the 
identity, purity, and quantity of these substances is uncertain and 
inconsistent, thus posing significant adverse health risks to users. 
The SCs encountered on the illicit drug market have no accepted medical 
use within the United States. Regardless, SC products continue to be 
easily available and abused by diverse populations. Unknown factors 
including detailed product analysis and dosage variations between 
various packages and batches present a significant danger to an abusing 
individual. Designer drug products have been found to vary in the 
amount and type of SC that plant material is laced with, which could be 
one explanation for the numerous emergency department admissions that 
have been connected to these substances. Similar to previous SCs, MAB-
CHMINACA has been found on plant material.

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 manufacture, distribution, importation, exportation, and 
abuse of MAB-CHMINACA poses an imminent hazard to the public safety. 
The DEA is not aware of any currently accepted medical uses for MAB-
CHMINACA 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, and a lack of accepted safety for use 
under medical supervision. Available data and information for MAB-
CHMINACA indicate that this substance has 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 May 14, 2015, notified the Assistant Secretary 
of the DEA's intention to temporarily this substance 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 Administrator considered 
available data and information, herein set forth the grounds for his 
determination that it is necessary to temporarily schedule MAB-CHMINACA 
in schedule I of the CSA, and finds that placement of this SC into 
schedule I of the CSA is necessary to avoid an imminent hazard to the 
public safety.
    Because the Administrator hereby finds that it is necessary to 
temporarily place this SC 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 Administrator to issue such a final order as 
soon as possible after the expiration of 30 days from the date of 
publication of this document. MAB-CHMINACA 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

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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).
    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 the Administrative Procedure Act (APA) at 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 5 
U.S.C. 553, 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.
    Although the DEA believes this notice of intent to issue a 
temporary scheduling order is not subject to the notice and comment 
requirements of the APA, the DEA notes that in accordance with 21 
U.S.C. 811(h)(4), the 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 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 paragraph (h)(25) to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (h) * * *
    (25) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-
1H-indazole-3-carboxamide, its optical, positional, and geometric 
isomers, salts and salts of isomers--7032 (Other names: MAB-CHMINACA; 
ADB-CHMINACA)

    Dated: September 10, 2015.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2015-23198 Filed 9-15-15; 8:45 am]
 BILLING CODE 4410-09-P