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[Federal Register Volume 81, Number 24 (Friday, February 5, 2016)]
[Rules and Regulations]
[Pages 6171-6175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02302]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-421F]

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

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

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SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this final order to temporarily schedule 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), and its optical, positional, and geometric 
isomers, salts, and salts of isomers 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. As a 
result of this order, the regulatory controls and administrative, 
civil, and criminal sanctions applicable to schedule I controlled 
substances will be imposed on persons who handle (manufacture, 
distribute, reverse distribute, import, export, engage in research, 
conduct instructional activities or chemical analysis, or possess), or 
propose to handle, MAB-CHMINACA.

DATES: This final order is effective February 5, 2016.

FOR FURTHER INFORMATION CONTACT: Barbara J. Boockholdt, Office of 
Diversion Control, Drug Enforcement Administration; Mailing Address: 
8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 
598-6812.

SUPPLEMENTARY INFORMATION: 

Legal Authority

    The Drug Enforcement Administration (DEA) implements and enforces 
titles II and III of the Comprehensive Drug Abuse Prevention and 
Control Act of 1970, as amended. Titles II and III are referred to as 
the ``Controlled Substances Act'' and the ``Controlled Substances 
Import and Export Act,'' respectively, and are collectively referred to 
as the ``Controlled Substances Act'' or the ``CSA'' for the purpose of 
this action. 21 U.S.C. 801-971. The DEA publishes the implementing 
regulations for these statutes in title 21 of the Code of Federal 
Regulations (CFR), chapter II. The CSA and its implementing regulations 
are designed to prevent, detect, and eliminate the diversion of 
controlled substances and listed chemicals into the illicit market 
while 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 
an 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

[[Page 6172]]

(FDCA), 21 U.S.C. 355. 21 U.S.C. 811(h)(1). The Attorney General has 
delegated her 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 the 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 the HHS had 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, and as required by 21 U.S.C. 
811(h)(1)(A), a notice of intent to temporarily schedule MAB-CHMINACA 
was published in the Federal Register on September 16, 2015. 80 FR 
55565.
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    \1\ As set forth in a memorandum of understanding entered into 
by the Food and Drug Administration (FDA) and the National Institute 
on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS 
in carrying out the Secretary's scheduling responsibilities under 
the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The 
Secretary of the HHS has delegated to the Assistant Secretary for 
Health of the HHS the authority to make domestic drug scheduling 
recommendations. 58 FR 35460, July 1, 1993. Accordingly, all 
subsequent references to ``Secretary'' have been replaced with 
``Assistant Secretary.''
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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).
    Available data and information for MAB-CHMINACA, summarized below, 
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 3-Factor analysis and the Assistant Secretary's 
June 3, 2015, letter are available in their entirety under the tab 
``Supporting Documents'' of the public docket of this action at 
www.regulations.gov under Docket Number DEA-421.\2\
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    \2\ Although the published notice of intent stated that such 
items had been placed into the docket on regulations.gov, the 
Administration discovered in preparing this final order that they 
had in fact not been posted. However, those documents were available 
for review at the DEA. The DEA posted the cited analysis and letter 
to regulations.gov upon discovery of the omission.
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Synthetic Cannabinoids

    Synthetic cannabinoids (SCs) 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 into 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 sources 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, and 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 an 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 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. Despite 
multiple administrative and legislative actions to place SCs found on 
the illicit market into schedule I of the CSA, new generations of SCs 
intended to circumvent current law continue to be encountered with 
serious outcomes. Traffickers of these dangerous substances continue to 
attempt to skirt the law even after multiple control actions 
demonstrating a lack of regard for public health and safety. MAB-
CHMINACA is an SC that was encountered following the hospitalization of 
125 individuals around the Baton Rouge, Louisiana area in October 2014 
(see factor 6 of the DEA 3-Factor). 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; Hampton, 
Virginia; Hagerstown, Maryland; and multiple cities in the State of 
Mississippi (see factor 6 of the DEA 3-Factor).

[[Page 6173]]

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 the ingestion of MAB-CHMINACA (see 
factor 6 of the DEA 3-Factor).
    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 of DEA 3-Factor).
    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 and ``e-cigarettes,'' which allow 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, illicit drug manufacturers and 
suppliers are adapting at an alarmingly quick pace to design new SCs in 
an attempt to 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 DEA 3-Factor). 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-CHMINACA) to the list 
of schedule I Controlled Dangerous Substances section of the Louisiana 
Administrative Code (La. Admin. Code tit. 46, Sec.  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 DEA 3-Factor). 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 \3\ (queried on May 27, 2015):
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    \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.

    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, Sec.  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 the DEA 3-Factor). 
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. Similar to previous SCs, MAB-CHMINACA has been found on 
plant material. Designer drug products have been found to vary in the 
amount and type of SC that plant material is laced with, which could be

[[Page 6174]]

one explanation for the numerous emergency department admissions that 
have been connected to these substances.

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 handling 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 
may only be placed in schedule I of the CSA. 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. 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 Administrator, 
through a letter dated May 14, 2015, notified the Assistant Secretary 
of the DEA's intention to temporarily place this substance in schedule 
I. The Assistant Secretary responded to this notice by letter dated 
June 3, 2015, and stated that the HHS had no objection to the temporary 
placement of MAB-CHMINACA into schedule I. A notice of intent was 
subsequently published in the Federal Register on September 16, 2015. 
80 FR 55565.

Conclusion

    In accordance with the provisions of section 201(h) of the CSA, 21 
U.S.C. 811(h), the Administrator considered available data and 
information, herein set forth the grounds for his determination that it 
is necessary to temporarily schedule MAB-CHMINACA into 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 of the CSA to avoid an 
imminent hazard to the public safety, the final order temporarily 
scheduling this substance will be effective on the date of publication 
in the Federal Register, and will be in effect for a period of two 
years, with a possible extension of one additional year, pending 
completion of the regular (permanent) scheduling process. 21 U.S.C. 
811(h)(1) and (2).
    The CSA sets forth specific criteria for scheduling a drug or other 
substance. Regular scheduling actions in accordance with 21 U.S.C. 
811(a) are subject to formal rulemaking procedures done ``on the record 
after opportunity for a hearing'' conducted pursuant to the provisions 
of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The regular scheduling process 
of formal rulemaking affords interested parties with appropriate 
process and the government with any additional relevant information 
needed to make a determination. Final decisions that conclude the 
regular scheduling process of formal rulemaking are subject to judicial 
review. 21 U.S.C. 877. Temporary scheduling orders are not subject to 
judicial review. 21 U.S.C. 811(h)(6).

Requirements for Handling

    Upon the effective date of this final order, MAB-CHMINACA will be 
subject to the regulatory controls and administrative, civil, and 
criminal sanctions applicable to the manufacture, distribution, reverse 
distribution, importation, exportation, engagement in research, and 
conduct of instructional activities or chemical analysis with, and 
possession of schedule I controlled substances including the following:
    1. Registration. Any person who handles (manufactures, distributes, 
reverse distributes, imports, exports, engages in research, or conducts 
instructional activities or chemical analysis with, or possesses), or 
who desires to handle, MAB-CHMINACA must be registered with the DEA to 
conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 
and in accordance with 21 CFR parts 1301 and 1312, as of February 5, 
2016. Any person who currently handles MAB-CHMINACA and is not 
registered with the DEA, must submit an application for registration 
and may not continue to handle MAB-CHMINACA as of February 5, 2016, 
unless the DEA has approved that application for registration. Retail 
sales of schedule I controlled substances to the general public are not 
allowed under the CSA. Possession of any quantity of this substance in 
a manner not authorized by the CSA on or after February 5, 2016 is 
unlawful and those in possession of any quantity of this substance may 
be subject to prosecution pursuant to the CSA.
    2. Disposal of stocks. Any person who does not desire or is not 
able to obtain a schedule I registration to handle MAB-CHMINACA, must 
surrender all quantities of currently held MAB-CHMINACA.
    3. Security. MAB-CHMINACA is subject to schedule I security 
requirements and must be handled and stored pursuant to 21 U.S.C. 821, 
823, 871(b), and in accordance with 21 CFR 1301.71-1301.93, as of 
February 5, 2016.
    4. Labeling and Packaging. All labels, labeling, and packaging for 
commercial containers of MAB-CHMINACA must be in compliance with 21 
U.S.C. 825, 958(e), and be in accordance with 21 CFR part 1302. Current 
DEA registrants shall have 30 calendar days from February 5, 2016, to 
comply with all labeling and packaging requirements.
    5. Quota. Only registered manufacturers may manufacture MAB-
CHMINACA in accordance with a quota assigned pursuant to 21 U.S.C. 826 
and in accordance with 21 CFR part 1303 as of February 5, 2016.
    6. Inventory. Every DEA registrant who possesses any quantity of 
MAB-CHMINACA on the effective date of this order, must take an 
inventory of all stocks of this substance on hand, pursuant to 21 
U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 
1304.11. Current DEA registrants shall have 30 calendar days from the 
effective date of this order to be in compliance with all inventory 
requirements. After the initial inventory, every DEA registrant must 
take an inventory of all controlled substances (including MAB-CHMINACA) 
on hand on a biennial basis, pursuant to 21 U.S.C. 827 and 958, and in 
accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    7. Records. All DEA registrants must maintain records with respect 
to MAB-CHMINACA pursuant to 21 U.S.C. 827 and 958(e), and in accordance 
with 21 CFR parts 1304 and 1312, 1317 and Sec.  1307.11. Current DEA 
registrants authorized to handle MAB-CHMINACA shall have 30 calendar 
days from the effective date of this order to be in compliance with all 
recordkeeping requirements.
    8. Reports. All DEA registrants who manufacture or distribute MAB-
CHMINACA must submit reports pursuant to 21 U.S.C. 827 and in 
accordance with 21 CFR 1304 and 1312 as of February 5, 2016.
    9. Order Forms. All DEA registrants who distribute MAB-CHMINACA 
must comply with order form requirements pursuant to 21 U.S.C. 828 and 
in accordance with 21 CFR part 1305 as of February 5, 2016.
    10. Importation and Exportation. All importation and exportation of 
MAB-CHMINACA must be in compliance

[[Page 6175]]

with 21 U.S.C. 952, 953, 957, 958, and in accordance with 21 CFR part 
1312 as of February 5, 2016.
    11. Liability. Any activity involving MAB-CHMINACA not authorized 
by, or in violation of the CSA, occurring as of February 5, 2016, is 
unlawful, and may subject the person to administrative, civil, and/or 
criminal sanctions.

Regulatory Analyses

    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 temporary scheduling action. In the 
alternative, even assuming that this action might be subject to 5 
U.S.C. 553, the Administrator finds that there is good cause to forgo 
the notice and comment requirements of 5 U.S.C. 553, as any further 
delays in the process for issuance of temporary scheduling orders would 
be impracticable and contrary to the public interest in view of the 
manifest urgency to avoid an imminent hazard to the public safety.
    Further, the DEA believes that this temporary scheduling action 
final order is not a ``rule'' as defined by 5 U.S.C. 601(2), and, 
accordingly, is not subject to the requirements of the Regulatory 
Flexibility Act (RFA). The requirements for the preparation of an 
initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not 
applicable where, as here, the DEA is not required by the APA or any 
other law to publish a general notice of proposed rulemaking.
    Additionally, this action is not a significant regulatory action as 
defined by Executive Order 12866 (Regulatory Planning and Review), 
section 3(f), and, accordingly, this action has not been reviewed by 
the Office of Management and Budget (OMB).
    This action will not have substantial direct effects on the States, 
on the relationship between the national government and the States, or 
on the distribution of power and responsibilities among the various 
levels of government. Therefore, in accordance with Executive Order 
13132 (Federalism) it is determined that this action does not have 
sufficient federalism implications to warrant the preparation of a 
Federalism Assessment.
    As noted above, this action is an order, not a rule. Accordingly, 
the Congressional Review Act (CRA) is inapplicable, as it applies only 
to rules. 5 U.S.C. 808(2). It is in the public interest to schedule 
this substance immediately because it poses a public health risk. This 
temporary scheduling action is taken pursuant to 21 U.S.C. 811(h), 
which is specifically designed to enable the DEA to act in an 
expeditious manner to avoid an imminent hazard to the public safety. 
Under 21 U.S.C. 811(h), temporary scheduling orders are not subject to 
notice and comment rulemaking procedures. The DEA understands that the 
CSA frames temporary scheduling actions as orders rather than rules to 
ensure that the process moves swiftly. For the same reasons that 
underlie 21 U.S.C. 811(h), that is, the need to move quickly to place 
this substance into schedule I because it poses an imminent hazard to 
public safety, it would be contrary to the public interest to delay 
implementation of the temporary scheduling order. Therefore, this order 
shall take effect immediately upon its publication.

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 amends 21 CFR part 1308 as 
follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for part 1308 continues to read as follows:

    Authority:  21 U.S.C. 811, 812, 871(b), unless otherwise noted.

0
2. Amend Sec.  1308.11 by adding 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 (Other names: MAB-CHMINACA; ADB-
CHMINACA) (7032)

    Dated: February 2, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-02302 Filed 2-4-16; 8:45 am]
 BILLING CODE 4410-09-P
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