[Federal Register Volume 81, Number 245 (Wednesday, December 21, 2016)]
[Rules and Regulations]
[Pages 93595-93599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30595]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-446]


Schedules of Controlled Substances: Temporary Placement of Six 
Synthetic Cannabinoids (5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-
CHMICA and MDMB-FUBINACA) Into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of intent.

-----------------------------------------------------------------------

SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this notice of intent to temporarily schedule six synthetic 
cannabinoids: methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-
3,3-dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-
fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate [5F-AMB]; N-
(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide [5F-
APINACA, 5F-AKB48]; N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-
fluorobenzyl)-1H-indazole-3-carboxamide [ADB-FUBINACA]; methyl 2-(1-
(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate 
[MDMB-CHMICA, MMB-CHMINACA] and methyl 2-(1-(4-fluorobenzyl)-1H-
indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA], into 
schedule I pursuant to the temporary scheduling provisions of the 
Controlled Substances Act (CSA). This action is based on a finding by 
the Administrator that the placement of these synthetic cannabinoids 
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 substances under the Controlled 
Substances Act on the manufacture, distribution, possession, 
importation, exportation of, and research and conduct with, 
instructional activities of these synthetic cannabinoids.

DATES: December 21, 2016.

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

SUPPLEMENTARY INFORMATION: Any final order will be published in the 
Federal Register and may not be effective prior to January 20, 2017.

Legal Authority

    The Drug Enforcement Administration (DEA) implements and enforces 
titles II and III of the Comprehensive Drug Abuse Prevention and 
Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III 
are referred to as the ``Controlled Substances Act'' and the 
``Controlled Substances Import and Export Act,'' respectively, and are 
collectively referred to as the ``Controlled Substances Act'' or the 
``CSA'' for the purpose of this action. The DEA publishes the 
implementing regulations for these statutes in title 21 of the Code of 
Federal Regulations (CFR), 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 providing for the legitimate medical, scientific, 
research, and industrial needs of the United States. Controlled 
substances have the potential for abuse and dependence and are 
controlled to protect the public health and safety.
    Under the CSA, every controlled substance is classified into one of 
five schedules based upon its potential for abuse, its currently 
accepted medical use in treatment in the United States, and the degree 
of dependence the drug or other substance may cause. 21 U.S.C. 812. The 
initial schedules of controlled substances established by Congress are 
found at 21 U.S.C. 812(c), and the current list of all scheduled 
substances is published at 21 CFR part 1308.
    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

[[Page 93596]]

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 (FDCA), 21 U.S.C. 355. 21 U.S.C. 
811(h)(1); 21 CFR part 1308. The Attorney General has delegated 
scheduling authority under 21 U.S.C. 811 to the Administrator of the 
DEA. 28 CFR 0.100.

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 any intention to temporarily place a substance 
into schedule I of the CSA.\1\ The Acting Administrator transmitted 
notice of his intent to place 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, 
MDMB-CHMICA and MDMB-FUBINACA in schedule I on a temporary basis to the 
Assistant Secretary by letter dated April 22, 2016. The Assistant 
Secretary responded to this notice by letter dated May 2, 2016, and 
advised that based on a review by the Food and Drug Administration 
(FDA), there were no investigational new drug applications or approved 
new drug applications for 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, 
MDMB-CHMICA or MDMB-FUBINACA. The Assistant Secretary also stated that 
the HHS had no objection to the temporary placement of 5F-ADB, 5F-AMB, 
5F-APINACA, ADB-FUBINACA, MDMB-CHMICA or MDMB-FUBINACA into schedule I 
of the CSA. 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA or 
MDMB-FUBINACA are not currently listed in any schedule under the CSA.
---------------------------------------------------------------------------

    \1\ As discussed 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 
Department of Health and Human Service (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.
---------------------------------------------------------------------------

    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 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).

5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA

    Available data and information for 5F-ADB, 5F-AMB, 5F-APINACA, ADB-
FUBINACA, MDMB-CHMICA and MDMB-FUBINACA indicate that these synthetic 
cannabinoids (SCs) have a high potential for abuse, no currently 
accepted medical use in treatment in the United States, and a lack of 
accepted safety for use under medical supervision.

Synthetic Cannabinoids

    SCs are substances synthesized in laboratories that mimic the 
biological effects of delta-9-tetrahydrocannabinol (THC), the main 
psychoactive ingredient in marijuana. It is believed that 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 the present, misuse and abuse of SCs has increased 
in the United States with law enforcement encounters describing SCs 
applied onto plant material and in designer drug products intended for 
human consumption. It has been demonstrated that the substances and the 
associated designer drug products are abused for their psychoactive 
properties. With many generations of SCs having been encountered since 
2009, 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-
FUBINACA are some of the latest, and the abuse of these substances is 
negatively impacting communities.
    As observed by the DEA and CBP, SCs originate from foreign sources, 
such as China. Bulk powder substances are smuggled via common carrier 
into the United States and find their way to clandestine designer drug 
product manufacturing operations located in residential neighborhoods, 
garages, warehouses, and other similar destinations throughout the 
country. According to online discussion boards and law enforcement 
encounters, applying by spraying or mixing the SCs with plant material 
provides a vehicle for the most common route of administration--smoking 
(using a pipe, a water pipe, or rolling the drug-laced plant material 
in cigarette papers).
    5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-
FUBINACA have no accepted medical use in the United States. Use of 
these specific SCs has been reported to result in adverse effects in 
humans including deaths (see 3-Factor document in ``Supporting and 
Related Material'' section). Use of other SCs has resulted in signs of 
addiction and withdrawal, and based on the similar pharmacological 
profile of these six substances, it is believed that there will be 
similar observed adverse effects.
    5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-
FUBINACA are SCs that have pharmacological effects similar to the 
schedule I hallucinogen delta-[Delta]-tetrahydrocannabinol (THC) and 
temporarily and permanently controlled schedule I synthetic cannabinoid 
substances. In addition, the misuse of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-
FUBINACA, MDMB-CHMICA and/or MDMB-FUBINACA have been associated with 
either overdoses requiring emergency medical intervention or death (see 
factor 6). With no approved medical use and limited safety or 
toxicological information, 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, 
MDMB-CHMICA and MDMB-FUBINACA have emerged on the designer drug market, 
and the abuse of these substances for their psychoactive properties is 
concerning. The DEA's analysis is available in its entirety under 
``Supporting and Related Material'' of the public docket for this 
action at www.regulations.gov under docket number DEA-443.

Factor 4. History and Current Pattern of Abuse

    Synthetic cannabinoids have been developed over the last 30 years 
as tools for investigating the endocannabinoid system (e.g. determining 
CB1 and CB2 receptor activity). The first encounter of SCs within the 
United States occurred in November 2008 by CBP. Since then the 
popularity of SCs and their

[[Page 93597]]

associated products has increased steadily as evidenced by law 
enforcement seizures, public health information, and media reports. 5F-
ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA 
are SCs that have been recently encountered (see ``Supporting and 
Related Material,'' Factor 5). Multiple overdoses involving emergency 
medical intervention or deaths have been associated with 5F-ADB, 5F-
AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA.
    Research and clinical reports have demonstrated that SCs are 
applied onto plant material so that the material may be smoked as users 
attempt to obtain a euphoric and/or psychoactive ``high,'' believed to 
be similar to marijuana. Data gathered from published studies, 
supplemented by discussions on Internet discussion Web sites, 
demonstrate that these products are being abused mainly by smoking for 
their psychoactive properties. The adulterated products are marketed as 
``legal'' alternatives to marijuana. In recent overdoses, 5F-ADB, 5F-
AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA have been 
shown to be applied onto plant material, similar to the SCs that have 
been previously available.
    Law enforcement personnel have encountered various application 
methods including buckets or cement mixers in which plant material and 
one or more SCs (including 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, 
MDMB-CHMICA and/or MDMB-FUBINACA) are mixed together, as well as large 
areas where the plant material is spread out so that a dissolved SC 
mixture can be applied directly. Once mixed, the SC plant material is 
then allowed to dry before manufacturers package the product for 
distribution, ignoring any control mechanisms to prevent contamination 
or to ensure a consistent, uniform concentration of the substance in 
each package. Adverse health consequences may also occur from directly 
ingesting the substance(s) during the manufacturing process. 5F-ADB, 
5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA, 
similar to other SCs, have been encountered in form of dried leaves or 
herbal blends.
    The designer drug products laced with SCs, including 5F-ADB, 5F-
AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA, 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, that they are 
a synthetic form of marijuana, and that labeling these products as 
``not for human consumption'' is a legal defense to criminal 
prosecution.
    A major concern, as reiterated by public health officials and 
medical professionals, is 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 media as abusing these 
substances and related products. Individuals, including minors, are 
purchasing SCs from Internet Web sites, gas stations, convenience 
stores, and head shops.

Factor 5. Scope, Duration and Significance of Abuse

    SCs, including 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-
CHMICA and MDMB-FUBINACA, continue to be encountered on the illicit 
market regardless of scheduling actions that attempt to safeguard the 
public from the adverse effects and safety issues associated with these 
substances. Numerous substances are encountered each month, differing 
only by small modifications intended to avoid prosecution while 
maintaining the pharmacological effects. Law enforcement and health 
care professionals continue to report abuse of these substances and 
their associated products.
    As described by the National Institute on Drug Abuse (NIDA), many 
substances being encountered in the illicit market, specifically SCs, 
have been available for years but have reentered the marketplace due to 
a renewed popularity.
    The threat of serious injury to the individual following the 
ingestion of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and 
MDMB-FUBINACA and other SCs persists. Numerous calls have been received 
by poison centers regarding the abuse of products potentially laced 
with SCs that have resulted in visits to emergency departments. Law 
enforcement continues to encounter novel SCs on the illicit market, 
including 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and 
MDMB-FUBINACA (see factor 5 in ``Supporting and Related Material'').
    The following information details information obtained through 
NFLIS \2\ (queried on November 7, 2016), including dates of first 
encounter, exhibits/reports, and locations.
---------------------------------------------------------------------------

    \2\ The 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.
---------------------------------------------------------------------------

    5F-ADB: NFLIS--2,311 reports, first encountered in September 2014, 
locations include: Arizona, Arkansas, California, Florida, Georgia, 
Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Missouri, New 
Jersey, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, 
Texas, Virginia, and Wisconsin.
    5F-AMB: NFLIS--3,349 reports, first encountered in January 2014, 
locations include: Arizona, Arkansas, California, Colorado, Florida, 
Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, 
Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, 
Nebraska, New Hampshire, New Jersey, New Mexico, New York, North 
Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, 
Tennessee, Texas, Utah, Virginia, Wisconsin, and Wyoming.
    5F-APINACA: NFLIS--1,936 reports, first encountered in August 2012, 
locations include: Alabama, Arizona, Arkansas, California, Colorado, 
Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, 
Kentucky, Louisiana, Maryland, Minnesota, Mississippi, Missouri, 
Nebraska, New Hampshire, New Jersey, North Dakota, Ohio, Oklahoma, 
Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, 
Virginia, West Virginia, Wisconsin, and Wyoming.
    ADB-FUBINACA: NFLIS--942 reports, first encountered in March 2014, 
locations include: Arkansas, California, Colorado, Florida, Georgia, 
Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, 
Mississippi, Missouri, New Jersey, New Mexico, New York, North Dakota, 
Ohio, Pennsylvania, Texas, Utah, Virginia, and Wyoming.
    MDMB-CHMICA: NFLIS--227 reports, first encountered in March 2015, 
locations include: Arkansas, Georgia, Indiana, Kentucky, Louisiana, 
Nevada, Ohio, Oklahoma, South Carolina, and Texas.
    MDMB-FUBINACA: NFLIS--507 reports, first encountered in July 2015, 
locations include: Arkansas, California, Colorado, Connecticut, 
Georgia, Idaho,

[[Page 93598]]

Indiana, Kansas, Kentucky, Louisiana, Missouri, Nevada, New Jersey, New 
Mexico, North Dakota, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, 
Wisconsin, and West Virginia.

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

    5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-
FUBINACA have all been identified in overdose and/or cases involving 
death attributed to their abuse. Adverse health effects reported from 
these incidents involving 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, 
MDMB-CHMICA and/or MDMB-FUBINACA have included: Nausea, persistent 
vomiting, agitation, altered mental status, seizures, convulsions, loss 
of consciousness and/or cardio toxicity. Large clusters of overdoses 
requiring medical care have been reported involving 5F-AMB, MDMB-
FUBINACA, MDMB-CHMICA and 5F-ADB. Reported deaths involving these SCs 
have included 5F-ADB (8); 5F-AMB (6); 5F-APINACA (1); ADB-FUBINACA (2); 
MDMB-CHMICA (4), European Monitoring Centre for Drugs and Drug 
Addiction has reported an additional 12 deaths involving MDMB-CHMICA; 
and MDMB-FUBINACA (1) (see factor 6 in ``Supporting and Related 
Material'').
Finding of Necessity of Schedule I Placement to Avoid Imminent Hazard 
to Public Safety
    In accordance with 21 U.S.C. 811 (h)(3), based on the available 
data and information summarized above, the continued uncontrolled 
manufacture, distribution, importation, exportation, conduct of 
research and chemical analysis, possession, and abuse of 5F-ADB, 5F-
AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA pose an 
imminent hazard to the public safety. The DEA is not aware of any 
currently accepted medical uses for these substances 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 5F-ADB, 5F-AMB, 5F-
APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA indicate that 
these SCs have a high potential for abuse, no currently accepted 
medical use in treatment in the United States, and a lack of accepted 
safety for use under medical supervision. As required by section 
201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Administrator, through a 
letter dated April 22, 2016, notified the Assistant Secretary of the 
DEA's intention to temporarily place these six substances in schedule 
I.
Conclusion
    This notice of intent initiates a 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 sets forth the grounds for his determination 
that it is necessary to temporarily schedule methyl 2-(1-(5-
fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate [5F-ADB; 
5F-MDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-
carboxamido)-3-methylbutanoate [5F-AMB]; N-(adamantan-1-yl)-1-(5-
fluoropentyl)-1H-indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N-(1-
amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-
carboxamide [ADB-FUBINACA]; methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-
carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA] and 
methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-
dimethylbutanoate [MDMB-FUBINACA] in schedule I of the CSA, and finds 
that the placement of these substances into schedule I of the CSA on a 
temporary basis is necessary to avoid an imminent hazard to the public 
safety.
    Because the Administrator hereby finds that it is necessary to 
temporarily place these SCs into schedule I to avoid an imminent hazard 
to the public safety, any subsequent final order temporarily scheduling 
these substances will be effective on the date of publication in the 
Federal Register, and will be in effect for a period of two years, with 
a possible extension of one additional year, pending completion of the 
regular (permanent) scheduling process. 21 U.S.C. 811(h)(1) and (2). It 
is the intention of the 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. 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, 
MDMB-CHMICA and MDMB-FUBINACA will then be subject to the regulatory 
controls and administrative, civil, and criminal sanctions applicable 
to the manufacture, distribution, importation, exportation, research, 
conduct of instructional activities, and chemical analysis and 
possession of a schedule I controlled substance.
    The CSA sets forth specific criteria for scheduling a drug or other 
substance. Regular scheduling actions in accordance with 21 U.S.C. 
811(a) are subject to formal rulemaking procedures done ``on the record 
after opportunity for a hearing'' conducted pursuant to the provisions 
of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The regular scheduling process 
of formal rulemaking affords interested parties with appropriate 
process and the government with any additional relevant information 
needed to make a determination. Final decisions that conclude the 
regular scheduling process of formal rulemaking are subject to judicial 
review. 21 U.S.C. 877. Temporary scheduling orders are not subject to 
judicial review. 21 U.S.C. 811(h)(6).
Regulatory Matters
    Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for an 
expedited temporary scheduling action where such action is necessary to 
avoid an imminent hazard to the public safety. As provided in this 
subsection, the Attorney General may, by order, schedule a substance in 
schedule I on a temporary basis. Such an order may not be issued before 
the expiration of 30 days from (1) the publication of a notice in the 
Federal Register of the intention to issue such order and the grounds 
upon which such order is to be issued, and (2) the date that notice of 
the proposed temporary scheduling order is transmitted to the Assistant 
Secretary. 21 U.S.C. 811(h)(1).
    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 section 553 of the Administrative Procedure 
Act (APA), 5 U.S.C. 553, do not apply to this notice of intent. In the 
alternative, even assuming that this notice of intent might be subject 
to section 553 of the APA, the Administrator finds that there is good 
cause to forgo the notice and comment requirements of section 553, as 
any further delays in the process for issuance of temporary scheduling 
orders would be impracticable and contrary to the public interest in 
view of the manifest urgency to avoid an imminent hazard to the public 
safety.
    Although the DEA believes this notice of intent to issue a 
temporary scheduling order is not subject to the notice and comment 
requirements of section 553 of the APA, the DEA notes

[[Page 93599]]

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 (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 section 553 of the APA or any other 
law to publish a general notice of proposed rulemaking.
    Additionally, this action is not a significant regulatory action as 
defined by Executive Order 12866 (Regulatory Planning and Review), 
section 3(f), and, accordingly, this action has not been reviewed by 
the Office of Management and Budget.
    This action will not have substantial direct effects on the States, 
on the relationship between the national government and the States, or 
on the distribution of power and responsibilities among the various 
levels of government. Therefore, in accordance with Executive Order 
13132 (Federalism) it is determined that this action does not have 
sufficient federalism implications to warrant the preparation of a 
Federalism Assessment.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Reporting and recordkeeping requirements.

    For the reasons set out above, the DEA 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. In Sec.  1308.11, add paragraphs (h)(23) through (28) to read as 
follows:


Sec.  1308.11   Schedule I

* * * * *
    (h) * * *

------------------------------------------------------------------------
 
------------------------------------------------------------------------
(23) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-                  (7034)
 carboxamido)-3,3-dimethylbutanoate, its optical,
 positional, and geometric isomers, salts and salts of
 isomers (Other names: 5F-ADB; 5F-MDMB-PINACA)..........
(24) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-                  (7033)
 carboxamido)-3-methylbutanoate, its optical,
 positional, and geometric isomers, salts and salts of
 isomers (Other names: 5F-AMB)..........................
(25) N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-         (7049)
 carboxamide, its optical, positional, and geometric
 isomers, salts and salts of isomers (Other names: 5F-
 APINACA, 5F-AKB48).....................................
(26) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-               (7010)
 fluorobenzyl)-1H-indazole-3-carboxamide, its optical,
 positional, and geometric isomers, salts and salts of
 isomers (Other names: ADB-FUBINACA)....................
(27) methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-                  (7042)
 carboxamido)-3,3-dimethylbutanoate, its optical,
 positional, and geometric isomers, salts and salts of
 isomers (Other names: MDMB-CHMICA, MMB-CHMINACA).......
(28) methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-                  (7020)
 carboxamido)-3,3-dimethylbutanoate, its optical,
 positional, and geometric isomers, salts and salts of
 isomers (Other names: MDMB-FUBINACA)...................
------------------------------------------------------------------------


    Dated: December 13, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-30595 Filed 12-20-16; 8:45 am]
BILLING CODE 4410-09-P