82_FR_17186 82 FR 17119 - 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

82 FR 17119 - 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

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 67 (April 10, 2017)

Page Range17119-17124
FR Document2017-07118

The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to 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], and their 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 these synthetic cannabinoids 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, 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA or MDMB-FUBINACA.

Federal Register, Volume 82 Issue 67 (Monday, April 10, 2017)
[Federal Register Volume 82, Number 67 (Monday, April 10, 2017)]
[Rules and Regulations]
[Pages 17119-17124]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-07118]


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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: Temporary scheduling order.

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SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this temporary scheduling order to 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], and 
their 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 these synthetic cannabinoids 
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, 5F-ADB, 5F-AMB, 
5F-APINACA, ADB-FUBINACA, MDMB-CHMICA or MDMB-FUBINACA.

DATES: This temporary scheduling order is effective on April 10, 2017. 
This temporary order will expire on April 10, 2019, unless it is 
extended for an additional year or a permanent scheduling proceeding is 
completed.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control 
Division, 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. 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 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.

[[Page 17120]]

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 he 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 \1\ for up to one year. 21 U.S.C. 811(h)(2).
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    \1\ Though DEA has used the term ``final order'' with respect to 
temporary scheduling orders in the past, this notification adheres 
to the statutory language of 21 U.S.C. 811(h), which refers to a 
``temporary scheduling order.'' No substantive change is intended.
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    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 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 his intention to temporarily place a substance 
into schedule I of the CSA.\2\ The Acting Administrator transmitted 
notice of his intent to place 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, 
MDMB-CHMICA and MDMB-FUBINACA into 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. The DEA has taken into consideration the Assistant 
Secretary's comments as required by 21 U.S.C. 811 (h)(4). 5F-ADB, 5F-
AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA or MDMB-FUBINACA are not 
currently listed in any schedule under the CSA, and no exemptions or 
approvals are in effect for 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, 
MDMB-CHMICA or MDMB-FUBINACA under section 505 of the FDCA, 21 U.S.C. 
355. The DEA has found that the control of 5F-ADB, 5F-AMB, 5F-APINACA, 
ADB-FUBINACA, MDMB-CHMICA or MDMB-FUBINACA in schedule I on a temporary 
basis is necessary to avoid an imminent hazard to the public safety, 
and as required by 21 U.S.C. 811(h)(1)(A), a notice of intent to 
temporarily schedule 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-
CHMICA or MDMB-FUBINACA was published in the Federal Register on 
December 21, 2016. 81 FR 93595.
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    \2\ 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.
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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 into 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 5F-ADB, 5F-AMB, 5F-APINACA, ADB-
FUBINACA, MDMB-CHMICA and MDMB-FUBINACA, summarized below, 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. The DEA's three-factor analysis, and the Assistant 
Secretary's May 2, 2016 letter are available in their entirety under 
the tab ``Supporting Documents'' of the public docket of this action at 
www.regulations.gov under FDMS Docket ID: DEA-2016-0020 (Docket Number 
DEA-446).

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 U.S. Customs and 
Border Protection. 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. 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

[[Page 17121]]

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 the form of dried leave 
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 \3\ (queried on November 7, 2016), including dates of first 
encounter, exhibits/reports, and locations.
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    \3\ 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.
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    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, 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); 
and MDMB-CHMICA (4). The 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

[[Page 17122]]

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 into 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 into 
schedule I. A notice of intent was subsequently published in the 
Federal Register on December 21, 2016.\4\ 81 FR 93595.
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    \4\ A publication error occurred with the December 21, 2016 
notification (81 FR 93595), which resulted in 21 CFR 1308.11 being 
amended. As a result, a correction was issued by the Federal 
Register on January 9, 2017 (82 FR 2218), and the amended text was 
removed. The original notice of intent was republished on January 9, 
2017 (82 FR 2280), with the corrected non-amendatory language.
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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, and herein set 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] into schedule I of the CSA to avoid 
an imminent hazard to the public safety.
    Because the Administrator hereby finds it necessary to temporarily 
place these SCs into schedule I to avoid an imminent hazard to the 
public safety, this temporary order 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).
    The CSA sets forth specific criteria for scheduling a drug or other 
substance. Permanent 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 permanent 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 permanent 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 temporary order, 5F-ADB, 5F-AMB, 
5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA will become 
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, 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-
CHMICA and/or MDMB-FUBINACA 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 April 10, 2017. Any 
person who currently handles 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, 
MDMB-CHMICA and/or MDMB-FUBINACA and is not registered with the DEA, 
must submit an application for registration and may not continue to 
handle 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and/or 
MDMB-FUBINACA as of April 10, 2017, 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 these substances in a manner not 
authorized by the CSA on or after April 10, 2017 is unlawful and those 
in possession of any quantity of these substances 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 5F-ADB, 5F-AMB, 5F-
APINACA, ADB-FUBINACA, MDMB-CHMICA and/or MDMB-FUBINACA, must surrender 
all quantities of currently held 5F-ADB, 5F-AMB, 5F-APINACA, ADB-
FUBINACA, MDMB-CHMICA and/or MDMB-FUBINACA.
    3. Security. 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA 
and/or MDMB-FUBINACA are 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 April 10, 2017.
    4. Labeling and Packaging. All labels, labeling, and packaging for 
commercial containers of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, 
MDMB-CHMICA and/or MDMB-FUBINACA 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 April 10, 2017, to comply 
with all labeling and packaging requirements.
    5. Inventory. Every DEA registrant who possesses any quantity of 
5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and/or MDMB-
FUBINACA on the effective date of this order, must take an inventory of 
all stocks of these substances 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 5F-ADB, 5F-AMB, 5F-
APINACA, ADB-FUBINACA, MDMB-CHMICA and/or MDMB-FUBINACA) on hand on a 
biennial basis, pursuant to 21 U.S.C. 827

[[Page 17123]]

and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    6. Records. All DEA registrants must maintain records with respect 
to 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and/or MDMB-
FUBINACA pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 
21 CFR parts 1304, 1312, and 1317 and Sec.  1307.11. Current DEA 
registrants authorized to handle 5F-ADB, 5F-AMB, 5F-APINACA, ADB-
FUBINACA, MDMB-CHMICA and/or MDMB-FUBINACA shall have 30 calendar days 
from the effective date of this order to be in compliance with all 
recordkeeping requirements.
    7. Reports. All DEA registrants who manufacture or distribute 5F-
ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and/or MDMB-FUBINACA 
must submit reports pursuant to 21 U.S.C. 827 and in accordance with 21 
CFR parts 1304 and 1312 as of April 10, 2017.
    8. Order Forms. All DEA registrants who distribute 5F-ADB, 5F-AMB, 
5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and/or MDMB-FUBINACA must comply 
with order form requirements pursuant to 21 U.S.C. 828 and in 
accordance with 21 CFR part 1305 as of April 10, 2017.
    9. Importation and Exportation. All importation and exportation of 
5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and/or MDMB-
FUBINACA must be in compliance with 21 U.S.C. 952, 953, 957, 958, and 
in accordance with 21 CFR part 1312 as of April 10, 2017.
    10. Quota. Only DEA registered manufacturers may manufacture 5F-
ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and/or MDMB-FUBINACA 
in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in 
accordance with 21 CFR part 1303 as of April 10, 2017.
    11. Liability. Any activity involving 5F-ADB, 5F-AMB, 5F-APINACA, 
ADB-FUBINACA, MDMB-CHMICA and/or MDMB-FUBINACA not authorized by, or in 
violation of the CSA, occurring as of April 10, 2017, is unlawful, and 
may subject the person to administrative, civil, and/or criminal 
sanctions.

Regulatory Matters

    Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for a 
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 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.
    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 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.
    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. However, if this were a rule, pursuant to the Congressional 
Review Act, ``any rule for which an agency for good cause finds that 
notice and public procedure thereon are impracticable, unnecessary, or 
contrary to the public interest, shall take effect at such time as the 
federal agency promulgating the rule determines. 5 U.S.C. 808(2). It is 
in the public interest to schedule these substances immediately because 
they pose 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. 21 U.S.C. 811(h) exempts the temporary 
scheduling order from standard notice and comment rulemaking procedures 
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 
these substances into schedule I because they pose 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. The DEA has 
submitted a copy of this temporary order to both Houses of Congress and 
to the Comptroller General, although such filing is not required under 
the Small Business Regulatory Enforcement Fairness Act of 1996 
(Congressional Review Act), 5 U.S.C. 801-808, because, as noted above, 
this action is an order, not a rule.

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 follow:

    Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise 
noted.


0
2. Section 1308.11 is amended by adding paragraphs (h)(10) through (15) 
to read as follows:


Sec.  1308.11   Schedule I.

* * * * *
    (h) * * *

(10) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-     (7034)
 3,3-dimethylbutanoate, its optical, positional, and geometric
 isomers, salts and salts of isomers (Other names: 5F-ADB; 5F-
 MDMB-PINACA)..................................................
(11) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-   (7033)
 methylbutanoate, its optical, positional, and geometric
 isomers, salts and salts of isomers (Other names: 5F-AMB).....

[[Page 17124]]

 
(12) 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)
(13) 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)...................................
(14) methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-     (7042)
 3,3-dimethylbutanoate, its optical, positional, and geometric
 isomers, salts and salts of isomers (Other names: MDMB-CHMICA,
 MMB-CHMINACA).................................................
(15) methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-     (7020)
 3,3-dimethylbutanoate, its optical, positional, and geometric
 isomers, salts and salts of isomers (Other names: MDMB-
 FUBINACA).....................................................
 


    Dated: April 4, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017-07118 Filed 4-7-17; 8:45 am]
BILLING CODE 4410-09-P



                                                                 Federal Register / Vol. 82, No. 67 / Monday, April 10, 2017 / Rules and Regulations                                         17119

                                             Cairo, IL, Cairo Rgnl, NDB RWY 14, Amdt 2B              Millington, TN, Millington Rgnl Jetport,              Act. This action is based on a finding by
                                             Cairo, IL, Cairo Rgnl, RNAV (GPS) RWY 32,                 Takeoff Minimums and Obstacle DP, Orig–             the Administrator that the placement of
                                               Orig–B                                                  A                                                   these synthetic cannabinoids into
                                             Chicago/Prospect Heights/Wheeling, IL,                  Canadian, TX, Hemphill County, RNAV
                                               Chicago Executive, RNAV (GPS) RWY 16,
                                                                                                                                                           schedule I of the Controlled Substances
                                                                                                       (GPS) RWY 4, Amdt 2
                                               Amdt 1E                                               Kerrville, TX, Kerrville Muni/Louis                   Act is necessary to avoid an imminent
                                             Anderson, IN, Anderson Muni-Darlington                    Schreiner Fld, NDB RWY 30, Amdt 4,                  hazard to the public safety. As a result
                                               Field, ILS OR LOC RWY 30, Amdt 2                        CANCELED                                            of this order, the regulatory controls and
                                             Anderson, IN, Anderson Muni-Darlington                  Terrell, TX, Terrell Muni, NDB RWY 17,                administrative, civil, and criminal
                                               Field, NDB RWY 30, Amdt 7                               Amdt 4                                              sanctions applicable to schedule I
                                             Indianapolis, IN, Indianapolis Rgnl, RNAV               Wheeler, TX, Wheeler Muni, RNAV (GPS)                 controlled substances will be imposed
                                               (GPS) RWY 25, Orig–C                                    RWY 17, Orig–A, CANCELED                            on persons who handle (manufacture,
                                             Logansport, IN, Logansport/Cass County,                 Wheeler, TX, Wheeler Muni, RNAV (GPS)
                                               VOR–A, Amdt 7A                                                                                              distribute, reverse distribute, import,
                                                                                                       RWY 35, Orig–A, CANCELED
                                             Marion, IN, Marion Muni, ILS OR LOC RWY                                                                       export, engage in research, conduct
                                                                                                     Wheeler, TX, Wheeler Muni, RNAV (GPS)–A,
                                               4, Amdt 7D                                              Orig                                                instructional activities or chemical
                                             Peru, IN, Peru Muni, VOR RWY 1, Amdt 8C                 Wheeler, TX, Wheeler Muni, RNAV (GPS)–B,              analysis, or possess), or propose to
                                             Wabash, IN, Wabash Muni, VOR–A, Amdt                      Orig                                                handle, 5F–ADB, 5F–AMB, 5F–
                                               11A                                                   Wheeler, TX, Wheeler Muni, VOR/DME–A,                 APINACA, ADB–FUBINACA, MDMB–
                                             Houma, LA, Houma-Terrebonne, ILS OR LOC                   Amdt 2, CANCELED                                    CHMICA or MDMB–FUBINACA.
                                               RWY 18, Amdt 5
                                             New Iberia, LA, Acadiana Rgnl, ILS OR LOC               [FR Doc. 2017–06771 Filed 4–7–17; 8:45 am]            DATES: This temporary scheduling order
                                               RWY 35, Amdt 1                                        BILLING CODE 4910–13–P                                is effective on April 10, 2017. This
                                             New Iberia, LA, Acadiana Rgnl, RNAV (GPS)                                                                     temporary order will expire on April 10,
                                               RWY 17, Amdt 1                                                                                              2019, unless it is extended for an
                                             New Iberia, LA, Acadiana Rgnl, RNAV (GPS)                                                                     additional year or a permanent
                                               RWY 35, Amdt 1                                        DEPARTMENT OF JUSTICE
                                                                                                                                                           scheduling proceeding is completed.
                                             New Iberia, LA, Acadiana Rgnl, Takeoff
                                               Minimums and Obstacle DP, Amdt 1                      Drug Enforcement Administration                       FOR FURTHER INFORMATION CONTACT:
                                             New Iberia, LA, Acadiana Rgnl, VOR OR                                                                         Michael J. Lewis, Diversion Control
                                               TACAN RWY 17, Amdt 2                                  21 CFR Part 1308                                      Division, Drug Enforcement
                                             New Iberia, LA, Acadiana Rgnl, VOR RWY                                                                        Administration; Mailing Address: 8701
                                               35, Amdt 2                                            [Docket No. DEA–446]
                                                                                                                                                           Morrissette Drive, Springfield, Virginia
                                             Cape Girardeau, MO, Cape Girardeau Rgnl,                                                                      22152; Telephone: (202) 598–6812.
                                               LOC/DME BC RWY 28, Amdt 8C                            Schedules of Controlled Substances:
                                             Charleston, MO, Mississippi County, NDB                 Temporary Placement of Six Synthetic                  SUPPLEMENTARY INFORMATION:
                                               RWY 36, Amdt 4B                                       Cannabinoids (5F–ADB, 5F–AMB, 5F–                     Legal Authority
                                             Gordon, NE, Gordon Muni, NDB RWY 22,                    APINACA, ADB–FUBINACA, MDMB–
                                               Amdt 4B                                               CHMICA and MDMB–FUBINACA) into                          The Drug Enforcement
                                             Gordon, NE, Gordon Muni, RNAV (GPS)
                                                                                                     Schedule I                                            Administration (DEA) implements and
                                               RWY 4, Amdt 1B                                                                                              enforces titles II and III of the
                                             Gordon, NE, Gordon Muni, RNAV (GPS)                     AGENCY:  Drug Enforcement                             Comprehensive Drug Abuse Prevention
                                               RWY 22, Amdt 1A                                       Administration, Department of Justice.                and Control Act of 1970, as amended. 21
                                             Burns Flat, OK, Clinton-Sherman, ILS OR
                                                                                                     ACTION: Temporary scheduling order.                   U.S.C. 801–971. Titles II and III are
                                               LOC RWY 17R, Amdt 8
                                             Burns Flat, OK, Clinton-Sherman, Takeoff                                                                      referred to as the ‘‘Controlled
                                               Minimums and Obstacle DP, Orig–A                      SUMMARY:   The Administrator of the Drug              Substances Act’’ and the ‘‘Controlled
                                             Burns Flat, OK, Clinton-Sherman, VOR RWY                Enforcement Administration is issuing                 Substances Import and Export Act,’’
                                               35L, Amdt 12                                          this temporary scheduling order to                    respectively, and are collectively
                                             Clinton, OK, Clinton Rgnl, RNAV (GPS) RWY               schedule six synthetic cannabinoids:                  referred to as the ‘‘Controlled
                                               17, Amdt 3                                            methyl 2-(1-(5-fluoropentyl)-1H-                      Substances Act’’ or the ‘‘CSA’’ for the
                                             Clinton, OK, Clinton Rgnl, RNAV (GPS) RWY               indazole-3-carboxamido)-3,3-                          purpose of this action. The DEA
                                               35, Amdt 4                                            dimethylbutanoate [5F–ADB; 5F–                        publishes the implementing regulations
                                             Clinton, OK, Clinton Rgnl, VOR/DME–A,
                                               Orig, CANCELED
                                                                                                     MDMB–PINACA]; methyl 2-(1-(5-                         for these statutes in title 21 of the Code
                                             Elk City, OK, Elk City Rgnl Business, RNAV              fluoropentyl)-1H-indazole-3-                          of Federal Regulations (CFR), chapter II.
                                               (GPS) RWY 17, Amdt 2                                  carboxamido)-3-methylbutanoate [5F–                   The CSA and its implementing
                                             Elk City, OK, Elk City Rgnl Business, RNAV              AMB]; N-(adamantan-1-yl)-1-(5-                        regulations are designed to prevent,
                                               (GPS) RWY 35, Amdt 2                                  fluoropentyl)-1H-indazole-3-                          detect, and eliminate the diversion of
                                             Weatherford, OK, Thomas P Stafford, RNAV                carboxamide [5F–APINACA, 5F–                          controlled substances and listed
                                               (GPS) RWY 35, Amdt 3                                  AKB48]; N-(1-amino-3,3-dimethyl-1-                    chemicals into the illicit market while
                                             Latrobe, PA, Arnold Palmer Rgnl, ILS OR                 oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-                 ensuring an adequate supply is available
                                               LOC RWY 23, Amdt 17
                                             Latrobe, PA, Arnold Palmer Rgnl, RNAV
                                                                                                     indazole-3-carboxamide [ADB–                          for the legitimate medical, scientific,
                                               (GPS) RWY 5, Amdt 1                                   FUBINACA]; methyl 2-(1-                               research, and industrial needs of the
                                             Latrobe, PA, Arnold Palmer Rgnl, RNAV                   (cyclohexylmethyl)-1H-indole-3-                       United States. Controlled substances
                                               (GPS) RWY 23, Amdt 1                                  carboxamido)-3,3-dimethylbutanoate                    have the potential for abuse and
                                             Latrobe, PA, Arnold Palmer Rgnl, Takeoff                [MDMB–CHMICA, MMB–CHMINACA]                           dependence and are controlled to
                                               Minimums and Obstacle DP, Amdt 6                      and methyl 2-(1-(4-fluorobenzyl)-1H-                  protect the public health and safety.
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                                             Majuro Atoll, RM, Marshall Islands Intl, NDB            indazole-3-carboxamido)-3,3-                            Under the CSA, every controlled
                                               RWY 7, Amdt 1A                                        dimethylbutanoate [MDMB–                              substance is classified into one of five
                                             Majuro Atoll, RM, Marshall Islands Intl, NDB
                                               RWY 25, Amdt 1A
                                                                                                     FUBINACA], and their optical,                         schedules based upon its potential for
                                             Majuro Atoll, RM, Marshall Islands Intl,                positional, and geometric isomers, salts,             abuse, its currently accepted medical
                                               RNAV (GPS) RWY 7, Orig–D                              and salts of isomers into schedule I                  use in treatment in the United States,
                                             Majuro Atoll, RM, Marshall Islands Intl,                pursuant to the temporary scheduling                  and the degree of dependence the drug
                                               RNAV (GPS) RWY 25, Orig–D                             provisions of the Controlled Substances               or other substance may cause. 21 U.S.C.


                                        VerDate Sep<11>2014   14:16 Apr 07, 2017   Jkt 241001   PO 00000   Frm 00023   Fmt 4700   Sfmt 4700   E:\FR\FM\10APR1.SGM   10APR1


                                             17120               Federal Register / Vol. 82, No. 67 / Monday, April 10, 2017 / Rules and Regulations

                                             812. The initial schedules of controlled                drug applications for 5F–ADB, 5F–                     potential for abuse, no currently
                                             substances established by Congress are                  AMB, 5F–APINACA, ADB–FUBINACA,                        accepted medical use in treatment in the
                                             found at 21 U.S.C. 812(c), and the                      MDMB–CHMICA or MDMB–                                  United States, and a lack of accepted
                                             current list of all scheduled substances                FUBINACA. The Assistant Secretary                     safety for use under medical
                                             is published at 21 CFR part 1308.                       also stated that the HHS had no                       supervision. The DEA’s three-factor
                                                Section 201 of the CSA, 21 U.S.C. 811,               objection to the temporary placement of               analysis, and the Assistant Secretary’s
                                             provides the Attorney General with the                  5F–ADB, 5F–AMB, 5F–APINACA,                           May 2, 2016 letter are available in their
                                             authority to temporarily place a                        ADB–FUBINACA, MDMB–CHMICA or                          entirety under the tab ‘‘Supporting
                                             substance into schedule I of the CSA for                MDMB–FUBINACA into schedule I of                      Documents’’ of the public docket of this
                                             two years without regard to the                         the CSA. The DEA has taken into                       action at www.regulations.gov under
                                             requirements of 21 U.S.C. 811(b) if he                  consideration the Assistant Secretary’s               FDMS Docket ID: DEA–2016–0020
                                             finds that such action is necessary to                  comments as required by 21 U.S.C. 811                 (Docket Number DEA–446).
                                             avoid an imminent hazard to the public                  (h)(4). 5F–ADB, 5F–AMB, 5F–
                                                                                                                                                           Factor 4. History and Current Pattern of
                                             safety. 21 U.S.C. 811(h)(1). In addition,               APINACA, ADB–FUBINACA, MDMB–
                                                                                                                                                           Abuse
                                             if proceedings to control a substance are               CHMICA or MDMB–FUBINACA are not
                                             initiated under 21 U.S.C. 811(a)(1), the                currently listed in any schedule under                   Synthetic cannabinoids have been
                                             Attorney General may extend the                         the CSA, and no exemptions or                         developed over the last 30 years as tools
                                             temporary scheduling 1 for up to one                    approvals are in effect for 5F–ADB, 5F–               for investigating the endocannabinoid
                                             year. 21 U.S.C. 811(h)(2).                              AMB, 5F–APINACA, ADB–FUBINACA,                        system (e.g., determining CB1 and CB2
                                                Where the necessary findings are                     MDMB–CHMICA or MDMB–                                  receptor activity). The first encounter of
                                             made, a substance may be temporarily                    FUBINACA under section 505 of the                     SCs within the United States occurred
                                             scheduled if it is not listed in any other              FDCA, 21 U.S.C. 355. The DEA has                      in November 2008 by U.S. Customs and
                                             schedule under section 202 of the CSA,                  found that the control of 5F–ADB, 5F–                 Border Protection. Since then the
                                             21 U.S.C. 812, or if there is no                        AMB, 5F–APINACA, ADB–FUBINACA,                        popularity of SCs and their associated
                                             exemption or approval in effect for the                 MDMB–CHMICA or MDMB–                                  products has increased steadily as
                                             substance under section 505 of the                      FUBINACA in schedule I on a                           evidenced by law enforcement seizures,
                                             Federal Food, Drug, and Cosmetic Act                    temporary basis is necessary to avoid an              public health information, and media
                                             (FDCA), 21 U.S.C. 355. 21 U.S.C.                        imminent hazard to the public safety,                 reports. 5F–ADB, 5F–AMB, 5F–
                                             811(h)(1). The Attorney General has                     and as required by 21 U.S.C.                          APINACA, ADB–FUBINACA, MDMB–
                                             delegated scheduling authority under 21                 811(h)(1)(A), a notice of intent to                   CHMICA and MDMB–FUBINACA are
                                             U.S.C. 811 to the Administrator of the                  temporarily schedule 5F–ADB, 5F–                      SCs that have been recently encountered
                                             DEA. 28 CFR 0.100.                                      AMB, 5F–APINACA, ADB–FUBINACA,                        (see ‘‘Supporting and Related Material,’’
                                                                                                     MDMB–CHMICA or MDMB–                                  factor 5). Multiple overdoses involving
                                             Background                                              FUBINACA was published in the                         emergency medical intervention or
                                               Section 201(h)(4) of the CSA 21 U.S.C.                Federal Register on December 21, 2016.                deaths have been associated with 5F–
                                             811(h)(4), requires the Administrator to                81 FR 93595.                                          ADB, 5F–AMB, 5F–APINACA, ADB–
                                             notify the Secretary of the Department                     To find that placing a substance                   FUBINACA, MDMB–CHMICA and
                                             of Health and Human Services (HHS) of                   temporarily into schedule I of the CSA                MDMB–FUBINACA.
                                             his intention to temporarily place a                    is necessary to avoid an imminent                        Research and clinical reports have
                                             substance into schedule I of the CSA.2                  hazard to the public safety, the                      demonstrated that SCs are applied onto
                                             The Acting Administrator transmitted                    Administrator is required to consider                 plant material so that the material may
                                             notice of his intent to place 5F–ADB,                   three of the eight factors set forth in               be smoked as users attempt to obtain a
                                             5F–AMB, 5F–APINACA, ADB–                                section 201(c) of the CSA, 21 U.S.C.                  euphoric and/or psychoactive ‘‘high,’’
                                             FUBINACA, MDMB–CHMICA and                               811(c): The substance’s history and                   believed to be similar to marijuana. Data
                                             MDMB–FUBINACA into schedule I on a                      current pattern of abuse; the scope,                  gathered from published studies,
                                             temporary basis to the Assistant                        duration and significance of abuse; and               supplemented by discussions on
                                             Secretary by letter dated April 22, 2016.               what, if any, risk there is to the public             Internet discussion Web sites,
                                             The Assistant Secretary responded to                    health. 21 U.S.C. 811(h)(3).                          demonstrate that these products are
                                             this notice by letter dated May 2, 2016,                Consideration of these factors includes               being abused mainly by smoking for
                                             and advised that based on a review by                   actual abuse, diversion from legitimate               their psychoactive properties. The
                                             the Food and Drug Administration                        channels, and clandestine importation,                adulterated products are marketed as
                                             (FDA), there were no investigational                    manufacture, or distribution. 21 U.S.C.               ‘‘legal’’ alternatives to marijuana. In
                                             new drug applications or approved new                   811(h)(3).                                            recent overdoses, 5F–ADB, 5F–AMB,
                                                                                                        A substance meeting the statutory                  5F–APINACA, ADB–FUBINACA,
                                                1 Though DEA has used the term ‘‘final order’’       requirements for temporary scheduling                 MDMB–CHMICA and MDMB–
                                             with respect to temporary scheduling orders in the      may only be placed into schedule I. 21                FUBINACA have been shown to be
                                             past, this notification adheres to the statutory        U.S.C. 811(h)(1). Substances in schedule              applied onto plant material, similar to
                                             language of 21 U.S.C. 811(h), which refers to a
                                             ‘‘temporary scheduling order.’’ No substantive
                                                                                                     I are those that have a high potential for            the SCs that have been previously
                                             change is intended.                                     abuse, no currently accepted medical                  available.
                                                2 As discussed in a memorandum of                    use in treatment in the United States,                   Law enforcement personnel have
                                             understanding entered into by the Food and Drug         and a lack of accepted safety for use                 encountered various application
                                             Administration (FDA) and the National Institute on      under medical supervision. 21 U.S.C.                  methods, including buckets or cement
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                                             Drug Abuse (NIDA), the FDA acts as the lead agency
                                             within the Department of Health and Human               812(b)(1).                                            mixers, in which plant material and one
                                             Service (HHS) in carrying out the Secretary’s              Available data and information for                 or more SCs (including 5F–ADB, 5F–
                                             scheduling responsibilities under the CSA, with the     5F–ADB, 5F–AMB, 5F–APINACA,                           AMB, 5F–APINACA, ADB–FUBINACA,
                                             concurrence of NIDA. 50 FR 9518, Mar. 8, 1985.          ADB–FUBINACA, MDMB–CHMICA and                         MDMB–CHMICA and/or MDMB–
                                             The Secretary of the HHS has delegated to the
                                             Assistant Secretary for Health of the HHS the
                                                                                                     MDMB–FUBINACA, summarized                             FUBINACA) are mixed together, as well
                                             authority to make domestic drug scheduling              below, indicate that these synthetic                  as large areas where the plant material
                                             recommendations. 58 FR 35460, July 1, 1993.             cannabinoids (SCs) have a high                        is spread out so that a dissolved SC


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                                                                 Federal Register / Vol. 82, No. 67 / Monday, April 10, 2017 / Rules and Regulations                                        17121

                                             mixture can be applied directly. Once                   these substances and their associated                 Pennsylvania, Puerto Rico, South
                                             mixed, the SC plant material is then                    products.                                             Carolina, Tennessee, Texas, Utah,
                                             allowed to dry before manufacturers                        As described by the National Institute             Virginia, West Virginia, Wisconsin, and
                                             package the product for distribution,                   on Drug Abuse (NIDA), many                            Wyoming.
                                             ignoring any control mechanisms to                      substances being encountered in the                      ADB–FUBINACA: NFLIS—942
                                             prevent contamination or to ensure a                    illicit market, specifically SCs, have                reports, first encountered in March
                                             consistent, uniform concentration of the                been available for years but have                     2014, locations include: Arkansas,
                                             substance in each package. Adverse                      reentered the marketplace due to a                    California, Colorado, Florida, Georgia,
                                             health consequences may also occur                      renewed popularity.                                   Illinois, Indiana, Iowa, Kansas,
                                             from directly ingesting the substance(s)                   The threat of serious injury to the                Kentucky, Louisiana, Maryland,
                                             during the manufacturing process. 5F–                   individual following the ingestion of                 Mississippi, Missouri, New Jersey, New
                                             ADB, 5F–AMB, 5F–APINACA, ADB–                           5F–ADB, 5F–AMB, 5F–APINACA,                           Mexico, New York, North Dakota, Ohio,
                                             FUBINACA, MDMB–CHMICA and                               ADB–FUBINACA, MDMB–CHMICA and                         Pennsylvania, Texas, Utah, Virginia,
                                             MDMB–FUBINACA, similar to other                         MDMB–FUBINACA and other SCs                           and Wyoming.
                                             SCs, have been encountered in the form                  persists. Numerous calls have been                       MDMB–CHMICA: NFLIS—227
                                             of dried leave or herbal blends.                        received by poison centers regarding the              reports, first encountered in March
                                                The designer drug products laced                     abuse of products potentially laced with              2015, locations include: Arkansas,
                                             with SCs, including 5F–ADB, 5F–AMB,                     SCs that have resulted in visits to                   Georgia, Indiana, Kentucky, Louisiana,
                                             5F–APINACA, ADB–FUBINACA,                               emergency departments. Law                            Nevada, Ohio, Oklahoma, South
                                             MDMB–CHMICA and MDMB–                                   enforcement continues to encounter                    Carolina, and Texas.
                                                                                                     novel SCs on the illicit market,                         MDMB–FUBINACA: NFLIS—507
                                             FUBINACA, are often sold under the
                                                                                                     including 5F–ADB, 5F–AMB, 5F–                         reports, first encountered in July 2015,
                                             guise of ‘‘herbal incense’’ or
                                                                                                     APINACA, ADB–FUBINACA, MDMB–                          locations include: Arkansas, California,
                                             ‘‘potpourri,’’ use various product names,
                                                                                                     CHMICA and MDMB–FUBINACA (see                         Colorado, Connecticut, Georgia, Idaho,
                                             and are routinely labeled ‘‘not for
                                                                                                     factor 5 in ‘‘Supporting and Related                  Indiana, Kansas, Kentucky, Louisiana,
                                             human consumption.’’ Additionally,
                                                                                                     Material’’).                                          Missouri, Nevada, New Jersey, New
                                             these products are marketed as a ‘‘legal                   The following information details                  Mexico, North Dakota, Ohio, Oklahoma,
                                             high’’ or ‘‘legal alternative to marijuana’’            information obtained through NFLIS 3                  Pennsylvania, Texas, Virginia,
                                             and are readily available over the                      (queried on November 7, 2016),                        Wisconsin, and West Virginia.
                                             Internet, in head shops, or sold in                     including dates of first encounter,
                                             convenience stores. There is an                         exhibits/reports, and locations.                      Factor 6. What, if Any, Risk There Is to
                                             incorrect assumption that these                            5F–ADB: NFLIS–2,311 reports, first                 the Public Health
                                             products are safe, that they are a                      encountered in September 2014,                           5F–ADB, 5F–AMB, 5F–APINACA,
                                             synthetic form of marijuana, and that                   locations include: Arizona, Arkansas,                 ADB–FUBINACA, MDMB–CHMICA and
                                             labeling these products as ‘‘not for                    California, Florida, Georgia, Idaho,                  MDMB–FUBINACA have all been
                                             human consumption’’ is a legal defense                  Indiana, Iowa, Kansas, Kentucky,                      identified in overdose and/or cases
                                             to criminal prosecution.                                Louisiana, Missouri, New Jersey, North                involving death attributed to their
                                                A major concern, as reiterated by                    Dakota, Ohio, Oklahoma, Pennsylvania,                 abuse. Adverse health effects reported
                                             public health officials and medical                     South Carolina, Texas, Virginia, and                  from these incidents involving 5F–ADB,
                                             professionals, is the targeting and direct              Wisconsin.                                            5F–AMB, 5F–APINACA, ADB–
                                             marketing of SCs and SC-containing                         5F–AMB: NFLIS–3,349 reports, first                 FUBINACA, MDMB–CHMICA and/or
                                             products to adolescents and youth. This                 encountered in January 2014, locations                MDMB–FUBINACA have included:
                                             is supported by law enforcement                         include: Arizona, Arkansas, California,               Nausea, persistent vomiting, agitation,
                                             encounters and reports from emergency                   Colorado, Florida, Georgia, Hawaii,                   altered mental status, seizures,
                                             departments; however, all age groups                    Idaho, Illinois, Indiana, Iowa, Kansas,               convulsions, loss of consciousness and/
                                             have been reported by media as abusing                  Kentucky, Louisiana, Maryland,                        or cardio toxicity. Large clusters of
                                             these substances and related products.                  Massachusetts, Minnesota, Mississippi,                overdoses requiring medical care have
                                             Individuals, including minors, are                      Missouri, Nebraska, New Hampshire,                    been reported involving 5F–AMB,
                                             purchasing SCs from Internet Web sites,                 New Jersey, New Mexico, New York,                     MDMB–FUBINACA, MDMB–CHMICA
                                             gas stations, convenience stores, and                   North Dakota, Ohio, Oklahoma, Oregon,                 and 5F–ADB. Reported deaths involving
                                             head shops.                                             Pennsylvania, South Carolina,                         these SCs have included 5F–ADB (8);
                                             Factor 5. Scope, Duration and                           Tennessee, Texas, Utah, Virginia,                     5F–AMB (6); 5F–APINACA (1); ADB–
                                             Significance of Abuse                                   Wisconsin, and Wyoming.                               FUBINACA (2); and MDMB–CHMICA
                                                                                                        5F–APINACA: NFLIS–1,936 reports,                   (4). The European Monitoring Centre for
                                                SCs, including 5F–ADB, 5F–AMB,                       first encountered in August 2012,                     Drugs and Drug Addiction has reported
                                             5F–APINACA, ADB–FUBINACA,                               locations include: Alabama, Arizona,                  an additional 12 deaths involving
                                             MDMB–CHMICA and MDMB–                                   Arkansas, California, Colorado,                       MDMB–CHMICA; and MDMB–
                                             FUBINACA, continue to be encountered                    Connecticut, Florida, Georgia, Idaho,                 FUBINACA (1) (see factor 6 in
                                             on the illicit market regardless of                     Illinois, Indiana, Iowa, Kansas,                      ‘‘Supporting and Related Material’’).
                                             scheduling actions that attempt to                      Kentucky, Louisiana, Maryland,
                                             safeguard the public from the adverse                   Minnesota, Mississippi, Missouri,                     Finding of Necessity of Schedule I
                                             effects and safety issues associated with               Nebraska, New Hampshire, New Jersey,                  Placement To Avoid Imminent Hazard
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                                             these substances. Numerous substances                   North Dakota, Ohio, Oklahoma,                         to Public Safety
                                             are encountered each month, differing                                                                           In accordance with 21 U.S.C.
                                             only by small modifications intended to                   3 The National Forensic Laboratory Information      811(h)(3), based on the available data
                                             avoid prosecution while maintaining                     System (NFLIS) is a national drug forensic            and information summarized above, the
                                                                                                     laboratory reporting system that systematically
                                             the pharmacological effects. Law                        collects results from drug chemistry analyses
                                                                                                                                                           continued uncontrolled manufacture,
                                             enforcement and health care                             conducted by state and local forensic laboratories    distribution, importation, exportation,
                                             professionals continue to report abuse of               in the United States.                                 conduct of research and chemical


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                                             17122               Federal Register / Vol. 82, No. 67 / Monday, April 10, 2017 / Rules and Regulations

                                             analysis, possession, and abuse of 5F–                  dimethylbutanoate [MDMB–                              FUBINACA, MDMB–CHMICA and/or
                                             ADB, 5F–AMB, 5F–APINACA, ADB–                           FUBINACA] into schedule I of the CSA                  MDMB–FUBINACA and is not
                                             FUBINACA, MDMB–CHMICA and                               to avoid an imminent hazard to the                    registered with the DEA, must submit an
                                             MDMB–FUBINACA pose an imminent                          public safety.                                        application for registration and may not
                                             hazard to the public safety. The DEA is                    Because the Administrator hereby                   continue to handle 5F–ADB, 5F–AMB,
                                             not aware of any currently accepted                     finds it necessary to temporarily place               5F–APINACA, ADB–FUBINACA,
                                             medical uses for these substances in the                these SCs into schedule I to avoid an                 MDMB–CHMICA and/or MDMB–
                                             United States. A substance meeting the                  imminent hazard to the public safety,                 FUBINACA as of April 10, 2017, unless
                                             statutory requirements for temporary                    this temporary order scheduling these                 the DEA has approved that application
                                             scheduling, 21 U.S.C. 811(h)(1), may                    substances will be effective on the date              for registration. Retail sales of schedule
                                             only be placed into schedule I.                         of publication in the Federal Register,               I controlled substances to the general
                                             Substances in schedule I are those that                 and will be in effect for a period of two             public are not allowed under the CSA.
                                             have a high potential for abuse, no                     years, with a possible extension of one               Possession of any quantity of these
                                             currently accepted medical use in                       additional year, pending completion of                substances in a manner not authorized
                                             treatment in the United States, and a                   the regular (permanent) scheduling                    by the CSA on or after April 10, 2017
                                             lack of accepted safety for use under                   process. 21 U.S.C. 811(h) (1) and (2).                is unlawful and those in possession of
                                             medical supervision. Available data and                    The CSA sets forth specific criteria for           any quantity of these substances may be
                                             information for 5F–ADB, 5F–AMB, 5F–                     scheduling a drug or other substance.                 subject to prosecution pursuant to the
                                             APINACA, ADB–FUBINACA, MDMB–                            Permanent scheduling actions in                       CSA.
                                             CHMICA and MDMB–FUBINACA                                accordance with 21 U.S.C. 811(a) are                     2. Disposal of stocks. Any person who
                                             indicate that these SCs have a high                     subject to formal rulemaking procedures               does not desire or is not able to obtain
                                             potential for abuse, no currently                       done ‘‘on the record after opportunity                a schedule I registration to handle 5F–
                                             accepted medical use in treatment in the                for a hearing’’ conducted pursuant to                 ADB, 5F–AMB, 5F–APINACA, ADB–
                                             United States, and a lack of accepted                   the provisions of 5 U.S.C. 556 and 557.               FUBINACA, MDMB–CHMICA and/or
                                             safety for use under medical                            21 U.S.C. 811. The permanent                          MDMB–FUBINACA, must surrender all
                                             supervision. As required by section                     scheduling process of formal                          quantities of currently held 5F–ADB,
                                             201(h)(4) of the CSA, 21 U.S.C.                         rulemaking affords interested parties                 5F–AMB, 5F–APINACA, ADB–
                                             811(h)(4), the Administrator, through a                 with appropriate process and the                      FUBINACA, MDMB–CHMICA and/or
                                             letter dated April 22, 2016, notified the               government with any additional                        MDMB–FUBINACA.
                                             Assistant Secretary of the DEA’s                        relevant information needed to make a                    3. Security. 5F–ADB, 5F–AMB, 5F–
                                             intention to temporarily place these six                determination. Final decisions that                   APINACA, ADB–FUBINACA, MDMB–
                                             substances into schedule I. A notice of                 conclude the permanent scheduling                     CHMICA and/or MDMB–FUBINACA are
                                             intent was subsequently published in                    process of formal rulemaking are subject              subject to schedule I security
                                             the Federal Register on December 21,                    to judicial review. 21 U.S.C. 877.                    requirements and must be handled and
                                             2016.4 81 FR 93595.                                     Temporary scheduling orders are not                   stored pursuant to 21 U.S.C. 821, 823,
                                                                                                     subject to judicial review. 21 U.S.C.                 871(b), and in accordance with 21 CFR
                                             Conclusion                                              811(h)(6).                                            1301.71–1301.93, as of April 10, 2017.
                                                In accordance with the provisions of                                                                          4. Labeling and Packaging. All labels,
                                                                                                     Requirements for Handling                             labeling, and packaging for commercial
                                             section 201(h) of the CSA, 21 U.S.C.
                                             811(h), the Administrator considered                      Upon the effective date of this                     containers of 5F–ADB, 5F–AMB, 5F–
                                             available data and information, and                     temporary order, 5F–ADB, 5F–AMB,                      APINACA, ADB–FUBINACA, MDMB–
                                             herein set forth the grounds for his                    5F–APINACA, ADB–FUBINACA,                             CHMICA and/or MDMB–FUBINACA
                                             determination that it is necessary to                   MDMB–CHMICA and MDMB–                                 must be in compliance with 21 U.S.C.
                                             temporarily schedule methyl 2-(1-(5-                    FUBINACA will become subject to the                   825, 958(e), and be in accordance with
                                             fluoropentyl)-1H-indazole-3-                            regulatory controls and administrative,               21 CFR part 1302. Current DEA
                                             carboxamido)-3,3-dimethylbutanoate                      civil, and criminal sanctions applicable              registrants shall have 30 calendar days
                                             [5F–ADB; 5F–MDMB–PINACA]; methyl                        to the manufacture, distribution, reverse             from April 10, 2017, to comply with all
                                             2-(1-(5-fluoropentyl)-1H-indazole-3-                    distribution, importation, exportation,               labeling and packaging requirements.
                                             carboxamido)-3-methylbutanoate [5F–                     engagement in research, and conduct of                   5. Inventory. Every DEA registrant
                                             AMB]; N-(adamantan-1-yl)-1-(5-                          instructional activities or chemical                  who possesses any quantity of 5F–ADB,
                                             fluoropentyl)-1H-indazole-3-                            analysis with, and possession of                      5F–AMB, 5F–APINACA, ADB–
                                             carboxamide [5F–APINACA, 5F–                            schedule I controlled substances                      FUBINACA, MDMB–CHMICA and/or
                                                                                                     including the following:                              MDMB–FUBINACA on the effective
                                             AKB48]; N-(1-amino-3,3-dimethyl-1-
                                                                                                       1. Registration. Any person who                     date of this order, must take an
                                             oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-
                                                                                                     handles (manufactures, distributes,                   inventory of all stocks of these
                                             indazole-3-carboxamide [ADB–
                                                                                                     reverse distributes, imports, exports,                substances on hand, pursuant to 21
                                             FUBINACA]; methyl 2-(1-
                                                                                                     engages in research, or conducts                      U.S.C. 827 and 958, and in accordance
                                             (cyclohexylmethyl)-1H-indole-3-
                                                                                                     instructional activities or chemical                  with 21 CFR 1304.03, 1304.04, and
                                             carboxamido)-3,3-dimethylbutanoate
                                                                                                     analysis with, or possesses), or who                  1304.11. Current DEA registrants shall
                                             [MDMB–CHMICA, MMB–CHMINACA]
                                                                                                     desires to handle, 5F–ADB, 5F–AMB,                    have 30 calendar days from the effective
                                             and methyl 2-(1-(4-fluorobenzyl)-1H-
                                                                                                     5F–APINACA, ADB–FUBINACA,                             date of this order to be in compliance
                                             indazole-3-carboxamido)-3,3-
                                                                                                     MDMB–CHMICA and/or MDMB–                              with all inventory requirements. After
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                                               4 A publication error occurred with the December      FUBINACA must be registered with the                  the initial inventory, every DEA
                                             21, 2016 notification (81 FR 93595), which resulted     DEA to conduct such activities pursuant               registrant must take an inventory of all
                                             in 21 CFR 1308.11 being amended. As a result, a         to 21 U.S.C. 822, 823, 957, and 958 and               controlled substances (including 5F–
                                             correction was issued by the Federal Register on        in accordance with 21 CFR parts 1301                  ADB, 5F–AMB, 5F–APINACA, ADB–
                                             January 9, 2017 (82 FR 2218), and the amended text
                                             was removed. The original notice of intent was
                                                                                                     and 1312, as of April 10, 2017. Any                   FUBINACA, MDMB–CHMICA and/or
                                             republished on January 9, 2017 (82 FR 2280), with       person who currently handles 5F–ADB,                  MDMB–FUBINACA) on hand on a
                                             the corrected non-amendatory language.                  5F–AMB, 5F–APINACA, ADB–                              biennial basis, pursuant to 21 U.S.C. 827


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                                                                 Federal Register / Vol. 82, No. 67 / Monday, April 10, 2017 / Rules and Regulations                                                      17123

                                             and 958, and in accordance with 21 CFR                  expiration of 30 days from (1) the                    take effect at such time as the federal
                                             1304.03, 1304.04, and 1304.11.                          publication of a notice in the Federal                agency promulgating the rule
                                               6. Records. All DEA registrants must                  Register of the intention to issue such               determines. 5 U.S.C. 808(2). It is in the
                                             maintain records with respect to 5F–                    order and the grounds upon which such                 public interest to schedule these
                                             ADB, 5F–AMB, 5F–APINACA, ADB–                           order is to be issued, and (2) the date               substances immediately because they
                                             FUBINACA, MDMB–CHMICA and/or                            that notice of the proposed temporary                 pose a public health risk. This
                                             MDMB–FUBINACA pursuant to 21                            scheduling order is transmitted to the                temporary scheduling action is taken
                                             U.S.C. 827 and 958(e), and in                           Assistant Secretary. 21 U.S.C. 811(h)(1).             pursuant to 21 U.S.C. 811(h), which is
                                             accordance with 21 CFR parts 1304,                         Inasmuch as section 201(h) of the                  specifically designed to enable the DEA
                                             1312, and 1317 and § 1307.11. Current                   CSA directs that temporary scheduling                 to act in an expeditious manner to avoid
                                             DEA registrants authorized to handle                    actions be issued by order and sets forth             an imminent hazard to the public safety.
                                             5F–ADB, 5F–AMB, 5F–APINACA,                             the procedures by which such orders are               21 U.S.C. 811(h) exempts the temporary
                                             ADB–FUBINACA, MDMB–CHMICA                               to be issued, the DEA believes that the               scheduling order from standard notice
                                             and/or MDMB–FUBINACA shall have                         notice and comment requirements of the                and comment rulemaking procedures to
                                             30 calendar days from the effective date                Administrative Procedure Act (APA) at                 ensure that the process moves swiftly.
                                             of this order to be in compliance with                  5 U.S.C. 553, do not apply to this                    For the same reasons that underlie 21
                                             all recordkeeping requirements.                         temporary scheduling action. In the                   U.S.C. 811(h), that is, the need to move
                                                7. Reports. All DEA registrants who                  alternative, even assuming that this                  quickly to place these substances into
                                             manufacture or distribute 5F–ADB, 5F–                   action might be subject to 5 U.S.C. 553,              schedule I because they pose an
                                             AMB, 5F–APINACA, ADB–FUBINACA,                          the Administrator finds that there is                 imminent hazard to public safety, it
                                             MDMB–CHMICA and/or MDMB–                                good cause to forgo the notice and                    would be contrary to the public interest
                                             FUBINACA must submit reports                            comment requirements of section 553,                  to delay implementation of the
                                             pursuant to 21 U.S.C. 827 and in                        as any further delays in the process for              temporary scheduling order. Therefore,
                                             accordance with 21 CFR parts 1304 and                   issuance of temporary scheduling orders               this order shall take effect immediately
                                             1312 as of April 10, 2017.                              would be impracticable and contrary to                upon its publication. The DEA has
                                                8. Order Forms. All DEA registrants                  the public interest in view of the                    submitted a copy of this temporary
                                             who distribute 5F–ADB, 5F–AMB, 5F–                      manifest urgency to avoid an imminent                 order to both Houses of Congress and to
                                             APINACA, ADB–FUBINACA, MDMB–                            hazard to the public safety.                          the Comptroller General, although such
                                             CHMICA and/or MDMB–FUBINACA                                Further, the DEA believes that this                filing is not required under the Small
                                             must comply with order form                             temporary scheduling action is not a                  Business Regulatory Enforcement
                                             requirements pursuant to 21 U.S.C. 828                  ‘‘rule’’ as defined by 5 U.S.C. 601(2),               Fairness Act of 1996 (Congressional
                                             and in accordance with 21 CFR part                      and, accordingly, is not subject to the               Review Act), 5 U.S.C. 801–808, because,
                                             1305 as of April 10, 2017.                              requirements of the Regulatory                        as noted above, this action is an order,
                                                9. Importation and Exportation. All                  Flexibility Act (RFA). The requirements               not a rule.
                                             importation and exportation of 5F–ADB,                  for the preparation of an initial
                                             5F–AMB, 5F–APINACA, ADB–                                regulatory flexibility analysis in 5 U.S.C.           List of Subjects in 21 CFR Part 1308
                                             FUBINACA, MDMB–CHMICA and/or                            603(a) are not applicable where, as here,               Administrative practice and
                                             MDMB–FUBINACA must be in                                the DEA is not required by the APA or                 procedure, Drug traffic control,
                                             compliance with 21 U.S.C. 952, 953,                     any other law to publish a general                    Reporting and recordkeeping
                                             957, 958, and in accordance with 21                     notice of proposed rulemaking.                        requirements.
                                             CFR part 1312 as of April 10, 2017.                        Additionally, this action is not a                   For the reasons set out above, the DEA
                                                10. Quota. Only DEA registered                       significant regulatory action as defined              amends 21 CFR part 1308 as follows:
                                             manufacturers may manufacture 5F–                       by Executive Order 12866 (Regulatory
                                             ADB, 5F–AMB, 5F–APINACA, ADB–                           Planning and Review), section 3(f), and,              PART 1308—SCHEDULES OF
                                             FUBINACA, MDMB–CHMICA and/or                            accordingly, this action has not been                 CONTROLLED SUBSTANCES
                                             MDMB–FUBINACA in accordance with                        reviewed by the Office of Management
                                             a quota assigned pursuant to 21 U.S.C.                  and Budget.                                           ■ 1. The authority citation for part 1308
                                             826 and in accordance with 21 CFR part                     This action will not have substantial              continues to read as follow:
                                             1303 as of April 10, 2017.                              direct effects on the States, on the                    Authority: 21 U.S.C. 811, 812, 871(b),
                                                11. Liability. Any activity involving                relationship between the national                     956(b), unless otherwise noted.
                                             5F–ADB, 5F–AMB, 5F–APINACA,                             government and the States, or on the                  ■ 2. Section 1308.11 is amended by
                                             ADB–FUBINACA, MDMB–CHMICA                               distribution of power and                             adding paragraphs (h)(10) through (15)
                                             and/or MDMB–FUBINACA not                                responsibilities among the various                    to read as follows:
                                             authorized by, or in violation of the                   levels of government. Therefore, in
                                             CSA, occurring as of April 10, 2017, is                 accordance with Executive Order 13132                 § 1308.11     Schedule I.
                                             unlawful, and may subject the person to                 (Federalism) it is determined that this               *       *    *         *      *
                                             administrative, civil, and/or criminal                  action does not have sufficient                           (h) * * *
                                             sanctions.                                              federalism implications to warrant the                 (10) methyl 2-(1-(5-fluoropentyl)-
                                                                                                     preparation of a Federalism Assessment.                  1H-indazole-3-carboxamido)-3,3-
                                             Regulatory Matters                                         As noted above, this action is an                     dimethylbutanoate, its optical,
                                               Section 201(h) of the CSA, 21 U.S.C.                  order, not a rule. Accordingly, the                      positional, and geometric iso-
                                             811(h), provides for a temporary                        Congressional Review Act (CRA) is                        mers, salts and salts of isomers
pmangrum on DSK3GDR082PROD with RULES




                                             scheduling action where such action is                  inapplicable, as it applies only to rules.               (Other names: 5F–ADB; 5F–
                                             necessary to avoid an imminent hazard                   However, if this were a rule, pursuant                   MDMB–PINACA) .........................       (7034)
                                                                                                                                                            (11) methyl 2-(1-(5-fluoropentyl)-
                                             to the public safety. As provided in this               to the Congressional Review Act, ‘‘any                   1H-indazole-3-carboxamido)-3-
                                             subsection, the Attorney General may,                   rule for which an agency for good cause                  methylbutanoate, its optical, po-
                                             by order, schedule a substance in                       finds that notice and public procedure                   sitional, and geometric isomers,
                                             schedule I on a temporary basis. Such                   thereon are impracticable, unnecessary,                  salts and salts of isomers (Other
                                             an order may not be issued before the                   or contrary to the public interest, shall                names: 5F–AMB). .........................    (7033)



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                                             17124                   Federal Register / Vol. 82, No. 67 / Monday, April 10, 2017 / Rules and Regulations

                                             (12)       N-(adamantan-1-yl)-1-(5-                           Click on Open Docket Folder on the line               DEPARTMENT OF HOMELAND
                                               fluoropentyl)-1H-indazole-3-                                associated with this deviation.                       SECURITY
                                               carboxamide, its optical, posi-
                                               tional, and geometric isomers,                              FOR FURTHER INFORMATION CONTACT:   If                 Coast Guard
                                               salts and salts of isomers (Other                           you have questions on this temporary
                                               names:      5F–APINACA,                   5F–               deviation, call or email Eric A.                      33 CFR Part 165
                                               AKB48) .........................................   (7049)   Washburn, Bridge Administrator,
                                             (13)     N-(1-amino-3,3-dimethyl-1-                                                                                 [Docket Number USCG–2017–0118]
                                                                                                           Western Rivers, Coast Guard; telephone
                                               oxobutan-2-yl)-1-(4-
                                               fluorobenzyl)-1H-indazole-3-                                314–269–2378, email Eric.Washburn@                    RIN 1625–AA00
                                               carboxamide, its optical, posi-                             uscg.mil.
                                               tional, and geometric isomers,                                                                                    Safety Zone; Columbia River, Sand
                                               salts and salts of isomers (Other                                                   The U.S.
                                                                                                           SUPPLEMENTARY INFORMATION:                            Island, WA
                                               names: ADB–FUBINACA) ...........         (7010) Army Rock Island Arsenal requested a
                                             (14)           methyl                     2-(1-   temporary deviation for the Rock Island                           Correction
                                               (cyclohexylmethyl)-1H-indole-3-                 Railroad and Highway Drawbridge,                                     In rule document 2017–04196,
                                               carboxamido)-3,3-                               across the Upper Mississippi River, mile                          appearing on pages 12416 through
                                               dimethylbutanoate, its optical,                                                                                   12418, in the issue of Friday, March 3,
                                                                                               482.9, at Rock Island, Illinois to remain
                                               positional, and geometric iso-
                                                                                               in the closed-to-navigation position for                          2017, make the following correction:
                                               mers, salts and salts of isomers
                                               (Other names: MDMB–CHMICA,                      a one and 1⁄2 hour period from 9:00 a.m.                             On page 12417, in the first column, on
                                               MMB–CHMINACA) .....................      (7042) to 10:30 a.m., April 8, 2017, while the                           the fourteenth line from the bottom of
                                             (15) methyl 2-(1-(4-fluorobenzyl)-                River Bandits 5K is held between the                              the page, ‘‘46°5′5″ N.’’ should read,
                                               1H-indazole-3-carboxamido)-3,3-                 cities of Davenport, IA and Rock Island,                          ‘‘46°15′45″ N.’’.
                                               dimethylbutanoate, its optical,                                                                                   [FR Doc. C1–2017–04196 Filed 4–7–17; 8:45 am]
                                                                                               IL.
                                               positional, and geometric iso-                                                                                    BILLING CODE 1301–00–D
                                               mers, salts and salts of isomers                   The Rock Island Railroad and
                                               (Other       names:               MDMB–         Highway Drawbridge currently operates
                                               FUBINACA) ..................................
                                                                                        (7020) in accordance with 33 CFR 117.5, which
                                                                                                                                                                 ENVIRONMENTAL PROTECTION
                                                                                               states the general requirement that                               AGENCY
                                                Dated: April 4, 2017.
                                                                                               drawbridges shall open promptly and
                                             Chuck Rosenberg,
                                                                                               fully for the passage of vessels when a                           40 CFR Part 52
                                             Acting Administrator.
                                                                                               request to open is given in accordance                            [EPA–R01–OAR–2016–0552; A–1–FRL–
                                             [FR Doc. 2017–07118 Filed 4–7–17; 8:45 am]
                                                                                               with the subpart.                                                 9960–86-Region 1]
                                             BILLING CODE 4410–09–P
                                                                                                  There are no alternate routes for
                                                                                               vessels transiting this section of the                            Approval and Promulgation of Air
                                                                                               Upper Mississippi River.                                          Quality Implementation Plans; Maine,
                                             DEPARTMENT OF HOMELAND                                                                                              New Hampshire, Rhode Island and
                                             SECURITY                                             The Rock Island Railroad and                                   Vermont; Interstate Transport of Fine
                                                                                               Highway Drawbridge has a vertical                                 Particle and Ozone Air Pollution
                                             Coast Guard                                       clearance of 23.8 feet above normal pool
                                                                                               in the closed-to-navigation position.                             AGENCY:  Environmental Protection
                                             33 CFR Part 117                                   Navigation on the waterway consists                               Agency (EPA).
                                             [Docket Number USCG–2017–0173]                    primarily of commercial tows and                                  ACTION: Final rule.
                                                                                               recreational watercraft. This temporary
                                             Drawbridge Operation Regulation;                  deviation has been coordinated with                               SUMMARY:    The Environmental Protection
                                             Upper Mississippi River, Rock Island,             waterway users. No objections were                                Agency (EPA) is approving State
                                             IL                                                received.                                                         Implementation Plan (SIP) submissions
                                                                                                                                                                 from the Maine Department of
                                             AGENCY: Coast Guard, DHS.                            In accordance with 33 CFR 117.35(e),                           Environmental Protection (ME DEP), the
                                             ACTION: Notice of deviation from                  the drawbridge must return to its regular                         New Hampshire Department of
                                             drawbridge regulation.                            operating schedule immediately at the                             Environmental Services (NH DES), the
                                                                                               end of the effective period of this                               Rhode Island Department of
                                             SUMMARY: The Coast Guard has issued a             temporary deviation. This deviation                               Environmental Management (RI DEM)
                                             temporary deviation from the operating            from the operating regulations is                                 and the Vermont Department of
                                             schedule that governs the Rock Island             authorized under 33 CFR 117.35.                                   Environmental Conservation (VT DEC).
                                             Railroad and Highway Drawbridge                                                                                     These SIP submissions address
                                             across the Upper Mississippi River, mile             Dated: March 31, 2017.
                                                                                                                                                                 provisions of the Clean Air Act that
                                             482.9, at Rock Island, Illinois. The              Eric  A. Washburn,
                                                                                                                                                                 require each state to submit a SIP to
                                             deviation is necessary to allow the Quad Bridge Administrator, Western Rivers.                                      address emissions that may adversely
                                             City Marathon to cross the bridge. This           [FR Doc. 2017–07115 Filed 4–7–17; 8:45 am]                        affect another state’s air quality through
                                             deviation allows the bridge to be                 BILLING CODE 9110–04–P                                            interstate transport. The EPA is finding
                                             maintained in the closed-to-navigation                                                                              that all four States have adequate
                                             position for ninety minutes.                                                                                        provisions to prohibit in-state emissions
pmangrum on DSK3GDR082PROD with RULES




                                             DATES: This deviation is effective from                                                                             activities from significantly contributing
                                             9 a.m. to 10:30 a.m. on April 8, 2017.                                                                              to nonattainment, or interfering with the
                                             ADDRESSES: The docket for this                                                                                      maintenance, of the 1997 ozone
                                             deviation, [USCG–2017–0173] is                                                                                      National Ambient Air Quality Standards
                                             available at http://www.regulations.gov.                                                                            (NAAQS) in other states, and that Rhode
                                             Type the docket number in the                                                                                       Island and Vermont have adequate
                                             ‘‘SEARCH’’ box and click ‘‘SEARCH.’’                                                                                provisions to prohibit in-state emissions


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Document Created: 2017-04-08 03:31:07
Document Modified: 2017-04-08 03:31:07
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionTemporary scheduling order.
DatesThis temporary scheduling order is effective on April 10, 2017. This temporary order will expire on April 10, 2019, unless it is extended for an additional year or a permanent scheduling proceeding is completed.
ContactMichael J. Lewis, Diversion Control
FR Citation82 FR 17119 
CFR AssociatedAdministrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements

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