83 FR 5188 - Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 25 (February 6, 2018)

Page Range		5188-5192
FR Document		2018-02319

The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule fentanyl-related substances that are not currently listed in any schedule of the Controlled Substances Act (CSA) and their isomers, esters, ethers, salts and salts of isomers, esters, and ethers in schedule I. This action is based on a finding by the Administrator that the placement of these synthetic opioids in schedule I 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 fentanyl-related substances.

Federal Register, Volume 83 Issue 25 (Tuesday, February 6, 2018)

[Federal Register Volume 83, Number 25 (Tuesday, February 6, 2018)]
[Rules and Regulations]
[Pages 5188-5192]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-02319]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-476]

Schedules of Controlled Substances: Temporary Placement of
Fentanyl-Related Substances in Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Temporary amendment; temporary scheduling order.

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SUMMARY: The Administrator of the Drug Enforcement Administration is
issuing this temporary scheduling order to schedule fentanyl-related
substances that are not currently listed in any schedule of the
Controlled Substances Act (CSA) and their isomers, esters, ethers,
salts and salts of isomers, esters, and ethers in schedule I. This
action is based on a finding by the Administrator that the placement of
these synthetic opioids in schedule I 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 fentanyl-related
substances.

DATES: This temporary scheduling order is effective February 6, 2018,
until February 6, 2020. If this order is extended or made permanent,
the DEA will publish a document in the Federal Register.

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

Section 201 of the Controlled Substances Act (CSA), 21 U.S.C. 811,
provides the Attorney General with the authority to temporarily place a
substance in 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
permanently are initiated under 21 U.S.C. 811(a)(1) while the substance
is temporarily controlled under section 811(h), 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 (FD&C Act), 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

The Nature of the Problem and DEA's Approach to Correct It

It is well known that deaths associated with the abuse of
substances structurally related to fentanyl \2\ in the United States
are on the rise and have already reached alarming levels. While a
number of factors appear to be contributing to this public health
crisis, chief among the causes is the sharp increase in recent years in
the availability of illicitly produced, potent substances structurally
related to fentanyl. Fentanyl is approximately 100 times more potent
than morphine, and the substances structurally related to fentanyl that
DEA is temporarily controlling also tend to be potent substances.
Typically, these substances are manufactured outside the United States
by clandestine manufacturers and then smuggled into the United States.
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\2\ As explained further below, in this document, the term
``fentanyl-related substances'' is defined to include substances
structurally related to fentanyl but which are not controlled under
a separate scheduling action (listed under another Administration
Controlled Substance Code Number). Thus, all ``fentanyl-related
substances'' are structurally related to fentanyl, but some
fentanyl-related substances are controlled under separate scheduling
actions.
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Fentanyl is often mixed with heroin and other substances (such as
cocaine and methamphetamine) or used in counterfeit pharmaceutical
prescription drugs. As a consequence, users who buy these substances on
the illicit market are often unaware of the specific substance they are
actually consuming and the associated risk. According to the Centers
for Disease Control and Prevention (CDC), drug overdose deaths
involving synthetic opioids (excluding methadone), such as fentanyl and
tramadol, increased from 5,544 in 2014 to 9,580 in 2015. According to
provisional data released in August 2017 by the CDC, National Center
for Health Statistics, an estimated 55 Americans are dying every day
from overdoses of synthetic opioids (excluding methadone).\3\ Drug
overdose deaths involving synthetic opioids excluding methadone for the
12-month period ending in January of 2017 (20,145 deaths) more than
doubled from the corresponding data for the period ending in January of
2016 (9,945 deaths).
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\3\ Provisional synthetic opioid death overdose counts are based
on CDC data available for analysis as of August 6, 2017, based on
the 12-month reporting period ending January 2017. See https://www.cdc.gov/nchs/data/health_policy/monthly-drug-overdose-death-estimates.pdf accessed 09-06-2017.
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DEA has responded to this crisis by issuing eight temporary
scheduling

[[Page 5189]]

orders to control seventeen substances structurally related to fentanyl
since 2015. However, this approach has not been completely effective in
preventing the emergence of new substances structurally related to
fentanyl. This is because when DEA temporarily controls a given
substance structurally related to fentanyl, illicit manufacturers
located abroad begin producing new such substances through other
structural modifications. Those new nonscheduled substances then are
smuggled into the United States, where they are distributed by
traffickers in this country as a purportedly ``noncontrolled''
substance.\4\ In this way, traffickers are effectively circumventing
the temporary control mechanism that Congress established under 21
U.S.C. 811(h) to combat newly emerging dangerous drugs. Post mortem
toxicology and medical examiner reports collected by the DEA show
mortality connected to substances structurally related to fentanyl.
Control of these substances is necessary to avoid an imminent hazard to
the public safety.
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\4\ Such trafficking is actually illegal as persons who do so
can be prosecuted using the controlled substance analogue provisions
of the CSA. 21 U.S.C. 802(32), 813. However, prosecution under the
analogue provisions requires proof of additional elements not
required for prosecuting trafficking in scheduled substances.
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Given the gravity of the ongoing fentanyl-related overdose crisis
in the United States, protection of the public safety demands the
utilization of 21 U.S.C. 811(h) in a manner that cannot be readily
circumvented by drug traffickers. Specifically, in issuing this
temporary scheduling order, DEA exercises its authority to avoid an
imminent hazard to the public safety by placing fentanyl-related
substances, as defined later in this document, in schedule I. As
explained below, these fentanyl-related substances--including those
that have not yet been introduced by traffickers into the U.S. market--
present a significant risk to the public health and safety and need to
be controlled under section 811(h) to avoid an imminent hazard to the
public safety. It should also be noted that none of the substances that
is being temporarily controlled has a currently accepted medical use in
treatment in the United States; nor is any of the substances the
subject of an exemption or approval under section 505 of the FD&C Act.
In accordance with section 811(h), if any exemption or approval is in
effect under section 505 of the FD&C Act with respect to a substance
that falls within the definition of a fentanyl-related substance set
forth in this document, such substance is excluded from the temporary
scheduling order.

What Is Controlled Under This Temporary Scheduling Order

On December 29, 2017, as required by 21 U.S.C. 811(h)(A), the DEA
Administrator published a notice of intent to issue an order
temporarily placing fentanyl-related substances in schedule I. 82 FR
61700. This temporary order places fentanyl-related substances in
schedule I of the CSA for two years. DEA may extend the temporary
scheduling for an additional year (a total of three years) if
proceedings to permanently schedule the substances are pending. As
defined in the notice of intent, as well as in this temporary order,
fentanyl-related substances includes any substance not otherwise
controlled in any schedule (i.e., not included under any other
Administration Controlled Substance Code Number) that is structurally
related to fentanyl by one or more of the following modifications:
(A) Replacement of the phenyl portion of the phenethyl group by any
monocycle, whether or not further substituted in or on the monocycle;
(B) substitution in or on the phenethyl group with alkyl, alkenyl,
alkoxyl, hydroxyl, halo, haloalkyl, amino or nitro groups;
(C) substitution in or on the piperidine ring with alkyl, alkenyl,
alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino or nitro
groups;
(D) replacement of the aniline ring with any aromatic monocycle
whether or not further substituted in or on the aromatic monocycle;
and/or
(E) replacement of the N-propionyl group by another acyl group.

How DEA Will Identify Individual Fentanyl-Related Substances That Fall
Within This Temporary Scheduling Order

As indicated, the temporary scheduling order includes all
substances that fall within the above definition--even if such
substances have not yet emerged on the illicit market in the United
States. As a result, DEA cannot currently specify the chemical name of
every potential substance that might fall under this new definition.
However, because the definition of fentanyl-related substance describes
a unique chemical structure, DEA has the authority to under 21 U.S.C.
811(h) to temporarily schedule this category of substance. In the
future, if and when DEA identifies a specific new substance that falls
under the definition, the agency will publish in the Federal Register,
and on the agency website, the chemical name of such substance. Thus,
the text of the definition of fentanyl-related substance includes
language indicating that it ``includes, but is not limited to, the
following substances:'' It bears emphasis, however, that even in the
absence of a future publication by DEA specifically identifying such a
substance, the substance is controlled by virtue of this temporary
scheduling order if it falls within the definition of fentanyl-related
substance.

Notification to the Secretary of Health and Human Services

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
in schedule I of the CSA.\5\ On November 6, 2017, the Administrator
transmitted notice by letter to the Assistant Secretary for Health of
HHS of his intent to place fentanyl-related substances, unless listed
in another schedule, in schedule I on a temporary basis. The Assistant
Secretary responded by letter dated November 29, 2017, and advised that
based on a review by the Food and Drug Administration (FDA), they are
not aware of any investigational new drug applications or approved new
drug applications for fentanyl-related substances as defined above
under section 505 of the FD&C Act, 21 U.S.C. 355, and that HHS has no
objection to the temporary placement of these substances in schedule I
of the CSA. As indicated, in accordance with section 811(h), fentanyl-
related substances are defined under this temporary scheduling order to
exclude any substance for which an exemption or approval is in effect
under section 505 of the FD&C Act.
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\5\ 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 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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Grounds for Temporary Scheduling Order

To find that placing a substance temporarily in schedule I of the
CSA is necessary to avoid an imminent hazard to the public safety, the
Administrator is required to consider three of the eight factors set
forth in 21 U.S.C. 811(c): The substance's history and current pattern
of abuse; the scope, duration and significance of abuse; and what, if
any,

[[Page 5190]]

risk there is to the public health. 21 U.S.C. 811(h)(3). These factors
include, but are not limited to, actual abuse, diversion from
legitimate channels, and clandestine importation, manufacture, or
distribution. Id. DEA has considered these factors for fentanyl-related
substances, as defined above, and finds that the information is
consistent across this class of substances. The DEA's three-factor
analysis is available in its entirety under ``Supporting and Related
Material'' of the public docket for this action at www.regulations.gov
under Docket Number DEA-476.
Substances that are included in the above-listed structural
modifications and any combination of these structural modifications
have been found to cause pharmacological effects that are similar to
those of fentanyl. It therefore is reasonable to expect that all such
substances, even if they have yet to appear on the illicit market in
the United States, share the dangerous and potentially lethal
properties that have caused the recent spike in fentanyl-related
overdose deaths in the United States. While these substances may not
yet have appeared in the domestic illicit market, with 21 U.S.C.
811(h), Congress empowered DEA to act proactively to ``avoid an
imminent hazard to the public safety'' by scheduling dangerous
substances on a temporary basis before they adversely impact the public
safety. Thus, where, as here, DEA has evidence indicating that certain
substances, due to their chemical structure and resulting
pharmacological properties, as well as observed patterns of production
and trafficking of closely related substances, will pose an imminent
hazard to the public safety in the absence of control in schedule I
(having considered the relevant factors under 21 U.S.C. 811(h)(3)), DEA
may issue a temporary order under 21 U.S.C. 811(h). By temporarily
placing these fentanyl-related substances in schedule I, it is DEA's
intention to deter the production and introduction of these substances
into the United States that traffickers might be considering--before
such activity even begins--thereby avoiding an imminent hazard to the
public safety. The alternative approach, of only temporarily
controlling substances that have already appeared in the illicit U.S.
market, is beneficial but has not eliminated the danger these newly
created substances pose and is not as effective in preventing future
deaths and serious injuries associated with these substances. In
addition, by controlling fentanyl-related substances, the temporary
scheduling order will facilitate the development of international,
national, and local prevention strategies that decrease morbidity and
mortality from overdoses caused by or associated with fentanyl-related
substances.
For these reasons, DEA has concluded that issuing a temporary
scheduling order is necessary to avoid an imminent hazard to the public
safety.

Schedule I Classification

A substance meeting the statutory requirements for temporary
scheduling may only be placed in schedule I. 21 U.S.C. 811(h)(1).
Substances in schedule I are those that have a high potential for
abuse, no currently accepted medical use in treatment in the United
States, and a lack of accepted safety for use under medical
supervision. 21 U.S.C. 812(b)(1).
As indicated, DEA finds that the fentanyl-related substances that
are temporarily controlled by virtue of this order have a high
potential for abuse. Information provided by the Assistant Secretary of
HHS indicates that these fentanyl-related substances, as defined, have
no currently accepted medical use in treatment in the United States and
lack accepted safety for use under medical supervision.

Conclusion

In accordance with the provisions of section 201(h) of the CSA, 21
U.S.C. 811(h), the Administrator issues this temporary scheduling order
to place fentanyl-related substances in schedule I of the CSA. Because
the Administrator hereby finds that it is necessary to temporarily
place fentanyl-related substances in schedule I to avoid an imminent
hazard to the public safety, this temporary order scheduling these
substances is effective on the date the order is published in the
Federal Register, and is in effect for a period of two years. DEA may
extend the temporary scheduling for an additional year (a total of
three years) if proceedings to permanently schedule the substances are
pending. 21 U.S.C. 811(h)(1) and (2).

Requirements for Handling

Upon the effective date of this temporary order, fentanyl-related
substances will be subject to the regulatory controls and
administrative, civil, and criminal sanctions applicable to the
manufacture, distribution, reverse distribution, importation,
exportation, engagement in research, and conduct of instructional
activities or chemical analysis with, and possession of schedule I
controlled substances including the following:
1. Registration. Any person who handles (manufactures, distributes,
reverse distributes, imports, exports, engages in research, or conducts
instructional activities or chemical analysis with, or possesses), or
who desires to handle, fentanyl-related substances must be registered
with the DEA to conduct such activities pursuant to 21 U.S.C. 822, 823,
957, and 958 and in accordance with 21 CFR parts 1301 and 1312, as of
February 6, 2018. Any person who currently handles fentanyl-related
substances, and is not registered with the DEA, must submit an
application for registration and may not continue to handle fentanyl-
related substances as of February 6, 2018, unless the DEA has approved
that application for registration pursuant to 21 U.S.C. 822, 823, 957,
958, and in accordance with 21 CFR parts 1301 and 1312. 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 February 6, 2018 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 fentanyl-related
substances must surrender all currently held quantities of fentanyl-
related substances.
3. Security. Fentanyl-related substances 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 February 6, 2018.
4. Labeling and packaging. All labels, labeling, and packaging for
commercial containers of fentanyl-related substances must be in
compliance with 21 U.S.C. 825, 958(e), and be in accordance with 21 CFR
part 1302. Current DEA registrants shall have 30 calendar days from
February 6, 2018, to comply with all labeling and packaging
requirements.
5. Inventory. Every DEA registrant who possesses any quantity of
fentanyl-related substances 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

[[Page 5191]]

substances (including fentanyl-related substances) on hand on a
biennial basis, pursuant to 21 U.S.C. 827 and 958, and in accordance
with 21 CFR 1304.03, 1304.04, and 1304.11.
6. Records. All DEA registrants must maintain records with respect
to fentanyl-related substances pursuant to 21 U.S.C. 827 and 958, and
in accordance with 21 CFR parts 1304, 1312, and 1317. Current DEA
registrants 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
fentanyl-related substances must submit reports pursuant to 21 U.S.C.
827 and in accordance with 21 CFR parts 1304 and 1312 as of February 6,
2018.
8. Order Forms. All DEA registrants who distribute fentanyl-related
substances must comply with order form requirements pursuant to 21
U.S.C. 828 and in accordance with 21 CFR part 1305 as of February 6,
2018.
9. Importation and Exportation. All importation and exportation of
fentanyl-related substances must be in compliance with 21 U.S.C. 952,
953, 957, 958, and in accordance with 21 CFR part 1312 as of February
6, 2018.
10. Quota. Only DEA registered manufacturers may manufacture
fentanyl-related substances in accordance with a quota assigned
pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 as of
February 6, 2018.
11. Liability. Any activity involving fentanyl-related substances
not authorized by, or in violation of, the CSA, occurring as of
February 6, 2018, 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 of HHS. 21 U.S.C. 811(h)(1).
Inasmuch as section 201(h) of the CSA directs that temporary
scheduling actions be issued by order and sets forth the procedures by
which such orders are to be issued, the notice-and-comment requirements
of section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553,
do not apply to this temporary order. In the alternative, even if this
order were subject to section 553 of the APA, the Administrator would
find 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 contrary to the public
interest in view of the urgent need to control fentanyl-related
substances to avoid an imminent hazard to the public safety.
Since this temporary scheduling action is not a ``rule'' as defined
by 5 U.S.C. 601(2), it is not subject to the requirements of the
Regulatory Flexibility Act (RFA). The requirements for the preparation
of an initial regulatory flexibility analysis in 5 U.S.C. 603(a) are
not applicable where, as here, the DEA is not required by section 553
of the APA or any other law to publish a general notice of proposed
rulemaking.
Additionally, this action is not a significant regulatory action as
defined by Executive Order 12866 (Regulatory Planning and Review),
section 3(f), and, accordingly, this action has not been reviewed by
the Office of Management and Budget.
This action will not have substantial direct effects on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government. Therefore, in accordance with Executive Order
13132 (Federalism) it is determined that this action does not have
sufficient federalism implications to warrant the preparation of a
Federalism Assessment.
As noted above, this action is an order, not a rule. Accordingly,
the Congressional Review Act 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 to
avoid an imminent hazard to the public safety. 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 DEA's need to
move quickly to place these substances in schedule I because they pose
an imminent hazard to the 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 follows:

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

0
2. In Sec. 1308.11, add paragraph (h)(30) to read as follows:

Sec. 1308.11 Schedule I.

* * * * *
(h) * * *

(30) Fentanyl-related substances, their isomers, esters, 9850
ethers, salts and salts of isomers, esters and ethers..

(i) Fentanyl-related substance means any substance not otherwise
listed under another Administration Controlled Substance Code Number,
and for which no exemption or approval is in effect under section 505
of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355], that is
structurally

[[Page 5192]]

related to fentanyl by one or more of the following modifications:
(A) Replacement of the phenyl portion of the phenethyl group by any
monocycle, whether or not further substituted in or on the monocycle;
(B) Substitution in or on the phenethyl group with alkyl, alkenyl,
alkoxyl, hydroxyl, halo, haloalkyl, amino or nitro groups;
(C) Substitution in or on the piperidine ring with alkyl, alkenyl,
alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino or nitro
groups;
(D) Replacement of the aniline ring with any aromatic monocycle
whether or not further substituted in or on the aromatic monocycle;
and/or
(E) Replacement of the N-propionyl group by another acyl group.
(ii) This definition includes, but is not limited to, the following
substances:
(A) [Reserved]
(B) [Reserved]

Dated: February 1, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-02319 Filed 2-5-18; 8:45 am]
BILLING CODE 4410-09-P

5188 Federal Register / Vol. 83, No. 25 / Tuesday, February 6, 2018 / Rules and Regulations

inspector, the manager of the local flight based on a finding by the Administrator Background
standards district office/certificate holding that the placement of these synthetic
district office. The Nature of the Problem and DEA’s
opioids in schedule I is necessary to
(2) Contacting the Manufacturer: For any Approach to Correct It
avoid an imminent hazard to the public
requirement in this AD to obtain corrective It is well known that deaths
actions from a manufacturer, the action must
safety. As a result of this order, the
regulatory controls and administrative, associated with the abuse of substances
be accomplished using a method approved
by the Manager, International Section, civil, and criminal sanctions applicable structurally related to fentanyl 2 in the
Transport Standards Branch, FAA; or the to schedule I controlled substances will United States are on the rise and have
European Aviation Safety Agency (EASA); or be imposed on persons who handle already reached alarming levels. While
Airbus’s EASA Design Organization (manufacture, distribute, reverse a number of factors appear to be
Approval (DOA). If approved by the DOA, distribute, import, export, engage in contributing to this public health crisis,
the approval must include the DOA- research, conduct instructional chief among the causes is the sharp
authorized signature. activities or chemical analysis, or increase in recent years in the
(j) Special Flight Permits possess), or propose to handle fentanyl- availability of illicitly produced, potent
related substances. substances structurally related to
Special flight permits, as described in
Section 21.197 and Section 21.199 of the
fentanyl. Fentanyl is approximately 100
DATES: This temporary scheduling order times more potent than morphine, and
Federal Aviation Regulations (14 CFR 21.197
and 21.199), are not allowed. is effective February 6, 2018, until the substances structurally related to
February 6, 2020. If this order is fentanyl that DEA is temporarily
(k) Related Information extended or made permanent, the DEA controlling also tend to be potent
(1) Refer to Mandatory Continuing will publish a document in the Federal substances. Typically, these substances
Airworthiness Information (MCAI) EASA Register. are manufactured outside the United
Airworthiness Directive 2017–0257R1, dated States by clandestine manufacturers and
January 9, 2018, for related information. You FOR FURTHER INFORMATION CONTACT:
Michael J. Lewis, Diversion Control then smuggled into the United States.
may examine the MCAI on the internet at
Fentanyl is often mixed with heroin
http://www.regulations.gov by searching for Division, Drug Enforcement
and locating Docket No. FAA–2018–0024. and other substances (such as cocaine
Administration; Mailing Address: 8701
(2) For more information about this AD, and methamphetamine) or used in
Morrissette Drive, Springfield, Virginia
contact Sanjay Ralhan, Aerospace Engineer, counterfeit pharmaceutical prescription
22152; Telephone: (202) 598–6812. drugs. As a consequence, users who buy
International Section, Transport Standards
Branch, FAA, 1601 Lind Avenue SW, SUPPLEMENTARY INFORMATION: these substances on the illicit market are
Renton, WA 98057–3356; telephone 425– often unaware of the specific substance
227–1405; fax 425–227–1149. Legal Authority they are actually consuming and the
(l) Material Incorporated by Reference Section 201 of the Controlled associated risk. According to the Centers
Substances Act (CSA), 21 U.S.C. 811, for Disease Control and Prevention
None.
provides the Attorney General with the (CDC), drug overdose deaths involving
Issued in Renton, Washington, on January synthetic opioids (excluding
19, 2018. authority to temporarily place a
substance in schedule I of the CSA for methadone), such as fentanyl and
Michael Kaszycki, tramadol, increased from 5,544 in 2014
two years without regard to the
Acting Director, System Oversight Division, to 9,580 in 2015. According to
Aircraft Certification Service.
requirements of 21 U.S.C. 811(b) if he
finds that such action is necessary to provisional data released in August
[FR Doc. 2018–02364 Filed 2–5–18; 8:45 am]
avoid an imminent hazard to the public 2017 by the CDC, National Center for
BILLING CODE 4910–13–P
safety. 21 U.S.C. 811(h)(1). In addition, Health Statistics, an estimated 55
if proceedings to control a substance Americans are dying every day from
permanently are initiated under 21 overdoses of synthetic opioids
DEPARTMENT OF JUSTICE U.S.C. 811(a)(1) while the substance is (excluding methadone).3 Drug overdose
temporarily controlled under section deaths involving synthetic opioids
Drug Enforcement Administration 811(h), the Attorney General may excluding methadone for the 12-month
extend the temporary scheduling 1 for period ending in January of 2017
21 CFR Part 1308 up to one year. 21 U.S.C. 811(h)(2). (20,145 deaths) more than doubled from
[Docket No. DEA–476]
the corresponding data for the period
Where the necessary findings are ending in January of 2016 (9,945
made, a substance may be temporarily deaths).
Schedules of Controlled Substances: scheduled if it is not listed in any other
Temporary Placement of Fentanyl- DEA has responded to this crisis by
schedule under section 202 of the CSA, issuing eight temporary scheduling
Related Substances in Schedule I 21 U.S.C. 812, or if there is no
AGENCY: Drug Enforcement exemption or approval in effect for the 2 As explained further below, in this document,

Administration, Department of Justice. substance under section 505 of the the term ‘‘fentanyl-related substances’’ is defined to
Federal Food, Drug, and Cosmetic Act include substances structurally related to fentanyl
ACTION: Temporary amendment; but which are not controlled under a separate
temporary scheduling order. (FD&C Act), 21 U.S.C. 355. 21 U.S.C. scheduling action (listed under another
811(h)(1). The Attorney General has Administration Controlled Substance Code
SUMMARY: The Administrator of the Drug delegated scheduling authority under 21 Number). Thus, all ‘‘fentanyl-related substances’’
Enforcement Administration is issuing U.S.C. 811 to the Administrator of the are structurally related to fentanyl, but some
fentanyl-related substances are controlled under
this temporary scheduling order to DEA. 28 CFR 0.100.
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separate scheduling actions.
schedule fentanyl-related substances 3 Provisional synthetic opioid death overdose

that are not currently listed in any 1 Though DEA has used the term ‘‘final order’’ counts are based on CDC data available for analysis
schedule of the Controlled Substances with respect to temporary scheduling orders in the as of August 6, 2017, based on the 12-month
past, this notification adheres to the statutory reporting period ending January 2017. See https://
Act (CSA) and their isomers, esters, language of 21 U.S.C. 811(h), which refers to a www.cdc.gov/nchs/data/health_policy/monthly-
ethers, salts and salts of isomers, esters, ‘‘temporary scheduling order.’’ No substantive drug-overdose-death-estimates.pdf accessed 09–06–
and ethers in schedule I. This action is change is intended. 2017.

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Federal Register / Vol. 83, No. 25 / Tuesday, February 6, 2018 / Rules and Regulations 5189

orders to control seventeen substances such substance is excluded from the chemical name of such substance. Thus,
structurally related to fentanyl since temporary scheduling order. the text of the definition of fentanyl-
2015. However, this approach has not related substance includes language
What Is Controlled Under This
been completely effective in preventing indicating that it ‘‘includes, but is not
Temporary Scheduling Order
the emergence of new substances limited to, the following substances:’’ It
structurally related to fentanyl. This is On December 29, 2017, as required by bears emphasis, however, that even in
because when DEA temporarily controls 21 U.S.C. 811(h)(A), the DEA the absence of a future publication by
a given substance structurally related to Administrator published a notice of DEA specifically identifying such a
fentanyl, illicit manufacturers located intent to issue an order temporarily substance, the substance is controlled
abroad begin producing new such placing fentanyl-related substances in by virtue of this temporary scheduling
substances through other structural schedule I. 82 FR 61700. This temporary order if it falls within the definition of
modifications. Those new nonscheduled order places fentanyl-related substances fentanyl-related substance.
substances then are smuggled into the in schedule I of the CSA for two years.
DEA may extend the temporary Notification to the Secretary of Health
United States, where they are and Human Services
distributed by traffickers in this country scheduling for an additional year (a total
as a purportedly ‘‘noncontrolled’’ of three years) if proceedings to Section 201(h)(4) of the CSA, 21
substance.4 In this way, traffickers are permanently schedule the substances U.S.C. 811(h)(4), requires the
effectively circumventing the temporary are pending. As defined in the notice of Administrator to notify the Secretary of
control mechanism that Congress intent, as well as in this temporary the Department of Health and Human
established under 21 U.S.C. 811(h) to order, fentanyl-related substances Services (HHS) of his intention to
combat newly emerging dangerous includes any substance not otherwise temporarily place a substance in
drugs. Post mortem toxicology and controlled in any schedule (i.e., not schedule I of the CSA.5 On November 6,
medical examiner reports collected by included under any other 2017, the Administrator transmitted
the DEA show mortality connected to Administration Controlled Substance notice by letter to the Assistant
substances structurally related to Code Number) that is structurally Secretary for Health of HHS of his intent
fentanyl. Control of these substances is related to fentanyl by one or more of the to place fentanyl-related substances,
necessary to avoid an imminent hazard following modifications: unless listed in another schedule, in
to the public safety. (A) Replacement of the phenyl schedule I on a temporary basis. The
portion of the phenethyl group by any Assistant Secretary responded by letter
Given the gravity of the ongoing monocycle, whether or not further dated November 29, 2017, and advised
fentanyl-related overdose crisis in the substituted in or on the monocycle; that based on a review by the Food and
United States, protection of the public (B) substitution in or on the phenethyl Drug Administration (FDA), they are not
safety demands the utilization of 21 group with alkyl, alkenyl, alkoxyl, aware of any investigational new drug
U.S.C. 811(h) in a manner that cannot be hydroxyl, halo, haloalkyl, amino or applications or approved new drug
readily circumvented by drug nitro groups; applications for fentanyl-related
traffickers. Specifically, in issuing this (C) substitution in or on the substances as defined above under
temporary scheduling order, DEA piperidine ring with alkyl, alkenyl, section 505 of the FD&C Act, 21 U.S.C.
exercises its authority to avoid an alkoxyl, ester, ether, hydroxyl, halo, 355, and that HHS has no objection to
imminent hazard to the public safety by haloalkyl, amino or nitro groups; the temporary placement of these
placing fentanyl-related substances, as (D) replacement of the aniline ring substances in schedule I of the CSA. As
defined later in this document, in with any aromatic monocycle whether indicated, in accordance with section
schedule I. As explained below, these or not further substituted in or on the 811(h), fentanyl-related substances are
fentanyl-related substances—including aromatic monocycle; and/or defined under this temporary
those that have not yet been introduced (E) replacement of the N-propionyl scheduling order to exclude any
by traffickers into the U.S. market— group by another acyl group. substance for which an exemption or
present a significant risk to the public approval is in effect under section 505
health and safety and need to be How DEA Will Identify Individual
Fentanyl-Related Substances That Fall of the FD&C Act.
controlled under section 811(h) to avoid
an imminent hazard to the public safety. Within This Temporary Scheduling Grounds for Temporary Scheduling
It should also be noted that none of the Order Order
substances that is being temporarily As indicated, the temporary To find that placing a substance
controlled has a currently accepted scheduling order includes all substances temporarily in schedule I of the CSA is
medical use in treatment in the United that fall within the above definition— necessary to avoid an imminent hazard
States; nor is any of the substances the even if such substances have not yet to the public safety, the Administrator is
subject of an exemption or approval emerged on the illicit market in the required to consider three of the eight
under section 505 of the FD&C Act. In United States. As a result, DEA cannot factors set forth in 21 U.S.C. 811(c): The
accordance with section 811(h), if any currently specify the chemical name of substance’s history and current pattern
exemption or approval is in effect under every potential substance that might fall of abuse; the scope, duration and
section 505 of the FD&C Act with under this new definition. However, significance of abuse; and what, if any,
respect to a substance that falls within because the definition of fentanyl-
the definition of a fentanyl-related related substance describes a unique 5 As discussed in a memorandum of

substance set forth in this document, chemical structure, DEA has the understanding entered into by the Food and Drug
Administration (FDA) and the National Institute on
authority to under 21 U.S.C. 811(h) to
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Drug Abuse (NIDA), the FDA acts as the lead agency
4 Such trafficking is actually illegal as persons temporarily schedule this category of within the HHS in carrying out the Secretary’s
who do so can be prosecuted using the controlled substance. In the future, if and when scheduling responsibilities under the CSA, with the
substance analogue provisions of the CSA. 21 DEA identifies a specific new substance concurrence of NIDA. 50 FR 9518, Mar. 8, 1985.
U.S.C. 802(32), 813. However, prosecution under The Secretary of the HHS has delegated to the
the analogue provisions requires proof of additional
that falls under the definition, the Assistant Secretary for Health of the HHS the
elements not required for prosecuting trafficking in agency will publish in the Federal authority to make domestic drug scheduling
scheduled substances. Register, and on the agency website, the recommendations. 58 FR 35460, July 1, 1993.

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5192 Federal Register / Vol. 83, No. 25 / Tuesday, February 6, 2018 / Rules and Regulations

related to fentanyl by one or more of the SUPPLEMENTARY INFORMATION: establishment, if no adjustment has
following modifications: I. Background been made) and the October 2015
(A) Replacement of the phenyl II. Calculation of Annual Adjustments CPI–U.
portion of the phenethyl group by any III. Procedural Requirements The Bureau issued an interim final
monocycle, whether or not further A. Regulatory Planning and Review (E.O.
rule providing for calculated catch-up
substituted in or on the monocycle; 12866, 13563, and 13771)
(B) Substitution in or on the B. Regulatory Flexibility Act adjustments on June 30, 2016 (81 FR
phenethyl group with alkyl, alkenyl, C. Small Business Regulatory Enforcement 42478) with an effective date of August
alkoxyl, hydroxyl, halo, haloalkyl, Fairness Act 1, 2016, and requesting comments post-
amino or nitro groups; D. Unfunded Mandates Reform Act promulgation. The Bureau issued a final
E. Takings (E.O. 12630) rule affirming the catch-up adjustments
(C) Substitution in or on the F. Federalism (E.O. 13132)
piperidine ring with alkyl, alkenyl, set forth in the interim final rule on
G. Civil Justice Reform (E.O. 12988)
alkoxyl, ester, ether, hydroxyl, halo, H. Consultation With Indian Tribes (E.O.
December 2, 2016 (81 FR 86953). The
haloalkyl, amino or nitro groups; 13175) Bureau then issued a final rule making
(D) Replacement of the aniline ring I. Paperwork Reduction Act the next scheduled annual inflation
with any aromatic monocycle whether J. National Environmental Policy Act adjustment for 2017 on January 23, 2017
or not further substituted in or on the K. Effects on the Energy Supply (E.O. (82 FR 7649).
aromatic monocycle; and/or 13211)
(E) Replacement of the N-propionyl L. Clarity of This Regulation II. Calculation of 2018 Annual
group by another acyl group. M. Administrative Procedure Act Adjustments
(ii) This definition includes, but is not I. Background OMB recently issued guidance to
limited to, the following substances: assist Federal agencies in implementing
(A) [Reserved] On November 2, 2015, the President
(B) [Reserved] signed into law the Federal Civil the annual adjustments required by the
Penalties Inflation Adjustment Act Act which agencies must complete by
Dated: February 1, 2018. Improvements Act of 2015 (Sec. 701 of January 15, 2018. See December 15,
Robert W. Patterson, Pub. L. 114–74) (‘‘the Act’’). The Act 2017, Memorandum for the Heads of
Acting Administrator. requires Federal agencies to adjust the Executive Departments and Agencies,
[FR Doc. 2018–02319 Filed 2–5–18; 8:45 am] level of civil monetary penalties with an from Mick Mulvaney, Director, Office of
BILLING CODE 4410–09–P initial ‘‘catch-up’’ adjustment through Management and Budget, re:
rulemaking and then make subsequent Implementation of the Penalty Inflation
annual adjustments for inflation. The Adjustments for 2018, Pursuant to the
DEPARTMENT OF THE INTERIOR purpose of these adjustments is to Federal Civil Penalties Inflation
maintain the deterrent effect of civil Adjustment Act Improvements Act of
Bureau of Indian Affairs penalties and to further the policy goals 2015 (M–18–03). The guidance states
[189A2100DD/AAKC001030/ of the underlying statutes. that the cost-of-living adjustment
A0A501010.999900253G] The Office of Management and Budget multiplier for 2018, based on the
(OMB) issued guidance for Federal Consumer Price Index (CPI–U) for the
25 CFR Parts 140, 141, 211, 213, 225, agencies on calculating the catch-up month of October 2017, not seasonally
226, 227, 243, and 249 adjustment. See February 24, 2016, adjusted, is 1.02041. (The annual
Memorandum for the Heads of inflation adjustments are based on the
RIN 1076–AF40
Executive Departments and Agencies, percent change between the October
Civil Penalties Inflation Adjustments; from Shaun Donovan, Director, Office of CPI–U preceding the date of the
Annual Adjustments Management and Budget, re: adjustment, and the prior year’s October
Implementation of the Federal Civil CPI–U. For 2017, OMB explains,
AGENCY: Bureau of Indian Affairs, Penalties Inflation Adjustment Act
Interior. October 2017 CPI–U (246.663)/October
Improvements Act of 2015 (M–16–06).
ACTION: Final rule.
2016 CPI–U (241.729) = 1.02041.) The
Under the guidance, the Department
guidance instructs agencies to complete
identified applicable civil monetary
SUMMARY: This rule provides for annual the 2018 annual adjustment by
penalties and calculated the catch-up
adjustments to the level of civil multiplying each applicable penalty by
adjustment. A civil monetary penalty is
monetary penalties contained in Bureau the multiplier, 1.02041, and rounding to
any assessment with a dollar amount
of Indian Affairs (Bureau) regulations to the nearest dollar. Further, agencies
that is levied for a violation of a Federal
account for inflation under the Federal should apply the multiplier to the most
civil statute or regulation, and is
Civil Penalties Inflation Adjustment Act assessed or enforceable through a civil recent penalty amount that includes the
Improvements Act of 2015 and Office of action in Federal court or an initial catch-up adjustment required by
Management and Budget (OMB) administrative proceeding. A civil the Act.
guidance. monetary penalty does not include a The annual adjustment applies to all
DATES: This rule is effective on February penalty levied for violation of a criminal civil monetary penalties with a dollar
6, 2018. statute, or fees for services, licenses, amount that are subject to the Act. This
FOR FURTHER INFORMATION CONTACT: permits, or other regulatory review. The final rule adjusts the following civil
Elizabeth Appel, Director, Office of calculated catch-up adjustment is based monetary penalties contained in the
Regulatory Affairs and Collaborative on the percent change between the Bureau’s regulations for 2018 by
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Action, Office of the Assistant Consumer Price Index for all Urban multiplying 1.02041 (i.e., the cost-of-
Secretary—Indian Affairs; telephone Consumers (CPI0–U) for the month of living adjustment multiplier for 2018)
(202) 273–4680, elizabeth.appel@ October in the year of the previous by each penalty amount as updated by
bia.gov. adjustment (or in the year of the adjustment made in 2017:

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Document Created: 2018-02-06 00:30:47
Document Modified: 2018-02-06 00:30:47

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Temporary amendment; temporary scheduling order.
Dates		This temporary scheduling order is effective February 6, 2018, until February 6, 2020. If this order is extended or made permanent, the DEA will publish a document in the Federal Register.
Contact		Michael J. Lewis, Diversion Control
FR Citation		83 FR 5188
CFR Associated		Administrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements

83 FR 5188 - Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 83, Issue 25 (February 6, 2018)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration