82 FR 61700 - Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 249 (December 29, 2017)

Page Range		61700-61703
FR Document		2017-28114

The Administrator of the Drug Enforcement Administration is publishing this notice of intent to issue an order temporarily scheduling fentanyl-related substances that are not currently listed in any schedule of the Controlled Substances Act (CSA). The temporary order will place these substances 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. When it is issued, the temporary scheduling order will impose regulatory requirements under the CSA on the manufacture, distribution, reverse distribution, possession, importation, exportation, research, and conduct of instructional activities, and chemical analysis of these synthetic opioids, as well as administrative, civil, and criminal remedies with respect to persons who fail to comply with such requirements or otherwise violate the CSA with respect to these substances.

Federal Register, Volume 82 Issue 249 (Friday, December 29, 2017)

[Federal Register Volume 82, Number 249 (Friday, December 29, 2017)]
[Proposed Rules]
[Pages 61700-61703]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-28114]

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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: Proposed amendment; notice of intent.

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SUMMARY: The Administrator of the Drug Enforcement Administration is
publishing this notice of intent to issue an order temporarily
scheduling fentanyl-related substances that are not currently listed in
any schedule of the Controlled Substances Act (CSA). The temporary
order will place these substances 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. When it is issued, the temporary scheduling order will
impose regulatory requirements under the CSA on the manufacture,
distribution, reverse distribution, possession, importation,
exportation, research, and conduct of instructional activities, and
chemical analysis of these synthetic opioids, as well as
administrative, civil, and criminal remedies with respect to persons
who fail to comply with such requirements or otherwise violate the CSA
with respect to these substances.

DATES: December 29, 2017.

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: This notice of intent is issued pursuant to
the temporary scheduling provisions of 21 U.S.C. 811(h). The Drug
Enforcement Administration (DEA) intends to issue a temporary order (in
the form of a temporary amendment) placing fentanyl-related substances
in schedule I of the Controlled Substances Act. The temporary
scheduling order will be published in the Federal Register on or after
January 29, 2018.

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 for up to one year. 21 U.S.C.
811(h)(2).
Where the necessary findings are made, a substance may be
temporarily scheduled if it is not listed in any other schedule under
section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or
approval in effect for the substance under section 505 of the Federal
Food, Drug, and Cosmetic Act (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 \1\ in the

[[Page 61701]]

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 will be 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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\1\ 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 (NCHS), an estimated 55 Americans are dying every
day from overdoses of synthetic opioids (excluding methadone).\2\ 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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\2\ 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 six temporary
scheduling orders to control nine substances structurally related to
fentanyl since 2015 and recently issued a notice of intent on November
21, 2017 to temporarily control another such substance. 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.\3\ 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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\3\ 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 the upcoming
temporary scheduling order, DEA will exercise 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
will be temporarily controlled has an accepted medical use 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 will be excluded from the temporary scheduling order.

What Will Be Controlled Under the Temporary Scheduling Order

When the temporary scheduling order is issued, fentanyl-related
substances will be placed 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. DEA's intention is that the temporary scheduling order will
define fentanyl-related substances to include 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 that is the subject of
this Notice of Intent will include 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. 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 will include 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 will be
controlled by virtue of the temporary scheduling order--at the time the
temporary scheduling order is published--if it falls within the
definition of fentanyl-related substance.

[[Page 61702]]

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.\4\ 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 into schedule
I of the CSA. As indicated, in accordance with section 811(h),
fentanyl-related substances will be defined under the 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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\4\ 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, 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. 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 ever 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
will be temporarily controlled 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

This notice of intent provides the 30-day notice pursuant to
section 201(h) of the CSA, 21 U.S.C. 811(h)(1), of DEA's intent to
issue a temporary scheduling order. The temporary placement of
fentanyl-related substances in schedule I of the CSA will take effect
pursuant to a temporary scheduling order, which will not be issued
before January 29, 2018. 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, the
temporary order scheduling these substances will be effective on the
date that order is published in the Federal Register, and will be 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). It is the intention of the Administrator to
issue a temporary scheduling order as soon as possible after the
expiration of 30 days from the date of publication of this document.
Upon publication of the temporary order, fentanyl-related substances,
as defined in the order, will be subject to the full range of
regulatory, civil, and criminal provisions of the CSA that apply to
schedule I controlled substances.

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 notice of intent. In the alternative, even if this
notice 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

[[Page 61703]]

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 notice of intent 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.

List of Subjects in 21 CFR Part 1308

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

For the reasons set out above, the DEA proposes to amend 21 CFR
part 1308 as follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

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

Authority: 21 U.S.C. 811, 812, 871(b), 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, ethers,
salts and salts of isomers, esters and ethers . . . 9850
(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 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:
[Reserved]
* * * * *

Dated: December 21, 2017.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2017-28114 Filed 12-28-17; 8:45 am]
BILLING CODE 4410-09-P

61700 Federal Register / Vol. 82, No. 249 / Friday, December 29, 2017 / Proposed Rules

1. On December 15, 2016, the to achieve the goals outlined in the analysis of these synthetic opioids, as
Commission issued a Notice of NOPR; however, we are persuaded by well as administrative, civil, and
Proposed Rulemaking (NOPR) in this comments that question whether the criminal remedies with respect to
proceeding.1 For the reasons set forth proposed reforms would bring sufficient persons who fail to comply with such
below, we are exercising our discretion value in all RTOs/ISOs and argued for requirements or otherwise violate the
to withdraw the NOPR and terminate regional flexibility. Having considered CSA with respect to these substances.
this rulemaking proceeding. these comments, we are persuaded to DATES: December 29, 2017.
2. In the NOPR, the Commission not require a uniform set of fast-start FOR FURTHER INFORMATION CONTACT:
preliminarily found that some existing pricing requirements that would apply Michael J. Lewis, Diversion Control
regional transmission organization/ to all RTOs/ISOs. Instead, we will Division, Drug Enforcement
independent system operator (RTO/ISO) pursue the goals of the NOPR through Administration; Mailing Address: 8701
fast-start pricing practices, or lack of section 206 actions involving NYISO, Morrissette Drive, Springfield, Virginia
fast-start pricing practices, may not PJM, and SPP 4 focusing on specific 22152; Telephone: (202) 598–6812.
result in rates that are just and concerns with each RTO’s/ISO’s
reasonable.2 As a result, the SUPPLEMENTARY INFORMATION: This
implementation of fast-start pricing
Commission proposed to require that consistent with the concerns outlined in notice of intent is issued pursuant to the
each RTO/ISO establish the following the NOPR. temporary scheduling provisions of 21
set of requirements for its fast-start 5. The Commission therefore U.S.C. 811(h). The Drug Enforcement
pricing: (1) Apply fast-start pricing to withdraws the NOPR and terminates Administration (DEA) intends to issue a
any resource committed by the RTO/ISO this rulemaking proceeding. temporary order (in the form of a
that is able to start up within ten temporary amendment) placing
By direction of the Commission. fentanyl-related substances in schedule
minutes, has a minimum run time of
Issued: December 21, 2017. I of the Controlled Substances Act. The
one hour or less, and that submits
Nathaniel J. Davis, Sr., temporary scheduling order will be
economic energy offers to the market;
(2) incorporate commitment costs, i.e., Deputy Secretary. published in the Federal Register on or
start-up and no-load costs, of fast-start [FR Doc. 2017–28201 Filed 12–28–17; 8:45 am] after January 29, 2018.
resources in energy and operating BILLING CODE 6717–01–P
Legal Authority
reserve prices; (3) modify fast-start
pricing to relax the economic minimum Section 201 of the Controlled
operating limit of fast-start resources DEPARTMENT OF JUSTICE Substances Act (CSA), 21 U.S.C. 811,
and treat them as dispatchable from zero provides the Attorney General with the
to the economic maximum operating Drug Enforcement Administration authority to temporarily place a
limit for the purpose of calculating substance in schedule I of the CSA for
prices; (4) if the RTO/ISO allows offline 21 CFR Part 1308 two years without regard to the
fast-start resources to set prices for [Docket No. DEA–476]
requirements of 21 U.S.C. 811(b) if he
addressing certain system needs, the finds that such action is necessary to
resource must be feasible and economic; Schedules of Controlled Substances: avoid an imminent hazard to the public
and (5) incorporate fast-start pricing in Temporary Placement of Fentanyl- safety. 21 U.S.C. 811(h)(1). In addition,
both the day-ahead and real-time Related Substances in Schedule I if proceedings to control a substance
markets. The Commission sought permanently are initiated under 21
comment on the proposed reforms.3 AGENCY: Drug Enforcement U.S.C. 811(a)(1) while the substance is
3. The Commission received a number Administration, Department of Justice. temporarily controlled under section
of comments in response to the ACTION: Proposed amendment; notice of 811(h), the Attorney General may
proposed reforms in the NOPR. Some intent. extend the temporary scheduling for up
commenters expressed support for the to one year. 21 U.S.C. 811(h)(2).
SUMMARY: The Administrator of the Drug
proposed reforms. Other commenters Where the necessary findings are
Enforcement Administration is
raised concerns about the need for the made, a substance may be temporarily
publishing this notice of intent to issue
proposed reforms relative to the burden scheduled if it is not listed in any other
an order temporarily scheduling
of implementing changes. Additionally, schedule under section 202 of the CSA,
fentanyl-related substances that are not
some commenters discussed the need 21 U.S.C. 812, or if there is no
currently listed in any schedule of the
for regional flexibility to allow RTOs/ exemption or approval in effect for the
Controlled Substances Act (CSA). The
ISOs to implement fast-start pricing substance under section 505 of the
temporary order will place these
practices that are appropriate for their Federal Food, Drug, and Cosmetic Act
substances in schedule I. This action is
regions. (FD&C Act), 21 U.S.C. 355. 21 U.S.C.
4. Upon further consideration and based on a finding by the Administrator
811(h)(1). The Attorney General has
after review of the comments received that the placement of these synthetic
delegated scheduling authority under 21
in response to the NOPR, we will opioids in schedule I is necessary to
U.S.C. 811 to the Administrator of the
withdraw the NOPR and terminate this avoid an imminent hazard to the public
DEA. 28 CFR 0.100.
proceeding. We appreciate the feedback safety. When it is issued, the temporary
received in response to the NOPR. We scheduling order will impose regulatory Background
continue to believe that improved fast- requirements under the CSA on the
The Nature of the Problem and DEA’s
ethrower on DSK3G9T082PROD with PROPOSALS

start pricing practices have the potential manufacture, distribution, reverse
Approach To Correct It
distribution, possession, importation,
1 Fast-Start exportation, research, and conduct of It is well known that deaths
Pricing in Markets Operated by
Regional Transmission Organizations and instructional activities, and chemical associated with the abuse of substances
Independent System Operators, 81 FR 96,391 (Dec. structurally related to fentanyl 1 in the
30, 2016), FERC Stats. & Regs. ¶ 32,720 (2016). 4 New York Independent System Operator, Inc.,
2 NOPR, FERC Stats. & Regs. ¶ 32,720 at PP 36–
161 FERC ¶ 61,294; PJM Interconnection, L.L.C., 161 1 As explained further below, in this document,
37. FERC ¶ 61,295; and Southwest Power Pool, Inc., 161 the term ‘‘fentanyl-related substances’’ is defined to
3 NOPR, FERC Stats. & Regs. ¶ 32,720 at P 44. FERC ¶ 61,296, (2017). include substances structurally related to fentanyl

VerDate Sep<11>2014 15:55 Dec 28, 2017 Jkt 244001 PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 E:\FR\FM\29DEP1.SGM 29DEP1

Federal Register / Vol. 82, No. 249 / Friday, December 29, 2017 / Proposed Rules 61701

United States are on the rise and have because when DEA temporarily controls will be placed in schedule I of the CSA
already reached alarming levels. While a given substance structurally related to for two years. DEA may extend the
a number of factors appear to be fentanyl, illicit manufacturers located temporary scheduling for an additional
contributing to this public health crisis, abroad begin producing new such year (a total of three years) if
chief among the causes is the sharp substances through other structural proceedings to permanently schedule
increase in recent years in the modifications. Those new nonscheduled the substances are pending. DEA’s
availability of illicitly produced, potent substances then are smuggled into the intention is that the temporary
substances structurally related to United States, where they are scheduling order will define fentanyl-
fentanyl. Fentanyl is approximately 100 distributed by traffickers in this country related substances to include any
times more potent than morphine, and as a purportedly ‘‘noncontrolled’’ substance not otherwise controlled in
the substances structurally related to substance.3 In this way, traffickers are any schedule (i.e., not included under
fentanyl that DEA will be temporarily effectively circumventing the temporary any other Administration Controlled
controlling also tend to be potent control mechanism that Congress Substance Code Number) that is
substances. Typically, these substances established under 21 U.S.C. 811(h) to structurally related to fentanyl by one or
are manufactured outside the United combat newly emerging dangerous more of the following modifications:
States by clandestine manufacturers and drugs. Post mortem toxicology and (A) Replacement of the phenyl
then smuggled into the United States. medical examiner reports collected by portion of the phenethyl group by any
Fentanyl is often mixed with heroin the DEA show mortality connected to monocycle, whether or not further
and other substances (such as cocaine substances structurally related to substituted in or on the monocycle;
and methamphetamine) or used in fentanyl. Control of these substances is
counterfeit pharmaceutical prescription necessary to avoid an imminent hazard (B) substitution in or on the phenethyl
drugs. As a consequence, users who buy to the public safety. group with alkyl, alkenyl, alkoxyl,
these substances on the illicit market are Given the gravity of the ongoing hydroxyl, halo, haloalkyl, amino or
often unaware of the specific substance fentanyl-related overdose crisis in the nitro groups;
they are actually consuming and the United States, protection of the public (C) substitution in or on the
associated risk. According to the Centers safety demands the utilization of 21 piperidine ring with alkyl, alkenyl,
for Disease Control and Prevention U.S.C. 811(h) in a manner that cannot be alkoxyl, ester, ether, hydroxyl, halo,
(CDC), drug overdose deaths involving readily circumvented by drug haloalkyl, amino or nitro groups;
synthetic opioids (excluding traffickers. Specifically, in issuing the (D) replacement of the aniline ring
methadone), such as fentanyl and upcoming temporary scheduling order, with any aromatic monocycle whether
tramadol, increased from 5,544 in 2014 DEA will exercise its authority to avoid or not further substituted in or on the
to 9,580 in 2015. According to an imminent hazard to the public safety aromatic monocycle; and/or
provisional data released in August by placing fentanyl-related substances, (E) replacement of the N-propionyl
2017 by the CDC, National Center for as defined later in this document, in group by another acyl group.
Health Statistics (NCHS), an estimated schedule I. As explained below, these
55 Americans are dying every day from fentanyl-related substances—including How DEA Will Identify Individual
overdoses of synthetic opioids those that have not yet been introduced Fentanyl-Related Substances That Fall
(excluding methadone).2 Drug overdose by traffickers into the U.S. market— Within This Temporary Scheduling
deaths involving synthetic opioids present a significant risk to the public Order
excluding methadone for the 12-month health and safety and need to be
As indicated, the temporary
period ending in January of 2017 controlled under section 811(h) to avoid
scheduling order that is the subject of
(20,145 deaths) more than doubled from an imminent hazard to the public safety.
this Notice of Intent will include all
the corresponding data for the period It should also be noted that none of the
substances that fall within the above
ending in January of 2016 (9,945 substances that will be temporarily
definition—even if such substances
deaths). controlled has an accepted medical use
have not yet emerged on the illicit
DEA has responded to this crisis by in the United States; nor is any of the
market in the United States. As a result,
issuing six temporary scheduling orders substances the subject of an exemption
DEA cannot currently specify the
to control nine substances structurally or approval under section 505 of the
chemical name of every potential
related to fentanyl since 2015 and FD&C Act. In accordance with section
substance that might fall under this new
recently issued a notice of intent on 811(h), if any exemption or approval is
definition. In the future, if and when
November 21, 2017 to temporarily in effect under section 505 of the FD&C
DEA identifies a specific new substance
control another such substance. Act with respect to a substance that falls
that falls under the definition, the
However, this approach has not been within the definition of a fentanyl-
agency will publish in the Federal
completely effective in preventing the related substance set forth in this
Register, and on the agency website, the
emergence of new substances document, such substance will be
chemical name of such substance. Thus,
structurally related to fentanyl. This is excluded from the temporary
the text of the definition of fentanyl-
scheduling order.
related substance will include language
but which are not controlled under a separate
scheduling action (listed under another
What Will Be Controlled Under the indicating that it ‘‘includes, but is not
Administration Controlled Substance Code Temporary Scheduling Order limited to, the following substances:’’ It
Number). Thus, all ‘‘fentanyl-related substances’’
When the temporary scheduling order bears emphasis, however, that even in
ethrower on DSK3G9T082PROD with PROPOSALS

are structurally related to fentanyl, but some the absence of a future publication by
fentanyl-related substances are controlled under is issued, fentanyl-related substances
separate scheduling actions. DEA specifically identifying such a
2 Provisional synthetic opioid death overdose 3 Such trafficking is actually illegal as persons substance, the substance will be
counts are based on CDC data available for analysis who do so can be prosecuted using the controlled controlled by virtue of the temporary
as of August 6, 2017, based on the 12-month substance analogue provisions of the CSA. 21 scheduling order—at the time the
reporting period ending January 2017. See https:// U.S.C. 802(32), 813. However, prosecution under
www.cdc.gov/nchs/data/health_policy/monthly- the analogue provisions requires proof of additional
temporary scheduling order is
drug-overdose-death-estimates.pdf accessed 09–06– elements not required for prosecuting trafficking in published—if it falls within the
2017. scheduled substances. definition of fentanyl-related substance.

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Document Created: 2018-01-03 13:16:59
Document Modified: 2018-01-03 13:16:59

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		Proposed Rules
Action		Proposed amendment; notice of intent.
Dates		December 29, 2017.
Contact		Michael J. Lewis, Diversion Control
FR Citation		82 FR 61700
CFR Associated		Administrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements

82 FR 61700 - Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 82, Issue 249 (December 29, 2017)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration