[Federal Register Volume 82, Number 249 (Friday, December 29, 2017)]
[Proposed Rules]
[Pages 61700-61703]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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