83 FR 44474 - Schedules of Controlled Substances: Temporary Placement of N

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 170 (August 31, 2018)

The Acting Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic cathinone, 1-(1,3-benzodioxol-5-yl)-2-(ethylamino)- pentan-1-one (N-ethylpentylone, ephylone) and its optical, positional, and geometric isomers, salts, and salts of isomers in schedule I. This action is based on a finding by the Acting Administrator that the placement of N-ethylpentylone in schedule I of the Controlled Substances Act (CSA) 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 N-ethylpentylone.

[Federal Register Volume 83, Number 170 (Friday, August 31, 2018)]
[Rules and Regulations]
[Pages 44474-44478]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-18988]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-482]


Schedules of Controlled Substances: Temporary Placement of N-
Ethylpentylone in Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Temporary amendment; temporary scheduling order.

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SUMMARY: The Acting Administrator of the Drug Enforcement 
Administration is issuing this temporary scheduling order to schedule 
the synthetic cathinone, 1-(1,3-benzodioxol-5-yl)-2-(ethylamino)-
pentan-1-one (N-ethylpentylone, ephylone) and its optical, positional, 
and geometric isomers, salts, and salts of isomers in schedule I. This 
action is based on a finding by the Acting Administrator that the 
placement of N-ethylpentylone in schedule I of the Controlled 
Substances Act (CSA) 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 N-ethylpentylone.

DATES: This temporary scheduling order is effective August 31, 2018, 
until August 31, 2020. If this order is extended or made permanent, the 
DEA will publish a document in the Federal Register.

FOR FURTHER INFORMATION CONTACT: Thomas D. Sonnen, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
2896.

SUPPLEMENTARY INFORMATION: 

Legal Authority

    Section 201 of the 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 document adheres to 
the statutory language of 21 U.S.C. 811(h), which refers to a 
``temporary scheduling order.'' No substantive change is intended.
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    Where the necessary findings are made, a substance may be 
temporarily scheduled if it is not listed in any other schedule under 
section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or 
approval in effect for the substance under section 505 of the Federal 
Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 
811(h)(1). The Attorney General has delegated scheduling authority 
under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

[[Page 44475]]

Background

    Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the 
Administrator to notify the Secretary of the Department of Health and 
Human Services (HHS) of his intention to temporarily place a substance 
in schedule I of the CSA.\2\ The Acting Administrator transmitted 
notice of his intent to place N-ethylpentylone in schedule I on a 
temporary basis to the Acting Assistant Secretary for Health of HHS by 
letter dated November 22, 2017. The Acting Assistant Secretary 
responded to this notice of intent by letter dated December 13, 2017, 
and advised that based on a review by the Food and Drug Administration 
(FDA), there are currently no active investigational new drug 
applications or approved new drug applications for N-ethylpentylone. 
The Acting Assistant Secretary also stated that HHS has no objection to 
the temporary placement of N-ethylpentylone in schedule I of the CSA. 
The DEA has taken into consideration the Assistant Secretary's comments 
as required by 21 U.S.C. 811(h)(4). N-Ethylpentylone is not currently 
listed in any schedule under the CSA, and no exemptions or approvals 
are in effect for this substance under section 505 of the FDCA, 21 
U.S.C. 355. The DEA has found that the control of N-ethylpentylone in 
schedule I on a temporary basis is necessary to avoid an imminent 
hazard to the public safety, and as required by 21 U.S.C. 811(h)(1)(A), 
a notice of intent to temporarily schedule N-ethylpentylone was 
published in the Federal Register on June 13, 2018. 83 FR 27520.
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    \2\ As discussed in a memorandum of understanding entered into 
by the Food and Drug Administration (FDA) and the National Institute 
on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS 
in carrying out the Secretary's scheduling responsibilities under 
the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The 
Secretary of the HHS has delegated to the Assistant Secretary for 
Health of the HHS the authority to make domestic drug scheduling 
recommendations. 58 FR 35460, July 1, 1993.
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    To find that placing a substance temporarily 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). 
Consideration of these factors includes actual abuse, diversion from 
legitimate channels, and clandestine importation, manufacture, or 
distribution. 21 U.S.C. 811(h)(3).
    A substance meeting the statutory requirements for temporary 
scheduling may only be placed in schedule I. 21 U.S.C. 811(h)(1). 
Substances in schedule I are those that have a high potential for 
abuse, no currently accepted medical use in treatment in the United 
States, and a lack of accepted safety for use under medical 
supervision. 21 U.S.C. 812(b)(1).
    Available data and information for N-ethylpentylone, summarized 
below, indicate that this synthetic cathinone has a high potential for 
abuse, no currently accepted medical use in treatment in the United 
States, and a lack of accepted safety for use under medical 
supervision. The DEA's three-factor analysis and the Assistant 
Secretary's December 13, 2017 letter are available in their entirety 
under the tab ``Supporting Documents'' of the public docket of this 
action at www.regulations.gov under FDMS Docket ID: DEA-2018-0011 
(Docket Number DEA-482).

N-Ethylpentylone

    Around 2014, the synthetic cathinone, N-ethylpentylone, emerged in 
the United States' illicit drug market after the scheduling of other 
popular synthetic cathinones (e.g., ethylone, 4-methyl-N-ethylcathinone 
(4-MEC), mephedrone, methylone, pentylone, and 3,4-
methylenedioxypyrovalerone (MDPV)). The identification of N-
ethylpentylone in forensic evidence and overdose deaths indicates that 
this substance is being misused and abused. Law enforcement encounters 
include those reported to the National Forensic Laboratory Information 
System (NFLIS), a DEA sponsored program that systematically collects 
drug identification results and associated information from drug cases 
analyzed by Federal, State, and local forensic laboratories, the System 
to Retrieve Information from Drug Evidence (STRIDE), a federal database 
for the drug samples analyzed by DEA forensic laboratories, and 
STARLiMS (a web-based, commercial laboratory information management 
system that replaced STRIDE in 2014). Forensic laboratories have 
analyzed drug exhibits received from Federal, State, or local, law 
enforcement agencies that were found to contain N-ethylpentylone.\3\ 
NFLIS registered over 6,000 reports from state and local forensic 
laboratories identifying this substance in drug-related exhibits for a 
period from January 2013 to December 2017 from 41 states. There were no 
occurrences of N-ethylpentylone reported in NFLIS for 2013. N-
Ethylpentylone was first identified in NFLIS in May 2014. STRIDE/
STARLiMS registered over 300 reports from DEA forensic laboratories 
from January 2013 to December 2017. There were no occurrences of N-
ethylpentylone reported in STRIDE/STARLiMS for 2013. N-Ethylpentylone 
was first reported to STRIDE/STARLiMS in December 2015. Additionally, 
U.S. Customs and Border Protection (CBP) encounters of N-ethylpentylone 
have occurred.
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    \3\ NFLIS and STRIDE/STARLiMS databases were queried on February 
8, 2018.
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    N-Ethylpentylone, like other synthetic cathinones, is a designer 
drug of the phenethylamine class and it is pharmacologically similar to 
schedule I synthetic cathinones (e.g., cathinone, methcathinone, 
mephedrone, methylone, pentylone, and MDPV) and well-known schedule I 
and II sympathomimetic agents (e.g., methamphetamine, 3,4-
methylenedioxymethamphetamine (MDMA), and cocaine). N-ethylpentylone, 
similar to these substances, causes stimulant related psychological and 
somatic effects. Consequently, there have been documented reports of 
emergency room admissions and numerous deaths associated with the abuse 
of N-ethylpentylone. No approved medical use has been identified for 
this substance, nor has it been approved by the FDA for human 
consumption.

Factor 4. History and Current Pattern of Abuse

    N-Ethylpentylone is a synthetic cathinone of the phenethylamine 
class and it is structurally and pharmacologically similar to 
cathinone, methcathinone, mephedrone, methylone, pentylone, MDPV, 
methamphetamine, MDMA, and other schedule I and II substances. Thus, it 
is highly likely that N-ethylpentylone is abused in the same manner and 
by the same users as these substances. That is, N-ethylpentylone, like 
these substances, is most likely ingested by swallowing capsules or 
tablets or snorted by nasal insufflation of the powder tablets. 
Products containing N-ethylpentylone, similar to schedule I synthetic 
cathinones, are likely to be falsely marketed as ``research 
chemicals,'' ``jewelry cleaner,'' ``stain remover,'' ``plant food or 
fertilizer,'' ``insect repellants'' or ``bath salts,'' sold at smoke 
shops, head shops, convenience stores, adult book stores, and gas 
stations, and purchased on the internet. Like those seen with 
commercial products that contain synthetic cathinones, the packages of 
products that contain N-ethylpentylone also

[[Page 44476]]

probably contain the warning ``not for human consumption,'' most likely 
in an effort to circumvent statutory restrictions for these substances. 
Demographic data collected from published reports and mortality records 
suggest that the main users of N-ethylpentylone, similar to schedule I 
synthetic cathinones and MDMA, are young adults.
    Available evidence suggests that the history and pattern of abuse 
of N-ethylpentylone parallels that of MDMA, methamphetamine, or cocaine 
and that N-ethylpentylone has been marketed as a replacement for these 
substances. N-Ethylpentylone has been identified in law enforcement 
seizures that were initially suspected to be MDMA. In addition, there 
are reports that abusers of N-ethylpentylone thought they were using
    MDMA or another illicit substance but toxicological analysis 
revealed that the psychoactive substance was N-ethylpentylone. 
Toxicology reports also revealed that N-ethylpentylone is being 
ingested with other substances including other synthetic cathinones, 
common cutting agents, or other recreational substances. Consequently, 
products containing synthetic cathinones, including N-ethylpentylone, 
are distributed to users, often with unpredictable outcomes. Thus, the 
recreational abuse of synthetic cathinones, including N-ethylpentylone, 
is a significant concern.

Factor 5. Scope, Duration and Significance of Abuse

    N-Ethylpentylone is a popular recreational drug that emerged on the 
United States' illicit drug market after the scheduling of other 
popular synthetic cathinones (e.g., ethylone, mephedrone, methylone, 
pentylone, and MDPV) (see DEA 3-Factor Analysis for a full discussion). 
Forensic laboratories have confirmed the presence of N-ethylpentylone 
in drug exhibits received from state, local, and federal law 
enforcement agencies. Law enforcement data show that N-ethylpentylone 
first appeared in the illicit drug market in 2014 with one encounter 
and began increasing thereafter.\4\ In 2015, NFLIS registered five 
reports from three states regarding N-ethylpentylone. However, in 2016, 
there were 2,074 reports from 39 states and, in 2017, there were 3,955 
reports from 39 states related to this substance registered in NFLIS. 
N-Ethylpentylone represented 60% of all synthetic cathinones 
encountered by local law enforcement agencies and reported to NFLIS in 
2017. From January 2013 to December 2017, NFLIS registered 6,035 
reports from state and local forensic laboratories identifying this 
substance in drug-related exhibits from 41 states. STRIDE/STARLiMS 
registered over 338 reports from DEA forensic laboratories during 
January 2013 to December 2017. There were no occurrences of N-
ethylpentylone reported in NFLIS or STRIDE/STARLiMS for 2013. 
Additionally, seizures of N-ethylpentylone have occurred by the U.S. 
Customs and Border Protection (CBP) beginning in 2016. Concerns over 
the continuing abuse of synthetic cathinones have led to the control of 
many synthetic cathinones.
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    \4\ NFLIS and STRIDE/STARLiMS databases were queried on February 
8, 2018.
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Factor 6. What, if Any, Risk There Is to the Public Health

    The identification of N-ethylpentylone in toxicological samples 
associated with fatal and non-fatal overdoses have been reported in 
medical and scientific literature, forensic laboratory reports, and 
public health documents. Like schedule I synthetic cathinones, N-
ethylpentylone has caused acute health problems leading to emergency 
department (ED) admissions, violent behaviors causing harm to self or 
others, and/or death. Adverse health effects associated with the abuse 
of N-ethylpentylone include a number of stimulant-like adverse health 
effects such as diaphoresis, insomnia, mydriasis, hyperthermia, 
vomiting, agitation, disorientation, paranoia, abdominal pain, cardiac 
arrest, respiratory failure, and coma. In addition, N-ethylpentylone 
has been involved in deaths of many individuals. The DEA is aware of 
approximately 151 overdose deaths involving N-ethylpentylone abuse 
reported in the United States between 2014 and 2018. Thus, the abuse of 
N-ethylpentylone, like that of the abuse of schedule I synthetic 
cathinones and stimulant drugs, poses significant adverse health risks. 
Furthermore, because abusers of synthetic cathinones obtain these 
substances through unregulated sources, the identity, purity, and 
quantity are uncertain and inconsistent. These unknown factors pose an 
additional risk for significant adverse health effects to the end user.
    Based on information received by the DEA, the misuse and abuse of 
N-ethylpentylone has led to, at least, the same qualitative public 
health risks as schedule I synthetic cathinones, MDMA, and 
methamphetamine. The public health risks attendant to the abuse of 
synthetic cathinones, including N-ethylpentylone, are well established 
and have resulted in large numbers of ED visits and fatal overdoses.

Finding of Necessity of Schedule I Placement To Avoid an Imminent 
Hazard to the Public Safety

    In accordance with 21 U.S.C. 811(h)(3), based on the available data 
and information, summarized above, the uncontrolled manufacture, 
distribution, reverse distribution, importation, exportation, conduct 
of research and chemical analysis, possession, and/or abuse of N-
ethylpentylone poses an imminent hazard to the public safety. The DEA 
is not aware of any currently accepted medical uses for this substance 
in the United States. A substance meeting the statutory requirements 
for temporary scheduling, 21 U.S.C. 811(h)(1), may only be placed in 
schedule I. Substances in schedule I are those that have a high 
potential for abuse, no currently accepted medical use in treatment in 
the United States, and a lack of accepted safety for use under medical 
supervision. Available data and information for N-ethylpentylone 
indicate that this synthetic cathinone has a high potential for abuse, 
no currently accepted medical use in treatment in the United States, 
and a lack of accepted safety for use under medical supervision. As 
required by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the 
Acting Administrator, through a letter dated November 22, 2017, 
notified the Acting Assistant Secretary of the DEA's intention to 
temporarily place this substance in schedule I. A notice of intent was 
subsequently published in the Federal Register on June 13, 2018. 83 FR 
27520.

Conclusion

    In accordance with the provisions of section 201(h) of the CSA, 21 
U.S.C. 811(h), the Acting Administrator considered available data and 
information, herein set forth the grounds for his determination that it 
is necessary to temporarily schedule N-ethylpentylone in schedule I of 
the CSA, and finds that placement of N-ethylpentylone in schedule I of 
the CSA is necessary in order to avoid an imminent hazard to the public 
safety.
    Because the Acting Administrator hereby finds that it is necessary 
to temporarily place N-ethylpentylone in schedule I to avoid an 
imminent hazard to the public safety, this temporary order scheduling 
this substance is effective on the date of publication in the Federal 
Register, and is in effect for a period of two years, with a possible 
extension of one additional year, pending completion of the regular

[[Page 44477]]

(permanent) scheduling process. 21 U.S.C. 811(h)(1) and (2).
    The CSA sets forth specific criteria for scheduling a drug or other 
substance. Permanent scheduling actions in accordance with 21 U.S.C. 
811(a) are subject to formal rulemaking procedures done ``on the record 
after opportunity for a hearing'' conducted pursuant to the provisions 
of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The permanent scheduling 
process of formal rulemaking affords interested parties with 
appropriate process and the government with any additional relevant 
information needed to make a determination. Final decisions that 
conclude the permanent scheduling process of formal rulemaking are 
subject to judicial review. 21 U.S.C. 877. Temporary scheduling orders 
are not subject to judicial review. 21 U.S.C. 811(h)(6).

Requirements for Handling

    Upon the effective date of this temporary order, N-ethylpentylone 
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, N-ethylpentylone 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 August 
31, 2018. Any person who currently handles N-ethylpentylone, and is not 
registered with the DEA, must submit an application for registration 
and may not continue to handle N-ethylpentylone as of August 31, 2018, 
unless the DEA has approved that application for registration pursuant 
to 21 U.S.C. 822, 823, 957, and 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 this substance in a manner not authorized by the CSA on or 
after August 31, 2018 is unlawful and those in possession of any 
quantity of this substance 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 N-ethylpentylone 
must surrender all currently held quantities of N-ethylpentylone.
    3. Security. N-ethylpentylone is 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 
August 31, 2018.
    4. Labeling and Packaging. All labels, labeling, and packaging for 
commercial containers of N-ethylpentylone 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 August 31, 2018, to 
comply with all labeling and packaging requirements.
    5. Inventory. Every DEA registrant who possesses any quantity of N-
ethylpentylone on the effective date of this order must take an 
inventory of all stocks of this substance on hand, pursuant to 21 
U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 
1304.11. Current DEA registrants shall have 30 calendar days from the 
effective date of this order to be in compliance with all inventory 
requirements. After the initial inventory, every DEA registrant must 
take an inventory of all controlled substances (including N-
ethylpentylone) 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 N-ethylpentylone pursuant to 21 U.S.C. 827 and 958(e), and in 
accordance with 21 CFR parts 1304, 1312, 1317 and Sec.  1307.11. 
Current DEA registrants authorized to handle N-ethylpentylone 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 N-
ethylpentylone must submit reports pursuant to 21 U.S.C. 827 and in 
accordance with 21 CFR parts 1304 and 1312 as of August 31, 2018.
    8. Order Forms. All DEA registrants who distribute N-ethylpentylone 
must comply with order form requirements pursuant to 21 U.S.C. 828 and 
in accordance with 21 CFR part 1305 as of August 31, 2018.
    9. Importation and Exportation. All importation and exportation of 
N-ethylpentylone must be in compliance with 21 U.S.C. 952, 953, 957, 
958, and in accordance with 21 CFR part 1312 as of August 31, 2018.
    10. Quota. Only DEA registered manufacturers may manufacture N-
ethylpentylone in accordance with a quota assigned pursuant to 21 
U.S.C. 826 and in accordance with 21 CFR part 1303 as of August 31, 
2018.
    11. Liability. Any activity involving N-ethylpentylone not 
authorized by, or in violation of the CSA, occurring as of August 31, 
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 DEA believes that the notice 
and comment requirements of section 553 of the Administrative Procedure 
Act (APA), 5 U.S.C. 553, do not apply to this notice of intent. In the 
alternative, even assuming that this notice of intent might be subject 
to section 553 of the APA, the Acting Administrator finds that there is 
good cause to forgo the notice and comment requirements of section 553, 
as any further delays in the process for issuance of temporary 
scheduling orders would be impracticable and contrary to the public 
interest in view of the manifest urgency to avoid an imminent hazard to 
the public safety.
    Further, the DEA believes that this temporary scheduling action is 
not a ``rule'' as defined by 5 U.S.C. 601(2), and, accordingly, is not 
subject to the requirements of the Regulatory Flexibility Act (RFA). 
The requirements for the preparation of an initial regulatory 
flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as 
here, the DEA is not required by 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

[[Page 44478]]

reviewed by the Office of Management and Budget.
    This action will not have substantial direct effects on the States, 
on the relationship between the national government and the States, or 
on the distribution of power and responsibilities among the various 
levels of government. Therefore, in accordance with Executive Order 
13132 (Federalism) it is determined that this action does not have 
sufficient federalism implications to warrant the preparation of a 
Federalism Assessment.
    As noted above, this action is an order, not a rule. Accordingly, 
the Congressional Review Act (CRA) is inapplicable, as it applies only 
to rules. However, if this were a rule, pursuant to the CRA, ``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 this substance 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 this substance in schedule I because it poses 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)(36) to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (h) * * *
    (36) N-Ethylpentylone, its optical, positional, and geometric 
isomers, salts and salts of isomers (Other names: ephylone, 1-(1,3-
benzodioxol-5-yl)-2-(ethylamino)-pentan-1-one)...........(7543)

    Dated: August 24, 2018.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2018-18988 Filed 8-30-18; 8:45 am]
 BILLING CODE 4410-09-P