44474 Federal Register / Vol. 83, No. 170 / Friday, August 31, 2018 / Rules and Regulations 

1Though 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. 

readily visible part of the outside of the 

floating cabin. 

* * * * * 

(c) A floating cabin moored at a 

location approved pursuant to the 

regulations in this subpart shall not be 

relocated and moored at a different 

location without prior approval by TVA, 

except for movement to a new location 

within the designated harbor limits of 

the same commercial dock or marina. 

§ 1304.103 [Removed and Reserved] 

■ 7. Remove and reserve § 1304.103. 

■ 8. Amend § 1304.204 by revising 

paragraphs (a), (b), and (n) to read as 

follows: 

§ 1304.204 Docks, piers, and boathouses. 

* * * * * 

(a) Docks, piers, boathouses, and all 

other residential water-use facilities 

shall not exceed a total footprint area of 

greater than 1,000 square feet, unless the 

proposed water-use facility will be 

located in an area of preexisting 

development. For the purpose of this 

regulation, ‘‘preexisting development’’ 

means either: The water-use facility will 

be located in a subdivision recorded 

before November 1, 1999, and TVA 

permitted at least one water-use facility 

in the subdivision prior to November 1, 

1999; or if there is no subdivision, 

where the water-use facility will be 

located within a quarter-mile radius of 

another water-use facility that TVA 

permitted prior to November 1, 1999. 

TVA may allow even larger facilities 

where an applicant requests and 

justifies a waiver or variance, set forth 

in §§ 1304.212 and 1304.408 

respectively, but such waivers or 

variances shall be made in TVA’s 

discretion and on a case-by-case basis. 

(b) Docks, boatslips, piers, and fixed 

or floating boathouses are allowable. 

These and other water-use facilities 

associated with a lot must be sited 

within a 1,000- or 1,800-square-foot 

rectangular or square area as required by 

§ 1304.204(a) at the lakeward end of the 

access walkway that extends from the 

shore to the structure. Access walkways 

to the water-use structure are not 

included in calculating the 1,000- or 

1,800-square foot area. 

* * * * * 

(n) Except for floating cabins 

approved in accordance with subpart B 

of this part, toilets and sinks are not 

permitted on water-use facilities. 

* * * * * 

§ 1304.406 [Amended] 

■ 9. Amend § 1304.406 in the first 

sentence by removing the words 

‘‘nonnavigable houseboat’’ and adding 

in their place the words ‘‘floating 

cabin’’. 

■ 10. Amend § 1304.412 by: 

■ a. Adding in alphabetical order 

definitions for ‘‘Existing floating cabin’’ 

and ‘‘New floating cabin’’; 

■ b. Removing the definition of 

‘‘Nonnavigable houseboat’’; and 

■ c. Adding in alphabetical order 

definitions for ‘‘Rebuilding’’ and 

‘‘Tennessee River System’’. 

The additions read as follows: 

§ 1304.412 Definitions. 

* * * * * 

Existing floating cabin means a 

floating cabin that was located or 

moored on the Tennessee River System 

on or before December 16, 2016. 

* * * * * 

New floating cabin means a floating 

cabin that was not located or moored on 

the Tennessee River System on or before 

December 16, 2016. 

* * * * * 

Rebuilding means replacement of all 

or a significant portion of an approved 

obstruction to the same configuration, 

total footprint, and dimensions (length, 

width, and height) as the approved 

plans, standards, and conditions of the 

Section 26a permit. 

* * * * * 

Tennessee River System means TVA 

reservoirs, the Tennessee River or any of 

the Tennessee River’s tributaries. 

* * * * * 

David L. Bowling, 

Vice President, Land & River Management. 

[FR Doc. 2018–18887 Filed 8–30–18; 8:45 am] 

BILLING CODE 8120–08–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–482] 

Schedules of Controlled Substances: 

Temporary Placement of NEthylpentylone in Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Temporary amendment; 

temporary scheduling order. 

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 Nethylpentylone 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). 

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. 


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2As 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. 

3NFLIS and STRIDE/STARLiMS databases were 

queried on February 8, 2018. 

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 Nethylpentylone. 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. 

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 Nethylpentylone, 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 threefactor 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 Nethylpentylone 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 webbased, 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 drugrelated exhibits for a period from 

January 2013 to December 2017 from 41 

states. There were no occurrences of Nethylpentylone 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 Nethylpentylone 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 Nethylpentylone have occurred. 

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). Nethylpentylone, 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 Nethylpentylone. 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 


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4NFLIS and STRIDE/STARLiMS databases were 

queried on February 8, 2018. 

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 Nethylpentylone, similar to schedule I 

synthetic cathinones and MDMA, are 

young adults. 

Available evidence suggests that the 

history and pattern of abuse of Nethylpentylone parallels that of MDMA, 

methamphetamine, or cocaine and that 

N-ethylpentylone has been marketed as 

a replacement for these substances. NEthylpentylone 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 Nethylpentylone. 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 Nethylpentylone 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. NEthylpentylone 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. 

Factor 6. What, if Any, Risk There Is to 

the Public Health 

The identification of Nethylpentylone 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 Nethylpentylone 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 Nethylpentylone 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 Nethylpentylone 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 Nethylpentylone in schedule I of the CSA, 

and finds that placement of Nethylpentylone 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 


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(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 Nethylpentylone, 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 Nethylpentylone must surrender all 

currently held quantities of Nethylpentylone. 

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 Nethylpentylone 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 Nethylpentylone pursuant to 21 U.S.C. 

827 and 958(e), and in accordance with 

21 CFR parts 1304, 1312, 1317 and 

§ 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 Nethylpentylone 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 Nethylpentylone 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 Nethylpentylone 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 


daltland on DSKBBV9HB2PROD with RULES
44478 Federal Register / Vol. 83, No. 170 / Friday, August 31, 2018 / Rules and Regulations 

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 

■ 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. 

■ 2. In § 1308.11, add paragraph (h)(36) 

to read as follows: 

§ 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 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2018–0841] 

Drawbridge Operation Regulation; 

Trent River, New Bern, NC 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of deviation from 

drawbridge regulation. 

SUMMARY: The Coast Guard has issued a 

temporary deviation from the operating 

schedule that governs the U.S. 70 

(Alfred A. Cunningham) Bridge across 

the Trent River, mile 0.0, at New Bern, 

NC. The deviation is necessary to 

accommodate the 30th Annual Bike MS: 

Historic New Bern Ride. This deviation 

allows the bridge to remain in the 

closed-to-navigation position. 

DATES: This deviation is effective from 

8:00 a.m. on September 8, 2018 to 9:30 

a.m. on September 9, 2018. 

ADDRESSES: The docket for this 

deviation, [USCG–2018–0841], is 

available at http://www.regulations.gov. 

Type the docket number in the 

‘‘SEARCH’’ box and click ‘‘SEARCH’’. 

Click on Open Docket Folder on the line 

associated with this deviation. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

deviation, call or email Ms. Kashanda 

Booker, Bridge Administration Branch 

Fifth District, Coast Guard, telephone 

(757) 398–6227, email 

kashanda.l.booker@uscg.mil. 

SUPPLEMENTARY INFORMATION: The event 

director, Game On Inc., with approval 

from the North Carolina Department of 

Transportation, who owns and operates 

the U.S. 70 (Alfred A. Cunningham) 

Bridge across the Trent River, mile 0.0, 

at New Bern, NC, has requested a 

temporary deviation from the current 

operating regulations. This temporary 

deviation is necessary to accommodate 

participation by cyclists during the 30th 

Annual Bike MS: Historic New Bern 

Ride. The bridge is a double bascule 

bridge and has a vertical clearance in 

the closed position of 14 feet above 

mean high water. 

The current operating schedule is set 

out in 33 CFR 117.843(a). Under this 

temporary deviation, the bridge will be 

maintained in the closed-to-navigation 

position from 8:00 a.m. to 9:30 a.m. on 

September 8th and September 9th 2018. 

The Trent River is used by a variety of 

vessels including small commercial 

vessels and recreational vessels. The 

Coast Guard has carefully coordinated 

the restrictions with waterway users in 

publishing this temporary deviation. 

Vessels able to pass through the 

bridge in the closed position may do so 

at anytime. There is no immediate 

alternate route for vessels unable to pass 

through the bridge in the closed 

position but the bridge will be able to 

open for emergencies. The Coast Guard 

will also inform users of the waterways 

through our Local and Broadcast Notice 

to Mariners of the change in operating 

schedule for the bridge so that vessels 

can arrange their transits to minimize 

any impacts caused by this temporary 

deviation. 

In accordance with 33 CFR 117.35(e), 

the drawbridge must return to its regular 

operating schedule immediately at the 

end of the effective period of this 

temporary deviation. This deviation 

from the operating regulations is 

authorized under 33 CFR 117.35. 

Dated: August 27, 2018. 

Hal R. Pitts, 

Bridge Program Manager, Fifth Coast Guard 

District. 

[FR Doc. 2018–18929 Filed 8–30–18; 8:45 am] 

BILLING CODE 9110–04–P 


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