Schedules of Controlled Substances: Temporary Placement of N-Ethylpentylone in Schedule I, 27520-27523 [2018-12669]
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27520
Proposed Rules
Federal Register
Vol. 83, No. 114
Wednesday, June 13, 2018
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.
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
Drug Enforcement
Administration, Department of Justice.
ACTION: Proposed amendment; notice of
intent.
AGENCY:
The Acting Administrator of
the Drug Enforcement Administration is
publishing this notice of intent to issue
an order temporarily scheduling N-1(1,3-benzodioxol-5-yl)-2-(ethylamino)-1pentanone (N-ethylpentylone, ephylone)
in schedule I. This action is based on a
finding by the Acting Administrator that
the placement of N-ethylpentylone 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 Controlled
Substances Act (CSA) on the
manufacture, distribution, reverse
distribution, possession, importation,
exportation, research, and conduct of
instructional activities, and chemical
analysis of N-ethylpentylone, 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 N-ethylpentylone.
DATES: June 13, 2018.
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
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SUMMARY:
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temporary amendment) placing Nethylpentylone in schedule I of the
Controlled Substances Act (CSA).1 The
temporary scheduling order will be
published in the Federal Register on or
after July 13, 2018.
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 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); 21 CFR part 1308. The
Attorney General has delegated
scheduling authority under 21 U.S.C.
811 to the Administrator of the DEA. 28
CFR 0.100.
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
1 Though DEA has used the term ‘‘final order’’
with respect to temporary scheduling orders in the
past, this notice of intent adheres to the statutory
language of 21 U.S.C. 811(h), which refers to a
‘‘temporary scheduling order.’’ No substantive
change is intended.
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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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 the HHS has
no objection to the temporary placement
of N-ethylpentylone in schedule I of the
CSA. 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.
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).
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, 4methyl-N-ethylcathinone (4–MEC),
mephedrone, methylone, pentylone, and
3,4-methylenedioxymethamphetamine
(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
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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 State, local, or Federal
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. 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. NEthylpentylone was first reported to
STRIDE/STARLiMS in December 2015.
Additionally, encounters of Nethylpentylone have occurred by the
U.S. Customs and Border Protection
(CBP).
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, 3,4methylenedioxymethamphetamine
(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.
Available data and information for Nethylpentylone, summarized below,
indicate that this substance 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 is available in its entirety under
3 NFLIS and STRIDE/STARLiMS databases were
queried on February 8, 2018.
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‘‘Supporting and Related Material’’ of
the public docket for this action at
www.regulations.gov under Docket
Number DEA–482.
often with unpredictable outcomes.
Thus, the recreational abuse of synthetic
cathinones, including N-ethylpentylone,
is a significant concern.
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
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 N-ethylpentylone.
Toxicology reports also revealed that Nethylpentylone is being ingested with
other substances including other
synthetic cathinones, common cutting
agents, or other recreational substances.
Consequently, products containing
synthetic cathinones, including Nethylpentylone, are distributed to users,
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. 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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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 the
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
4 NFLIS and STRIDE/STARLiMS databases were
queried on February 8, 2018.
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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 resulting
from the lack of control of this
substance 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
substance 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 Administrator, through a
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letter dated November 22, 2017, notified
the Acting Assistant Secretary of the
DEA’s intention to temporarily place
this substance in schedule I.
Conclusion
This notice of intent provides the 30day notice pursuant to section 201(h) of
the CSA, 21 U.S.C. 811(h), of DEA’s
intent to issue a temporary scheduling
order. 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
on a temporary basis is necessary in
order to avoid an imminent hazard to
the public safety.
The temporary placement of Nethylpentylone in schedule I of the CSA
will take effect pursuant to a temporary
scheduling order, which will not be
issued before July 13, 2018. Because the
Acting Administrator hereby finds that
it is necessary to temporarily place Nethylpentylone in schedule I to avoid an
imminent hazard to the public safety,
the temporary order scheduling this
substance 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, with a possible
extension of one additional year,
pending completion of the regular
(permanent) scheduling process. 21
U.S.C. 811(h)(1) and (2). It is the
intention of the Acting Administrator to
issue a temporary scheduling order as
soon as possible after the expiration of
30 days from the date of publication of
this notice. Upon publication of the
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, research,
conduct of instructional activities and
chemical analysis, and possession of a
schedule I controlled substance.
The CSA sets forth specific criteria for
scheduling a drug or other substance.
Regular 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 regular 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
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decisions that conclude the regular
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).
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
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.
Although the DEA believes this notice
of intent to issue a temporary
scheduling order is not subject to the
notice and comment requirements of
section 553 of the APA, the DEA notes
that in accordance with 21 U.S.C.
811(h)(4), the Acting Administrator took
into consideration comments submitted
by the Acting Assistant Secretary in
response to notice that DEA transmitted
to the Acting Assistant Secretary
pursuant to section 811(h)(4).
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
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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.
SUMMARY:
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:
David A. Trissell, General Counsel, at
202–789–6820.
SUPPLEMENTARY INFORMATION:
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:
■
*
Schedule I.
*
*
(h) * * *
*
Submit comments
electronically via the Commission’s
Filing Online system at https://
www.prc.gov. Those who cannot submit
comments electronically should contact
the person identified in the FOR FURTHER
INFORMATION CONTACT section by
telephone for advice on filing
alternatives.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Table of Contents
I. Introduction
II. Proposal Three
III. Notice and Comment
IV. Ordering Paragraphs
I. Introduction
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
§ 1308.11
The Commission is noticing a
recent filing requesting that the
Commission initiate an informal
rulemaking proceeding to consider
changes to an analytical method for use
in periodic reporting (Proposal Three).
This document informs the public of the
filing, invites public comment, and
takes other administrative steps.
DATES: Comments are due: June 29,
2018.
On June 1, 2018, the Postal Service
filed a petition pursuant to 39 CFR
3050.11, requesting that the
Commission initiate a rulemaking
proceeding to consider changes to
analytical principles relating to periodic
reports.1 The Petition identifies the
proposed analytical changes filed in this
docket as Proposal Three.
II. Proposal Three
*
Background. The Commission
adopted the use of incremental costs as
the basis for class-level and productlevel attributable costs in September of
2016.2 In FY 2017, the methodology was
fully applied for the first time.3 Proposal
(7543)
Three seeks to revise two incremental
*
*
*
*
*
costing procedures in accordance with
this methodological change.
Dated: June 6, 2018.
The first proposed revision concerns
Robert W. Patterson,
the Postal Service’s method for
Acting Administrator.
calculating incremental costs for
[FR Doc. 2018–12669 Filed 6–12–18; 8:45 am]
competitive products collectively.
BILLING CODE 4410–09–P
Under current analytical principles, the
Postal Service calculates these costs
using a so-called ‘‘hybrid’’ approach.
POSTAL REGULATORY COMMISSION
The Postal Service first calculates the
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(36) N-Ethylpentylone, its optical,
positional, and geometric isomers, salts and salts of isomers
(Other names: ephylone, N-1(1,3-benzodioxol-5-yl)-2(ethylamino)-1-pentanone) ..........
39 CFR Part 3050
[Docket No. RM2018–6; Order No. 4635]
Periodic Reporting
Postal Regulatory Commission.
Notice of proposed rulemaking.
AGENCY:
ACTION:
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1 Petition of the United States Postal Service for
the Initiation of a Proceeding to Consider Proposed
Changes in Analytical Principles (Proposal Three),
June 1, 2018 (Petition).
2 Docket No. ACR2017, Annual Compliance
Report, December 29, 2017, at 4–6.
3 Docket No. ACR2017, Annual Compliance
Determination, March 29, 2018, at 8.
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incremental costs of competitive
domestic products (including group
specific costs for these products) and
then adds it to the volume variable and
product specific costs of competitive
international products. This ‘‘hybrid’’
approach blends an estimate of
competitive domestic incremental costs
with a proxy estimate of competitive
international incremental costs.
The second proposed revision relates
to estimating inframarginal costs for
products with insufficient data at the
cost pool level. The Postal Service states
that this revision primarily concerns
negotiated service agreements (NSAs),
because NSAs are classified as
independent products, which can have
low volumes. Petition, Proposal Three at
1. Furthermore, the Postal Service
contends that NSAs create practical
issues in calculating incremental costs,
in part because the Postal Service’s data
systems do not distinguish between
NSA and non-NSA mailpieces. Id. at 13.
This prevents the Postal Service from
creating the standard cost drivers for
NSAs (e.g. volume, weight, cubic
volume), which are necessary for
calculating incremental costs. Id.
Proposal. As discussed above, the
Postal Service proposes two procedures
to revise its calculation of incremental
costs.
Under procedure one, the Postal
Service seeks to replace the ‘‘hybrid’’
approach to calculating aggregate
incremental costs, which relies on a
proxy for international costs, with a
direct estimation of those costs. Id. at 4.
Due to improvements suggested in the
FY 2016 Annual Compliance
Determination, in conjunction with
corresponding analytical improvements,
the Postal Service states that it can now
directly estimate the actual incremental
costs of international mail. Id. at 6.
Under procedure two, the Postal
Service proposes thresholds for
calculating inframarginal costs and an
alternative methodology for
approximating the appropriate cost
driver ratios for NSAs. Id. at 8.
Specifically, the Postal Service suggests
that it should not have to calculate the
incremental costs if an NSA has less
than 0.3 percent of the product type’s
(e.g. Priority Mail, Parcel Select) volume
variable cost or less than $8 million in
volume variable cost. Id. at 11. The
Postal Service also seeks to use the ratio
of NSA volume variable costs to product
type volume variable costs as a proxy
cost driver to calculate the incremental
cost of NSA products. Id. at 12–20.
Rationale and impact. The Postal
Service contends that procedure one
will allow it ‘‘to rely upon the best
available information’’ because the
E:\FR\FM\13JNP1.SGM
13JNP1
Agencies
[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Proposed Rules]
[Pages 27520-27523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12669]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 /
Proposed Rules
[[Page 27520]]
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: Proposed amendment; notice of intent.
-----------------------------------------------------------------------
SUMMARY: The Acting Administrator of the Drug Enforcement
Administration is publishing this notice of intent to issue an order
temporarily scheduling N-1-(1,3-benzodioxol-5-yl)-2-(ethylamino)-1-
pentanone (N-ethylpentylone, ephylone) in schedule I. This action is
based on a finding by the Acting Administrator that the placement of N-
ethylpentylone 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 Controlled Substances Act
(CSA) on the manufacture, distribution, reverse distribution,
possession, importation, exportation, research, and conduct of
instructional activities, and chemical analysis of N-ethylpentylone, 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 N-ethylpentylone.
DATES: June 13, 2018.
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 N-ethylpentylone in schedule
I of the Controlled Substances Act (CSA).\1\ The temporary scheduling
order will be published in the Federal Register on or after July 13,
2018.
---------------------------------------------------------------------------
\1\ Though DEA has used the term ``final order'' with respect to
temporary scheduling orders in the past, this notice of intent
adheres to the statutory language of 21 U.S.C. 811(h), which refers
to a ``temporary scheduling order.'' No substantive change is
intended.
---------------------------------------------------------------------------
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 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); 21 CFR part 1308. The Attorney General has delegated
scheduling authority under 21 U.S.C. 811 to the Administrator of the
DEA. 28 CFR 0.100.
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 the HHS has no
objection to the temporary placement of N-ethylpentylone in schedule I
of the CSA. 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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).
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-
methylenedioxymethamphetamine (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
[[Page 27521]]
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 State,
local, or Federal 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. 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. N-Ethylpentylone was
first reported to STRIDE/STARLiMS in December 2015. Additionally,
encounters of N-ethylpentylone have occurred by the U.S. Customs and
Border Protection (CBP).
---------------------------------------------------------------------------
\3\ NFLIS and STRIDE/STARLiMS databases were queried on February
8, 2018.
---------------------------------------------------------------------------
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.
Available data and information for N-ethylpentylone, summarized
below, indicate that this substance 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 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-482.
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 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. 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.
---------------------------------------------------------------------------
\4\ NFLIS and STRIDE/STARLiMS databases were queried on February
8, 2018.
---------------------------------------------------------------------------
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 the
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
[[Page 27522]]
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 resulting from the lack of control of this substance
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 substance 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
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.
Conclusion
This notice of intent provides the 30-day notice pursuant to
section 201(h) of the CSA, 21 U.S.C. 811(h), of DEA's intent to issue a
temporary scheduling order. 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 on a temporary basis is
necessary in order to avoid an imminent hazard to the public safety.
The temporary placement of N-ethylpentylone in schedule I of the
CSA will take effect pursuant to a temporary scheduling order, which
will not be issued before July 13, 2018. 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, the temporary order scheduling this substance 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, with a possible extension of
one additional year, pending completion of the regular (permanent)
scheduling process. 21 U.S.C. 811(h)(1) and (2). It is the intention of
the Acting Administrator to issue a temporary scheduling order as soon
as possible after the expiration of 30 days from the date of
publication of this notice. Upon publication of the 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, research, conduct of instructional activities and chemical
analysis, and possession of a schedule I controlled substance.
The CSA sets forth specific criteria for scheduling a drug or other
substance. Regular 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 regular 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
regular 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).
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 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.
Although the DEA believes this notice of intent to issue a
temporary scheduling order is not subject to the notice and comment
requirements of section 553 of the APA, the DEA notes that in
accordance with 21 U.S.C. 811(h)(4), the Acting Administrator took into
consideration comments submitted by the Acting Assistant Secretary in
response to notice that DEA transmitted to the Acting Assistant
Secretary pursuant to section 811(h)(4).
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
[[Page 27523]]
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)(36) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(h) * * *
(36) N-Ethylpentylone, its optical, positional, and geometric (7543)
isomers, salts and salts of isomers (Other names: ephylone, N-
1-(1,3-benzodioxol-5-yl)-2-(ethylamino)-1-pentanone)..........
* * * * *
Dated: June 6, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-12669 Filed 6-12-18; 8:45 am]
BILLING CODE 4410-09-P