Schedules of Controlled Substances: Temporary Placement of N, 18423-18428 [2019-08704]
Download as PDF
<![CDATA[
Federal Register / Vol. 84, No. 84 / Wednesday, May 1, 2019 / Proposed Rules
DEPARTMENT OF JUSTICE
requirements or otherwise violate the
CSA with respect to these substances.
DATES: May 1, 2019.
FOR FURTHER INFORMATION CONTACT:
Lynnette M. Wingert, Regulatory
Drafting and Policy Support Section
(DPW), Diversion Control Division, Drug
Enforcement Administration; Mailing
Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone:
(202) 598–6812.
SUPPLEMENTARY INFORMATION: This
notice of intent contained in this
document 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 scheduling order (in the form
of a temporary amendment) placing Nethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP in
schedule I of the Controlled Substances
Act (CSA).1 The temporary scheduling
order will be published in the Federal
Register on or after May 31, 2019.
Drug Enforcement Administration
Legal Authority
DOE will provide a grace period of 180
days for the manufacturer to begin to
use the DOE test procedure or the
alternate test procedure specified in the
decision and order on the petition to
make representations of energy
efficiency.
*
*
*
*
*
(h) Duration. (1) Interim waivers
remain in effect until the earlier of the
following:
(i) DOE publishes a decision on a
petition for waiver pursuant to
paragraph (f) of this section in the
Federal Register; or
(ii) DOE publishes in the Federal
Register a new or amended test
procedure that addresses the issues
presented in the waiver.
*
*
*
*
*
[FR Doc. 2019–08699 Filed 4–30–19; 8:45 am]
BILLING CODE 6450–01–P
21 CFR Part 1308
[Docket No. DEA–495]
Schedules of Controlled Substances:
Temporary Placement of NEthylhexedrone, α-PHP, 4-MEAP,
MPHP, PV8, and 4-Chloro-α-PVP 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
issuing this notice of intent to publish
a temporary order to schedule the
synthetic cathinones, N-ethylhexedrone;
alpha-pyrrolidinohexanophenone
(trivial name: a-PHP); 4-methyl-alphaethylaminopentiophenone (trivial name:
4-MEAP); 4′-methyl-alphapyrrolidinohexiophenone (trivial name:
MPHP); alpha-pyrrolidinoheptaphenone
(trivial name: PV8); and 4-chloro-alphapyrrolidinovalerophenone (trivial name:
4-chloro-a-PVP), in schedule I. 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, conduct of
instructional activities, and chemical
analysis of these synthetic cathinones,
as well as administrative, civil, and
criminal remedies with respect to
persons who fail to comply with such
jbell on DSK30RV082PROD with PROPOSALS
SUMMARY:
VerDate Sep<11>2014
18:57 Apr 30, 2019
Jkt 247001
Section 201 of the Controlled
Substances Act (CSA), 21 U.S.C. 811,
provides the Attorney General with the
authority to temporarily place a
substance in schedule I of the CSA for
two years without regard to the
requirements of 21 U.S.C. 811(b), if he
finds that such action is necessary to
avoid an imminent hazard to the public
safety. 21 U.S.C. 811(h)(1). In addition,
if proceedings to control a substance
permanently are initiated under 21
U.S.C. 811(a)(1) while the substance is
temporarily controlled under section
811(h), the Attorney General may
extend the temporary scheduling for up
to one year. 21 U.S.C. 811(h)(2).
Where the necessary findings are
made, a substance may be temporarily
scheduled if it is not listed in any other
schedule under section 202 of the CSA,
21 U.S.C. 812, or if there is no
exemption or approval in effect for the
substance under section 505 of the
Federal Food, Drug, and Cosmetic Act
(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
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.
PO 00000
Frm 00010
Fmt 4702
Sfmt 4702
18423
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-ethylhexedrone, aPHP, 4-MEAP, MPHP, PV8, and 4chloro-a-PVP in schedule I on a
temporary basis to the Assistant
Secretary for Health of HHS by letter
dated March 9, 2018. The Acting
Assistant Secretary responded to this
notice of intent by letter dated March
27, 2018, and advised that based on a
review by the Food and Drug
Administration (FDA), there were
currently no approved new drug
applications or active investigational
new drug applications for Nethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP. The
Acting Assistant Secretary also stated
that the HHS had no objection to the
temporary placement of Nethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP in
schedule I of the CSA. NEthylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP are not
currently listed in any schedule under
the CSA, and no exemptions or
approvals are in effect for Nethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP under
section 505 of the FDCA, 21 U.S.C. 355.
In order to find that placing a
substance temporarily in schedule I of
the CSA is necessary to avoid an
imminent hazard to the public safety,
the Administrator is required to
consider three of the eight factors set
forth in 21 U.S.C. 811(c): The
substance’s history and current pattern
of abuse; the scope, duration and
significance of abuse; and what, if any,
risk there is to the public health. 21
U.S.C. 811(h)(3). 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,
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.
E:\FR\FM\01MYP1.SGM
01MYP1
18424
Federal Register / Vol. 84, No. 84 / Wednesday, May 1, 2019 / Proposed Rules
jbell on DSK30RV082PROD with PROPOSALS
and a lack of accepted safety for use
under medical supervision. 21 U.S.C.
812(b)(1).
Synthetic Cathinones
Recently, novel synthetic cathinones
that mimic the biological effects of
substances with stimulant-like effects
have emerged on the illicit drug market.
These novel cathinones, also known as
designer drugs, are structurally similar
to several drugs of abuse such as
schedule I synthetic cathinones (e.g.,
methcathinone, mephedrone,
methylone, pentylone, and 3,4methylenedioxypyrovalerone (MDPV)).
The illicit use of synthetic cathinones
has continued throughout the United
States, resulting in severe adverse
effects, overdoses, and deaths. Indeed,
hospital reports, scientific publications
and/or law enforcement reports
demonstrate that these types of
substances are being abused for their
psychoactive properties and they cause
harm (see DEA 3-Factor Analysis).
Recreational effects reported by abusers
of synthetic cathinones include
euphoria, sense of well-being, increased
sociability, energy, empathy, increased
alertness, improved concentration, and
focus. Adverse effects such as
tachycardia, hypertension,
rhabdomyolysis, hyponatremia,
seizures, and altered mental status
(paranoia, hallucinations, and
delusions) have also been reported from
the abuse of synthetic cathinones.
Consequently, there are documented
reports of emergency room admissions
and deaths associated with the abuse of
synthetic cathinone substances. With
many generations of synthetic
cathinones having been encountered
since 2009, the abuse of Nethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP is
impacting or will negatively impact
communities.
Law enforcement data indicate that Nethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP have
appeared in the United States’ illicit
drug market (see DEA 3-Factor
Analysis). 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. From January 2012 to
September 24, 2018, NFLIS registered
1,131 drug exhibits pertaining to the
trafficking, distribution and abuse of Nethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP. These
exhibits had a net weight of
VerDate Sep<11>2014
18:57 Apr 30, 2019
Jkt 247001
approximately 18.7 kilograms and were
encountered in powder, crystal, rock,
resin, capsule, and tablet forms.
As observed by the DEA and by the
United States Customs and Border
Protection (CBP), synthetic cathinones
originate from foreign sources, such as
China. Bulk powder substances are
smuggled via common carrier into the
United States and find their way to
clandestine designer drug product
manufacturing operations located in
residential neighborhoods, garages,
warehouses, and other similar
destinations throughout the country.
Encounters of N-ethylhexedrone, a-PHP,
4-MEAP, MPHP, PV8, and 4-chloro-aPVP have occurred by the CBP (see DEA
3-Factor Analysis).
N-Ethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP have
no accepted medical use in the United
States. N-Ethylhexedrone, a-PHP, 4MEAP, MPHP, PV8, and 4-chloro-a-PVP
have been seized by law enforcement in
the United States. The misuse of a-PHP,
4-MEAP, MPHP, and PV8 has been
reported to result in adverse effects in
humans in the United States. Although
no overdose information is currently
available for N-ethylhexedrone and 4chloro-a-PVP, law enforcement seizures
of these two substances and their
pharmacological similarity to currently
controlled schedule I synthetic
cathinones (e.g., methcathinone,
mephedrone, methylone, pentylone,
MDPV) suggest that these two synthetic
cathinones are likely to produce adverse
effects similar to those produced by
other synthetic cathinones.
N-Ethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP are
synthetic cathinones that have
pharmacological effects similar to
schedule I synthetic cathinone
substances such as methcathinone,
mephedrone, methylone, pentylone, and
MDPV and schedule II stimulants such
as methamphetamine and cocaine. The
misuse of a-PHP, 4-MEAP, MPHP, and
PV8 has been associated with one or
more overdoses with some requiring
emergency medical intervention in the
United States. With no approved
medical use and limited safety or
toxicological information, Nethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP have
emerged on the designer drug market,
and the abuse or trafficking of these
substances for their psychoactive
properties is concerning.
Factor 4. History and Current Pattern of
Abuse
N-Ethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP are
synthetic cathinones that have been
PO 00000
Frm 00011
Fmt 4702
Sfmt 4702
identified in the United States’ illicit
drug market. Evidence indicates that
these substances are being substituted
for schedule I synthetic cathinones.
Products containing synthetic
cathinones have been falsely marketed
as ‘‘research chemicals,’’ ‘‘jewelry
cleaner,’’ ‘‘stain remover,’’ ‘‘plant food
or fertilizer,’’ ‘‘insect repellants,’’ or
‘‘bath salts.’’ They have been sold at
smoke shops, head shops, convenience
stores, adult bookstores, and gas
stations. They can also be purchased on
the internet. These substances are
commonly encountered in the form of
powders, crystals, tablets, and capsules.
Other encountered forms include resin,
rock, liquid, and deposits on plant
matter. Law enforcement has
encountered N-ethylhexedrone, a-PHP,
4-MEAP, MPHP, PV8, and 4-chloro-aPVP in powder, crystal, resin, rock,
capsule, or tablet forms. The packages of
these commercial products usually
contain the warning ‘‘not for human
consumption,’’ most likely in an effort
to circumvent statutory restrictions for
these substances.
N-Ethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP are
likely to be abused in the same manner
as schedule I synthetic cathinones such
as methcathinone, mephedrone,
methylone, pentylone, and MDPV.
Information from published scientific
studies indicate that the most common
routes of administration for synthetic
cathinones are nasal insufflation by
snorting the powder and ingestion by
swallowing capsules or tablets. The
powder can also be injected or
swallowed. Other methods of intake
include rectal administration, ingestion
by ‘‘bombing’’ (wrapping a dose of
powder in a paper wrap and
swallowing) and intramuscular
injection.
Based upon the information collected
from case reports, medical journals, and
scientific publications including survey
data, the main users of synthetic
cathinones are youths and young adults.
Given that N-ethylhexedrone, a-PHP, 4MEAP, MPHP, PV8, and 4-chloro-a-PVP
are newly emerging synthetic
cathinones, it is likely that these
substances will be used by the same
population. This is consistent with data
collected from the use of schedule I
synthetic cathinones (e.g., mephedrone,
methylone, pentylone, MDPV).
According to Monitoring the Future
(MTF) survey data,3 the 2017 annual
3 Monitoring the Future (MTF) is a research
program conducted at the University of Michigan’s
Institute for Social Research under grants from
NIDA. MTF tracks drug use trends among United
States adolescents in the 8th, 10th, and 12th grades
E:\FR\FM\01MYP1.SGM
01MYP1
Federal Register / Vol. 84, No. 84 / Wednesday, May 1, 2019 / Proposed Rules
jbell on DSK30RV082PROD with PROPOSALS
prevalence rate of synthetic cathinone
use was 0.6% for high school seniors
and 0.3% for young adults (19–30
years). However, there was an 18
percentage point increase in the
perceived risk of trying ‘‘bath salts’’ in
young adults (aged 19–26 years).
N-Ethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP are
likely to have duration of effects similar
to those of schedule I synthetic
cathinones because of their structural
and pharmacological similarities. Users
report (drug surveys, scientific and
medical literature, etc.) that the effects
of synthetic cathinones occur a few
minutes to 15 minutes after
administration, depending on the
synthetic cathinone and the route of
administration (oral, insufflation,
intravenous, etc.), and can last up to
three hours.
Evidence indicated that Nethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP are
ingested with other substances. This is
likely to either heighten the effects or
ameliorate the come-down effects of the
synthetic cathinones. Co-ingestions can
be from the ingestion of multiple
products separately or a single product
that is composed of multiple substances
(e.g., one tablet containing Nethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, 4-chloro-a-PVP and other
illicit substances). Indeed, law
enforcement routinely encounters
synthetic cathinone mixtures.
Substances found in combination with
N-ethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, or 4-chloro-a-PVP are:
Other synthetic cathinones (e.g., MDPV,
4-chloromethcathinone, Nethylpentylone, a-PVP), common
cutting agents (e.g., caffeine), or other
recreational substances (e.g.,
methamphetamine, fentanyl, fentanyl
analogues, carfentanil, benzodiazepines
(e.g., alprazolam), heroin, cocaine,
synthetic cannabinoids,
fluoroamphetamine, MDMA). Multiple
drug use and potential co-ingestions are
confirmed by forensic analysis of seized
and purchased synthetic cathinone
products.
Factor 5. Scope, Duration and
Significance of Abuse
Since 2009, the popularity of
synthetic cathinones and their
associated products has continued, as
evidenced by law enforcement seizures,
public health information, and media
reports. As one synthetic cathinone is
controlled, another unscheduled
synthetic cathinone appears in the
and high school graduates into adulthood by
conducting national surveys.
VerDate Sep<11>2014
18:57 Apr 30, 2019
Jkt 247001
recreational drug market. NEthylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP are
synthetic cathinones that have been
identified in the United States’ illicit
drug market (see DEA 3-Factor Analysis
for a full discussion).
Law enforcement data indicate that Nethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP are
being abused in the United States as
recreational drugs. While law
enforcement data are not direct
evidence of abuse, the data can infer
that a drug has been diverted and
abused.4 Forensic laboratories have
confirmed the presence of these
substances in drug exhibits received
from state, local, and federal law
enforcement agencies. From January
2012 to September 24, 2018, there were
1,131 exhibits reported to NFLIS
databases (federal, state, and local
forensic laboratories) pertaining to the
trafficking, distribution and abuse of Nethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP. These
exhibits had a net weight of
approximately 18.7 kilograms. These
data also indicated that the abuse of Nethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP is
widespread and has been encountered
in many states since 2012 in the United
States.
The following information details
data obtained from the NFLIS database
(queried on September 24, 2018),
including dates of first encounter,
exhibits/reports, and locations.
N-ethylhexedrone: NFLIS—233
reports, first encountered in August
2016, locations include: Arizona,
Florida, Georgia, Illinois, Indiana,
Kansas, Kentucky, Louisiana, Michigan,
Minnesota, Mississippi, Missouri, North
Dakota, Ohio, Oklahoma, Oregon,
Pennsylvania, South Carolina,
Tennessee, Texas, Virginia, and
Wyoming.
a-PHP: NFLIS—395 reports, first
encountered in May 2014, locations
include: Arkansas, California, Colorado,
Florida, Georgia, Idaho, Illinois,
Indiana, Iowa, Kentucky, Maine,
Massachusetts, Michigan, Minnesota,
Missouri, New Hampshire, New Jersey,
New York, Ohio, Oregon, Pennsylvania,
South Carolina, South Dakota,
Tennessee, Texas, Utah, Virginia,
Wisconsin, and Wyoming.
4–MEAP: NFLIS—105 reports, first
encountered in August 2013, locations
include: Alabama, Arkansas, California,
Colorado, Connecticut, Florida, Georgia,
Illinois, Indiana, Kansas, Louisiana,
Maryland, Minnesota, New Hampshire,
4 See
PO 00000
76 FR 77330, 77332, Dec. 12, 2011.
Frm 00012
Fmt 4702
Sfmt 4702
18425
New York, Ohio, Oklahoma, Oregon,
Pennsylvania, Tennessee, and Texas.
MPHP: NFLIS—71 reports, first
encountered in June 2012, locations
include: California, Connecticut,
Florida, Georgia, Indiana, Kansas,
Kentucky, Maine, Minnesota, Missouri,
Nebraska, Nevada, New Jersey, Ohio,
Pennsylvania, and Texas.
PV8: NFLIS—166 reports, first
encountered in December 2013,
locations include: Arizona, Connecticut,
District of Columbia, Florida, Georgia,
Idaho, Indiana, Iowa, Kentucky,
Louisiana, Maine, Massachusetts,
Minnesota, Missouri, Nebraska, Nevada,
New Hampshire, New Jersey, New York,
North Dakota, Ohio, Oklahoma, Oregon,
Pennsylvania, South Carolina,
Tennessee, Texas, Utah, Virginia, and
Wisconsin.
4-Chloro-a-PVP: NFLIS—160 reports,
first encountered in December 2015,
locations include: California, District of
Columbia, Louisiana, Maryland,
Arizona, Connecticut, Florida, Georgia,
Idaho, Illinois, Indiana, Iowa, Kansas,
Kentucky, Maine, Massachusetts,
Minnesota, Missouri, New Jersey, New
York, Ohio, Oklahoma, Oregon,
Pennsylvania, Rhode Island, South
Carolina, Tennessee, Texas, Utah,
Virginia, and Washington.
Additionally, encounters/seizures of
these substances have occurred by the
CBP at United States ports of entry. As
observed by the DEA and CBP, synthetic
cathinones originate from foreign
sources, such as China. Bulk powder
substances are smuggled via common
carrier into the United States and find
their way to clandestine designer drug
product manufacturing operations
located in residential neighborhoods,
garages, warehouses, and other similar
destinations throughout the country.
From 2014 to 2017, CBP encountered 73
shipments of products containing Nethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, or 4-chloro-a-PVP.
Additional evidence indicates that some
of these synthetic cathinones have been
seized abroad. N-Ethylhexedrone and 4chloro-a-PVP have been identified in
seized materials in China and Poland,
respectively. These data demonstrate
that these substances are being
trafficked and abused in the United
States and abroad.
Concerns over the abuse of synthetic
cathinone substances have led to the
control of many synthetic cathinones.
The DEA controlled 13 synthetic
cathinones: methylone, mephedrone,
MDPV, 4-methyl-N-ethylcathinone (4MEC), 4-methyl-alphapyrrolidinopropiophenone (4-MePPP),
alpha-pyrrolidinopentiophenone (aPVP), butylone (1-(1,3-benzodioxol-5-
E:\FR\FM\01MYP1.SGM
01MYP1
18426
Federal Register / Vol. 84, No. 84 / Wednesday, May 1, 2019 / Proposed Rules
jbell on DSK30RV082PROD with PROPOSALS
yl)-2-(methylamino)butan-1-one),
pentedrone (2-(methylamino)-1phenylpentan-1-one), pentylone, 4fluoro-N-methylcathinone (4-FMC), 3fluoro-N-methylcathinone (3-FMC),
naphyrone (1-(naphthalen-2-yl)-2(pyrrolidin-1-yl)pentan-1-one), and
alpha-pyrrolidinobutiophenone (a-PBP)
from 2011 to 2014 (October 21, 2011; 76
FR 65371 and March 7, 2014; 79 FR
12938). Recently, the DEA controlled
another synthetic cathinone, Nethylpentylone (August, 31, 2018; 83 FR
44474), as a schedule I substance.
Factor 6. What, if Any, Risk There Is to
the Public Health
Available evidence on the overall
public health risks associated with the
use of synthetic cathinones suggests that
N-ethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP can
cause acute health problems leading to
emergency department (ED) admissions,
violent behaviors causing harm to self or
others, or death. Acute adverse effects of
synthetic cathinone substances are those
typical of sympathomimetic agents (e.g.,
cocaine, methamphetamine,
amphetamine) and include among other
effects tachycardia, headache,
palpitations, agitation, anxiety,
mydriasis, tremor, fever or sweating,
and hypertension. Other effects, with
possible public health risk implications,
that have been reported from the use of
synthetic cathinone substances include
psychological effects such as psychosis,
paranoia, hallucinations, and agitation.
a-PHP, 4-MEAP, MPHP, and PV8
have been associated with the overdoses
or deaths of individuals. There have
been documented reports of ED
admissions or deaths associated with
the abuse of a-PHP, 4-MEAP, MPHP,
and PV8. Individuals under the
influence of 4-MEAP and MPHP have
acted violently or unpredictably causing
harm, or even death, to themselves or
others. Adverse effects associated with
a-PHP, 4-MEAP, MPHP, and PV8 abuse
included vomiting, agitation, paranoia,
hypertension, unconsciousness,
tachycardia, seizures, cardiac arrest,
rhabdomyolysis, or death. No overdose
information is currently available for Nethylhexedrone and 4-chloro-a-PVP, but
the pharmacological similarity of these
substances to other currently controlled
schedule I synthetic cathinones (e.g.,
methcathinone, mephedrone,
methylone, pentylone, MDPV) suggests
that these substances can also pose an
imminent hazard to public safety.
It remains highly likely that
additional cases of adverse health
effects involving a-PHP, 4-MEAP,
MPHP, and PV8 in the United States
may have occurred and will continue to
VerDate Sep<11>2014
18:57 Apr 30, 2019
Jkt 247001
be under-reported as these substances,
as well as N-ethylhexedrone and 4chloro-a-PVP, are not part of standard
panels for biological specimens. The
pharmacological data for Nethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP alone
or combined with documented case
reports, if any, demonstrate that the
potential for fatal and non-fatal
overdoses exists for N-ethylhexedrone,
a-PHP, 4-MEAP, MPHP, PV8, and 4chloro-a-PVP; thus, these substances
pose an imminent hazard to the public
health and safety.
As found with other synthetic
cathinone substances, products
containing synthetic cathinones often
do not bear labeling information
regarding the ingredients or the health
risks and potential hazards associated
with these products. The limited
knowledge about product content and
its purity, as well as lack of information
about its effects, pose additional risks
for significant adverse health effects to
the users.
Based on pharmacological data or
documented case reports of overdose
fatalities, the misuse and abuse of Nethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP leads
to the same qualitative public health
risks as schedule I and II substances
such as cathinone, methcathinone,
mephedrone, methylone, pentylone,
MDPV, methamphetamine, cocaine, and
MDMA. a-PHP, MPHP, and PV8 have
been associated with fatalities. As the
data demonstrates, the potential for fatal
and non-fatal overdoses exists for Nethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP; thus,
N-ethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP pose
an imminent hazard to the public safety.
N-ethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP are
being encountered on the illicit drug
market in the United States and have no
accepted medical use in the United
States. Regardless, these products
continue to be easily available and
abused by diverse populations.
Finding of Necessity of Schedule I
Placement To Avoid Imminent Hazard
to Public Safety
In accordance with 21 U.S.C.
811(h)(3), based on the available data
and information summarized above, the
continued uncontrolled manufacture,
distribution, reverse distribution,
importation, exportation, conduct of
research and chemical analysis,
possession, and/or abuse of Nethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP,
resulting from the lack of control of
PO 00000
Frm 00013
Fmt 4702
Sfmt 4702
these substances, pose an imminent
hazard to the public safety. The DEA is
not aware of any currently accepted
medical uses for N-ethylhexedrone, aPHP, 4-MEAP, MPHP, PV8, and 4chloro-a-PVP 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 Nethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP
indicate that these synthetic cathinones
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. As required by
section 201(h)(4) of the CSA, 21 U.S.C.
811(h)(4), the Acting Administrator,
through a letter dated March 9, 2018,
notified the Acting Assistant Secretary
of the DEA’s intention to temporarily
place N-ethylhexedrone, a-PHP, 4MEAP, MPHP, PV8, and 4-chloro-a-PVP
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 the 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 to
temporarily schedule N-ethylhexedrone;
alpha-pyrrolidinohexanophenone
(trivial name: a-PHP); 4-methyl-alphaethylaminopentiophenone (trivial name:
4-MEAP); 4′-methyl-alphapyrrolidinohexiophenone (trivial name:
MPHP); alpha-pyrrolidinoheptaphenone
(trivial name: PV8); and 4-chloro-alphapyrrolidinovalerophenone (trivial name:
4-chloro-a-PVP) in schedule I of the
CSA, and finds that placement of Nethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP in
schedule I of the CSA on a temporary
basis is necessary to avoid an imminent
hazard to the public safety.
The temporary placement of Nethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP in
schedule I of the CSA will take effect
pursuant to a temporary scheduling
order, which will not be issued before
May 31, 2019. Because the Acting
Administrator hereby finds that it is
necessary to temporarily place N-
E:\FR\FM\01MYP1.SGM
01MYP1
18427
Federal Register / Vol. 84, No. 84 / Wednesday, May 1, 2019 / Proposed Rules
ethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP in
schedule I to avoid an imminent hazard
to the public safety, the temporary order
scheduling these substances will be
effective on the date that the 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, Nethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP 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).
jbell on DSK30RV082PROD with PROPOSALS
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).
VerDate Sep<11>2014
18:57 Apr 30, 2019
Jkt 247001
Inasmuch as section 201(h) of the
CSA directs that temporary scheduling
actions be issued by order (as distinct
from a rule) 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,
which are applicable to rulemaking, do
not apply to this notice of intent. The
APA expressly differentiates between an
order and a rule, as it defines an ‘‘order’’
to mean a ‘‘final disposition, whether
affirmative, negative, injunctive, or
declaratory in form, of an agency in a
matter other than rule making.’’ 5 U.S.C.
551(6) (emphasis added). The specific
language chosen by Congress indicates
an intention for the DEA to proceed
through the issuance of an order instead
of proceeding by rulemaking. Given that
Congress specifically requires the
Attorney General to follow rulemaking
procedures for other kinds of scheduling
actions, see section 201(a) of the CSA,
21 U.S.C. 811(a), it is noteworthy that,
in section 201(h), Congress authorized
the issuance of temporary scheduling
actions by order rather than by rule.
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.
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 Assistant Secretary in response to
the notice that DEA transmitted to the
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
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
PO 00000
Frm 00014
Fmt 4702
Sfmt 4702
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
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 paragraphs (h)(42)
through (47) to read as follows:
■
§ 1308.11
*
Schedule I.
*
*
(h) * * *
*
*
(42) N-Ethylhexedrone, its optical,
positional, and geometric isomers, salts and salts of isomers ..
(43)
alphaPyrrolidinohexanophenone,
its
optical, positional, and geometric
isomers, salts and salts of isomers (Other names: a-PHP) .........
(44)
4-Methyl-alphaethylaminopentiophenone,
its
optical, positional, and geometric
isomers, salts and salts of isomers (Other names: 4-MEAP) ......
(45)
4′-Methyl-alphapyrrolidinohexiophenone, its optical, positional, and geometric
isomers, salts and salts of isomers (Other names: MPHP) .........
(46)
alphaPyrrolidinoheptaphenone, its optical, positional, and geometric
isomers, salts and salts of isomers (Other names: PV8) .............
(47)
4-Chloro-alphapyrrolidinovalerophenone,
its
optical, positional, and geometric
isomers, salts and salts of isomers (Other names: 4-chloro-aPVP) ..............................................
E:\FR\FM\01MYP1.SGM
01MYP1
(7246)
(7544)
(7245)
(7446)
(7548)
(7443)
18428
Federal Register / Vol. 84, No. 84 / Wednesday, May 1, 2019 / Proposed Rules
Dated: April 22, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019–08704 Filed 4–30–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF THE INTERIOR
Office of Surface Mining Reclamation
and Enforcement
30 CFR Part 913
[SATS No. IL–109–FOR; Docket ID: OSM–
2019–0003 S1D1S SS08011000 SX064A000
190S180110; S2D2S SS08011000
SX064A000 19XS501520]
Illinois Regulatory Program
Office of Surface Mining
Reclamation and Enforcement, Interior.
ACTION: Proposed rule; public comment
period and opportunity for public
hearing on proposed amendment.
AGENCY:
We, the Office of Surface
Mining Reclamation and Enforcement
(OSMRE), are announcing receipt of a
proposed amendment to the Illinois
regulatory program (Illinois program)
under the Surface Mining Control and
Reclamation Act of 1977 (SMCRA or the
Act). Illinois proposes revisions to its
regulations, including allowing the
extraction of coal as an incidental part
of a government-financed construction
project, revising its Ownership and
Control rules, and clarifying land use
changes requiring a significant permit
revision. Illinois intends to revise its
program to be as effective as the Federal
regulations. This document gives the
times and locations where the Illinois
program documents and this proposed
amendment to that program are
available for your inspection,
establishes the comment period during
which you may submit written
comments on the amendment, and
describes the procedures that we will
follow for the public hearing, if one is
requested.
DATES: We will accept written
comments on this amendment until 4:00
p.m., CST, May 31, 2019. If requested,
we will hold a public hearing on the
amendment on May 28, 2019. We will
accept requests to speak at a hearing
until 4:00 p.m., CST on May 16, 2019.
ADDRESSES: You may submit comments,
identified by SATS No. IL–109–FOR, by
any of the following methods:
• Mail/Hand Delivery: Paul Ehret,
Acting Chief, Alton Field Division,
Office of Surface Mining Reclamation
and Enforcement, 501 Belle Street, Suite
216, Alton, Illinois 62002–6169.
jbell on DSK30RV082PROD with PROPOSALS
SUMMARY:
VerDate Sep<11>2014
18:57 Apr 30, 2019
Jkt 247001
• Fax: (618) 463–6470
• Federal eRulemaking Portal: The
amendment has been assigned Docket
ID OSM–2019–0003. If you would like
to submit comments go to https://
www.regulations.gov. Follow the
instructions for submitting comments.
Instructions: All submissions received
must include the agency name and
docket number for this rulemaking. For
detailed instructions on submitting
comments and additional information
on the rulemaking process, see the
‘‘Public Comment Procedures’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
review copies of the Illinois program,
this amendment, a listing of any
scheduled public hearings, and all
written comments received in response
to this document, you must go to the
address listed below during normal
business hours, Monday through Friday,
excluding holidays. You may receive
one free copy of the amendment by
contacting OSMRE’s Alton Field
Division, or the full text of the program
amendment is available for you to
review at www.regulations.gov. Paul J.
Ehret, Acting Chief, Alton Field
Division, Office of Surface Mining
Reclamation and Enforcement, 501 Belle
Street, Suite 216, Alton, Illinois 62002–
6169, Telephone: (618) 463–6463,
Email: pehret@osmre.gov.
In addition, you may review a copy of
the amendment during regular business
hours at the following location: Office of
Mines and Minerals, Illinois Department
of Natural Resources, One Natural
Resources Way, Springfield, IL 62702–
1271, Telephone: (618) 439–9111.
FOR FURTHER INFORMATION CONTACT: Paul
Ehret, Acting Chief, Alton Field
Division, Telephone: (618) 463–6463,
Email: pehret@osmre.gov.
SUPPLEMENTARY INFORMATION:
I. Background on the Illinois Program
II. Description of the Proposed Amendment
III. Public Comment Procedures
IV. Procedural Determinations
I. Background on the Illinois Program
Section 503(a) of the Act permits a
State to assume primacy for the
regulation of surface coal mining and
reclamation operations on non-Federal
and non-Indian lands within its borders
by demonstrating that its program
includes, among other things, State laws
and regulations that govern surface coal
mining and reclamation operations in
accordance with the Act and consistent
with the Federal regulations. See 30
U.S.C. 1253(a)(1) and (7). On the basis
of these criteria, the Secretary of the
Interior conditionally approved the
Illinois program effective June 1, 1982.
PO 00000
Frm 00015
Fmt 4702
Sfmt 4702
You can find background information
on the Illinois program, including the
Secretary’s findings, the disposition of
comments, and the conditions of
approval of the Illinois program in the
June 1, 1982, Federal Register (47 FR
23858). You can also find later actions
concerning the Illinois program and
program amendments at 30 CFR 913.10,
913.15, and 913.17.
II. Description of the Proposed
Amendment
By letter dated December 5, 2018
(Administrative Record No. IL–5100),
Illinois sent us an amendment to its
program under SMCRA (30 U.S.C. 1201
et seq.) at its own initiative. By email
dated December 11, 2018, Illinois
requested that OSMRE’s review be put
on hold until they could resubmit the
proposed amendment due to editorial
changes requested by the Illinois Joint
Committee on Administrative Rules.
Illinois resubmitted the proposed
amendment to OSMRE on February 20,
2019. OSMRE will use this date for its
review. Below is a summary of the
changes proposed by Illinois. The full
text of the program amendment is
available for you to read at the locations
listed above under ADDRESSES.
Illinois proposes to revise the Illinois
Surface Coal Mining Land Conservation
and Reclamation Act (225 ILCS 720),
Section 1.06, ‘‘Scope of the Act,’’ by
adding language allowing coal
extraction as an incidental part of a
government-financed project. The
language added is nearly identical to
that found in Section 528 of SMCRA (30
U.S.C. 1278).
Illinois also proposes to revise the
following Parts of Title 62 of the Illinois
Administrative Code:
Section 1701
Appendix A. Definitions
Illinois proposes to revise its
regulation at section 1701 Appendix A,
amending a number of its definitions,
including those for ‘‘ownership,’’
‘‘control,’’ and ‘‘violations,’’ to conform
with the Federal definitions at 30 CFR
701.5 and 707.5.
Section 1703 Exemption for Coal
Extraction Incident to GovernmentFinanced Highway or Other
Construction
Illinois proposes adding a new section
1703 to allow the extraction of coal as
an incidental part of a governmentfinanced construction project, which
incorporates language identical to the
Federal regulations at 30 CFR part 707.
E:\FR\FM\01MYP1.SGM
01MYP1
]]>Agencies
[Federal Register Volume 84, Number 84 (Wednesday, May 1, 2019)]
[Proposed Rules]
[Pages 18423-18428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08704]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-495]
Schedules of Controlled Substances: Temporary Placement of N-
Ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-Chloro-[alpha]-
PVP 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 issuing this notice of intent to publish a temporary
order to schedule the synthetic cathinones, N-ethylhexedrone; alpha-
pyrrolidinohexanophenone (trivial name: [alpha]-PHP); 4-methyl-alpha-
ethylaminopentiophenone (trivial name: 4-MEAP); 4'-methyl-alpha-
pyrrolidinohexiophenone (trivial name: MPHP); alpha-
pyrrolidinoheptaphenone (trivial name: PV8); and 4-chloro-alpha-
pyrrolidinovalerophenone (trivial name: 4-chloro-[alpha]-PVP), in
schedule I. 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, conduct of
instructional activities, and chemical analysis of these synthetic
cathinones, as well as administrative, civil, and criminal remedies
with respect to persons who fail to comply with such requirements or
otherwise violate the CSA with respect to these substances.
DATES: May 1, 2019.
FOR FURTHER INFORMATION CONTACT: Lynnette M. Wingert, Regulatory
Drafting and Policy Support Section (DPW), Diversion Control Division,
Drug Enforcement Administration; Mailing Address: 8701 Morrissette
Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.
SUPPLEMENTARY INFORMATION: This notice of intent contained in this
document 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 scheduling order (in the form of a temporary
amendment) placing N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8,
and 4-chloro-[alpha]-PVP in schedule I of the Controlled Substances Act
(CSA).\1\ The temporary scheduling order will be published in the
Federal Register on or after May 31, 2019.
---------------------------------------------------------------------------
\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 Controlled Substances Act (CSA), 21 U.S.C. 811,
provides the Attorney General with the authority to temporarily place a
substance in schedule I of the CSA for two years without regard to the
requirements of 21 U.S.C. 811(b), if he finds that such action is
necessary to avoid an imminent hazard to the public safety. 21 U.S.C.
811(h)(1). In addition, if proceedings to control a substance
permanently are initiated under 21 U.S.C. 811(a)(1) while the substance
is temporarily controlled under section 811(h), the Attorney General
may extend the temporary scheduling for up to one year. 21 U.S.C.
811(h)(2).
Where the necessary findings are made, a substance may be
temporarily scheduled if it is not listed in any other schedule under
section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or
approval in effect for the substance under section 505 of the Federal
Food, Drug, and Cosmetic Act (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-ethylhexedrone, [alpha]-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-[alpha]-PVP in schedule I on a temporary basis
to the Assistant Secretary for Health of HHS by letter dated March 9,
2018. The Acting Assistant Secretary responded to this notice of intent
by letter dated March 27, 2018, and advised that based on a review by
the Food and Drug Administration (FDA), there were currently no
approved new drug applications or active investigational new drug
applications for N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and
4-chloro-[alpha]-PVP. The Acting Assistant Secretary also stated that
the HHS had no objection to the temporary placement of N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP in schedule I of the CSA. N-Ethylhexedrone, [alpha]-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-[alpha]-PVP are not currently listed in any
schedule under the CSA, and no exemptions or approvals are in effect
for N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-
[alpha]-PVP 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.
---------------------------------------------------------------------------
In order to find that placing a substance temporarily in schedule I
of the CSA is necessary to avoid an imminent hazard to the public
safety, the Administrator is required to consider three of the eight
factors set forth in 21 U.S.C. 811(c): The substance's history and
current pattern of abuse; the scope, duration and significance of
abuse; and what, if any, risk there is to the public health. 21 U.S.C.
811(h)(3). 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,
[[Page 18424]]
and a lack of accepted safety for use under medical supervision. 21
U.S.C. 812(b)(1).
Synthetic Cathinones
Recently, novel synthetic cathinones that mimic the biological
effects of substances with stimulant-like effects have emerged on the
illicit drug market. These novel cathinones, also known as designer
drugs, are structurally similar to several drugs of abuse such as
schedule I synthetic cathinones (e.g., methcathinone, mephedrone,
methylone, pentylone, and 3,4-methylenedioxypyrovalerone (MDPV)). The
illicit use of synthetic cathinones has continued throughout the United
States, resulting in severe adverse effects, overdoses, and deaths.
Indeed, hospital reports, scientific publications and/or law
enforcement reports demonstrate that these types of substances are
being abused for their psychoactive properties and they cause harm (see
DEA 3-Factor Analysis). Recreational effects reported by abusers of
synthetic cathinones include euphoria, sense of well-being, increased
sociability, energy, empathy, increased alertness, improved
concentration, and focus. Adverse effects such as tachycardia,
hypertension, rhabdomyolysis, hyponatremia, seizures, and altered
mental status (paranoia, hallucinations, and delusions) have also been
reported from the abuse of synthetic cathinones. Consequently, there
are documented reports of emergency room admissions and deaths
associated with the abuse of synthetic cathinone substances. With many
generations of synthetic cathinones having been encountered since 2009,
the abuse of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-
chloro-[alpha]-PVP is impacting or will negatively impact communities.
Law enforcement data indicate that N-ethylhexedrone, [alpha]-PHP,
4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP have appeared in the United
States' illicit drug market (see DEA 3-Factor Analysis). 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. From January 2012 to September 24, 2018, NFLIS
registered 1,131 drug exhibits pertaining to the trafficking,
distribution and abuse of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP,
PV8, and 4-chloro-[alpha]-PVP. These exhibits had a net weight of
approximately 18.7 kilograms and were encountered in powder, crystal,
rock, resin, capsule, and tablet forms.
As observed by the DEA and by the United States Customs and Border
Protection (CBP), synthetic cathinones originate from foreign sources,
such as China. Bulk powder substances are smuggled via common carrier
into the United States and find their way to clandestine designer drug
product manufacturing operations located in residential neighborhoods,
garages, warehouses, and other similar destinations throughout the
country. Encounters of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP,
PV8, and 4-chloro-[alpha]-PVP have occurred by the CBP (see DEA 3-
Factor Analysis).
N-Ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-
[alpha]-PVP have no accepted medical use in the United States. N-
Ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP have been seized by law enforcement in the United States. The
misuse of [alpha]-PHP, 4-MEAP, MPHP, and PV8 has been reported to
result in adverse effects in humans in the United States. Although no
overdose information is currently available for N-ethylhexedrone and 4-
chloro-[alpha]-PVP, law enforcement seizures of these two substances
and their pharmacological similarity to currently controlled schedule I
synthetic cathinones (e.g., methcathinone, mephedrone, methylone,
pentylone, MDPV) suggest that these two synthetic cathinones are likely
to produce adverse effects similar to those produced by other synthetic
cathinones.
N-Ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-
[alpha]-PVP are synthetic cathinones that have pharmacological effects
similar to schedule I synthetic cathinone substances such as
methcathinone, mephedrone, methylone, pentylone, and MDPV and schedule
II stimulants such as methamphetamine and cocaine. The misuse of
[alpha]-PHP, 4-MEAP, MPHP, and PV8 has been associated with one or more
overdoses with some requiring emergency medical intervention in the
United States. With no approved medical use and limited safety or
toxicological information, N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP,
PV8, and 4-chloro-[alpha]-PVP have emerged on the designer drug market,
and the abuse or trafficking of these substances for their psychoactive
properties is concerning.
Factor 4. History and Current Pattern of Abuse
N-Ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-
[alpha]-PVP are synthetic cathinones that have been identified in the
United States' illicit drug market. Evidence indicates that these
substances are being substituted for schedule I synthetic cathinones.
Products containing synthetic cathinones have been falsely marketed as
``research chemicals,'' ``jewelry cleaner,'' ``stain remover,'' ``plant
food or fertilizer,'' ``insect repellants,'' or ``bath salts.'' They
have been sold at smoke shops, head shops, convenience stores, adult
bookstores, and gas stations. They can also be purchased on the
internet. These substances are commonly encountered in the form of
powders, crystals, tablets, and capsules. Other encountered forms
include resin, rock, liquid, and deposits on plant matter. Law
enforcement has encountered N-ethylhexedrone, [alpha]-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-[alpha]-PVP in powder, crystal, resin, rock,
capsule, or tablet forms. The packages of these commercial products
usually contain the warning ``not for human consumption,'' most likely
in an effort to circumvent statutory restrictions for these substances.
N-Ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-
[alpha]-PVP are likely to be abused in the same manner as schedule I
synthetic cathinones such as methcathinone, mephedrone, methylone,
pentylone, and MDPV. Information from published scientific studies
indicate that the most common routes of administration for synthetic
cathinones are nasal insufflation by snorting the powder and ingestion
by swallowing capsules or tablets. The powder can also be injected or
swallowed. Other methods of intake include rectal administration,
ingestion by ``bombing'' (wrapping a dose of powder in a paper wrap and
swallowing) and intramuscular injection.
Based upon the information collected from case reports, medical
journals, and scientific publications including survey data, the main
users of synthetic cathinones are youths and young adults. Given that
N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP are newly emerging synthetic cathinones, it is likely that these
substances will be used by the same population. This is consistent with
data collected from the use of schedule I synthetic cathinones (e.g.,
mephedrone, methylone, pentylone, MDPV). According to Monitoring the
Future (MTF) survey data,\3\ the 2017 annual
[[Page 18425]]
prevalence rate of synthetic cathinone use was 0.6% for high school
seniors and 0.3% for young adults (19-30 years). However, there was an
18 percentage point increase in the perceived risk of trying ``bath
salts'' in young adults (aged 19-26 years).
---------------------------------------------------------------------------
\3\ Monitoring the Future (MTF) is a research program conducted
at the University of Michigan's Institute for Social Research under
grants from NIDA. MTF tracks drug use trends among United States
adolescents in the 8th, 10th, and 12th grades and high school
graduates into adulthood by conducting national surveys.
---------------------------------------------------------------------------
N-Ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-
[alpha]-PVP are likely to have duration of effects similar to those of
schedule I synthetic cathinones because of their structural and
pharmacological similarities. Users report (drug surveys, scientific
and medical literature, etc.) that the effects of synthetic cathinones
occur a few minutes to 15 minutes after administration, depending on
the synthetic cathinone and the route of administration (oral,
insufflation, intravenous, etc.), and can last up to three hours.
Evidence indicated that N-ethylhexedrone, [alpha]-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-[alpha]-PVP are ingested with other substances.
This is likely to either heighten the effects or ameliorate the come-
down effects of the synthetic cathinones. Co-ingestions can be from the
ingestion of multiple products separately or a single product that is
composed of multiple substances (e.g., one tablet containing N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, 4-chloro-[alpha]-PVP
and other illicit substances). Indeed, law enforcement routinely
encounters synthetic cathinone mixtures. Substances found in
combination with N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, or
4-chloro-[alpha]-PVP are: Other synthetic cathinones (e.g., MDPV, 4-
chloromethcathinone, N-ethylpentylone, [alpha]-PVP), common cutting
agents (e.g., caffeine), or other recreational substances (e.g.,
methamphetamine, fentanyl, fentanyl analogues, carfentanil,
benzodiazepines (e.g., alprazolam), heroin, cocaine, synthetic
cannabinoids, fluoroamphetamine, MDMA). Multiple drug use and potential
co-ingestions are confirmed by forensic analysis of seized and
purchased synthetic cathinone products.
Factor 5. Scope, Duration and Significance of Abuse
Since 2009, the popularity of synthetic cathinones and their
associated products has continued, as evidenced by law enforcement
seizures, public health information, and media reports. As one
synthetic cathinone is controlled, another unscheduled synthetic
cathinone appears in the recreational drug market. N-Ethylhexedrone,
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP are synthetic
cathinones that have been identified in the United States' illicit drug
market (see DEA 3-Factor Analysis for a full discussion).
Law enforcement data indicate that N-ethylhexedrone, [alpha]-PHP,
4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP are being abused in the
United States as recreational drugs. While law enforcement data are not
direct evidence of abuse, the data can infer that a drug has been
diverted and abused.\4\ Forensic laboratories have confirmed the
presence of these substances in drug exhibits received from state,
local, and federal law enforcement agencies. From January 2012 to
September 24, 2018, there were 1,131 exhibits reported to NFLIS
databases (federal, state, and local forensic laboratories) pertaining
to the trafficking, distribution and abuse of N-ethylhexedrone,
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP. These
exhibits had a net weight of approximately 18.7 kilograms. These data
also indicated that the abuse of N-ethylhexedrone, [alpha]-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-[alpha]-PVP is widespread and has been
encountered in many states since 2012 in the United States.
---------------------------------------------------------------------------
\4\ See 76 FR 77330, 77332, Dec. 12, 2011.
---------------------------------------------------------------------------
The following information details data obtained from the NFLIS
database (queried on September 24, 2018), including dates of first
encounter, exhibits/reports, and locations.
N-ethylhexedrone: NFLIS--233 reports, first encountered in August
2016, locations include: Arizona, Florida, Georgia, Illinois, Indiana,
Kansas, Kentucky, Louisiana, Michigan, Minnesota, Mississippi,
Missouri, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South
Carolina, Tennessee, Texas, Virginia, and Wyoming.
[alpha]-PHP: NFLIS--395 reports, first encountered in May 2014,
locations include: Arkansas, California, Colorado, Florida, Georgia,
Idaho, Illinois, Indiana, Iowa, Kentucky, Maine, Massachusetts,
Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York,
Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee,
Texas, Utah, Virginia, Wisconsin, and Wyoming.
4-MEAP: NFLIS--105 reports, first encountered in August 2013,
locations include: Alabama, Arkansas, California, Colorado,
Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana,
Maryland, Minnesota, New Hampshire, New York, Ohio, Oklahoma, Oregon,
Pennsylvania, Tennessee, and Texas.
MPHP: NFLIS--71 reports, first encountered in June 2012, locations
include: California, Connecticut, Florida, Georgia, Indiana, Kansas,
Kentucky, Maine, Minnesota, Missouri, Nebraska, Nevada, New Jersey,
Ohio, Pennsylvania, and Texas.
PV8: NFLIS--166 reports, first encountered in December 2013,
locations include: Arizona, Connecticut, District of Columbia, Florida,
Georgia, Idaho, Indiana, Iowa, Kentucky, Louisiana, Maine,
Massachusetts, Minnesota, Missouri, Nebraska, Nevada, New Hampshire,
New Jersey, New York, North Dakota, Ohio, Oklahoma, Oregon,
Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, and
Wisconsin.
4-Chloro-[alpha]-PVP: NFLIS--160 reports, first encountered in
December 2015, locations include: California, District of Columbia,
Louisiana, Maryland, Arizona, Connecticut, Florida, Georgia, Idaho,
Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Massachusetts,
Minnesota, Missouri, New Jersey, New York, Ohio, Oklahoma, Oregon,
Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah,
Virginia, and Washington.
Additionally, encounters/seizures of these substances have occurred
by the CBP at United States ports of entry. As observed by the DEA and
CBP, synthetic cathinones originate from foreign sources, such as
China. Bulk powder substances are smuggled via common carrier into the
United States and find their way to clandestine designer drug product
manufacturing operations located in residential neighborhoods, garages,
warehouses, and other similar destinations throughout the country. From
2014 to 2017, CBP encountered 73 shipments of products containing N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, or 4-chloro-[alpha]-
PVP. Additional evidence indicates that some of these synthetic
cathinones have been seized abroad. N-Ethylhexedrone and 4-chloro-
[alpha]-PVP have been identified in seized materials in China and
Poland, respectively. These data demonstrate that these substances are
being trafficked and abused in the United States and abroad.
Concerns over the abuse of synthetic cathinone substances have led
to the control of many synthetic cathinones. The DEA controlled 13
synthetic cathinones: methylone, mephedrone, MDPV, 4-methyl-N-
ethylcathinone (4-MEC), 4-methyl-alpha-pyrrolidinopropiophenone (4-
MePPP), alpha-pyrrolidinopentiophenone ([alpha]-PVP), butylone (1-(1,3-
benzodioxol-5-
[[Page 18426]]
yl)-2-(methylamino)butan-1-one), pentedrone (2-(methylamino)-1-
phenylpentan-1-one), pentylone, 4-fluoro-N-methylcathinone (4-FMC), 3-
fluoro-N-methylcathinone (3-FMC), naphyrone (1-(naphthalen-2-yl)-2-
(pyrrolidin-1-yl)pentan-1-one), and alpha-pyrrolidinobutiophenone
([alpha]-PBP) from 2011 to 2014 (October 21, 2011; 76 FR 65371 and
March 7, 2014; 79 FR 12938). Recently, the DEA controlled another
synthetic cathinone, N-ethylpentylone (August, 31, 2018; 83 FR 44474),
as a schedule I substance.
Factor 6. What, if Any, Risk There Is to the Public Health
Available evidence on the overall public health risks associated
with the use of synthetic cathinones suggests that N-ethylhexedrone,
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP can cause
acute health problems leading to emergency department (ED) admissions,
violent behaviors causing harm to self or others, or death. Acute
adverse effects of synthetic cathinone substances are those typical of
sympathomimetic agents (e.g., cocaine, methamphetamine, amphetamine)
and include among other effects tachycardia, headache, palpitations,
agitation, anxiety, mydriasis, tremor, fever or sweating, and
hypertension. Other effects, with possible public health risk
implications, that have been reported from the use of synthetic
cathinone substances include psychological effects such as psychosis,
paranoia, hallucinations, and agitation.
[alpha]-PHP, 4-MEAP, MPHP, and PV8 have been associated with the
overdoses or deaths of individuals. There have been documented reports
of ED admissions or deaths associated with the abuse of [alpha]-PHP, 4-
MEAP, MPHP, and PV8. Individuals under the influence of 4-MEAP and MPHP
have acted violently or unpredictably causing harm, or even death, to
themselves or others. Adverse effects associated with [alpha]-PHP, 4-
MEAP, MPHP, and PV8 abuse included vomiting, agitation, paranoia,
hypertension, unconsciousness, tachycardia, seizures, cardiac arrest,
rhabdomyolysis, or death. No overdose information is currently
available for N-ethylhexedrone and 4-chloro-[alpha]-PVP, but the
pharmacological similarity of these substances to other currently
controlled schedule I synthetic cathinones (e.g., methcathinone,
mephedrone, methylone, pentylone, MDPV) suggests that these substances
can also pose an imminent hazard to public safety.
It remains highly likely that additional cases of adverse health
effects involving [alpha]-PHP, 4-MEAP, MPHP, and PV8 in the United
States may have occurred and will continue to be under-reported as
these substances, as well as N-ethylhexedrone and 4-chloro-[alpha]-PVP,
are not part of standard panels for biological specimens. The
pharmacological data for N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP,
PV8, and 4-chloro-[alpha]-PVP alone or combined with documented case
reports, if any, demonstrate that the potential for fatal and non-fatal
overdoses exists for N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8,
and 4-chloro-[alpha]-PVP; thus, these substances pose an imminent
hazard to the public health and safety.
As found with other synthetic cathinone substances, products
containing synthetic cathinones often do not bear labeling information
regarding the ingredients or the health risks and potential hazards
associated with these products. The limited knowledge about product
content and its purity, as well as lack of information about its
effects, pose additional risks for significant adverse health effects
to the users.
Based on pharmacological data or documented case reports of
overdose fatalities, the misuse and abuse of N-ethylhexedrone, [alpha]-
PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP leads to the same
qualitative public health risks as schedule I and II substances such as
cathinone, methcathinone, mephedrone, methylone, pentylone, MDPV,
methamphetamine, cocaine, and MDMA. [alpha]-PHP, MPHP, and PV8 have
been associated with fatalities. As the data demonstrates, the
potential for fatal and non-fatal overdoses exists for N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP; thus, N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-
chloro-[alpha]-PVP pose an imminent hazard to the public safety.
N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-
[alpha]-PVP are being encountered on the illicit drug market in the
United States and have no accepted medical use in the United States.
Regardless, these products continue to be easily available and abused
by diverse populations.
Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard
to Public Safety
In accordance with 21 U.S.C. 811(h)(3), based on the available data
and information summarized above, the continued uncontrolled
manufacture, distribution, reverse distribution, importation,
exportation, conduct of research and chemical analysis, possession,
and/or abuse of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and
4-chloro-[alpha]-PVP, resulting from the lack of control of these
substances, pose an imminent hazard to the public safety. The DEA is
not aware of any currently accepted medical uses for N-ethylhexedrone,
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP 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-ethylhexedrone,
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP indicate that
these synthetic cathinones 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. As required
by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Acting
Administrator, through a letter dated March 9, 2018, notified the
Acting Assistant Secretary of the DEA's intention to temporarily place
N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP 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 the 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 to temporarily schedule N-
ethylhexedrone; alpha-pyrrolidinohexanophenone (trivial name: [alpha]-
PHP); 4-methyl-alpha-ethylaminopentiophenone (trivial name: 4-MEAP);
4'-methyl-alpha-pyrrolidinohexiophenone (trivial name: MPHP); alpha-
pyrrolidinoheptaphenone (trivial name: PV8); and 4-chloro-alpha-
pyrrolidinovalerophenone (trivial name: 4-chloro-[alpha]-PVP) in
schedule I of the CSA, and finds that placement of N-ethylhexedrone,
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP in schedule I
of the CSA on a temporary basis is necessary to avoid an imminent
hazard to the public safety.
The temporary placement of N-ethylhexedrone, [alpha]-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-[alpha]-PVP in schedule I of the CSA will take
effect pursuant to a temporary scheduling order, which will not be
issued before May 31, 2019. Because the Acting Administrator hereby
finds that it is necessary to temporarily place N-
[[Page 18427]]
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP in schedule I to avoid an imminent hazard to the public safety, the
temporary order scheduling these substances will be effective on the
date that the 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-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP 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 (as distinct from a rule) 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, which are
applicable to rulemaking, do not apply to this notice of intent. The
APA expressly differentiates between an order and a rule, as it defines
an ``order'' to mean a ``final disposition, whether affirmative,
negative, injunctive, or declaratory in form, of an agency in a matter
other than rule making.'' 5 U.S.C. 551(6) (emphasis added). The
specific language chosen by Congress indicates an intention for the DEA
to proceed through the issuance of an order instead of proceeding by
rulemaking. Given that Congress specifically requires the Attorney
General to follow rulemaking procedures for other kinds of scheduling
actions, see section 201(a) of the CSA, 21 U.S.C. 811(a), it is
noteworthy that, in section 201(h), Congress authorized the issuance of
temporary scheduling actions by order rather than by rule.
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.
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 Assistant Secretary in response
to the notice that DEA transmitted to the 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 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 paragraphs (h)(42) through (47) to read as
follows:
Sec. 1308.11 Schedule I.
* * * * *
(h) * * *
(42) N-Ethylhexedrone, its optical, positional, and geometric (7246)
isomers, salts and salts of isomers...........................
(43) alpha-Pyrrolidinohexanophenone, its optical, positional, (7544)
and geometric isomers, salts and salts of isomers (Other
names: [alpha]-PHP)...........................................
(44) 4-Methyl-alpha-ethylaminopentiophenone, its optical, (7245)
positional, and geometric isomers, salts and salts of isomers
(Other names: 4-MEAP).........................................
(45) 4'-Methyl-alpha-pyrrolidinohexiophenone, its optical, (7446)
positional, and geometric isomers, salts and salts of isomers
(Other names: MPHP)...........................................
(46) alpha-Pyrrolidinoheptaphenone, its optical, positional, (7548)
and geometric isomers, salts and salts of isomers (Other
names: PV8)...................................................
(47) 4-Chloro-alpha-pyrrolidinovalerophenone, its optical, (7443)
positional, and geometric isomers, salts and salts of isomers
(Other names: 4-chloro-[alpha]-PVP)...........................
[[Page 18428]]
Dated: April 22, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-08704 Filed 4-30-19; 8:45 am]
BILLING CODE 4410-09-P
