[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]


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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.

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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.
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    \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.
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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.
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    \2\ As discussed in a memorandum of understanding entered into 
by the Food and Drug Administration (FDA) and the National Institute 
on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS 
in carrying out the Secretary's scheduling responsibilities under 
the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The 
Secretary of the HHS has delegated to the Assistant Secretary for 
Health of the HHS the authority to make domestic drug scheduling 
recommendations. 58 FR 35460, July 1, 1993.
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    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).
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    \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.
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    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.
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    \4\ See 76 FR 77330, 77332, Dec. 12, 2011.
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    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