[Federal Register Volume 86, Number 134 (Friday, July 16, 2021)]
[Proposed Rules]
[Pages 37719-37725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15114]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-495]


Schedules of Controlled Substances: Placement of N-
Ethylhexedrone, alpha-Pyrrolidinohexanophenone, 4-Methyl-alpha-
ethylaminopentiophenone, 4'-Methyl-alpha-pyrrolidinohexiophenone, 
alpha-Pyrrolidinoheptaphenone, and 4'-Chloro-alpha-
pyrrolidinovalerophenone in Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Drug Enforcement Administration proposes placing six 
synthetic cathinones, as identified in this proposed rule, in schedule 
I of the Controlled Substances Act. If finalized, this action would 
make permanent the existing regulatory controls and administrative, 
civil, and criminal sanctions applicable to schedule I controlled 
substances on persons who handle (manufacture, distribute, reverse 
distribute, import, export, engage in research, conduct instructional 
activities or chemical analysis, or possess), or propose to handle 
these six specified controlled substances.

DATES: Comments must be submitted electronically or postmarked on or 
before August 16, 2021.
    Requests for hearing and waivers of an opportunity for a hearing or 
to participate in a hearing must be received on or before August 16, 
2021.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-495'' on all electronic and written correspondence, 
including any attachments.
     Electronic comments: The Drug Enforcement Administration 
(DEA) encourages that all comments be submitted electronically through 
the Federal eRulemaking Portal which provides the ability to type short 
comments directly into the comment field on the web page or attach a 
file for lengthier comments. Please go to http://www.regulations.gov 
and follow the online instructions at that site for submitting 
comments. Upon completion of your submission you will receive a Comment 
Tracking Number for your comment. Please be aware that submitted 
comments are not instantaneously available for public view on 
Regulations.gov. If you have received a Comment Tracking Number, your 
comment has been successfully submitted and there is no need to 
resubmit the same comment.
     Paper comments: Paper comments that duplicate the 
electronic submission are not necessary. Should you wish to mail a 
paper comment, in lieu of an electronic comment, it should be sent via 
regular or express mail to: Drug Enforcement Administration, Attn: DEA 
Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.
     Hearing requests: All requests for a hearing and waivers 
of participation, together with a written statement of position on the 
matters of fact and law asserted in the hearing, must be sent to: Drug 
Enforcement Administration, Attn: Administrator, 8701 Morrissette 
Drive, Springfield, Virginia 22152. All requests for hearing and 
waivers of participation should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Ph.D., Drug and 
Chemical Evaluation Section, Drug Enforcement Administration; 
Telephone: (571) 362-3249.

SUPPLEMENTARY INFORMATION: 
    In this proposed rule, the Drug Enforcement Administration (DEA) 
proposes to permanently schedule the following six controlled 
substances in schedule I of the Controlled Substances Act (CSA), 
including their salts, isomers, and salts of isomers whenever the 
existence of such salts, isomers, and salts of isomers is possible 
within the specific chemical designation:
     N-ethylhexedrone (other names: [alpha]-
ethylaminohexanophenone, ethyl hexedrone, HEXEN, 2-(ethylamino)-1-
phenylhexan-1-one),
     alpha-pyrrolidinohexanophenone (other names: [alpha]-
pyrrolidino-hexanophenone, alpha-PHP, [alpha]-PHP, PV7, 1-phenyl-2-
(pyrrolidin-1-yl)hexan-1-one),
     4-methyl-alpha-ethylaminopentiophenone (other names: N-
ethyl-4-methylnorpentedrone, 4-methyl-[alpha]-ethylaminopentiophenone, 
4-MEAP, 2-(ethylamino)-1-(4-methylphenyl)pentan-1-one),
     4'-methyl-alpha-pyrrolidinohexiophenone (other names: 4'-
methyl-[alpha]-PHP, 4'-methyl PHP, PV4, 4-MPHP, MPHP, 4-methyl-alpha-
pyrrolidino hexanophenone, 1-(4-methylphenyl)-2-(pyrrolidin-1-yl)hexan-
1-one),
     alpha-pyrrolidinoheptaphenone (other names: alpha-
pyrrolidinoheptiophenone, alpha-PHpP, PV8, 1-phenyl-2-(pyrrolidin-1-
yl)heptan-1-one), and
     4'-chloro-alpha-pyrrolidinovalerophenone (other names: 4-
chloro-[alpha]-pyrrolidinopentiophenone, 4-chloro-[alpha]-PVP, 4-Cl-
[alpha]-PVP, 4-chloro-2-(1-pyrrolidinyl)-valerophenone, 1-(4-
chlorophenyl)-2-(pyrrolidin-1-yl)pentan-1-one).

Posting of Public Comments

    Please note that all comments received in response to this docket 
are considered part of the public record. They will, unless reasonable 
cause is given, be made available by DEA for public inspection online 
at http://www.regulations.gov. Such information includes personal 
identifying information (such as your name, address, etc.) voluntarily 
submitted by the commenter. The Freedom of Information Act applies to 
all comments received. If you want to submit personal identifying 
information (such as your name, address, etc.) as part of your comment, 
but do not want it to be made publicly available, you must include the 
phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of 
your comment. You must also place all of the personal identifying 
information you do not want made publicly available in the first 
paragraph of your comment and identify what information you want 
redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify the 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information or 
confidential business information identified as directed above will be 
made publicly available in redacted form. If a comment has so much 
confidential business information that it cannot be effectively 
redacted, all or part of that comment may not be made publicly 
available. Comments posted to http://www.regulations.gov may include 
any

[[Page 37720]]

personal identifying information (such as name, address, and phone 
number) included in the text of your electronic submission that is not 
identified as directed above as confidential.
    An electronic copy of this document and supplemental information to 
this proposed rule are available at http://www.regulations.gov for easy 
reference.

Request for Hearing or Waiver of Particpation in Hearing

    Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking 
``on the record after opportunity for a hearing.'' Such proceedings are 
conducted pursuant to the provisions of the Administrative Procedure 
Act, 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316, 
subpart D. Interested persons may file requests for hearing or notices 
of intent to participate in a hearing in conformity with the 
requirements of 21 CFR 1308.44(a) or (b), and include a statement of 
interest in the proceeding and the objections or issues, if any, 
concerning which the person desires to be heard. Any interested person 
may file a waiver of an opportunity for a hearing or to participate in 
a hearing together with a written statement regarding the interested 
person's position on the matters of fact and law involved in any 
hearing as set forth in 21 CFR 1308.44(c).
    All requests for a hearing and waivers of participation, together 
with a written statement of position on the matters of fact and law 
involved in such hearing, must be sent to DEA using the address 
information provided above.

Legal Authority

    The CSA provides that proceedings for the issuance, amendment, or 
repeal of the scheduling of any drug or other substance may be 
initiated by the Attorney General on his own motion. 21 U.S.C. 811(a). 
This proposed action is supported by a recommendation from the 
Assistant Secretary for Health of the Department of Health and Human 
Services (HHS) and an evaluation of all other relevant data by DEA. If 
finalized, this action would make permanent the existing temporary 
regulatory controls and administrative, civil, and criminal sanctions 
for schedule I controlled substances on any person who handles 
(manufactures, distributes, imports, exports, engages in research, 
conducts instructional activities or chemical analysis, or possesses) 
or proposes to handle N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, 
or 4-chloro-[alpha]-PVP.

Background

    On July 18, 2019, pursuant to 21 U.S.C. 811(h)(1), DEA published an 
order in the Federal Register (84 FR 34291) temporarily placing N-
ethylhexedrone, alpha-pyrrolidinohexanophenone ([alpha]-PHP), 4-methyl-
alpha-ethylaminopentiophenone (4-MEAP), 4'-methyl-alpha-
pyrrolidinohexiophenone (MPHP), alpha-pyrrolidinoheptaphenone (PV8), 
and 4'-chloro-alpha-pyrrolidinovalerophenone (4-chloro-[alpha]-PVP) in 
schedule I of the CSA upon finding that these synthetic cathinones pose 
an imminent hazard to the public safety. That temporary order was 
effective on the date of publication. Pursuant to 21 U.S.C. 811(h)(2), 
the temporary control of these substances is set to expire on July 18, 
2021. However, this same subsection also provides that, during the 
pendency of proceedings under 21 U.S.C. 811(a)(1) with respect to a 
substance, the temporary scheduling of that substance may be extended 
for up to one year. Proceedings for the scheduling of a substance under 
21 U.S.C. 811(a) may be initiated by the Attorney General (delegated to 
the Administrator of DEA (Administrator) pursuant to 28 CFR 0.100) on 
his own motion, at the request of the Secretary of HHS,\1\ or on the 
petition of any interested party. An extension of the existing 
temporary order is being ordered by the Administrator in a separate 
action, and is being simultaneously published elsewhere in this issue 
of the Federal Register.
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    \1\ Because the Secretary of HHS has delegated to the Assistant 
Secretary for Health (Assistant Secretary) the authority to make 
domestic drug scheduling recommendations, for purposes of this 
proposed rulemaking, all subsequent references to ``Secretary'' have 
been replaced with ``Assistant Secretary.''
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    The Administrator, on her own motion, is initiating proceedings 
under 21 U.S.C. 811(a)(1) to permanently schedule N-ethylhexedrone, 
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP. DEA has 
gathered and reviewed the available information regarding the 
pharmacology, chemistry, trafficking, actual abuse, pattern of abuse, 
and the relative potential for abuse for these synthetic cathinones. On 
October 22, 2020, the Acting Administrator of DEA submitted a request 
to the Assistant Secretary for Health of HHS (Assistant Secretary) to 
provide DEA with a scientific and medical evaluation of available 
information and a scheduling recommendation for N-ethylhexedrone, 
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP, in accordance 
with 21 U.S.C. 811(b) and (c). Upon evaluating the scientific and 
medical evidence, on July 8, 2021, the Assistant Secretary submitted to 
the Acting Administrator HHS's scientific and medical evaluation and 
scheduling recommendation for these substances. Upon receipt of the 
scientific and medical evaluation and scheduling recommendation from 
HHS, DEA reviewed the document and all other relevant data, and 
conducted its own eight-factor analysis of the abuse potential of N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP in accordance with 21 U.S.C. 811(c).

Proposed Determination of Schedule N-Ethylhexedrone, [alpha]-PHP, 4-
MEAP, MPHP, PV8, and 4-Chloro-[alpha]-PVP

    As discussed in the background section, the Administrator is 
initiating proceedings, pursuant to 21 U.S.C. 811(a)(1), to add N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP permanently to schedule I. DEA has reviewed the scientific and 
medical evaluation and scheduling recommendation, received from HHS, 
and all other relevant data and conducted its own eight-factor analysis 
of the abuse potential of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, 
PV8, and 4-chloro-[alpha]-PVP pursuant to 21 U.S.C. 811(c). Included 
below is a brief summary of each factor as analyzed by HHS and DEA, and 
as considered by DEA in its proposed scheduling action. Please note 
that both the DEA and the HHS 8-Factor analyses and the Assistant 
Secretary's July 8, 2021 letter are available in their entirety under 
the tab ``Supporting Documents'' of the public docket of this 
rulemaking action at http://www.regulations.gov, under Docket Number 
``DEA-495.''
    1. The Drug's Actual or Relative Potential for Abuse: Both the DEA 
and the HHS 8-factor analyses found that N-ethylhexedrone, [alpha]-PHP, 
4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP have abuse potential 
associated with its abilities to produce psychoactive effects that are 
similar to those produced by schedule I synthetic cathinones such as 
methcathinone, mephedrone, methylone, pentylone, and 3,4-
methylenedioxypyrovalerone (MDPV) and schedule II stimulants such as 
methamphetamine and cocaine that have a high potential for abuse. In 
particular, the responses in humans to N-ethylhexedrone, [alpha]-PHP, 
4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP are stimulant-like and 
include paranoia, agitation, palpitations, tachycardia, hypertension, 
and hyperthermia.
    N-Ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-
[alpha]-PVP have no approved medical uses in the United

[[Page 37721]]

States but there have been reports of individuals experiencing adverse 
outcomes after taking these substances. Because these substances are 
not approved drug products, a practitioner may not legally prescribe 
them, and they cannot be dispensed to an individual. The use of these 
substances without medical advice leads to the conclusion that these 
synthetic cathinones are being abused for their psychoactive 
properties.
    Reports from public health and law enforcement state that these 
substances are being abused and taken in amounts sufficient to create a 
hazard to an individual's health. This hazard is evidenced by emergency 
department admissions or deaths, representing a significant safety 
issue for those in the community. Further, from January 2012 through 
December 2020 (query date: May 3, 2021), the National Forensic 
Laboratory Information System (NFLIS) databases registered a total of 
2,289 reports by participating DEA, State, local, and other forensic 
laboratories, as applicable, pertaining to N-ethylhexedrone, [alpha]-
PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP.\2\ NFLIS registered 
these reports identifying these substances in drug-related exhibits 
from more than 40 States. MPHP was first identified in June 2012 in 
seized drug evidence (although MPHP was identified in blood samples 
from a 27-year-old decedent in 2011), followed by 4-MEAP and PV8 
(August and December 2013, respectively), alpha-PHP (May 2014), 4-
chloro-[alpha]-PVP (December 2015) and most recently N-ethylhexedrone 
(August 2016). Consequently, the data indicate that N-ethylhexedrone, 
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP are being 
abused, and they present safety hazards to the health of individuals 
who consume them due to their stimulant properties.
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    \2\ NFLIS is a national drug forensic laboratory reporting 
system that systematically collects results from drug chemistry 
analyses conducted by state and local forensic laboratories across 
the country. The NFLIS participation rate, defined as the percentage 
of the national drug caseload represented by laboratories that have 
joined NFLIS, is over 97 percent. NFLIS includes drug chemistry 
results from completed analyses only.
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    2. Scientific Evidence of the Drug's Pharmacological Effects, if 
Known: As described by HHS, studies show that N-ethylhexedrone, 
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP produce 
pharmacological effects that are similar to those produced by schedule 
I and II substances such as methamphetamine (II), cocaine (II), 
mephedrone (I), MDPV (I), and methylone (I). Similar to these schedule 
I and II substances, N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, 
and 4-chloro-[alpha]-PVP bind to monoamine transporters for dopamine 
and norepinephrine, and block the uptake of these neurotransmitters at 
their transporters. N-Ethylhexedrone, [alpha]-PHP, and MPHP (4-MEAP, 
PV8, and 4-chloro-[alpha]-PVP were not tested in this assay) do not 
promote the release of these monoamines. Additionally, behavioral 
studies in animals demonstrate that N-ethylhexedrone, [alpha]-PHP, 4-
MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP produce locomotor behavior 
and discriminative stimulus effects that are similar to those of 
methamphetamine and cocaine. Overall, these data indicate that N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP produce pharmacological effects and stimulant-like behaviors that 
are similar to those of other schedule I synthetic cathinones such as 
methcathinone, mephedrone, MDPV, and methylone, as well as schedule II 
stimulants methamphetamine and cocaine.
    3. The State of Current Scientific Knowledge Regarding the Drug or 
Other Substance: N-Ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 
4-chloro-[alpha]-PVP are designer drugs of the phenethylamine class and 
they are structurally similar to permanently controlled schedule I 
synthetic cathinones and schedule II stimulants like methamphetamine.
    Pharmacokinetic studies show that humans, in general, metabolize 
synthetic cathinones to their corresponding amphetamines followed by 
reduction of the beta-keto group to the corresponding alcohol which can 
involve hydrogenation, deethylation, demethylation, or hydroxylation. 
Given that N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-
chloro-[alpha]-PVP are synthetic cathinones, it is likely that these 
six synthetic cathinones are also metabolized to their corresponding 
amphetamines and alcohols.
    Neither DEA nor HHS is aware of any currently accepted medical use 
for N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-
[alpha]-PVP. According to HHS's 2021 scientific and medical evaluation 
and scheduling recommendation, the Food and Drug Administration (FDA) 
has not approved marketing applications for drug products containing N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP for any therapeutic indication, nor is HHS aware of any reports of 
clinical studies or claims of accepted medical use for N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP in the United States.
    A drug has a ``currently accepted medical use'' if DEA concludes 
that it satisfies a five-part test. Specifically, with respect to a 
drug that has not been approved by FDA, all of the following must be 
demonstrated: The drug's chemistry is known and reproducible; there are 
adequate safety studies; there are adequate and well-controlled studies 
proving efficacy; the drug is accepted by qualified experts; and the 
scientific evidence is widely available.\3\ Based on this analysis, N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP have no currently accepted medical use in the United States. 
Furthermore, DEA has not found any references regarding clinical 
testing of these substances in the scientific and medical literature. 
Although the chemistry of synthetic cathinones, in general, is known 
and has been reproduced, as mentioned above there are no clinical 
studies involving N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 
4-chloro-[alpha]-PVP. Taken together with HHS's conclusion, DEA finds 
that there is no legitimate medical use for N-ethylhexedrone, [alpha]-
PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP in the United States.
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    \3\ 57 FR 10499 (1992), pet. for rev. denied, Alliance for 
Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994).
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    4. History and Current Pattern of Abuse: Available evidence 
suggests that the history and pattern of abuse of N-ethylhexedrone, 
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP parallel that 
of permanently controlled schedule I cathinone stimulants. N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP are synthetic cathinones of the phenethylamine class and they are 
structurally and pharmacologically similar to schedule I and II 
substances such as methcathinone (I) and methamphetamine (II). Like 
these schedule I and II substances, N-ethylhexedrone, [alpha]-PHP, 4-
MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP are most likely ingested by 
swallowing capsules or tablets or snorted by nasal insufflation of the 
powder tablets. As reported by DEA and HHS, products containing N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, or 4-chloro-[alpha]-
PVP, similar to schedule I synthetic cathinones, are likely to be 
falsely marketed as ``research chemicals,'' ``jewelry cleaner,'' 
``stain remover,'' ``plant food or fertilizer,'' ``insect repellants,'' 
or ``bath salts;'' sold at smoke shops, head shops, convenience stores, 
adult book stores, or gas stations; and purchased on the internet. Like 
those seen with commercial products

[[Page 37722]]

that contain synthetic cathinones, the packages of products that 
contain N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, or 4-chloro-
[alpha]-PVP also probably contain the warning ``not for human 
consumption,'' most likely in an effort to circumvent statutory 
restrictions for these substances. Law enforcement data indicate that 
N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP are available for illicit use and are being abused. Demographic 
data collected from published reports and mortality records suggest 
that the main users of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, 
PV8, and 4-chloro-[alpha]-PVP, similar to other schedule I synthetic 
cathinones permanently placed in schedule I, are young adults. 
Toxicology reports also revealed that N-ethylhexedrone, [alpha]-PHP, 4-
MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP are being ingested with other 
substances including other synthetic cathinones, common cutting agents, 
or other recreational substances. Consequently, products containing 
synthetic cathinones, including N-ethylhexedrone, [alpha]-PHP, 4-MEAP, 
MPHP, PV8, or 4-chloro-[alpha]-PVP, are distributed to users, often 
with unpredictable outcomes. Thus, the recreational abuse of N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP is a significant concern. These data indicate that N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP have a history and current pattern of abuse.
    5. Scope, Duration and Significance of Abuse: N-ethylhexedrone, 
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP are 
recreational drugs that emerged on the United States' illicit drug 
market after the scheduling of other synthetic cathinones (e.g., N-
ethylpentylone, ethylone, mephedrone, methylone, pentylone, and MDPV) 
(see DEA's Eight Factor Analysis for a full discussion). Forensic 
laboratories have confirmed the presence of N-ethylhexedrone, [alpha]-
PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP in drug exhibits 
received from Federal, State, and local law enforcement agencies. MPHP 
was first identified in June 2012 in seized drug evidence (although 
MPHP was identified in blood samples from a 27-year-old decedent in 
2011--see Factor 6 for details), followed by 4-MEAP and PV8 (August and 
December 2013, respectively), alpha-PHP (May 2014), 4-chloro-[alpha]-
PVP (December 2015) and most recently N-ethylhexedrone (August 2016). 
From January 2012 through December 2020 (query date: May 3, 2021), 
NFLIS database registered a total of 2,289 reports from forensic 
laboratories pertaining to the 6 synthetic cathinones (N-
ethylhexedrone, 613 reports; [alpha]-PHP--984 reports; 4-MEAP--131 
reports; MPHP--92 reports; PV8--174 reports; and 4-chloro-[alpha]-PVP--
295 reports). HHS reported that there were 13,238 calls to United 
States poison control centers (PCCs) \4\ involving synthetic cathinones 
from 2010 to 2019 and 39 mentions of cathinones of which 23 were for 
[alpha]-PHP on the Dashboard \5\ from July 2018 to July 2020. 
Accordingly, concerns over the continuing abuse of synthetic cathinones 
have led to the control of many synthetic cathinones. A full 
presentation of the NFLIS reports by substance and year, PCC, and 
Dashboard data are available in both DEA's and HHS's eight-factor 
analyses within the Supporting Documents section of the public docket 
available at http://www.regulations.gov.
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    \4\ PCC data are derived from the National Poison Data System, a 
database managed by the American Association of Poison Control 
Centers (AAPCC). AAPCC is a nationwide network of PCCs that receive 
calls from individuals, healthcare professionals, and other 
interested persons in the general U.S. population regarding 
exposures to prescription drugs and other substances.
    \5\ The Dashboard is an online, interactive tool that reports on 
the identification of certain novel psychoactive substances in de-
identified sample extracts from forensic investigations, including 
medicolegal death investigations and toxicology testing. The 
Dashboard was accessed on February 26, 2021.
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    6. What, if Any, Risk There Is to the Public Health: HHS reported 
that the public health risks of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, 
MPHP, PV8, and 4-chloro-[alpha]-PVP result from their ability to induce 
stimulant-like responses, which may lead to impaired judgement and 
dangerous behavior. Adverse health effects associated with the abuse of 
N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP include a number of stimulant-like adverse health effects such as 
diaphoresis, insomnia, mydriasis, hyperthermia, vomiting, agitation, 
disorientation, paranoia, and abdominal pain. Serious adverse events 
such as acute kidney failure, cardiac arrest, rhabdomyolysis, and coma 
have been associated with the use of N-ethylhexedrone, [alpha]-PHP, 4-
MEAP, and PV8. In addition, N-ethylhexedrone, [alpha]-PHP, MPHP, and 
PV8 have been involved in the deaths of individuals. The identification 
of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, or 4-chloro-
[alpha]-PVP in toxicological samples associated with fatal and non-
fatal overdoses as reported in the medical and scientific literature, 
forensic laboratory reports, and public health documents confirms these 
adverse effects of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, or 
4-chloro-[alpha]-PVP. Like schedule I synthetic cathinones, N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP have caused acute health problems leading to emergency department 
(ED) admissions, violent behaviors causing harm to self or others, and/
or death. Specifically, evidence demonstrate that all six synthetic 
cathinones have resulted in ED visits that required medical attention, 
but only N-ethylhexedrone, [alpha]-PHP, MPHP, and PV8 abuse have been 
associated with the deaths of individuals. It remains highly likely 
that additional cases of adverse health effects involving N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP in the United States have occurred and will continue to be under-
reported as these substances are not part of standard panels for 
toxicological analyses of biological specimens. Thus, the abuse of N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP, like that of the abuse of schedule I synthetic cathinones and 
stimulant drugs, poses significant adverse health risks including 
death.
    Furthermore, because abusers of synthetic cathinones obtain these 
substances through unregulated sources, the identity, purity, and 
quantity are uncertain and inconsistent. These unknown factors pose an 
additional risk for significant adverse health effects to the end user.
    Based on information received by DEA, the abuse of N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP has led to, at least, the same qualitative public health risks as 
other schedule I synthetic cathinones and the schedule II stimulant 
methamphetamine. The public health risks attendant to the abuse of 
synthetic cathinones, including N-ethylhexedrone, [alpha]-PHP, 4-MEAP, 
MPHP, PV8, or 4-chloro-[alpha]-PVP, are well established and have 
resulted in large numbers of ED visits and fatal overdoses.
    7. Its Psychic or Physiological Dependence Liability: According to 
HHS, the psychic or physiological dependence liability of N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP is demonstrated by their positive abuse-related studies in animals 
and reported stimulant effects in humans. The results from two 
behavioral studies (drug discrimination and locomotor studies) 
demonstrate that N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, or 
4-chloro-[alpha]-PVP produced behavioral effects that are similar to 
those of substances with

[[Page 37723]]

stimulant effects such as the schedule II stimulants cocaine and 
methamphetamine. Thus, based on the structural and pharmacological 
similarities of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 
4-chloro-[alpha]-PVP to schedule II stimulant substances that have 
demonstrated psychic or physiological dependence liability, it is 
anticipated that the stimulant properties of N-ethylhexedrone, [alpha]-
PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP produce psychic 
dependence liability.
    8. Whether the Substance is an Immediate Precursor of a Substance 
Already Controlled Under the CSA: N-Ethylhexedrone, [alpha]-PHP, 4-
MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP are not immediate precursors 
of any controlled substance under the CSA as defined by 21 U.S.C. 
802(23).
    Conclusion: After considering the scientific and medical evaluation 
conducted by HHS, HHS's scheduling recommendation, and DEA's own eight-
factor analysis, DEA finds that the facts and all relevant data 
constitute substantial evidence of the potential for abuse of N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP. As such, DEA hereby proposes to permanently schedule N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP as controlled substances under the CSA.

Proposed Determination of Appropriate Schedule

    The CSA establishes five schedules of controlled substances known 
as schedules I, II, III, IV, and V. The CSA also outlines the findings 
required to place a drug or other substance in any particular schedule. 
21 U.S.C. 812(b). After consideration of the analysis and 
recommendation of the Assistant Secretary for Health of HHS and review 
of all other available data, the Administrator of DEA, pursuant to 21 
U.S.C. 811(a) and 812(b)(1), finds that:
    1. N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-
[alpha]-PVP have a high potential for abuse;
    2. N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-
[alpha]-PVP have no currently accepted medical use in treatment in the 
United States; and
    3. There is a lack of accepted safety for use of N-ethylhexedrone, 
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP under medical 
supervision.
    Based on these findings, the Administrator concludes that N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP, including their salts, isomers, and salts of isomers, whenever the 
existence of such salts, isomers, and salts of isomers is possible 
within the specific chemical designation, warrant control in schedule I 
of the CSA. 21 U.S.C. 812(b)(1).

Requirements for Handling N-Ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, 
PV8, and 4-Chloro-[alpha]-PVP

    If this rule is finalized as proposed, N-ethylhexedrone, [alpha]-
PHP, 4-MEAP, MPHP, PV8, or 4-chloro-[alpha]-PVP would continue \6\ to 
be subject to the CSA's schedule I regulatory controls and 
administrative, civil, and criminal sanctions applicable to the 
manufacture, distribution, reverse distribution, importation, 
exportation, research, and conduct of instructional activities 
involving the handling of schedule I controlled substances including 
the following:
---------------------------------------------------------------------------

    \6\ N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-
chloro-[alpha]-PVP are currently subject to schedule I controls on a 
temporary basis, pursuant to 21 U.S.C. 811(h). 84 FR 34291, July 18, 
2019. An order extending the temporary scheduling of N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-
[alpha]-PVP for one year is published elsewhere in this issue of the 
Federal Register, on the same day as this notice of proposed 
rulemaking.
---------------------------------------------------------------------------

    1. Registration. Any person who handles (manufactures, distributes, 
reverse distributes, imports, exports, engages in research, or conducts 
instructional activities or chemical analysis with, or possesses) or 
who desires to handle N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, 
or 4-chloro-[alpha]-PVP is required to be registered with DEA to 
conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958, 
and in accordance with 21 CFR parts 1301 and 1312.
    2. Security. N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 
4-chloro-[alpha]-PVP are subject to schedule I security requirements 
and must be handled and stored pursuant to 21 U.S.C. 823 and in 
accordance with 21 CFR 1301.71-1301.76. Non-practitioners handling N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, or 4-chloro-[alpha]-PVP 
must also comply with the employee screening requirements of 21 CFR 
1301.90-1301.93.
    3. Labeling and Packaging. All labels, labeling, and packaging for 
commercial containers of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, 
PV8, and 4-chloro-[alpha]-PVP must be in compliance with 21 U.S.C. 825, 
and be in accordance with 21 CFR part 1302.
    4. Quota. Only registered manufacturers are permitted to 
manufacture N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, or 4-
chloro-[alpha]-PVP in accordance with a quota assigned pursuant to 21 
U.S.C. 826 and in accordance with 21 CFR part 1303.
    5. Inventory. Any person registered with DEA to handle N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, or 4-chloro-[alpha]-PVP 
must have an initial inventory of all stocks of controlled substances 
(including N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-
chloro-[alpha]-PVP) on hand on the date the registrant first engages in 
the handling of controlled substances pursuant to 21 U.S.C. 827 and in 
accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    After the initial inventory, every DEA registrant must take an 
inventory of all controlled substances (including N-ethylhexedrone, 
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP) on hand every 
two years, pursuant to 21 U.S.C. 827 and in accordance with 21 CFR 
1304.03, 1304.04, and 1304.11.
    6. Records and Reports. Every DEA registrant is required to 
maintain records and submit reports with respect to N-ethylhexedrone, 
[alpha]-PHP, 4-MEAP, MPHP, PV8, or 4-chloro-[alpha]-PVP pursuant to 21 
U.S.C. 827, and in accordance with 21 CFR 1301.74(b) and (c) and parts 
1304, 1312, and 1317. Manufacturers and distributors must submit 
reports regarding these substances to the Automation of Reports and 
Consolidated Order System pursuant to 21 U.S.C. 827 and in accordance 
with 21 CFR parts 1304 and 1312.
    7. Order Forms. Every DEA registrant who distributes N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, or 4-chloro-[alpha]-PVP 
is required to comply with the order form requirements, pursuant to 21 
U.S.C. 828 and 21 CFR part 1305.
    8. Importation and Exportation. All importation and exportation of 
N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, or 4-chloro-[alpha]-
PVP must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in 
accordance with 21 CFR part 1312.
    9. Liability. Any activity involving N-ethylhexedrone, [alpha]-PHP, 
4-MEAP, MPHP, PV8, or 4-chloro-[alpha]-PVP not authorized by, or in 
violation of the CSA or its implementing regulations, is unlawful, and 
could subject the person to administrative, civil, and/or criminal 
sanctions.

Regulatory Analyses

Executive Orders 12866 (Regulatory Planning and Review) and 13563 
(Improving Regulation and Regulatory Review)

    In accordance with 21 U.S.C. 811(a), this proposed scheduling 
action is subject to formal rulemaking procedures performed ``on the 
record after opportunity for a hearing,'' which are conducted pursuant 
to the provisions of 5 U.S.C. 556 and 557. The CSA sets

[[Page 37724]]

forth the criteria for scheduling a drug or other substance. Such 
actions are exempt from review by the Office of Management and Budget 
(OMB) pursuant to section 3(d)(1) of Executive Order (E.O.) 12866 and 
the principles reaffirmed in E.O. 13563.

Executive Order 12988, Civil Justice Reform

    This proposed regulation meets the applicable standards set forth 
in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors 
and ambiguity, minimize litigation, provide a clear legal standard for 
affected conduct, and promote simplification and burden reduction.

Executive Order 13132, Federalism

    This proposed rulemaking does not have federalism implications 
warranting the application of E.O. 13132. The proposed rule does not 
have substantial direct effects on the States, on the relationship 
between the national government and the States, or the distribution of 
power and responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This proposed rule does not have tribal implications warranting the 
application of E.O. 13175. It does not have substantial direct effects 
on one or more Indian tribes, on the relationship between the Federal 
government and Indian tribes, or on the distribution of power and 
responsibilities between the Federal government and Indian tribes.

Regulatory Flexibility Act

    The Administrator, in accordance with the Regulatory Flexibility 
Act, 5 U.S.C. 601-612, has reviewed this proposed rule and by approving 
it certifies that it will not have a significant economic impact on a 
substantial number of small entities. On July 18, 2019, DEA published 
an order to temporarily place N-ethylhexedrone, [alpha]-PHP, 4-MEAP, 
MPHP, PV8, and 4-chloro-[alpha]-PVP in schedule I of the CSA pursuant 
to the temporary scheduling provisions of 21 U.S.C. 811(h). DEA 
estimates that all entities handling or planning to handle these 
substances have already established and implemented the systems and 
processes required to handle N-ethylhexedrone, [alpha]-PHP, 4-MEAP, 
MPHP, PV8, or 4-chloro-[alpha]-PVP. There are currently 34 unique 
registrations authorized to handle N-ethylhexedrone, [alpha]-PHP, 4-
MEAP, MPHP, PV8, or 4-chloro-[alpha]-PVP specifically, as well as a 
number of registered analytical labs that are authorized to handle 
schedule I controlled substances generally. From review of entity 
names, DEA estimates these 34 registrations represent 29 entities. Some 
of these entities are likely to be large entities. However, since DEA 
does not have information of registrant size and the majority of DEA 
registrants are small entities or are employed by small entities, DEA 
estimates a maximum of 29 entities are small entities. Therefore, DEA 
conservatively estimates as many as 29 small entities are affected by 
this proposed rule.
    A review of the 34 registrations indicates that all entities that 
currently handle N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, or 
4-chloro-[alpha]-PVP also handle other schedule I controlled 
substances, and thus they have established and implemented (or 
maintain) the systems and processes required to handle N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP as a schedule I substance. Therefore, DEA anticipates that this 
proposed rule will impose minimal or no economic impact on any affected 
entities, and, thus, will not have a significant economic impact on any 
of the 29 affected small entities. Therefore, DEA has concluded that 
this proposed rule will not have a significant economic impact on a 
substantial number of small entities.

Unfunded Mandates Reform Act of 1995

    In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 
2 U.S.C. 1501 et seq., DEA has determined and certifies that this 
proposed action would not result in any Federal mandate that may result 
``in the expenditure by State, local, and tribal governments, in the 
aggregate, or by the private sector, of $100,000,000 or more (adjusted 
annually for inflation) in any 1 year * * * .'' Therefore, neither a 
Small Government Agency Plan nor any other action is required under 
UMRA of 1995.

Paperwork Reduction Act of 1995

    This proposed action does not impose a new collection of 
information under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-
3521. This proposed action would not impose recordkeeping or reporting 
requirements on State or local governments, individuals, businesses, or 
organizations. An agency may not conduct or sponsor, and a person is 
not required to respond to, a collection of information unless it 
displays a currently valid OMB control number.

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, 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. Amend Sec.  1308.11 by:
0
a. Adding paragraphs (d)(94) through (99); and
0
b. Removing and reserving paragraphs (h)(42) through (h)(47).
    The additions to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (d) * * *

(94) N-Ethylhexedrone (Other name: [alpha]-                         7246
 ethylaminohexanophenone)...............................
(95) alpha-Pyrrolidinohexanophenone (Other names:                   7544
 [alpha]-PHP, [alpha]-pyrrolidino-hexanophenone, 1-
 phenyl-2-(pyrrolidin-1-yl)hexan-1-one).................
(96) 4-Methyl-alpha-Ethylaminopentiophenone (Other                  7245
 names: 4-MEAP, 2-(ethylamino)-1-(4-methylphenyl)pentan-
 1-one).................................................
(97) 4'-Methyl-alpha-pyrrolidinohexiophenone (Other                 7446
 names: MPHP, 4'-methyl-alpha- pyrrolidino
 hexanophenone; 1-(4-methylphenyl)-2-(pyrrolidin-1-
 yl)hexan-1-one)........................................
(98) alpha-Pyrrolidinoheptaphenone (Other names: PV8, 1-            7548
 phenyl-2-(pyrrolidin-1-yl)heptan-1-one)................
(99) 4'-Chloro-alpha-Pyrrolidinovalerophenone (Other                7443
 names: 4-chloro-[alpha]-PVP, 4-chloro-[alpha]-
 pyrrolidinopentiophenone, 1-(4-chlorophenyl)-2-
 (pyrrolidin-1-yl)pentan-1-one).........................
 


[[Page 37725]]

* * * * *

Anne Milgram,
Administrator.
[FR Doc. 2021-15114 Filed 7-15-21; 8:45 am]
BILLING CODE 4410-09-P