[Federal Register Volume 86, Number 168 (Thursday, September 2, 2021)]
[Proposed Rules]
[Pages 49267-49273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18843]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-737]


Schedules of Controlled Substances: Placement of Methiopropamine 
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 N-methyl-
1-(thiophen-2-yl)propan-2-amine (methiopropamine), including its salts, 
isomers, and salts of isomers, in schedule I of the Controlled 
Substances Act. This action is being taken to enable the United States 
to meet its obligations under the 1971 Convention on Psychotropic 
Substances. If finalized, this action would impose the 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 methiopropamine.

DATES: Comments must be submitted electronically or postmarked on or 
before October 4, 2021.
    Interested persons may file written comments on this proposal in 
accordance with 21 CFR 1308.43(g). Commenters should be aware that the 
electronic Federal Docket Management System will not accept comments 
after 11:59 p.m. Eastern Time on the last day of the comment period.
    Interested persons may file a request for a hearing or waiver of 
hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 
1316.45 and/or 1316.47, as applicable. Requests for a hearing and 
waivers of an opportunity for a hearing or to participate in a hearing, 
together with a written statement of position on the matters of

[[Page 49268]]

fact and law asserted in the hearing, must be received on or before 
October 4, 2021.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-737'' 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: Dr. Terrence L. Boos, Drug and 
Chemical Evaluation Section, Diversion Control Division, Drug 
Enforcement Administration; Telephone: (571) 362-3249.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received in response to this docket 
are considered part of the public record. The Drug Enforcement 
Administration (DEA) will make them available, unless reasonable cause 
is given, 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.
    DEA will make available publicly in redacted form comments 
containing personal identifying information or confidential business 
information identified as directed above. If a comment has so much 
confidential business information that it cannot be redacted 
effectively, all or part of that comment may not be made available 
publicly. Comments posted to http://www.regulations.gov may include any 
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 as directed above.
    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 Appearance; Waiver

    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. 21 CFR 1316.47(a). 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 
asserted in the hearing, must be sent to DEA using the address 
information provided above.

Legal Authority

    The United States is a party to the 1971 United Nations Convention 
on Psychotropic Substances (1971 Convention), February 21, 1971, 32 
U.S.T. 543, 1019 U.N.T.S. 175, as amended. Procedures respecting 
changes in drug schedules under the 1971 Convention are governed 
domestically by 21 U.S.C. 811(d)(2-4). When the United States receives 
notification of a scheduling decision pursuant to Article 2 of the 1971 
Convention adding a drug or other substance to a specific schedule, the 
Secretary of the Department of Health and Human Services (HHS),\1\ 
after consultation with the Attorney General, shall first determine 
whether existing legal controls under subchapter I of the Controlled 
Substances Act (CSA) and the Federal Food, Drug, and Cosmetic Act meet 
the requirements of the schedule specified in the notification with 
respect to the specific drug or substance. 21 U.S.C. 811(d)(3). In the 
event that the Secretary of HHS (Secretary) did not consult with the 
Attorney General, and the Attorney General did not issue a temporary 
order, as provided under 21 U.S.C. 811(d)(4), the procedures for 
permanent scheduling set forth in 21 U.S.C. 811(a) and (b) control. 
Pursuant to 21 U.S.C. 811(a)(1), the Attorney General, by rule, may add 
to such a schedule any drug or other substance, if he finds that such 
drug or other substance has a potential

[[Page 49269]]

for abuse, and makes with respect to such drug or other substance the 
findings prescribed by 21 U.S.C. 812(b) for the schedule in which such 
drug is to be placed. The Attorney General has delegated this 
scheduling authority to the Administrator of DEA. 28 CFR 0.100.
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    \1\ As discussed in a memorandum of understanding entered into 
by the Food and Drug Administration (FDA) and the National Institute 
on Drug Abuse (NIDA), FDA acts as the lead agency within HHS in 
carrying out the Secretary's scheduling responsibilities under the 
Controlled Substances Act, with the concurrence of NIDA. 50 FR 9518 
(March 8, 1985). The Secretary of HHS has delegated to the Assistant 
Secretary for Health of HHS the authority to make domestic drug 
scheduling recommendations. 58 FR 35460 (July 1, 1993).
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Background

    Methiopropamine is a central nervous stimulant and is structurally 
related to the schedule II stimulants methamphetamine and amphetamine. 
On April 21, 2017, the Secretary-General of the United Nations advised 
the Secretary of State of the United States that during its 60th 
session, on March 16, 2017, the Commission on Narcotic Drugs voted to 
place N-methyl-1-(thiophen-2-yl)propan-2-amine (methiopropamine) in 
Schedule II of the 1971 Convention (CND Dec/60/8). Because the 
procedures in 21 U.S.C. 811(d)(3) and (4) for consultation and issuance 
of a temporary order for methiopropamine, discussed in the above legal 
authority section, were not followed, DEA is utilizing the procedures 
for permanent scheduling set forth in 21 U.S.C. 811(a) and (b) to 
control methiopropamine. Such scheduling would satisfy the United 
States' international obligations.
    Article 2, paragraph 7(b), of the 1971 Convention sets forth the 
minimum requirements that the United States must meet when a substance 
has been added to Schedule II of the 1971 Convention. Pursuant to the 
1971 Convention, the United States must require licenses for the 
manufacture, export and import, and distribution of methiopropamine. 
This license requirement is accomplished by the CSA's registration 
requirement as set forth in 21 U.S.C. 822, 823, 957, 958 and in 
accordance with 21 CFR parts 1301 and 1312. In addition, the United 
States must adhere to specific export and import provisions set forth 
in the 1971 Convention. This requirement is accomplished by the CSA's 
export and import provisions established in 21 U.S.C. 952, 953, 957, 
958 and in accordance with 21 CFR part 1312. Likewise, under Article 
13, paragraphs 1 and 2, of the 1971 Convention, a party to the 1971 
Convention may notify through the UN Secretary-General another party 
that it prohibits the importation of a substance in Schedule II, III, 
or IV of the 1971 Convention. If such notice is presented to the United 
States, the United States shall take measures to ensure that the named 
substance is not exported to the notifying country. This requirement is 
also accomplished by the CSA's export provisions mentioned above. Under 
Article 16, paragraph 4, of the 1971 Convention, the United States is 
required to provide annual statistical reports to the International 
Narcotics Control Board (INCB). Using INCB Form P, the United States 
shall provide the following information: (1) In regard to each 
substance in Schedule I and II of the 1971 Convention, quantities 
manufactured in, exported to, and imported from each country or region 
as well as stocks held by manufacturers; (2) in regard to each 
substance in Schedule II and III of the 1971 Convention, quantities 
used in the manufacture of exempt preparations; and (3) in regard to 
each substance in Schedule II-IV of the 1971 Convention, quantities 
used for the manufacture of non-psychotropic substances or products. 
Lastly, under Article 2 of the 1971 Convention, the United States must 
adopt measures in accordance with Article 22 to address violations of 
any statutes or regulations that are adopted pursuant to its 
obligations under the 1971 Convention. Persons acting outside the legal 
framework established by the CSA are subject to administrative, civil, 
and/or criminal action; therefore, the United States complies with this 
provision.
    DEA notes that there are differences between the schedules of 
substances in the 1971 Convention and the CSA. The CSA has five 
schedules (schedules I-V) with specific criteria set forth for each 
schedule. Schedule I is the only possible schedule in which a drug or 
other substance may be placed if it has high potential for abuse and no 
currently accepted medical use in treatment in the United States. See 
21 U.S.C. 812(b). In contrast, the 1971 Convention has four schedules 
(Schedules I-IV) but does not have specific criteria for each schedule. 
The 1971 Convention simply defines its four schedules, in Article 1, to 
mean the correspondingly numbered lists of psychotropic substances 
annexed to the Convention, and altered in accordance with Article 2.

Proposed Determination To Schedule Methiopropamine

    On November 20, 2018, DEA requested HHS conduct a scientific and 
medical evaluation and recommend whether methiopropamine should be 
controlled under the CSA. On August 27, 2020 (dated August 25, 2020), 
HHS provided DEA a scientific and medical evaluation entitled ``Basis 
for the recommendation to control methiopropamine and its salts in 
schedule I of the Controlled Substance Act'' and a scheduling 
recommendation. Pursuant to 21 U.S.C. 811(b), following consideration 
of the eight-factors and findings related to the substance's abuse 
potential, legitimate medical use, safety, and dependence liability, 
HHS recommended that methiopropamine be controlled in schedule I of the 
CSA under 21 U.S.C. 812(b). Upon receipt of the scientific and medical 
evaluation and scheduling recommendation from HHS, DEA reviewed the 
documents and all other relevant data and conducted its own eight-
factor analysis in accordance with 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 DEA and HHS eight-factor analyses 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-737.''
    1. The Drug's Actual or Relative Potential for Abuse: The term 
``abuse'' is not defined in the CSA. However, the legislative history 
of the CSA suggests that DEA consider the following criteria when 
determining whether a particular drug or substance has a potential for 
abuse: \2\
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    \2\ Comprehensive Drug Abuse Prevention and Control Act of 1970, 
H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970); reprinted in 1970 
U.S.C.C.A.N. 4566, 4603.

    (a) There is evidence that individuals are taking the drug or 
drugs containing such a substance in amounts sufficient to create a 
hazard to their health or to the safety of other individuals or to 
the community; or
    (b) There is significant diversion of the drug or drugs 
containing such a substance from legitimate drug channels; or
    (c) Individuals are taking the drug or drugs containing such a 
substance on their own initiative rather than on the basis of 
medical advice from a practitioner licensed by law to administer 
such drugs in the course of his professional practice; or
    (d) The drug or drugs containing such a substance are new drugs 
so related in their action to a drug or drugs already listed as 
having a potential for abuse to make it likely that the drug will 
have the same potentiality for abuse as such drugs, thus making it 
reasonable to assume that there may be significant diversions from 
legitimate channels, significant use contrary to or without medical 
advice, or that it has a substantial capability of creating hazards 
to the health of the user or to the safety of the community.

    Both DEA and HHS eight-factor analyses found that methiopropamine 
has abuse potential associated with its abilities to produce 
psychoactive effects that are similar to those produced by schedule II 
stimulants such as amphetamine and methamphetamine

[[Page 49270]]

that have a high potential for abuse. In particular, the responses in 
humans to methiopropamine are stimulant-like and include tachycardia, 
anxiety, insomnia, perspiration, and hallucination.
    Methiopropamine has no approved medical uses in the United States. 
Because this substance is not an approved drug product, a practitioner 
may not legally prescribe it, and it cannot be dispensed to an 
individual. The use of this substance without medical advice leads to 
the conclusion that this stimulant is being abused for its psychoactive 
properties.
    Reports from public health and law enforcement suggest that this 
substance is being abused and taken in amounts sufficient to create a 
hazard to an individual's health. This hazard is evidenced by deaths, 
representing a safety issue for those in the community. Further, 
methiopropamine was first identified in the National Forensic 
Laboratory Information System (NFLIS) \3\ database in 2011; a September 
29, 2020 query of this database for methiopropamine reports indicated a 
total of 128 such reports through 2018 from 19 states by participating 
federal, state, and local forensic laboratories. Consequently, the data 
indicate that methiopropamine is being abused, and it presents safety 
hazards to the health of individuals who consume it due to its 
stimulant properties, making it a hazard to the safety of the 
community.
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    \3\ NFLIS represents an important resource in monitoring illicit 
drug trafficking, including the diversion of legally manufactured 
pharmaceuticals into illegal markets. NFLIS is a comprehensive 
information system that includes data from forensic laboratories 
that handle more than 96% of an estimated 1.0 million distinct 
annual State and local drug analysis cases. NFLIS includes drug 
chemistry results from completed analyses only. While NFLIS data is 
not direct evidence of abuse, it can lead to an inference that a 
drug has been diverted and abused. See 76 FR 77330, 77332, Dec. 12, 
2011.
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    2. Scientific Evidence of the Drug's Pharmacological Effects, if 
Known: As described by HHS, studies show that methiopropamine produces 
pharmacological effects that are similar to those produced by schedule 
II substances such as amphetamine and methamphetamine. Similar to these 
schedule II substances, methiopropamine binds to monoamine transporters 
for dopamine and norepinephrine and blocks the uptake of these 
neurotransmitters at their transporters. However, methiopropamine does 
not have an affinity for serotonin transporters or a significant effect 
on serotonin transporter activity. Behavioral studies in animals 
demonstrate that methiopropamine produces locomotor behavior similar to 
those of amphetamine and methamphetamine. Self-reports by 
methiopropamine users demonstrate that methiopropamine produces classic 
stimulant-like effects, including euphoria, psychological and 
psychomotor stimulation, insomnia, anxiety, panic attacks, and an 
increased heart rate. Overall, these data indicate that methiopropamine 
produces pharmacological effects and stimulant-like behaviors that are 
similar to those of schedule II substances amphetamine and 
methamphetamine.
    3. The State of Current Scientific Knowledge Regarding the Drug or 
Other Substance: Methiopropamine is structurally similar to the 
schedule II substances methamphetamine and amphetamine. Specifically, 
methiopropamine is a thiophene analog of methamphetamine.
    Self-reports by methiopropamine users in 2020 suggest that the 
pharmacokinetics of the drug following insufflation are rapid, with the 
onset of effects occurring five to ten minutes after administration. 
Methiopropamine reaches its maximum concentration at approximately 
thirty to sixty minutes later, with a duration of action that can 
persist for two to four hours. Limited studies identify nor-
methiopropamine as the main metabolite found in bodily fluids.
    Neither DEA nor HHS is aware of any currently accepted medical use 
for methiopropamine. According to HHS's August 2020 scientific and 
medical evaluation and scheduling recommendation, the Food and Drug 
Administration (FDA) has not approved a marketing application for a 
drug product containing methiopropamine for any therapeutic indication, 
nor is HHS aware of any reports of clinical studies or claims of an 
accepted medical use for methiopropamine in the United States.
    Although no evidence suggests that methiopropamine has a currently 
accepted medical use in treatment in the United States, it bears noting 
that a drug cannot be found to have such medical use unless 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. 57 
FR 10499 (1992), pet. for rev. denied, Alliance for Cannabis 
Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994). Based on this 
analysis, methiopropamine has no currently accepted medical use in the 
United States. Furthermore, DEA has not found any references regarding 
clinical testing of methiopropamine in the scientific and medical 
literature. Taken together with HHS's conclusion, DEA finds that there 
is no legitimate medical use for methiopropamine in the United States.
    4. History and Current Pattern of Abuse: As described by DEA and 
HHS, methiopropamine is a stimulant and is structurally and 
pharmacologically similar to the schedule II substances methamphetamine 
and amphetamine. Methiopropamine has been trafficked and abused in 
North America and Europe since its first report of abuse in 2011. In 
addition, methiopropamine has been identified in law enforcement 
seizures in the United States since 2011 through 2018. Thus, 
methiopropamine abuse occurs worldwide.
    5. Scope, Duration and Significance of Abuse: Forensic laboratories 
have confirmed the presence of methiopropamine in drug exhibits 
received from state, local, and federal law enforcement agencies. Law 
enforcement data show that methiopropamine first appeared in the 
illicit drug market in 2011 with four encounters. Overall, from 2011 
through 2018, NFLIS registered 128 reports from federal, state and 
local forensic laboratories identifying this substance in drug-related 
exhibits from 19 states. Thus, methiopropamine abuse is wide-spread.
    6. What, if Any, Risk There Is to the Public Health: Based on the 
review of both HHS and DEA, public health risks of methiopropamine 
result from its ability to induce stimulant-like responses, which may 
lead to adverse events that include psychological and cognitive 
impairment. In addition, methiopropamine has been involved, with one or 
more other substances, in 14 deaths in the United Kingdom from 2012 to 
2016, with methiopropamine being the sole contributing substance in one 
death in Australia in 2015. Thus, the public health risks associated 
with methiopropamine are confirmed by the pharmacological profile along 
with the fatalities associated with methiopropamine.
    7. Its Psychic or Physiological Dependence Liability: According to 
HHS, the psychic or physiological dependence liability of 
methiopropamine is demonstrated by its positive abuse-related studies 
in animals and reported stimulant effects in humans. The results from 
two behavioral locomotor studies in 2016 demonstrate that 
methiopropamine produced behavioral effects similar to

[[Page 49271]]

those of substances with stimulant effects such as amphetamine and 
methamphetamine. Furthermore, according to self-reports of drug users 
in 2020, methiopropamine has been abused for its stimulant properties. 
In addition, DEA notes that because methiopropamine shares 
pharmacological properties with schedule II stimulant substances such 
as amphetamine and methamphetamine, methiopropamine likely has a 
dependence profile similar to these substances, which are known to 
cause substance dependence.
    In summary, data suggests that methiopropamine produces behavioral 
effects in animals and humans similar to those of schedule II 
stimulants. Although there are no clinical studies evaluating 
dependence liabilities specific for methiopropamine, the 
pharmacological profile of this substance suggests that it possesses 
dependence liabilities qualitatively similar to schedule II substances 
such as amphetamine and methamphetamine.
    8. Whether the Substance is an Immediate Precursor of a Substance 
Already Controlled Under the CSA: Methiopropamine is not an immediate 
precursor 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 
methiopropamine. As such, DEA hereby proposes to permanently schedule 
methiopropamine as a schedule I controlled substance 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, pursuant to 21 U.S.C. 
811(a) and 812(b)(1), finds that:

1. Methiopropamine Has a High Potential for Abuse

    Methiopropamine, similar to the schedule II stimulants amphetamine 
and methamphetamine, is a stimulant with a high potential for abuse. In 
animals, behavioral locomotor studies show that methiopropamine 
produces stimulation similar to that of methamphetamine. As HHS 
mentions, methiopropamine abuse in humans has been reported in at least 
16 countries, including North America and Europe. Additionally, typical 
stimulant effects such as euphoria, psychomotor stimulation, and 
anxiety have been described from self-reports of methiopropamine 
abusers. These effects are similar to those of schedule II stimulant 
such as methamphetamine and amphetamine. These data collectively 
indicate that methiopropamine has a high potential for abuse similar to 
other substances in schedule II such as amphetamine and 
methamphetamine.

2. Methiopropamine Currently Has No Accepted Medical Use in Treatment 
in the United States

    According to HHS, FDA has not approved a marketing application for 
a drug product containing methiopropamine for any therapeutic 
indication. As HHS states, there are also no clinical studies or 
petitioners that claim an accepted medical use in the United States. In 
addition, as discussed above in the Factor 3 analysis, methiopropamine 
does not satisfy DEA's five-part test for having a currently accepted 
medical use in treatment in the United States.

3. There Is a Lack of Accepted Safety for Use of Methiopropamine Under 
Medical Supervision

    Currently, methiopropamine does not have an accepted medical use as 
noted by HHS. Because methiopropamine has no approved medical use in 
treatment in the United States and has not been investigated as a new 
drug, its safety for use under medical supervision has not been 
determined. Thus, there is a lack of accepted safety for use of 
methiopropamine under medical supervision.
    Although the first finding shows methiopropamine to have similar 
effects to schedule II substances such as amphetamine and 
methamphetamine, it bears reiterating that there is only one possible 
schedule in the CSA--schedule I--to place methiopropamine since it has 
no currently accepted medical use in treatment in the United States. 
See the background section for additional discussion.
    Based on these findings, the Administrator concludes that 
methiopropamine (chemical name: N-methyl-1-(thiophen-2-yl)propan-2-
amine), including its salts, isomers, and salts of isomers, warrants 
control in schedule I of the CSA. 21 U.S.C. 812(b)(1). More precisely, 
because of its stimulant-like effects, DEA is proposing to place 
methiopropamine in 21 CFR 1308.11(f) (the stimulants category of 
schedule I). As such, the proposed control of methiopropamine includes 
the substance as well as its salts, isomers, and salts of isomers.

Requirements for Handling Methiopropamine

    If this rule is finalized as proposed, methiopropamine would become 
subject to the CSA's schedule I regulatory controls and administrative, 
civil, and criminal sanctions applicable to the manufacture, 
distribution, reverse distribution, importation, exportation, 
engagement in research, and conduct of instructional activities or 
chemical analysis with, and possession of schedule I controlled 
substances, including the following (as of the effective date of the 
planned final scheduling action):
    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) 
methiopropamine, or who desires to handle methiopropamine, 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 as of the effective date of a final scheduling action. Any 
person who currently handles methiopropamine, and is not registered 
with DEA, would need to submit an application for registration and may 
not continue to handle methiopropamine as of the effective date of a 
final scheduling action, unless DEA has approved that application for 
registration pursuant to 21 U.S.C. 822, 823, 957, 958, and in 
accordance with 21 CFR parts 1301 and 1312.
    2. Disposal of stocks. Any person who does not desire or is not 
able to obtain a schedule I registration would be required to surrender 
all quantities of currently held methiopropamine or to transfer all 
quantities of currently held methiopropamine to a person registered 
with DEA before the effective date of a final scheduling action, in 
accordance with all applicable Federal, State, local, and tribal laws. 
As of the effective date of a final scheduling action, methiopropamine 
would be required to be disposed of in accordance with 21 CFR part 
1317, in addition to all other applicable Federal, State, local, and 
tribal laws.
    3. Security. Methiopropamine would be subject to schedule I 
security requirements and would need to be

[[Page 49272]]

handled and stored pursuant to 21 U.S.C. 821, 823, 871(b) and in 
accordance with 21 CFR 1301.71-1301.93 as of the effective date of a 
final scheduling action. Non-practitioners handling methiopropamine 
would also need to comply with the employee screening requirements of 
21 CFR 1301.90-1301.93.
    4. Labeling and Packaging. All labels, labeling, and packaging for 
commercial containers of methiopropamine would need to be in compliance 
with 21 U.S.C. 825 and 958(e) and be in accordance with 21 CFR part 
1302 as of the effective date of a final scheduling action.
    5. Quota. Only registered manufacturers would be permitted to 
manufacture methiopropamine in accordance with a quota assigned 
pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 as of 
the effective date of a final scheduling action.
    6. Inventory. Every DEA registrant who possesses any quantity of 
methiopropamine on the effective date of a final scheduling action 
would be required to take an inventory of methiopropamine on hand at 
that time, pursuant to 21 U.S.C. 827 and 958 and in accordance with 21 
CFR 1304.03, 1304.04, and 1304.11(a) and (d).
    Any person who becomes registered with DEA to handle 
methiopropamine on or after the effective date of a final scheduling 
action would be required to have an initial inventory of all stocks of 
controlled substances (including methiopropamine) on hand on the date 
the registrant first engages in the handling of controlled substances 
pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 
1304.03, 1304.04, and 1304.11(a) and (b).
    After the initial inventory, every DEA registrant must take an 
inventory of all controlled substances (including methiopropamine) on 
hand every two years, pursuant to 21 U.S.C. 827 and 958, and in 
accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    7. Records and Reports. Every DEA registrant would be required to 
maintain records and submit reports with respect to methiopropamine 
pursuant to 21 U.S.C. 827 and 958(e) and in accordance with 21 CFR 
parts 1304 and 1312, as of the effective date of a final scheduling 
action. Manufacturers and distributors would be required to submit 
reports regarding methiopropamine 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, as of the effective date of a final 
scheduling action.
    8. Order Forms. Every DEA registrant who distributes 
methiopropamine would be required to comply with the order form 
requirements, pursuant to 21 U.S.C. 828 and in accordance with 21 CFR 
part 1305, as of the effective date of a final scheduling action.
    9. Importation and Exportation. All importation and exportation of 
methiopropamine would need to be in compliance with 21 U.S.C. 952, 953, 
957, and 958, and in accordance with 21 CFR part 1312, as of the 
effective date of a final scheduling action.
    10. Liability. Any activity involving methiopropamine not 
authorized by, or in violation of, the CSA or its implementing 
regulations would be unlawful, and may 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 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. 601-602, 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.
    DEA proposes placing the substance methiopropamine (chemical name: 
N-methyl-1-(thiophen-2-yl)propan-2-amine), including its salts, 
isomers, and salts of isomers, in schedule I of the CSA. This action is 
being taken to enable the United States to meet its obligations under 
the 1971 Convention on Psychotropic Substances. If finalized, this 
action would impose the 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 with, or possess), or propose to handle, 
methiopropamine.
    According to HHS, methiopropamine has a high potential for abuse, 
has no currently accepted medical use in treatment in the United 
States, and lacks accepted safety for use under medical supervision. 
DEA's research confirms that there is no legitimate commercial market 
for methiopropamine in the United States. Therefore, DEA estimates that 
no United States entity currently handles methiopropamine and does not 
expect any United States entity to handle methiopropamine in the 
foreseeable future. DEA concludes that no legitimate United States 
entity would be affected by this rule if finalized. As such, the 
proposed rule will not have a significant effect 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 
action would not result in any Federal mandate that may result ``in the 
expenditure by State, local, and tribal

[[Page 49273]]

governments, in the aggregate, or by the private sector, of $100 
million 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 action does not impose a new collection of information under 
the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521.

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 further amend 21 CFR 
part 1308, which we proposed to amend on August 11, 2021 at 86 FR 
43983, as follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for 21 CFR 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 redesignating paragraph (f)(9) through 
(f)(11) as (f)(10) through (f)(12) and adding new paragraph (f)(9) to 
read as follows:


Sec.  1308.1  Schedule I.

* * * * *
    (f) * * *

 (9) Methiopropamine (N-methyl-1-(thiophen-2-yl)propan-2-amine)..   1478
 

* * * * *

Anne Milgram,
Administrator.
[FR Doc. 2021-18843 Filed 9-1-21; 8:45 am]
BILLING CODE 4410-09-P