[Federal Register Volume 86, Number 153 (Thursday, August 12, 2021)]
[Rules and Regulations]
[Pages 44270-44273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17052]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-498]


Schedules of Controlled Substances: Placement of 4,4'-DMAR in 
Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: With the issuance of this final rule, the Drug Enforcement 
Administration places 4,4'-dimethylaminorex (common name: 4,4'-DMAR) 
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. This action imposes the regulatory controls 
and administrative, civil, and criminal sanctions applicable to 
schedule I controlled substances on persons who handle (manufacture, 
distribute, import, export, engage in research, conduct instructional 
activities or chemical analysis, or possess), or propose to handle 
4,4'-DMAR.

DATES: Effective date: September 13, 2021.

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

SUPPLEMENTARY INFORMATION:

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 so 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 are set forth in 21 U.S.C. 811(a) and (b). 
Pursuant to 21 U.S.C. 811(a)(1), the Attorney General may, by rule, add 
to such a schedule or transfer between such schedules any drug or other 
substance, if he finds that such drug or other substance has a 
potential 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 or other substance is to be placed. The Attorney 
General has delegated this scheduling authority to the Administrator of 
the Drug Enforcement Administration (DEA Administrator or 
Administrator). 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 
CSA, 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

    4,4'-Dimethylaminorex (common name: 4,4'-DMAR; other names: 4,5-
dihydro-4-methyl-5-(4-methylphenyl)-2-oxazolamine; 4-methyl-5-(4-
methylphenyl)-4,5-dihydro-1,3-oxazol-2-amine) is a synthetic stimulant 
drug structurally related to 4-methylaminorex (4-MAR), a schedule I 
substance in the United States and a Schedule I substance in the 1971 
Convention. In November 2015, the Director-General of the World Health 
Organization recommended the Secretary-General of the United Nations 
(UN Secretary-General) place 4,4'-DMAR in Schedule II of the 1971 
Convention, as 4,4'-DMAR produces a spectrum of pharmacological effects 
similar to psychomotor stimulants listed in Schedule II of the 1971 
Convention, and has dependence and abuse potential. In May 2016, the UN 
Secretary-General advised the Secretary of State of the United States 
(U.S. Secretary of State) that the Commission on Narcotic Drugs (CND) 
voted to place 4,4'-dimethylaminorex (4,4'-DMAR) in Schedule II of the 
1971 Convention (CND Dec/59/5) during its 59th Session in March 2016.

[[Page 44271]]

DEA and HHS Eight Factor Analyses

    On October 12, 2018, in accordance with 21 U.S.C. 811(b), and in 
response to DEA's March 21, 2017 request, HHS provided to DEA a 
scientific and medical evaluation and a scheduling recommendation for 
4,4'-DMAR. DEA subsequently reviewed HHS' evaluation and recommendation 
for schedule I placement and all other relevant data, and conducted its 
own analysis under the eight factors stipulated in 21 U.S.C. 811(c). 
DEA found, under 21 U.S.C. 812(b)(1), that this substance warrants 
control in schedule I. Both DEA and HHS analyses are available in their 
entirety in the public docket for this rule (Docket Number DEA-498) at 
http://www.regulations.gov under ``Supporting Documents.''

Notice of Proposed Rulemaking to Schedule 4,4'-DMAR

    On April 7, 2020, DEA published a notice of proposed rulemaking 
(NPRM) entitled ``Schedules of Controlled Substances: Placement of 
4,4'-DMAR in schedule I of the CSA.'' 85 FR 19401. The NPRM provided an 
opportunity for interested persons to file a request for hearing in 
accordance with DEA regulations on or before June 8, 2020. No requests 
for such a hearing were received by DEA. The NPRM also provided an 
opportunity for interested persons to submit comments on the proposed 
rule on or before June 8, 2020.

Comments Received

    DEA received two comments on the proposed rule to control 4,4'-DMAR 
in schedule I of the CSA.
    Support for rulemaking: One commenter recognized the dangers and 
public health risks, and supported the placement of 4,4'-DMAR in 
schedule I.
    DEA Response: DEA appreciates the comment in support of this 
rulemaking.
    Dissent for rulemaking: One commenter stated that the number of 
4,4'-DMAR related deaths reported in Europe is small relative to its 
population, and evidence supporting scheduling is anecdotal. The 
commenter stated that schedule I control would restrict the ability to 
conduct research, and suggested that additional research with 4,4'-DMAR 
should take place first before clamping down. This commenter questioned 
the appropriateness of control of 4,4'-DMAR as a schedule I substance 
and suggested schedule II control for this substance.
    DEA Response: DEA does not agree. As discussed above, in May 2016, 
the Secretary-General advised the U.S. Secretary of State that the CND 
voted in March 2016 to place 4,4'-DMAR in Schedule II of the 1971 
Convention. As the CSA recognizes, under 21 U.S.C. 801(7), the United 
States is a party to international conventions, including the 1971 
Convention, and is obligated to maintain appropriate control provisions 
related to the drugs that are covered by the treaty. In addition, DEA 
conducted an eight-factor analysis pursuant to 21 U.S.C. 811(c), and 
based its scheduling determination on a comprehensive evaluation of all 
available data, not just the number of deaths and anecdotal data. As 
stated in the proposed rulemaking, after careful review of all data, 
DEA concurred with HHS' assessment that 4,4'-DMAR has abuse potential 
comparable to other schedule I (e.g. aminorex and 3,4-
methylenedioxymethamphetamine) or II (d-amphetamine) substances, and is 
therefore promulgating this final rule placing 4,4'-DMAR in schedule I 
under the CSA.
    With regard to the commenter's statement that placement of 4,4'-
DMAR in schedule I would restrict research on this substance, DEA notes 
that placing a substance in schedule I does not prohibit research on 
that substance. Persons interested in conducting research with 4,4'-
DMAR can do so provided that they have a DEA schedule I researcher 
registration and meet all other statutory and regulatory criteria. This 
registration can be obtained by submitting an application for schedule 
I registration in accordance with 21 CFR 1301.11, 1301.13, 1301.18, and 
1301.32. The CSA provides the specific administrative process for the 
Attorney General (as delegated to the Administrator), in consultation 
with the Secretary, to approve the registration for the bonafide 
research with schedule I drug substances. 21 U.S.C. 823(f); see 21 CFR 
1301.18. Thus, DEA believes that adding 4,4'-DMAR in the list of 
schedule I substances will not restrict any legitimate research.
    With regard to the commenter's suggestion that 4,4'-DMAR be placed 
under schedule II, as DEA has stated in prior scheduling petitions, 
``Congress established only one schedule, schedule I, for drugs of 
abuse with `no currently accepted medical use in treatment in the 
United States' and `lack of accepted safety for use . . . under medical 
supervision.' 21 U.S.C. 812(b).'' 76 FR 40552 (2011); 66 FR 20038 
(2001). As stated by HHS in its scientific and medical evaluation of 
4,4'-DMAR, there are currently no Food and Drug Administration (FDA)-
approved drug products containing 4,4'-DMAR for any clinical 
indication, nor are there clinical studies or petitioners that claim an 
accepted medical use in the United States. Thus, 4,4'-DMAR currently 
has no accepted medical use in treatment in the United States.\2\ 
Therefore, placement of 4,4'-DMAR in schedule I of the CSA is 
appropriate.
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    \2\ Although there is no evidence suggesting that 4,4'-DMAR 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, to have a currently accepted medical use in treatment in the 
United States, all of the following must be demonstrated: i. The 
drug's chemistry must be known and reproducible; ii. there must be 
adequate safety studies; iii. there must be adequate and well-
controlled studies proving efficacy; iv. the drug must be accepted 
by qualified experts; and v. the scientific evidence must be 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).
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Scheduling Conclusion

    After consideration of the public comments, the scientific and 
medical evaluations and accompanying recommendation of HHS, and 
conducting an independent eight-factor analysis, DEA finds substantial 
evidence of potential for abuse of 4,4'-DMAR. As such, DEA is 
permanently scheduling 4,4'-DMAR as a controlled substance under the 
CSA.

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 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) 4,4'-DMAR has a high potential for abuse. This potential is 
comparable to other schedule I substances (e.g., aminorex and 3,4-
methylenedioxymethamphetamine) or schedule II substances (e.g., d-
amphetamine);
    (2) 4,4'-DMAR has no currently accepted medical use in treatment in 
the United States; and
    (3) There is a lack of accepted safety for use of 4,4'-DMAR under 
medical supervision.
    Based on these findings, the Administrator concludes that 4,4'-
DMAR, including its salts, isomers, and salts of isomers, warrants 
control in schedule I of the CSA. 21 U.S.C. 812(b)(1).

Requirements for Handling 4,4'-DMAR

    4,4'-DMAR is subject to the CSA's schedule I regulatory controls 
and

[[Page 44272]]

administrative, civil, and criminal sanctions applicable to the 
manufacture, distribution, dispensing, importing, exporting, research, 
and conduct of instructional activities, including the following:
    1. Registration. Any person who handles (manufactures, distributes, 
imports, exports, engages in research, or conducts instructional 
activities or chemical analysis with, or possesses), or who desires to 
handle 4,4'-DMAR, must 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. Any person who currently 
handles 4,4'-DMAR and is not registered with DEA must submit an 
application for registration and may not continue to handle 4,4'-DMAR, 
unless DEA has approved that application, pursuant to 21 U.S.C. 822, 
823, 957, and 958 and in accordance with 21 CFR parts 1301 and 1312.
    2. Disposal of stocks. Any person unwilling or unable to obtain a 
schedule I registration must surrender all quantities of currently held 
4,4'-DMAR, or may transfer all quantities of currently held 4,4'-DMAR 
to a person registered with DEA. 4,4'-DMAR is 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. 4,4'-DMAR is subject to schedule I security 
requirements and must be handled and stored pursuant to 21 U.S.C. 821 
and 823 and in accordance with 21 CFR 1301.71-1301.76. Non-
practitioners handling 4,4'-DMAR must also 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 4,4'-DMAR must comply with 21 U.S.C. 825 and 
958(e), and be in accordance with 21 CFR part 1302.
    5. Quota. Only registered manufacturers are permitted to 
manufacture 4,4'-DMAR in accordance with a quota assigned pursuant to 
21 U.S.C. 826 and in accordance with 21 CFR part 1303.
    6. Inventory. Every DEA registrant who possesses any quantity of 
4,4'-DMAR, must take an inventory of 4,4'-DMAR on hand 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 registers with DEA must take an initial inventory of 
all stocks of controlled substances (including 4,4'-DMAR) on hand on 
the date the registrant first engages in the handling of controlled 
substances, pursuant to 21 U.S.C. 827, 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 4,4'-DMAR) 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 must maintain records 
and submit reports with respect to 4,4'-DMAR, pursuant to 21 U.S.C. 827 
and 958(e), and in accordance with 21 CFR parts 1304, 1312, and 1317. 
Manufacturers and distributors must submit reports regarding 4,4'-DMAR 
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.
    8. Order Forms. Every DEA registrant who distributes 4,4'-DMAR must 
comply with the order form requirements, pursuant to 21 U.S.C. 828 and 
in accordance with 21 CFR part 1305.
    9. Importation and Exportation. All importation and exportation of 
4,4'-DMAR must comply with 21 U.S.C. 952, 953, 957, and 958, and in 
accordance with 21 CFR part 1312.
    10. Liability. Any activity involving 4,4'-DMAR not authorized by, 
or in violation of, the CSA or its implementing regulations, is 
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 final 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 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 rulemaking does not have federalism implications warranting 
the application of E.O. 13132. The 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 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 final rule and by approving it 
certifies that it will not have a significant economic impact on a 
substantial number of small entities.
    DEA is placing the substance 4,4'-DMAR, 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. This action imposes 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 4,4'-DMAR.
    Based on the review of HHS' scientific and medical evaluation and 
all other relevant data, DEA determined that 4,4'-DMAR 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 4,4'-DMAR in the United States. Therefore, DEA 
estimates that no United States entity currently handles 4,4'-DMAR and 
does not expect any United States entity to handle 4,4'-DMAR in the 
foreseeable future. DEA concludes that no legitimate United States 
entity would be affected by this rule. As such, this rule will not have 
a

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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 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.

Congressional Review Act

    This rule is not a major rule as defined by the Congressional 
Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is 
submitting a copy of this final rule to the Government Accountability 
Office, the House, and the Senate under the CRA.

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. This 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, 21 CFR part 1308 is amended 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. In Sec.  1308.11, redesignate paragraphs (f)(4) through (8) as 
(f)(5) through (9) and add a new paragraph (f)(4) to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (f) * * *

 (4) 4,4'-Dimethylaminorex (4,4'-DMAR; 4,5-dihydro-4-               1595
 methyl-5-(4-methylphenyl)-2-oxazolamine; 4-methyl-5-(4-
 methylphenyl)-4,5-dihydro-1,3-oxazol-2-amine)..........
 

* * * * *

Anne Milgram,
Administrator.
[FR Doc. 2021-17052 Filed 8-11-21; 8:45 am]
BILLING CODE 4410-09-P