Rule2021-17052
Schedules of Controlled Substances: Placement of 4,4′-DMAR in Schedule I
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 12, 2021
Effective
September 13, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 153 (Thursday, August 12, 2021)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
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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
<a href="http://www.regulations.gov">http://www.regulations.gov</a> 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
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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
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.