[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Rules and Regulations]
[Pages 4411-4412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01746]



Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / 
Rules and Regulations

[[Page 4411]]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-421]


Schedules of Controlled Substances: Extension of Temporary 
Placement of MAB-CHMINACA in Schedule I of the Controlled Substances 
Act

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Temporary rule; temporary scheduling order; extension.

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SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this temporary scheduling order to extend the temporary 
schedule I status of a synthetic cannabinoid, N-(1-amino-3,3-dimethyl-
1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (other 
names: MAB-CHMINACA; ADB-CHMINACA), including its optical, positional 
and geometric isomers, salts, and salts of isomers. The schedule I 
status of MAB-CHMINACA currently is in effect through February 4, 2018. 
This temporary order will extend the temporary scheduling of MAB-
CHMINACA for one year, or until the permanent scheduling action for 
this substance is completed, whichever occurs first.

DATES: This temporary scheduling order, which extends the final order 
(81 FR 6171, February 5, 2016), is effective February 5, 2018 and 
expires on February 5, 2019. If DEA publishes a final rule making this 
scheduling action permanent, this order will expire on the effective 
date of that rule, if the effective date is earlier than February 5, 
2019.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.

SUPPLEMENTARY INFORMATION: 

Background and Legal Authority

    On February 5, 2016, the Acting Administrator of the Drug 
Enforcement Administration (DEA) published a final order in the Federal 
Register (81 FR 6171) temporarily placing N-(1-amino-3,3-dimethyl-1-
oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (other 
names: MAB-CHMINACA; ADB-CHMINACA), a synthetic cannabinoid (SC) 
substance, in schedule I of the Controlled Substances Act (CSA) 
pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). 
That final order was effective on the date of publication, and was 
based on findings by the Acting Administrator of the DEA that the 
temporary scheduling of this SC was necessary to avoid an imminent 
hazard to the public safety pursuant to 21 U.S.C. 811(h)(1). Section 
201(h)(2) of the CSA, 21 U.S.C. 811(h)(2), requires that the temporary 
control of this substance expires two years from the effective date of 
the scheduling order, or on February 5, 2018. However, the CSA also 
provides that during the pendency of proceedings under 21 U.S.C. 
811(a)(1) with respect to the substance, the temporary scheduling \1\ 
of that substance could 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 the DEA 
pursuant to 28 CFR 0.100) on his own motion, at the request of the 
Secretary of Health and Human Services,\2\ or on the petition of any 
interested party.
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    \1\ Though DEA has used the term ``final order'' with respect to 
temporary scheduling orders in the past, this notice adheres to the 
statutory language of 21 U.S.C. 811(h), which refers to a 
``temporary scheduling order.'' No substantive change is intended.
    \2\ Because the Secretary of the Department of Health and Human 
Services (HHS) has delegated to the Assistant Secretary for Health 
of the HHS the authority to make domestic drug scheduling 
recommendations, for purposes of this temporary scheduling order, 
all subsequent references to ``Secretary'' have been replaced with 
``Assistant Secretary.''
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    The Acting Administrator of the DEA, on his own motion pursuant to 
21 U.S.C. 811(a), has initiated proceedings under 21 U.S.C. 811(a)(1) 
to permanently schedule MAB-CHMINACA. The 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 this SC. On May 18, 2016, the DEA submitted a request to 
the HHS to provide the DEA with a scientific and medical evaluation of 
available information and a scheduling recommendation for MAB-CHMINACA, 
and in accordance with 21 U.S.C. 811(b) and (c). Upon evaluating the 
scientific and medical evidence, on January 19, 2018, the HHS submitted 
to the Acting Administrator of the DEA its scientific and medical 
evaluation for MAB-CHMINACA. Upon receipt of the scientific and medical 
evaluation and scheduling recommendation from the HHS, the DEA reviewed 
the documents and all other relevant data, and conducted its own eight-
factor analysis of the abuse potential of MAB-CHMINACA in accordance 
with 21 U.S.C. 811(c). The DEA published a notice of proposed 
rulemaking for the placement of MAB-CHMINACA in schedule I elsewhere in 
this issue of the Federal Register. If this order is made permanent, 
the Drug Enforcement Administration will publish a final rule in the 
Federal Register.
    Pursuant to 21 U.S.C. 811(h)(2), the Acting Administrator of the 
DEA orders that the temporary scheduling of MAB-CHMINACA, including its 
optical, positional and geometric isomers, salts, and salts of isomers, 
be extended for one year, or until the permanent scheduling proceeding 
is completed, whichever occurs first.
    In accordance with this temporary scheduling order, the schedule I 
requirements for handling MAB-CHMINACA, including its optical, 
positional and geometric isomers, salts, and salts of isomers, will 
remain in effect for one year, or until the permanent scheduling 
proceeding is completed, whichever occurs first.

Regulatory Matters

    The CSA provides for an expedited temporary scheduling action where 
such action is necessary to avoid an imminent hazard to the public 
safety. 21 U.S.C. 811(h). The Attorney General may, by order, schedule 
a substance in schedule I on a temporary basis. Id. 21 U.S.C. 811(h) 
also provides that the temporary scheduling of a substance shall expire 
at the end of two years from the date of the issuance of the order 
scheduling such substance, except that the Attorney General may, during 
the pendency of proceedings to permanently schedule the substance, 
extend the temporary scheduling for up to one year.
    To the extent that 21 U.S.C. 811(h) directs that temporary 
scheduling actions be issued by order and sets forth the procedures by 
which such orders are to be issued and extended, the DEA believes that 
the notice and comment requirements of section 553 of the 
Administrative Procedure Act (APA), 5 U.S.C. 553, do not apply to this 
extension of the temporary scheduling action. In the alternative, even 
assuming that this action might be subject to section 553 of the APA, 
the Acting Administrator finds that there is good cause to forgo the 
notice and comment requirements of section 553, as any further delays 
in the process for extending the temporary scheduling order would be 
impracticable and contrary to the public interest in view of the 
manifest urgency to avoid an imminent hazard to the public safety. 
Further, the DEA believes that this order

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extending the temporary scheduling action is not a ``rule'' as defined 
by 5 U.S.C. 601(2), and, accordingly, is not subject to the 
requirements of the Regulatory Flexibility Act (RFA). The requirements 
for the preparation of an initial regulatory flexibility analysis in 5 
U.S.C. 603(a) are not applicable where, as here, the DEA is not 
required by section 553 of the APA or any other law to publish a 
general notice of proposed rulemaking.
    Additionally, this action is not a significant regulatory action as 
defined by Executive Order 12866 (Regulatory Planning and Review), 
section 3(f), and, accordingly, this action has not been reviewed by 
the Office of Management and Budget (OMB).
    This action will not have substantial direct effects on the States, 
on the relationship between the national government and the States, or 
on the distribution of power and responsibilities among the various 
levels of government. Therefore, in accordance with Executive Order 
13132 (Federalism) it is determined that this action does not have 
sufficient federalism implications to warrant the preparation of a 
Federalism Assessment.
    As noted above, this action is an order, not a rule. Accordingly, 
the Congressional Review Act (CRA) is inapplicable, as it applies only 
to rules. However, if this were a rule, pursuant to the CRA, ``any rule 
for which an agency for good cause finds that notice and public 
procedure thereon are impracticable, unnecessary, or contrary to the 
public interest, shall take effect at such time as the federal agency 
promulgating the rule determines.'' 5 U.S.C. 808(2). It is in the 
public interest to maintain the temporary placement of MAB-CHMINACA in 
schedule I because it poses a public health risk. The temporary 
scheduling action was taken pursuant to 21 U.S.C. 811(h), which is 
specifically designed to enable the DEA to act in an expeditious manner 
to avoid an imminent hazard to the public safety. Under 21 U.S.C. 
811(h), temporary scheduling orders are not subject to notice and 
comment rulemaking procedures. The DEA understands that the CSA frames 
temporary scheduling actions as orders rather than rules to ensure that 
the process moves swiftly, and this extension of the temporary 
scheduling order continues to serve that purpose. For the same reasons 
that underlie 21 U.S.C. 811(h), that is, the need to place this 
substance in schedule I because it poses an imminent hazard to public 
safety, it would be contrary to the public interest to delay 
implementation of this extension of the temporary scheduling order. 
Therefore, in accordance with section 808(2) of the CRA, this order 
extending the temporary scheduling order shall take effect immediately 
upon its publication. The DEA has submitted a copy of this temporary 
scheduling order to both Houses of Congress and to the Comptroller 
General, although such filing is not required under the Small Business 
Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act), 
5 U.S.C. 801-808 because, as noted above, this action is an order, not 
a rule.

    Dated: January 24, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-01746 Filed 1-29-18; 8:45 am]
 BILLING CODE 4410-09-P