[Federal Register Volume 82, Number 17 (Friday, January 27, 2017)]
[Rules and Regulations]
[Pages 8590-8592]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01517]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-402]


Schedules of Controlled Substances: Extension of Temporary 
Placement of THJ-2201, AB-PINACA and AB-CHMINACA in Schedule I of the 
Controlled Substances Act

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Temporary order.

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[[Page 8591]]

SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this temporary order to extend the temporary schedule I status 
of three synthetic cannabinoids pursuant to the temporary scheduling 
provisions of the Controlled Substances Act. The substances are: [1-(5-
Fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201); N-
1-Amino-3-methyl-1-oxo-2-butanyl]-1-pentyl-1H-indazole-3-carboxamide 
(AB-PINACA); N-[1-Amino-3-methyl-1-oxo-2-butanyl]-1-(cyclohexylmethyl)-
1H-indazole-3-carboxamide (AB-CHMINACA), including their optical, 
positional and geometric isomers, salts, and salts of isomers. The 
current final order temporarily placing THJ-2201, AB-PINACA and AB-
CHMINACA into schedule I is in effect through January 29, 2017. This 
order will extend the temporary scheduling of THJ-2201, AB-PINACA and 
AB-CHMINACA for one year, or until the permanent scheduling action for 
these three substances is completed, whichever occurs first.

DATES: This temporary order is effective January 27, 2017. This 
temporary order will expire on January 29, 2018, or when a permanent 
scheduling proceeding is completed, whichever occurs first.

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: 

Legal Authority

    The Drug Enforcement Administration (DEA) implements and enforces 
titles II and III of the Comprehensive Drug Abuse Prevention and 
Control Act of 1970, as amended. Titles II and III are referred to as 
the ``Controlled Substances Act'' and the ``Controlled Substances 
Import and Export Act,'' respectively, and are collectively referred to 
as the ``Controlled Substances Act'' or the ``CSA'' for the purpose of 
this action. 21 U.S.C. 801-971. The DEA published the implementing 
regulations for these statutes in title 21 of the Code of Federal 
Regulations (CFR), chapter II.
    The CSA and its implementing regulations are designed to prevent, 
detect, and eliminate the diversion of controlled substances and listed 
chemicals into the illicit market while ensuring an adequate supply is 
available for the legitimate medical, scientific, research, and 
industrial needs of the United States. Controlled substances have the 
potential for abuse and dependence and are controlled to protect the 
public health and safety.
    Under the CSA, every controlled substance is classified into one of 
five schedules based upon its potential for abuse, its currently 
accepted medical use in treatment in the United States, and the degree 
of dependence the drug or other substance may cause. 21 U.S.C. 812. The 
initial schedules of controlled substances established by Congress are 
found at 21 U.S.C. 812(c), and the current list of all scheduled 
substances is published at 21 CFR part 1308.
    Section 201 of the CSA (21 U.S.C. 811) provides the Attorney 
General with the authority to temporarily place a substance into 
schedule I of the CSA for two years without regard to the requirements 
of 21 U.S.C. 811(b) if she finds that such action is necessary to avoid 
an imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In 
addition, if proceedings to control a substance are initiated under 21 
U.S.C. 811(a)(1), the Attorney General may extend the temporary 
scheduling for up to one year. 21 U.S.C. 811(h)(2).
    Where the necessary findings are made, a substance may be 
temporarily scheduled if it is not listed in any other schedule under 
section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or 
approval in effect for the substance under section 505 of the Federal 
Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 
811(h)(1). The Attorney General has delegated her scheduling authority 
under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

Background

    On January 30, 2015, the DEA published a final order in the Federal 
Register amending 21 CFR 1308.11(h) to temporarily place the three 
synthetic cannabinoids [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-
1-yl)methanone (THJ-2201); N-1-amino-3-methyl-1-oxo-2-butanyl]-1-
pentyl-1H-indazole-3-carboxamide (AB-PINACA); and N-[1-amino-3-methyl-
1-oxo-2-butanyl]-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-
CHMINACA) into schedule I of the CSA pursuant to the temporary 
scheduling provisions of 21 U.S.C. 811(h). 80 FR 5042. That final order 
was effective on the date of publication, and was based on findings by 
the Administrator of the DEA that the temporary scheduling of these 
three synthetic cannabinoids 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 
these substances expires two years from the effective date of the 
scheduling order, or on January 29, 2017. 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 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 or her own motion, at the request of 
the Secretary of Health and Human Services,\1\ or on the petition of 
any interested party.
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    \1\ Because the Secretary of the Department of Health and Human 
Services has delegated to the Assistant Secretary for Health of the 
Department of Health and Human Services the authority to make 
domestic drug scheduling recommendations, for purposes of this 
order, all subsequent references to ``Secretary'' have been replaced 
with ``Assistant Secretary.''
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    The 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 THJ-2201, AB-PINACA and AB-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 these three synthetic 
cannabinoids. On August 26, 2015, 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 THJ-2201, AB-
PINACA and AB-CHMINACA, in accordance with 21 U.S.C. 811(b) and (c). 
Upon evaluating the scientific and medical evidence, on November 14, 
2016, the HHS submitted to the Administrator of the DEA its three 
scientific and medical evaluations for these substances. Upon receipt 
of the scientific and medical evaluation and scheduling recommendations 
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 THJ-2201, AB-PINACA and AB-CHMINACA in accordance with 21 
U.S.C. 811(c). The DEA has published a notice of proposed rulemaking 
for the placement of THJ-2201, AB-PINACA and AB-CHMINACA into schedule 
I elsewhere in this issue of the Federal Register.
    Pursuant to 21 U.S.C. 811(h)(2), the Administrator of the DEA 
orders that the temporary scheduling of THJ-2201, AB-PINACA and AB-
CHMINACA, including their optical, positional and geometric isomers, 
salts, and salts of

[[Page 8592]]

isomers, be extended for one year, or until the permanent scheduling 
proceeding is completed, whichever occurs first.
    In accordance with this temporary order, the schedule I 
requirements for handling THJ-2201, AB-PINACA and AB-CHMINACA, 
including their optical, positional and geometric isomers, salts, and 
salts of isomers, are extended 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 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 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. It is in the public interest to maintain the temporary 
placement of THJ-2201, AB-PINACA and AB-CHMINACA in schedule I because 
they pose 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 these substances 
in schedule I because they pose 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 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 17, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017-01517 Filed 1-26-17; 8:45 am]
 BILLING CODE 4410-09-P