[Federal Register Volume 81, Number 24 (Friday, February 5, 2016)]
[Rules and Regulations]
[Pages 6175-6177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02308]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-385E]


Schedules of Controlled Substances: Extension of Temporary 
Placement of PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA in Schedule I 
of the Controlled Substances Act

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

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SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this final order to extend the temporary schedule I status of 
four synthetic cannabinoids pursuant to the temporary scheduling 
provisions of the Controlled Substances Act. The substances are: 
quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC); 
quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-
22; 5F-PB-22); N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-
1H-indazole-3-carboxamide (AB-FUBINACA); and N-(1-amino-3,3-dimethyl-1-
oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA), 
including their optical, positional and geometric isomers, salts, and 
salts of isomers. The current final order temporarily placing PB-22, 
5F-PB-22, AB-FUBINACA, and ADB-PINACA into schedule I is in effect 
through February 9, 2016. This final order will extend the temporary 
scheduling of PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA for one 
year, or until the permanent scheduling action for these four 
substances is completed, whichever occurs first.

DATES: This final order is effective February 5, 2016.

FOR FURTHER INFORMATION CONTACT: Barbara J. Boockholdt, Office of 
Diversion Control, 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

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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 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 February 10, 2014, the DEA published a final order in the 
Federal Register amending 21 CFR 1308.11(h) to temporarily place the 
four synthetic cannabinoids quinolin-8-yl 1-pentyl-1H-indole-3-
carboxylate (PB-22; QUPIC); quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-
3-carboxylate (5-fluoro-PB-22; 5F-PB-22); N-(1-amino-3-methyl-1-
oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-
FUBINACA); and N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-
indazole-3-carboxamide (ADB-PINACA), into schedule I of the CSA 
pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). 79 
FR 7577. That final order was effective on the date of publication, and 
was based on findings by the Deputy Administrator of the DEA that the 
temporary scheduling of these four 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 expire two years from 
the effective date of the scheduling order, which was February 10, 
2014. 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 final 
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 PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA. 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 four synthetic 
cannabinoids. On December 30, 2014, 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 PB-22, 5F-PB-
22, AB-FUBINACA, and ADB-PINACA, and in accordance with 21 U.S.C. 811 
(b) and (c). Upon evaluating the scientific and medical evidence, on 
January 19, 2016, the HHS submitted to the Administrator of the DEA its 
four 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 PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA in 
accordance with 21 U.S.C. 811(c). The DEA published a notice of 
proposed rulemaking for the placement of PB-22, 5F-PB-22, AB-FUBINACA, 
and ADB-PINACA 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 PB-22, 5F-PB-22, AB-FUBINACA 
and ADB-PINACA, including their 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 final order, the schedule I requirements 
for handling PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA, including 
their 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

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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 final 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. 5 U.S.C. 808(2). It is in the public interest to maintain the 
temporary placement of PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA 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 final 
order extending the temporary scheduling order shall take effect 
immediately upon its publication. The DEA has submitted a copy of this 
final 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: February 2, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-02308 Filed 2-4-16; 8:45 am]
 BILLING CODE 4410-09-P