[Federal Register Volume 80, Number 219 (Friday, November 13, 2015)]
[Rules and Regulations]
[Pages 70658-70659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29028]



[[Page 70657]]

Vol. 80

Friday,

No. 219

November 13, 2015

Part V





 Department of Justice





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 Drug Enforcement Administration





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21 CFR Part 1308





Schedules of Controlled Substances: Extension of Temporary Placement of 
Three Synthetic Phenethylamines in Schedule I; Final Order

  Federal Register / Vol. 80 , No. 219 / Friday, November 13, 2015 / 
Rules and Regulations  

[[Page 70658]]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-424]


Schedules of Controlled Substances: Extension of Temporary 
Placement of Three Synthetic Phenethylamines in Schedule I

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 extending the temporary schedule I status for 
three synthetic phenethylamines into the Controlled Substances Act 
pursuant to the temporary scheduling provisions of the Act. The 
substances are: 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-
methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5), 2-(4-
chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 
2C-C-NBOMe; 25C; Cimbi-82), and 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-
methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36) 
[hereinafter 25I-NBOMe, 2C-NBOMe, and 25-NBOMe, respectively]. The 
initial temporary scheduling was based on a finding by the Deputy 
Administrator that the placement of these synthetic phenethylamines and 
their optical, positional, and geometric isomers, salts, and salts of 
isomers into schedule I of the Controlled Substances Act is necessary 
to avoid an imminent hazard to the public safety. The current final 
order temporarily placing 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe in 
schedule I is due to expire on November 14, 2015. This final order will 
extend the temporary scheduling of 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe 
for one year, or until the permanent scheduling action for these three 
substances is completed, whichever occurs first. As a result of this 
order, the full effect of the Controlled Substances Act and its 
implementing regulations, including criminal, civil and administrative 
penalties, sanctions, and regulatory controls of schedule I substances 
will be imposed on the manufacture, distribution, possession, 
importation, and exportation of these synthetic phenethylamines.

DATES: This final order is effective November 13, 2015.

FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, 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 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 November 15, 2013, the DEA published a final order in the 
Federal Register amending 21 CFR 1308.11(h) to temporarily place the 
three synthetic phenethylamines 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-
methoxybenzyl)ethanamine (25I-NBOMe, 2C-I-NBOMe, 25I, Cimbi-5); 2-(4-
chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe, 
2C-C-NBOMe, 25C, Cimbi-82); and 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-
methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36) into 
schedule I of the CSA pursuant to the temporary scheduling provisions 
of 21 U.S.C. 811(h). 78 FR 68716. 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 three 
synthetic phenethylamines 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, or on or before November 14, 2015. However, the CSA 
also provides that the temporary scheduling may be extended for up to 
one year, during the pendency of proceedings under 21 U.S.C. 811(a)(1). 
21 U.S.C. 811(h)(2). Proceedings for the permanent 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 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe. The DEA has 
gathered and reviewed the available information regarding the 
pharmacology, chemistry, trafficking, actual abuse, pattern of

[[Page 70659]]

abuse, and the relative potential for abuse for these three synthetic 
phenethylamines. On July 23, 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 25I-NBOMe, 
25C-NBOMe, and 25B-NBOMe, in accordance with 21 U.S.C. 811 (b) and (c). 
Upon evaluating the scientific and medical evidence, on August 12, 
2015, the HHS submitted to the Administrator of the DEA its three 
scientific and medical evaluations entitled, ``Basis for the 
Recommendation to Place 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-
methoxybenzyl)ethanamine (25I-NBOMe) and its Salts in Schedule I of the 
Controlled Substances Act (CSA),'' ``Basis for the Recommendation to 
Place 2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine 
(25C-NBOMe) and its Salts in Schedule I of the Controlled Substances 
Act (CSA),'' and ``Basis for the Recommendation to Place 2-(4-bromo-
2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe) and its 
Salts in Schedule I of the Controlled Substances Act (CSA).'' 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 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe in accordance 
with 21 U.S.C. 811(c). The DEA published a notice of proposed 
rulemaking for the placement of 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe 
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 25I-NBOMe, 25C-NBOMe, and 25B-
NBOMe, including their optical, positional, and geometric isomers, 
salts, and salts of isomers whenever the existence of such salts, 
isomers, and salts of isomers is possible, be extended for one year, or 
until the proceedings to permanently schedule these three substances is 
completed, whichever occurs first.
    In accordance with this final order, the schedule I requirements 
for handling 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe, including their 
optical, positional, and geometric isomers, salts, and salts of isomers 
whenever the existence of such salts, isomers, and salts of isomers is 
possible, 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 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.
    Pursuant to section 808(2) of the Congressional Review Act (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 25I-
NBOMe, 25C-NBOMe, and 25B-NBOMe 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: November 10, 2015.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2015-29028 Filed 11-12-15; 8:45 am]
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