[Federal Register Volume 81, Number 187 (Tuesday, September 27, 2016)]
[Rules and Regulations]
[Pages 66181-66184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23185]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-423]


Schedules of Controlled Substances: Placement of Three Synthetic 
Phenethylamines Into 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 Administrator of the 
Drug Enforcement Administration places 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), 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, 
into schedule I of the Controlled Substances Act. This scheduling 
action is pursuant to the Controlled Substances Act which requires that 
such actions be made on the record after opportunity for a hearing 
through formal rulemaking. This action continues the application of 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, or 
possess), or propose to handle 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe.

DATES: Effective: October 27, 2016.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, 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. 21 U.S.C. 801-971. 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 purposes of this action. The DEA publishes 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, each 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 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.
    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 subsection (b) of section 
812 of this title for the schedule in which such drug is to be placed * 
* *.'' The Attorney General has delegated scheduling authority under 21 
U.S.C. 811 to the Administrator of the DEA, 28 CFR 0.100, who in turn 
has redelegated that authority to the Deputy Administrator of the DEA. 
28 CFR part 0, appendix to subpart R.
    The CSA provides that proceedings for the issuance, amendment, or 
repeal of the scheduling of any drug or other substance may be 
initiated by the

[[Page 66182]]

Attorney General (1) on her own motion; (2) at the request of the 
Secretary of the Department of Health and Human Services (HHS),\1\ or 
(3) on the petition of any interested party. 21 U.S.C. 811(a). This 
action was initiated on the Attorney General's own motion, as delegated 
to the Drug Enforcement Administration, and is supported by, inter 
alia, a recommendation from the Assistant Secretary for Health of the 
HHS \2\ and an evaluation of all relevant data by the DEA. This action 
continues the application of the regulatory controls and 
administrative, civil, and criminal sanctions of schedule I controlled 
substances on any person who handles, or proposes to handle, 25I-NBOMe, 
25C-NBOMe, or 25B-NBOMe.
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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), the FDA acts as the lead agency within the 
Department of Health and Human Services (HHS) in carrying out the 
Secretary's scheduling responsibilities under the CSA, with the 
concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The Secretary of the 
HHS has delegated to the Assistant Secretary for Health of the HHS 
the authority to make domestic drug scheduling recommendations. 58 
FR 35460, July 1, 1993.
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Background

    On October 10, 2013, the DEA published a notice of intent to 
temporarily place 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 pursuant to the temporary scheduling provisions of the CSA. 
78 FR 61991. On November 15, 2013, the DEA published a final order 
amending 21 CFR 1308.11(h) to temporarily place these three synthetic 
phenethylamines into schedule I of the CSA. 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 phenethylamine substances was 
necessary to avoid an imminent hazard to public safety pursuant to 21 
U.S.C. 811(h)(1). Section 201(h)(2) of the CSA requires that the 
temporary scheduling of a substance expire two years from the effective 
date of the scheduling order, or on or before November 14, 2015. 21 
U.S.C. 811(h)(2). 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). Id. Accordingly, on November 13, 
2015, the DEA published a notice of proposed rulemaking (NPRM) to 
permanently control 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe in schedule I 
of the CSA. 80 FR 70649. Specifically, the DEA proposed to add these 
substances to 21 CFR 1308.11(d), hallucinogenic substances. Also, on 
November 13, 2015, the DEA extended the temporary scheduling of 25I-
NBOMe, 25C-NBOMe, and 25B-NBOMe by one year, until November 13, 2016. 
80 FR 70658.

DEA and HHS Eight Factor Analyses

    On August 12, 2015, the HHS provided the DEA with three scientific 
and medical evaluation documents prepared by the FDA 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).'' After 
considering the eight factors in 21 U.S.C. 811(c), including 
consideration of each substance's abuse potential, legitimate medical 
use, and dependence liability, the Assistant Secretary of the HHS 
recommended that 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe be controlled in 
schedule I of the CSA. In response, the DEA conducted its own 
eightfactor analysis of 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe. Both the 
DEA and HHS analyses are available in their entirety under the tab 
``Supporting Documents'' of the public docket of this action at http://www.regulations.gov under FDMS Docket ID: DEA-2015-0019 (Docket Number 
DEA-423).

Determination to Schedule 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe

    After a review of the available data, including the scientific and 
medical evaluations and the scheduling recommendations from the HHS, 
the DEA published an NPRM entitled ``Schedules of Controlled 
Substances: Placement of Three Synthetic Phenethylamines into Schedule 
I,'' proposing to control 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe in 
schedule I of the CSA. 80 FR 70649, November 13, 2015. The proposed 
rule provided an opportunity for interested persons to file a request 
for hearing in accordance with DEA regulations on or before December 
14, 2015. No requests for such a hearing were received by the DEA. The 
NPRM also provided an opportunity for interested persons to submit 
written comments on the proposal on or before December 14, 2015.

Comments Received

    The DEA received no comments on the proposed rule to schedule 25I-
NBOMe, 25C-NBOMe, and 25B-NBOMe.

Scheduling Conclusion

    After consideration of the scientific and medical evaluations and 
accompanying recommendations of the HHS, and the DEA's consideration of 
its own eight-factor analyses, the DEA finds that these facts and all 
other relevant data constitute substantial evidence of potential for 
abuse of 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe. As such, the DEA is 
permanently scheduling 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe as 
controlled substances 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 the DEA, pursuant to 21 
U.S.C. 811(a) and 21 U.S.C. 812(b)(1), finds that:
    (1) 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe have a high potential for 
abuse that is comparable to other schedule I substances such as 2C-I, 
2C-C, 2C-B, LSD and DOM;
    (2) 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe have no currently accepted 
medical use in treatment in the United States; and
    (3) There is a lack of accepted safety for use of 25I-NBOMe, 25C-
NBOMe, or 25B-NBOMe under medical supervision.
    Based on these findings, the Administrator of the DEA concludes 
that 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), including their optical, positional, 
and geometric isomers, salts and salts of isomers, whenever the 
existence of such salts, isomers, and salts of isomers is

[[Page 66183]]

possible, warrant control in schedule I of the CSA. 21 U.S.C. 
812(b)(1).

Requirements for Handling 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe

    25I-NBOMe, 25C-NBOMe, or 25B-NBOMe are currently scheduled on a 
temporary basis in schedule I \2\ and are therefore currently subject 
to the CSA regulatory controls and administrative, civil, and criminal 
sanctions applicable to the manufacture, distribution, reverse 
distribution, importation, exportation, engagement in research, conduct 
of instructional activities or chemical analysis, and possession of 
schedule I controlled substances, including those listed below. These 
controls will continue on a permanent basis:
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    \2\ 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe are currently subject to 
schedule I controls on a temporary basis, pursuant to 21 U.S.C. 
811(h). 80 FR 70658, Nov. 13, 2015.
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    1. Registration. Any person who handles (manufactures, distributes, 
reverse distributes, imports, exports, engages in research, or conducts 
instructional activities or chemical analysis with, or possesses) 25I-
NBOMe, 25C-NBOMe, or 25B-NBOMe, or who desires to handle 25I-NBOMe, 
25C-NBOMe, or 25B-NBOMe must be registered with the 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.
    2. Disposal of Stocks. 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe must be 
disposed of in accordance with 21 CFR part 1317, in addition to all 
other applicable federal, state, local, and tribal laws.
    3. Security. 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe continue to be 
subject to schedule I security requirements and must be handled and 
stored pursuant to 21 U.S.C. 821, 823, and 871(b), and in accordance 
with 21 CFR 1301.71-1301.93.
    4. Labeling and Packaging. All labels, labeling, and packaging for 
commercial containers of 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe must be in 
compliance 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 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe 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 required to keep records and who 
possesses any quantity of 25I-NBOMe, 25C-NBOMe, and/or 25B-NBOMe is 
required to maintain an inventory of all stocks of NBOMes on hand, 
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 25I-NBOMe, 25C-NBOMe, and/or 25B-
NBOMe pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 
parts 1304 and 1317. Manufacturers and distributors must submit reports 
regarding 25I-NBOMe, 25C-NBOMe, and/or 25B-NBOMe to the Automation of 
Reports and Consolidated Order System (ARCOS) pursuant to 21 U.S.C. 827 
and in accordance with 21 CFR 1304.33.
    8. Order Forms. Every DEA registrant who distributes 25I-NBOMe, 
25C-NBOMe, or 25B-NBOMe must continue to 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 
25I-NBOMe, 25C-NBOMe, or 25B-NBOMe must be in compliance with 21 U.S.C. 
952, 953, 957, and 958, and be in accordance with 21 CFR part 1312.
    10. Liability. Any activity involving 25I-NBOMe, 25C-NBOMe, or 25B-
NBOMe not authorized by, or in violation of, the CSA or its 
implementing regulations continues to be unlawful, and may subject the 
person to administrative, civil, and/or criminal sanctions.

Regulatory Analyses

Executive Orders 12866 and 13563, Regulatory Planning and Review, and 
13563, Improving Regulation and Regulatory Review

    In accordance with 21 U.S.C. 811(a), this scheduling action is 
subject to formal rulemaking procedures done ``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 12866 and the principles reaffirmed in 
Executive Order 13563.

Executive Order 12988, Civil Justice Reform

    This regulation meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 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 Executive Order 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 Executive Order 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 (RFA), 5 U.S.C. 601-602, has reviewed this rule and by approving 
it, certifies that it will not have a significant economic impact on a 
substantial number of small entities. On November 15, 2013, the DEA 
published a final order to temporarily place these three synthetic 
phenethylamines into schedule I of the CSA pursuant to the temporary 
scheduling provisions of 21 U.S.C. 811(h). 78 FR 68716. On November 13, 
2015, the DEA published a final order extending the temporary placement 
of these substances in schedule I of the CSA for up to one year 
pursuant to 21 U.S.C. 811(h)(2). 80 FR 70658. The DEA estimates that 
all entities handling or planning to handle 25I-NBOMe, 25C-NBOMe, or 
25B-NBOMe are currently registered to handle these substances. There 
are currently 18 registrations authorized to handle 25I-NBOMe, 25C-
NBOMe, or 25B-NBOMe, as well as a number of registered analytical labs 
that are authorized to handle schedule I controlled substances 
generally. These 18 registrations represent 13 entities, of which 6 are 
small entities Therefore, the DEA estimates six small entities are 
affected by this rule.
    A review of the 18 registrations indicates that all entities that 
currently handle 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe handle other 
schedule I controlled substances, and have established and implemented 
(or currently maintain) the systems and processes required to handle 
25I-NBOMe, 25C-NBOMe, or 25B-NBOMe.

[[Page 66184]]

Therefore, the DEA anticipates that this rule will impose minimal or no 
economic impact on any affected entities; and thus, will not have a 
significant economic impact on any of the six affected small entities. 
Therefore, the DEA has concluded that this rule will not have a 
significant effect on a substantial number of small entities.

Unfunded Mandates Reform Act of 1995

    On the basis of information contained in the ``Regulatory 
Flexibility Act'' section above, the DEA has determined and certifies 
pursuant to the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 
1501 et seq., 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 for inflation) in any one year. 
Therefore, neither a Small Government Agency Plan nor any other action 
is required under provisions of the UMRA of 1995.

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.

Congressional Review Act

    This rule is not a major rule as defined by section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996 
(Congressional Review Act (CRA)). This rule will not result in: An 
annual effect on the economy of $100,000,000 or more; a major increase 
in costs or prices for consumers, individual industries, federal, 
state, or local government agencies, or geographic regions; or 
significant adverse effects on competition, employment, investment, 
productivity, innovation, or on the ability of U.S.-based companies to 
compete with foreign based companies in domestic and export markets. 
However, pursuant to the CRA, the DEA has submitted a copy of this 
final rule to both Houses of Congress and to the Comptroller General.

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 to read 
as follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for part 1308 continues to read as follows:

     Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.


0
2. Amend Sec.  1308.11 by:
0
a. Adding paragraphs (d)(55) through (57); and
0
b. Removing paragraphs (h)(1) through (3) and redesignating paragraphs 
(h)(4) through (20) as (h)(1) through (17), respectively.
    The additions read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (d) * * *
    (55) 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine 
(25I-NBOMe, 2C-I-NBOMe) (7538)
    (56) 2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine 
(25C-NBOMe, 2C-C-NBOMe) (7537)
    (57) 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine 
(25B-NBOMe, 2C-B-NBOMe) (7536)
* * * * *

    Dated: September 15, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-23185 Filed 9-26-16; 8:45 am]
 BILLING CODE 4410-09-P