[Federal Register Volume 80, Number 219 (Friday, November 13, 2015)]
[Proposed Rules]
[Pages 70650-70655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29026]



[[Page 70649]]

Vol. 80

Friday,

No. 219

November 13, 2015

Part IV





Department of Justice





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Drug Enforcement Administration





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21 CFR Part 1308





Schedules of Controlled Substances: Placement of Three Synthetic 
Phenethylamines Into Schedule I; Proposed Rule

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

[[Page 70650]]


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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: Notice of proposed rulemaking.

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SUMMARY: The Drug Enforcement Administration proposes placing 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 Controlled Substances Act. This proposed scheduling 
action is pursuant to the Controlled Substance Act which requires that 
such actions be made on the record after opportunity for a hearing 
through formal rulemaking. If finalized, this action would impose the 
regulatory controls and administrative, civil, and criminal sanctions 
applicable to schedule I controlled substances on persons who handle 
(manufacture, 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: Interested persons may file written comments on this proposal in 
accordance with 21 CFR 1308.43(g). Electronic comments must be 
submitted, and written comments must be postmarked, on or before 
December 14, 2015. Commenters should be aware that the electronic 
Federal Docket Management System will not accept comments after 11:59 
p.m. Eastern Time on the last day of the comment period.
    Interested persons, defined at 21 CFR 1300.01 as those ``adversely 
affected or aggrieved by any rule or proposed rule issuable pursuant to 
section 201 of the Act (21 U.S.C. 811),'' may file a request for 
hearing, notice of appearance, or waiver of hearing pursuant to 21 CFR 
1308.44 and in accordance with 21 CFR 1316.45, 1316.47, and/or 1316.48, 
as applicable. Requests for hearing, notices of appearance, and waivers 
of an opportunity for a hearing or to participate in a hearing must be 
received on or before December 14, 2015.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-423'' on all correspondence, including any 
attachments.
     Electronic comments: The Drug Enforcement Administration 
encourages that all comments be submitted electronically through the 
Federal eRulemaking Portal, which provides the ability to type short 
comments directly into the comment field on the Web page or to attach a 
file for lengthier comments. Please go to http://www.regulations.gov 
and follow the online instructions at that site for submitting 
comments. Upon completion of your submission you will receive a Comment 
Tracking Number for your comment. Please be aware that submitted 
comments are not instantaneously available for public view on 
Regulations.gov. If you have received a Comment Tracking Number, your 
comment has been successfully submitted and there is no need to 
resubmit the same comment.
     Paper comments: Paper comments that duplicate the 
electronic submission are not necessary and are discouraged. Should you 
wish to mail a paper comment in lieu of an electronic comment, it 
should be sent via regular or express mail to: Drug Enforcement 
Administration, Attn: DEA Federal Register Representative/ODL, 8701 
Morrissette Drive, Springfield, Virginia 22152.
     Hearing requests: All requests for hearing and waivers of 
participation must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for hearing and waivers of participation should also be sent 
to: Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 
Morrissette Drive, Springfield, Virginia 22152.

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: 

Posting of Public Comments

    Please note that all comments received are considered part of the 
public record. They will, unless reasonable cause is given, be made 
available by the Drug Enforcement Administration (DEA) for public 
inspection online at http://www.regulations.gov. Such information 
includes personal identifying information (such as your name, address, 
etc.) voluntarily submitted by the commenter. The Freedom of 
Information Act (FOIA) applies to all comments received. If you want to 
submit personal identifying information (such as your name, address, 
etc.) as part of your comment, but do not want it to be made publicly 
available, you must include the phrase ``PERSONAL IDENTIFYING 
INFORMATION'' in the first paragraph of your comment. You must also 
place all of the personal identifying information you do not want made 
publicly available in the first paragraph of your comment and identify 
what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information and 
confidential business information identified as directed above will 
generally be made publicly available in redacted form. If a comment has 
so much confidential business information or personal identifying 
information that it cannot be effectively redacted, all or part of that 
comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information 
(such as name, address, and phone number) included in the text of your 
electronic submission that is not identified as directed above as 
confidential.
    An electronic copy of this document and supplemental information to 
this proposed rule are available at http://www.regulations.gov for easy 
reference.

Request for Hearing, Notice of Appearance at Hearing, Waiver of an 
Opportunity for a Hearing or To Participate in a Hearing

    Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking 
``on the record after opportunity for a hearing.'' Such proceedings are 
conducted pursuant to the provisions of the Administrative Procedure 
Act (APA), 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316, 
subpart D. In accordance with 21 CFR 1308.44(a)-(c), requests for 
hearing, notices of appearance, and waivers of an opportunity for a 
hearing or to participate in a hearing may be submitted only by 
interested persons, defined as those ``adversely affected or aggrieved 
by any rule or proposed rule

[[Page 70651]]

issuable pursuant to section 201 of the Act (21 U.S.C. 811).'' 21 CFR 
1300.01. Such requests or notices must conform to the requirements of 
21 CFR 1308.44(a) or (b), and 1316.47 or 1316.48, as applicable, and 
include a statement of interest of the person in the proceeding and the 
objections or issues, if any, concerning which the person desires to be 
heard. Any waiver must conform to the requirements of 21 CFR 1308.44(c) 
and may include a written statement regarding the interested person's 
position on the matters of fact and law involved in any hearing.
    Please note that pursuant to 21 U.S.C. 811(a), the purpose and 
subject matter of a hearing is restricted to: ``(A) find[ing] that such 
drug or other substance has a potential for abuse, and (B) mak[ing] 
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. . . .'' All requests for hearing and waivers 
of participation must be sent to the DEA using the address information 
provided above.

Legal Authority

    The 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. 21 U.S.C. 801-971. 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 providing 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 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 (A) finds that such drug or other substance has a 
potential for abuse, and (B) 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.
    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 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 proposed action is supported by a recommendation from the 
Assistant Secretary of the HHS and an evaluation of all other relevant 
data by the DEA. If finalized, this action would impose 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 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 November 15, 2013, the DEA published a final order in the 
Federal Register amending 21 CFR 1308.11(h) to temporarily place 2-(4-
iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe), 2-
(4-chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-
NBOMe), and 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-
methoxybenzyl)ethanamine (25B-NBOMe) 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, which became effective on the date of 
publication, 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). At the time the final 
order took effect, section 201(h)(2) of the CSA, 21 U.S.C. 811(h)(2), 
required that the temporary scheduling of a substance expire at the end 
of two years from the date of issuance of the scheduling order, and it 
provided that, during the pendency of proceedings under 21 U.S.C. 
811(a)(1) with respect to the substance, temporary scheduling of that 
substance could be extended for up to 1 year. Pursuant to 21 U.S.C. 
811(h)(2), the temporary scheduling of 25I-NBOMe, 25C-NBOMe, and 25B-
NBOMe expires on November 14, 2015, unless extended. An extension of 
the temporary order is being ordered by the DEA Administrator in a 
separate action.
    As described in the final order published on November 15, 2013, 
25I-NBOMe, 25C-NBOMe, and 25B-NBOMe are structurally and 
pharmacologically similar to 2,5-dimethoxy-4-iodophenethylamine (2C-I), 
2,5-dimethoxy-4-chlorophenethylamine (2C-C), and 2,5-dimethoxy-4-
bromophenthylamine (2C-B). While 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe 
have been used as research chemicals and/or studied due to their misuse 
and abuse, based on the review of the scientific literature, there are 
no known medical uses for 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe. The 
Assistant Secretary of Health for the U.S. Department of Health and 
Human Services (HHS) has advised that there are no exemptions or 
approvals in effect for 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe under 
section 505 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 355. 
As stated by the HHS, 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe have no known 
accepted medical use. They are not the subject of any approved new drug 
applications (NDAs) or investigational new drug applications (INDs), 
and are not currently marketed as approved drug products.

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

    Pursuant to 21 U.S.C. 811(a)(1), proceedings to add a drug or 
substance to those controlled under the CSA may be initiated by the 
Attorney General, or her delegate, the DEA Administrator. On July 23, 
2014, the DEA requested a scientific and medical evaluation and 
scheduling recommendations from the Assistant Secretary of Health for 
the HHS for 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe pursuant to 21 U.S.C. 
811(b). Upon receipt of the scientific and medical evaluation and 
scheduling recommendations from the HHS dated

[[Page 70652]]

August 12, 2015, 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 pursuant to 21 U.S.C. 
811(c).
    Included below is a brief summary of each of the eight factors as 
analyzed by the HHS and the DEA, and as considered by the DEA in this 
proposed action. Please note that both the DEA and the HHS analyses are 
available under ``Supporting Documents'' of the public docket for this 
proposed rule at http://www.regulations.gov under docket number DEA-
423.
    1. The Drug's Actual or Relative Potential for Abuse: As described 
by the HHS, the abuse potentials of 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe 
are associated with their abilities to produce psychoactive effects 
that are similar to those produced by other schedule I hallucinogens 
that have a high potential for abuse such as 2,5-dimethoxy-4-
methylamphetamine (DOM), 2,5-dimethoxy-4-iodophenethylamine (2C-I), 
2,5-dimethoxy-4-chlorophenethylamine (2C-C), 2,5-dimethoxy-4-
bromophenthylamine (2C-B), and lysergic acid diethylamide (LSD).
    The legislative history of the CSA suggests the DEA consider the 
following factors when determining whether a particular drug or 
substance has a potential for abuse: \2\
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    \2\ Comprehensive Drug Abuse Prevention and Control Act of 1970, 
H.R. Rep. No. 91-1444, 91st Cong., Sess. 2 (1970); reprinted in 1970 
U.S.C.C.A.N. 4566, 4601.
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    (1) There is evidence that individuals are taking the drug or drugs 
containing such a substance in amounts sufficient to create a hazard to 
their health or to the safety of other individuals or of the community;
    (2) There is significant diversion of the drug or drugs containing 
such a substance from legitimate drug channels;
    (3) Individuals are taking the drug or drugs containing such a 
substance on their own initiative rather than on the basis of medical 
advice from a practitioner licensed by law to administer such drugs in 
the course of his professional practice; or
    (4) The drug or drugs containing such a substance are new drugs so 
related in their action to a drug or drugs already listed as having a 
potential for abuse to make it likely that the drug will have the same 
potentiality for abuse as such drugs, thus making it reasonable to 
assume that there may be significant diversions from legitimate 
channels, significant use contrary to or without medical advice, or 
that it has a substantial capability of creating hazards to the health 
of the user or to the safety of the community.
    The substances 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe have no approved 
medical uses in the United States and they have been encountered on the 
illicit market with adverse outcomes on the public health and safety. 
Human use of these substances is due to the individual's own initiative 
and it has been established that they are being abused for their 
psychoactive properties. For these reasons, there are no legitimate 
drug channels for NBOMEs as marketed drugs and these substances should 
be limited to scientific research. Reports from public health and law 
enforcement communicate that these substances are being abused and 
taken in amounts sufficient to create a hazard to one's own health as 
evidenced by the emergency department admissions and deaths and this 
misuse is also a significant safety issue for those in the community. 
Data from forensic databases are used as indicators of illicit activity 
with drugs and abuse \3\ within the United States and include the 
System to Retrieve Information from Drug Evidence (STRIDE),\4\ 
STARLiMS, and the National Forensic Laboratory Information System 
(NFLIS).\5\ From January 2011 through August 2015 (query dates: 
September 22 & 23, 2015), STRIDE, STARLiMS, and NFLIS databases 
registered a total of 4,868 reports containing the three NBOMes (25I-
NBOMe--2,714 reports; 25C-NBOMe--1,291 reports; 25B-NBOMe--863 
reports). These drug reports represent NBOMe data reported to these 
databases by participating DEA, Customs and Border Protection (CBP), 
state, and local/municipal forensic laboratories in the United States. 
25I-NBOMe, 25C-NBOMe, and 25B-NBOMe have been reported to produce 
hallucinogenic effects. There have been numerous anecdotal self-reports 
substantiating that 25I-NBOMe, 25C-NBOMe, and/or 25B-NBOMe and their 
products are abused by humans for their hallucinogenic effects, as well 
as published reports indicating an increase in the abuse of these 
substances. These reports of abuse are in agreement with the large 
number of encounters of these substances by law enforcement.
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    \3\ While law enforcement data is not direct evidence of abuse, 
it can lead to an inference that a drug has been diverted and 
abused. See 76 FR 77330, 77332, Dec. 12, 2011.
    \4\ STRIDE was a database that collected analyses of results 
from drug evidence sent to DEA laboratories. Evidence was submitted 
by the DEA, other Federal agencies, and select local law enforcement 
agencies. On October 1, 2014, STARLiMS replaced STRIDE as the DEA 
system of record for forensic laboratory drug evidence data.
    \5\ NFLIS is a DEA program and a national forensic laboratory 
reporting system that systematically collects results from drug 
chemistry analyses conducted by state and local forensic 
laboratories in the United States. The NFLIS database also contains 
Federal data from CBP. NFLIS includes drug chemistry results from 
completed analyses only.
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    2. Scientific Evidence of the Drug's Pharmacological Effects, If 
Known: Studies show that 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe are full 
agonists at the 5-HT2A serotonin receptor based on the 
receptor binding and functional activity profiles in in vitro studies. 
In vivo experimental animal studies have reported that 25I-NBOMe and 
25B-NBOMe significantly increase the head twitch response, a response 
associated with hallucinogens that act on the 5-HT2A 
serotonin receptor. In addition, 25I-NBOMe was more potent than the 
schedule I hallucinogen 2C-I, and 25B-NBOMe was more potent than the 
hallucinogen DOI in eliciting the head twitch response.
    According to the HHS, there are no reported human clinical trials 
with 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe but there is evidence that 
these substances are abused for their hallucinogenic effects. Clinical 
case reports indicate that 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe produce 
a number of stimulant-like adverse effects. According to the HHS, 
adverse health effects associated with products containing synthetic 
phenethylamines include: Hallucinations (open and closed eye visuals), 
nausea, excessive sweating, tachycardia, psychomotor agitation, 
prolonged seizures, rhabdomyolysis, and renal failure.
    3. The State of Current Scientific Knowledge Regarding the Drug or 
Other Substance: 25I-NBOMe, 25C-NBOMe and 25B-NBOMe are classified as 
2C compounds, a structural class with a phenethylamine core substituted 
with methoxy groups on the 2 and 5 positions of the phenyl ring. 25I-
NBOMe, 25C-NBOMe, and 25B-NBOMe are structurally similar to the 2C-X 
compounds (2C-I, 2C-C, and 2C-B, respectively) which are controlled as 
schedule I hallucinogenic substances under the CSA. Data indicate that 
25I-NBOMe, 25C-NBOMe, and 25B-NBOMe are rapidly distributed from the 
blood into the brain, liver, and bile. Studies examining elimination of 
NBOMes have reported that 90% of the parent compound is eliminated from 
the plasma within 90 minutes and urine samples suggest that the 
corresponding 2C compounds (i.e., 2C-I, 2C-C, and 2C-B) may be 
metabolites of the NBOMes. According to the HHS, 25I-NBOMe,

[[Page 70653]]

25C-NBOMe and 25B-NBOMe are not U.S. Food and Drug Administration 
(FDA)-approved drug products. The DEA is not aware of any currently 
accepted medical use or NDAs for 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe. 
Furthermore, the Assistant Secretary of the HHS responded that there 
were no current INDs or NDAs for these synthetic phenethylamines in the 
scientific and medical evaluations and recommendations addressed to the 
DEA Deputy Administrator dated August 12, 2015.
    4. Its History and Current Pattern of Abuse: Law enforcement has 
encountered 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe in the illicit drug 
market. These synthetic substances are available over the Internet and 
sold through illicit channels, often purported to be schedule I 
hallucinogens, like LSD. Market names for products found to contain 
NBOMe include, but are not limited to: ``Smiles,'' ``N-bomb,'' ``Cimbi-
5,'' ``25I,'' and others. 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe have been 
seized as powders, as solutions, on blotter paper, and laced on food 
items. According to the HHS, 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe are 
abused in the same manner as schedule I hallucinogens such as LSD, DOM, 
2C-I, 2C-B, and 2C-C. Furthermore, evidence indicates that youth appear 
to be the primary abusers of these synthetic substances.
    5. The Scope, Duration, and Significance of Abuse: Evidence from 
law enforcement indicates that the abuse of 25I-NBOMe, 25C-NBOMe, and 
25B-NBOMe is widespread. Law enforcement databases registered a total 
of 4,868 drug reports involving 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe 
(query date: September 22 & 23, 2015) spanning a time period from 
January 2011 through August 2015. Law enforcement encounters of 25I-
NBOMe, 25C-NBOMe, or 25B-NBOMe have occurred in at least 43 states and 
the District of Columbia. As stated by the HHS, based on the 
pharmacological properties of the substances, it is reasonable to 
assume that, if uncontrolled, the scope, duration, and significance of 
25I-NBOMe, 25C-NBOMe, or 25B-NBOMe abuse could be similar to that of 
LSD. Concerns over the abuse of 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe have 
prompted state, military, and international control of these 
substances.
    6. What, if Any, Risk There is to the Public Health: Law 
enforcement, medical community representatives, and public health 
officials have reported exposure incidents that demonstrate the dangers 
associated with the abuse of 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe to 
individual abusers as well as to the public. Furthermore, the HHS 
stated that the NBOMe series of drugs have much narrower 
``therapeutic'' ratios and much smaller margins of safety than most 
other known hallucinogens, and so carry greater risk of acute toxicity 
and death.
    There have been numerous reports of deaths associated with the 
abuse of 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe. Published case reports 
have also described deaths associated with the ingestion of the NBOMe 
substances. As of October 2013, the DEA has obtained medical examiner 
and postmortem toxicology reports implicating some combination of 25I-
NBOMe, 25C-NBOMe, and 25B-NBOMe in the death of 17 individuals. The 
average age of these individuals is 20 years (range 15 to 29 years). 
The circumstances surrounding the deaths include acute toxicity (14) or 
unpredictable, violent behavior due to 25I-NBOMe toxicity ultimately 
leading to death (3). As detailed above, there are reported instances 
of emergency department admissions and deaths associated with the abuse 
of these synthetic substances. There is no accepted medical use of 
these substances in the United States.
    7. Its Psychic or Physiological Dependence Liability: According to 
the HHS, the pharmacologic profiles of 25I-NBOMe, 25C-NBOMe, and 25B-
NBOMe strongly suggest that they possess physiological and 
psychological dependence liability that is similar to that of schedule 
I hallucinogens such as LSD, 2C-I, 2C-C, 2C-B, and DOM, although there 
are no studies or case reports that document the psychic or 
physiological dependence potential of these substances. However, based 
on the structural similarity between the NBOMes (25I-NBOMe, 25C-NBOMe, 
and 25B-NBOMe) and other schedule I hallucinogens (2C-I, 2C-B, 2C-C) 
and the similarity in pharmacological actions and resulting effects in 
the hallucinogen drug class (e.g. LSD, psilocybin), it is expected that 
the NBOMes will share a similar psychic and psychological dependence 
liability.
    8. Whether the Substance is an Immediate Precursor of a Substance 
Already Controlled Under the CSA: 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe 
are not considered immediate precursors of any controlled substance of 
the CSA as defined by 21 U.S.C 802(23).
    Conclusion: Based on consideration of the scientific and medical 
evaluations and accompanying recommendation of the HHS, and based on 
the DEA's considerations of its own eight-factor analysis, the DEA 
finds that these facts and all other relevant data constitute 
substantial evidence of the potential for abuse of 25I-NBOMe, 25C-
NBOMe, and 25B-NBOMe. As such, the DEA hereby proposes to schedule 25I-
NBOMe, 25C-NBOMe, and 25B-NBOMe as controlled substances under the CSA.

Proposed 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 salts, isomers and 
salts of isomers, whenever the existence of such salts, isomers, and 
salts of isomers is 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

    If this rule is finalized as proposed, persons who handle 25I-
NBOMe, 25C-NBOMe, or 25B-NBOMe would continue \6\ to be subject to the 
regulatory controls and administrative, civil, and criminal sanctions 
applicable to the manufacture, distribution, possession, importing, and 
exporting of schedule I controlled substances, including those listed 
below:
---------------------------------------------------------------------------

    \6\ 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). 78 FR 68716.

---------------------------------------------------------------------------

[[Page 70654]]

    1. Registration. Any person who handles (manufactures, 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 would be required to 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. Security. 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe would be subject 
to schedule I security requirements and would need to 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.
    3. Labeling and Packaging. All labels, labeling, and packaging for 
commercial containers of 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe would need 
to be in compliance with 21 U.S.C. 825 and 958(e), and be in accordance 
with 21 CFR part 1302.
    4. Quota. Only registered manufacturers would be 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.
    5. Inventory. Any person who becomes registered with the DEA on or 
after the effective date of the final rule must take an initial 
inventory of all stocks of controlled substances (including NBOMes) on 
hand on the date the registrant first engages in the handling of 
controlled substances pursuant to 21 U.S.C. 827 and 958, and in 
accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    After the initial inventory, every DEA registrant must take a new 
inventory of all stocks of controlled substances (including NBOMes) on 
hand every two years pursuant to 21 U.S.C. 827 and 958, and in 
accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    6. Records and Reports. Every DEA registrant would be required to 
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 1312.
    7. Order Forms. Every DEA registrant who distributes 25I-NBOMe, 
25C-NBOMe, or 25B-NBOMe would be required to comply with the order form 
requirements, pursuant to 21 U.S.C. 828, and 21 CFR part 1305.
    8. Importation and Exportation. All importation and exportation of 
25I-NBOMe, 25C-NBOMe, and 25B-NBOMe would need to be in compliance with 
21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 
1312.
    9. Liability. Any activity involving 25I-NBOMe, 25C-NBOMe, or 25B-
NBOMe not authorized by, or in violation of, the CSA or its 
implementing regulations would be unlawful, and could subject the 
person to administrative, civil, and/or criminal sanctions.

Regulatory Analyses

Executive Orders 12866 and 13563

    In accordance with 21 U.S.C. 811(a), this proposed 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

    This proposed 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

    This proposed rulemaking does not have federalism implications 
warranting the application of Executive Order 13132. The proposed 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

    This proposed 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 proposed 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). 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 proposed 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. Therefore, the DEA anticipates that 
this proposed 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 proposed 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

[[Page 70655]]

required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

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 proposed to be 
amended as follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for 21 CFR part 1308 continues to read as 
follows:

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

0
2. In Sec.  1308.11:
0
a. Add paragraphs (d)(48) through (50);
0
b. Remove paragraphs (h)(4), (5), and (6); and
0
c. Redesignate paragraphs (h)(7) through (24) as (h)(4) through (21).
    The additions read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (d) * * *

(48) 2-(4-iodo-2,5-dimethoxy-phenyl)-N-(2-                        (7538)
 methoxybenzyl)ethanamine (25I-NBOMe or 2C-I-NBOMe)............
(49) 2-(4-chloro-2,5-dimethoxy-phenyl)-N-(2-                      (7537)
 methoxybenzyl)ethanamine (25C-NBOMe or 2C-C-NBOMe)............
(50) 2-(4-bromo-2,5-dimethoxy-phenyl)-N-(2-                       (7536)
 methoxybenzyl)ethanamine (25B-NBOMe or 2C-B-NBOMe)............
 

* * * * *

    Dated: November 10, 2015.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2015-29026 Filed 11-12-15; 8:45 am]
 BILLING CODE 4410-09-P