[Federal Register Volume 81, Number 173 (Wednesday, September 7, 2016)]
[Proposed Rules]
[Pages 61636-61638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21477]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-440]


Schedules of Controlled Substances: Temporary Placement of U-
47700 Into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of intent.

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SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this notice of intent to temporarily schedule the synthetic 
opioid, 3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide 
(also known as U-47700), into schedule I pursuant to the temporary 
scheduling provisions of the Controlled Substances Act. This action is 
based on a finding by the Administrator that the placement of this 
synthetic opioid into schedule I of the Controlled Substances Act is 
necessary to avoid an imminent hazard to the public safety. Any final 
order will impose the administrative, civil, and criminal sanctions and 
regulatory controls applicable to schedule I controlled substances 
under the Controlled Substances Act on the manufacture, distribution, 
possession, importation, exportation, research, and conduct of, 
instructional activities of this synthetic opioid.

DATES: September 7, 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: Any final order will be published in the 
Federal Register and may not be effective prior to October 7, 2016.

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 purpose 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 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 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 
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 scheduling authority 
under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

Background

    Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the 
Administrator to notify the Secretary of the Department of Health and 
Human Services (HHS) of his intention to temporarily place a substance 
into schedule I of the CSA.\1\ The Administrator transmitted notice of 
his intent to place U-47700 in schedule I on a temporary basis to the 
Assistant Secretary by letter dated April 18, 2016. The Assistant 
Secretary responded to this notice by letter dated April 28, 2016, and 
advised that based on review by the Food and Drug Administration (FDA), 
there are currently no investigational new drug applications or 
approved new drug applications for U-47700. The Assistant Secretary 
also stated that the HHS has no objection to the temporary placement of 
U-47700 into schedule I of the CSA. U-47700 is not currently listed in 
any schedule under the CSA, and no exemptions or approvals are in 
effect for U-47700 under section 505 of the FDCA, 21 U.S.C. 355. The 
DEA has found that the control of U-47700 in schedule I on a temporary 
basis is necessary to avoid an imminent hazard to public safety.
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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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    To find that placing a substance temporarily into schedule I of the 
CSA is necessary to avoid an imminent hazard to the public safety, the 
Administrator is required to consider three of the eight factors set 
forth in section 201(c) of the CSA, 21 U.S.C. 811(c): The substance's 
history and current pattern of abuse; the scope, duration and 
significance of abuse; and what, if any, risk there is to the public 
health. 21 U.S.C. 811(h)(3). Consideration of these factors includes 
actual abuse, diversion from legitimate channels, and clandestine 
importation, manufacture, or distribution. 21 U.S.C. 811(h)(3).
    A substance meeting the statutory requirements for temporary 
scheduling may only be placed in schedule I. 21 U.S.C. 811(h)(1). 
Substances in schedule I are those that have a high potential for 
abuse, no currently accepted medical use in treatment in the United 
States, and a lack of accepted safety for use under medical 
supervision. 21 U.S.C. 812(b)(1).

U-47700

    The substance U-47700 was first described in 1978 in the patent 
literature. Publications in the scientific literature in the early 
1980's found that U-47700 behaved similarly to morphine in animal 
models. No approved medical

[[Page 61637]]

use has been identified for this synthetic opioid, nor has it been 
approved by the FDA for human consumption. The recent identification of 
U-47700 in drug evidence and the identification of this substance in 
association with fatal overdose events indicate that this substance is 
being abused for its morphine-like properties. In addition, U-47700 is 
available for purchase over the Internet and is marketed as a 
``research chemical.'' Labels which state ``not for human consumption'' 
or ``for research purposes only'' have been encountered and are likely 
used in an effort to circumvent statutory restrictionson controlled 
substance analogues. 21 U.S.C. 813.
    Available data and information for U-47700, summarized below, 
indicate that this synthetic opioid has a high potential for abuse, no 
currently accepted medical use in treatment in the United States, and a 
lack of accepted safety for use under medical supervision. The DEA's 
three-factor analysis is available in its entirety under the public 
docket of this action as a supporting document at www.regulations.gov 
under Docket Number DEA-440.

Factor 4. History and Current Pattern of Abuse

    The National Forensic Laboratory Information System (NFLIS) is a 
national drug forensic laboratory reporting system that systematically 
collects results from drug chemistry analyses conducted by State and 
local forensic laboratories across the country. The first laboratory 
submissions of U-47700 were recorded in the first quarter of 2016; 10 
records were reported from January-March 2016 according to NFLIS (query 
date: 06/20/2016).
    On October 1, 2014, the DEA implemented STARLiMS (a web-based, 
commercial laboratory information management system) as its laboratory 
drug evidence data system of record. DEA laboratory data submitted 
after September 30, 2014, are reposited in STARLiMS; data from STARLiMS 
were queried on April 12, 2016. STARLiMS registered one report 
containing U-47700 in 2016 from Montana. Through information collected 
from law enforcement reports and personal communications,2 3 
the DEA is aware of the identification of U-47700 from toxicology 
reports and submitted evidence to forensic laboratories in several 
states, including New Hampshire, New Jersey, New York, North Carolina, 
Ohio, Oregon, Texas, and Wisconsin. These identifications occurred in 
2015 and 2016.
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    \2\ Email from North Carolina Department of Health and Human 
Services, to DEA (April 13, 2016 09:54 a.m. EST) (on file with DEA).
    \3\ Email from Erie County, Central Police Services, to DEA 
(March 22, 2016 10:12 a.m. EST) (on file with DEA).
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    Evidence suggests that the pattern of abuse of synthetic opioids, 
including U-47700, parallels that of heroin and prescription opioid 
analgesics. Seizures of U-47700 have been encountered in powder form 
and in counterfeit tablets that mimic pharmaceutical opioids. U-47700 
has also been encountered in glassine bags and envelopes and knotted 
corners of plastic bags, which demonstrates the abuse of this substance 
as a replacement for heroin or other opioids, either knowingly or 
unknowingly. U-47700 has been encountered as a single substance as well 
as in combination with other substances, including heroin, fentanyl, 
and furanyl fentanyl.

Factor 5. Scope, Duration and Significance of Abuse

    The DEA is currently aware of at least 15 confirmed fatalities 
associated with U-47700. The information on these deaths occurring in 
2015 and 2016 was collected from personal communications and toxicology 
and medical examiner reports and was reported from New Hampshire (1), 
North Carolina (10), Ohio (1), Texas (2), and Wisconsin (1). The 
population likely to abuse U-47700 appears to overlap with the 
populations abusing prescription opioid analgesics and heroin, as 
evidenced by drug use history documented in U-47700 fatal overdose 
cases. This is further supported by U-47700 being sold on the illicit 
market in glassine bags, some of which are marked with stamped logos, 
imitating the sale of heroin. Because abusers of U-47700 are likely to 
obtain this substance through non-regulated sources, the identity, 
purity, and quantity is uncertain and inconsistent, thus posing 
significant adverse health risks to the end user. Individuals who 
initiate (i.e. use an illicit drug for the first time) U-47700 abuse 
are likely to be at risk of developing substance use disorder, 
overdose, and death similar to that of other opioid analgesics (e.g., 
fentanyl, morphine, etc.).
    STARLiMS contains a report in which U-47700 was identified in drug 
exhibits submitted in 2016 from Montana. A query of NFLIS returned 10 
records of U-47700 being identified in exhibits submitted to Federal, 
State and local forensic laboratories in the first quarter of 2016. The 
DEA is not aware of any laboratory analyses of drug evidence 
identifying U-47700 prior to 2015, indicating that this synthetic 
opioid only recently became available as a replacement for other 
opioids that are commonly abused (i.e. oxycodone, heroin, fentanyl). U-
47700 is available over the Internet and is marketed as a ``research 
chemical'' which allows this substance to be easily obtainable.

Factor 6. What, if Any, Risk There Is to the Public Health

    U-47700 exhibits pharmacological profiles similar to that of 
morphine and other mu-opioid receptor agonists. Due to limited 
scientific data, the potency and toxicity of U-47700 are not known; 
however, the toxic effects of U-47700 in humans are demonstrated by 
overdose fatalities associated with this substance. Abusers of U-47700 
may not know the origin, identity, or purity of these substances, thus 
posing significant adverse health risks when compared to abuse of 
pharmaceutical preparations of opioid analgesics, such as morphine and 
oxycodone.
    Based on the documented case reports of overdose fatalities, the 
abuse of U-47700 leads to the same qualitative public health risks as 
heroin, fentanyl and other opioid analgesic substances. The public 
health risks attendant to the abuse of heroin and opioid analgesics are 
well established and have resulted in large numbers of drug treatment 
admissions, emergency department visits, and fatal overdoses.
    U-47700 has been associated with fatalities. At least 15 confirmed 
overdose deaths involving U-47700 occurred in 2015 and 2016 in New 
Hampshire (1), North Carolina (10), Ohio (1), Texas (2), and Wisconsin 
(1). This indicates that U-47700 poses an imminent hazard to the public 
safety.

Finding of Necessity of Schedule I Placement to Avoid Imminent Hazard 
To Public Safety

    In accordance with 21 U.S.C. 811(h)(3), based on the available data 
and information summarized above, the continued uncontrolled 
manufacture, distribution, reverse distribution, importation, 
exportation, conduct of research and chemical analysis, possession, and 
abuse of U-47700 poses an imminent hazard to the public safety. The DEA 
is not aware of any currently accepted medical uses for U-47700 in the 
United States. A substance meeting the statutory requirements for 
temporary scheduling, 21 U.S.C. 811(h)(1), may only be placed in 
schedule I. Substances in schedule I are those that have a high 
potential for abuse, no currently accepted medical use in treatment in 
the United States, and a lack of accepted safety for use under medical 
supervision. Available data and

[[Page 61638]]

information for U-47700 indicate that this substance has a high 
potential for abuse, no currently accepted medical use in treatment in 
the United States, and a lack of accepted safety for use under medical 
supervision. As required by section 201(h)(4) of the CSA, 21 U.S.C. 
811(h)(4), the Administrator, through a letter dated April 18, 2016, 
notified the Assistant Secretary of the DEA's intention to temporarily 
place this substance in schedule I.

Conclusion

    This notice of intent initiates an expedited temporary scheduling 
action and provides the 30-day notice pursuant to section 201(h) of the 
CSA, 21 U.S.C. 811(h). In accordance with the provisions of section 
201(h) of the CSA, 21 U.S.C. 811(h), the Administrator considered 
available data and information, herein set forth the grounds for his 
determination that it is necessary to temporarily schedule U-47700 in 
schedule I of the CSA, and finds that placement of this synthetic 
opioid into schedule I of the CSA is necessary in order to avoid an 
imminent hazard to the public safety.
    Because the Administrator hereby finds that it is necessary to 
temporarily place this synthetic opioid into schedule I to avoid an 
imminent hazard to the public safety, any subsequent final order 
temporarily scheduling this substance will be effective on the date of 
publication in the Federal Register, and will be in effect for a period 
of two years, with a possible extension of one additional year, pending 
completion of the regular scheduling process. 21 U.S.C. 811(h) (1) and 
(2). It is the intention of the Administrator to issue such a final 
order as soon as possible after the expiration of 30 days from the date 
of publication of this notice. U-47700 will then be subject to the 
regulatory controls and administrative, civil, and criminal sanctions 
applicable to the manufacture, distribution, reverse distribution, 
importation, exportation, research, conduct of instructional activities 
and chemical analysis, and possession of a schedule I controlled 
substance.
    The CSA sets forth specific criteria for scheduling a drug or other 
substance. Regular scheduling actions in accordance with 21 U.S.C. 
811(a) are subject to formal rulemaking procedures done ``on the record 
after opportunity for a hearing'' conducted pursuant to the provisions 
of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The regular scheduling process 
of formal rulemaking affords interested parties with appropriate 
process and the government with any additional relevant information 
needed to make a determination. Final decisions that conclude the 
regular scheduling process of formal rulemaking are subject to judicial 
review. 21 U.S.C. 877. Temporary scheduling orders are not subject to 
judicial review. 21 U.S.C. 811(h)(6).

Regulatory Matters

    Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for an 
expedited temporary scheduling action where such action is necessary to 
avoid an imminent hazard to the public safety. As provided in this 
subsection, the Attorney General may, by order, schedule a substance in 
schedule I on a temporary basis. Such an order may not be issued before 
the expiration of 30 days from (1) the publication of a notice in the 
Federal Register of the intention to issue such order and the grounds 
upon which such order is to be issued, and (2) the date that notice of 
the proposed temporary scheduling order is transmitted to the Assistant 
Secretary of HHS. 21 U.S.C. 811(h)(1).
    Inasmuch as section 201(h) of the CSA directs that temporary 
scheduling actions be issued by order and sets forth the procedures by 
which such orders are to be issued, 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 notice of intent. In the 
alternative, even assuming that this notice of intent 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 issuance of temporary scheduling 
orders would be impracticable and contrary to the public interest in 
view of the manifest urgency to avoid an imminent hazard to the public 
safety.
    Although the DEA believes this notice of intent to issue a 
temporary scheduling order is not subject to the notice and comment 
requirements of section 553 of the APA, the DEA notes that in 
accordance with 21 U.S.C. 811(h)(4), the Administrator will take into 
consideration any comments submitted by the Assistant Secretary with 
regard to the proposed temporary scheduling order.
    Further, the DEA believes that this 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.

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, the DEA proposes to amend 21 CFR 
part 1308 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. In Sec.  1308.11, add paragraph (h)(21).
    The addition reads as follows:


Sec.  1308.11  Schedule I

* * * * *
    (h) * * *
    (21) 3,4-Dichloro-N-[2-(dimethylamino)cyclohexyl]-N-
methylbenzamide, its isomers, esters, ethers, salts and salts of 
isomers, esters and ethers (Other names: U-47700). (9547)
* * * * *

     Dated: August 31, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-21477 Filed 9-6-16; 8:45 am]
 BILLING CODE 4410-09-P