[Federal Register Volume 82, Number 223 (Tuesday, November 21, 2017)]
[Proposed Rules]
[Pages 55333-55336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25077]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-474]


Schedules of Controlled Substances: Temporary Placement of 
Cyclopropyl Fentanyl into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

[[Page 55334]]


ACTION: Proposed amendment; notice of intent.

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SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this notice of intent to publish a temporary order to schedule 
the synthetic opioid, N-(1-phenethylpiperidin-4-yl)-N-
phenylcyclopropanecarboxamide (cyclopropyl fentanyl), into Schedule I. 
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. When it is issued, the temporary scheduling 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, reverse 
distribution, possession, importation, exportation, research, and 
conduct of instructional activities, and chemical analysis of this 
synthetic opioid.

DATES: November 21, 2017.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.

SUPPLEMENTARY INFORMATION: This notice of intent contained in this 
document is issued pursuant to the temporary scheduling provisions of 
21 U.S.C. 811(h). The Drug Enforcement Administration (DEA) intends to 
issue a temporary scheduling order (in the form of a temporary 
amendment) to add cyclopropyl fentanyl to Schedule I under the 
Controlled Substances Act.\1\ The temporary scheduling order will be 
published in the Federal Register, but will not be issued before 
December 21, 2017.
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    \1\ Though DEA has used the term ``final order'' with respect to 
temporary scheduling orders in the past, this notice of intent 
adheres to the statutory language of 21 U.S.C. 811(h), which refers 
to a ``temporary scheduling order.'' No substantive change is 
intended.
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Legal Authority

    Section 201 of the Controlled Substances Act (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 he 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); 21 CFR part 1308. 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.\2\ The Acting Administrator transmitted 
notice of his intent to place cyclopropyl fentanyl in Schedule I on a 
temporary basis to the Assistant Secretary for Health of HHS by letter 
dated August 28, 2017. The Assistant Secretary responded to this notice 
of intent by letter dated September 6, 2017, and advised that based on 
a review by the Food and Drug Administration (FDA), there are currently 
no investigational new drug applications or approved new drug 
applications for cyclopropyl fentanyl. The Assistant Secretary also 
stated that the HHS has no objection to the temporary placement of 
cyclopropyl fentanyl into Schedule I of the CSA. Cyclopropyl fentanyl 
is not currently listed in any schedule under the CSA, and no 
exemptions or approvals are in effect for cyclopropyl fentanyl under 
section 505 of the FDCA, 21 U.S.C. 355.
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    \2\ 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 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).

Cyclopropyl Fentanyl

    The recent identification of cyclopropyl fentanyl in drug evidence 
and the identification of this substance in association with fatal 
overdose events indicate that this substance is being abused for its 
opioid properties. No approved medical use has been identified for 
cyclopropyl fentanyl, nor has it been approved by the FDA for human 
consumption.
    Available data and information for cyclopropyl fentanyl, 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 ``Supporting and Related Material'' of the public docket 
for this action at www.regulations.gov under Docket Number DEA-474.

Factor 4. History and Current Pattern of Abuse

    The recreational abuse of fentanyl-like substances continues to be 
a significant concern. These substances are distributed to users, often 
with unpredictable outcomes. Cyclopropyl fentanyl has been encountered 
by law enforcement and public health officials beginning as early as 
May 2017. The DEA is not aware of any laboratory identifications of 
this substance prior to 2017. Adverse health effects and outcomes of 
cyclopropyl fentanyl abuse are consistent with those of other opioids 
and are demonstrated by fatal overdose cases involving this substance.
    On October 1, 2014, the DEA implemented STARLiMS (a web-based, 
commercial laboratory information management system) to replace the 
System to Retrieve Information from Drug Evidence (STRIDE) as its 
laboratory drug evidence data system of record. DEA laboratory data 
submitted after September 30, 2014, are reposited in STARLiMS. Data 
from STRIDE and STARLiMS were queried on August 25,

[[Page 55335]]

2017. STARLiMS registered a total of three reports containing 
cyclopropyl fentanyl from California, Connecticut, and New York. Of 
these three exhibits, one had a net weight of approximately one 
kilogram. According to STARLiMS, the first laboratory submission of 
cyclopropyl fentanyl occurred in Connecticut in June 2017.
    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 other 
federal, state and local forensic laboratories across the country. 
NFLIS registered 10 reports containing cyclopropyl fentanyl from state 
or local forensic laboratories in Oklahoma in July 2017 (query date: 
August 29, 2017).\3\
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    \3\ Data are still being collected for May 2017-August 2017 due 
to the normal lag period for labs reporting to NFLIS.
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    In addition to data recorded in NFLIS and STARLiMS, cyclopropyl 
fentanyl was identified in drug evidence submitted to state and local 
forensic laboratories in Georgia and Pennsylvania. Cyclopropyl fentanyl 
was confirmed in combination with U-47700, another synthetic opioid 
temporarily controlled in Schedule I of the CSA, in 24 glassine paper 
packets submitted to a law enforcement forensic laboratory in 
Pennsylvania.\4\ A law enforcement forensic laboratory in Georgia 
confirmed \5\ the presence of cyclopropyl fentanyl in counterfeit 
oxycodone tablets which also contained U-47700. The distribution of 
cyclopropyl fentanyl in these forms, and in combination with another 
synthetic opioid, suggests that this substance was marketed as heroin 
or prescription opioids in the illicit market.
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    \4\ Email from Philadelphia Police Department--Office of 
Forensic Science, to DEA (August 18, 2017 11:09 a.m.) (on file with 
DEA).
    \5\ Laboratory report obtained from Division of Forensic 
Science, Georgia Bureau of Investigation.
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    Evidence suggests that the pattern of abuse of fentanyl analogues, 
including cyclopropyl fentanyl, parallels that of heroin and 
prescription opioid analgesics. Seizures of cyclopropyl fentanyl have 
been encountered in powder form, similar to fentanyl and heroin, and in 
counterfeit prescription opioid products (i.e. counterfeit oxycodone 
tablets). Cyclopropyl fentanyl was also confirmed in toxicology samples 
from fatal overdose cases.

Factor 5. Scope, Duration and Significance of Abuse

    Reports collected by the DEA demonstrate that cyclopropyl fentanyl 
is being abused for its opioid properties. Abuse of cyclopropyl 
fentanyl has resulted in mortality (see DEA 3-Factor Analysis for full 
discussion). The DEA collected post-mortem toxicology and medical 
examiner reports on 115 confirmed fatalities associated with 
cyclopropyl fentanyl which occurred in Georgia (1), Maryland (24), 
Mississippi (1), North Carolina (75), and Wisconsin (14). It is likely 
that the prevalence of this substance in opioid related emergency room 
admissions and deaths is underreported as standard immunoassays may not 
differentiate this fentanyl analogue from fentanyl.
    NFLIS and STARLiMS have a total of 13 drug reports in which 
cyclopropyl fentanyl was identified in drug exhibits submitted to 
forensic laboratories in 2017 from law enforcement encounters in 
California, Connecticut, New York, and Oklahoma. In addition to the 
data collected in these databases, cyclopropyl fentanyl was identified 
in drug evidence submitted to forensic laboratories in Georgia 
(counterfeit oxycodone preparation) and Pennsylvania (24 glassine paper 
packets).
    The population likely to abuse cyclopropyl fentanyl overlaps with 
the population abusing prescription opioid analgesics, heroin, fentanyl 
and other fentanyl-related substances. This is supported by cyclopropyl 
fentanyl being identified in powder contained within glassine paper 
packets and counterfeit prescription opioid products. This is also 
demonstrated by routes of drug administration and drug use history 
documented in cyclopropyl fentanyl fatal overdose cases. Because 
abusers of cyclopropyl fentanyl obtain this substance through 
unregulated sources, the identity, purity, and quantity are uncertain 
and inconsistent, thus posing significant adverse health risks to the 
end user. Individuals who initiate (i.e. use a drug for the first time) 
cyclopropyl fentanyl 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.).

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

    With no legitimate medical use, cyclopropyl fentanyl has emerged on 
the illicit drug market and is being misused and abused for its opioid 
properties. Cyclopropyl fentanyl exhibits pharmacological profiles 
similar to that of fentanyl and other [micro]-opioid receptor agonists. 
The abuse of cyclopropyl fentanyl poses significant adverse health 
risks when compared to abuse of pharmaceutical preparations of opioid 
analgesics, such as morphine and oxycodone. The toxic effects of 
cyclopropyl fentanyl in humans are demonstrated by overdose fatalities 
involving this substance.
    Based on information received by the DEA, the misuse and abuse of 
cyclopropyl fentanyl lead to, at least, the same qualitative public 
health risks as heroin, fentanyl, and other opioid analgesic 
substances. As with any non-medically approved opioid, the health and 
safety risks for users are high. 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.
    Cyclopropyl fentanyl has been associated with numerous fatalities. 
At least 115 confirmed overdose deaths involving cyclopropyl fentanyl 
abuse have been reported from Georgia (1), Maryland (24), Mississippi 
(1), North Carolina (75), and Wisconsin (14) in 2017. As the data 
demonstrate, the potential for fatal and non-fatal overdoses exists for 
cyclopropyl fentanyl and this substance 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, importation, possession, and abuse of 
cyclopropyl fentanyl pose an imminent hazard to the public safety. The 
DEA is not aware of any currently accepted medical uses for cyclopropyl 
fentanyl 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 information for 
cyclopropyl fentanyl 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 August 28, 2017, 
notified the Assistant Secretary of the DEA's intention to temporarily 
place this substance in Schedule I.

[[Page 55336]]

Conclusion

    This notice of intent initiates a temporary scheduling process and 
provides the 30-day notice pursuant to section 201(h) of the CSA, 21 
U.S.C. 811(h), of DEA's intent to issue a temporary scheduling order. 
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 cyclopropyl fentanyl 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.
    The temporary placement of cyclopropyl fentanyl into Schedule I of 
the CSA will take effect pursuant to a temporary scheduling order, 
which will not be issued before December 21, 2017. Because the 
Administrator hereby finds that it is necessary to temporarily place 
cyclopropyl fentanyl into Schedule I to avoid an imminent hazard to the 
public safety, the temporary order scheduling this substance will be 
effective on the date that order is published 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 
(permanent) scheduling process. 21 U.S.C. 811(h)(1) and (2). It is the 
intention of the Administrator to issue a temporary scheduling order as 
soon as possible after the expiration of 30 days from the date of 
publication of this notice. Upon publication of the temporary order, 
cyclopropyl fentanyl will 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 a 
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 in 
response to the notice that DEA transmitted to the Assistant Secretary 
pursuant to section 811(h)(4).
    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.
    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), 956(b), unless otherwise 
noted.

0
2. In Sec.  1308.11, add paragraph (h)(22) to read as follows:


Sec.  1308.11  Schedule I

* * * * *
    (h) * * *
    (22) N-(1-phenethylpiperidin-4-yl)-N-phenylcyclopropanecarboxamide, 
its isomers, esters, ethers, salts and salts of isomers, esters and 
ethers (Other name: cyclopropyl fentanyl) . . . (9845)
* * * * *

    Dated: November 13, 2017.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2017-25077 Filed 11-20-17; 8:45 am]
 BILLING CODE 4410-09-P