[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\3\ Data are still being collected for May 2017-August 2017 due
to the normal lag period for labs reporting to NFLIS.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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