Schedules of Controlled Substances: Temporary Placement of Cyclopropyl Fentanyl in Schedule I, 469-472 [2017-28470]
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Federal Register / Vol. 83, No. 3 / Thursday, January 4, 2018 / Rules and Regulations
List of Subjects in 18 CFR Part 381
Electric power plants, Electric
utilities, Natural gas, reporting and
recordkeeping requirements.
Temporary amendment;
temporary scheduling order.
ACTION:
Anton C. Porter,
Executive Director.
In consideration of the foregoing, the
Commission amends Part 381, Chapter I,
Title 18, Code of Federal Regulations, as
set forth below.
PART 381—FEES
1. The authority citation for Part 381
continues to read as follows:
■
Authority: 15 U.S.C. 717–717w; 16 U.S.C.
791–828c, 2601–2645; 31 U.S.C. 9701; 42
U.S.C. 7101–7352; 49 U.S.C. 60502; 49 App.
U.S.C. 1–85.
§ 381.302
[Amended]
2. In 381.302, paragraph (a) is
amended by removing ‘‘$25,640’’ and
adding ‘‘$27,130’’ in its place.
■
§ 381.303
[Amended]
3. In 381.303, paragraph (a) is
amended by removing ‘‘$37,430’’ and
adding ‘‘$39,610’’ in its place.
■
§ 381.304
[Amended]
4. In 381.304, paragraph (a) is
amended by removing ‘‘$19,630’’ and
adding ‘‘$20,770’’ in its place.
■
§ 381.305
FOR FURTHER INFORMATION CONTACT:
[Amended]
Michael J. Lewis, Diversion Control
Division, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone: (202) 598–6812.
SUPPLEMENTARY INFORMATION:
5. In 381.305, paragraph (a) is
amended by removing ‘‘$7,350’’ and
adding ‘‘$7,780’’ in its place.
■
§ 381.403
[Amended]
6. Section 381.403 is amended by
removing ‘‘$12,760’’ and adding
‘‘$13,500’’ in its place.
■
§ 381.505
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 in 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 1 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,
[Amended]
7. In 381.505, paragraph (a) is
amended by removing ‘‘$22,050’’ and
adding ‘‘$23,330’’ in its place and by
removing ‘‘$24,960’’ and adding
‘‘$26,410’’ in its place.
■
[FR Doc. 2017–28466 Filed 1–3–18; 8:45 am]
BILLING CODE 6717–01–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
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21 CFR Part 1308
[Docket No. DEA–474]
Schedules of Controlled Substances:
Temporary Placement of Cyclopropyl
Fentanyl in Schedule I
Drug Enforcement
Administration, Department of Justice.
AGENCY:
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The Administrator of the Drug
Enforcement Administration is issuing
this temporary scheduling order to
schedule the synthetic opioid, N-(1phenethylpiperidin-4-yl)-Nphenylcyclopropanecarboxamide
(cyclopropyl fentanyl), and its isomers,
esters, ethers, salts, and salts of isomers,
esters, and ethers in schedule I. This
action is based on a finding by the
Administrator that the placement of
cyclopropyl fentanyl in schedule I of the
Controlled Substances Act is necessary
to avoid an imminent hazard to the
public safety. As a result of this order,
the regulatory controls and
administrative, civil, and criminal
sanctions applicable to schedule I
controlled substances will be imposed
on persons who handle (manufacture,
distribute, reverse distribute, import,
export, engage in research, conduct
instructional activities or chemical
analysis, or possess), or propose to
handle, cyclopropyl fentanyl.
DATES: This temporary scheduling order
is effective January 4, 2018, until
January 4, 2020. If this order is extended
or made permanent, the DEA will
publish a document in the Federal
Register.
SUMMARY:
1 Though DEA has used the term ‘‘final order’’
with respect to temporary scheduling orders in the
past, this document 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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469
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 in
schedule I of the CSA.2 The
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 by letter
dated September 6, 2017, 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 cyclopropyl fentanyl.
The Assistant Secretary also stated that
the HHS has no objection to the
temporary placement of cyclopropyl
fentanyl in schedule I of the CSA. The
DEA has taken into consideration the
Assistant Secretary’s comments as
required by 21 U.S.C. 811(h)(4).
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.
The DEA has found that the control of
cyclopropyl fentanyl in schedule I on a
temporary basis is necessary to avoid an
imminent hazard to the public safety,
and as required by 21 U.S.C.
811(h)(1)(A), a notice of intent to
temporarily schedule cyclopropyl
fentanyl was published in the Federal
Register on November 21, 2017. 82 FR
55333.
To find that placing a substance
temporarily in 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
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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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).
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 threefactor analysis and the Assistant
Secretary’s September 6, 2017 letter are
available in their entirety under the tab
‘‘Supporting Documents’’ of the public
docket of this action at
www.regulations.gov under FDMS
Docket ID: DEA–2017–0005 (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,
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
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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
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.
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 analgesics (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 effects.
Abuse of cyclopropyl fentanyl has
resulted in mortality (see DEA 3-Factor
Analysis for full discussion). The DEA
collected post-mortem toxicology and
3 Data are still being collected for May 2017–
August 2017 due to the normal lag period for labs
reporting to NFLIS.
4 Email from Philadelphia Police DepartmentOffice 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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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 mopioid 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.
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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 nonmedically approved opioid agonist, 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.
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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 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, by letter
dated August 28, 2017, notified the
Assistant Secretary of the DEA’s
intention to temporarily place this
substance in schedule I. A notice of
intent was subsequently published in
the Federal Register on November 21,
2017. 82 FR 55333.
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Conclusion
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, and
herein sets forth the grounds for his
determination that it is necessary to
temporarily schedule cyclopropyl
fentanyl in schedule I of the CSA to
avoid an imminent hazard to the public
safety.
Because the Administrator hereby
finds it necessary to temporarily place
this synthetic opioid in schedule I to
avoid an imminent hazard to the public
safety, this temporary order scheduling
cyclopropyl fentanyl is effective on the
date of publication in the Federal
Register, and is 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).
The CSA sets forth specific criteria for
scheduling a drug or other substance.
Permanent 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 permanent
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 permanent 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).
Requirements for Handling
Upon the effective date of this
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, engagement in
research, and conduct of instructional
activities or chemical analysis with, and
possession of schedule I controlled
substances including the following:
1. Registration. Any person who
handles (manufactures, distributes,
reverse distributes, imports, exports,
engages in research, or conducts
instructional activities or chemical
analysis with, or possesses), or who
desires to handle, cyclopropyl fentanyl
must be registered with the DEA to
conduct such activities pursuant to 21
U.S.C. 822, 823, 957, and 958 and in
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471
accordance with 21 CFR parts 1301 and
1312, as of January 4, 2018. Any person
who currently handles cyclopropyl
fentanyl, and is not registered with the
DEA, must submit an application for
registration and may not continue to
handle cyclopropyl fentanyl as of
January 4, 2018, unless the DEA has
approved that application for
registration pursuant to 21 U.S.C. 822,
823, 957, 958, and in accordance with
21 CFR parts 1301 and 1312. Retail sales
of schedule I controlled substances to
the general public are not allowed under
the CSA. Possession of any quantity of
this substance in a manner not
authorized by the CSA on or after
January 4, 2018 is unlawful and those in
possession of any quantity of this
substance may be subject to prosecution
pursuant to the CSA.
2. Disposal of stocks. Any person who
does not desire or is not able to obtain
a schedule I registration to handle
cyclopropyl fentanyl must surrender all
currently held quantities of cyclopropyl
fentanyl.
3. Security. Cyclopropyl fentanyl is
subject to schedule I security
requirements and must be handled and
stored pursuant to 21 U.S.C. 821, 823,
871(b), and in accordance with 21 CFR
1301.71–1301.93, as of January 4, 2018.
4. Labeling and packaging. All labels,
labeling, and packaging for commercial
containers of cyclopropyl fentanyl must
be in compliance with 21 U.S.C. 825,
958(e), and be in accordance with 21
CFR part 1302. Current DEA registrants
shall have 30 calendar days from
January 4, 2018, to comply with all
labeling and packaging requirements.
5. Inventory. Every DEA registrant
who possesses any quantity of
cyclopropyl fentanyl on the effective
date of this order must take an inventory
of all stocks of this substance on hand,
pursuant to 21 U.S.C. 827 and 958, and
in accordance with 21 CFR 1304.03,
1304.04, and 1304.11. Current DEA
registrants shall have 30 calendar days
from the effective date of this order to
be in compliance with all inventory
requirements. After the initial
inventory, every DEA registrant must
take an inventory of all controlled
substances (including cyclopropyl
fentanyl) on hand on a biennial basis,
pursuant to 21 U.S.C. 827 and 958, and
in accordance with 21 CFR 1304.03,
1304.04, and 1304.11.
6. Records. All DEA registrants must
maintain records with respect to
cyclopropyl fentanyl pursuant to 21
U.S.C. 827 and 958, and in accordance
with 21 CFR parts 1304, 1312, 1317, and
§ 1307.11. Current DEA registrants shall
have 30 calendar days from the effective
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date of this order to be in compliance
with all recordkeeping requirements.
7. Reports. All DEA registrants who
manufacture or distribute cyclopropyl
fentanyl must submit reports pursuant
to 21 U.S.C. 827 and in accordance with
21 CFR parts 1304 and 1312 as of
January 4, 2018.
8. Order Forms. All DEA registrants
who distribute cyclopropyl fentanyl
must comply with order form
requirements pursuant to 21 U.S.C. 828
and in accordance with 21 CFR part
1305 as of January 4, 2018.
9. Importation and Exportation. All
importation and exportation of
cyclopropyl fentanyl must be in
compliance with 21 U.S.C. 952, 953,
957, 958, and in accordance with 21
CFR part 1312 as of January 4, 2018.
10. Quota. Only DEA registered
manufacturers may manufacture
cyclopropyl fentanyl in accordance with
a quota assigned pursuant to 21 U.S.C.
826 and in accordance with 21 CFR part
1303 as of January 4, 2018.
11. Liability. Any activity involving
cyclopropyl fentanyl not authorized by,
or in violation of, the CSA, occurring as
of January 4, 2018, is unlawful, and may
subject the person to administrative,
civil, and/or criminal sanctions.
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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. 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 the
Administrative Procedure Act (APA) at
5 U.S.C. 553, do not apply to this
temporary scheduling action. In the
alternative, even assuming that this
action might be subject to 5 U.S.C. 553,
the Administrator finds that there is
good cause to forgo the notice and
comment requirements of 5 U.S.C. 553,
as any further delays in the process for
issuance of temporary scheduling orders
would be contrary to the public interest
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in view of the manifest urgency to avoid
an imminent hazard to the public safety.
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. 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 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.
As noted above, this action is an
order, not a rule. Accordingly, the
Congressional Review Act (CRA) is
inapplicable, as it applies only to rules.
However, if this were a rule, pursuant
to the Congressional Review Act, ‘‘any
rule for which an agency for good cause
finds that notice and public procedure
thereon are impracticable, unnecessary,
or contrary to the public interest, shall
take effect at such time as the federal
agency promulgating the rule
determines.’’ 5 U.S.C. 808(2). It is in the
public interest to schedule this
substance immediately to avoid an
imminent hazard to the public safety.
This temporary scheduling action is
taken pursuant to 21 U.S.C. 811(h),
which is specifically designed to enable
the DEA to act in an expeditious manner
to avoid an imminent hazard to the
public safety. 21 U.S.C. 811(h) exempts
the temporary scheduling order from
standard notice and comment
rulemaking procedures to ensure that
the process moves swiftly. For the same
reasons that underlie 21 U.S.C. 811(h),
that is, the DEA’s need to move quickly
to place this substance in schedule I
because it poses an imminent hazard to
the public safety, it would be contrary
to the public interest to delay
implementation of the temporary
scheduling order. Therefore, this order
shall take effect immediately upon its
publication. The DEA has submitted a
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copy of this temporary order to both
Houses of Congress and to the
Comptroller General, although such
filing is not required under the Small
Business Regulatory Enforcement
Fairness Act of 1996 (Congressional
Review Act), 5 U.S.C. 801–808 because,
as noted above, this action is an order,
not a rule.
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
amends 21 CFR part 1308 as follows:
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
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.
2. In § 1308.11, add paragraph (h)(22)
to read as follows:
■
§ 1308.11
Schedule I.
*
*
*
*
*
(h) * * *
(22) N-(1-phenethylpiperidin-4-yl)-Nphenylcyclopropanecarboxamide, its
isomers, esters, ethers, salts and salts of
isomers, esters and ethers (Other name:
cyclopropyl fentanyl). . . . . . . . . . . .(9845)
Dated: December 28, 2017.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2017–28470 Filed 1–3–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
44 CFR Chapter I
[Docket ID FEMA–2016–0022]
Revisions to the Public Assistance
Program and Policy Guide
Federal Emergency
Management Agency, DHS.
ACTION: Notification of availability.
AGENCY:
This document provides
notice of the availability of the final
policy Public Assistance Program and
Policy Guide (PAPPG).
DATES: FEMA applies the revisions in
this policy to incidents declared on or
after August 23, 2017, or to any
application for assistance that, as of
January 1, 2018 is pending before
SUMMARY:
E:\FR\FM\04JAR1.SGM
04JAR1
Agencies
[Federal Register Volume 83, Number 3 (Thursday, January 4, 2018)]
[Rules and Regulations]
[Pages 469-472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-28470]
=======================================================================
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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 in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Temporary amendment; temporary scheduling order.
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SUMMARY: The Administrator of the Drug Enforcement Administration is
issuing this temporary scheduling order to schedule the synthetic
opioid, N-(1-phenethylpiperidin-4-yl)-N-phenylcyclopropanecarboxamide
(cyclopropyl fentanyl), and its isomers, esters, ethers, salts, and
salts of isomers, esters, and ethers in schedule I. This action is
based on a finding by the Administrator that the placement of
cyclopropyl fentanyl in schedule I of the Controlled Substances Act is
necessary to avoid an imminent hazard to the public safety. As a result
of this order, the regulatory controls and administrative, civil, and
criminal sanctions applicable to schedule I controlled substances will
be imposed on persons who handle (manufacture, distribute, reverse
distribute, import, export, engage in research, conduct instructional
activities or chemical analysis, or possess), or propose to handle,
cyclopropyl fentanyl.
DATES: This temporary scheduling order is effective January 4, 2018,
until January 4, 2020. If this order is extended or made permanent, the
DEA will publish a document in the Federal Register.
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:
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 in 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 \1\ for up to one year. 21 U.S.C. 811(h)(2).
---------------------------------------------------------------------------
\1\ Though DEA has used the term ``final order'' with respect to
temporary scheduling orders in the past, this document adheres to
the statutory language of 21 U.S.C. 811(h), which refers to a
``temporary scheduling order.'' No substantive change is intended.
---------------------------------------------------------------------------
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
in schedule I of the CSA.\2\ The 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 by letter dated
September 6, 2017, 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 cyclopropyl
fentanyl. The Assistant Secretary also stated that the HHS has no
objection to the temporary placement of cyclopropyl fentanyl in
schedule I of the CSA. The DEA has taken into consideration the
Assistant Secretary's comments as required by 21 U.S.C. 811(h)(4).
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. The DEA has
found that the control of cyclopropyl fentanyl in schedule I on a
temporary basis is necessary to avoid an imminent hazard to the public
safety, and as required by 21 U.S.C. 811(h)(1)(A), a notice of intent
to temporarily schedule cyclopropyl fentanyl was published in the
Federal Register on November 21, 2017. 82 FR 55333.
---------------------------------------------------------------------------
\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 in 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
[[Page 470]]
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).
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 and the Assistant
Secretary's September 6, 2017 letter are available in their entirety
under the tab ``Supporting Documents'' of the public docket of this
action at www.regulations.gov under FDMS Docket ID: DEA-2017-0005
(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, 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 analgesics (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 effects. 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.
[[Page 471]]
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 agonist, 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, reverse distribution, importation,
exportation, conduct of research and chemical analysis, 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, by letter dated August 28, 2017, notified
the Assistant Secretary of the DEA's intention to temporarily place
this substance in schedule I. A notice of intent was subsequently
published in the Federal Register on November 21, 2017. 82 FR 55333.
Conclusion
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, and herein sets forth the grounds for his determination
that it is necessary to temporarily schedule cyclopropyl fentanyl in
schedule I of the CSA to avoid an imminent hazard to the public safety.
Because the Administrator hereby finds it necessary to temporarily
place this synthetic opioid in schedule I to avoid an imminent hazard
to the public safety, this temporary order scheduling cyclopropyl
fentanyl is effective on the date of publication in the Federal
Register, and is 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).
The CSA sets forth specific criteria for scheduling a drug or other
substance. Permanent 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 permanent 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 permanent 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).
Requirements for Handling
Upon the effective date of this 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,
engagement in research, and conduct of instructional activities or
chemical analysis with, and possession of schedule I controlled
substances including the following:
1. Registration. Any person who handles (manufactures, distributes,
reverse distributes, imports, exports, engages in research, or conducts
instructional activities or chemical analysis with, or possesses), or
who desires to handle, cyclopropyl fentanyl must be registered with the
DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and
958 and in accordance with 21 CFR parts 1301 and 1312, as of January 4,
2018. Any person who currently handles cyclopropyl fentanyl, and is not
registered with the DEA, must submit an application for registration
and may not continue to handle cyclopropyl fentanyl as of January 4,
2018, unless the DEA has approved that application for registration
pursuant to 21 U.S.C. 822, 823, 957, 958, and in accordance with 21 CFR
parts 1301 and 1312. Retail sales of schedule I controlled substances
to the general public are not allowed under the CSA. Possession of any
quantity of this substance in a manner not authorized by the CSA on or
after January 4, 2018 is unlawful and those in possession of any
quantity of this substance may be subject to prosecution pursuant to
the CSA.
2. Disposal of stocks. Any person who does not desire or is not
able to obtain a schedule I registration to handle cyclopropyl fentanyl
must surrender all currently held quantities of cyclopropyl fentanyl.
3. Security. Cyclopropyl fentanyl is subject to schedule I security
requirements and must be handled and stored pursuant to 21 U.S.C. 821,
823, 871(b), and in accordance with 21 CFR 1301.71-1301.93, as of
January 4, 2018.
4. Labeling and packaging. All labels, labeling, and packaging for
commercial containers of cyclopropyl fentanyl must be in compliance
with 21 U.S.C. 825, 958(e), and be in accordance with 21 CFR part 1302.
Current DEA registrants shall have 30 calendar days from January 4,
2018, to comply with all labeling and packaging requirements.
5. Inventory. Every DEA registrant who possesses any quantity of
cyclopropyl fentanyl on the effective date of this order must take an
inventory of all stocks of this substance on hand, pursuant to 21
U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and
1304.11. Current DEA registrants shall have 30 calendar days from the
effective date of this order to be in compliance with all inventory
requirements. After the initial inventory, every DEA registrant must
take an inventory of all controlled substances (including cyclopropyl
fentanyl) on hand on a biennial basis, pursuant to 21 U.S.C. 827 and
958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
6. Records. All DEA registrants must maintain records with respect
to cyclopropyl fentanyl pursuant to 21 U.S.C. 827 and 958, and in
accordance with 21 CFR parts 1304, 1312, 1317, and Sec. 1307.11.
Current DEA registrants shall have 30 calendar days from the effective
[[Page 472]]
date of this order to be in compliance with all recordkeeping
requirements.
7. Reports. All DEA registrants who manufacture or distribute
cyclopropyl fentanyl must submit reports pursuant to 21 U.S.C. 827 and
in accordance with 21 CFR parts 1304 and 1312 as of January 4, 2018.
8. Order Forms. All DEA registrants who distribute cyclopropyl
fentanyl must comply with order form requirements pursuant to 21 U.S.C.
828 and in accordance with 21 CFR part 1305 as of January 4, 2018.
9. Importation and Exportation. All importation and exportation of
cyclopropyl fentanyl must be in compliance with 21 U.S.C. 952, 953,
957, 958, and in accordance with 21 CFR part 1312 as of January 4,
2018.
10. Quota. Only DEA registered manufacturers may manufacture
cyclopropyl fentanyl in accordance with a quota assigned pursuant to 21
U.S.C. 826 and in accordance with 21 CFR part 1303 as of January 4,
2018.
11. Liability. Any activity involving cyclopropyl fentanyl not
authorized by, or in violation of, the CSA, occurring as of January 4,
2018, is unlawful, and may subject the person to administrative, civil,
and/or criminal sanctions.
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. 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 the Administrative Procedure Act (APA) at 5
U.S.C. 553, do not apply to this temporary scheduling action. In the
alternative, even assuming that this action might be subject to 5
U.S.C. 553, the Administrator finds that there is good cause to forgo
the notice and comment requirements of 5 U.S.C. 553, as any further
delays in the process for issuance of temporary scheduling orders would
be contrary to the public interest in view of the manifest urgency to
avoid an imminent hazard to the public safety.
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. 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 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.
As noted above, this action is an order, not a rule. Accordingly,
the Congressional Review Act (CRA) is inapplicable, as it applies only
to rules. However, if this were a rule, pursuant to the Congressional
Review Act, ``any rule for which an agency for good cause finds that
notice and public procedure thereon are impracticable, unnecessary, or
contrary to the public interest, shall take effect at such time as the
federal agency promulgating the rule determines.'' 5 U.S.C. 808(2). It
is in the public interest to schedule this substance immediately to
avoid an imminent hazard to the public safety. This temporary
scheduling action is taken pursuant to 21 U.S.C. 811(h), which is
specifically designed to enable the DEA to act in an expeditious manner
to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h)
exempts the temporary scheduling order from standard notice and comment
rulemaking procedures to ensure that the process moves swiftly. For the
same reasons that underlie 21 U.S.C. 811(h), that is, the DEA's need to
move quickly to place this substance in schedule I because it poses an
imminent hazard to the public safety, it would be contrary to the
public interest to delay implementation of the temporary scheduling
order. Therefore, this order shall take effect immediately upon its
publication. The DEA has submitted a copy of this temporary order to
both Houses of Congress and to the Comptroller General, although such
filing is not required under the Small Business Regulatory Enforcement
Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801-808
because, as noted above, this action is an order, not a rule.
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 amends 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: December 28, 2017.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2017-28470 Filed 1-3-18; 8:45 am]
BILLING CODE 4410-09-P