82_FR_55556 82 FR 55333 - Schedules of Controlled Substances: Temporary Placement of Cyclopropyl Fentanyl into Schedule I

82 FR 55333 - Schedules of Controlled Substances: Temporary Placement of Cyclopropyl Fentanyl into Schedule I

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 223 (November 21, 2017)

Page Range55333-55336
FR Document2017-25077

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.

Federal Register, Volume 82 Issue 223 (Tuesday, November 21, 2017)
[Federal Register Volume 82, Number 223 (Tuesday, November 21, 2017)]
[Proposed Rules]
[Pages 55333-55336]
From the Federal Register Online  [www.thefederalregister.org]
[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



                                                                          Federal Register / Vol. 82, No. 223 / Tuesday, November 21, 2017 / Proposed Rules                                                55333

                                                      Costs of Compliance                                     Procedures (44 FR 11034, February 26,                 Pilatus Service Bulletin 32–028, dated
                                                                                                              1979),                                                September 20, 2017.
                                                        We estimate that this proposed AD
                                                      will affect 18 products of U.S. registry.                 (3) Will not affect intrastate aviation             (g) Other FAA AD Provisions
                                                      We also estimate that it would take                     in Alaska, and                                           The following provisions also apply to this
                                                      about 2.5 work-hours per product to                       (4) Will not have a significant                     AD:
                                                      comply with the basic requirements of                   economic impact, positive or negative,                   (1) Alternative Methods of Compliance
                                                      this proposed AD. The average labor                     on a substantial number of small entities             (AMOCs): The Manager, Small Airplane
                                                      rate is $85 per work-hour.                              under the criteria of the Regulatory                  Standards Branch, FAA, has the authority to
                                                        Based on these figures, we estimate                   Flexibility Act.                                      approve AMOCs for this AD, if requested
                                                      the cost of the proposed AD on U.S.                                                                           using the procedures found in 14 CFR 39.19.
                                                                                                              List of Subjects in 14 CFR Part 39                    Send information to ATTN: Doug Rudolph,
                                                      operators to be $3,825, or $212.50 per                                                                        Aerospace Engineer, FAA, Small Airplane
                                                      product.                                                  Air transportation, Aircraft, Aviation
                                                                                                                                                                    Standards Branch, 901 Locust, Room 301,
                                                                                                              safety, Incorporation by reference,                   Kansas City, Missouri 64106; telephone:
                                                      Authority for This Rulemaking                           Safety.                                               (816) 329–4059; fax: (816) 329–4090; email:
                                                         Title 49 of the United States Code                                                                         doug.rudolph@faa.gov. Before using any
                                                                                                              The Proposed Amendment
                                                      specifies the FAA’s authority to issue                                                                        approved AMOC on any airplane to which
                                                      rules on aviation safety. Subtitle I,                     Accordingly, under the authority                    the AMOC applies, notify your appropriate
                                                      section 106, describes the authority of                 delegated to me by the Administrator,                 principal inspector (PI) in the FAA Flight
                                                      the FAA Administrator. ‘‘Subtitle VII:                  the FAA proposes to amend 14 CFR part                 Standards District Office (FSDO), or lacking
                                                      Aviation Programs,’’ describes in more                  39 as follows:                                        a PI, your local FSDO.
                                                      detail the scope of the Agency’s                                                                                 (2) Contacting the Manufacturer: For any
                                                      authority.                                              PART 39—AIRWORTHINESS                                 requirement in this AD to obtain corrective
                                                         We are issuing this rulemaking under                 DIRECTIVES                                            actions from a manufacturer, the action must
                                                                                                                                                                    be accomplished using a method approved
                                                      the authority described in ‘‘Subtitle VII,                                                                    by the Manager, Small Airplane Standards
                                                      Part A, Subpart III, Section 44701:                     ■ 1. The authority citation for part 39
                                                                                                              continues to read as follows:                         Branch, FAA; or the Federal Office of Civil
                                                      General requirements.’’ Under that                                                                            Aviation (FOCA), which is the aviation
                                                      section, Congress charges the FAA with                      Authority: 49 U.S.C. 106(g), 40113, 44701.        authority for Switzerland.
                                                      promoting safe flight of civil aircraft in
                                                                                                              § 39.13   [Amended]                                   (h) Related Information
                                                      air commerce by prescribing regulations
                                                      for practices, methods, and procedures                  ■ 2. The FAA amends § 39.13 by adding                   Refer to MCAI FOCA AD HB–2017–002,
                                                      the Administrator finds necessary for                   the following new AD:                                 dated October 20, 2017; and Pilatus Service
                                                                                                                                                                    Bulletin No. 32–028, dated September 20,
                                                      safety in air commerce. This regulation                 Pilatus Aircraft Limited: Docket No. FAA–             2017, for related information. You may
                                                      is within the scope of that authority                        2017–1079; Product Identifier 2017–CE–           examine the MCAI on the Internet at http://
                                                      because it addresses an unsafe condition                     039–AD.                                          www.regulations.gov by searching for and
                                                      that is likely to exist or develop on                   (a) Comments Due Date                                 locating Docket No. FAA–2017–1079. For
                                                      products identified in this rulemaking                                                                        service information related to this AD,
                                                                                                                We must receive comments by January 5,
                                                      action.                                                                                                       contact PILATUS Aircraft Ltd., Customer
                                                                                                              2018.
                                                         This AD is issued in accordance with                                                                       Technical Support (MCC), P.O. Box 992, CH–
                                                      authority delegated by the Executive                    (b) Affected ADs                                      6371 Stans, Switzerland; phone: +41 (0)41
                                                      Director, Aircraft Certification Service,                 None.                                               619 67 74; fax: +41 (0)41 619 67 73; email:
                                                      as authorized by FAA Order 8000.51C.                                                                          techsupport@pilatus-aircraft.com; Internet:
                                                                                                              (c) Applicability                                     http://www.pilatus-aircraft.com. You may
                                                      In accordance with that order, issuance
                                                                                                                 This AD applies to Pilatus Aircraft Limited        review this referenced service information at
                                                      of ADs is normally a function of the                                                                          the FAA, Policy and Innovation Division, 901
                                                      Compliance and Airworthiness                            Model PC–7 airplanes, manufacturer serial
                                                                                                              numbers 101 through 618, certificated in any          Locust, Kansas City, Missouri 64106. For
                                                      Division, but during this transition                                                                          information on the availability of this
                                                                                                              category.
                                                      period, the Executive Director has                                                                            material at the FAA, call (816) 329–4148.
                                                      delegated the authority to issue ADs                    (d) Subject
                                                                                                                                                                      Issued in Kansas City, Missouri, on
                                                      applicable to small airplanes and                         Air Transport Association of America                November 9, 2017.
                                                      domestic business jet transport                         (ATA) Code 32: Landing Gear.                          Pat Mullen,
                                                      airplanes to the Director of the Policy                 (e) Reason                                            Acting Deputy Director, Policy & Innovation
                                                      and Innovation Division.                                                                                      Division, Aircraft Certification Service.
                                                                                                                 This AD was prompted by mandatory
                                                      Regulatory Findings                                     continuing airworthiness information (MCAI)           [FR Doc. 2017–25006 Filed 11–20–17; 8:45 am]
                                                                                                              originated by an aviation authority of another
                                                        We determined that this proposed AD                                                                         BILLING CODE 4910–13–P
                                                                                                              country to identify and correct an unsafe
                                                      would not have federalism implications                  condition on an aviation product. The MCAI
                                                      under Executive Order 13132. This                       describes the unsafe condition as the brakes
                                                      proposed AD would not have a                            remaining activated after release of the brake        DEPARTMENT OF JUSTICE
                                                      substantial direct effect on the States, on             pedal. We are issuing this AD to prevent the
                                                      the relationship between the national                   brakes from remaining activated after the             Drug Enforcement Administration
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS




                                                      Government and the States, or on the                    brake pedal has been released, which could
                                                      distribution of power and                               lead to asymmetric braking and subsequent             21 CFR Part 1308
                                                      responsibilities among the various                      loss of control.
                                                                                                                                                                    [Docket No. DEA–474]
                                                      levels of government.                                   (f) Actions and Compliance
                                                        For the reasons discussed above, I                       Unless already done, within the next 90            Schedules of Controlled Substances:
                                                      certify this proposed regulation:                       days after the effective date of this AD,             Temporary Placement of Cyclopropyl
                                                        (1) Is not a ‘‘significant regulatory                 modify the brake pedal interconnecting tie            Fentanyl into Schedule I
                                                      action’’ under Executive Order 12866,                   rods by removing the bonding straps and
                                                        (2) Is not a ‘‘significant rule’’ under               attachment hardware following sections A, B,          AGENCY:Drug Enforcement
                                                      the DOT Regulatory Policies and                         and C of the Accomplishment Instructions in           Administration, Department of Justice.


                                                 VerDate Sep<11>2014   18:16 Nov 20, 2017   Jkt 244001   PO 00000   Frm 00002   Fmt 4702   Sfmt 4702   E:\FR\FM\21NOP1.SGM   21NOP1


                                                      55334                Federal Register / Vol. 82, No. 223 / Tuesday, November 21, 2017 / Proposed Rules

                                                      ACTION:   Proposed amendment; notice of                 Attorney General may extend the                       Consideration of these factors includes
                                                      intent.                                                 temporary scheduling for up to one                    actual abuse, diversion from legitimate
                                                                                                              year. 21 U.S.C. 811(h)(2).                            channels, and clandestine importation,
                                                      SUMMARY:    The Administrator of the Drug                 Where the necessary findings are                    manufacture, or distribution. 21 U.S.C.
                                                      Enforcement Administration is issuing                   made, a substance may be temporarily                  811(h)(3).
                                                      this notice of intent to publish a                      scheduled if it is not listed in any other              A substance meeting the statutory
                                                      temporary order to schedule the                         schedule under section 202 of the CSA,                requirements for temporary scheduling
                                                      synthetic opioid, N-(1-                                 21 U.S.C. 812, or if there is no                      may only be placed in Schedule I. 21
                                                      phenethylpiperidin-4-yl)-N-                             exemption or approval in effect for the               U.S.C. 811(h)(1). Substances in
                                                      phenylcyclopropanecarboxamide                           substance under section 505 of the                    Schedule I are those that have a high
                                                      (cyclopropyl fentanyl), into Schedule I.                Federal Food, Drug, and Cosmetic Act                  potential for abuse, no currently
                                                      This action is based on a finding by the                (FDCA), 21 U.S.C. 355. 21 U.S.C.                      accepted medical use in treatment in the
                                                      Administrator that the placement of this                811(h)(1); 21 CFR part 1308. The                      United States, and a lack of accepted
                                                      synthetic opioid into Schedule I of the                 Attorney General has delegated                        safety for use under medical
                                                      Controlled Substances Act is necessary                  scheduling authority under 21 U.S.C.                  supervision. 21 U.S.C. 812(b)(1).
                                                      to avoid an imminent hazard to the                      811 to the Administrator of the DEA. 28
                                                      public safety. When it is issued, the                                                                         Cyclopropyl Fentanyl
                                                                                                              CFR 0.100.
                                                      temporary scheduling order will impose                                                                           The recent identification of
                                                      the administrative, civil, and criminal                 Background                                            cyclopropyl fentanyl in drug evidence
                                                      sanctions and regulatory controls                          Section 201(h)(4) of the CSA, 21                   and the identification of this substance
                                                      applicable to Schedule I controlled                     U.S.C. 811(h)(4), requires the                        in association with fatal overdose events
                                                      substances under the Controlled                         Administrator to notify the Secretary of              indicate that this substance is being
                                                      Substances Act on the manufacture,                      the Department of Health and Human                    abused for its opioid properties. No
                                                      distribution, reverse distribution,                     Services (HHS) of his intention to                    approved medical use has been
                                                      possession, importation, exportation,                   temporarily place a substance into                    identified for cyclopropyl fentanyl, nor
                                                      research, and conduct of instructional                  Schedule I of the CSA.2 The Acting                    has it been approved by the FDA for
                                                      activities, and chemical analysis of this               Administrator transmitted notice of his               human consumption.
                                                      synthetic opioid.                                       intent to place cyclopropyl fentanyl in                  Available data and information for
                                                      DATES: November 21, 2017.                               Schedule I on a temporary basis to the                cyclopropyl fentanyl, summarized
                                                      FOR FURTHER INFORMATION CONTACT:                        Assistant Secretary for Health of HHS by              below, indicate that this synthetic
                                                      Michael J. Lewis, Diversion Control                     letter dated August 28, 2017. The                     opioid has a high potential for abuse, no
                                                      Division, Drug Enforcement                              Assistant Secretary responded to this                 currently accepted medical use in
                                                      Administration; Mailing Address: 8701                   notice of intent by letter dated                      treatment in the United States, and a
                                                      Morrissette Drive, Springfield, Virginia                September 6, 2017, and advised that                   lack of accepted safety for use under
                                                      22152; Telephone: (202) 598–6812.                       based on a review by the Food and Drug                medical supervision. The DEA’s three-
                                                      SUPPLEMENTARY INFORMATION: This                         Administration (FDA), there are                       factor analysis is available in its entirety
                                                      notice of intent contained in this                      currently no investigational new drug                 under ‘‘Supporting and Related
                                                      document is issued pursuant to the                      applications or approved new drug                     Material’’ of the public docket for this
                                                      temporary scheduling provisions of 21                   applications for cyclopropyl fentanyl.                action at www.regulations.gov under
                                                      U.S.C. 811(h). The Drug Enforcement                     The Assistant Secretary also stated that              Docket Number DEA–474.
                                                      Administration (DEA) intends to issue a                 the HHS has no objection to the
                                                                                                              temporary placement of cyclopropyl                    Factor 4. History and Current Pattern of
                                                      temporary scheduling order (in the form                                                                       Abuse
                                                      of a temporary amendment) to add                        fentanyl into Schedule I of the CSA.
                                                      cyclopropyl fentanyl to Schedule I                      Cyclopropyl fentanyl is not currently                    The recreational abuse of fentanyl-like
                                                      under the Controlled Substances Act.1                   listed in any schedule under the CSA,                 substances continues to be a significant
                                                      The temporary scheduling order will be                  and no exemptions or approvals are in                 concern. These substances are
                                                      published in the Federal Register, but                  effect for cyclopropyl fentanyl under                 distributed to users, often with
                                                      will not be issued before December 21,                  section 505 of the FDCA, 21 U.S.C. 355.               unpredictable outcomes. Cyclopropyl
                                                      2017.                                                      To find that placing a substance                   fentanyl has been encountered by law
                                                                                                              temporarily into Schedule I of the CSA                enforcement and public health officials
                                                      Legal Authority                                         is necessary to avoid an imminent                     beginning as early as May 2017. The
                                                         Section 201 of the Controlled                        hazard to the public safety, the                      DEA is not aware of any laboratory
                                                      Substances Act (CSA), 21 U.S.C. 811,                    Administrator is required to consider                 identifications of this substance prior to
                                                      provides the Attorney General with the                  three of the eight factors set forth in 21            2017. Adverse health effects and
                                                      authority to temporarily place a                        U.S.C. 811(c): The substance’s history                outcomes of cyclopropyl fentanyl abuse
                                                      substance into Schedule I of the CSA for                and current pattern of abuse; the scope,              are consistent with those of other
                                                      two years without regard to the                         duration and significance of abuse; and               opioids and are demonstrated by fatal
                                                      requirements of 21 U.S.C. 811(b) if he                  what, if any, risk there is to the public             overdose cases involving this substance.
                                                      finds that such action is necessary to                  health. 21 U.S.C. 811(h)(3).                             On October 1, 2014, the DEA
                                                      avoid an imminent hazard to the public                                                                        implemented STARLiMS (a web-based,
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS




                                                      safety. 21 U.S.C. 811(h)(1). In addition,                 2 As discussed in a memorandum of                   commercial laboratory information
                                                      if proceedings to control a substance are               understanding entered into by the Food and Drug       management system) to replace the
                                                                                                              Administration (FDA) and the National Institute on
                                                      initiated under 21 U.S.C. 811(a)(1), the                Drug Abuse (NIDA), the FDA acts as the lead agency
                                                                                                                                                                    System to Retrieve Information from
                                                                                                              within the HHS in carrying out the Secretary’s        Drug Evidence (STRIDE) as its
                                                         1 Though DEA has used the term ‘‘final order’’       scheduling responsibilities under the CSA, with the   laboratory drug evidence data system of
                                                      with respect to temporary scheduling orders in the      concurrence of NIDA. 50 FR 9518, Mar. 8, 1985.        record. DEA laboratory data submitted
                                                      past, this notice of intent adheres to the statutory    The Secretary of the HHS has delegated to the
                                                      language of 21 U.S.C. 811(h), which refers to a         Assistant Secretary for Health of the HHS the
                                                                                                                                                                    after September 30, 2014, are reposited
                                                      ‘‘temporary scheduling order.’’ No substantive          authority to make domestic drug scheduling            in STARLiMS. Data from STRIDE and
                                                      change is intended.                                     recommendations. 58 FR 35460, July 1, 1993.           STARLiMS were queried on August 25,


                                                 VerDate Sep<11>2014   18:16 Nov 20, 2017   Jkt 244001   PO 00000   Frm 00003   Fmt 4702   Sfmt 4702   E:\FR\FM\21NOP1.SGM   21NOP1


                                                                          Federal Register / Vol. 82, No. 223 / Tuesday, November 21, 2017 / Proposed Rules                                          55335

                                                      2017. STARLiMS registered a total of                    being abused for its opioid properties.               opioid analgesics, such as morphine and
                                                      three reports containing cyclopropyl                    Abuse of cyclopropyl fentanyl has                     oxycodone. The toxic effects of
                                                      fentanyl from California, Connecticut,                  resulted in mortality (see DEA 3-Factor               cyclopropyl fentanyl in humans are
                                                      and New York. Of these three exhibits,                  Analysis for full discussion). The DEA                demonstrated by overdose fatalities
                                                      one had a net weight of approximately                   collected post-mortem toxicology and                  involving this substance.
                                                      one kilogram. According to STARLiMS,                    medical examiner reports on 115                         Based on information received by the
                                                      the first laboratory submission of                      confirmed fatalities associated with                  DEA, the misuse and abuse of
                                                      cyclopropyl fentanyl occurred in                        cyclopropyl fentanyl which occurred in                cyclopropyl fentanyl lead to, at least,
                                                      Connecticut in June 2017.                               Georgia (1), Maryland (24), Mississippi
                                                                                                                                                                    the same qualitative public health risks
                                                         The National Forensic Laboratory                     (1), North Carolina (75), and Wisconsin
                                                      Information System (NFLIS) is a                                                                               as heroin, fentanyl, and other opioid
                                                                                                              (14). It is likely that the prevalence of
                                                      national drug forensic laboratory                                                                             analgesic substances. As with any non-
                                                                                                              this substance in opioid related
                                                      reporting system that systematically                                                                          medically approved opioid, the health
                                                                                                              emergency room admissions and deaths
                                                      collects results from drug chemistry                    is underreported as standard                          and safety risks for users are high. The
                                                      analyses conducted by other federal,                    immunoassays may not differentiate this               public health risks attendant to the
                                                      state and local forensic laboratories                   fentanyl analogue from fentanyl.                      abuse of heroin and opioid analgesics
                                                      across the country. NFLIS registered 10                    NFLIS and STARLiMS have a total of                 are well established and have resulted
                                                      reports containing cyclopropyl fentanyl                 13 drug reports in which cyclopropyl                  in large numbers of drug treatment
                                                      from state or local forensic laboratories               fentanyl was identified in drug exhibits              admissions, emergency department
                                                      in Oklahoma in July 2017 (query date:                   submitted to forensic laboratories in                 visits, and fatal overdoses.
                                                      August 29, 2017).3                                      2017 from law enforcement encounters                    Cyclopropyl fentanyl has been
                                                        In addition to data recorded in NFLIS                 in California, Connecticut, New York,                 associated with numerous fatalities. At
                                                      and STARLiMS, cyclopropyl fentanyl                      and Oklahoma. In addition to the data                 least 115 confirmed overdose deaths
                                                      was identified in drug evidence                         collected in these databases,                         involving cyclopropyl fentanyl abuse
                                                      submitted to state and local forensic                   cyclopropyl fentanyl was identified in                have been reported from Georgia (1),
                                                      laboratories in Georgia and                             drug evidence submitted to forensic                   Maryland (24), Mississippi (1), North
                                                      Pennsylvania. Cyclopropyl fentanyl was                  laboratories in Georgia (counterfeit                  Carolina (75), and Wisconsin (14) in
                                                      confirmed in combination with U–                        oxycodone preparation) and                            2017. As the data demonstrate, the
                                                      47700, another synthetic opioid                         Pennsylvania (24 glassine paper                       potential for fatal and non-fatal
                                                      temporarily controlled in Schedule I of                 packets).                                             overdoses exists for cyclopropyl
                                                      the CSA, in 24 glassine paper packets                      The population likely to abuse                     fentanyl and this substance poses an
                                                      submitted to a law enforcement forensic                 cyclopropyl fentanyl overlaps with the                imminent hazard to the public safety.
                                                      laboratory in Pennsylvania.4 A law                      population abusing prescription opioid
                                                      enforcement forensic laboratory in                      analgesics, heroin, fentanyl and other                Finding of Necessity of Schedule I
                                                      Georgia confirmed 5 the presence of                     fentanyl-related substances. This is                  Placement To Avoid Imminent Hazard
                                                      cyclopropyl fentanyl in counterfeit                     supported by cyclopropyl fentanyl being               to Public Safety
                                                      oxycodone tablets which also contained                  identified in powder contained within
                                                                                                              glassine paper packets and counterfeit                   In accordance with 21 U.S.C.
                                                      U–47700. The distribution of
                                                                                                              prescription opioid products. This is                 811(h)(3), based on the available data
                                                      cyclopropyl fentanyl in these forms, and
                                                                                                              also demonstrated by routes of drug                   and information, summarized above, the
                                                      in combination with another synthetic
                                                                                                              administration and drug use history                   continued uncontrolled manufacture,
                                                      opioid, suggests that this substance was
                                                                                                              documented in cyclopropyl fentanyl                    distribution, importation, possession,
                                                      marketed as heroin or prescription
                                                                                                              fatal overdose cases. Because abusers of              and abuse of cyclopropyl fentanyl pose
                                                      opioids in the illicit market.
                                                                                                              cyclopropyl fentanyl obtain this                      an imminent hazard to the public safety.
                                                         Evidence suggests that the pattern of
                                                                                                              substance through unregulated sources,                The DEA is not aware of any currently
                                                      abuse of fentanyl analogues, including
                                                                                                              the identity, purity, and quantity are                accepted medical uses for cyclopropyl
                                                      cyclopropyl fentanyl, parallels that of
                                                                                                              uncertain and inconsistent, thus posing               fentanyl in the United States. A
                                                      heroin and prescription opioid
                                                                                                              significant adverse health risks to the               substance meeting the statutory
                                                      analgesics. Seizures of cyclopropyl
                                                                                                              end user. Individuals who initiate (i.e.              requirements for temporary scheduling,
                                                      fentanyl have been encountered in
                                                                                                              use a drug for the first time) cyclopropyl            21 U.S.C. 811(h)(1), may only be placed
                                                      powder form, similar to fentanyl and
                                                                                                              fentanyl abuse are likely to be at risk of            in Schedule I. Substances in Schedule I
                                                      heroin, and in counterfeit prescription
                                                                                                              developing substance use disorder,                    are those that have a high potential for
                                                      opioid products (i.e. counterfeit
                                                                                                              overdose, and death similar to that of                abuse, no currently accepted medical
                                                      oxycodone tablets). Cyclopropyl
                                                                                                              other opioid analgesics (e.g., fentanyl,              use in treatment in the United States,
                                                      fentanyl was also confirmed in
                                                                                                              morphine, etc.).                                      and a lack of accepted safety for use
                                                      toxicology samples from fatal overdose
                                                                                                                                                                    under medical supervision. Available
                                                      cases.                                                  Factor 6. What, if Any, Risk There Is to              data and information for cyclopropyl
                                                      Factor 5. Scope, Duration and                           the Public Health                                     fentanyl indicate that this substance has
                                                      Significance of Abuse                                     With no legitimate medical use,                     a high potential for abuse, no currently
                                                                                                              cyclopropyl fentanyl has emerged on                   accepted medical use in treatment in the
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS




                                                        Reports collected by the DEA
                                                      demonstrate that cyclopropyl fentanyl is                the illicit drug market and is being                  United States, and a lack of accepted
                                                                                                              misused and abused for its opioid                     safety for use under medical
                                                        3 Data are still being collected for May 2017–        properties. Cyclopropyl fentanyl                      supervision. As required by section
                                                      August 2017 due to the normal lag period for labs       exhibits pharmacological profiles                     201(h)(4) of the CSA, 21 U.S.C.
                                                      reporting to NFLIS.                                     similar to that of fentanyl and other m-              811(h)(4), the Administrator, through a
                                                        4 Email from Philadelphia Police Department—
                                                                                                              opioid receptor agonists. The abuse of                letter dated August 28, 2017, notified
                                                      Office of Forensic Science, to DEA (August 18, 2017
                                                      11:09 a.m.) (on file with DEA).                         cyclopropyl fentanyl poses significant                the Assistant Secretary of the DEA’s
                                                        5 Laboratory report obtained from Division of         adverse health risks when compared to                 intention to temporarily place this
                                                      Forensic Science, Georgia Bureau of Investigation.      abuse of pharmaceutical preparations of               substance in Schedule I.


                                                 VerDate Sep<11>2014   18:16 Nov 20, 2017   Jkt 244001   PO 00000   Frm 00004   Fmt 4702   Sfmt 4702   E:\FR\FM\21NOP1.SGM   21NOP1


                                                      55336               Federal Register / Vol. 82, No. 223 / Tuesday, November 21, 2017 / Proposed Rules

                                                      Conclusion                                              review. 21 U.S.C. 877. Temporary                        Additionally, this action is not a
                                                         This notice of intent initiates a                    scheduling orders are not subject to                  significant regulatory action as defined
                                                      temporary scheduling process and                        judicial review. 21 U.S.C. 811(h)(6).                 by Executive Order 12866 (Regulatory
                                                      provides the 30-day notice pursuant to                                                                        Planning and Review), section 3(f), and,
                                                                                                              Regulatory Matters
                                                      section 201(h) of the CSA, 21 U.S.C.                                                                          accordingly, this action has not been
                                                                                                                 Section 201(h) of the CSA, 21 U.S.C.               reviewed by the Office of Management
                                                      811(h), of DEA’s intent to issue a                      811(h), provides for a temporary
                                                      temporary scheduling order. In                                                                                and Budget.
                                                                                                              scheduling action where such action is                  This action will not have substantial
                                                      accordance with the provisions of                       necessary to avoid an imminent hazard
                                                      section 201(h) of the CSA, 21 U.S.C.                                                                          direct effects on the States, on the
                                                                                                              to the public safety. As provided in this             relationship between the national
                                                      811(h), the Administrator considered                    subsection, the Attorney General may,
                                                      available data and information, herein                                                                        government and the States, or on the
                                                                                                              by order, schedule a substance in                     distribution of power and
                                                      set forth the grounds for his                           Schedule I on a temporary basis. Such
                                                      determination that it is necessary to                                                                         responsibilities among the various
                                                                                                              an order may not be issued before the                 levels of government. Therefore, in
                                                      temporarily schedule cyclopropyl                        expiration of 30 days from (1) the
                                                      fentanyl in Schedule I of the CSA, and                                                                        accordance with Executive Order 13132
                                                                                                              publication of a notice in the Federal                (Federalism) it is determined that this
                                                      finds that placement of this synthetic                  Register of the intention to issue such
                                                      opioid into Schedule I of the CSA is                                                                          action does not have sufficient
                                                                                                              order and the grounds upon which such                 federalism implications to warrant the
                                                      necessary in order to avoid an imminent                 order is to be issued, and (2) the date
                                                      hazard to the public safety.                                                                                  preparation of a Federalism Assessment.
                                                                                                              that notice of the proposed temporary
                                                         The temporary placement of                           scheduling order is transmitted to the                List of Subjects in 21 CFR Part 1308
                                                      cyclopropyl fentanyl into Schedule I of                 Assistant Secretary of HHS. 21 U.S.C.
                                                      the CSA will take effect pursuant to a                                                                          Administrative practice and
                                                                                                              811(h)(1).                                            procedure, Drug traffic control,
                                                      temporary scheduling order, which will                     Inasmuch as section 201(h) of the
                                                      not be issued before December 21, 2017.                                                                       Reporting and recordkeeping
                                                                                                              CSA directs that temporary scheduling                 requirements.
                                                      Because the Administrator hereby finds                  actions be issued by order and sets forth
                                                      that it is necessary to temporarily place               the procedures by which such orders are                 For the reasons set out above, the DEA
                                                      cyclopropyl fentanyl into Schedule I to                 to be issued, the DEA believes that the               proposes to amend 21 CFR part 1308 as
                                                      avoid an imminent hazard to the public                  notice and comment requirements of                    follows:
                                                      safety, the temporary order scheduling                  section 553 of the Administrative
                                                      this substance will be effective on the                                                                       PART 1308—SCHEDULES OF
                                                                                                              Procedure Act (APA), 5 U.S.C. 553, do                 CONTROLLED SUBSTANCES
                                                      date that order is published in the                     not apply to this notice of intent. In the
                                                      Federal Register, and will be in effect                 alternative, even assuming that this                  ■ 1. The authority citation for part 1308
                                                      for a period of two years, with a possible              notice of intent might be subject to                  continues to read as follows:
                                                      extension of one additional year,                       section 553 of the APA, the
                                                      pending completion of the regular                                                                               Authority: 21 U.S.C. 811, 812, 871(b),
                                                                                                              Administrator finds that there is good
                                                      (permanent) scheduling process. 21                                                                            956(b), unless otherwise noted.
                                                                                                              cause to forgo the notice and comment
                                                      U.S.C. 811(h)(1) and (2). It is the                     requirements of section 553, as any                   ■ 2. In § 1308.11, add paragraph (h)(22)
                                                      intention of the Administrator to issue                 further delays in the process for                     to read as follows:
                                                      a temporary scheduling order as soon as                 issuance of temporary scheduling orders
                                                      possible after the expiration of 30 days                                                                      § 1308.11    Schedule I
                                                                                                              would be impracticable and contrary to
                                                      from the date of publication of this                    the public interest in view of the                    *     *    *      *    *
                                                      notice. Upon publication of the                         manifest urgency to avoid an imminent                   (h) * * *
                                                      temporary order, cyclopropyl fentanyl                   hazard to the public safety.                            (22) N-(1-phenethylpiperidin-4-yl)-N-
                                                      will be subject to the regulatory controls                 Although the DEA believes this notice              phenylcyclopropanecarboxamide, its
                                                      and administrative, civil, and criminal                 of intent to issue a temporary                        isomers, esters, ethers, salts and salts of
                                                      sanctions applicable to the manufacture,                scheduling order is not subject to the                isomers, esters and ethers (Other name:
                                                      distribution, reverse distribution,                     notice and comment requirements of                    cyclopropyl fentanyl) . . . (9845)
                                                      importation, exportation, research,                     section 553 of the APA, the DEA notes                 *     *    *      *    *
                                                      conduct of instructional activities and                 that in accordance with 21 U.S.C.                       Dated: November 13, 2017.
                                                      chemical analysis, and possession of a                  811(h)(4), the Administrator will take                Robert W. Patterson,
                                                      Schedule I controlled substance.                        into consideration any comments
                                                         The CSA sets forth specific criteria for                                                                   Acting Administrator.
                                                                                                              submitted by the Assistant Secretary in
                                                      scheduling a drug or other substance.                                                                         [FR Doc. 2017–25077 Filed 11–20–17; 8:45 am]
                                                                                                              response to the notice that DEA
                                                      Regular scheduling actions in                           transmitted to the Assistant Secretary                BILLING CODE 4410–09–P
                                                      accordance with 21 U.S.C. 811(a) are                    pursuant to section 811(h)(4).
                                                      subject to formal rulemaking procedures                    Further, the DEA believes that this
                                                      done ‘‘on the record after opportunity                  temporary scheduling action is not a                  DEPARTMENT OF HOMELAND
                                                      for a hearing’’ conducted pursuant to                   ‘‘rule’’ as defined by 5 U.S.C. 601(2),               SECURITY
                                                      the provisions of 5 U.S.C. 556 and 557.                 and, accordingly, is not subject to the
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS




                                                      21 U.S.C. 811. The regular scheduling                   requirements of the Regulatory                        Coast Guard
                                                      process of formal rulemaking affords                    Flexibility Act (RFA). The requirements
                                                      interested parties with appropriate                     for the preparation of an initial                     33 CFR Part 165
                                                      process and the government with any                     regulatory flexibility analysis in 5 U.S.C.           [Docket Number USCG–2017–0994]
                                                      additional relevant information needed                  603(a) are not applicable where, as here,
                                                      to make a determination. Final                          the DEA is not required by section 553                RIN 1625–AA00
                                                      decisions that conclude the regular                     of the APA or any other law to publish                Safety Zone; Spa Creek, Annapolis, MD
                                                      scheduling process of formal                            a general notice of proposed
                                                      rulemaking are subject to judicial                      rulemaking.                                           AGENCY:     Coast Guard, DHS.


                                                 VerDate Sep<11>2014   18:16 Nov 20, 2017   Jkt 244001   PO 00000   Frm 00005   Fmt 4702   Sfmt 4702   E:\FR\FM\21NOP1.SGM   21NOP1



Document Created: 2017-11-21 00:42:50
Document Modified: 2017-11-21 00:42:50
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed amendment; notice of intent.
DatesNovember 21, 2017.
ContactMichael J. Lewis, Diversion Control
FR Citation82 FR 55333 
CFR AssociatedAdministrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR