[Federal Register Volume 83, Number 22 (Thursday, February 1, 2018)]
[Rules and Regulations]
[Pages 4580-4585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02008]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-475]


Schedules of Controlled Substances: Temporary Placement of Seven 
Fentanyl-Related Substances 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 seven fentanyl-
related substances in schedule I. These seven substances are: N-(1-
phenethylpiperidin-4-yl)-N-phenylpentanamide (valeryl fentanyl), N-(4-
fluorophenyl)-N-(1-phenethylpiperidin-4-yl)butyramide (para-
fluorobutyryl fentanyl), N-(4-methoxyphenyl)-N-(1-phenethylpiperidin-4-
yl)butyramide (para-methoxybutyryl fentanyl), N-(4-chlorophenyl)-N-(1-
phenethylpiperidin-4-yl)isobutyramide (para-chloroisobutyryl fentanyl), 
N-(1-phenethylpiperidin-4-yl)-N-phenylisobutyramide (isobutyryl 
fentanyl), N-(1-phenethylpiperidin-4-yl)-N-
phenylcyclopentanecarboxamide (cyclopentyl fentanyl), and N-(2-
fluorophenyl)-2-methoxy-N-(1-phenethylpiperidin-4-yl)acetamide 
(ocfentanil). This action is based on a finding by the Administrator 
that the placement of these seven synthetic opioids 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

[[Page 4581]]

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, valeryl fentanyl, para-fluorobutyryl 
fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, 
isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil.

DATES: This temporary scheduling order is effective February 1, 2018, 
until February 1, 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).
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    \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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    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 valeryl fentanyl, para-fluorobutyryl fentanyl, 
para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, 
isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil in schedule I 
on a temporary basis to the Assistant Secretary for Health of HHS by 
letter dated October 20, 2017. The Assistant Secretary responded to 
this notice of intent by letter dated November 8, 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 valeryl fentanyl, para-fluorobutyryl fentanyl, 
para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, 
isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil. The 
Assistant Secretary also stated that the HHS has no objection to the 
temporary placement of these seven substances 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). Valeryl fentanyl, para-
fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-
chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, 
and ocfentanil are not currently listed in any schedule under the CSA, 
and no exemptions or approvals are in effect for these seven substances 
under section 505 of the FDCA, 21 U.S.C. 355. The DEA has found that 
the control of valeryl fentanyl, para-fluorobutyryl fentanyl, para-
methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl 
fentanyl, cyclopentyl fentanyl, and ocfentanil 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 valeryl fentanyl, para-fluorobutyryl fentanyl, 
para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, 
isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil was published 
in the Federal Register on December 13, 2017. 82 FR 58575.
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    \2\ As discussed in a memorandum of understanding entered into 
by the Food and Drug Administration (FDA) and the National Institute 
on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS 
in carrying out the Secretary's scheduling responsibilities under 
the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The 
Secretary of the HHS has delegated to the Assistant Secretary for 
Health of the HHS the authority to make domestic drug scheduling 
recommendations. 58 FR 35460, July 1, 1993.
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    To find that placing a substance temporarily 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 
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 valeryl fentanyl, para-
fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-
chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, 
and ocfentanil, summarized below, indicate that these synthetic opioids 
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. The DEA's three-factor analysis and the 
Assistant Secretary's November 8, 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-2017-0016-
0001 (Docket Number DEA-475).

Factor 4. History and Current Pattern of Abuse

    The recreational abuse of fentanyl-related substances continues to 
be a significant concern. These substances are distributed to users, 
often with unpredictable outcomes. Evidence suggests that the pattern 
of abuse of these fentanyl-related substances parallels that of heroin 
and prescription opioid analgesics. Valeryl fentanyl, para-
fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-
chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, 
and ocfentanil are fentanyl-related substances that have been 
encountered by law enforcement and/or reported in the scientific 
literature by public health officials. Adverse health effects and 
outcomes related to the abuse of fentanyl-related substances have been 
documented in previous temporary

[[Page 4582]]

scheduling actions (see DEA 3-Factor Analysis).
    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 November 2, 2017. STARLiMS 
registered the following reports: valeryl fentanyl (15), para-
fluorobutyryl fentanyl (5), isobutyryl fentanyl (116), and cyclopentyl 
fentanyl (1). These identifications were made beginning in 2015.
    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 was queried on November 3, 2017 \3\ and the following substances 
(number of drug reports) were identified from state and local forensic 
laboratories since 2015: valeryl fentanyl (69), para-fluorobutyryl 
fentanyl (220), para-methoxybutyryl fentanyl (1), and isobutyryl 
fentanyl (4). The identification in other countries of para-
fluorobutyryl fentanyl (Poland and Sweden), para-methoxybutyryl 
fentanyl (Sweden), ocfentanil (Belgium and Switzerland), cylcopentyl 
fentanyl (Sweden), and para-chloroisobutyryl fentanyl (Sweden) in 
toxicological samples associated with fatal and non-fatal overdoses was 
reported in the scientific literature.
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    \3\ Data are still being collected for July 2017-October 2017 
due to the normal lag period for labs reporting to NFLIS.
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Factor 5. Scope, Duration and Significance of Abuse

    Fentanyl-related substances have recently re-emerged on the illicit 
market (see DEA 3-Factor Analysis for full discussion). Valeryl 
fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, 
para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl 
fentanyl, and ocfentanil have been identified in evidence submitted to 
law enforcement and/or reported in the scientific literature by public 
health forensic laboratories.
    The identification of valeryl fentanyl, para-fluorobutyryl 
fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, 
isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil in forensic 
evidence indicates that these substances are intended to be 
replacements for controlled synthetic opioids, heroin, and/or 
prescription opioids. Because abusers of these fentanyl-related 
substances obtain these substances 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) abuse of these 
substances 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).

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

    With no legitimate medical use in the United States, valeryl 
fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, 
para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl 
fentanyl, and ocfentanil have emerged on the illicit drug market. 
Substances within this chemical structural class have demonstrated 
pharmacological profiles similar to that of fentanyl and other [micro]-
opioid receptor agonists (see DEA 3-Factor Analysis). The abuse of 
these fentanyl-related substances poses significant adverse health 
risks when compared to abuse of pharmaceutical preparations of opioid 
analgesics, such as morphine and oxycodone. The toxic effects of 
substances within this structural class in humans are demonstrated by 
overdose fatalities described in previous scheduling actions.
    Based on information received by the DEA, the misuse and abuse of 
valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl 
fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, 
cyclopentyl fentanyl, and ocfentanil 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.

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 valeryl fentanyl, para-fluorobutyryl fentanyl, para-
methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl 
fentanyl, cyclopentyl fentanyl, and ocfentanil pose an imminent hazard 
to the public safety. The DEA is not aware of any currently accepted 
medical uses for these seven substances 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 valeryl fentanyl, para-fluorobutyryl fentanyl, para-
methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl 
fentanyl, cyclopentyl fentanyl, and ocfentanil indicate that these 
substances 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. As required by section 
201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Administrator, by letter 
dated October 20, 2017, notified the Assistant Secretary of the DEA's 
intention to temporarily place these substances in schedule I. A notice 
of intent was subsequently published in the Federal Register on 
December 13, 2017. 82 FR 58575.

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 valeryl fentanyl, para-
fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-
chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, 
and ocfentanil 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 these synthetic opioids in schedule I to avoid an imminent hazard 
to the public safety, this temporary order scheduling valeryl fentanyl, 
para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-
chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, 
and ocfentanil is effective on

[[Page 4583]]

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, valeryl fentanyl, 
para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-
chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, 
and ocfentanil 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, valeryl fentanyl, para-fluorobutyryl fentanyl, 
para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, 
isobutyryl fentanyl, cyclopentyl fentanyl, or ocfentanil 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 February 1, 2018. Any person who currently handles 
valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl 
fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, 
cyclopentyl fentanyl, or ocfentanil, and is not registered with the 
DEA, must submit an application for registration and may not continue 
to handle valeryl fentanyl, para-fluorobutyryl fentanyl, para-
methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl 
fentanyl, cyclopentyl fentanyl, or ocfentanil as of February 1, 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 these substances in a manner not authorized by the CSA on 
or after February 1, 2018, is unlawful and those in possession of any 
quantity of these substances 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 valeryl fentanyl, 
para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-
chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, 
or ocfentanil, must surrender all currently held quantities of valeryl 
fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, 
para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl 
fentanyl, or ocfentanil.
    3. Security. Valeryl fentanyl, para-fluorobutyryl fentanyl, para-
methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl 
fentanyl, cyclopentyl fentanyl, and ocfentanil are 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 February 1, 2018.
    4. Labeling and packaging. All labels, labeling, and packaging for 
commercial containers of valeryl fentanyl, para-fluorobutyryl fentanyl, 
para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, 
isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil 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 
February 1, 2018, to comply with all labeling and packaging 
requirements.
    5. Inventory. Every DEA registrant who possesses any quantity of 
valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl 
fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, 
cyclopentyl fentanyl, or ocfentanil on the effective date of this order 
must take an inventory of all stocks of these substances 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 valeryl fentanyl, para-fluorobutyryl fentanyl, para-
methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl 
fentanyl, cyclopentyl fentanyl, and ocfentanil) 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 valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl 
fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, 
cyclopentyl fentanyl, and ocfentanil 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 date of this order to be in compliance with all recordkeeping 
requirements.
    7. Reports. All DEA registrants who manufacture or distribute 
valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl 
fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, 
cyclopentyl fentanyl, or ocfentanil must submit reports pursuant to 21 
U.S.C. 827, and in accordance with 21 CFR parts 1304 and 1312, as of 
February 1, 2018.
    8. Order Forms. All DEA registrants who distribute valeryl 
fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, 
para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl 
fentanyl, or ocfentanil must comply with order form requirements 
pursuant to 21 U.S.C. 828, and in accordance with 21 CFR part 1305, as 
of February 1, 2018.
    9. Importation and Exportation. All importation and exportation of 
valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl 
fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, 
cyclopentyl fentanyl, and ocfentanil must be in compliance with 21 
U.S.C. 952, 953, 957, 958, and in accordance with 21 CFR part 1312, as 
of February 1, 2018.
    10. Quota. Only DEA registered manufacturers may manufacture 
valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl 
fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, 
cyclopentyl fentanyl, or ocfentanil in accordance with a quota assigned 
pursuant to 21 U.S.C. 826, and

[[Page 4584]]

in accordance with 21 CFR part 1303, as of February 1, 2018.
    11. Liability. Any activity involving valeryl fentanyl, para-
fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-
chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, 
or ocfentanil not authorized by, or in violation of, the CSA, occurring 
as of February 1, 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 impracticable and 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 CRA, ``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 these substances 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 these substances in schedule I because they pose 
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 paragraphs (h)(23) through (29) to read as 
follows:


Sec.  1308.11  Schedule I.

* * * * *
    (h) * * *

------------------------------------------------------------------------
 
------------------------------------------------------------------------
(23) N-(1-phenethylpiperidin-4-yl)-N-phenylpentanamide, its       (9804)
 isomers, esters, ethers, salts and salts of isomers,
 esters and ethers (Other name: valeryl fentanyl)..........
(24) N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-                (9823)
 yl)butyramide, its isomers, esters, ethers, salts and
 salts of isomers, esters and ethers (Other name: para-
 fluorobutyryl fentanyl)...................................
(25) N-(4-methoxyphenyl)-N-(1-phenethylpiperidin-4-               (9837)
 yl)butyramide, its isomers, esters, ethers, salts and
 salts of isomers, esters and ethers (Other name: para-
 methoxybutyryl fentanyl)..................................
(26) N-(4-chlorophenyl)-N-(1-phenethylpiperidin-4-                (9826)
 yl)isobutyramide, its isomers, esters, ethers, salts and
 salts of isomers, esters and ethers (Other name: para-
 chloroisobutyryl fentanyl)................................
(27) N-(1-phenethylpiperidin-4-yl)-N-phenylisobutyramide,         (9827)
 its isomers, esters, ethers, salts and salts of isomers,
 esters and ethers (Other name: isobutyryl fentanyl).......
(28) N-(1-phenethylpiperidin-4-yl)-N-                             (9847)
 phenylcyclopentanecarboxamide, its isomers, esters,
 ethers, salts and salts of isomers, esters and ethers
 (Other name: cyclopentyl fentanyl)........................
(29) N-(2-fluorophenyl)-2-methoxy-N-(1-phenethylpiperidin-4-      (9832)
 yl)acetamide, its isomers, esters, ethers, salts and salts
 of isomers, esters and ethers (Other name: ocfentanil)....
------------------------------------------------------------------------



[[Page 4585]]

    Dated: January 26, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-02008 Filed 1-31-18; 8:45 am]
 BILLING CODE 4410-09-P