[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Proposed Rules]
[Pages 58575-58578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26854]


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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: Proposed amendment; notification of intent.

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SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this notice of intent to publish a temporary order to schedule 
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-phenylcyclopentane carboxamide (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 (CSA) 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 CSA on the manufacture, distribution, reverse 
distribution, possession, importation, exportation, research, and 
conduct of instructional activities, and chemical analysis of these 
synthetic opioids.

DATES: December 13, 2017.

ADDRESSES: 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-475.

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 valeryl fentanyl, para-fluorobutyryl fentanyl, para-
methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl 
fentanyl, cyclopentyl fentanyl, and ocfentanil to schedule I of the 
Controlled Substances Act.\1\ The temporary scheduling order will be 
published in the Federal Register, but will not be issued before 
January 12, 2018.
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    \1\ Though DEA has used the term ``final order'' with respect to 
temporary scheduling orders in the past, this notice of intent 
adheres to the statutory language of 21 U.S.C. 811(h), which refers 
to a ``temporary scheduling order.'' No substantive change is 
intended.
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Legal Authority

    Section 201 of the Controlled Substances Act (CSA), 21 U.S.C. 811, 
provides the Attorney General with the authority to temporarily place a 
substance 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 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.

[[Page 58576]]

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. 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.
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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 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).
    The recent 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 being misused and abused. 
No approved medical use has been identified for these seven substances, 
nor have they been approved by the FDA for human consumption.
    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 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. 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-
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 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

[[Page 58577]]

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, 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 [mu]-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 an Imminent 
Hazard to the Public Safety

    In accordance with 21 U.S.C. 811(h)(3), based on the available data 
and information, summarized above, the 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, resulting from the lack of control of these 
substances, pose an imminent hazard to the public safety. The DEA is 
not aware of any currently accepted medical uses for these seven 
fentanyl-related 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, through a 
letter dated October 20, 2017, notified the Assistant Secretary of the 
DEA's intention to temporarily place these substances in schedule I.

Conclusion

    This notice of intent 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 
valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl 
fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, 
cyclopentyl fentanyl, and ocfentanil in schedule I of the CSA, and 
finds that placement of these seven fentanyl-related substances into 
schedule I of the CSA is necessary in order to avoid an imminent hazard 
to the public safety.
    The temporary placement of valeryl fentanyl, para-fluorobutyryl 
fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, 
isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil in schedule I 
of the CSA will take effect pursuant to a temporary scheduling order, 
which will not be issued before January 12, 2018. Because the 
Administrator hereby finds that it is necessary to temporarily place 
valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl 
fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, 
cyclopentyl fentanyl, and ocfentanil in schedule I to avoid an imminent 
hazard to the public safety, the temporary order scheduling these 
substances 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, 
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, 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

[[Page 58578]]

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 took into 
consideration comments submitted by the Assistant Secretary in response 
to 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), 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 
isomers, esters, ethers, salts and salts of isomers, esters and ethers 
(Other name: valeryl fentanyl) . . . (9804)
    (24) N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)butyramide, 
its isomers, esters, ethers, salts and salts of isomers, esters and 
ethers (Other name: para-fluorobutyryl fentanyl) . . . (9823)
    (25) N-(4-methoxyphenyl)-N-(1-phenethylpiperidin-4-yl)butyramide, 
its isomers, esters, ethers, salts and salts of isomers, esters and 
ethers (Other name: para-methoxybutyryl fentanyl) . . . (9837)
    (26) N-(4-chlorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide, 
its isomers, esters, ethers, salts and salts of isomers, esters and 
ethers (Other name: para-chloroisobutyryl fentanyl) . . . (9826)
    (27) N-(1-phenethylpiperidin-4-yl)-N-phenylisobutyramide, its 
isomers, esters, ethers, salts and salts of isomers, esters and ethers 
(Other name: isobutyryl fentanyl) . . . (9827)
    (28) N-(1-phenethylpiperidin-4-yl)-N-phenylcyclopentanecarboxamide, 
its isomers, esters, ethers, salts and salts of isomers, esters and 
ethers (Other name: cyclopentyl fentanyl) . . . (9847)
    (29) N-(2-fluorophenyl)-2-methoxy-N-(1-phenethylpiperidin-4-
yl)acetamide, its isomers, esters, ethers, salts and salts of isomers, 
esters and ethers (Other name: ocfentanil) . . . (9832)

    Dated: December 5, 2017.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2017-26854 Filed 12-12-17; 8:45 am]
 BILLING CODE 4410-09-P