[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Rules and Regulations]
[Pages 85873-85877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28693]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-448]


Schedules of Controlled Substances: Temporary Placement of 
Furanyl Fentanyl Into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

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SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this final order to temporarily schedule the synthetic opioid, 
N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide (furanyl 
fentanyl), and its isomers, esters, ethers, salts and salts of isomers, 
esters and ethers, into schedule I pursuant to the temporary scheduling 
provisions of the Controlled Substances Act. This action is based on a 
finding by the Administrator that the placement of furanyl fentanyl 
into schedule I of the Controlled Substances Act is necessary to avoid 
an imminent hazard to the public safety. As a result of this order, the 
regulatory controls and administrative, civil, and criminal sanctions 
applicable to schedule I controlled substances will be imposed

[[Page 85874]]

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, furanyl fentanyl.

DATES: This final order is effective on November 29, 2016.

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

    The Drug Enforcement Administration (DEA) implements and enforces 
titles II and III of the Comprehensive Drug Abuse Prevention and 
Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III 
are referred to as the ``Controlled Substances Act'' and the 
``Controlled Substances Import and Export Act,'' respectively, and are 
collectively referred to as the ``Controlled Substances Act'' or the 
``CSA'' for the purpose of this action. The DEA publishes the 
implementing regulations for these statutes in title 21 of the Code of 
Federal Regulations (CFR), chapter II. The CSA and its implementing 
regulations are designed to prevent, detect, and eliminate the 
diversion of controlled substances and listed chemicals into the 
illicit market while ensuring an adequate supply is available for the 
legitimate medical, scientific, research, and industrial needs of the 
United States. Controlled substances have the potential for abuse and 
dependence and are controlled to protect the public health and safety.
    Under the CSA, every controlled substance is classified into one of 
five schedules based upon its potential for abuse, its currently 
accepted medical use in treatment in the United States, and the degree 
of dependence the drug or other substance may cause. 21 U.S.C. 812. The 
initial schedules of controlled substances established by Congress are 
found at 21 U.S.C. 812(c), and the current list of all scheduled 
substances is published at 21 CFR part 1308.
    Section 201 of the 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 she 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). The Attorney General has delegated her 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.\1\ The Administrator transmitted the notice 
of intent to place furanyl fentanyl into schedule I on a temporary 
basis to the Assistant Secretary by letter dated June 22, 2016. The 
Assistant Secretary responded to this notice by letter dated July 8, 
2016, and advised that based on review by the Food and Drug 
Administration (FDA), there are currently no investigational new drug 
applications or approved new drug applications for furanyl fentanyl. 
The Assistant Secretary also stated that the HHS has no objection to 
the temporary placement of furanyl fentanyl into 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). Furanyl fentanyl is not currently 
listed in any schedule under the CSA, and no exemptions or approvals 
are in effect for furanyl fentanyl under section 505 of the FDCA, 21 
U.S.C. 355. The DEA has found that the control of furanyl fentanyl in 
schedule I on a temporary basis is necessary to avoid an imminent 
hazard to the public safety, and as required by 21 U.S.C. 811(h)(1)(A), 
a notice of intent to temporarily schedule furanyl fentanyl was 
published in the Federal Register on September 27, 2016. 81 FR 66224.
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    \1\ 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 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 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 into 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 
furanyl 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 updated three-factor analysis, and 
the Assistant Secretary's July 8, 2016, 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-2016-0018 
(Docket Number DEA-448).

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 with 
often unpredictable outcomes. Furanyl fentanyl has recently been 
encountered by law enforcement and public health officials and the 
adverse health effects and outcomes are documented in the scientific 
literature. The documented negative effects of furanyl fentanyl are 
consistent with those of other opioids. 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, 2016. STARLiMS registered 113

[[Page 85875]]

reports containing furanyl fentanyl, all reported in 2016, from 
Alabama, California, Connecticut, Delaware, Florida, Georgia, Illinois, 
Maryland, Mississippi, Missouri, Montana, New Jersey, New York, North 
Carolina, North Dakota, Rhode Island, Tennessee, Texas, Utah, Virginia, 
Wisconsin, West Virginia, and the District of Columbia.
    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 
participating Federal, State and local forensic laboratories across the 
country. According to NFLIS, the first report of furanyl fentanyl was 
recorded in December 2015 in Oregon. From December 2015 through 
September 2016, a total of 494 submissions to state and local forensic 
laboratories identifying furanyl fentanyl were reported in NFLIS as a 
result of law enforcement encounters in California, Connecticut, 
Florida, Iowa, Kentucky, Massachusetts, Minnesota, Missouri, New 
Jersey, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Virginia, 
and Wisconsin (query date: November 2, 2016). The DEA is not aware of 
any laboratory identifications of furanyl fentanyl prior to 2015.
    Evidence suggests that the pattern of abuse of fentanyl analogues, 
including furanyl fentanyl, parallels that of heroin and prescription 
opioid analgesics. Seizures of furanyl fentanyl have been encountered 
in powder form. Furanyl fentanyl has also been encountered in drug 
paraphernalia commonly associated with heroin or other opioid abuse 
including glassine bags, and as a residue on spoons and bottle caps. 
Furanyl fentanyl has been encountered as a single substance as well as 
in combination with other substances of abuse, including heroin, 
fentanyl, butyryl fentanyl, and U-47700. Furanyl fentanyl has been 
connected to fatal overdoses, in which intravenous routes of 
administration are documented.

Factor 5. Scope, Duration and Significance of Abuse

    The scientific literature and reports collected by the DEA 
demonstrate furanyl fentanyl is being abused for its opioid properties. 
This abuse of furanyl fentanyl has resulted in morbidity and mortality 
(see updated DEA 3-Factor Analysis for full discussion). The DEA has 
received reports for at least 128 confirmed fatalities associated with 
furanyl fentanyl. The information on these deaths occurring in 2015 and 
2016 was collected from email communications or toxicology and medical 
examiner reports received by the DEA. These deaths were reported from 
five states--Illinois (36), Maryland (41), New Jersey (1), North 
Carolina (49), and Ohio (1). The scientific literature notes additional 
fatal overdoses connected to furanyl fentanyl. STARLiMS and NFLIS have 
a total of 607 drug reports in which furanyl fentanyl was identified in 
drug exhibits submitted to forensic laboratories from December 2015 
through September 2016 from law enforcement encounters. It is likely 
that the prevalence of furanyl fentanyl in opioid analgesic-related 
emergency room admissions and deaths is underreported as standard 
immunoassays may not differentiate this substance from fentanyl.
    The population likely to abuse furanyl fentanyl overlaps with the 
population abusing prescription opioid analgesics and heroin. This is 
evidenced by the routes of drug administration and drug use history 
documented in furanyl fentanyl fatal overdose cases. Because abusers of 
furanyl fentanyl are likely to obtain this substance through 
unregulated sources (i.e. on-line purchases or drug dealers), 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) furanyl 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

    Furanyl fentanyl exhibits pharmacological profiles similar to that 
of fentanyl and other [micro]-opioid receptor agonists. The toxic 
effects of furanyl fentanyl in humans are demonstrated by overdose 
fatalities involving this substance. Abusers of furanyl fentanyl may 
not know the origin, identity, or purity of this substance, thus posing 
significant adverse health risks when compared to abuse of 
pharmaceutical preparations of opioid analgesics, such as morphine and 
oxycodone.
    Based on reports in the scientific literature and information 
received by the DEA, the abuse of furanyl fentanyl leads to 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 great. 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.
    Furanyl fentanyl has been associated with a number of fatalities 
and non-fatal overdoses as detailed in the scientific literature. The 
DEA has received information connecting furanyl fentanyl to at least 
128 confirmed overdose deaths occurring in 2015 and 2016 in Illinois 
(36), Maryland (41), New Jersey (1), North Carolina (49), and Ohio (1).

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 data and 
information summarized above, the continued uncontrolled manufacture, 
distribution, importation, exportation, and abuse of furanyl fentanyl 
pose an imminent hazard to the public safety. The DEA is not aware of 
any currently accepted medical uses for this substance in treatment in 
the United States. A substance meeting the statutory requirements for 
temporary scheduling, 21 U.S.C. 811(h)(1), may only be placed into 
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 furanyl 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 June 22, 2016, notified the 
Assistant Secretary of the DEA's intention to temporarily place this 
substance into schedule I.

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, herein sets forth the grounds for his determination that 
it is necessary to temporarily schedule furanyl fentanyl into schedule 
I of the CSA, and finds that placement of this synthetic opioid into 
schedule I of the CSA is necessary to avoid an imminent hazard to the 
public safety. Because the Administrator hereby finds it necessary to 
temporarily place this synthetic opioid into schedule I to avoid an 
imminent hazard to the public safety, this final order temporarily 
scheduling furanyl fentanyl will be effective on the date of 
publication in the Federal Register, and will be in effect for a period 
of two

[[Page 85876]]

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 final order, furanyl fentanyl will 
become 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, furanyl fentanyl must be registered with the DEA 
to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 
and in accordance with 21 CFR parts 1301 and 1312, as of November 29, 
2016. Any person who currently handles furanyl fentanyl, and is not 
registered with the DEA, must submit an application for registration 
and may not continue to handle furanyl fentanyl as of November 29, 
2016, unless the DEA has approved that application for registration 
pursuant to 21 U.S.C. 822, 823, 957, 958, and in accordance with 21 CFR 
parts 1301 and 1312. Retail sales of schedule I controlled substances 
to the general public are not allowed under the CSA. Possession of any 
quantity of this substance in a manner not authorized by the CSA on or 
after November 29, 2016 is unlawful and those in possession of any 
quantity of this substance may be subject to prosecution pursuant to 
the CSA.
    2. Disposal of stocks. Any person who does not desire or is not 
able to obtain a schedule I registration to handle furanyl fentanyl, 
must surrender all quantities of currently held furanyl fentanyl.
    3. Security. Furanyl fentanyl is subject to schedule I security 
requirements and must be handled and stored pursuant to 21 U.S.C. 821, 
823, 871(b), and in accordance with 21 CFR 1301.71-1301.93, as of 
November 29, 2016.
    4. Labeling and packaging. All labels, labeling, and packaging for 
commercial containers of furanyl fentanyl must be in compliance with 21 
U.S.C. 825, 958(e), and be in accordance with 21 CFR part 1302. Current 
DEA registrants shall have 30 calendar days from November 29, 2016, to 
comply with all labeling and packaging requirements.
    5. Inventory. Every DEA registrant who possesses any quantity of 
furanyl fentanyl on the effective date of this order must take an 
inventory of all stocks of this substance on hand, pursuant to 21 
U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 
1304.11. Current DEA registrants shall have 30 calendar days from the 
effective date of this order to be in compliance with all inventory 
requirements. After the initial inventory, every DEA registrant must 
take an inventory of all controlled substances (including furanyl 
fentanyl) on hand on a biennial basis, pursuant to 21 U.S.C. 827 and 
958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    6. Records. All DEA registrants must maintain records with respect 
to furanyl fentanyl pursuant to 21 U.S.C. 827 and 958, and in 
accordance with 21 CFR parts 1304, and 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 
furanyl fentanyl must submit reports pursuant to 21 U.S.C. 827 and in 
accordance with 21 CFR parts 1304, and 1312 as of November 29, 2016.
    8. Order Forms. All DEA registrants who distribute furanyl fentanyl 
must comply with order form requirements pursuant to 21 U.S.C. 828 and 
in accordance with 21 CFR part 1305 as of November 29, 2016.
    9. Importation and Exportation. All importation and exportation of 
furanyl fentanyl must be in compliance with 21 U.S.C. 952, 953, 957, 
958, and in accordance with 21 CFR part 1312 as of November 29, 2016.
    10. Quota. Only DEA registered manufacturers may manufacture 
furanyl fentanyl in accordance with a quota assigned pursuant to 21 
U.S.C. 826 and in accordance with 21 CFR part 1303 as of November 29, 
2016.
    11. Liability. Any activity involving furanyl fentanyl not 
authorized by, or in violation of the CSA, occurring as of November 29, 
2016, 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).

[[Page 85877]]

    This action will not have substantial direct effects on the States, 
on the relationship between the national government and the States, or 
on the distribution of power and responsibilities among the various 
levels of government. Therefore, in accordance with Executive Order 
13132 (Federalism) it is determined that this action does not have 
sufficient federalism implications to warrant the preparation of a 
Federalism Assessment.
    As noted above, this action is an order, not a rule. Accordingly, 
the Congressional Review Act (CRA) is inapplicable, as it applies only 
to rules. However, if this were a rule, pursuant to the Congressional 
Review Act, ``any rule for which an agency for good cause finds that 
notice and public procedure thereon are impracticable, unnecessary, or 
contrary to the public interest, shall take effect at such time as the 
federal agency promulgating the rule determines.'' 5 U.S.C. 808(2). It 
is in the public interest to schedule this substance immediately to 
avoid an imminent hazard to the public safety. This temporary 
scheduling action is taken pursuant to 21 U.S.C. 811(h), which is 
specifically designed to enable the DEA to act in an expeditious manner 
to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h) 
exempts the temporary scheduling order from standard notice and comment 
rulemaking procedures to ensure that the process moves swiftly. For the 
same reasons that underlie 21 U.S.C. 811(h), that is, the DEA's need to 
move quickly to place this substance into schedule I because it poses 
an imminent hazard to the public safety, it would be contrary to the 
public interest to delay implementation of the temporary scheduling 
order. Therefore, this order shall take effect immediately upon its 
publication. The DEA has submitted a copy of this final 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.

0
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), unless otherwise noted.


0
2. Amend Sec.  1308.11 by adding paragraph (h)(19) to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (h) * * *
    (19) N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide, its 
isomers, esters, ethers, salts and salts of isomers, esters and ethers 
(Other name: Furanyl fentanyl) (9834).

    Dated: November 22, 2016
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-28693 Filed 11-28-16; 8:45 am]
 BILLING CODE 4410-09-P