[Federal Register Volume 81, Number 187 (Tuesday, September 27, 2016)]
[Proposed Rules]
[Pages 66224-66227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23183]


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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: Notice of intent.

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SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this notice of intent to temporarily schedule the synthetic 
opioid, N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide 
(furanyl fentanyl), 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 this 
synthetic opioid into schedule I of the Controlled Substances Act is 
necessary to avoid an imminent hazard to the public safety. Any final 
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, 
possession, importation, exportation, research, and conduct of, 
instructional activities of this synthetic opioid.

DATES: September 27, 2016.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Office of Diversion 
Control, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.

SUPPLEMENTARY INFORMATION: Any final order will be published in the 
Federal Register and may not be effective prior to October 27, 2016.

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 providing 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, each 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 
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 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

[[Page 66225]]

Administrator transmitted notice of his intent to place furanyl 
fentanyl in 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. 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 public safety.
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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 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).

Furanyl Fentanyl

    Furanyl fentanyl was first described in 1986 in the patent 
literature. The scientific literature reported overdose events 
involving furanyl fentanyl, among other fentanyl analogues in 2015 in 
Sweden. No approved medical use has been identified for furanyl 
fentanyl, nor has it been approved by the FDA for human consumption. 
The recent identification of furanyl 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 morphine-
like properties.
    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 three-factor analysis is available in its 
entirety under the public docket of this action as a supporting 
document at www.regulations.gov under Docket Number DEA-448.

Factor 4. History and Current Pattern of Abuse

    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 July 11, 2016. STARLiMS 
registered 36 reports containing furanyl fentanyl, all reported in 
2016, from California, Connecticut, Florida, Georgia, Maryland, 
Montana, New Jersey, New York, North Carolina, North Dakota, Tennessee, 
Utah, West Virginia, and the District of Columbia. The DEA is not aware 
of any laboratory identifications of furanyl fentanyl prior to 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. 
According to NFLIS, the first report of furanyl fentanyl at other 
federal, state, or local forensic laboratories was recorded in January 
2016 in Ohio. From January through May 2016, a total of 80 submissions 
involving furanyl fentanyl were reported in NFLIS as a result of law 
enforcement encounters in Iowa, New Jersey, North Dakota, Ohio, and 
Wisconsin (query date: July 11, 2016).
    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 caused 
fatal overdoses, in which intravenous routes of administration are 
documented.

Factor 5. Scope, Duration and Significance of Abuse

    The DEA is currently aware of at least 128 confirmed fatalities 
associated with furanyl fentanyl. The information on these deaths 
occurring in 2015 and 2016 was collected from personal 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). STARLiMS and NFLIS 
have a total of 116 drug reports in which furanyl fentanyl was 
identified in drug exhibits submitted to forensic laboratories in 2016 
from law enforcement encounters in California, Connecticut, Florida, 
Georgia, Iowa, Maryland, Montana, New Jersey, New York, North Carolina, 
North Dakota, Ohio, Tennessee, Utah, West Virginia, Wisconsin, and the 
District of Columbia. 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, 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 an illicit 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

[[Page 66226]]

preparations of opioid analgesics, such as morphine and oxycodone.
    Based on the documented case reports of overdose fatalities, the 
abuse of furanyl fentanyl leads to the same qualitative public health 
risks as heroin, fentanyl and other opioid analgesic substances. 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 numerous fatalities. At 
least 128 confirmed overdose deaths involving furanyl fentanyl abuse 
have been reported throughout Illinois (36), Maryland (41), New Jersey 
(1), North Carolina (49), and Ohio (1) between 2015 and 2016.

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 furanyl fentanyl poses an imminent hazard to the public 
safety. The DEA is not aware of any currently accepted medical uses for 
furanyl 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 
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 in schedule I.

Conclusion

    This notice of intent initiates an expedited temporary scheduling 
action and provides the 30-day notice pursuant to section 201(h) of the 
CSA, 21 U.S.C. 811(h). 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 furanyl 
fentanyl in schedule I of the CSA, and finds that placement of this 
synthetic opioid substance into schedule I of the CSA is necessary in 
order to avoid an imminent hazard to the public safety.
    Because the Administrator hereby finds that it is necessary to 
temporarily place furanyl fentanyl into schedule I to avoid an imminent 
hazard to the public safety, any subsequent final order temporarily 
scheduling this substance will be effective on the date of publication 
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 scheduling process. 21 U.S.C. 811(h)(1) and 
(2). It is the intention of the Administrator to issue such a final 
order as soon as possible after the expiration of 30 days from the date 
of publication of this notice. Furanyl fentanyl will then 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 an 
expedited 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 with 
regard to the proposed temporary scheduling order.
    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 (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

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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 paragraph (h)(21) to read as follows:


Sec.  1308.11  Schedule I

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

    Dated: September 15, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-23183 Filed 9-26-16; 8:45 am]
 BILLING CODE 4410-09-P