Federal Register, Volume 81 Issue 229 (Tuesday, November 29, 2016)


[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

\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.
---------------------------------------------------------------------------

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