[Federal Register Volume 82, Number 55 (Thursday, March 23, 2017)]
[Proposed Rules]
[Pages 14842-14845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05728]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-452]


Schedules of Controlled Substances: Temporary Placement of 4-
Fluoroisobutyryl 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 issue a temporary order to schedule 
the synthetic opioid, N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-
yl)isobutyramide (4-fluoroisobutyryl fentanyl or para-fluoroisobutyryl 
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. 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 Controlled Substances Act on the 
manufacture, distribution, reverse distribution, possession, 
importation, exportation, research, and conduct of instructional 
activities, and chemical analysis of this synthetic opioid.

DATES: The date of this notice of intent is March 23, 2017.

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 is issued pursuant to 
the temporary scheduling provisions of 21 U.S.C. 811(h). DEA intends to 
issue a temporary order to add 4-fluoroisobutyryl fentanyl to Schedule 
I

[[Page 14843]]

under the Controlled Substances Act.\1\ The temporary scheduling order 
will be published in the Federal Register, but that order will not be 
issued before April 24, 2017.
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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

    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 he 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); 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.

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.\2\ The Administrator transmitted notice of 
his intent to place 4-fluoroisobutyryl fentanyl in Schedule I on a 
temporary basis to the Assistant Secretary by letter dated January 5, 
2017. The Assistant Secretary responded to this notice by letter dated 
January 17, 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 4-
fluoroisobutyryl fentanyl. The Assistant Secretary also stated that the 
HHS has no objection to the temporary placement of 4-fluoroisobutyryl 
fentanyl into Schedule I of the CSA. 4-Fluoroisobutyryl fentanyl is not 
currently listed in any schedule under the CSA, and no exemptions or 
approvals are in effect for 4-fluoroisobutyryl fentanyl under section 
505 of the FDCA, 21 U.S.C. 355. The DEA has found that the control of 
4-fluoroisobutyryl fentanyl in Schedule I on a temporary basis is 
necessary to avoid an imminent hazard to the public safety.
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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 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 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).

4-Fluoroisobutyryl Fentanyl

    The chemical structure of 4-fluoroisobutyryl fentanyl was first 
described in 1999 in the scientific literature. No approved medical use 
has been identified for 4-fluoroisobutyryl fentanyl, nor has it been 
approved by the FDA for human consumption. The recent identification of 
4-fluoroisobutyryl 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 opioid properties.
    Available data and information for 4-fluoroisobutyryl 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 ``Supporting and Related Material'' of the public docket 
for this action at www.regulations.gov under Docket Number DEA-452.

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, often 
with unpredictable outcomes. 4-Fluoroisobutyryl fentanyl has recently 
been encountered by law enforcement and public health officials and the 
adverse health effects and outcomes are demonstrated by fatal overdose 
cases. The documented negative effects of 4-fluoroisobutyryl 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

[[Page 14844]]

STARLiMS were queried on December 21, 2016. STARLiMS registered 21 
reports containing 4-fluoroisobutyryl fentanyl, all reported in 2016, 
from Florida, Maryland, Mississippi, New Jersey, New York, Texas, and 
the District of Columbia. According to STARLiMS, the first laboratory 
submission of 4-fluoroisobutyryl fentanyl occurred in March 2016 in 
Maryland. The DEA is not aware of any laboratory identifications of 4-
fluoroisobutyryl fentanyl prior to 2016.
    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 only report of 4-fluoroisobutyryl fentanyl from 
state or local forensic laboratories was recorded in August 2016 in 
Pennsylvania. Due to normal lag time in reporting, NFLIS data from 
August through November 2016 is incomplete.\3\
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    \3\ Information was obtained from NFLIS on December 21, 2016.
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    Evidence suggests that the pattern of abuse of fentanyl analogues, 
including 4-fluoroisobutyryl fentanyl, parallels that of heroin and 
prescription opioid analgesics. Seizures of 4-fluoroisobutyryl fentanyl 
have been encountered in powder form and packaged similar to that of 
heroin. 4-Fluoroisobutyryl fentanyl has been encountered as a single 
substance as well as in combination with other substances of abuse, 
including heroin, fentanyl, furanyl fentanyl, methamphetamine, and 
cocaine. 4-Fluoroisobutyryl fentanyl has been connected to fatal 
overdoses, in which insufflation and intravenous routes of 
administration are documented.

Factor 5. Scope, Duration and Significance of Abuse

    Reports collected by the DEA demonstrate 4-fluoroisobutyryl 
fentanyl is being abused for its opioid properties. This abuse of 4-
fluoroisobutyryl fentanyl has resulted in morbidity and mortality (see 
DEA 3-Factor Analysis for full discussion). The DEA has received 
reports for at least 62 confirmed fatalities associated with 4-
fluoroisobutyryl fentanyl. Information on these deaths, occurring as 
early as August 2016, was collected from post-mortem toxicology and 
medical examiner reports by the DEA. These deaths were reported from, 
and occurred in, Maryland. NFLIS and STARLiMS have a total of 22 drug 
reports in which 4-fluoroisobutyryl fentanyl was identified in drug 
exhibits submitted to forensic laboratories in 2016 from law 
enforcement encounters in Florida, Maryland, Mississippi, New Jersey, 
New York, Pennsylvania, Texas, and the District of Columbia. It is 
likely that the prevalence of 4-fluoroisobutyryl 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 4-fluoroisobutyryl 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 4-fluoroisobutyryl fentanyl fatal overdose cases. 
Because abusers of 4-fluoroisobutyryl 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 a drug for the first time) 4-fluoroisobutyryl 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

    4-Fluoroisobutyryl fentanyl exhibits pharmacological profiles 
similar to that of fentanyl and other [mu]-opioid receptor agonists. 
The toxic effects of 4-fluoroisobutyryl fentanyl in humans are 
demonstrated by overdose fatalities involving this substance. Abusers 
of 4-fluoroisobutyryl 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 information received by the DEA, the abuse of 4-
fluoroisobutyryl 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.
    4-Fluoroisobutyryl fentanyl has been associated with numerous 
fatalities. At least 62 confirmed overdose deaths involving 4-
fluoroisobutyryl fentanyl abuse have been reported from Maryland in 
2016. As the data demonstrates, the potential for fatal and non-fatal 
overdoses exists for 4-fluoroisobutyryl fentanyl and 4-fluoroisobutyryl 
fentanyl poses an imminent hazard to the public safety.

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 4-fluoroisobutyryl fentanyl poses an imminent hazard to the 
public safety. The DEA is not aware of any currently accepted medical 
uses for 4-fluoroisobutyryl 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 4-fluoroisobutyryl 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 
January 5, 2017, notified the Assistant Secretary of the DEA's 
intention to temporarily place this substance in Schedule I.

Conclusion

    This notice of intent initiates a temporary scheduling process and 
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 4-fluoroisobutyryl 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.
    The temporary placement of 4-fluoroisobutyryl fentanyl into 
schedule I

[[Page 14845]]

of the CSA will take effect upon publication of a temporary scheduling 
order, which will not be issued before April 24, 2017. Because the 
Administrator hereby finds that it is necessary to temporarily place 4-
fluoroisobutyryl fentanyl into Schedule I to avoid an imminent hazard 
to the public safety, the temporary order scheduling this substance 
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, 
4-fluoroisobutyryl 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 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 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.
    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), 956(b), unless otherwise 
noted.

0
2. In Sec.  1308.11, add paragraph (h)(10) to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (h) * * *
    (10) N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide, 
its isomers, esters, ethers, salts and salts of isomers, esters and 
ethers (Other names: 4-fluoroisobutyryl fentanyl, para-fluoroisobutyryl 
fentanyl). . . . . (9824).

    Dated: March 16, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017-05728 Filed 3-22-17; 8:45 am]
 BILLING CODE 4410-09-P