[Federal Register Volume 82, Number 84 (Wednesday, May 3, 2017)]
[Rules and Regulations]
[Pages 20544-20548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08943]


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

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: Temporary scheduling order.

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

SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this temporary scheduling order to schedule the synthetic 
opioid, N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide 
(4-fluoroisobutyryl fentanyl or para-fluoroisobutyryl 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 4-fluoroisobutyryl 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 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, 4-
fluoroisobutyryl fentanyl.

DATES: This temporary scheduling order is effective May 3, 2017, until 
May 3, 2019, unless it is extended for an additional year or a 
permanent scheduling proceeding is completed. The DEA will publish a 
document in the Federal Register announcing an extension or permanence.

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

    Section 201 of the Controlled Substances Act (CSA), 21 U.S.C. 811, 
provides the Attorney General with the authority to temporarily place a 
substance 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 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 \1\ for up to one year. 21 U.S.C. 811(h)(2).
---------------------------------------------------------------------------

    \1\ Though DEA has used the term ``final order'' with respect to 
temporary scheduling orders in the past, this notice adheres to the 
statutory language of 21 U.S.C. 811(h), which refers to a 
``temporary scheduling order.'' No substantive change is intended.
---------------------------------------------------------------------------

    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.

[[Page 20545]]

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 the notice 
of intent to place 4-fluoroisobutyryl fentanyl into 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 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. The DEA has taken into consideration the 
Assistant Secretary's comments as required by 21 U.S.C. 811(h)(4). 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, and as required by 21 U.S.C. 811(h)(1)(A), 
a notice of intent to issue a temporary order to schedule 4-
fluoroisobutyryl fentanyl was published in the Federal Register on 
March 23, 2017. 82 FR 14842.
---------------------------------------------------------------------------

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

    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 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, and the Assistant 
Secretary's January 17, 2017, 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-2017-0004 
(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 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\
---------------------------------------------------------------------------

    \3\ Information was obtained from NFLIS on December 21, 2016.
---------------------------------------------------------------------------

    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

[[Page 20546]]

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 [micro]-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 
overdose exists for 4-fluoroisobutyryl fentanyl; thus, 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 data and 
information summarized above, the continued uncontrolled manufacture, 
distribution, importation, exportation, and abuse of 4-fluoroisobutyryl 
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 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 into schedule I. A notice of intent was 
subsequently published in the Federal Register on March 23, 2017. 82 FR 
14842.

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 4-fluoroisobutyryl 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 temporary order scheduling 4-
fluoroisobutyryl fentanyl 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 (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 temporary order, 4-fluoroisobutyryl 
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, 4-fluoroisobutyryl 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 
May 3, 2017. Any person who currently handles 4-fluoroisobutyryl 
fentanyl, and is not registered with the DEA, must submit an 
application for registration and may not continue to handle 4-
fluoroisobutyryl fentanyl as of May 3, 2017, 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 May 3, 2017 
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 4-fluoroisobutyryl 
fentanyl, must surrender all quantities of currently held 4-
fluoroisobutyryl fentanyl.
    3. Security. 4-Fluoroisobutyryl 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 May 3, 2017.

[[Page 20547]]

    4. Labeling and packaging. All labels, labeling, and packaging for 
commercial containers of 4-fluoroisobutyryl 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 May 
3, 2017, to comply with all labeling and packaging requirements.
    5. Inventory. Every DEA registrant who possesses any quantity of 4-
fluoroisobutyryl 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 4-
fluoroisobutyryl 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 4-fluoroisobutyryl 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 4-
fluoroisobutyryl fentanyl must submit reports pursuant to 21 U.S.C. 827 
and in accordance with 21 CFR parts 1304, and 1312 as of May 3, 2017.
    8. Order Forms. All DEA registrants who distribute 4-
fluoroisobutyryl fentanyl must comply with order form requirements 
pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305 as of 
May 3, 2017.
    9. Importation and Exportation. All importation and exportation of 
4-fluoroisobutyryl fentanyl must be in compliance with 21 U.S.C. 952, 
953, 957, 958, and in accordance with 21 CFR part 1312 as of May 3, 
2017.
    10. Quota. Only DEA registered manufacturers may manufacture 4-
fluoroisobutyryl fentanyl in accordance with a quota assigned pursuant 
to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 as of May 3, 
2017.
    11. Liability. Any activity involving 4-fluoroisobutyryl fentanyl 
not authorized by, or in violation of the CSA, occurring as of May 3, 
2017, 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).
    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 temporary 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.

    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)(16) to read as follows:


Sec.  1308.11  Schedule I

* * * * *
    (h) * * *

[[Page 20548]]



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


    Dated: April 27, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017-08943 Filed 5-2-17; 8:45 am]
 BILLING CODE 4410-09-P