Schedules of Controlled Substances: Temporary Placement of 4-Fluoroisobutyryl Fentanyl into Schedule I, 20544-20548 [2017-08943]
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20544
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Rules and Regulations
Minimum limits of—
Grade
U.S.
U.S.
U.S.
U.S.
No.
No.
No.
No.
Test weight
per bushel
(pounds)
1
2
3
4
Suitable
malting
types
(percent)
47.0
45.0
43.0
43.0
1 Injured-by-frost
Maximum limits of—
Sound
barley 1
(percent)
97.0
97.0
95.0
95.0
Damaged
kernels 1
(percent)
98.0
98.0
96.0
93.0
Foreign
material
(percent)
Wild oats
(percent)
2.0
3.0
4.0
5.0
1.0
1.0
2.0
3.0
No.
No.
No.
No.
Test weight
per bushel
(pounds)
1
2
3
4
Suitable
malting
types
(percent)
50.0
48.0
48.0
48.0
1 Injured-by-frost
7.0
10.0
15.0
15.0
§ 810.205 Grades and grade requirements
for Two-rowed Malting barley.
6. Section 810.205 is revised to read
as follows:
■
Sound
barley 1
(percent)
97.0
97.0
95.0
95.0
Damaged
kernels 1
(percent)
98.0
98.0
96.0
93.0
Foreign
material
(percent)
Wild oats
(percent)
2.0
3.0
4.0
5.0
1.0
1.0
2.0
3.0
Other grains
(percent)
Skinned and
broken
kernels
(percent)
2.0
3.0
5.0
5.0
4.0
6.0
8.0
10.0
0.5
1.0
2.0
3.0
Thin barley
(percent)
5.0
7.0
10.0
10.0
kernels and injured-by-mold kernels are not considered damaged kernels or considered against sound barley.
Mark C. Craig,
Acting Administrator, Grain Inspection,
Packers and Stockyards Administration.
[FR Doc. 2017–08942 Filed 5–2–17; 8:45 am]
BILLING CODE 3410–KD–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–452]
Schedules of Controlled Substances:
Temporary Placement of 4Fluoroisobutyryl Fentanyl into
Schedule I
Drug Enforcement
Administration, Department of Justice.
ACTION: Temporary scheduling order.
AGENCY:
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4.0
6.0
8.0
10.0
Thin barley
(percent)
Maximum limits of—
Note: Malting barley must not be infested
in accordance with § 810.107(b) and must not
contain any special grades as defined in
§ 810.206. Six-rowed Malting barley and Sixrowed Blue Malting barley varieties not
meeting the requirements of this section must
be graded in accordance with standards
established for the class Barley.
The Administrator of the Drug
Enforcement Administration is issuing
this temporary scheduling order to
schedule the synthetic opioid, N-(4fluorophenyl)-N-(1-phenethylpiperidin4-yl)isobutyramide (4-fluoroisobutyryl
fentanyl or para-fluoroisobutyryl
SUMMARY:
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2.0
3.0
5.0
5.0
0.5
1.0
2.0
3.0
must be graded in accordance with standards
established for the class Barley.
Minimum limits of—
U.S.
U.S.
U.S.
U.S.
Skinned and
broken
kernels
(percent)
kernels and injured-by-mold kernels are not considered damaged kernels or considered against sound barley.
Note: Malting barley must not be infested
in accordance with § 810.107(b) and must not
contain any special grades as defined in
§ 810.206. Six-rowed Malting barley varieties
not meeting the requirements of this section
Grade
Other grains
(percent)
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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 4fluoroisobutyryl 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.
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.
DATES:
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:
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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).
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.
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.
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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 4fluoroisobutyryl 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 4fluoroisobutyryl fentanyl under section
505 of the FDCA, 21 U.S.C. 355. The
DEA has found that the control of 4fluoroisobutyryl 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 4fluoroisobutyryl fentanyl was published
in the Federal Register on March 23,
2017. 82 FR 14842.
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,
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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13:33 May 02, 2017
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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 4fluoroisobutyryl 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 threefactor 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. 4Fluoroisobutyryl 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 4fluoroisobutyryl 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 4fluoroisobutyryl fentanyl prior to 2016.
The National Forensic Laboratory
Information System (NFLIS) is a
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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
Evidence suggests that the pattern of
abuse of fentanyl analogues, including
4-fluoroisobutyryl fentanyl, parallels
that of heroin and prescription opioid
analgesics. Seizures of 4fluoroisobutyryl fentanyl have been
encountered in powder form and
packaged similar to that of heroin. 4Fluoroisobutyryl 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. 4Fluoroisobutyryl 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 4fluoroisobutyryl fentanyl. Information
on these deaths, occurring as early as
August 2016, was collected from postmortem 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 4fluoroisobutyryl fentanyl overlaps with
3 Information was obtained from NFLIS on
December 21, 2016.
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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) 4fluoroisobutyryl 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.).
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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 m-opioid receptor
agonists. The toxic effects of 4fluoroisobutyryl fentanyl in humans are
demonstrated by overdose fatalities
involving this substance. Abusers of 4fluoroisobutyryl 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 4fluoroisobutyryl fentanyl; thus, 4fluoroisobutyryl 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,
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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
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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 4fluoroisobutyryl 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 4fluoroisobutyryl 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.
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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 4fluoroisobutyryl 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 4fluoroisobutyryl fentanyl pursuant to 21
U.S.C. 827 and 958, and in accordance
with 21 CFR parts 1304, and 1312, 1317
and § 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 4fluoroisobutyryl 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 4fluoroisobutyryl 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 4fluoroisobutyryl 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 4fluoroisobutyryl 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.
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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
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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
1. The authority citation for part 1308
continues to read as follows:
■
Authority: 21 U.S.C. 811, 812, 871(b),
unless otherwise noted.
2. Amend § 1308.11 by adding
paragraph (h)(16) to read as follows:
■
§ 1308.11
*
Schedule I
*
*
(h) * * *
E:\FR\FM\03MYR1.SGM
03MYR1
*
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20548
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Rules and Regulations
(16) 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) ........................................................................
Dated: April 27, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017–08943 Filed 5–2–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
29 CFR Part 1904
[Docket No. OSHA–2015–0006]
RIN 1218–AC84
Clarification of Employer’s Continuing
Obligation To Make and Maintain an
Accurate Record of Each Recordable
Injury and Illness
Occupational Safety and Health
Administration (OSHA), Labor.
ACTION: Final rule.
AGENCY:
Under the Congressional
Review Act, Congress has passed, and
the President has signed, Public Law
115–21, a resolution of disapproval of
OSHA’s final rule titled, ‘‘Clarification
of Employer’s Continuing Obligation to
Make and Maintain an Accurate Record
of each Recordable Injury and Illness.’’
OSHA published the rule, which
contained various amendments to
OSHA’s recordkeeping regulations, on
December 19, 2016. The amendments
became effective on January 18, 2017.
Because Public Law 115–21 invalidates
the amendments to OSHA’s
recordkeeping regulations contained in
the rule promulgated on December 19,
2016, OSHA is hereby removing those
amendments from the Code of Federal
Regulations.
DATES: This final rule becomes effective
on May 3, 2017.
FOR FURTHER INFORMATION CONTACT:
Press inquiries: Mr. Frank Meilinger,
Director, Office of Communications,
OSHA, U.S. Department of Labor, Room
N–3647, 200 Constitution Avenue NW.,
Washington, DC 20210; telephone (202)
693–1999; email meilinger.francis2@
dol.gov.
Technical inquiries: Ms. Mandy
Edens, Director, Directorate of Technical
Support and Emergency Management,
OSHA, U.S. Department of Labor, Room
N–3653, 200 Constitution Avenue NW.,
Washington, DC 20210; telephone (202)
693–2270; email edens.mandy@dol.gov.
nlaroche on DSK30NT082PROD with RULES
SUMMARY:
VerDate Sep<11>2014
13:33 May 02, 2017
Jkt 241001
Copies of this Federal Register notice
and news releases: Electronic copies of
these documents are available at
OSHA’s Web page at https://
www.osha.gov.
SUPPLEMENTARY INFORMATION: On
December 19, 2016, OSHA issued a final
rule titled, ‘‘Clarification of Employer’s
Continuing Obligation to Make and
Maintain an Accurate Record of Each
Recordable Injury and Illness.’’ See 81
FR 91792. The final rule, which became
effective on January 18, 2017, resulted
in various amendments to OSHA’s
recordkeeping regulations clarifying that
the duty to make and maintain accurate
records of work-related injuries and
illnesses is an ongoing obligation. On
March 1, 2017 (Cong. Rec. pp. H1421–
H1430), the House of Representatives
passed a resolution of disapproval (H.J.
Res. 83) of the rule under the
Congressional Review Act (5 U.S.C. 801
et seq.). The Senate then passed H.J.
Res. 83 on March 22, 2017. President
Trump signed the resolution into law as
Public Law 115–21 on April 3, 2017.
Accordingly, OSHA is hereby removing
the affected amendments to the
recordkeeping regulations from the
Code of Federal Regulations.
List of Subjects in 29 CFR Part 1904
Health statistics, Occupational safety
and health, Safety, Reporting and
recordkeeping requirements, State
plans.
Accordingly, the Occupational Safety
and Health Administration amends part
1904 of title 29 of the Code of Federal
Regulations as follows:
PART 1904—RECORDING AND
REPORTING OCCUPATIONAL
INJURIES AND ILLNESSES
1. Revise the authority citation for part
1904 to read as follows:
■
Authority: 29 U.S.C. 657, 658, 660, 666,
669, 673, Secretary of Labor’s Order No. 1–
2012 (77 FR 3912, Jan. 25, 2012).
■
2. Revise § 1904.0 to read as follows:
§ 1904.0
Purpose.
The purpose of this rule (part 1904) is
to require employers to record and
report work-related fatalities, injuries,
and illnesses.
Note to § 1904.0: Recording or reporting a
work-related injury, illness, or fatality does
not mean that the employer or employee was
at fault, that an OSHA rule has been violated,
PO 00000
Frm 00008
Fmt 4700
Sfmt 4700
(9824)
or that the employee is eligible for workers’
compensation or other benefits.
Subpart C—Recordkeeping Forms and
Recording Criteria
3. Revise the heading of subpart C to
read as set forth above.
■ 4. In § 1904.4, remove the note to
§ 1904.4(a) and revise paragraph (a)
introductory text to read as follows:
■
§ 1904.4
Recording criteria.
(a) Basic requirement. Each employer
required by this part to keep records of
fatalities, injuries, and illnesses must
record each fatality, injury and illness
that:
*
*
*
*
*
■ 5. Revise § 1904.29(b)(3) to read as
follows:
§ 1904.29
Forms.
*
*
*
*
*
(b) * * *
(3) How quickly must each injury or
illness be recorded? You must enter
each recordable injury or illness on the
OSHA 300 Log and 301 Incident Report
within seven (7) calendar days of
receiving information that a recordable
injury or illness has occurred.
*
*
*
*
*
■ 6. Revise the heading and paragraphs
(a) and (b)(1) of § 1904.32 to read as
follows:
§ 1904.32
Annual summary.
(a) Basic requirement. At the end of
each calendar year, you must:
(1) Review the OSHA 300 Log to
verify that the entries are complete and
accurate, and correct any deficiencies
identified;
(2) Create an annual summary of
injuries and illnesses recorded on the
OSHA 300 Log;
(3) Certify the summary; and
(4) Post the annual summary
(b) * * *
(1) How extensively do I have to
review the OSHA 300 Log entries at the
end of the year? You must review the
entries as extensively as necessary to
make sure that they are complete and
correct.
*
*
*
*
*
■ 7. Revise the heading and paragraph
(b) of § 1904.33 to read as follows:
§ 1904.33
*
E:\FR\FM\03MYR1.SGM
*
Retention and updating.
*
03MYR1
*
*
Agencies
[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]]
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------------------------------------------------------------------------
(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