Schedules of Controlled Substances: Temporary Placement of Acetyl Fentanyl Into Schedule I, 42381-42385 [2015-17563]
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Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Rules and Regulations
untreated wood components. Therefore
this rule would be expected to impact
only a small number of manufacturers
and importers or at most, a small
portion of the toys in the market.
Second, manufacturers of toys
containing unfinished and untreated
wood components still would be
required to test to other aspects of the
ASTM toy standard, so the impact of
this rule relative to production costs for
most firms should be small. Due to the
small number of entities affected and
the limited scope of the impact, the
Commission certifies that this rule will
not have a significant impact on a
substantial number of small entities
pursuant to section 605(b) of the RFA,
5 U.S.C. 605(b).
G. Environmental Considerations
The Commission’s regulations
provide a categorical exclusion for
Commission rules from any requirement
to prepare an environmental assessment
or an environmental impact statement
because they ‘‘have little or no potential
for affecting the human environment.’’
16 CFR 1021.5(c)(2). This rule falls
within the categorical exclusion, so no
environmental assessment or
environmental impact statement is
required. The Commission’s regulations
state that safety standards for products
normally have little or no potential for
affecting the human environment. 16
CFR 1021.5(c)(1). Nothing in this rule
alters that expectation.
List of Subjects
Business and industry, Infants and
children, Consumer protection, Imports,
Product testing and certification, Toys.
Accordingly, 16 CFR part 1251 is
added to read as follows:
ingested, must comply with solubility
limits that the toy standard establishes
for eight heavy elements. Materials used
in toys subject to section 4.3.5 of the toy
standard must comply with the third
party testing requirements of section
14(a)(2) of the Consumer Product Safety
Act (‘‘CPSA’’), unless listed in § 1251.2.
§ 1251.2
Wood.
(a) Unfinished and untreated wood
does not exceed the limits for the heavy
elements established in section 4.3.5 of
the toy standard with a high degree of
assurance as that term is defined in 16
CFR part 1107, provided that the
material has been neither treated nor
adulterated with materials that could
result in the addition of any of the
heavy elements listed in the toy
standard at levels above their respective
solubility limits.
(b) For purposes of this section,
unfinished and untreated wood means
wood harvested from the trunks of trees
with no added surface coatings (such as,
varnish, paint, shellac, or polyurethane)
and no materials added to the wood
substrate (such as, stains, dyes,
preservatives, antifungals, or
insecticides). Unfinished and untreated
wood does not include manufactured or
engineered woods (such as pressed
wood, plywood, particle board, or
fiberboard).
Dated: July 13, 2015.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 2015–17413 Filed 7–16–15; 8:45 am]
BILLING CODE 6355–01–P
DEPARTMENT OF JUSTICE
PART 1251—TOYS: DETERMINATIONS
REGARDING HEAVY ELEMENTS
LIMITS FOR CERTAIN MATERIALS
Drug Enforcement Administration
Sec.
1251.1 The toy standard and testing
requirements.
1251.2 Wood.
[Docket No. DEA–413F]
Schedules of Controlled Substances:
Temporary Placement of Acetyl
Fentanyl Into Schedule I
Authority: Sec. 3, Pub. L. 110–314, 122
Stat. 3016; 15 U.S.C. 2063(d)(3)(B).
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The Consumer Product Safety
Improvement Act of 2008 (‘‘CPSIA’’)
made provisions of ASTM F963,
Consumer Product Safety Specifications
for Toy Safety (‘‘toy standard’’), a
mandatory consumer product safety
standard. Among the mandated
provisions is section 4.3.5 of ASTM
F963 which requires that surface coating
materials and accessible substrates of
toys that can be sucked, mouthed, or
17:58 Jul 16, 2015
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Drug Enforcement
Administration, Department of Justice.
ACTION: Final order.
AGENCY:
§ 1251.1 The toy standard and testing
requirements.
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21 CFR Part 1308
The Administrator of the Drug
Enforcement Administration is issuing
this final order to temporarily schedule
the synthetic opioid, N-(1phenethylpiperidin-4-yl)-Nphenylacetamide (acetyl fentanyl), and
its optical, positional, and geometric
isomers, salts and salts of isomers, into
schedule I pursuant to the temporary
scheduling provisions of the Controlled
SUMMARY:
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42381
Substances Act. This action is based on
a finding by the Administrator that the
placement of this opioid substance 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, import, export, engage in
research, or possess), or propose to
handle, acetyl fentanyl.
DATES: This final order is effective on
July 17, 2015.
FOR FURTHER INFORMATION CONTACT: John
R. Scherbenske, Office of Diversion
Control, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152, Telephone: (202) 598–6812.
SUPPLEMENTARY INFORMATION:
Legal Authority
The Drug Enforcement
Administration (DEA) implements and
enforces titles II and III of the
Comprehensive Drug Abuse Prevention
and Control Act of 1970, as amended.
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. 21
U.S.C. 801–971. The DEA publishes the
implementing regulations for these
statutes in title 21 of the Code of Federal
Regulations (CFR), chapter II. The CSA
and its implementing regulations are
designed to prevent, detect, and
eliminate the diversion of controlled
substances and listed chemicals into the
illicit market while ensuring an
adequate supply is available for the
legitimate medical, scientific, research,
and industrial needs of the United
States. Controlled substances have the
potential for abuse and dependence and
are controlled to protect the public
health and safety.
Under the CSA, every controlled
substance is classified into one of five
schedules based upon its potential for
abuse, its currently accepted medical
use in treatment in the United States,
and the degree of dependence the drug
or other substance may cause. 21 U.S.C.
812. The initial schedules of controlled
substances established by Congress are
found at 21 U.S.C. 812(c), and the
current list of all scheduled substances
is published at 21 CFR part 1308.
Section 201 of the CSA, 21 U.S.C. 811,
provides the Attorney General with the
authority to temporarily place a
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substance into schedule I of the CSA for
two years without regard to the
requirements of 21 U.S.C. 811(b) if she
finds that such action is necessary to
avoid an imminent hazard to the public
safety. 21 U.S.C. 811(h)(1). In addition,
if proceedings to control a substance are
initiated under 21 U.S.C. 811(a)(1), the
Attorney General may extend the
temporary scheduling for up to one
year. 21 U.S.C. 811(h)(2).
Where the necessary findings are
made, a substance may be temporarily
scheduled if it is not listed in any other
schedule under section 202 of the CSA,
21 U.S.C. 812, or if there is no
exemption or approval in effect for the
substance under section 505 of the
Federal Food, Drug, and Cosmetic Act
(FDCA), 21 U.S.C. 355. 21 U.S.C.
811(h)(1). The Attorney General has
delegated her scheduling authority
under 21 U.S.C. 811 to the
Administrator of the DEA. 28 CFR
0.100.
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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 the Administrator’s
intention to temporarily place a
substance into schedule I of the CSA.1
The Administrator transmitted the
notice of intent to place acetyl fentanyl
into schedule I on a temporary basis to
the Assistant Secretary by letter dated
April 7, 2015. The Assistant Secretary
responded to this notice by letter dated
April 29, 2015 (received by the DEA on
May 05, 2015), and advised that based
on review by the FDA, there are
currently no investigational new drug
applications or approved new drug
applications for acetyl fentanyl. The
Assistant Secretary also stated that the
HHS has no objection to the temporary
placement of acetyl 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). Acetyl fentanyl is not
currently listed in any schedule under
the CSA, and no exemptions or
approvals are in effect for acetyl
fentanyl under section 505 of the FDCA,
1 Because the Secretary of the HHS has delegated
to the Assistant Secretary for Health of the HHS the
authority to make domestic drug scheduling
recommendations, for purposes of this final order,
all subsequent references to ‘‘Secretary’’ have been
replaced with ‘‘Assistant Secretary.’’ As set forth in
a memorandum of understanding entered into by
HHS, 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 Assistant Secretary’s scheduling
responsibilities under the CSA, with the
concurrence of NIDA. 50 FR 9518, Mar. 8, 1985.
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21 U.S.C. 355. The DEA has found that
the scheduling of acetyl fentanyl in
schedule I on a temporary basis is
necessary to avoid an imminent hazard
to public safety, and as required by 21
U.S.C. 811(h)(1)(A), a notice of intent to
temporarily schedule acetyl fentanyl
was published in the Federal Register
on May 21, 2015. 80 FR 29227.
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 acetyl 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
analysis is available in its entirety under
the tab ‘‘Supporting and Related
Material’’ of the public docket of this
action at www.regulations.gov under
Docket Number DEA–413F.
Factor 4. History and Current Pattern of
Abuse
Clandestinely produced substances
structurally related to the schedule II
opioid analgesic fentanyl were
trafficked and abused on the West Coast
in the late 1970s and 1980s. These
clandestinely produced fentanyl-like
substances were commonly known as
designer drugs, and recently, there has
been a reemergence in the trafficking
and abuse of designer drug substances,
including fentanyl-like substances.
Alpha-methylfentanyl, the first fentanyl
analogue identified in California, was
placed into schedule I of the CSA in
September 1981. Following the control
of alpha-methylfentanyl, the DEA
identified several other fentanyl
analogues (3-methylthiofentanyl, acetyl-
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alpha-methylfentanyl, beta-hydroxy-3methylfentanyl, alphamethylthiofentanyl, thiofentanyl, betahydroxyfentanyl, para-fluorofentanyl
and 3-methylfentanyl) in submissions to
forensic laboratories. These substances
were temporarily controlled under
schedule I of the CSA after finding that
they posed an imminent hazard to
public safety and were subsequently
permanently placed into schedule I of
the CSA.
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 State and local
forensic laboratories across the country.
The first laboratory submission of acetyl
fentanyl was recorded in Maine in April
2013 according to NFLIS. NFLIS
registered eight reports containing
acetyl fentanyl in 2013 in Louisiana,
Maine, and North Dakota; and 30
reports in 2014 in Florida, Illinois,
Louisiana, Maine, New Jersey, Ohio,
Oregon, Pennsylvania, and Virginia.
The System to Retrieve Information
from Drug Evidence (STRIDE) is a
database of drug exhibits sent to DEA
laboratories for analysis. Exhibits from
this database are from the DEA, other
Federal agencies, and some local law
enforcement agencies. Acetyl fentanyl
was first reported to STRIDE in
September 2013 from exhibits obtained
through a controlled purchase in
Louisiana. In October 2013, an exhibit
collected from a controlled purchase of
suspected oxycodone tablets in Rhode
Island contained acetyl fentanyl as the
primary substance. In 2014, STARLiMS
(a Web-based, commercial laboratory
information management system that is
in transition to replace STRIDE) and
STRIDE reported eight additional
seizures in Colorado, Florida, Georgia,
and Washington.
In August 2013, the Centers for
Disease Control and Prevention
published an article in its Morbidity and
Mortality Weekly Report documenting a
series of 14 fatalities related to acetyl
fentanyl that occurred between March
and May 2013. In December 2013,
another fatality associated with acetyl
fentanyl was reported in Rhode Island
for a total of 15 fatalities. In February
2014, the North Carolina Department of
Health and Human Services issued a
health advisory related to acetyl
fentanyl following at least three deaths
related to this synthetic drug.
Toxicologists at the North Carolina
Office of the Chief Medical Examiner
detected acetyl fentanyl in specimens
associated with deaths that occurred in
January 2014 in Sampson, Person, and
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Transylvania counties. In July and
August 2014, four additional fatalities
involving acetyl fentanyl were reported
for a total of seven fatalities in North
Carolina. Deaths involving acetyl
fentanyl have also been reported in
California (1), Louisiana (14), Oregon (1)
and Pennsylvania (1).
A significant seizure of acetyl fentanyl
occurred in April 2013 during a law
enforcement investigation in Montreal,
Canada. Approximately three kilograms
of acetyl fentanyl in powder form and
approximately 11,000 tablets containing
acetyl fentanyl were seized. Given that
a typical dose of acetyl fentanyl is in the
microgram range, a three kilogram
quantity could potentially produce
millions of dosage units. In the United
States, tablets that mimic
pharmaceutical opioid products have
been reported in multiple states,
including Colorado, Florida, Georgia,
Rhode Island, and Washington. Recent
reports indicate that acetyl fentanyl in
powder form is available over the
Internet and has been imported to
addresses within the United States.
Evidence also suggests that the
pattern of abuse of fentanyl analogues,
including acetyl fentanyl, parallels that
of heroin and prescription opioid
analgesics. For example, seizures of
acetyl fentanyl have been encountered
both in powder and in tablet form. It is
also known to have caused many fatal
overdoses, in which intravenous routes
of administration and histories of drug
abuse are documented.
Factor 5. Scope, Duration and
Significance of Abuse
The DEA is currently aware of at least
39 fatalities associated with acetyl
fentanyl. These deaths occurred in 2013
and 2014 from six states including
California, Louisiana, North Carolina,
Oregon, Pennsylvania, and Rhode
Island. STARLiMS and STRIDE,
databases capturing drug evidence
information from DEA forensic
laboratories, have a total of 10 drug
reports in which acetyl fentanyl was
identified in six cases for analyzed
drugs submitted from January 2010—
December 2014 from Colorado, Florida,
Georgia, Louisiana, Rhode Island, and
Washington. It is likely that the
prevalence of acetyl fentanyl in opioid
analgesic-related emergency room
admissions and deaths is underreported
since standard immunoassays cannot
differentiate acetyl fentanyl from
fentanyl.
The population likely to abuse acetyl
fentanyl overlaps with the populations
abusing prescription opioid analgesics
and heroin. This is evidenced by the
routes of administration and drug use
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history documented in acetyl fentanyl
fatal overdose cases. Because abusers of
acetyl fentanyl are likely to obtain the
drug through illicit sources, the identity,
purity, and quantity is uncertain and
inconsistent, thus posing significant
adverse health risks to its abusers. This
risk is particularly heightened by the
fact that acetyl fentanyl is a highly
potent opioid (15.7 fold more potent
than that of morphine as tested in mice
using an acetic acid writhing method).
Thus small changes in the amount and
purity of the substance could potentially
lead to overdose and death.
Factor 6. What, if Any, Risk There Is to
the Public Health
Acetyl fentanyl exhibits a
pharmacological profile similar to that
of fentanyl and other opioid analgesic
compounds, and it is a potent opioid
analgesic reported to be 1/3 as potent as
fentanyl and 15.7 times as potent as
morphine in mice tested in an acetic
acid writhing method. In addition,
studies also showed that the range
between the effective dose (ED50) and
the lethal dose (LD50) of acetyl fentanyl
is narrower than that of morphine and
fentanyl, increasing the risk of fatal
overdose. Thus, its abuse is likely to
pose quantitatively greater risks to the
public health and safety than abuse of
traditional opioid analgesics such as
morphine.
Based on the above pharmacological
data, the abuse of acetyl fentanyl at least
leads to the same qualitative public
health risks as heroin, fentanyl, and
other opioid analgesic compounds. The
public health risks attendant to the
abuse of heroin and opioid analgesics
are well established. The abuse of
opioid analgesics has resulted in large
numbers of drug treatment admissions,
emergency department visits, and fatal
overdoses.
Acetyl fentanyl has been associated
with numerous fatalities. At least 39
overdose deaths due to acetyl fentanyl
abuse have been reported in six states in
2013 and 2014, California, Louisiana,
North Carolina, Oregon, Pennsylvania,
and Rhode Island. This indicates that
acetyl fentanyl poses an imminent
hazard to public safety.
Finding of Necessity of Schedule I
Placement To Avoid Imminent Hazard
to Public Safety
Based on the data and information
summarized above, the continued
uncontrolled manufacture, distribution,
importation, exportation, and abuse of
acetyl fentanyl poses an imminent
hazard to the public safety. The DEA is
not aware of any currently accepted
medical uses for this substance in the
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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 acetyl 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 April 7, 2015,
notified the Assistant Secretary of the
DEA’s intention to temporarily place
this substance into schedule I.
Conclusion
In accordance with the provisions of
section 201(h) of the CSA, 21 U.S.C.
811(h), the Administrator considered
available data and information, herein
sets forth the grounds for his
determination that it is necessary to
temporarily schedule N-(1phenethylpiperidin-4-yl)-Nphenylacetamide (acetyl fentanyl), into
schedule I of the CSA, and finds that
placement of this synthetic opioid into
schedule I of the CSA is necessary to
avoid an imminent hazard to the public
safety. Because the Administrator
hereby finds it necessary to temporarily
place this synthetic opioid into
schedule I to avoid an imminent hazard
to the public safety, this final order
temporarily scheduling acetyl 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.
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
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scheduling orders are not subject to
judicial review. 21 U.S.C. 811(h)(6).
Requirements for Handling
Upon the effective date of this final
order, acetyl fentanyl will become
subject to the regulatory controls and
administrative, civil, and criminal
sanctions applicable to the manufacture,
distribution, importation, exportation,
research, conduct of instructional
activities, and possession of schedule I
controlled substances including the
following:
1. Registration. Any person who
handles (manufactures, distributes,
imports, exports, engages in research,
conducts instructional activities with, or
possesses), or who desires to handle,
acetyl 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 July 17, 2015.
Any person who currently handles
acetyl fentanyl, and is not registered
with the DEA, must submit an
application for registration and may not
continue to handle acetyl fentanyl as of
July 17, 2015, 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 July
17, 2015 is unlawful and those in
possession of any quantity of this
substance may be subject to prosecution
pursuant to the CSA.
2. Security. Acetyl 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 July 17, 2015.
3. Labeling and packaging. All labels,
labeling, and packaging for commercial
containers of acetyl fentanyl must be in
compliance with 21 U.S.C. 825, 958(e),
and be in accordance with 21 CFR part
1302 as of July 17, 2015. Current DEA
registrants shall have 30 calendar days
from July 17, 2015, to comply with all
labeling and packaging requirements.
4. Inventory. Every DEA registrant
who possesses any quantity of acetyl
fentanyl on the effective date of this
order must take an inventory of all
stocks of this substance on hand as of
July 17, 2015, pursuant to 21 U.S.C. 827
and 958, and in accordance with 21 CFR
1304.03, 1304.04, and 1304.11(a) and
(d). Current DEA registrants shall have
30 calendar days from the effective date
of this order to be in compliance with
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all inventory requirements. After the
initial inventory, every DEA registrant
must take an inventory of all controlled
substances (including acetyl 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.
5. Records. All DEA registrants must
maintain records with respect to acetyl
fentanyl pursuant to 21 U.S.C. 827 and
958, and in accordance with 21 CFR
parts 1304, 1307, and 1312 as of July 17,
2015. Current DEA registrants
authorized to handle acetyl fentanyl
shall have 30 calendar days from the
effective date of this order to be in
compliance with all recordkeeping
requirements.
6. Reports. All DEA registrants who
manufacture or distribute acetyl
fentanyl must submit reports pursuant
to 21 U.S.C. 827 and in accordance with
21 CFR parts 1304, 1307, and 1312 as
of July 17, 2015.
7. Order Forms. All DEA registrants
who distribute acetyl fentanyl must
comply with order form requirements
pursuant to 21 U.S.C. 828 and in
accordance with 21 CFR part 1305 as of
July 17, 2015.
8. Importation and Exportation. All
importation and exportation of acetyl
fentanyl must be in compliance with 21
U.S.C. 952, 953, 957, 958, and in
accordance with 21 CFR part 1312 as of
July 17, 2015.
9. Quota. Only DEA registered
manufacturers may manufacture acetyl
fentanyl in accordance with a quota
assigned pursuant to 21 U.S.C. 826 and
in accordance with 21 CFR part 1303 as
of July 17, 2015.
10. Liability. Any activity involving
acetyl fentanyl not authorized by, or in
violation of the CSA, occurring as of
July 17, 2015, 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 an expedited
temporary scheduling action where
such action is necessary to avoid an
imminent hazard to the public safety.
As provided in this subsection, the
Attorney General may, by order,
schedule a substance in schedule I on a
temporary basis. Such an order may not
be issued before the expiration of 30
days from (1) the publication of a notice
in the Federal Register of the intention
to issue such order and the grounds
upon which such order is to be issued,
and (2) the date that notice of the
proposed temporary scheduling order is
transmitted to the Assistant Secretary.
21 U.S.C. 811(h)(1).
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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 final order
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.
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 these substances
immediately because they pose a public
health risk. 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
E:\FR\FM\17JYR1.SGM
17JYR1
Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Rules and Regulations
Big Foot Tension Leg Platform
construction site, located in Walker
Ridge Block 29 on the Outer Continental
Shelf (OCS) in the Gulf of Mexico. The
purpose of this interim rule is to include
the construction area and protect the
facility and all operations during the
construction phase from all vessels
operating outside the normal shipping
channels and fairways that are not
providing services to or working with
the facility. Placing a safety zone around
the facility while under construction
that includes the construction site will
List of Subjects in 21 CFR Part 1308
significantly reduce the threat of
Administrative practice and
allisions, collisions, security breaches,
procedure, Drug traffic control,
oil spills, releases of natural gas, and
Reporting and recordkeeping
thereby protect the safety of life,
requirements.
property, and the environment.
For the reasons set out above, the DEA DATES: This rule is effective without
amends 21 CFR part 1308 as follows:
actual notice July 17, 2015. For the
purposes of enforcement, actual notice
PART 1308—SCHEDULES OF
will be used from June 3, 2015 until July
CONTROLLED SUBSTANCES
17, 2015. Comments and related
material must be received by the Coast
■ 1. The authority citation for part 1308
Guard on or before August 3, 2015.
continues to read as follows:
ADDRESSES: Documents mentioned in
Authority: 21 U.S.C. 811, 812, 871(b),
this preamble are part of Docket Number
unless otherwise noted.
USCG–2014–0863. To view documents
■ 2. Amend § 1308.11 by adding
mentioned in this preamble as being
paragraph (h)(24) to read as follows:
available in the docket, go to https://
www.regulations.gov, type the docket
§ 1308.11 Schedule I.
number in the ‘‘SEARCH’’ box and click
*
*
*
*
*
‘‘SEARCH.’’ Click on ‘‘Open Docket
(h) * * *
Folder’’ on the line associated with this
(24) N-(1-phenethylpiperidinrulemaking. You may also visit the
4-yl)-N-phenylacetamide, its
Docket Management Facility in Room
optical, positional, and geoW12–140 on the ground floor of the
metric isomers, salts and
Department of Transportation West
salts of isomers (Other
names: acetyl fentanyl) ........
(9821). Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m.
*
*
*
*
*
and 5 p.m., Monday through Friday,
Dated: July 13, 2015.
except Federal holidays.
Chuck Rosenberg,
You may submit comments, identified
Acting Administrator.
by docket number, using any one of the
following methods:
[FR Doc. 2015–17563 Filed 7–16–15; 8:45 am]
(1) Federal eRulemaking Portal:
BILLING CODE 4410–09–P
https://www.regulations.gov.
(2) Fax: (202) 493–2251.
(3) Mail or Delivery: Docket
DEPARTMENT OF HOMELAND
Management Facility (M–30), U.S.
SECURITY
Department of Transportation, West
Building Ground Floor, Room W12–140,
Coast Guard
1200 New Jersey Avenue SE.,
Washington, DC 20590–0001. Deliveries
33 CFR Part 147
accepted between 9 a.m. and 5 p.m.,
[Docket Number USCG–2014–0863]
Monday through Friday, except federal
holidays. The telephone number is 202–
RIN 1625–AA00
366–9329.
Safety Zone; Big Foot TLP, Walker
See the ‘‘Public Participation and
Ridge 29, Outer Continental Shelf on
Request for Comments’’ portion of the
the Gulf of Mexico
SUPPLEMENTARY INFORMATION section
below for further instructions on
AGENCY: Coast Guard, DHS.
submitting comments. To avoid
ACTION: Interim rule and request for
duplication, please use only one of
comments.
these three methods.
FOR FURTHER INFORMATION CONTACT: If
SUMMARY: The Coast Guard is
you have questions on this rule, call or
establishing a safety zone around the
asabaliauskas on DSK5VPTVN1PROD with RULES
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
public safety, it would be contrary to the
public interest to delay implementation
of the temporary scheduling order.
Therefore, in accordance with 5 U.S.C.
808(2), this order shall take effect
immediately upon its publication.
VerDate Sep<11>2014
17:58 Jul 16, 2015
Jkt 235001
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
42385
email Mr. Rusty Wright, U.S. Coast
Guard, District Eight Waterways
Management Branch; telephone 504–
671–2138, rusty.h.wright@uscg.mil. If
you have questions on viewing or
submitting material to the docket, call
Cheryl Collins, Program Manager,
Docket Operations, telephone (202)
366–9826.
SUPPLEMENTARY INFORMATION:
Table of Acronyms
DHS Department of Homeland Security
NPRM Notice of Proposed Rulemaking
OCS Outer Continental Shelf
A. Public Participation and Request for
Comments
We encourage you to participate in
this rulemaking by submitting
comments and related materials. All
comments received will be posted
without change to https://
www.regulations.gov and will include
any personal information you have
provided.
1. Submitting Comments
If you submit a comment, please
include the docket number for this
rulemaking, indicate the specific section
of this document to which each
comment applies, and provide a reason
for each suggestion or recommendation.
You may submit your comments and
material online at https://
www.regulations.gov, or by fax, mail, or
hand delivery, but please use only one
of these means. If you submit a
comment online, it will be considered
received by the Coast Guard when you
successfully transmit the comment. If
you fax, hand deliver, or mail your
comment, it will be considered as
having been received by the Coast
Guard when it is received at the Docket
Management Facility. We recommend
that you include your name and a
mailing address, an email address, or a
telephone number in the body of your
document so that we can contact you if
we have questions regarding your
submission.
To submit your comment online, go to
https://www.regulations.gov, type the
docket number in the ‘‘SEARCH’’ box
and click ‘‘SEARCH.’’ Click on ‘‘Submit
a Comment’’ on the line associated with
this rulemaking.
If you submit your comments by mail
or hand delivery, submit them in an
unbound format, no larger than 81⁄2 by
11 inches, suitable for copying and
electronic filing. If you submit
comments by mail and would like to
know that they reached the Facility,
please enclose a stamped, self-addressed
postcard or envelope. We will consider
all comments and material received
E:\FR\FM\17JYR1.SGM
17JYR1
]]>Agencies
[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Rules and Regulations]
[Pages 42381-42385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17563]
=======================================================================
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-413F]
Schedules of Controlled Substances: Temporary Placement of Acetyl
Fentanyl Into Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Administrator of the Drug Enforcement Administration is
issuing this final order to temporarily schedule the synthetic opioid,
N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl fentanyl), and
its optical, positional, and geometric isomers, salts and salts of
isomers, 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 opioid
substance 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, import, export,
engage in research, or possess), or propose to handle, acetyl fentanyl.
DATES: This final order is effective on July 17, 2015.
FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, Office of
Diversion Control, Drug Enforcement Administration; Mailing Address:
8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202)
598-6812.
SUPPLEMENTARY INFORMATION:
Legal Authority
The Drug Enforcement Administration (DEA) implements and enforces
titles II and III of the Comprehensive Drug Abuse Prevention and
Control Act of 1970, as amended. 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. 21 U.S.C. 801-971. The DEA publishes the implementing
regulations for these statutes in title 21 of the Code of Federal
Regulations (CFR), chapter II. The CSA and its implementing regulations
are designed to prevent, detect, and eliminate the diversion of
controlled substances and listed chemicals into the illicit market
while ensuring an adequate supply is available for the legitimate
medical, scientific, research, and industrial needs of the United
States. Controlled substances have the potential for abuse and
dependence and are controlled to protect the public health and safety.
Under the CSA, every controlled substance is classified into one of
five schedules based upon its potential for abuse, its currently
accepted medical use in treatment in the United States, and the degree
of dependence the drug or other substance may cause. 21 U.S.C. 812. The
initial schedules of controlled substances established by Congress are
found at 21 U.S.C. 812(c), and the current list of all scheduled
substances is published at 21 CFR part 1308.
Section 201 of the CSA, 21 U.S.C. 811, provides the Attorney
General with the authority to temporarily place a
[[Page 42382]]
substance into schedule I of the CSA for two years without regard to
the requirements of 21 U.S.C. 811(b) if she finds that such action is
necessary to avoid an imminent hazard to the public safety. 21 U.S.C.
811(h)(1). In addition, if proceedings to control a substance are
initiated under 21 U.S.C. 811(a)(1), the Attorney General may extend
the temporary scheduling for up to one year. 21 U.S.C. 811(h)(2).
Where the necessary findings are made, a substance may be
temporarily scheduled if it is not listed in any other schedule under
section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or
approval in effect for the substance under section 505 of the Federal
Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C.
811(h)(1). The Attorney General has delegated her scheduling authority
under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.
Background
Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the
Administrator to notify the Secretary of the Department of Health and
Human Services (HHS) of the Administrator's intention to temporarily
place a substance into schedule I of the CSA.\1\ The Administrator
transmitted the notice of intent to place acetyl fentanyl into schedule
I on a temporary basis to the Assistant Secretary by letter dated April
7, 2015. The Assistant Secretary responded to this notice by letter
dated April 29, 2015 (received by the DEA on May 05, 2015), and advised
that based on review by the FDA, there are currently no investigational
new drug applications or approved new drug applications for acetyl
fentanyl. The Assistant Secretary also stated that the HHS has no
objection to the temporary placement of acetyl 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). Acetyl
fentanyl is not currently listed in any schedule under the CSA, and no
exemptions or approvals are in effect for acetyl fentanyl under section
505 of the FDCA, 21 U.S.C. 355. The DEA has found that the scheduling
of acetyl fentanyl in schedule I on a temporary basis is necessary to
avoid an imminent hazard to public safety, and as required by 21 U.S.C.
811(h)(1)(A), a notice of intent to temporarily schedule acetyl
fentanyl was published in the Federal Register on May 21, 2015. 80 FR
29227.
---------------------------------------------------------------------------
\1\ Because the Secretary of the HHS has delegated to the
Assistant Secretary for Health of the HHS the authority to make
domestic drug scheduling recommendations, for purposes of this final
order, all subsequent references to ``Secretary'' have been replaced
with ``Assistant Secretary.'' As set forth in a memorandum of
understanding entered into by HHS, 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 Assistant
Secretary's scheduling responsibilities under the CSA, with the
concurrence of NIDA. 50 FR 9518, Mar. 8, 1985.
---------------------------------------------------------------------------
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
acetyl 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 analysis is available in its
entirety under the tab ``Supporting and Related Material'' of the
public docket of this action at www.regulations.gov under Docket Number
DEA-413F.
Factor 4. History and Current Pattern of Abuse
Clandestinely produced substances structurally related to the
schedule II opioid analgesic fentanyl were trafficked and abused on the
West Coast in the late 1970s and 1980s. These clandestinely produced
fentanyl-like substances were commonly known as designer drugs, and
recently, there has been a reemergence in the trafficking and abuse of
designer drug substances, including fentanyl-like substances. Alpha-
methylfentanyl, the first fentanyl analogue identified in California,
was placed into schedule I of the CSA in September 1981. Following the
control of alpha-methylfentanyl, the DEA identified several other
fentanyl analogues (3-methylthiofentanyl, acetyl-alpha-methylfentanyl,
beta-hydroxy-3-methylfentanyl, alpha-methylthiofentanyl, thiofentanyl,
beta-hydroxyfentanyl, para-fluorofentanyl and 3-methylfentanyl) in
submissions to forensic laboratories. These substances were temporarily
controlled under schedule I of the CSA after finding that they posed an
imminent hazard to public safety and were subsequently permanently
placed into schedule I of the CSA.
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 State and
local forensic laboratories across the country. The first laboratory
submission of acetyl fentanyl was recorded in Maine in April 2013
according to NFLIS. NFLIS registered eight reports containing acetyl
fentanyl in 2013 in Louisiana, Maine, and North Dakota; and 30 reports
in 2014 in Florida, Illinois, Louisiana, Maine, New Jersey, Ohio,
Oregon, Pennsylvania, and Virginia.
The System to Retrieve Information from Drug Evidence (STRIDE) is a
database of drug exhibits sent to DEA laboratories for analysis.
Exhibits from this database are from the DEA, other Federal agencies,
and some local law enforcement agencies. Acetyl fentanyl was first
reported to STRIDE in September 2013 from exhibits obtained through a
controlled purchase in Louisiana. In October 2013, an exhibit collected
from a controlled purchase of suspected oxycodone tablets in Rhode
Island contained acetyl fentanyl as the primary substance. In 2014,
STARLiMS (a Web-based, commercial laboratory information management
system that is in transition to replace STRIDE) and STRIDE reported
eight additional seizures in Colorado, Florida, Georgia, and
Washington.
In August 2013, the Centers for Disease Control and Prevention
published an article in its Morbidity and Mortality Weekly Report
documenting a series of 14 fatalities related to acetyl fentanyl that
occurred between March and May 2013. In December 2013, another fatality
associated with acetyl fentanyl was reported in Rhode Island for a
total of 15 fatalities. In February 2014, the North Carolina Department
of Health and Human Services issued a health advisory related to acetyl
fentanyl following at least three deaths related to this synthetic
drug. Toxicologists at the North Carolina Office of the Chief Medical
Examiner detected acetyl fentanyl in specimens associated with deaths
that occurred in January 2014 in Sampson, Person, and
[[Page 42383]]
Transylvania counties. In July and August 2014, four additional
fatalities involving acetyl fentanyl were reported for a total of seven
fatalities in North Carolina. Deaths involving acetyl fentanyl have
also been reported in California (1), Louisiana (14), Oregon (1) and
Pennsylvania (1).
A significant seizure of acetyl fentanyl occurred in April 2013
during a law enforcement investigation in Montreal, Canada.
Approximately three kilograms of acetyl fentanyl in powder form and
approximately 11,000 tablets containing acetyl fentanyl were seized.
Given that a typical dose of acetyl fentanyl is in the microgram range,
a three kilogram quantity could potentially produce millions of dosage
units. In the United States, tablets that mimic pharmaceutical opioid
products have been reported in multiple states, including Colorado,
Florida, Georgia, Rhode Island, and Washington. Recent reports indicate
that acetyl fentanyl in powder form is available over the Internet and
has been imported to addresses within the United States.
Evidence also suggests that the pattern of abuse of fentanyl
analogues, including acetyl fentanyl, parallels that of heroin and
prescription opioid analgesics. For example, seizures of acetyl
fentanyl have been encountered both in powder and in tablet form. It is
also known to have caused many fatal overdoses, in which intravenous
routes of administration and histories of drug abuse are documented.
Factor 5. Scope, Duration and Significance of Abuse
The DEA is currently aware of at least 39 fatalities associated
with acetyl fentanyl. These deaths occurred in 2013 and 2014 from six
states including California, Louisiana, North Carolina, Oregon,
Pennsylvania, and Rhode Island. STARLiMS and STRIDE, databases
capturing drug evidence information from DEA forensic laboratories,
have a total of 10 drug reports in which acetyl fentanyl was identified
in six cases for analyzed drugs submitted from January 2010--December
2014 from Colorado, Florida, Georgia, Louisiana, Rhode Island, and
Washington. It is likely that the prevalence of acetyl fentanyl in
opioid analgesic-related emergency room admissions and deaths is
underreported since standard immunoassays cannot differentiate acetyl
fentanyl from fentanyl.
The population likely to abuse acetyl fentanyl overlaps with the
populations abusing prescription opioid analgesics and heroin. This is
evidenced by the routes of administration and drug use history
documented in acetyl fentanyl fatal overdose cases. Because abusers of
acetyl fentanyl are likely to obtain the drug through illicit sources,
the identity, purity, and quantity is uncertain and inconsistent, thus
posing significant adverse health risks to its abusers. This risk is
particularly heightened by the fact that acetyl fentanyl is a highly
potent opioid (15.7 fold more potent than that of morphine as tested in
mice using an acetic acid writhing method). Thus small changes in the
amount and purity of the substance could potentially lead to overdose
and death.
Factor 6. What, if Any, Risk There Is to the Public Health
Acetyl fentanyl exhibits a pharmacological profile similar to that
of fentanyl and other opioid analgesic compounds, and it is a potent
opioid analgesic reported to be 1/3 as potent as fentanyl and 15.7
times as potent as morphine in mice tested in an acetic acid writhing
method. In addition, studies also showed that the range between the
effective dose (ED50) and the lethal dose (LD50) of acetyl fentanyl is
narrower than that of morphine and fentanyl, increasing the risk of
fatal overdose. Thus, its abuse is likely to pose quantitatively
greater risks to the public health and safety than abuse of traditional
opioid analgesics such as morphine.
Based on the above pharmacological data, the abuse of acetyl
fentanyl at least leads to the same qualitative public health risks as
heroin, fentanyl, and other opioid analgesic compounds. The public
health risks attendant to the abuse of heroin and opioid analgesics are
well established. The abuse of opioid analgesics has resulted in large
numbers of drug treatment admissions, emergency department visits, and
fatal overdoses.
Acetyl fentanyl has been associated with numerous fatalities. At
least 39 overdose deaths due to acetyl fentanyl abuse have been
reported in six states in 2013 and 2014, California, Louisiana, North
Carolina, Oregon, Pennsylvania, and Rhode Island. This indicates that
acetyl fentanyl poses an imminent hazard to public safety.
Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard
to Public Safety
Based on the data and information summarized above, the continued
uncontrolled manufacture, distribution, importation, exportation, and
abuse of acetyl fentanyl poses an imminent hazard to the public safety.
The DEA is not aware of any currently accepted medical uses for this
substance 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 acetyl
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 April 7, 2015, notified the
Assistant Secretary of the DEA's intention to temporarily place this
substance into schedule I.
Conclusion
In accordance with the provisions of section 201(h) of the CSA, 21
U.S.C. 811(h), the Administrator considered available data and
information, herein sets forth the grounds for his determination that
it is necessary to temporarily schedule N-(1-phenethylpiperidin-4-yl)-
N-phenylacetamide (acetyl fentanyl), into schedule I of the CSA, and
finds that placement of this synthetic opioid into schedule I of the
CSA is necessary to avoid an imminent hazard to the public safety.
Because the Administrator hereby finds it necessary to temporarily
place this synthetic opioid into schedule I to avoid an imminent hazard
to the public safety, this final order temporarily scheduling acetyl
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. 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
[[Page 42384]]
scheduling orders are not subject to judicial review. 21 U.S.C.
811(h)(6).
Requirements for Handling
Upon the effective date of this final order, acetyl fentanyl will
become subject to the regulatory controls and administrative, civil,
and criminal sanctions applicable to the manufacture, distribution,
importation, exportation, research, conduct of instructional
activities, and possession of schedule I controlled substances
including the following:
1. Registration. Any person who handles (manufactures, distributes,
imports, exports, engages in research, conducts instructional
activities with, or possesses), or who desires to handle, acetyl
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 July 17, 2015. Any person who currently
handles acetyl fentanyl, and is not registered with the DEA, must
submit an application for registration and may not continue to handle
acetyl fentanyl as of July 17, 2015, 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 July 17, 2015 is unlawful and
those in possession of any quantity of this substance may be subject to
prosecution pursuant to the CSA.
2. Security. Acetyl 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 July
17, 2015.
3. Labeling and packaging. All labels, labeling, and packaging for
commercial containers of acetyl fentanyl must be in compliance with 21
U.S.C. 825, 958(e), and be in accordance with 21 CFR part 1302 as of
July 17, 2015. Current DEA registrants shall have 30 calendar days from
July 17, 2015, to comply with all labeling and packaging requirements.
4. Inventory. Every DEA registrant who possesses any quantity of
acetyl fentanyl on the effective date of this order must take an
inventory of all stocks of this substance on hand as of July 17, 2015,
pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR
1304.03, 1304.04, and 1304.11(a) and (d). 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 acetyl 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.
5. Records. All DEA registrants must maintain records with respect
to acetyl fentanyl pursuant to 21 U.S.C. 827 and 958, and in accordance
with 21 CFR parts 1304, 1307, and 1312 as of July 17, 2015. Current DEA
registrants authorized to handle acetyl fentanyl shall have 30 calendar
days from the effective date of this order to be in compliance with all
recordkeeping requirements.
6. Reports. All DEA registrants who manufacture or distribute
acetyl fentanyl must submit reports pursuant to 21 U.S.C. 827 and in
accordance with 21 CFR parts 1304, 1307, and 1312 as of July 17, 2015.
7. Order Forms. All DEA registrants who distribute acetyl fentanyl
must comply with order form requirements pursuant to 21 U.S.C. 828 and
in accordance with 21 CFR part 1305 as of July 17, 2015.
8. Importation and Exportation. All importation and exportation of
acetyl fentanyl must be in compliance with 21 U.S.C. 952, 953, 957,
958, and in accordance with 21 CFR part 1312 as of July 17, 2015.
9. Quota. Only DEA registered manufacturers may manufacture acetyl
fentanyl in accordance with a quota assigned pursuant to 21 U.S.C. 826
and in accordance with 21 CFR part 1303 as of July 17, 2015.
10. Liability. Any activity involving acetyl fentanyl not
authorized by, or in violation of the CSA, occurring as of July 17,
2015, 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 an
expedited temporary scheduling action where such action is necessary to
avoid an imminent hazard to the public safety. As provided in this
subsection, the Attorney General may, by order, schedule a substance in
schedule I on a temporary basis. Such an order may not be issued before
the expiration of 30 days from (1) the publication of a notice in the
Federal Register of the intention to issue such order and the grounds
upon which such order is to be issued, and (2) the date that notice of
the proposed temporary scheduling order is transmitted to the Assistant
Secretary. 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
final order 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.
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 these substances immediately because they
pose a public health risk. 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
[[Page 42385]]
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 public safety,
it would be contrary to the public interest to delay implementation of
the temporary scheduling order. Therefore, in accordance with 5 U.S.C.
808(2), this order shall take effect immediately upon its publication.
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)(24) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(h) * * *
(24) N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide, its (9821).
optical, positional, and geometric isomers, salts and
salts of isomers (Other names: acetyl fentanyl)...........
* * * * *
Dated: July 13, 2015.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2015-17563 Filed 7-16-15; 8:45 am]
BILLING CODE 4410-09-P
