Schedules of Controlled Substances: Temporary Placement of U-47700 Into Schedule I, 79389-79393 [2016-27357]
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Certification Office (ACO), FAA; or the
Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has
been authorized by the Manager, Seattle
ACO, to approve the part.
(ii) The replacement MOV actuator must be
fully interchangeable with the part specified
in Boeing Service Bulletin 777–28A0034,
Revision 3, dated September 25, 2015.
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(j) Credit for Previous Actions
(1) This paragraph provides credit for the
requirements of paragraph (g) of this AD, if
those actions were performed before the
effective date of this AD using Boeing Special
Attention Service Bulletin 777–28–0061,
dated October 25, 2010; or Boeing Special
Attention Service Bulletin 777–28–0061,
Revision 1, dated January 26, 2012; as
applicable. These documents are not
incorporated by reference in this AD.
(2) This paragraph provides credit for the
requirements of paragraph (i) of this AD, if
those actions were performed before April
25, 2013 (the effective date of AD 2013–05–
03, Amendment 39–17375 (78 FR 17290,
March 21, 2013), ‘‘AD 2013–05–03’’), using
Boeing Alert Service Bulletin 777–28A0034,
dated August 2, 2007; or Boeing Alert Service
Bulletin 777–28A0034, Revision 1, dated
May 20, 2010; except that the replacement of
MOV actuators of the left and right engine
fuel spar valves must also include cap sealing
the bonding jumper, as described in Boeing
Service Bulletin 777–28A0034, Revision 2,
dated September 20, 2010; and provided that
the replacement is an MOV actuator
identified in paragraph (j)(2)(i) or (j)(2)(ii) of
this AD. Boeing Alert Service Bulletin 777–
28A0034, dated August 2, 2007, and Boeing
Alert Service Bulletin 777–28A0034,
Revision 1, dated May 20, 2010, are not
incorporated by reference in this AD. Boeing
Service Bulletin 777–28A0034, Revision 2,
dated September 20, 2010, is incorporated by
reference in AD 2013–05–03.
(i) An MOV actuator that has P/N
MA30A1001, MA30A1017, or MA20A2027.
(ii) An MOV actuator that has a part
number other than P/N MA20A1001–1 and
meets the criteria specified in paragraphs
(i)(2)(i) and (i)(2)(ii) of this AD.
(3) This paragraph provides credit for the
requirements of paragraph (i) of this AD, if
those actions were performed before the
effective date of this AD using Boeing Service
Bulletin 777–28A0034, Revision 2, dated
September 20, 2010, which was incorporated
by reference in AD 2013–05–03.
(k) Alternative Methods of Compliance
(AMOCs)
(1) The Manager, Seattle ACO, FAA, has
the authority to approve AMOCs for this AD,
if requested using the procedures found in 14
CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector
or local Flight Standards District Office, as
appropriate. If sending information directly
to the manager of the ACO, send it to the
attention of the person identified in
paragraph (l)(1) of this AD. Information may
be emailed to: 9-ANM-Seattle-ACO-AMOCRequests@faa.gov.
(2) Before using any approved AMOC,
notify your appropriate principal inspector,
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or lacking a principal inspector, the manager
of the local flight standards district office/
certificate holding district office.
(3) An AMOC that provides an acceptable
level of safety may be used for any repair,
modification, or alteration required by this
AD if it is approved by the Boeing
Commercial Airplanes ODA that has been
authorized by the Manager, Seattle ACO, to
make those findings. To be approved, the
repair method, modification deviation, or
alteration deviation must meet the
certification basis of the airplane and the
approval must specifically refer to this AD.
(l) Related Information
(1) For more information about this AD,
contact Brendan Shanley, Aerospace
Engineer, Systems and Equipment Branch,
ANM–130S, FAA, Seattle Aircraft
Certification Office, 1601 Lind Avenue SW.,
Renton, WA 98057–3356; telephone: 425–
917–6492; fax: 425–917–6590; email:
brendan.shanley@faa.gov.
(2) Service information identified in this
AD that is not incorporated by reference is
available at the addresses specified in
paragraphs (m)(3) and (m)(4) of this AD.
(m) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference
(IBR) of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR
part 51.
(2) You must use this service information
as applicable to do the actions required by
this AD, unless the AD specifies otherwise.
(i) Boeing Special Attention Service
Bulletin 777–28–0061, Revision 2, dated May
4, 2015.
(ii) Boeing Service Bulletin 777–28A0034,
Revision 3, dated September 25, 2015.
(3) For Boeing service information
identified in this AD, contact Boeing
Commercial Airplanes, Attention: Data &
Services Management, P.O. Box 3707, MC
2H–65, Seattle, WA 98124–2207; telephone
206–544–5000, extension 1; fax 206–766–
5680; Internet https://
www.myboeingfleet.com.
(4) You may view this service information
at FAA, Transport Airplane Directorate, 1601
Lind Avenue SW., Renton, WA. For
information on the availability of this
material at the FAA, call 425–227–1221.
(5) You may view this service information
that is incorporated by reference at the
National Archives and Records
Administration (NARA). For information on
the availability of this material at NARA, call
202–741–6030, or go to: https://
www.archives.gov/federal-register/cfr/ibrlocations.html.
Issued in Renton, Washington, on October
7, 2016.
Michael Kaszycki,
Acting Manager, Transport Airplane
Directorate, Aircraft Certification Service.
[FR Doc. 2016–25491 Filed 11–10–16; 8:45 am]
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79389
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–440]
Schedules of Controlled Substances:
Temporary Placement of U–47700 Into
Schedule I
Drug Enforcement
Administration, Department of Justice.
ACTION: Final order.
AGENCY:
The Administrator of the Drug
Enforcement Administration is issuing
this final order to temporarily schedule
the synthetic opioid, 3,4-dichloro-N-[2(dimethylamino)cyclohexyl]-Nmethylbenzamide (also known as
U–47700), 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
U–47700 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,
U–47700.
DATES: This final order is effective on
November 14, 2016.
FOR FURTHER INFORMATION CONTACT:
Michael J. Lewis, Diversion Control
Division, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone: (202) 598–6812.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Legal Authority
The Drug Enforcement
Administration (DEA) implements and
enforces titles II and III of the
Comprehensive Drug Abuse Prevention
and Control Act of 1970, as amended. 21
U.S.C. 801–971. Titles II and III are
referred to as the ‘‘Controlled
Substances Act’’ and the ‘‘Controlled
Substances Import and Export Act,’’
respectively, and are collectively
referred to as the ‘‘Controlled
Substances Act’’ or the ‘‘CSA’’ for the
purpose of this action. The DEA
publishes the implementing regulations
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for these statutes in title 21 of the Code
of Federal Regulations (CFR), chapter II.
The CSA and its implementing
regulations are designed to prevent,
detect, and eliminate the diversion of
controlled substances and listed
chemicals into the illicit market while
ensuring an adequate supply is available
for the legitimate medical, scientific,
research, and industrial needs of the
United States. Controlled substances
have the potential for abuse and
dependence and are controlled to
protect the public health and safety.
Under the CSA, every controlled
substance is classified into one of five
schedules based upon its potential for
abuse, its currently accepted medical
use in treatment in the United States,
and the degree of dependence the drug
or other substance may cause. 21 U.S.C.
812. The initial schedules of controlled
substances established by Congress are
found at 21 U.S.C. 812(c), and the
current list of all scheduled substances
is published at 21 CFR part 1308.
Section 201 of the CSA, 21 U.S.C. 811,
provides the Attorney General with the
authority to temporarily place a
substance into schedule I of the CSA for
two years without regard to the
requirements of 21 U.S.C. 811(b) if she
finds that such action is necessary to
avoid an imminent hazard to the public
safety. 21 U.S.C. 811(h)(1). In addition,
if proceedings to control a substance are
initiated under 21 U.S.C. 811(a)(1), the
Attorney General may extend the
temporary scheduling for up to one
year. 21 U.S.C. 811(h)(2).
Where the necessary findings are
made, a substance may be temporarily
scheduled if it is not listed in any other
schedule under section 202 of the CSA,
21 U.S.C. 812, or if there is no
exemption or approval in effect for the
substance under section 505 of the
Federal Food, Drug, and Cosmetic Act
(FDCA), 21 U.S.C. 355. 21 U.S.C.
811(h)(1). The Attorney General has
delegated her scheduling authority
under 21 U.S.C. 811 to the
Administrator of the DEA. 28 CFR
0.100.
Background
Section 201(h)(4) of the CSA, 21
U.S.C. 811(h)(4), requires the
Administrator to notify the Secretary of
the Department of Health and Human
Services (HHS) of his intention to
temporarily place a substance into
schedule I of the CSA.1 The
1 As discussed in a memorandum of
understanding entered into by the Food and Drug
Administration (FDA) and the National Institute on
Drug Abuse (NIDA), the FDA acts as the lead agency
within the HHS in carrying out the Secretary’s
scheduling responsibilities under the CSA, with the
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Administrator transmitted the notice of
intent to place U–47700 into schedule I
on a temporary basis to the Assistant
Secretary by letter dated April 18, 2016.
The Assistant Secretary responded to
this notice by letter dated April 28,
2016, and advised that based on review
by the Food and Drug Administration
(FDA), there are currently no
investigational new drug applications or
approved new drug applications for U–
47700. The Assistant Secretary also
stated that the HHS has no objection to
the temporary placement of U–47700
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). U–47700 is not
currently listed in any schedule under
the CSA, and no exemptions or
approvals are in effect for U–47700
under section 505 of the FDCA, 21
U.S.C. 355. The DEA has found that the
control of U–47700 in schedule I on a
temporary basis is necessary to avoid an
imminent hazard to the public safety,
and as required by 21 U.S.C.
811(h)(1)(A), a notice of intent to
temporarily schedule U–47700 was
published in the Federal Register on
September 7, 2016. 81 FR 61636.
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 U–47700, 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
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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medical supervision. The DEA’s
updated three-factor analysis, and the
Assistant Secretary’s April 28, 2016,
letter, are available in their entirety
under the tab ‘‘Supporting Documents’’
of the public docket of this action at
www.regulations.gov under FDMS
Docket ID: DEA–2016–0016 (Docket
Number DEA–440).
Factor 4. History and Current Pattern of
Abuse
The recreational abuse of novel
opioids continues to be a significant
concern. These substances are
distributed to users with often
unpredictable outcomes. The novel
synthetic opioid U–47700 has recently
been encountered by law enforcement
and public health officials and the
adverse health effects and outcomes are
documented in the scientific literature.
Self-reporting by users describes the
effects of U–47700 to be similar to other
opioids. The negative effects
documented in the scientific literature
are also consistent with other opioids.
The National Forensic Laboratory
Information System (NFLIS) is a
national drug forensic laboratory
reporting system that systematically
collects results from drug chemistry
analyses conducted by participating
Federal, State, and local forensic
laboratories across the country. The
DEA utilizes NFLIS to monitor for drug
trends. The first laboratory submission
of U–47700 was recorded in October
2015; a total of 88 records were reported
from State and local forensic
laboratories between October 2015—
September 2016 according to NFLIS
(query date: October 24, 2016).
On October 1, 2014, the DEA
implemented STARLiMS (a web-based,
commercial laboratory information
management system) as its laboratory
drug evidence data system of record.
DEA laboratory data submitted after
September 30, 2014, are reposited in
STARLiMS; data from STARLiMS were
queried on November 1, 2016.
STARLiMS registered 45 reports
containing
U–47700 in 2016 from California,
Connecticut, Florida, Maryland,
Montana, North Dakota, New Jersey,
New York, Tennessee, Texas, Virginia,
West Virginia, and the District of
Columbia. Through information
collected from NFLIS, law enforcement
reports, and email communications, the
DEA is aware of the identification of
U–47700 from toxicology reports and
submitted evidence to forensic
laboratories in several states, including
Arkansas, California, Colorado,
Connecticut, Florida, Georgia, Iowa,
Kentucky, Missouri, Montana, New
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Hampshire, New Jersey, New York,
North Carolina, North Dakota, Ohio,
Oklahoma, Oregon, Pennsylvania,
Texas, and Wisconsin. These
identifications occurred in 2015 and
2016.
Evidence suggests that the pattern of
abuse of U–47700 parallels that of
heroin, prescription opioid analgesics,
and other novel opioids. Seizures of
U–47700 have been encountered in
powder form and in counterfeit tablets
that mimic pharmaceutical opioids.
U–47700 has also been encountered in
glassine bags and envelopes and knotted
corners of plastic bags. These
clandestine forms of distribution
demonstrate the abuse of this substance
as a replacement for heroin or other
opioids, either knowingly or
unknowingly. Further, U–47700 has
been encountered as a single substance
as well as in combination with other
substances, including heroin, fentanyl,
and furanyl fentanyl in drug exhibits.
The scientific literature and
information collected by DEA
demonstrate U–47700 is being abused
for its opioid properties. The
distribution of U–47700 and the
increased prevalence of abuse remain
deeply concerning to the DEA.
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Factor 5. Scope, Duration and
Significance of Abuse
The scientific literature and reports
collected by the DEA demonstrate
U–47700 is being abused for its opioid
properties. This abuse of U–47700 has
resulted in morbidity and mortality (see
updated DEA 3-Factor Analysis for full
discussion). The DEA has received
reports for at least 46 confirmed
fatalities 2 associated with U–47700. The
information on these deaths occurring
in 2015 and 2016 was collected from
email communications and toxicology
and medical examiner reports and was
reported from New Hampshire (1), New
York (31), North Carolina (10), Ohio (1),
Texas (2), and Wisconsin (1). The
scientific literature notes additional
fatal overdoses connected to U–47700.
The population likely to abuse U–47700
appears to overlap with the populations
abusing prescription opioid analgesics,
other ‘‘designer opioids,’’ and heroin, as
evidenced by drug use history
documented in U–47700 fatal overdose
cases. This observation is further
supported by U–47700 being sold on the
illicit market in glassine bags, some of
which are marked with stamped logos,
imitating the sale of heroin.
2 Due to a proofreading error, the number of
fatalities listed in the U–47700 NOI, which was 15,
is incorrect. The correct number, 46, has been
added to this Final Order.
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Additionally, U–47700 has been found
in counterfeit pills. Because abusers of
U–47700 are likely to obtain this
substance through non-regulated
sources (i.e., on-line purchases or drug
dealers), the identity, purity, and
quantity are uncertain and inconsistent,
thus posing significant adverse health
risks to the end user. Individuals who
initiate (i.e., use a drug for the first time)
U–47700 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.).
STARLiMS contains 45 reports in
which U–47700 was identified in drug
exhibits submitted in 2016. A query of
NFLIS returned 88 records of U–47700
being identified in exhibits submitted to
State and local forensic laboratories
between October 2015—September
2016. The DEA is not aware of any
laboratory analyses of drug evidence
identifying U–47700 prior to 2015,
indicating that this synthetic opioid
only recently became available as a
replacement for other opioids that are
commonly abused (i.e. oxycodone,
heroin, fentanyl). U–47700 is available
over the Internet and is marketed as a
‘‘research chemical.’’ The on-line sale
and marketing of U–47700 are similar to
other new psychoactive substances that
have rapidly appeared on the
recreational drug market and also
resulted in negative consequences for
the user.
Factor 6. What, if Any, Risk There Is to
the Public Health
U–47700 exhibits pharmacological
profiles similar to that of morphine and
other mu-opioid receptor agonists. Cases
of intoxication are reported in the
literature with morbidity and mortality
associated with U–47700 use. The toxic
effects of U–47700 in humans are
demonstrated by overdoses and
overdose fatalities associated with this
substance, as reported in the scientific
literature. Abusers of U–47700 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. Additionally, the potent
opioid U–47700 may serve as a
precursor to problematic opioid use and
dependence.
Based on reports in the scientific
literature and information received by
the DEA, the abuse of U–47700 leads to
the same qualitative public health risks
as heroin, fentanyl and other opioid
analgesic substances. As with any nonmedically approved opioid, the health
and safety risks for users are great. The
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79391
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.
U–47700 has been associated with a
number of fatalities and non-fatal
overdoses as detailed in the scientific
literature. The DEA has received
information connecting U–47700 to at
least 46 confirmed overdose deaths,
occurring in 2015 and 2016 in New
Hampshire (1), New York (31), North
Carolina (10), Ohio (1), Texas (2), and
Wisconsin (1).
Finding of Necessity of Schedule I
Placement To Avoid Imminent Hazard
to Public Safety
In accordance with 21 U.S.C.
811(h)(3), based on the data and
information summarized above, the
continued uncontrolled manufacture,
distribution, importation, exportation,
and abuse of U–47700 pose 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 U–47700
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 18, 2016, notified the
Assistant Secretary of the DEA’s
intention to temporarily place this
substance into schedule I.
Conclusion
In accordance with the provisions of
section 201(h) of the CSA, 21 U.S.C.
811(h), the Administrator considered
available data and information, herein
sets forth the grounds for his
determination that it is necessary to
temporarily schedule U–47700 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
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to the public safety, this final order
temporarily scheduling U–47700 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 final
order, U–47700 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, U–47700 must be
registered with the DEA to conduct such
activities pursuant to 21 U.S.C. 822,
823, 957, and 958 and in accordance
with 21 CFR parts 1301 and 1312, as of
November 14, 2016. Any person who
currently handles U–47700, and is not
registered with the DEA, must submit an
application for registration and may not
continue to handle U–47700 as of
November 14, 2016, unless the DEA has
approved that application for
registration pursuant to 21 U.S.C. 822,
823, 957, 958, and in accordance with
21 CFR parts 1301 and 1312. Retail sales
of schedule I controlled substances to
the general public are not allowed under
the CSA. Possession of any quantity of
this substance in a manner not
authorized by the CSA on or after
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November 14, 2016 is unlawful and
those in possession of any quantity of
this substance may be subject to
prosecution pursuant to the CSA.
2. Disposal of stocks. Any person who
does not desire or is not able to obtain
a schedule I registration to handle U–
47700, must surrender all quantities of
currently held U–47700.
3. Security. U–47700 is subject to
schedule I security requirements and
must be handled and stored pursuant to
21 U.S.C. 821, 823, 871(b), and in
accordance with 21 CFR 1301.71–
1301.93, as of November 14, 2016.
4. Labeling and packaging. All labels,
labeling, and packaging for commercial
containers of U–47700 must be in
compliance with 21 U.S.C. 825, 958(e),
and be in accordance with 21 CFR part
1302. Current DEA registrants shall have
30 calendar days from November 14,
2016, to comply with all labeling and
packaging requirements.
5. Inventory. Every DEA registrant
who possesses any quantity of U–47700
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 U–
47700) 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 U–
47700 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 U–47700 must
submit reports pursuant to 21 U.S.C.
827 and in accordance with 21 CFR
parts 1304, and 1312 as of November 14,
2016.
8. Order Forms. All DEA registrants
who distribute U–47700 must comply
with order form requirements pursuant
to 21 U.S.C. 828 and in accordance with
21 CFR part 1305 as of November 14,
2016.
9. Importation and Exportation. All
importation and exportation of U–47700
must be in compliance with 21 U.S.C.
952, 953, 957, 958, and in accordance
with 21 CFR part 1312 as of November
14, 2016.
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
10. Quota. Only DEA registered
manufacturers may manufacture U–
47700 in accordance with a quota
assigned pursuant to 21 U.S.C. 826 and
in accordance with 21 CFR part 1303 as
of November 14, 2016.
11. Liability. Any activity involving
U–47700 not authorized by, or in
violation of the CSA, occurring as of
November 14, 2016, is unlawful, and
may subject the person to
administrative, civil, and/or criminal
sanctions.
Regulatory Matters
Section 201(h) of the CSA, 21 U.S.C.
811(h), provides for a temporary
scheduling action where such action is
necessary to avoid an imminent hazard
to the public safety. As provided in this
subsection, the Attorney General may,
by order, schedule a substance in
schedule I on a temporary basis. Such
an order may not be issued before the
expiration of 30 days from (1) the
publication of a notice in the Federal
Register of the intention to issue such
order and the grounds upon which such
order is to be issued, and (2) the date
that notice of the proposed temporary
scheduling order is transmitted to the
Assistant Secretary. 21 U.S.C. 811(h)(1).
Inasmuch as section 201(h) of the
CSA directs that temporary scheduling
actions be issued by order and sets forth
the procedures by which such orders are
to be issued, the DEA believes that the
notice and comment requirements of the
Administrative Procedure Act (APA) at
5 U.S.C. 553, do not apply to this
temporary scheduling action. In the
alternative, even assuming that this
action might be subject to 5 U.S.C. 553,
the Administrator finds that there is
good cause to forgo the notice and
comment requirements of 5 U.S.C. 553,
as any further delays in the process for
issuance of temporary scheduling orders
would be impracticable and contrary to
the public interest in view of the
manifest urgency to avoid an imminent
hazard to the public safety.
Further, the DEA believes that this
temporary scheduling action is not a
‘‘rule’’ as defined by 5 U.S.C. 601(2),
and, accordingly, is not subject to the
requirements of the Regulatory
Flexibility Act. The requirements for the
preparation of an initial regulatory
flexibility analysis in 5 U.S.C. 603(a) are
not applicable where, as here, the DEA
is not required by the APA or any other
law to publish a general notice of
proposed rulemaking.
Additionally, this action is not a
significant regulatory action as defined
by Executive Order 12866 (Regulatory
Planning and Review), section 3(f), and,
accordingly, this action has not been
E:\FR\FM\14NOR1.SGM
14NOR1
Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Rules and Regulations
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 because it poses
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 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
and it would be contrary to the public
interest to delay implementation of the
temporary scheduling order. Therefore,
this order shall take effect immediately
upon its publication. The DEA has
submitted a copy of this final order to
both Houses of Congress and to the
Comptroller General, although such
filing is not required under the Small
Business Regulatory Enforcement
Fairness Act of 1996 (Congressional
Review Act), 5 U.S.C. 801–808, because,
as noted above, this action is an order,
not a rule.
Lhorne on DSK30JT082PROD with RULES
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:
VerDate Sep<11>2014
15:02 Nov 10, 2016
Jkt 241001
79393
Click on Open Docket Folder on the line
associated with this deviation.
FOR FURTHER INFORMATION CONTACT: If
■ 1. The authority citation for part 1308
you have questions on this temporary
continues to read as follows:
deviation, call or email Mr. Hal R. Pitts,
Authority: 21 U.S.C. 811, 812, 871(b),
Bridge Administration Branch Fifth
unless otherwise noted.
District, Coast Guard, telephone 757–
398–6222, email Hal.R.Pitts@uscg.mil.
■ 2. Amend § 1308.11 by adding
SUPPLEMENTARY INFORMATION: The
paragraph (h)(18) to read as follows:
County of Cape May, NJ, that owns and
§ 1308.11 Schedule I.
operates the Stone Harbor Boulevard
*
*
*
*
*
(CR657) Bridge across the Great
(h) * * *
Channel, mile 102.0, New Jersey
(18)
3,4-Dichloro-N-[2Intracoastal Waterway, at Stone Harbor,
(dimethylamino)cyclohexyl]-NNJ, has requested a temporary deviation
methylbenzamide, its isomers,
from the current operating regulations to
esters, ethers, salts and salts of
avoid bridge failure and perform
isomers, esters and ethers
emergency repairs to the bridge, due to
(Other name: U–47700) .............
(9547)
a serious crack in one of two main
*
*
*
*
*
bridge girders, causing the bridge to be
unsafe for vehicular traffic and
Dated: November 7, 2016.
movement of the bascule spans. The
Chuck Rosenberg,
bridge is a bascule drawbridge and has
Acting Administrator.
a vertical clearance in the closed
[FR Doc. 2016–27357 Filed 11–10–16; 8:45 am]
position of 10 feet above mean high
BILLING CODE 4410–09–P
water.
The current operating schedule is set
out in 33 CFR 117.733(h). Under this
DEPARTMENT OF HOMELAND
temporary deviation, the bridge will
SECURITY
remain in the closed-to-navigation
position until 4 p.m. on December 2,
Coast Guard
2016.
The Great Channel, New Jersey
33 CFR Part 117
Intracoastal Waterway is used by a
[Docket No. USCG–2016–1008]
variety of vessels including small public
vessels, small commercial vessels, tug
Drawbridge Operation Regulation;
and barge traffic, and recreational
Great Channel, New Jersey
vessels. The Coast Guard has carefully
Intracoastal Waterway, Stone Harbor,
considered the nature and volume of
NJ
vessel traffic on the waterway in
publishing this temporary deviation.
AGENCY: Coast Guard, DHS.
Vessels able to safely pass through the
ACTION: Notice of deviation from
bridge in the closed position may do so
drawbridge regulation.
at any time. The bridge will not be able
to open for emergencies and there is no
SUMMARY: The Coast Guard has issued a
immediate alternate route for vessels to
temporary deviation from the operating
pass. The Coast Guard will also inform
schedule that governs the Stone Harbor
the users of the waterways through our
Boulevard (CR657) Bridge across the
Local and Broadcast Notices to Mariners
Great Channel, mile 102.0, New Jersey
Intracoastal Waterway, at Stone Harbor, of the change in operating schedule for
the bridge so that vessel operators can
NJ. This deviation is necessary to avoid
arrange their transit to minimize any
bridge failure and perform emergency
bridge repairs. This deviation allows the impact caused by the temporary
deviation.
bridge to remain in the closed-toIn accordance with 33 CFR 117.35(e),
navigation position.
the drawbridge must return to its regular
DATES: This deviation is effective
operating schedule immediately at the
without actual notice from November
14, 2016 through 4 p.m. on December 2, end of the effective period of this
temporary deviation. This deviation
2016. For the purposes of enforcement,
from the operating regulations is
actual notice will be used from
authorized under 33 CFR 117.35.
November 8, 2016, until November 14,
Dated: November 8, 2016.
2016.
Hal R. Pitts,
ADDRESSES: The docket for this
Bridge Program Manager, Fifth Coast Guard
deviation, [USCG–2016–1008] is
available at https://www.regulations.gov. District.
[FR Doc. 2016–27281 Filed 11–10–16; 8:45 am]
Type the docket number in the
‘‘SEARCH’’ box and click ‘‘SEARCH’’.
BILLING CODE 9110–04–P
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
PO 00000
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Fmt 4700
Sfmt 9990
E:\FR\FM\14NOR1.SGM
14NOR1
Agencies
[Federal Register Volume 81, Number 219 (Monday, November 14, 2016)]
[Rules and Regulations]
[Pages 79389-79393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27357]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-440]
Schedules of Controlled Substances: Temporary Placement of U-
47700 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,
3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide (also
known as U-47700), 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 U-47700
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, U-47700.
DATES: This final order is effective on November 14, 2016.
FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control
Division, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.
SUPPLEMENTARY INFORMATION:
Legal Authority
The Drug Enforcement Administration (DEA) implements and enforces
titles II and III of the Comprehensive Drug Abuse Prevention and
Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III
are referred to as the ``Controlled Substances Act'' and the
``Controlled Substances Import and Export Act,'' respectively, and are
collectively referred to as the ``Controlled Substances Act'' or the
``CSA'' for the purpose of this action. The DEA publishes the
implementing regulations
[[Page 79390]]
for these statutes in title 21 of the Code of Federal Regulations
(CFR), chapter II. The CSA and its implementing regulations are
designed to prevent, detect, and eliminate the diversion of controlled
substances and listed chemicals into the illicit market while ensuring
an adequate supply is available for the legitimate medical, scientific,
research, and industrial needs of the United States. Controlled
substances have the potential for abuse and dependence and are
controlled to protect the public health and safety.
Under the CSA, every controlled substance is classified into one of
five schedules based upon its potential for abuse, its currently
accepted medical use in treatment in the United States, and the degree
of dependence the drug or other substance may cause. 21 U.S.C. 812. The
initial schedules of controlled substances established by Congress are
found at 21 U.S.C. 812(c), and the current list of all scheduled
substances is published at 21 CFR part 1308.
Section 201 of the CSA, 21 U.S.C. 811, provides the Attorney
General with the authority to temporarily place a substance into
schedule I of the CSA for two years without regard to the requirements
of 21 U.S.C. 811(b) if she finds that such action is necessary to avoid
an imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In
addition, if proceedings to control a substance are initiated under 21
U.S.C. 811(a)(1), the Attorney General may extend the temporary
scheduling for up to one year. 21 U.S.C. 811(h)(2).
Where the necessary findings are made, a substance may be
temporarily scheduled if it is not listed in any other schedule under
section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or
approval in effect for the substance under section 505 of the Federal
Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C.
811(h)(1). The Attorney General has delegated her scheduling authority
under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.
Background
Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the
Administrator to notify the Secretary of the Department of Health and
Human Services (HHS) of his intention to temporarily place a substance
into schedule I of the CSA.\1\ The Administrator transmitted the notice
of intent to place U-47700 into schedule I on a temporary basis to the
Assistant Secretary by letter dated April 18, 2016. The Assistant
Secretary responded to this notice by letter dated April 28, 2016, and
advised that based on review by the Food and Drug Administration (FDA),
there are currently no investigational new drug applications or
approved new drug applications for U-47700. The Assistant Secretary
also stated that the HHS has no objection to the temporary placement of
U-47700 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). U-47700 is not currently listed in any schedule under
the CSA, and no exemptions or approvals are in effect for U-47700 under
section 505 of the FDCA, 21 U.S.C. 355. The DEA has found that the
control of U-47700 in schedule I on a temporary basis is necessary to
avoid an imminent hazard to the public safety, and as required by 21
U.S.C. 811(h)(1)(A), a notice of intent to temporarily schedule U-47700
was published in the Federal Register on September 7, 2016. 81 FR
61636.
---------------------------------------------------------------------------
\1\ As discussed in a memorandum of understanding entered into
by the Food and Drug Administration (FDA) and the National Institute
on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS
in carrying out the Secretary's scheduling responsibilities under
the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The
Secretary of the HHS has delegated to the Assistant Secretary for
Health of the HHS the authority to make domestic drug scheduling
recommendations. 58 FR 35460, July 1, 1993.
---------------------------------------------------------------------------
To find that placing a substance temporarily into schedule I of the
CSA is necessary to avoid an imminent hazard to the public safety, the
Administrator is required to consider three of the eight factors set
forth in section 201(c) of the CSA, 21 U.S.C. 811(c): The substance's
history and current pattern of abuse; the scope, duration and
significance of abuse; and what, if any, risk there is to the public
health. 21 U.S.C. 811(h)(3). Consideration of these factors includes
actual abuse, diversion from legitimate channels, and clandestine
importation, manufacture, or distribution. 21 U.S.C. 811(h)(3).
A substance meeting the statutory requirements for temporary
scheduling may only be placed into schedule I. 21 U.S.C. 811(h)(1).
Substances in schedule I are those that have a high potential for
abuse, no currently accepted medical use in treatment in the United
States, and a lack of accepted safety for use under medical
supervision. 21 U.S.C. 812(b)(1). Available data and information for U-
47700, summarized below, indicate that this synthetic opioid has a high
potential for abuse, no currently accepted medical use in treatment in
the United States, and a lack of accepted safety for use under medical
supervision. The DEA's updated three-factor analysis, and the Assistant
Secretary's April 28, 2016, letter, are available in their entirety
under the tab ``Supporting Documents'' of the public docket of this
action at www.regulations.gov under FDMS Docket ID: DEA-2016-0016
(Docket Number DEA-440).
Factor 4. History and Current Pattern of Abuse
The recreational abuse of novel opioids continues to be a
significant concern. These substances are distributed to users with
often unpredictable outcomes. The novel synthetic opioid U-47700 has
recently been encountered by law enforcement and public health
officials and the adverse health effects and outcomes are documented in
the scientific literature. Self-reporting by users describes the
effects of U-47700 to be similar to other opioids. The negative effects
documented in the scientific literature are also consistent with other
opioids. The National Forensic Laboratory Information System (NFLIS) is
a national drug forensic laboratory reporting system that
systematically collects results from drug chemistry analyses conducted
by participating Federal, State, and local forensic laboratories across
the country. The DEA utilizes NFLIS to monitor for drug trends. The
first laboratory submission of U-47700 was recorded in October 2015; a
total of 88 records were reported from State and local forensic
laboratories between October 2015--September 2016 according to NFLIS
(query date: October 24, 2016).
On October 1, 2014, the DEA implemented STARLiMS (a web-based,
commercial laboratory information management system) as its laboratory
drug evidence data system of record. DEA laboratory data submitted
after September 30, 2014, are reposited in STARLiMS; data from STARLiMS
were queried on November 1, 2016. STARLiMS registered 45 reports
containing U-47700 in 2016 from California, Connecticut, Florida,
Maryland, Montana, North Dakota, New Jersey, New York, Tennessee,
Texas, Virginia, West Virginia, and the District of Columbia. Through
information collected from NFLIS, law enforcement reports, and email
communications, the DEA is aware of the identification of U-47700 from
toxicology reports and submitted evidence to forensic laboratories in
several states, including Arkansas, California, Colorado, Connecticut,
Florida, Georgia, Iowa, Kentucky, Missouri, Montana, New
[[Page 79391]]
Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio,
Oklahoma, Oregon, Pennsylvania, Texas, and Wisconsin. These
identifications occurred in 2015 and 2016.
Evidence suggests that the pattern of abuse of U-47700 parallels
that of heroin, prescription opioid analgesics, and other novel
opioids. Seizures of U-47700 have been encountered in powder form and
in counterfeit tablets that mimic pharmaceutical opioids. U-47700 has
also been encountered in glassine bags and envelopes and knotted
corners of plastic bags. These clandestine forms of distribution
demonstrate the abuse of this substance as a replacement for heroin or
other opioids, either knowingly or unknowingly. Further, U-47700 has
been encountered as a single substance as well as in combination with
other substances, including heroin, fentanyl, and furanyl fentanyl in
drug exhibits.
The scientific literature and information collected by DEA
demonstrate U-47700 is being abused for its opioid properties. The
distribution of U-47700 and the increased prevalence of abuse remain
deeply concerning to the DEA.
Factor 5. Scope, Duration and Significance of Abuse
The scientific literature and reports collected by the DEA
demonstrate U-47700 is being abused for its opioid properties. This
abuse of U-47700 has resulted in morbidity and mortality (see updated
DEA 3-Factor Analysis for full discussion). The DEA has received
reports for at least 46 confirmed fatalities \2\ associated with U-
47700. The information on these deaths occurring in 2015 and 2016 was
collected from email communications and toxicology and medical examiner
reports and was reported from New Hampshire (1), New York (31), North
Carolina (10), Ohio (1), Texas (2), and Wisconsin (1). The scientific
literature notes additional fatal overdoses connected to U-47700. The
population likely to abuse U-47700 appears to overlap with the
populations abusing prescription opioid analgesics, other ``designer
opioids,'' and heroin, as evidenced by drug use history documented in
U-47700 fatal overdose cases. This observation is further supported by
U-47700 being sold on the illicit market in glassine bags, some of
which are marked with stamped logos, imitating the sale of heroin.
Additionally, U-47700 has been found in counterfeit pills. Because
abusers of U-47700 are likely to obtain this substance through non-
regulated sources (i.e., on-line purchases or drug dealers), the
identity, purity, and quantity are uncertain and inconsistent, thus
posing significant adverse health risks to the end user. Individuals
who initiate (i.e., use a drug for the first time) U-47700 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.).
---------------------------------------------------------------------------
\2\ Due to a proofreading error, the number of fatalities listed
in the U-47700 NOI, which was 15, is incorrect. The correct number,
46, has been added to this Final Order.
---------------------------------------------------------------------------
STARLiMS contains 45 reports in which U-47700 was identified in
drug exhibits submitted in 2016. A query of NFLIS returned 88 records
of U-47700 being identified in exhibits submitted to State and local
forensic laboratories between October 2015--September 2016. The DEA is
not aware of any laboratory analyses of drug evidence identifying U-
47700 prior to 2015, indicating that this synthetic opioid only
recently became available as a replacement for other opioids that are
commonly abused (i.e. oxycodone, heroin, fentanyl). U-47700 is
available over the Internet and is marketed as a ``research chemical.''
The on-line sale and marketing of U-47700 are similar to other new
psychoactive substances that have rapidly appeared on the recreational
drug market and also resulted in negative consequences for the user.
Factor 6. What, if Any, Risk There Is to the Public Health
U-47700 exhibits pharmacological profiles similar to that of
morphine and other mu-opioid receptor agonists. Cases of intoxication
are reported in the literature with morbidity and mortality associated
with U-47700 use. The toxic effects of U-47700 in humans are
demonstrated by overdoses and overdose fatalities associated with this
substance, as reported in the scientific literature. Abusers of U-47700
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. Additionally, the potent opioid U-47700 may serve as a
precursor to problematic opioid use and dependence.
Based on reports in the scientific literature and information
received by the DEA, the abuse of U-47700 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.
U-47700 has been associated with a number of fatalities and non-
fatal overdoses as detailed in the scientific literature. The DEA has
received information connecting U-47700 to at least 46 confirmed
overdose deaths, occurring in 2015 and 2016 in New Hampshire (1), New
York (31), North Carolina (10), Ohio (1), Texas (2), and Wisconsin (1).
Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard
to Public Safety
In accordance with 21 U.S.C. 811(h)(3), based on the data and
information summarized above, the continued uncontrolled manufacture,
distribution, importation, exportation, and abuse of U-47700 pose 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 U-47700 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 18, 2016, notified the Assistant Secretary of the
DEA's intention to temporarily place this substance into schedule I.
Conclusion
In accordance with the provisions of section 201(h) of the CSA, 21
U.S.C. 811(h), the Administrator considered available data and
information, herein sets forth the grounds for his determination that
it is necessary to temporarily schedule U-47700 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
[[Page 79392]]
to the public safety, this final order temporarily scheduling U-47700
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 final order, U-47700 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, U-47700 must be registered with the DEA to
conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958
and in accordance with 21 CFR parts 1301 and 1312, as of November 14,
2016. Any person who currently handles U-47700, and is not registered
with the DEA, must submit an application for registration and may not
continue to handle U-47700 as of November 14, 2016, unless the DEA has
approved that application for registration pursuant to 21 U.S.C. 822,
823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312.
Retail sales of schedule I controlled substances to the general public
are not allowed under the CSA. Possession of any quantity of this
substance in a manner not authorized by the CSA on or after November
14, 2016 is unlawful and those in possession of any quantity of this
substance may be subject to prosecution pursuant to the CSA.
2. Disposal of stocks. Any person who does not desire or is not
able to obtain a schedule I registration to handle U-47700, must
surrender all quantities of currently held U-47700.
3. Security. U-47700 is subject to schedule I security requirements
and must be handled and stored pursuant to 21 U.S.C. 821, 823, 871(b),
and in accordance with 21 CFR 1301.71-1301.93, as of November 14, 2016.
4. Labeling and packaging. All labels, labeling, and packaging for
commercial containers of U-47700 must be in compliance with 21 U.S.C.
825, 958(e), and be in accordance with 21 CFR part 1302. Current DEA
registrants shall have 30 calendar days from November 14, 2016, to
comply with all labeling and packaging requirements.
5. Inventory. Every DEA registrant who possesses any quantity of U-
47700 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 U-47700) 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 U-47700 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 U-
47700 must submit reports pursuant to 21 U.S.C. 827 and in accordance
with 21 CFR parts 1304, and 1312 as of November 14, 2016.
8. Order Forms. All DEA registrants who distribute U-47700 must
comply with order form requirements pursuant to 21 U.S.C. 828 and in
accordance with 21 CFR part 1305 as of November 14, 2016.
9. Importation and Exportation. All importation and exportation of
U-47700 must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in
accordance with 21 CFR part 1312 as of November 14, 2016.
10. Quota. Only DEA registered manufacturers may manufacture U-
47700 in accordance with a quota assigned pursuant to 21 U.S.C. 826 and
in accordance with 21 CFR part 1303 as of November 14, 2016.
11. Liability. Any activity involving U-47700 not authorized by, or
in violation of the CSA, occurring as of November 14, 2016, is
unlawful, and may subject the person to administrative, civil, and/or
criminal sanctions.
Regulatory Matters
Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for a
temporary scheduling action where such action is necessary to avoid an
imminent hazard to the public safety. As provided in this subsection,
the Attorney General may, by order, schedule a substance in schedule I
on a temporary basis. Such an order may not be issued before the
expiration of 30 days from (1) the publication of a notice in the
Federal Register of the intention to issue such order and the grounds
upon which such order is to be issued, and (2) the date that notice of
the proposed temporary scheduling order is transmitted to the Assistant
Secretary. 21 U.S.C. 811(h)(1).
Inasmuch as section 201(h) of the CSA directs that temporary
scheduling actions be issued by order and sets forth the procedures by
which such orders are to be issued, the DEA believes that the notice
and comment requirements of the Administrative Procedure Act (APA) at 5
U.S.C. 553, do not apply to this temporary scheduling action. In the
alternative, even assuming that this action might be subject to 5
U.S.C. 553, the Administrator finds that there is good cause to forgo
the notice and comment requirements of 5 U.S.C. 553, as any further
delays in the process for issuance of temporary scheduling orders would
be impracticable and contrary to the public interest in view of the
manifest urgency to avoid an imminent hazard to the public safety.
Further, the DEA believes that this temporary scheduling action is
not a ``rule'' as defined by 5 U.S.C. 601(2), and, accordingly, is not
subject to the requirements of the Regulatory Flexibility Act. The
requirements for the preparation of an initial regulatory flexibility
analysis in 5 U.S.C. 603(a) are not applicable where, as here, the DEA
is not required by the APA or any other law to publish a general notice
of proposed rulemaking.
Additionally, this action is not a significant regulatory action as
defined by Executive Order 12866 (Regulatory Planning and Review),
section 3(f), and, accordingly, this action has not been
[[Page 79393]]
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
because it poses 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 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 and it would be contrary to the public
interest to delay implementation of the temporary scheduling order.
Therefore, this order shall take effect immediately upon its
publication. The DEA has submitted a copy of this final order to both
Houses of Congress and to the Comptroller General, although such filing
is not required under the Small Business Regulatory Enforcement
Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801-808,
because, as noted above, this action is an order, not a rule.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
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)(18) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(h) * * *
(18) 3,4-Dichloro-N-[2-(dimethylamino)cyclohexyl]-N- (9547)
methylbenzamide, its isomers, esters, ethers, salts and salts
of isomers, esters and ethers (Other name: U-47700)..........
* * * * *
Dated: November 7, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-27357 Filed 11-10-16; 8:45 am]
BILLING CODE 4410-09-P