Schedules of Controlled Substances: Placement of Butyryl Fentanyl and U-47700 Into Schedule I, 17486-17488 [2018-08280]
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Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Rules and Regulations
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Division, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone: (202) 598–6812.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2018–08138 Filed 4–19–18; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–478]
Schedules of Controlled Substances:
Placement of Butyryl Fentanyl and
U–47700 Into Schedule I
Drug Enforcement
Administration, Department of Justice.
ACTION: Final order.
AGENCY:
With the issuance of this final
order, the Administrator of the Drug
Enforcement Administration maintains
the placement of the substances butyryl
fentanyl (N-(1-phenethylpiperidin-4-yl)N-phenylbutanamide) and U–47700
(3,4-dichloro-N-[2(dimethylamino)cyclohexyl]-Nmethylbenzamide), including their
isomers, esters, ethers, salts, and salts of
isomers, esters and ethers, in schedule
I of the Controlled Substances Act. This
scheduling action discharges the United
States obligations under the Single
Convention on Narcotic Drugs (1961).
This action continues to impose the
regulatory controls and administrative,
civil, and criminal sanctions applicable
to schedule I controlled substances on
persons who handle (manufacture,
distribute, import, export, engage in
research or conduct instructional
activities with, or possess), or propose
to handle, butyryl fentanyl and U–
47700.
DATES: Effective April 20, 2018.
FOR FURTHER INFORMATION CONTACT:
Michael J. Lewis, Diversion Control
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SUMMARY:
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Legal Authority
Section 201(d)(1) of the Controlled
Substances Act (CSA) (21 U.S.C.
811(d)(1)) states that, if control of a
substance is required ‘‘by United States
obligations under international treaties,
conventions, or protocols in effect on
October 27, 1970, the Attorney General
shall issue an order controlling such
drug under the schedule he deems most
appropriate to carry out such
obligations, without regard to the
findings required by section 201 (a) (21
U.S.C. 811 (a) or section 202(b) (21
U.S.C. 812(b)) of the Act and without
regard to the procedures prescribed by
section 201 (a) and (b) (21 U.S.C. 811(a)
and (b).’’ If a substance is added to one
of the schedules of the Single
Convention on Narcotic Drugs (1961),
then, in accordance with article 3,
paragraph 7 of the Convention, as a
signatory Member State, the United
States is obligated to control the
substance under its national drug
control legislation, the CSA. The
Attorney General has delegated
scheduling authority under 21 U.S.C.
811 to the Administrator of the Drug
Enforcement Administration (DEA)
(Administrator). 28 CFR 0.100.
Background
On April 21, 2017, the SecretaryGeneral of the United Nations advised
the Secretary of State of the United
States, that during the 60th session of
the Commission on Narcotic Drugs,
butyryl fentanyl and U–47700 were
added to schedule I of the Single
Convention on Narcotic Drugs, 1961.
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RNAV (GPS) RWY 8, Orig.
VOR RWY 8, Amdt 8A.
RNAV (GPS) RWY 26, Orig.
VOR/DME RWY 16, Amdt 1B.
RNAV (GPS) RWY 16, Orig-B.
RNAV (GPS) RWY 12, Amdt 1.
Takeoff Minimums and Obstacle
DP, Amdt 1.
RNAV (GPS)-D, Amdt 2.
NDB RWY 18, Amdt 5D.
RNAV (GPS) Y RWY 19, Orig.
Takeoff Minimums and Obstacle
DP, Amdt 3.
RNAV (GPS) Z RWY 18R, Amdt
2E.
This letter was prompted by a decision
at the 60th session of the Commission
on Narcotic Drugs in March 2017 to
schedule butyryl fentanyl and U–47700
under schedule I of the Single
Convention on Narcotic Drugs. As a
signatory Member State to the Single
Convention on Narcotic Drugs, the
United States is obligated to control
butyryl fentanyl and U–47700 under its
national drug control legislation, the
CSA, in the schedule deemed most
appropriate to carry out its international
obligations. 21 U.S.C. 811(d)(1).
Butyryl Fentanyl and U–47700
On May 12, 2016, and November 14,
2016, butyryl fentanyl and U–47700,
respectively, were temporarily placed in
schedule I of the CSA by the
Administrator in order to avoid an
imminent hazard to the public safety
((81 FR 29492-butyryl fentanyl) and (81
FR 79389–U–47700)). Butyryl fentanyl
and U–47700 share a pharmacological
profile similar to fentanyl, morphine,
and other synthetic opioids. Law
enforcement and public health reports
demonstrate the illicit use and
distribution of these substances, which
are available on the internet. Both
butyryl fentanyl and U–47700 are
abused for their opioid-like effects.
Evidence suggests the pattern of abuse
of butyryl fentanyl and U–47700
parallels that of heroin and prescription
opioid analgesics. Because both butyryl
fentanyl and U–47700 can be obtained
through illicit sources, information on
their purity and potency is often
unknown, thus posing significant
adverse health risks to the users.
Similar to morphine and fentanyl,
both butyryl fentanyl and U–47700 act
as m-opioid receptor agonists. Data
obtained from preclinical studies (in
vitro and in vivo) demonstrate that
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Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Rules and Regulations
butyryl fentanyl and U–47700 produce
pharmacological effects similar to
fentanyl and morphine. Specifically, in
a drug discrimination study in animals,
a behavioral test used to determine
subjective effect and pharmacological
similarity between a test substance and
a known drug of abuse, butyryl fentanyl
substituted fully for morphine. Further,
data obtained from a drug dependency
study showed that butyryl fentanyl
completely suppressed signs of
withdrawal in morphine-dependent
monkeys. Data obtained from in vivo (in
animal) studies demonstrated that U–
47700, similar to fentanyl and
morphine, produced analgesic effect
and functioned as a m opioid receptor
agonist. Specifically, analgesic activity
of U–47700 was attenuated by
naltrexone, an opioid receptor
antagonist.
Since 2014, butyryl fentanyl has been
associated with numerous incidences of
adverse health effects in humans. The
DEA is aware of at least 40 confirmed
fatalities associated with the misuse
and/or abuse of butyryl fentanyl in the
United States. Similarly, U–47700 has
been associated with numerous cases of
overdoses and overdose deaths.
The DEA is not aware of any claims
or any medical or scientific literature
suggesting that butyryl fentanyl and U–
47700 have a currently accepted
medical use in treatment in the United
States. In addition, HHS advised the
DEA, by letters dated January 13, 2016,
and April 28, 2016, that there were no
investigational new drug applications or
approved new drug applications for
butyryl fentanyl and U–47700.
By letters dated December 8, 2016,
and March 1, 2017, the DEA requested
that HHS conduct a scientific and
medical evaluation of and a scheduling
recommendation for butyryl fentanyl
and U–47700, respectively. The DEA is
not required under 21 U.S.C. 811(d)(1)
to make any findings required by 21
U.S.C. 811(a) or 812(b), and is not
required to follow the procedures
prescribed by 21 U.S.C. 811(a) and (b).
By letter dated November 1, 2017, the
Acting Administrator advised HHS that
the DEA no longer requires scientific
and medical evaluations and scheduling
recommendations for butyryl fentanyl
and U–47700. Therefore, consistent
with the framework of 21 U.S.C. 811(d),
the DEA concludes that butyryl fentanyl
and U–47700 have no currently
accepted medical use in treatment in the
United States and are most
appropriately placed (as they have been
since May 2016 and November 2016,
respectively) in schedule I of the CSA.
Further, while the DEA temporarily
scheduled these substances under 21
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CFR 1308.11(h), a subsection reserved
for the temporary listing of substances
subject to emergency scheduling, this
order moves both substances to 21 CFR
1308.11(b). As explained above, since
control is required under the Single
Convention on Narcotic Drugs (1961),
the DEA will not be initiating regular
rulemaking proceedings to schedule
these substances pursuant to 21 U.S.C.
811(a).
Conclusion
In order to meet the United States’
obligations under the Single Convention
on Narcotic Drugs (1961), and because
butyryl fentanyl and U–47700 have no
currently accepted medical use in
treatment in the United States, the
Administrator has determined that these
substances should remain in schedule I
of the CSA.
Requirements for Handling
Butyryl fentanyl and U–47700 have
been controlled as schedule I controlled
substances since May 12, 2016, and
November 14, 2016, respectively. With
publication of this final order, butyryl
fentanyl and U–47700 remain subject to
the CSA’s schedule I regulatory controls
and administrative, civil, and criminal
sanctions applicable to the manufacture,
distribution, importation, exportation,
engagement in research, and conduct of
instructional activities with, and
possession of schedule I controlled
substances including the following:
1. Registration. Any person who
handles (manufactures, distributes,
imports, exports, engages in research or
conducts instructional activities with, or
possesses), or who desires to handle,
butyryl fentanyl and 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.
2. Disposal of stocks. Butyryl fentanyl
and U–47700 must be disposed of in
accordance with 21 CFR part 1317, in
addition to all other applicable federal,
state, local, and tribal laws.
3. Security. Butyryl fentanyl and U–
47700 are 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.
4. Labeling and packaging. All labels,
labeling, and packaging for commercial
containers of butyryl fentanyl and U–
47700 must be in compliance with 21
U.S.C. 825, 958(e), and be in accordance
with 21 CFR part 1302.
5. Quota. A quota assigned pursuant
to 21 U.S.C. 826 and in accordance with
21 CFR part 1303 is required in order to
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17487
manufacture butyryl fentanyl and U–
47700.
6. Inventory. Every DEA registrant
who possesses any quantity of butyryl
fentanyl and U–47700 were required to
keep an inventory of all stocks of these
substances on hand as of May 12, 2016,
and November 14, 2016, respectively,
pursuant to 21 U.S.C. 827 and 958, and
in accordance with 21 CFR 1304.03,
1304.04, and 1304.11.
7. Records and Reports. Every DEA
registrant must maintain records and
submit reports with respect to butyryl
fentanyl and U–47700 pursuant to 21
U.S.C. 827 and 958, and in accordance
with 21 CFR parts 1304 and 1312.
8. Order Forms. All DEA registrants
who distribute butyryl fentanyl and U–
47700 must comply with order form
requirements pursuant to 21 U.S.C. 828
and in accordance with 21 CFR part
1305.
9. Importation and Exportation. All
importation and exportation of butyryl
fentanyl and U–47700 must be in
compliance with 21 U.S.C. 952, 953,
957, 958, and in accordance with 21
CFR part 1312.
10. Liability. Any activity involving
butyryl fentanyl and U–47700 not
authorized by, or in violation of, the
CSA, is unlawful, and may subject the
person to administrative, civil, and/or
criminal sanctions.
Regulatory Analyses
Executive Order 12866
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).
Executive Order 13132
This action does not have federalism
implications warranting the application
of Executive Order 13132. This action
does 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.
Executive Order 13175
This action does not have tribal
implications warranting the application
of Executive Order 13175. The action
does not have substantial direct effects
on one or more Indian tribes, on the
relationship between the Federal
government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
government and Indian tribes.
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Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Rules and Regulations
Administrative Procedure Act
The CSA provides for an expedited
scheduling action where control is
required by the United States
obligations under international treaties,
conventions, or protocols. 21 U.S.C.
811(d)(1). If control is required pursuant
to such international treaty, convention,
or protocol, the Attorney General must
issue an order controlling such drug
under the schedule he deems most
appropriate to carry out such
obligations, without regard to the
findings or procedures otherwise
required for scheduling actions. Id.
To the extent that 21 U.S.C. 811(d)(1)
directs that if control is required by the
United States obligations under
international treaties, conventions, or
protocols in effect on October 27, 1970,
scheduling actions shall be issued by
order (as compared to scheduling
pursuant to 21 U.S.C. 811(a) by rule),
the DEA believes that the notice and
comment requirements of section 553 of
the Administrative Procedure Act
(APA), 5 U.S.C. 553, do not apply to this
scheduling action. In the alternative,
even if this action does constitute ‘‘rule
making’’ under 5 U.S.C. 551(5), this
action is exempt from the notice and
comment requirements of 5 U.S.C. 553
pursuant to 21 U.S.C. 553(a)(1) as an
action involving a foreign affairs
function of the United States given that
this action is being done in accordance
with 21 U.S.C. 811(d)(1)’s requirement
that the United States comply with its
obligations under the specified
international agreements.
Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA)
(5 U.S.C. 601–612) applies to rules that
are subject to notice and comment
under section 553(b) of the APA or any
other law. As explained above, the CSA
exempts this final order from notice and
comment. Consequently, the RFA does
not apply to this action.
sradovich on DSK3GMQ082PROD with RULES
Paperwork Reduction Act of 1995
This action does not impose a new
collection of information requirement
under the Paperwork Reduction Act of
1995. 44 U.S.C. 3501–3521. An agency
may not conduct or sponsor, and a
person is not required to respond to, a
collection of information unless it
displays a currently valid OMB control
number.
Congressional Review Act
This action is not a major rule as
defined by section 804 of the Small
Business Regulatory Enforcement
Fairness Act of 1996 (Congressional
Review Act (CRA)). This order will not
result in: ‘‘an annual effect on the
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economy of $100,000,000 or more; a
major increase in costs or prices for
consumers, individual industries,
Federal, State, or local government
agencies, or geographic regions; or
significant adverse effects on
competition, employment, investment,
productivity, innovation, or on the
ability of United States-based
enterprises to compete with foreignbased enterprises in domestic and
export markets.’’ However, pursuant to
the CRA, the DEA has submitted a copy
of this final order to both Houses of
Congress and to the Comptroller
General.
List of Subjects in 21 CFR Part 1308
For the reasons set out above, the DEA
amends 21 CFR part 1308 as follows:
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
1. The authority citation for part 1308
continues to read as follows:
■
Authority: 21 U.S.C. 811, 812, 871(b),
956(b), unless otherwise noted.
2. In § 1308.11:
a. Redesignate paragraphs (b)(18)
through (58) as (b)(19) through (59) and
add a new paragraph (b)(18);
■ b. Add paragraph (b)(60); and
■ c. Remove and reserve paragraphs
(h)(2) and (4).
The additions read as follows:
■
■
*
Schedule I.
*
*
(b) * * *
*
*
(18)
Butyryl
fentanyl
(N-(1phenethylpiperidin-4-yl)-Nphenylbutyramide) .......................
*
*
*
*
9822
*
(60) U–47700 (3,4-Dichloro-N-[2(dimethylamino)cyclohexyl]-Nmethylbenzamide) .......................
*
*
*
*
9547
*
Dated: April 11, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018–08280 Filed 4–19–18; 8:45 am]
BILLING CODE 4410–09–P
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22 CFR Part 172
[Public Notice: 10248]
RIN 1400–AE49
Service of Process; Production or
Disclosure of Official Information in
Response to Court Orders,
Subpoenas, Notices of Depositions,
Requests for Admissions,
Interrogatories, or Similar Requests or
Demands in Connection With Federal
or State Litigation; Expert Testimony
Department of State.
Final rule.
AGENCY:
ACTION:
The Department of State
corrects erroneous citations and
typographical errors within part 172 by
correcting or removing them.
DATES: This rule is effective on May 21,
2018.
FOR FURTHER INFORMATION CONTACT:
Alice Kottmyer, Attorney-Adviser, 202–
647–2318, kottmyeram@state.gov.
SUPPLEMENTARY INFORMATION: Section
172 of Title 22, Code of Federal
Regulations, describes procedures for
the public to follow to request testimony
or production of documents for
litigation (so-called ‘‘Touhy requests’’).
See United States ex rel. Touhy v.
Ragen, 340 U.S. 462 (1951).
In this rulemaking, the Department is
replacing the reference to Executive
Order 12356 in the first sentence of
§ 172.1(e) to instead reference Executive
Order 13526 (75 FR 707), the most
recent executive order relating to
classified national security information.
Executive Order 12356 was revoked by
Executive Order 12958, which in turn
was revoked by Executive Order 13526.
The Department also corrects a
typographical error in § 172.2(c) so that
the first sentence references § 172.3(c)
instead of § 173.3(c). Section 173.3(c)
has no connection to service of process,
whereas § 172.3(c) relates directly to
service of process.
The Department deletes the following
sentence in § 172.5(a): ‘‘Where
documents or other materials are
sought, the party should provide a
description using the types of
identifying information suggested in 22
CFR 171.10(a) and 171.31.’’ The two
citations are not valid, and are likely
artifacts from Part 172 as it existed in
the past. The Department does not
believe it is necessary to provide
alternative citations. First, there are no
analogs in the current regulation for the
old §§ 171.10(a) or 171.31. Second,
since the sentence immediately
preceding the eliminated sentence calls
SUMMARY:
Administrative practice and
procedure, Drug traffic control,
Reporting and recordkeeping
requirements.
§ 1308.11
DEPARTMENT OF STATE
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]]>Agencies
[Federal Register Volume 83, Number 77 (Friday, April 20, 2018)]
[Rules and Regulations]
[Pages 17486-17488]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08280]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-478]
Schedules of Controlled Substances: Placement of Butyryl Fentanyl
and U-47700 Into Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: With the issuance of this final order, the Administrator of
the Drug Enforcement Administration maintains the placement of the
substances butyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-
phenylbutanamide) and U-47700 (3,4-dichloro-N-[2-
(dimethylamino)cyclohexyl]-N-methylbenzamide), including their isomers,
esters, ethers, salts, and salts of isomers, esters and ethers, in
schedule I of the Controlled Substances Act. This scheduling action
discharges the United States obligations under the Single Convention on
Narcotic Drugs (1961). This action continues to impose the regulatory
controls and administrative, civil, and criminal sanctions applicable
to schedule I controlled substances on persons who handle (manufacture,
distribute, import, export, engage in research or conduct instructional
activities with, or possess), or propose to handle, butyryl fentanyl
and U-47700.
DATES: Effective April 20, 2018.
FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control
Division, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.
SUPPLEMENTARY INFORMATION:
Legal Authority
Section 201(d)(1) of the Controlled Substances Act (CSA) (21 U.S.C.
811(d)(1)) states that, if control of a substance is required ``by
United States obligations under international treaties, conventions, or
protocols in effect on October 27, 1970, the Attorney General shall
issue an order controlling such drug under the schedule he deems most
appropriate to carry out such obligations, without regard to the
findings required by section 201 (a) (21 U.S.C. 811 (a) or section
202(b) (21 U.S.C. 812(b)) of the Act and without regard to the
procedures prescribed by section 201 (a) and (b) (21 U.S.C. 811(a) and
(b).'' If a substance is added to one of the schedules of the Single
Convention on Narcotic Drugs (1961), then, in accordance with article
3, paragraph 7 of the Convention, as a signatory Member State, the
United States is obligated to control the substance under its national
drug control legislation, the CSA. The Attorney General has delegated
scheduling authority under 21 U.S.C. 811 to the Administrator of the
Drug Enforcement Administration (DEA) (Administrator). 28 CFR 0.100.
Background
On April 21, 2017, the Secretary-General of the United Nations
advised the Secretary of State of the United States, that during the
60th session of the Commission on Narcotic Drugs, butyryl fentanyl and
U-47700 were added to schedule I of the Single Convention on Narcotic
Drugs, 1961. This letter was prompted by a decision at the 60th session
of the Commission on Narcotic Drugs in March 2017 to schedule butyryl
fentanyl and U-47700 under schedule I of the Single Convention on
Narcotic Drugs. As a signatory Member State to the Single Convention on
Narcotic Drugs, the United States is obligated to control butyryl
fentanyl and U-47700 under its national drug control legislation, the
CSA, in the schedule deemed most appropriate to carry out its
international obligations. 21 U.S.C. 811(d)(1).
Butyryl Fentanyl and U-47700
On May 12, 2016, and November 14, 2016, butyryl fentanyl and U-
47700, respectively, were temporarily placed in schedule I of the CSA
by the Administrator in order to avoid an imminent hazard to the public
safety ((81 FR 29492-butyryl fentanyl) and (81 FR 79389-U-47700)).
Butyryl fentanyl and U-47700 share a pharmacological profile similar to
fentanyl, morphine, and other synthetic opioids. Law enforcement and
public health reports demonstrate the illicit use and distribution of
these substances, which are available on the internet. Both butyryl
fentanyl and U-47700 are abused for their opioid-like effects. Evidence
suggests the pattern of abuse of butyryl fentanyl and U-47700 parallels
that of heroin and prescription opioid analgesics. Because both butyryl
fentanyl and U-47700 can be obtained through illicit sources,
information on their purity and potency is often unknown, thus posing
significant adverse health risks to the users.
Similar to morphine and fentanyl, both butyryl fentanyl and U-47700
act as [micro]-opioid receptor agonists. Data obtained from preclinical
studies (in vitro and in vivo) demonstrate that
[[Page 17487]]
butyryl fentanyl and U-47700 produce pharmacological effects similar to
fentanyl and morphine. Specifically, in a drug discrimination study in
animals, a behavioral test used to determine subjective effect and
pharmacological similarity between a test substance and a known drug of
abuse, butyryl fentanyl substituted fully for morphine. Further, data
obtained from a drug dependency study showed that butyryl fentanyl
completely suppressed signs of withdrawal in morphine-dependent
monkeys. Data obtained from in vivo (in animal) studies demonstrated
that U-47700, similar to fentanyl and morphine, produced analgesic
effect and functioned as a [mu] opioid receptor agonist. Specifically,
analgesic activity of U-47700 was attenuated by naltrexone, an opioid
receptor antagonist.
Since 2014, butyryl fentanyl has been associated with numerous
incidences of adverse health effects in humans. The DEA is aware of at
least 40 confirmed fatalities associated with the misuse and/or abuse
of butyryl fentanyl in the United States. Similarly, U-47700 has been
associated with numerous cases of overdoses and overdose deaths.
The DEA is not aware of any claims or any medical or scientific
literature suggesting that butyryl fentanyl and U-47700 have a
currently accepted medical use in treatment in the United States. In
addition, HHS advised the DEA, by letters dated January 13, 2016, and
April 28, 2016, that there were no investigational new drug
applications or approved new drug applications for butyryl fentanyl and
U-47700.
By letters dated December 8, 2016, and March 1, 2017, the DEA
requested that HHS conduct a scientific and medical evaluation of and a
scheduling recommendation for butyryl fentanyl and U-47700,
respectively. The DEA is not required under 21 U.S.C. 811(d)(1) to make
any findings required by 21 U.S.C. 811(a) or 812(b), and is not
required to follow the procedures prescribed by 21 U.S.C. 811(a) and
(b). By letter dated November 1, 2017, the Acting Administrator advised
HHS that the DEA no longer requires scientific and medical evaluations
and scheduling recommendations for butyryl fentanyl and U-47700.
Therefore, consistent with the framework of 21 U.S.C. 811(d), the DEA
concludes that butyryl fentanyl and U-47700 have no currently accepted
medical use in treatment in the United States and are most
appropriately placed (as they have been since May 2016 and November
2016, respectively) in schedule I of the CSA. Further, while the DEA
temporarily scheduled these substances under 21 CFR 1308.11(h), a
subsection reserved for the temporary listing of substances subject to
emergency scheduling, this order moves both substances to 21 CFR
1308.11(b). As explained above, since control is required under the
Single Convention on Narcotic Drugs (1961), the DEA will not be
initiating regular rulemaking proceedings to schedule these substances
pursuant to 21 U.S.C. 811(a).
Conclusion
In order to meet the United States' obligations under the Single
Convention on Narcotic Drugs (1961), and because butyryl fentanyl and
U-47700 have no currently accepted medical use in treatment in the
United States, the Administrator has determined that these substances
should remain in schedule I of the CSA.
Requirements for Handling
Butyryl fentanyl and U-47700 have been controlled as schedule I
controlled substances since May 12, 2016, and November 14, 2016,
respectively. With publication of this final order, butyryl fentanyl
and U-47700 remain subject to the CSA's schedule I regulatory controls
and administrative, civil, and criminal sanctions applicable to the
manufacture, distribution, importation, exportation, engagement in
research, and conduct of instructional activities with, and possession
of schedule I controlled substances including the following:
1. Registration. Any person who handles (manufactures, distributes,
imports, exports, engages in research or conducts instructional
activities with, or possesses), or who desires to handle, butyryl
fentanyl and 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.
2. Disposal of stocks. Butyryl fentanyl and U-47700 must be
disposed of in accordance with 21 CFR part 1317, in addition to all
other applicable federal, state, local, and tribal laws.
3. Security. Butyryl fentanyl and U-47700 are 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.
4. Labeling and packaging. All labels, labeling, and packaging for
commercial containers of butyryl fentanyl and U-47700 must be in
compliance with 21 U.S.C. 825, 958(e), and be in accordance with 21 CFR
part 1302.
5. Quota. A quota assigned pursuant to 21 U.S.C. 826 and in
accordance with 21 CFR part 1303 is required in order to manufacture
butyryl fentanyl and U-47700.
6. Inventory. Every DEA registrant who possesses any quantity of
butyryl fentanyl and U-47700 were required to keep an inventory of all
stocks of these substances on hand as of May 12, 2016, and November 14,
2016, respectively, pursuant to 21 U.S.C. 827 and 958, and in
accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
7. Records and Reports. Every DEA registrant must maintain records
and submit reports with respect to butyryl fentanyl and U-47700
pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR parts
1304 and 1312.
8. Order Forms. All DEA registrants who distribute butyryl fentanyl
and U-47700 must comply with order form requirements pursuant to 21
U.S.C. 828 and in accordance with 21 CFR part 1305.
9. Importation and Exportation. All importation and exportation of
butyryl fentanyl and U-47700 must be in compliance with 21 U.S.C. 952,
953, 957, 958, and in accordance with 21 CFR part 1312.
10. Liability. Any activity involving butyryl fentanyl and U-47700
not authorized by, or in violation of, the CSA, is unlawful, and may
subject the person to administrative, civil, and/or criminal sanctions.
Regulatory Analyses
Executive Order 12866
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).
Executive Order 13132
This action does not have federalism implications warranting the
application of Executive Order 13132. This action does 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.
Executive Order 13175
This action does not have tribal implications warranting the
application of Executive Order 13175. The action does not have
substantial direct effects on one or more Indian tribes, on the
relationship between the Federal government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
government and Indian tribes.
[[Page 17488]]
Administrative Procedure Act
The CSA provides for an expedited scheduling action where control
is required by the United States obligations under international
treaties, conventions, or protocols. 21 U.S.C. 811(d)(1). If control is
required pursuant to such international treaty, convention, or
protocol, the Attorney General must issue an order controlling such
drug under the schedule he deems most appropriate to carry out such
obligations, without regard to the findings or procedures otherwise
required for scheduling actions. Id.
To the extent that 21 U.S.C. 811(d)(1) directs that if control is
required by the United States obligations under international treaties,
conventions, or protocols in effect on October 27, 1970, scheduling
actions shall be issued by order (as compared to scheduling pursuant to
21 U.S.C. 811(a) by rule), the DEA believes that the notice and comment
requirements of section 553 of the Administrative Procedure Act (APA),
5 U.S.C. 553, do not apply to this scheduling action. In the
alternative, even if this action does constitute ``rule making'' under
5 U.S.C. 551(5), this action is exempt from the notice and comment
requirements of 5 U.S.C. 553 pursuant to 21 U.S.C. 553(a)(1) as an
action involving a foreign affairs function of the United States given
that this action is being done in accordance with 21 U.S.C. 811(d)(1)'s
requirement that the United States comply with its obligations under
the specified international agreements.
Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to
rules that are subject to notice and comment under section 553(b) of
the APA or any other law. As explained above, the CSA exempts this
final order from notice and comment. Consequently, the RFA does not
apply to this action.
Paperwork Reduction Act of 1995
This action does not impose a new collection of information
requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-
3521. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.
Congressional Review Act
This action is not a major rule as defined by section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996
(Congressional Review Act (CRA)). This order will not result in: ``an
annual effect on the economy of $100,000,000 or more; a major increase
in costs or prices for consumers, individual industries, Federal,
State, or local government agencies, or geographic regions; or
significant adverse effects on competition, employment, investment,
productivity, innovation, or on the ability of United States-based
enterprises to compete with foreign-based enterprises in domestic and
export markets.'' However, pursuant to the CRA, the DEA has submitted a
copy of this final order to both Houses of Congress and to the
Comptroller General.
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), 956(b), unless otherwise
noted.
0
2. In Sec. 1308.11:
0
a. Redesignate paragraphs (b)(18) through (58) as (b)(19) through (59)
and add a new paragraph (b)(18);
0
b. Add paragraph (b)(60); and
0
c. Remove and reserve paragraphs (h)(2) and (4).
The additions read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(b) * * *
------------------------------------------------------------------------
------------------------------------------------------------------------
(18) Butyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- 9822
phenylbutyramide)......................................
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
------------------------------------------------------------------------
(60) U-47700 (3,4-Dichloro-N-[2- 9547
(dimethylamino)cyclohexyl]-N-methylbenzamide)..........
------------------------------------------------------------------------
* * * * *
Dated: April 11, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-08280 Filed 4-19-18; 8:45 am]
BILLING CODE 4410-09-P
