Schedules of Controlled Substances: Placement of Oliceridine in Schedule II, 30772-30775 [2021-11981]
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Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Rules and Regulations
contains a stage 7 port, P/N 2614M30P01,
with a port casting serial number (S/N) listed
in Table 1 in Planning Information,
Paragraph 3.A., of CFM Service Bulletin (SB)
LEAP–1A–72–00–0421–01A–930A–D, Issue
001, dated October 22, 2020.
(d) Subject
Joint Aircraft System Component (JASC)
Code 7250, Turbine Section.
(e) Unsafe Condition
This AD was prompted by a report of a
manufacturing quality escape found during
inspection of an HPT case. The FAA is
issuing this AD to prevent failure of the HPT
case. The unsafe condition, if not addressed,
could result in failure of the HPT case,
uncontained rotor release, damage to the
engine, and damage to the airplane.
(f) Compliance
Comply with this AD within the
compliance times specified, unless already
done.
(g) Required Actions
Before the HPT case exceeds the cycles
since new limit in Table 1, Planning
Information, Paragraph 3.A., of CFM SB
LEAP–1A–72–00–0421–01A–930A–D, Issue
001, dated October 22, 2020, or during the
next piece part exposure, whichever occurs
first after the effective date of this AD,
remove the affected HPT case from service
and replace with a part eligible for
installation.
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(h) Definitions
For the purpose of this AD:
(1) A part eligible for installation is an HPT
case, P/N 2668M94G01, that contains a stage
7 port, P/N 2614M30P01, with an S/N that
is not listed in Table 1 in Planning
Information, Paragraph 3.A., of CFM SB
LEAP–1A–72–00–0421–01A–930A–D, Issue
001, dated October 22, 2020.
(2) Piece-part exposure is when the HPT
case is removed from the engine and fully
disassembled.
(i) Alternative Methods of Compliance
(AMOCs)
(1) The Manager, ECO Branch, 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 certification office,
send it to the attention of the person
identified in Related Information. You may
email your request to: ANE-AD-AMOC@
faa.gov.
(2) Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the local flight standards district office/
certificate holding district office.
(j) Related Information
For more information about this AD,
contact Christopher McGuire, Aviation Safety
Engineer, ECO Branch, FAA, 1200 District
Avenue, Burlington, MA 01803; phone: (781)
238–7120; fax: (781) 238–7199; email:
Chris.McGuire@faa.gov.
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(k) Material Incorporated by Reference
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(2) You must use this service information
as applicable to do the actions required by
this AD, unless the AD specifies otherwise.
(i) CFM Service Bulletin LEAP–1A–72–00–
0421–01A–930A–D, Issue 001, dated October
22, 2020.
(ii) [Reserved]
(3) For CFM service information identified
in this AD, contact CFM International, S.A.,
Aviation Operations Center, 1 Neumann
Way, M/D Room 285, Cincinnati, OH 45125;
phone: (877) 432–3272; email:
aviation.fleetsupport@ge.com.
(4) You may view this service information
at FAA, Airworthiness Products Section,
Operational Safety Branch, 1200 District
Avenue, Burlington, MA 01803. For
information on the availability of this
material at the FAA, call (781) 238–7759.
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email: fedreg.legal@nara.gov, or go to:
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ibr-locations.html.
Issued on May 21, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2021–12137 Filed 6–9–21; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–715]
Schedules of Controlled Substances:
Placement of Oliceridine in Schedule II
Drug Enforcement
Administration, Department of Justice.
ACTION: Final rule.
AGENCY:
This final rule adopts, with a
change as mentioned below, an interim
final rule with request for comments
published in the Federal Register on
October 30, 2020, placing oliceridine, N[(3-methoxythiophen-2-yl)methyl]({2[(9R)-9-(pyridin-2-yl)-6oxaspiro[4.5]decan-9-yl]ethyl})amine
fumarate, including its isomers, esters,
ethers, salts and salts of isomers, esters
and ethers whenever the existence of
such isomers, esters, ethers and salts is
possible, in schedule II of the Controlled
Substances Act. In response to an error
in the chemical name of oliceridine as
noted by one of the commenters to the
interim final rule, the Drug Enforcement
SUMMARY:
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Administration makes a correction to
the above mentioned chemical name of
oliceridine by removing the word
‘‘fumarate’’ to read as N-[(3methoxythiophen-2-yl)methyl]({2-[(9R)9-(pyridin-2-yl)-6-oxaspiro[4.5]decan-9yl]ethyl}amine. This change clarifies the
control of oliceridine free base and its
salts, to include the fumarate salt, by
definition.
DATES: Effective July 12, 2021.
FOR FURTHER INFORMATION CONTACT: Dr.
Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control
Division, Drug Enforcement
Administration; Telephone: (571) 362–
3249.
SUPPLEMENTARY INFORMATION:
Background and Legal Authority
On October 30, 2020, the Drug
Enforcement Administration (DEA),
pursuant to 21 U.S.C. 811(j), published
an interim final rule (IFR) to place
oliceridine (including its isomers,
esters, ethers, salts and salts of isomers,
esters and ethers whenever the
existence of such isomers, esters, ethers
and salts is possible), a medication
approved recently by the Food and Drug
Administration (FDA) for medical use as
an intravenous drug for the management
of acute pain severe enough to require
an intravenous opioid analgesic and for
patients for whom alternative treatments
are inadequate, in schedule II of the
Controlled Substances Act (CSA). 85 FR
68749. The IFR provided an opportunity
for interested persons to submit
comments, as well as file a request for
hearing or waiver of hearing, on or
before November 30, 2020. DEA
received three comments and did not
receive any requests for hearing or
waiver of hearing.
Comments Received
In response to the IFR, DEA received
three comments. The submissions were
from individuals or anonymous
commenters. One commenter suggested
that oliceridine be placed in schedule III
rather than schedule II, one commenter
had a statement on the controlled name,
and the third commenter discussed
another substance entirely that was
unrelated to oliceridine. As such, the
third comment was outside the scope of
this current scheduling action.
Comment: One commenter suggested
that oliceridine be placed in schedule III
of the CSA, rather than schedule II. The
commenter mentioned that placement of
oliceridine in schedule II will limit its
medical applications and limit access to
the drug due to schedule II
manufacturing quotas. The commenter
stated that oliceridine has the potential
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to revolutionize gastrointestinal
endoscopy because it does not cause
respiratory depression. Lastly, the
commenter stated that since oliceridine
is not indicated for home-use, abuse of
the medication by drug users would be
difficult.
DEA Response: DEA notes that FDA
approved a New Drug Application
(NDA) for oliceridine and provided DEA
with a scheduling recommendation for
oliceridine. The scheduling
recommendation by Health and Human
Services (HHS) and their notification to
DEA regarding the FDA approval of the
NDA initiated the DEA review and
scheduling action. As stated in the IFR,
after careful consideration of data from
preclinical and clinical studies, DEA
concurred with the HHS
recommendation that oliceridine has
abuse potential comparable to other
schedule II opioids and therefore
supported—and continues to support
through this final rule—placement of
oliceridine in schedule II under the
CSA. Contrary to the commenter’s
opinion about schedule II controls on a
drug limiting its medical applications
and access due to manufacturing quota
requirements, DEA notes that currently
several schedule II drugs (oxycodone,
hydrocodone etc.) are extensively
prescribed and used in medical practice.
Comment: One commenter stated that
the chemical name provided in the
interim final rule indicates oliceridine is
‘‘N-[(3-methoxythiophen-2yl)methyl]({2-[(9R)-9-(pyridin-2-yl)-6oxaspiro[4.5]decan-9-yl]ethyl})amine
fumarate’’, though this is the name of
the fumarate salt of oliceridine. The
commenter noted that the other
substances listed in 21 CFR 1308.12,
and in most other sections of the CSA
list only the base form of the drug, and
control salts by definition. The
commenter suggested to provide the
chemical name for oliceridine base, and
the fumarate salt would be controlled
under the preamble in 12 CFR 1308.12.
DEA Response: DEA agrees with
commenter regarding the error in the
chemical name of oliceridine and
corrects appropriately by removing the
word ‘‘fumarate’’ to read oliceridine as,
N-[(3-methoxythiophen-2-yl)methyl]({2[(9R)-9-(pyridin-2-yl)-6oxaspiro[4.5]decan-9-yl]ethyl})amine.
The correction will make clear precisely
which substance is being controlled
because the fumarate salt was not the
accurate designation for the controlled
substance. The listing of the base form
and removal of the salt designation is
consistent with other controlled
substance listings under the CFR and
the substance designated for control
remains unchanged. The base form
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listing minus the salt designation
(‘‘fumarate’’) is readily understood by
those registered to handle the substance
and would not be misunderstood by the
public. For this reason, DEA believes
the change will not have an impact.
Based on the rationale set forth in the
interim final rule, DEA adopts the IFR,
with the above mentioned correction to
the chemical name of oliceridine.
Requirements for Handling Oliceridine
As indicated above, oliceridine has
been a schedule II controlled substance
by virtue of an IFR issued by DEA in
October 2020. Thus, this final rule does
not alter the regulatory requirements
applicable to handlers of oliceridine
that have been in place since that time.
Nonetheless, for informational
purposes, we restate here those
requirements. Oliceridine is subject to
the CSA’s schedule II regulatory
controls and administrative, civil, and
criminal sanctions applicable to the
manufacture, distribution, reverse
distribution, dispensing, importing,
exporting, research, and conduct of
instructional activities and chemical
analysis with, and possession involving
schedule II substances, including the
following:
1. Registration. Any person who
handles (manufactures, distributes,
reverse distributes, dispenses, imports,
exports, engages in research, or
conducts instructional activities or
chemical analysis with, or possesses)
oliceridine, or who desires to handle
oliceridine, must be registered with
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. Any person who currently
handles or intends to handle
oliceridine, and is not registered with
DEA, must submit an application for
registration and may not continue to
handle oliceridine, unless DEA has
approved the application for
registration, pursuant to 21 U.S.C. 822,
823, 957, and 958, and in accordance
with 21 CFR parts 1301 and 1312. These
registration requirements, however, are
not applicable to patients (end users)
who possess oliceridine pursuant to a
lawful prescription.
2. Quota. Only registered
manufacturers are permitted to
manufacture oliceridine in accordance
with a quota assigned pursuant to 21
U.S.C. 826 and in accordance with 21
CFR part 1303.
3. Disposal of stocks. Any person who
does not desire or is not able to
maintain a schedule II registration must
surrender all quantities of currently
held oliceridine, or may transfer all
quantities of currently held oliceridine
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to a person registered with DEA in
accordance with 21 CFR part 1317, in
addition to all other applicable Federal,
State, local, and tribal laws.
4. Security. Oliceridine is subject to
schedule II security requirements and
must be handled and stored pursuant to
21 U.S.C. 821 and 823 and in
accordance with 21 CFR 1301.71–
1301.93. Non-practitioners handling
oliceridine must also comply with the
employee screening requirements of 21
CFR 1301.90–1301.93.
5. Labeling and Packaging. All labels,
labeling, and packaging for commercial
containers of oliceridine must comply
with 21 U.S.C. 825 and 958(e) and be in
accordance with 21 CFR part 1302.
6. Inventory. Every DEA registrant
who possesses any quantity of
oliceridine must take an inventory of
oliceridine on hand, pursuant to 21
U.S.C. 827 and 958(e), and in
accordance with 21 CFR 1304.03,
1304.04, and 1304.11.
Any person who becomes registered
with DEA to handle oliceridine must
take an initial inventory of all stocks of
controlled substances containing
oliceridine on hand on the date the
registrant first engages in the handling
of controlled substances, pursuant to 21
U.S.C. 827 and 958(e), and in
accordance with 21 CFR 1304.03,
1304.04, and 1304.11.
After the initial inventory, every DEA
registrant must take a new inventory of
all stocks of controlled substances
(including oliceridine) on hand every
two years, pursuant to 21 U.S.C. 827
and 958(e), and in accordance with 21
CFR 1304.03, 1304.04, and 1304.11.
7. Records and Reports. DEA
registrants must maintain records and
submit reports for oliceridine, pursuant
to 21 U.S.C. 827 and 958(e), and in
accordance with 21 CFR parts 1304,
1312, and 1317.
8. Orders for oliceridine. Every DEA
registrant who distributes oliceridine is
required to comply with order form
requirements, pursuant to 21 U.S.C. 828,
and in accordance with 21 CFR part
1305.
9. Prescriptions. All prescriptions for
oliceridine or products containing
oliceridine must comply with 21 U.S.C.
829, and be issued in accordance with
21 CFR parts 1306 and 1311, subpart C.
10. Manufacturing and Distributing.
In addition to the general requirements
of the CSA and DEA regulations that are
applicable to manufacturers and
distributors of schedule II controlled
substances, such registrants should be
advised that (consistent with the
foregoing considerations) any
manufacturing or distribution of
oliceridine may only be for the
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Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Rules and Regulations
legitimate purposes consistent with the
drug’s labeling, or for research activities
authorized by the Federal Food, Drug,
and Cosmetic Act, as applicable, and the
CSA.
11. Importation and Exportation. All
importation and exportation of
oliceridine must be in compliance with
21 U.S.C. 952, 953, 957, and 958, and
in accordance with 21 CFR part 1312.
12. Liability. Any activity involving
oliceridine not authorized by, or in
violation of, the CSA or its
implementing regulations, is unlawful,
and may subject the person to
administrative, civil, and/or criminal
sanctions.
Regulatory Analyses
Administrative Procedure Act
This final rule, with a correction in
the chemical name of oliceridine as
discussed above, affirms the amendment
made by the IFR that is already in effect.
Section 553 of the Administrative
Procedure Act (APA) (5 U.S.C. 553)
generally requires notice and comment
for rulemaking. However, 21 U.S.C.
811(j) provides that in cases where a
certain new drug is: (1) Approved by
HHS and (2) HHS recommends control
in CSA schedule II–V, DEA shall issue
an IFR scheduling the drug within 90
days. Additionally, subsection (j)
specifies that the rulemaking shall
become immediately effective as an
interim final rule without requiring DEA
to demonstrate good cause. DEA issued
an IFR on October 30, 2020, and
solicited public comments on that rule.
Subsection (j) further provides that after
giving interested persons the
opportunity to comment and to request
a hearing, the Attorney General, as
delegated to the Administrator of DEA,
shall issue a final rule in accordance
with the scheduling criteria of 21 U.S.C.
811(b) through (d) and 812(b). DEA is
now responding to the comments
submitted by the public and issuing the
final rule, in conformity with the APA
and the procedure required by 21 U.S.C.
811.
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Executive Orders 12866 (Regulatory
Planning and Review) and 13563
(Improving Regulation and Regulatory
Review)
In accordance with 21 U.S.C. 811(a)
and (j), this scheduling action is subject
to formal rulemaking procedures
performed ‘‘on the record after
opportunity for a hearing,’’ which are
conducted pursuant to the provisions of
5 U.S.C. 556 and 557. The CSA sets
forth the procedures and criteria for
scheduling a drug or other substance.
Such actions are exempt from review by
the Office of Management and Budget
(OMB) pursuant to section 3(d)(1) of
Executive Order (E.O.)12866 and the
principles reaffirmed in E.O. 13563.
Executive Order 12988, Civil Justice
Reform
This regulation meets the applicable
standards set forth in sections 3(a) and
3(b)(2) of E.O. 12988 to eliminate
drafting errors and ambiguity, minimize
litigation, provide a clear legal standard
for affected conduct, and promote
simplification and burden reduction.
Executive Order 13132, Federalism
This rulemaking does not have
federalism implications warranting the
application of E.O. 13132. The rule 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, Consultation
and Coordination With Indian Tribal
Governments
This rule does not have tribal
implications warranting the application
of E.O. 13175. It 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.
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. Under
21 U.S.C. 811(j), DEA is not required to
publish a general notice of proposed
rulemaking. Consequently, the RFA
does not apply.
2 U.S.C. 1501 et seq., DEA has
determined that this action would not
result in any Federal mandate that may
result ‘‘in the expenditure by State,
local, and tribal governments, in the
aggregate, or by the private sector, of
$100 million or more (adjusted for
inflation) in any one year.’’ Therefore,
neither a Small Government Agency
Plan nor any other action is required
under UMRA of 1995.
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. This action
does not impose recordkeeping or
reporting requirements on State or local
governments, individuals, businesses, or
organizations. 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 rule is not a major rule as
defined by the Congressional Review
Act (CRA), 5 U.S.C. 804. However,
pursuant to the CRA, DEA is submitting
a copy of this final rule 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.
Accordingly, the interim final rule
amending 21 CFR part 1308, which
published on October 30, 2020 (85 FR
68749), is adopted as a final rule with
the following amendment:
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. Amend § 1308.12 by revising
paragraph (c)(18) to read as follows:
■
Unfunded Mandates Reform Act of 1995
§ 1308.12
In accordance with the Unfunded
Mandates Reform Act (UMRA) of 1995,
*
Schedule II.
*
*
(c) * * *
*
*
(18) Oliceridine (N-[(3-methoxythiophen-2-yl)methyl]({2-[(9R)-9-(pyridin-2-yl)-6-oxaspiro[4.5]decan-9-yl]ethyl})amine) ....................
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Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Rules and Regulations
*
*
*
*
• 1-(4-cyanobutyl)-N-(2phenylpropan-2-yl)-1H-indazole-3carboxamide (other names: 4-CNCUMYL-BUTINACA, 4-cyano-CUMYLBUTINACA; 4-CN-CUMYL BINACA,
CUMYL-4CN-BINACA, or SGT-78),
• methyl 2-(1-(cyclohexylmethyl)-1Hindole-3-carboxamido)-3methylbutanoate (other names: MMBCHMICA or AMB-CHMICA), and
• 1-(5-fluoropentyl)-N-(2phenylpropan-2-yl)-1H-pyrrolo[2,3b]pyridine-3-carboxamide (other name:
5F-CUMYL-P7AICA).
*
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021–11981 Filed 6–9–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–479]
Schedules of Controlled Substances:
Placement of NM2201, 5F-AB-PINACA,
4-CN-CUMYL-BUTINACA, MMBCHMICA, and 5F-CUMYL-P7AICA in
Schedule I
Drug Enforcement
Administration, Department of Justice.
ACTION: Final rule.
AGENCY:
By this rule, the Drug
Enforcement Administration
permanently places five synthetic
cannabinoids, as identified in this final
rule, in schedule I of the Controlled
Substances Act. These five substances
are currently listed in Schedule I
pursuant to a temporary scheduling
order. As a result of this rule, 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, conduct instructional
activities or chemical analysis, or
possess), or propose to handle these five
specified controlled substances will
continue to apply.
DATES: Effective June 10, 2021.
FOR FURTHER INFORMATION CONTACT:
Terrence L. Boos, Drug & Chemical
Evaluation Section, Diversion Control
Division, Drug Enforcement
Administration; Telephone: (571) 362–
3249.
SUMMARY:
In this
final rule, the Drug Enforcement
Administration (DEA) is permanently
scheduling the following five controlled
substances in schedule I of the
Controlled Substances Act (CSA),
including their salts, isomers, and salts
of isomers whenever the existence of
such salts, isomers, and salts of isomers
is possible:
• naphthalen-1-yl 1-(5-fluoropentyl)1H-indole-3-carboxylate (other names:
NM2201 or CBL2201),
• N-(1-amino-3-methyl-1-oxobutan-2yl)-1-(5-fluoropentyl)-1H-indazole-3carboxamide (other name: 5F–ABPINACA),
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SUPPLEMENTARY INFORMATION:
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Legal Authority
The CSA provides that issuing,
amending, or repealing of the
scheduling of any drug or other
substance may be initiated by the
Attorney General (1) on his own motion;
(2) at the request of the Secretary of the
Department of Health and Human
Services (HHS); 1 or (3) on the petition
of any interested party. 21 U.S.C. 811(a).
The Attorney General initiated this
action on his own motion, as delegated
to the Administrator of DEA, and is
supported by, inter alia, a
recommendation from the Assistant
Secretary for Health of HHS (Assistant
Secretary) and an evaluation of all
relevant data by DEA. The regulatory
controls and administrative, civil, and
criminal sanctions of schedule I
controlled substances on any person
who handles (manufactures, distributes,
imports, exports, engages in research, or
conducts instructional activities or
chemical analysis with, or possesses) or
proposes to handle NM2201, 5F-ABPINACA, 4-CN-CUMYL-BUTINACA,
MMB-CHMICA, and 5F-CUMYLP7AICA will continue to apply as a
result of this action.
Background
On July 10, 2018, DEA published an
order in the Federal Register amending
21 CFR 1308.11(h) to temporarily place
naphthalen-1-yl 1-(5-fluoropentyl)-1Hindole-3-carboxylate (other names:
NM2201 or CBL2201); N-(1-amino-3methyl-1-oxobutan-2-yl)-1-(5fluoropentyl)-1H-indazole-3carboxamide (other name: 5F-ABPINACA); 1-(4-cyanobutyl)-N-(2phenylpropan-2-yl)-1H-indazole-3carboxamide (other names: 4-CN1 As set forth in a memorandum of understanding
entered into by the Food and Drug Administration
(FDA) and the National Institute on Drug Abuse
(NIDA), FDA acts as the lead agency within 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 HHS has delegated to the Assistant
Secretary for Health of HHS the authority to make
domestic drug scheduling recommendations. 58 FR
35460, July 1, 1993.
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CUMYL-BUTINACA, 4-cyano-CUMYLBUTINACA, 4-CN-CUMYL BINACA,
CUMYL-4CN-BINACA or SGT-78);
methyl 2-(1-(cyclohexylmethyl)-1Hindole-3-carboxamido)-3methylbutanoate (other names: MMBCHMICA or AMB-CHMICA) and 1-(5fluoropentyl)-N-(2-phenylpropan-2-yl)1H-pyrrolo[2,3-b]pyridine-3carboxamide (other name: 5F-CUMYLP7AICA) in schedule I of the CSA
pursuant to the temporary scheduling
provisions of 21 U.S.C. 811(h). 83 FR
31877. That temporary scheduling order
took effect on the date of publication,
and was based on findings by the former
Acting Administrator of DEA that the
temporary scheduling of these five
synthetic cannabinoids (SCs) was
necessary to avoid an imminent hazard
to the public safety pursuant to 21
U.S.C. 811(h)(1).
On July 13, 2020, DEA published an
order to extend the temporary
scheduling of the five SCs by one year,
until July 10, 2021. 85 FR 42296. Also,
on that same date and in the same issue
of the Federal Register, DEA published
a notice of proposed rulemaking
(NPRM) to permanently control the five
SCs in schedule I of the CSA. 85 FR
42290. Specifically, DEA proposed to
add these five SCs to the hallucinogenic
substances list under 21 CFR
1308.11(d).
DEA and HHS Eight Factor Analyses
On May 29, 2020, HHS provided DEA
with a scientific and medical evaluation
and scheduling recommendation,
prepared by the Food and Drug
Administration (FDA), entitled ‘‘Basis
for the Recommendation to Place
Naphthalen-1-yl 1-(5-fluoropentyl)-lHindole-3-carboxylate [NM2201;
CBL2201], N-(1-amino-3-methyl-1oxobutan-2-yl)-1-(5-fluoropentyl)-lHindazole-3-carboxamide [5F-ABPINACA], 1-(4-cyanobutyl)-N-(2phenylpropan-2-yl)lH-indazole-3carboxamide (4-CN-CUMYLBUTINACA; 4-cyano-CUMYLBUTINACA; 4-CN-CUMYL BINACA;
CUMYL-4CN-BINACA; SGT-78], methyl
2-(1-(cyclohexylmethyl)-lH-indole-3carboxamido)-3-methylbutanoate
[MMB-CHMICA; AMB-CHMICA], and 1(5-fluoropentyl)-N-(2-phenylpropan-2yl)-1H-pyrrolo[2,3-b]pyridine-3carboxamide [5F-CUMYL-P7AICA;
CUMYL-5F-P7AICA; SGT-263] and
Their Salts in Schedule I of the
Controlled Substances Act.’’
After considering the eight factors in
21 U.S.C. 811(c), each substance’s abuse
potential, lack of legitimate medical use
in the United States, and lack of
accepted safety for use under medical
supervision pursuant to 21 U.S.C.
E:\FR\FM\10JNR1.SGM
10JNR1
]]>Agencies
[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Rules and Regulations]
[Pages 30772-30775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11981]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-715]
Schedules of Controlled Substances: Placement of Oliceridine in
Schedule II
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: This final rule adopts, with a change as mentioned below, an
interim final rule with request for comments published in the Federal
Register on October 30, 2020, placing oliceridine, N-[(3-
methoxythiophen-2-yl)methyl]({2-[(9R)-9-(pyridin-2-yl)-6-
oxaspiro[4.5]decan-9-yl]ethyl{time} )amine fumarate, including its
isomers, esters, ethers, salts and salts of isomers, esters and ethers
whenever the existence of such isomers, esters, ethers and salts is
possible, in schedule II of the Controlled Substances Act. In response
to an error in the chemical name of oliceridine as noted by one of the
commenters to the interim final rule, the Drug Enforcement
Administration makes a correction to the above mentioned chemical name
of oliceridine by removing the word ``fumarate'' to read as N-[(3-
methoxythiophen-2-yl)methyl]({2-[(9R)-9-(pyridin-2-yl)-6-
oxaspiro[4.5]decan-9-yl]ethyl{time} amine. This change clarifies the
control of oliceridine free base and its salts, to include the fumarate
salt, by definition.
DATES: Effective July 12, 2021.
FOR FURTHER INFORMATION CONTACT: Dr. Terrence L. Boos, Drug and
Chemical Evaluation Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION:
Background and Legal Authority
On October 30, 2020, the Drug Enforcement Administration (DEA),
pursuant to 21 U.S.C. 811(j), published an interim final rule (IFR) to
place oliceridine (including its isomers, esters, ethers, salts and
salts of isomers, esters and ethers whenever the existence of such
isomers, esters, ethers and salts is possible), a medication approved
recently by the Food and Drug Administration (FDA) for medical use as
an intravenous drug for the management of acute pain severe enough to
require an intravenous opioid analgesic and for patients for whom
alternative treatments are inadequate, in schedule II of the Controlled
Substances Act (CSA). 85 FR 68749. The IFR provided an opportunity for
interested persons to submit comments, as well as file a request for
hearing or waiver of hearing, on or before November 30, 2020. DEA
received three comments and did not receive any requests for hearing or
waiver of hearing.
Comments Received
In response to the IFR, DEA received three comments. The
submissions were from individuals or anonymous commenters. One
commenter suggested that oliceridine be placed in schedule III rather
than schedule II, one commenter had a statement on the controlled name,
and the third commenter discussed another substance entirely that was
unrelated to oliceridine. As such, the third comment was outside the
scope of this current scheduling action.
Comment: One commenter suggested that oliceridine be placed in
schedule III of the CSA, rather than schedule II. The commenter
mentioned that placement of oliceridine in schedule II will limit its
medical applications and limit access to the drug due to schedule II
manufacturing quotas. The commenter stated that oliceridine has the
potential
[[Page 30773]]
to revolutionize gastrointestinal endoscopy because it does not cause
respiratory depression. Lastly, the commenter stated that since
oliceridine is not indicated for home-use, abuse of the medication by
drug users would be difficult.
DEA Response: DEA notes that FDA approved a New Drug Application
(NDA) for oliceridine and provided DEA with a scheduling recommendation
for oliceridine. The scheduling recommendation by Health and Human
Services (HHS) and their notification to DEA regarding the FDA approval
of the NDA initiated the DEA review and scheduling action. As stated in
the IFR, after careful consideration of data from preclinical and
clinical studies, DEA concurred with the HHS recommendation that
oliceridine has abuse potential comparable to other schedule II opioids
and therefore supported--and continues to support through this final
rule--placement of oliceridine in schedule II under the CSA. Contrary
to the commenter's opinion about schedule II controls on a drug
limiting its medical applications and access due to manufacturing quota
requirements, DEA notes that currently several schedule II drugs
(oxycodone, hydrocodone etc.) are extensively prescribed and used in
medical practice.
Comment: One commenter stated that the chemical name provided in
the interim final rule indicates oliceridine is ``N-[(3-
methoxythiophen-2-yl)methyl]({2-[(9R)-9-(pyridin-2-yl)-6-
oxaspiro[4.5]decan-9-yl]ethyl{time} )amine fumarate'', though this is
the name of the fumarate salt of oliceridine. The commenter noted that
the other substances listed in 21 CFR 1308.12, and in most other
sections of the CSA list only the base form of the drug, and control
salts by definition. The commenter suggested to provide the chemical
name for oliceridine base, and the fumarate salt would be controlled
under the preamble in 12 CFR 1308.12.
DEA Response: DEA agrees with commenter regarding the error in the
chemical name of oliceridine and corrects appropriately by removing the
word ``fumarate'' to read oliceridine as, N-[(3-methoxythiophen-2-
yl)methyl]({2-[(9R)-9-(pyridin-2-yl)-6-oxaspiro[4.5]decan-9-
yl]ethyl{time} )amine. The correction will make clear precisely which
substance is being controlled because the fumarate salt was not the
accurate designation for the controlled substance. The listing of the
base form and removal of the salt designation is consistent with other
controlled substance listings under the CFR and the substance
designated for control remains unchanged. The base form listing minus
the salt designation (``fumarate'') is readily understood by those
registered to handle the substance and would not be misunderstood by
the public. For this reason, DEA believes the change will not have an
impact.
Based on the rationale set forth in the interim final rule, DEA
adopts the IFR, with the above mentioned correction to the chemical
name of oliceridine.
Requirements for Handling Oliceridine
As indicated above, oliceridine has been a schedule II controlled
substance by virtue of an IFR issued by DEA in October 2020. Thus, this
final rule does not alter the regulatory requirements applicable to
handlers of oliceridine that have been in place since that time.
Nonetheless, for informational purposes, we restate here those
requirements. Oliceridine is subject to the CSA's schedule II
regulatory controls and administrative, civil, and criminal sanctions
applicable to the manufacture, distribution, reverse distribution,
dispensing, importing, exporting, research, and conduct of
instructional activities and chemical analysis with, and possession
involving schedule II substances, including the following:
1. Registration. Any person who handles (manufactures, distributes,
reverse distributes, dispenses, imports, exports, engages in research,
or conducts instructional activities or chemical analysis with, or
possesses) oliceridine, or who desires to handle oliceridine, must be
registered with 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. Any person who currently handles or intends to handle
oliceridine, and is not registered with DEA, must submit an application
for registration and may not continue to handle oliceridine, unless DEA
has approved the application for registration, pursuant to 21 U.S.C.
822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and
1312. These registration requirements, however, are not applicable to
patients (end users) who possess oliceridine pursuant to a lawful
prescription.
2. Quota. Only registered manufacturers are permitted to
manufacture oliceridine in accordance with a quota assigned pursuant to
21 U.S.C. 826 and in accordance with 21 CFR part 1303.
3. Disposal of stocks. Any person who does not desire or is not
able to maintain a schedule II registration must surrender all
quantities of currently held oliceridine, or may transfer all
quantities of currently held oliceridine to a person registered with
DEA in accordance with 21 CFR part 1317, in addition to all other
applicable Federal, State, local, and tribal laws.
4. Security. Oliceridine is subject to schedule II security
requirements and must be handled and stored pursuant to 21 U.S.C. 821
and 823 and in accordance with 21 CFR 1301.71-1301.93. Non-
practitioners handling oliceridine must also comply with the employee
screening requirements of 21 CFR 1301.90-1301.93.
5. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of oliceridine must comply with 21 U.S.C. 825 and
958(e) and be in accordance with 21 CFR part 1302.
6. Inventory. Every DEA registrant who possesses any quantity of
oliceridine must take an inventory of oliceridine on hand, pursuant to
21 U.S.C. 827 and 958(e), and in accordance with 21 CFR 1304.03,
1304.04, and 1304.11.
Any person who becomes registered with DEA to handle oliceridine
must take an initial inventory of all stocks of controlled substances
containing oliceridine on hand on the date the registrant first engages
in the handling of controlled substances, pursuant to 21 U.S.C. 827 and
958(e), and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
After the initial inventory, every DEA registrant must take a new
inventory of all stocks of controlled substances (including
oliceridine) on hand every two years, pursuant to 21 U.S.C. 827 and
958(e), and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
7. Records and Reports. DEA registrants must maintain records and
submit reports for oliceridine, pursuant to 21 U.S.C. 827 and 958(e),
and in accordance with 21 CFR parts 1304, 1312, and 1317.
8. Orders for oliceridine. Every DEA registrant who distributes
oliceridine is required to comply with order form requirements,
pursuant to 21 U.S.C. 828, and in accordance with 21 CFR part 1305.
9. Prescriptions. All prescriptions for oliceridine or products
containing oliceridine must comply with 21 U.S.C. 829, and be issued in
accordance with 21 CFR parts 1306 and 1311, subpart C.
10. Manufacturing and Distributing. In addition to the general
requirements of the CSA and DEA regulations that are applicable to
manufacturers and distributors of schedule II controlled substances,
such registrants should be advised that (consistent with the foregoing
considerations) any manufacturing or distribution of oliceridine may
only be for the
[[Page 30774]]
legitimate purposes consistent with the drug's labeling, or for
research activities authorized by the Federal Food, Drug, and Cosmetic
Act, as applicable, and the CSA.
11. Importation and Exportation. All importation and exportation of
oliceridine must be in compliance with 21 U.S.C. 952, 953, 957, and
958, and in accordance with 21 CFR part 1312.
12. Liability. Any activity involving oliceridine not authorized
by, or in violation of, the CSA or its implementing regulations, is
unlawful, and may subject the person to administrative, civil, and/or
criminal sanctions.
Regulatory Analyses
Administrative Procedure Act
This final rule, with a correction in the chemical name of
oliceridine as discussed above, affirms the amendment made by the IFR
that is already in effect. Section 553 of the Administrative Procedure
Act (APA) (5 U.S.C. 553) generally requires notice and comment for
rulemaking. However, 21 U.S.C. 811(j) provides that in cases where a
certain new drug is: (1) Approved by HHS and (2) HHS recommends control
in CSA schedule II-V, DEA shall issue an IFR scheduling the drug within
90 days. Additionally, subsection (j) specifies that the rulemaking
shall become immediately effective as an interim final rule without
requiring DEA to demonstrate good cause. DEA issued an IFR on October
30, 2020, and solicited public comments on that rule. Subsection (j)
further provides that after giving interested persons the opportunity
to comment and to request a hearing, the Attorney General, as delegated
to the Administrator of DEA, shall issue a final rule in accordance
with the scheduling criteria of 21 U.S.C. 811(b) through (d) and
812(b). DEA is now responding to the comments submitted by the public
and issuing the final rule, in conformity with the APA and the
procedure required by 21 U.S.C. 811.
Executive Orders 12866 (Regulatory Planning and Review) and 13563
(Improving Regulation and Regulatory Review)
In accordance with 21 U.S.C. 811(a) and (j), this scheduling action
is subject to formal rulemaking procedures performed ``on the record
after opportunity for a hearing,'' which are conducted pursuant to the
provisions of 5 U.S.C. 556 and 557. The CSA sets forth the procedures
and criteria for scheduling a drug or other substance. Such actions are
exempt from review by the Office of Management and Budget (OMB)
pursuant to section 3(d)(1) of Executive Order (E.O.)12866 and the
principles reaffirmed in E.O. 13563.
Executive Order 12988, Civil Justice Reform
This regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors
and ambiguity, minimize litigation, provide a clear legal standard for
affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism
This rulemaking does not have federalism implications warranting
the application of E.O. 13132. The rule 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, Consultation and Coordination With Indian Tribal
Governments
This rule does not have tribal implications warranting the
application of E.O. 13175. It 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.
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. Under 21 U.S.C. 811(j), DEA is not required to publish a
general notice of proposed rulemaking. Consequently, the RFA does not
apply.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has determined that this action would not
result in any Federal mandate that may result ``in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million or more (adjusted for inflation) in any
one year.'' Therefore, neither a Small Government Agency Plan nor any
other action is required under UMRA of 1995.
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. This action does not impose recordkeeping or reporting
requirements on State or local governments, individuals, businesses, or
organizations. 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 rule is not a major rule as defined by the Congressional
Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is
submitting a copy of this final rule 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.
Accordingly, the interim final rule amending 21 CFR part 1308,
which published on October 30, 2020 (85 FR 68749), is adopted as a
final rule with the following amendment:
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. Amend Sec. 1308.12 by revising paragraph (c)(18) to read as
follows:
Sec. 1308.12 Schedule II.
* * * * *
(c) * * *
(18) Oliceridine (N-[(3-methoxythiophen-2-yl)methyl]({2-[(9R)-9- 9245
(pyridin-2-yl)-6-oxaspiro[4.5]decan-9-yl]ethyl{time} )amine)....
[[Page 30775]]
* * * * *
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-11981 Filed 6-9-21; 8:45 am]
BILLING CODE 4410-09-P
