Schedules of Controlled Substances: Placement of Oliceridine in Schedule II

Citation85 FR 68749
Record Number2020-22762
Published date30 October 2020
SectionRules and Regulations
CourtDrug Enforcement Administration
68749
Federal Register / Vol. 85, No. 211 / Friday, October 30, 2020 / Rules and Regulations
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
: Interim final rule, with request
for comments.
SUMMARY
: On August 7, 2020, the U.S.
Food and Drug Administration
approved a new drug application for
oliceridine, chemically known as N-[(3-
methoxythiophen-2-yl)methyl] ({2-
[(9R)-9-(pyridin-2-yl)-6-oxaspiro
[4.5]decan-9-yl]ethyl})amine fumarate.
The Department of Health and Human
Services provided the Drug Enforcement
Administration (DEA) with a scheduling
recommendation to place oliceridine in
schedule II of the Controlled Substances
Act (CSA). In accordance with the CSA,
as revised by the Improving Regulatory
Transparency for New Medical
Therapies Act, DEA is hereby issuing an
interim final rule placing 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, in schedule II of the CSA.
DATES
: The effective date of this
rulemaking is October 30, 2020.
Interested persons may file written
comments on this rulemaking in
accordance with 21 U.S.C. 811(j)(3) and
21 CFR 1308.43(g). Electronic comments
must be submitted, and written
comments must be postmarked, on or
before November 30, 2020. Commenters
should be aware that the electronic
Federal Docket Management System
will not accept comments after 11:59
p.m. Eastern Time on the last day of the
comment period.
Interested persons may file a request
for hearing or waiver of hearing in
accordance with 21 U.S.C. 811(j)(3) and
21 CFR 1308.44. Requests for hearing
and waivers of an opportunity for a
hearing or to participate in a hearing
must be received on or before November
30, 2020.
ADDRESSES
: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–715’’ on all correspondence,
including any attachments.
Electronic comments: The Drug
Enforcement Administration encourages
that all comments be submitted
electronically through the Federal
eRulemaking Portal, which provides the
ability to type short comments directly
into the comment field on the web page
or attach a file for lengthier comments.
Please go to http://www.regulations.gov
and follow the online instructions at
that site for submitting comments. Upon
completion of your submission, you will
receive a Comment Tracking Number for
your comment. Please be aware that
submitted comments are not
instantaneously available for public
view on Regulations.gov. If you have
received a Comment Tracking Number,
your comment has been successfully
submitted and there is no need to
resubmit the same comment.
Paper comments: Paper comments
that duplicate the electronic submission
are not necessary and are discouraged.
Should you wish to mail a paper
comment in lieu of an electronic
comment, it should be sent via regular
or express mail to: Drug Enforcement
Administration, Attn: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, VA
22152.
Hearing requests: All requests for
hearing and waivers of participation
must be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for hearing
and waivers of participation should also
be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/LJ,
8701 Morrissette Drive, Springfield,
Virginia 22152; and (2) Drug
Enforcement Administration, Attn: DEA
Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield,
Virginia 22152.
FOR FURTHER INFORMATION CONTACT
:
Scott A. Brinks, Regulatory Drafting and
Policy Support Section, Diversion
Control Division, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone: (571) 362–3261.
SUPPLEMENTARY INFORMATION
:
Posting of Public Comments
Please note that all comments
received are considered part of the
public record. They will, unless
reasonable cause is given, be made
available by the Drug Enforcement
Administration (DEA) for public
inspection online at http://
www.regulations.gov. Such information
includes personal identifying
information (such as your name,
address, etc.) voluntarily submitted by
the commenter. The Freedom of
Information Act applies to all comments
received. If you want to submit personal
identifying information (such as your
name, address, etc.) as part of your
comment, but do not want it to be made
publicly available, you must include the
phrase ‘‘PERSONAL IDENTIFYING
INFORMATION’’ in the first paragraph
of your comment. You must also place
all of the personal identifying
information you do not want made
publicly available in the first paragraph
of your comment and identify what
information you want redacted.
If you want to submit confidential
business information as part of your
comment, but do not want it to be made
publicly available, you must include the
phrase ‘‘CONFIDENTIAL BUSINESS
INFORMATION’’ in the first paragraph
of your comment. You must also
prominently identify the confidential
business information to be redacted
within the comment.
Comments containing personal
identifying information and confidential
business information identified as
directed above will generally be made
publicly available in redacted form. If a
comment has so much confidential
business information or personal
identifying information that it cannot be
effectively redacted, all or part of that
comment may not be made publicly
available. Comments posted to http://
www.regulations.gov may include any
personal identifying information (such
as name, address, and phone number)
included in the text of your electronic
submission that is not identified as
directed above as confidential.
An electronic copy of this document
and supplemental information,
including the complete Department of
Health and Human Services (HHS) and
DEA eight-factor analyses, to this
interim final rule (IFR) are available at
http://www.regulations.gov for easy
reference.
Request for Hearing or Appearance;
Waiver
Pursuant to 21 U.S.C. 811(a), this
action is a formal rulemaking ‘‘on the
record after opportunity for a hearing.’’
Such proceedings are conducted
pursuant to the provisions of the
Administrative Procedure Act (APA), 5
U.S.C. 551–559. 21 CFR 1308.41–
1308.45; 21 CFR part 1316, subpart D.
Interested persons may file requests for
a hearing or notices of intent to
participate in a hearing in conformity
with the requirements of 21 CFR
1308.44 (a) or (b), and include a
statement of interest in the proceeding
and the objections or issues, if any,
concerning which the person desires to
be heard. Any interested person may file
a waiver of an opportunity for a hearing
or to participate in a hearing together
with a written statement regarding the
interested person’s position on the
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1
Given the parameters of subsection (j), in DEA’s
view, it would not apply to a reformulation of a
drug containing a substance currently in schedules
II through V for which an NDA has recently been
approved.
2
NFLIS represents an important resource in
monitoring illicit drug trafficking, including the
diversion of legally manufactured pharmaceuticals
into illegal markets. NFLIS is a comprehensive
information system that includes data from forensic
laboratories that handle more than 96 percent of an
estimated 1.0 million distinct annual State and
local drug analysis cases. NFLIS includes drug
chemistry results from completed analyses only.
While NFLIS data is not direct evidence of abuse,
it can lead to an inference that a drug has been
diverted and abused. See 76 FR 77330, 77332 (Dec.
12, 2011). NFLIS data were queried on July 28,
2020.
3
On October 1, 2014, DEA implemented
STARLiMS (a web-based, commercial laboratory
information management system) to replace the
System to Retrieve Information from Drug Evidence
(STRIDE) as its laboratory drug evidence data
system of record. DEA laboratory data submitted
after September 30, 2014, are reposited in
STARLiMS. STARLiMS data were queried on July
28, 2020.
4
Comprehensive Drug Abuse Prevention and
Control Act of 1970, H.R. Rep. No. 91–1444, 91st
Cong., Sess. 1 (1970), reprinted in U.S.C.C.A.N.
4566, 4603.
matters of fact and law involved in any
hearing as set forth in 21 CFR
1308.44(c).
All requests for a hearing and waivers
of participation must be sent to DEA
using the address information provided
above.
Background and Legal Authority
Under the Improving Regulatory
Transparency for New Medical
Therapies Act, Public Law 114–89, 2(b),
129 Stat. 698, 700 (2015), DEA is
required to commence an expedited
scheduling action with respect to
certain new drugs approved by the U.S.
Food and Drug Administration (FDA).
As provided in 21 U.S.C. 811(j), this
expedited scheduling is required where
both of the following conditions apply:
(1) The Secretary of the Department of
Health and Human Services (the
Secretary) has advised DEA that an
application for a new drug has been
submitted for a drug that has a
stimulant, depressant, or hallucinogenic
effect on the central nervous system,
and that it appears that such drug has
an abuse potential; and, (2) the
Secretary recommends that DEA control
the drug in schedule II, III, IV, or V
pursuant to 21 U.S.C. 811(a) and (b). In
these circumstances, DEA is required to
issue an IFR controlling the drug within
90 days.
The law further states that the 90-day
timeframe starts the later of (1) the date
DEA receives the HHS scientific and
medical evaluation/scheduling
recommendation, or (2) the date DEA
receives notice of the application
approval by HHS. In addition, the law
specifies that the rulemaking shall
become immediately effective as an IFR
without requiring DEA to demonstrate
good cause therefor. Thus, the purpose
of subsection (j) is to speed the process
by which DEA schedules newly
approved drugs that are currently either
in schedule I or not controlled (but
which have sufficient abuse potential to
warrant control) so that such drugs may
be marketed without undue delay
following FDA approval.
1
Subsection (j) further provides that
the IFR shall give interested persons the
opportunity to comment and to request
a hearing. After the conclusion of such
proceedings, DEA must issue a final rule
in accordance with the scheduling
criteria of subsections 21 U.S.C. 811(b),
(c), and (d) and 21 U.S.C. 812(b).
On November 2, 2017, Trevena, Inc.
(Sponsor) submitted an initial New Drug
Application (NDA) to FDA for
oliceridine that was subsequently
resubmitted on February 7, 2020. FDA
determined that oliceridine is a new
molecular entity, and HHS determined
that oliceridine has a depressant effect
on the central nervous system. On
August 7, 2020, FDA approved the NDA
for oliceridine 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.
Determination To Schedule Oliceridine
On July 27, 2020, DEA received a
scientific and medical evaluation
document from HHS prepared by FDA
related to oliceridine, titled: ‘‘Basis for
the Recommendation to Control
Oliceridine and its Salts in Schedule II
of the Controlled Substances Act.’’
Pursuant to 21 U.S.C. 811(b), this
document contained an eight-factor
analysis of the abuse potential of
oliceridine, along with HHS’s
recommendation to control oliceridine
under schedule II of the CSA.
Subsequently, on August 7, 2020, DEA
received notification from HHS that
FDA had approved an NDA for
oliceridine (OLINVYK).
In response, DEA reviewed the
scientific and medical evaluation and
scheduling recommendation provided
by HHS, along with all other relevant
data, and completed its own eight-factor
review document pursuant to 21 U.S.C.
811(c). DEA concluded that oliceridine
met the 21 U.S.C. 812(b)(2) criteria for
placement in schedule II of the CSA.
Pursuant to subsection 811(j), and
based on HHS’s recommendation, the
NDA approval by HHS/FDA, and DEA’s
determination, DEA is issuing this IFR
to schedule oliceridine as a schedule II
controlled substance under the CSA.
Included below is a brief summary of
each factor as analyzed by HHS and
DEA, and as considered by DEA in its
scheduling action. Please note that both
the DEA and HHS analyses are available
in their entirety under ‘‘Supporting
Documents’’ in the public docket for
this IFR at http://www.regulations.gov,
under Docket Number ‘‘DEA–715.’’ Full
analysis of, and citations to, the
information referenced in the summary
may also be found in the supporting and
related material.
1. Its Actual or Relative Potential for
Abuse: Oliceridine is a new molecular
entity that has not been marketed in the
United States or any other country.
Thus, information about the diversion
and actual abuse of oliceridine is
limited. Oliceridine is currently not
available for medical treatment, has not
been diverted from legitimate sources,
and individuals have not taken this
substance in amounts sufficient to
create a hazard to public health and
safety. DEA notes that there are no
reports for oliceridine in the National
Forensic Laboratory Information System
(NFLIS),
2
which collects drug
identification results from drug cases
submitted to and analyzed by Federal,
State, and local forensic laboratories.
There were also no reports in DEA’s
laboratory drug evidence data system of
record, STARLiMS.
3
According to the legislative history of
the CSA, one of the criteria by which
DEA should assess actual or relative
potential for abuse is whether the
substance in question ‘‘is so related in
its action to a substance already listed
as having a potential for abuse to make
it likely that it will have the same
potential for abuse as such substance,
thus making it reasonable to assume that
there may be significant diversions from
legitimate channels, significant use
contrary to or without medical advice,
or that it has a substantial capability of
creating hazards to the health of the user
or to the safety of the community.’’
4
As
stated by HHS, oliceridine is a high-
affinity mu opioid agonist that produces
behavioral effects similar to other mu
opioid agonists, such as the schedule II
opioid morphine. Moreover, in a rat
drug discrimination study, oliceridine
generalized to morphine, showing that
oliceridine has opioid-like properties. In
a clinical study investigating the abuse
potential of oliceridine, HHS concluded
that oliceridine produced subjective
responses that were similar to those for
morphine. Specifically, like morphine,
oliceridine produced positive subjective
responses and euphoria-related adverse
events in clinical studies. Together, this
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evidence demonstrates that oliceridine
is related in action and effect to the
schedule II substance morphine, and
can therefore be expected to have a
similar potential for abuse.
2. Scientific Evidence of Its
Pharmacological Effects, if Known:
Oliceridine has high affinity for the mu-
opioid receptor and does not bind to
any other receptors that are typically
associated with abuse, such as kappa
and delta opioid receptors, cannabinoid
receptors, GABAergic receptors, or other
ion channels. According to HHS,
general behavioral studies in animals
indicate that oliceridine produces
behavioral and motor effects similar to
those of morphine, a schedule II
substance. Additionally, oliceridine
produces self-administration in rats.
Furthermore, in a drug discrimination
study used to predict subjective effects
in humans, oliceridine mimicked the
stimulus effects of morphine. In a
human abuse potential (HAP) study,
therapeutic and supratherapeutic doses
of oliceridine produced euphoria,
somnolence, and paresthesia. These
adverse events are consistent with those
of other schedule II opioids such as
morphine. In other clinical studies,
adverse events such as somnolence,
sedation, anxiety, restlessness, and
paresthesia were seen in subjects treated
with oliceridine. As concluded by HHS,
results from preclinical and clinical
studies indicate that oliceridine has
abuse potential similar to morphine.
3. The State of Current Scientific
Knowledge Regarding the Drug or Other
Substance: Oliceridine is a new
molecular entity, chemically known as
N-[(3-methoxythiophen-2-yl)methyl]
({2-[(9R)-9-(pyridin-2-yl)-6-oxaspiro
[4.5]decan-9-yl]ethyl})amine fumarate.
It has a molecular formula of
C
22
H
30
N
2
O
2
S.C
4
H
4
O
4.
Oliceridine is a
white to lightly-colored solid that is
sparingly soluble in water. On August 7,
2020, FDA approved an NDA for
oliceridine for medical use to manage
acute pain severe enough to require an
intravenous opioid analgesic and for
which alternative treatments are
inadequate. Thus, oliceridine has an
accepted medical use in the United
States. Oliceridine will be marketed as
an intravenous medication formulated
in vials containing 1, 2, or 30 mg of
oliceridine.
4. Its History and Current Pattern of
Abuse: There is no information
available relating to the history and
current pattern of abuse of oliceridine,
since this drug is not currently marketed
in any country. HHS notes that
oliceridine produces abuse-related
signals, such as euphoria and
somnolence, and abuse potential similar
to that of schedule II controlled
substance morphine. DEA searched
NFLIS and STARLiMS databases for
oliceridine encounters. Consistent with
the fact that oliceridine is a new
molecular entity, these databases had no
records of encounters of oliceridine by
law enforcement.
5. The Scope, Duration, and
Significance of Abuse: Oliceridine is
currently not marketed in any country.
Thus, information on the scope,
duration, and significance of abuse for
oliceridine is lacking. However, as
stated by HHS, data from animal and
human studies indicate that oliceridine
has abuse potential similar to morphine.
Therefore, upon marketing, oliceridine
scope of abuse is expected to be similar
to morphine.
6. What, if any, Risk There is to the
Public Health: The extent of abuse
potential of a drug is an indication of its
public health risk. Data from the
preclinical and clinical studies suggest
that the abuse potential and physical or
psychological dependence potential of
oliceridine are similar to the schedule II
substance morphine. Thus, oliceridine
upon its availability for marketing
would be expected to create a public
health risk.
7. Its Psychic or Physiological
Dependence Liability: Physical
dependence for oliceridine was tested in
an animal toxicity study. According to
HHS, the animal toxicity study using
rats demonstrated dose-dependent
decreases in food consumption and
body weight as well as classic opioid
withdrawal signs from discontinuation
of oliceridine. In a rat self-
administration study as well as in
clinical studies, oliceridine produced
rewarding effects similar to morphine.
Based on these studies, HHS stated that
oliceridine may produce physical and
psychological dependence.
8. Whether the Substance is an
Immediate Precursor of a Substance
Already Controlled under the CSA:
Oliceridine is not an immediate
precursor of any controlled substance,
as defined in 21 U.S.C. 802(23).
Conclusion: After considering the
scientific and medical evaluation
conducted by HHS, HHS’s scheduling
recommendation, and its own eight-
factor analysis, DEA has determined
that these facts and all relevant data
constitute substantial evidence of a
potential for abuse of oliceridine. As
such, DEA hereby schedules oliceridine
as a controlled substance under the
CSA.
Determination of Appropriate Schedule
The CSA outlines the findings
required to place a drug or other
substance in any particular schedule (I,
II, III, IV, or V). 21 U.S.C. 812(b). After
consideration of the analysis and
recommendation of the Assistant
Secretary for Health of HHS and review
of all available data, the Acting
Administrator of DEA, pursuant to 21
U.S.C. 812(b)(2), finds that:
1. Oliceridine Has a High Potential for
Abuse
Oliceridine is a mu-opioid receptor
agonist and produces behavioral effects
that are similar to those of morphine
(schedule II opioid substance) in
animals and humans. A self-
administration study in animals
demonstrated that oliceridine produced
self-administration that was comparable
to morphine. Additionally, a drug-
discrimination study in animals
demonstrated that oliceridine
generalized to morphine, indicating that
it has mu-opioid receptor agonist
properties. Results from a HAP study
showed that oliceridine produces
positive subjective effects as well as
adverse events such as euphoria, similar
to that of morphine, a schedule II
substance with a high potential for
abuse. Lastly, clinical studies in healthy
individuals indicate that oliceridine
produces abuse-related adverse events
such as euphoria and sedation. These
data collectively indicate that
oliceridine has a high potential for
abuse similar to the schedule II
substance morphine.
2. Oliceridine Has a Currently Accepted
Medical Use in the United States
FDA recently approved a NDA for
oliceridine for the management of acute
pain severe enough to require an
intravenous opioid analgesic and for
patients for whom alternative treatments
are inadequate. Thus, oliceridine has a
currently accepted medical use in
treatment in the United States.
3. Abuse of Oliceridine May Lead To
Severe Psychological or Physical
Dependence
Chronic administration of oliceridine
in rats followed by drug discontinuation
produced classic opioid withdrawal
signs, similar to that of schedule II drug
morphine. This study would indicate
oliceridine’s potential to cause physical
dependence similar to that of morphine.
Oliceridine also produces self-
administration in rats and positive
subjective responses in a HAP study.
These results parallel those produced by
morphine and suggest that oliceridine
can also produce psychological
dependence. These data collectively
suggest that oliceridine abuse may lead
to psychological and physical
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5
Office of Management and Budget, Executive
Office of The President, Interim Guidance
Implementing Section 2 of the Executive Order of
January 30, 2017, Titled ‘‘Reducing Regulation and
Controlling Regulatory Costs’’ (Feb. 2, 2017).
dependence similar to that of schedule
II opioids.
Based on these findings, the Acting
Administrator of DEA concludes that
oliceridine warrants control in schedule
II of the CSA. 21 U.S.C. 812(b)(2).
Requirements for Handling Oliceridine
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.
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.
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. Every DEA
registrant 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
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
Public Law 114–89 was signed into
law, amending 21 U.S.C. 811. This
amendment provides that in cases
where a 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, the law specifies
that the rulemaking shall become
immediately effective as an IFR without
requiring DEA to demonstrate good
cause. Therefore, DEA has determined
that the notice and comment
requirements of section 553 of the APA,
5 U.S.C. 553, do not apply to this
scheduling action.
Executive Orders 12866, 13563, and
13771, Regulatory Planning and Review,
Improving Regulation and Regulatory
Review, and Reducing Regulation and
Controlling Regulatory Costs
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.
This IFR is not an E.O. 13771
regulatory action pursuant to E.O. 12866
and OMB guidance.
5
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.
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68753
Federal Register / Vol. 85, No. 211 / Friday, October 30, 2020 / Rules and Regulations
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 to this IFR.
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. This rule does
not result in: An annual effect on the
economy of $100 million 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 U.S.-based companies to
compete with foreign based companies
in domestic and export markets.
However, pursuant to the CRA, DEA has
submitted a copy of this IFR to both
Houses of Congress and to the
Comptroller General.
List of Subjects
21 CFR Part 1308
Administrative practice and
procedure, Drug traffic control,
Reporting and recordkeeping
requirements.
For the reasons set out above, DEA
amends 21 CFR part 1308 as follows:
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
1. The authority citation for 21 CFR
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:
a. Redesignating paragraph (c)(18)
through (c)(29) as (c)(19) through (c)(30);
b. Adding new paragraph (c)(18).
The addition to read as follows:
§ 1308.12 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 fumarate) ........... 9245
* * * * *
Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020–22762 Filed 10–29–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
[Docket ID: DOD–2020–HA–0050]
RIN 0720–AB83
TRICARE Coverage of National
Institute of Allergy and Infectious
Disease Coronavirus Disease 2019
Clinical Trials
AGENCY
: Office of the Secretary,
Department of Defense (DoD).
ACTION
: Interim final rule with request
for comments.
SUMMARY
: The Assistant Secretary of
Defense for Health Affairs (ASD(HA))
issues this interim final rule (IFR) with
request for comments to temporarily
modify the TRICARE regulation by
adding coverage for National Institute of
Allergy and Infectious Disease (NIAID)-
sponsored clinical trials for the
treatment or prevention of coronavirus
disease 2019 (COVID–19).
DATES
: Effective date: This interim final
rule is effective on October 30, 2020
through the end of the President’s
national emergency regarding COVID–
19 (Proclamation 9994, 85 FR 15337
(Mar. 18, 2020)). The ASD(HA) will
publish a document announcing the
expiration date.
Comment date: Comments are invited
and must be submitted on or before
November 30, 2020.
ADDRESSES
: You may submit comments,
identified by docket number and/or
Regulation Identification Number (RIN)
number and title, by any of the
following methods:
Federal Rulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments.
Mail: The DoD cannot receive
written comments at this time due to the
COVID–19 pandemic. Comments should
be sent electronically to the docket
listed above.
Instructions: All submissions received
must include the agency name and
docket number or RIN for this Federal
Register document. The general policy
for comments and other submissions
from members of the public is to make
these submissions available for public
viewing on the internet at http://
www.regulations.gov as they are
received without change, including any
personal identifiers or contact
information.
FOR FURTHER INFORMATION CONTACT
:
Erica Ferron, Medical Benefits and
Reimbursement Section, 303–676–3626,
erica.c.ferron.civ@mail.mil.
SUPPLEMENTARY INFORMATION
: Expiration
Date: Unless extended after
consideration of submitted comments,
this IFR will cease to be in effect upon
termination of the President’s declared
national emergency regarding COVID–
19, in accordance with applicable law
(50 U.S.C.1622(a)).
If the ASD(HA) determines it would
be appropriate to make these changes
permanent, the ASD(HA) will follow-up
with final rulemaking. The ASD(HA)
will publish a document in the Federal
Register announcing the expiration
date.
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