[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Notices]
[Pages 10097-10103]
[FR Doc No: 2021-03268]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0165]

International Drug Scheduling; Convention on Psychotropic
Substances; Single Convention on Narcotic Drugs; World Health
Organization; Scheduling Recommendations; Isotonitazene; MDMB-4en-
PINACA; CUMYL-PEGACLONE; Flubromazolam; Clonazolam; Diclazepam; 3-
Methoxyphencyclidine; Diphenidine; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing interested
persons with the opportunity to submit written comments concerning
recommendations by the World Health Organization (WHO) to impose
international manufacturing and distributing restrictions, under
international treaties, on certain drug substances. The comments
received in response to this notice will be considered in preparing the
United States' position on these proposals for a meeting of the United
Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in April
2021. This notice is issued under the Controlled Substances Act (CSA).

DATES: Submit either electronic or written comments by March 22, 2021.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-N-0165 for ``International Drug Scheduling; Convention on
Psychotropic Substances; Single Convention on Narcotic Drugs; World
Health Organization; Scheduling Recommendations; Isotonitazene; MDMB-
4en-PINACA; CUMYL-PEGACLONE; Flubromazolam; Clonazolam; Diclazepam; 3-
Methoxyphencyclidine; Diphenidine; Request for Comments.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: James R. Hunter, Center for Drug
Evaluation and Research, Controlled Substance Staff, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5150, Silver
Spring, MD 20993-0002,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The United States is a party to the 1971 Convention on Psychotropic
Substances (1971 Convention). Section 201(d)(2)(B) of the CSA (21
U.S.C. 811(d)(2)(B)) provides that when the United States is notified
under Article 2 of the 1971 Convention that the CND proposes to decide
whether to add a drug or other substance to one of the schedules of the
1971 Convention, transfer a drug or substance from one schedule to
another, or delete it from the schedules, the Secretary of State must
transmit notice of such information to the Secretary of Health and
Human Services (Secretary of HHS). The Secretary of HHS must then
publish a summary of such information in the Federal Register and
provide opportunity for interested persons to submit comments. The
Secretary of HHS must then evaluate the proposal and furnish a
recommendation to the Secretary of State that shall be binding on the
representative of the United States in discussions and negotiations
relating to the proposal.

    As detailed in the following paragraphs, the Secretary of State has
received notification from the Secretary-General of the United Nations
(the Secretary-General) regarding seven substances to be considered for
control under the 1971 Convention. This notification reflects the
recommendation from the 43rd WHO Expert Committee for Drug Dependence
(ECDD), which met in October 2020. In the Federal Register of August 4,
2020 (85 FR 47217), FDA announced the WHO ECDD review and invited
interested persons to submit information for WHO's consideration.
    The full text of the notification from the Secretary-General is
provided in section II. Section 201(d)(2)(B) of the CSA requires the
Secretary of HHS, after receiving a notification proposing scheduling,
to publish a notice in the Federal Register to provide the opportunity
for interested persons to submit information and comments on the
proposed scheduling action.
    The United States is also a party to the 1961 Single Convention on
Narcotic Drugs (1961 Convention). The Secretary of State has received a
notification from the Secretary-General regarding one substance to be
considered for control under this convention. The CSA does not require
HHS to publish a summary of such information in the Federal Register.
Nevertheless, to provide interested and affected persons an opportunity
to submit comments regarding the WHO recommendations for drugs under
the 1961 Convention, the notification regarding these substances is
also included in this Federal Register notice. The comments will be
shared with other relevant Agencies to assist the Secretary of State in
formulating the position of the United States on the control of these
substances. The HHS recommendations are not binding on the
representative of the United States in discussions and negotiations
relating to the proposal regarding control of substances under the 1961
Convention.

II. United Nations Notification

    The formal notification from the United Nations that identifies the
drug substances and explains the basis for the scheduling
recommendations is reproduced as follows (non-relevant text removed):

Reference:
NAR/CL.1/2020
WHO/ECDD43; 1961C-Art.3, 1971C-Art.2
CU 2021/7(A)/DTA/SGB

    The Secretariat of the United Nations presents its compliments
to the Permanent Mission of the United States of America and has the
honour to inform the Government that in a letter dated 30 November
2020, the Director-General of the World Health Organization (WHO),
pursuant to article 3, paragraphs 1 and 3 of the Single Convention
on Narcotic Drugs of 1961 as amended by the 1972 Protocol (1961
Convention), and article 2, paragraphs 1 and 4 of the Convention on
Psychotropic Substances of 1971 (1971 Convention), notified the
Secretary-General of the following recommendations of the forty-
third Meeting of the WHO's Expert Committee on Drug Dependence
(ECDD):

    Substance recommended to be added to Schedule I of the 1961
Convention:

--Isotonitazene
chemical name: N,N-diethyl-2-(2-(4-isopropoxybenzyl)-5-nitro-1H-
benzo[d]imidazol-1-yl)ethan-1-amine

    Substances recommended to be added to Schedule II of the 1971
Convention:

--CUMYL-PEGACLONE
chemical name: 5-pentyl-2-(2-phenylpropan-2-yl)-2,5-dihydro-1H-
pyrido[4,3-b]indol-1-one
--MDMB-4en-PINACA
chemical name: methyl 3,3-dimethyl-2-(1-(pent-4-en-1-yl)-1H-
indazole-3-carboxamido)butanoate
--3-Methoxyphencyclidine
chemical name: 1-(1-(3-methoxyphenyl)cyclohexyl)piperidine
--Diphenidine
chemical name: 1-(1,2-diphenylethyl)piperidine

    Substances recommended to be added to Schedule IV of the 1971
Convention:

--Clonazolam
chemical name: 6-(2-chlorophenyl)-1-methyl-8-nitro-4H-
benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine
--Diclazepam
chemical name: 7-chloro-5-(2-chlorophenyl)-1- methyl-1,3-dihydro-2H-
benzo[e][1,4]diazepin2-one
--Flubromazolam
chemical name: 8-bromo-6-(2-fluorophenyl)-1-methyl-4H-
benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine

    In accordance with the provisions of article 3, paragraph 2 of
the 1961 Convention and article 2, paragraph 2 of the 1971
Convention, the Secretary-General hereby transmits the notification
as annex I to the present note. In connection with the notification,
WHO also submitted an extract of the report of the forty-third
meeting of the WHO Expert Committee on Drug Dependence, which
provides a summary of the assessment and recommendations made by the
Expert Committee on Drug Dependence (attached as annex II).
    Also in accordance with the same provisions, the notification
from WHO will be brought to the attention of the sixty-fourth
session of the Commission on Narcotic Drugs (12-16 April 2021) in a
pre-session document that will be made available in the six official
languages of the United Nations on the website of the 64th session
of the CND:

https://www.unodc.org/unodc/en/commissions/CND/session/64_Session_2021/session-64-of-the-commission-on-narcotic-drugs.html

    In order to assist the Commission in reaching a decision, it
would be appreciated if the Government could communicate any
comments it considers relevant to the possible scheduling of
substances recommended by WHO to be placed under international
control under the 1961 Convention, namely:

--Isotonitazene

    as well as any economic, social, legal, administrative or other
factors that it considers relevant to the possible scheduling of
substances recommended by WHO to be placed under international
control under the 1971 Convention, namely:

--CUMYL-PEGACLONE
--MDMB-4en-PINACA
--3-Methoxyphencyclidine
--Diphenidine
--Clonazolam
--Diclazepam
--Flubromazolam

    The Secretariat of the United Nations avails itself of this
opportunity to renew to the Permanent Mission of the United States
of America to the United Nations (Vienna) the assurances of its
highest consideration.

12 January 2012

Annex I

Letter addressed to the Secretary-General of the United Nations
From the Director-General of the World Health Organization, dated
30 November 2020

    ``The Forty-third meeting of the WHO Expert Committee on Drug
Dependence was convened in a virtual format from 12 to 16 October
2020 and was coordinated from the WHO headquarters in Geneva. The
objective of this meeting was to carry out an in-depth evaluation of
the abuse and dependence-producing capacity of psychoactive
substances in order to make recommendations on appropriate
international scheduling measures.
    The Forty-third WHO ECDD Meeting critically reviewed eleven
psychoactive substances, including one synthetic opioid, one
hallucinogen, one synthetic stimulant, two synthetic cannabinoid
receptor agonists, three dissociative-type drugs, and three
benzodiazepines. These substances had not previously been formally
reviewed by WHO and are currently not under international control.
Information was brought to WHO's attention that these substances are
clandestinely manufactured, of especially serious risk to public
health and society, and of no recognised therapeutic use by any
Party. Therefore, a critical review to consider international
scheduling measures was undertaken for each substance.
    With reference to Article 3, paragraphs 1 and 3 of the Single
Convention on Narcotic Drugs (1961), as amended by the 1972
Protocol, and Article 2, paragraphs 1 and 4 of the Convention on
Psychotropic Substances (1971), WHO is pleased to submit
recommendations of the Forty-second Meeting of ECDD as follows:

    To be added to Schedule I of the Single Convention on Narcotic
Drugs (1961):

--Isotonitazene
chemical name: N,N-diethyl-2-(2-(4-isopropoxybenzyl)-5-nitro-1H-
benzo[d]imidazol-1-yl)ethan-1-amine

    To be added to Schedule II of the Convention on Psychotropic
Substances (1971):

--CUMYL-PEGACLONE
chemical name: 5-pentyl-2-(2-phenylpropan-2-yl)-2,5-dihydro-1H-
pyrido[4,3-b]indol-1-one
--MDMB-4en-PINACA
chemical name: methyl 3,3-dimethyl-2-(1-(pent-4-en-1-yl)-1H-
indazole-3-carboxamido)butanoate
--3-methoxyphencyclidine
chemical name: 1-(1-(3-methoxyphenyl)cyclohexyl)piperidine
--Diphenidine
chemical name: 1-(1,2-diphenylethyl)piperidine

    To be added to Schedule IV of the Convention on Psychotropic
Substances (1971):

--Clonazolam
chemical name: 6-(2-chlorophenyl)-1-methyl-8-nitro-4H-
benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine
--Diclazepam
chemical name: 7-chloro-5-(2-chlorophenyl)-1-methyl-1,3-dihydro-2H-
benzo[e][1,4]diazepin2-one
--Flubromazolam
chemical name: 8-bromo-6-(2-fluorophenyl)-1-methyl-4H-
benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine

    The assessments and findings on which these recommendations are
based are set out in detail in the forty-third meeting report of the
WHO Expert Committee on Drug Dependence. An extract of this report,
providing a summary of the assessment and recommendations made by
the ECDD, is contained in Annex 1 to this letter.
    I am very pleased with the ongoing collaboration between WHO,
the United Nations Office on Drugs and Crime (UNODC) and the
International Narcotics Control Board (INCB) and in particular, how
this collaboration has benefited the work of the WHO Expert
Committee on Drug Dependence and more generally, the implementation
of the operational recommendations of the United Nations General
Assembly Special Session 2016.

Annex II

Summary Assessment and Recommendations of the 43rd Expert Committee
on Drug Dependence, 12-16 October 2020

    To be added to Schedule I of the Single Convention on Narcotic
Drugs (1961):

Isotonitazene
Substance identification
    Isotonitazene (Chemical name: N,N-diethyl-2-(2-(4-
isopropoxybenzyl)-5-nitro-1H-benzo[d]imidazol-1-yl)ethan-1-amine)
belongs to the 2-benzylbenzimidazole group of compounds, which
includes the closely related opioids etonitazene, metonitazene, and
clonitazene. It is found in yellow, brown, or off-white powder
forms.

WHO Review History

    Isotonitazene has never been formally reviewed by WHO and is not
currently under international control. Information was brought to
WHO's attention that this substance is clandestinely manufactured,
poses a risk to public health, and has no recognized therapeutic
use.

Similarity to Known Substances and Effects on Central Nervous System

    Isotonitazene is a chemical analogue of etonitazene and
clonitazene, both of which are Schedule I compounds under the Single
Convention on Narcotic Drugs, 1961. Isotonitazene is a potent opioid
analgesic with a rapid onset of action. Preclinical studies have
demonstrated that isotonitazene is more potent than fentanyl and
hydromorphone, and substantially more potent than morphine. There is
limited research on the effects of this compound on the central
nervous system, but given its demonstrated potency at the [mu]-
opioid receptor, it would be expected to produce analgesia,
respiratory depression and sedation.

Dependence Potential

    No controlled animal or human studies have assessed the
dependence potential of isotonitazene. As a potent [mu]-opioid
agonist, it would be expected to produce dependence. An unverified
online report described dependent use and withdrawal symptoms,
including flu-like symptoms and anxiety.

Actual Abuse and/or Evidence of Likelihood of Abuse

    There are no controlled studies of the abuse potential of
isotonitazene, but as a potent [mu]-opioid receptor agonist, it
would be expected to produce euphoria and other effects predictive
of high abuse liability.
    Due to its relatively recent appearance on the illicit drug
market, there is limited information on the prevalence of use of
isotonitazene or its associated harms. Seizures have been reported
in multiple countries and regions. It is noted to be used via a
range of routes including sublingually, vaping and intravenously.
    The number of deaths involving isotonitazene has increased in a
short time span. Deaths commonly occur in combination with other
opioids or benzodiazepines. Isotonitazene deaths share common
features with heroin deaths, including evidence of injection, and
signs consistent with opioid overdose such as pulmonary and/or
cerebral oedema. Deaths are likely to be underreported due to its
recent and rapid appearance.

Recommendation

    Isotonitazene (Chemical name: N,N-diethyl-2-(2-(4-
isopropoxybenzyl)-5-nitro-1H-benzo[d]imidazol-1-yl)ethan-1-amine)
has a mechanism of action such that it is liable to similar abuse
and productive of similar ill effects as other opioids which are
controlled under Schedule I of the 1961 Single Convention on
Narcotic Drugs. Its use has been reported in a number of countries
and has been associated with adverse effects including deaths. It
has no known therapeutic use and is likely to cause substantial
harm.

Therapeutic Usefulness

    Isotonitazene is not known to have any therapeutic use.

    To be added to Schedule II of the Convention on Psychotropic
Substances (1971):

CUMYL-PEGACLONE

Substance Identification

    CUMYL[hyphen]PEGACLONE (Chemical name: 5-pentyl-2-(2-
phenylpropan-2-yl)-2,5-dihydro-1H-pyrido[4,3-b]indol-1-one) is a
synthetic cannabinoid. It has been found in seized material
formulated for smoking and vaping.

WHO Review History

    CUMYL-PEGACLONE has never been formally reviewed by WHO and is
not currently under international control. Information was brought
to WHO's attention that this substance is clandestinely
manufactured, poses a risk to public health, and has no recognized
therapeutic use.

Similarity to Known Substances and Effects on Central Nervous System

    CUMYL-PEGACLONE is a synthetic cannabinoid with a mechanism of
action similar to that of other synthetic cannabinoids. It is a
potent full agonist at CB1 receptors.
    There are no controlled studies of its effects, but there are
online user reports describing euphoria, dissociation, red eyes, dry
mouth and appetite stimulation. These effects are consistent with
known cannabinoid agonist effects.

Dependence Potential

    There are no controlled animal or human studies that address the
dependence potential of CUMYL-PEGACLONE. However, CUMYL-PEGACLONE
has been shown to be a full and potent agonist at the CB1 receptor
and therefore would be expected to produce dependence consistent
with other CB1 receptor agonists.

Actual Abuse and/or Evidence of Likelihood of Abuse

    There are no controlled animal or human studies that address the
abuse potential of CUMYL-PEGACLONE.
    A number of countries across several regions have reported that
CUMYL-PEGACLONE is being used for its psychoactive properties.
    There are reports of adverse effects such as seizures and of
fatalities involving CUMYL-PEGACLONE. While other drugs were
present, CUMYL-PEGACLONE was deemed to be a causal or contributory
factor in a number of these deaths.

Therapeutic Usefulness

    CUMYL-PEGACLONE is not known to have any therapeutic use.

Recommendation

    CUMYL[hyphen]PEGACLONE (Chemical name: 5-pentyl-2-(2-
phenylpropan-2-yl)-2,5-dihydro-1H-pyrido[4,3-b]indol-1-one) is a
synthetic cannabinoid receptor agonist with a mode of action that
suggests a likelihood of dependence and abuse, and similar ill-
effects to other synthetic cannabinoids. Its use has been associated
with severe adverse effects and fatalities. The effects of
CUMYL[hyphen]PEGACLONE are similar to those of other synthetic
cannabinoids that are controlled under Schedule II of the

Convention on Psychotropic Substances of 1971.
CUMYL[hyphen]PEGACLONE has no therapeutic use, and its use
constitutes a substantial risk to public health.
     The committee recommended that CUMYL[hyphen]PEGACLONE
(Chemical name: 5-pentyl-2-(2-phenylpropan-2-yl)-2,5-dihydro-1H-
pyrido[4,3-b]indol-1-one), be added to Schedule II of the Convention
on Psychotropic Substances of 1971.

MDMB-4en-PINACA

Substance Identification

    MDMB-4en-PINACA (Chemical name: methyl (S)-3,3-dimethyl-2-(1-
(pent-4-en-1-yl)-1H-indazole-3-carboxamido)butanoate) is a synthetic
cannabinoid. It has been identified in seized material formulated
for smoking, and found as white to yellow/brown powder.

WHO Review History

    MDMB-4en-PINACA has never been formally reviewed by WHO and is
not currently under international control. Information was brought
to WHO's attention that this substance is clandestinely
manufactured, poses a risk to public health, and has no recognized
therapeutic use.

Similarity to Known Substances and Effects on Central Nervous System

    MDMB-4en-PINACA is a synthetic cannabinoid that binds to CB1
cannabinoid receptors as a full and potent agonist. It is
structurally similar to 5F-MDMB-PINACA (5F-ADB) which is controlled
under Schedule II of the Convention on Psychotropic Substances of
1971. A report from an unpublished animal study indicates that MDMB-
4en-PINACA can produce the characteristic effects of CB1 cannabinoid
agonists such as hypothermia and lethargy. Reports from online user
forums describe cannabis-like euphoria at moderate levels of intake,
with dissociation described at higher doses. Both sedation and
stimulation have been reported, in addition to memory loss,
confusion and agitation.

Dependence Potential

    No animal or human studies were identified that described the
dependence potential of MDMB-4en-PINACA. As a full CB1 agonist, it
would be expected to produce dependence similar to other CB1
receptor agonists.

Actual Abuse and/or Evidence of Likelihood of Abuse

    No animal or human studies have been conducted to provide an
indication of the likelihood of abuse of MDMB-4en-PINACA, though CB1
receptor agonists have known abuse potential. A number of countries
across different regions have reported MDMB-4en-PINACA use. Its use
has been associated with cases of impaired driving and death.

Therapeutic Usefulness

    MDMB-4en-PINACA is not known to have any therapeutic use.

Recommendation

    MDMB-4en-PINACA (Chemical name: methyl (S)-3,3-dimethyl-2-(1-
(pent-4-en-1-yl)-1H-indazole-3-carboxamido)butanoate) is a potent
synthetic cannabinoid receptor agonist with a similar mechanism of
action, and similar effects to a number of other synthetic
cannabinoids that are controlled under Schedule II of the Convention
on Psychotropic Substances of 1971. Use of MDMB-4en-PINACA has been
associated with severe adverse effects, including fatal
intoxications, and cases of impaired driving. MDMB-4en-PINACA has no
therapeutic use.
     The Committee recommended that MDMB-4en-PINACA
(Chemical name: methyl (S)-3,3-dimethyl-2-(1-(pent-4-en-1-yl)-1H-
indazole-3-carboxamido)butanoate) be added to Schedule II of the
Convention on Psychotropic Substances of 1971.

3-methoxyphencyclidine (3-MeO-PCP)

Substance Identification

    3-methoxyphencyclidine (3-MeO-PCP), (Chemical name: 1-[1-(3-
methoxyphenyl)cyclohexyl]piperidine) is an arylcyclohexylamine and
3-methoxy derivative of phencyclidine (PCP) which is controlled
under Schedule II of the Convention on Psychotropic Substances of
1971. It appears as powder and tablets.

WHO Review History

    3-methoxyphencyclidine has never been formally reviewed by WHO
and is not currently under international control. Information was
brought to WHO's attention that this substance is clandestinely
manufactured, poses a risk to public health, and has no recognized
therapeutic use.

Similarity to Known Substances and Effects on Central Nervous System

    3-methoxyphencyclidine is an N-methyl-D-aspartate (NMDA)
receptor antagonist with a similar mechanism of action and effects
to phencyclidine. These effects include an altered mental state
characterized by confusion, disorientation and out of body
experiences as well as hallucinations and other psychotic symptoms.

Dependence Potential

    No human or animal studies have examined the dependence
potential of 3-methoxyphencyclidine.

Actual Abuse and/or Evidence of Likelihood of Abuse

    As an NMDA receptor antagonist, 3-methoxyphencyclidine would be
expected to produce similar effects, and have abuse potential
similar to that of phencyclidine.
    Adverse effects include cardiovascular effects (such as
hypertension and tachycardia) and cognitive effects including
psychosis, confusion and agitation. There may be a greater risk of
psychosis in those with a history of, or vulnerability to psychotic
illness. Cases of severe and fatal intoxication are reported from
several countries and regions.
    Seizures have been reported in a number of countries from
several different regions.

Therapeutic Usefulness

    3-methoxyphencyclidine is not known to have any therapeutic use.

Recommendation

    3-methoxyphencyclidine (Chemical name: 1-[1-(3-
methoxyphenyl)cyclohexyl] piperidine) is an analogue of, and has
similar effects to phencyclidine (PCP), which is controlled under
Schedule II of the 1971 Convention on Psychotropic Substances. Its
mode of action suggests a likelihood of abuse. There is evidence of
use of this substance in a number of countries across different
regions. 3-methoxyphencyclidine causes substantial harm, including
severe adverse events such as hallucinations, other psychotic
symptoms, and fatal intoxications. It has no therapeutic use.
     The Committee recommended that 3-methoxyphencyclidine
(Chemical name: 1-[1-(3-methoxyphenyl)cyclohexyl]piperidine) be
added to Schedule II of the Convention on Psychotropic Substances of
1971.

Diphenidine

Substance Identification

    Diphenidine (Chemical name: 1-(1,2-diphenylethyl)piperidine) is
a dissociative and hallucinogenic substance of the 1,2-
diarylethylamine class. It appears as powder and tablets.

WHO Review History

    Diphenidine has never been formally reviewed by WHO and is not
currently under international control. Information was brought to
WHO's attention that this substance is clandestinely manufactured,
poses a risk to public health, and has no recognized therapeutic
use.

Similarity to Known Substances and Effects on Central Nervous System

    Diphenidine is known to produce hallucinogenic and dissociative
effects through its action as an N-methyl-D-aspartate (NMDA)
receptor antagonist. This mechanism of action as well as its effects
are similar to those of phencyclidine (PCP) which is controlled
under Schedule II of the 1971 Convention on Psychotropic Substances.

Dependence Potential

    No animal or human studies have determined the dependence
potential for diphenidine.

Actual Abuse and/or Evidence of Likelihood of Abuse

    As an NMDA receptor antagonist, diphenidine would be expected to
have abuse potential similar to that of phencyclidine. In addition,
diphenidine causes dopamine release, in a manner similar to, but to
a lesser degree, than cocaine. This effect may also contribute to
its abuse potential.
    Cases of intoxication requiring hospitalization are reported.
Adverse effects include cardiovascular effects (such as tachycardia
and hypertension) and central nervous system effects including
hallucinations, depersonalization, delusions, paranoia,
dissociation, confusion, nystagmus and muscle rigidity. These
effects have resulted in cases of acute intoxication leading to
emergency department admissions. A small number of fatal
intoxications involving diphenidine have been documented. All deaths
involved multiple drug toxicity, though cardiovascular and
hallucinogenic symptoms described in the cases are consistent with
the effects of diphenidine.
    Seizures have been reported in a number of countries from
several different regions.

Therapeutic Usefulness

    Diphenidine is not known to have any therapeutic use.

Recommendation

    The available evidence indicates that diphenidine (Chemical
name: 1-(1,2-diphenylethyl)piperidine) has a mechanism of action and
effects that are similar to those of phencyclidine (PCP), which is
controlled under Schedule II of the 1971 Convention on Psychotropic
Substances. Its mode of action suggests a likelihood of abuse. There
is evidence of significant harm due to diphenidine, including
psychosis and cardiovascular effects, which represents a substantial
risk to public health. Diphenidine has no therapeutic use.
     The Committee recommended that diphenidine (Chemical
name: 1-(1,2-diphenylethyl)piperidine) be added to Schedule II of
the Convention on Psychotropic Substances of 1971.

    Substances recommended to be scheduled in Schedule IV of the
Convention on Psychotropic Substances (1971):

Clonazolam

Substance Identification

    Clonazolam (Chemical name: 6-(2-chlorophenyl)-1-methyl-8-nitro-
4H-benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine) is 1-4
triazolobenzodiazepine similar to clonazepam, triazolam and
alprazolam. It is sold in powder, blotter, liquid and tablet form.

WHO Review History

    Clonazolam has never been formally reviewed by WHO and is not
currently under international control. Information was brought to
WHO's attention that this substance is clandestinely manufactured,
poses a risk to public health, and has no recognized therapeutic
use.

Similarity to Known Substances and Effects on Central Nervous System

    Clonazolam enhances the effects of the inhibitory
neurotransmitter gamma-aminobutyric acid (GABA) through binding at
the benzodiazepine site of the GABA-A receptor. This mechanism of
action, as well as its effects (sedation, muscle relaxation, slurred
speech and loss of motor control, amnesia) are similar to those of
the benzodiazepines (such as diazepam, triazolam and alprazolam)
which are controlled under Schedule IV of the 1971 Convention on
Psychotropic Substances.
    In cases of clonazolam poisoning, the effects have been reversed
with the benzodiazepine antagonist flumazenil, confirming that its
action is mediated via the benzodiazepine receptor in the GABA-A
receptor complex.

Dependence Potential

    No controlled animal or human studies have examined the
dependence potential of clonazolam, though based on its
pharmacological effects, and similarity to other benzodiazepines, it
would be expected to have potential to produce dependence.
    The development of tolerance to the effects of clonazolam
following repeated use and the onset of withdrawal symptoms after
cessation of use have been reported on online forums.

Actual Abuse and/or Evidence of Likelihood of Abuse

    No human or animal studies have examined abuse liability. Online
forums describe its recreational use and consistently report its
strong anxiolytic effects.
    A number of published reports describe the management of cases
of intoxication involving clonazolam in emergency departments or
intensive care. Clonazolam use has been analytically confirmed in
cases of impaired driving, in combination with other substances.
Clonazolam has the potential to increase the effects of other drugs,
including opioids, and on its own can cause severe central nervous
system depression, including somnolence, confusion, sedation and
unconsciousness.
    There are reports of its identification in multiple countries
representing all regions, indicating that its use may be increasing.
Clonazolam is increasingly sold as falsified pharmaceutical
benzodiazepines.

Therapeutic Usefulness

    Clonazolam is not known to have any therapeutic use, is not
listed on the WHO Model List of Essential Medicines, and has never
been marketed as a medicinal product.

Recommendation

    Clonazolam (Chemical name: 6-(2-chlorophenyl)-1-methyl-8-nitro-
4H-benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine) is a 1-4
triazolobenzodiazepine that has actions and effects very similar to
those of benzodiazepines listed under Schedule IV in the Convention
on Psychotropic Substances of 1971. Like other benzodiazepines,
clonazolam can produce a state of dependence and central nervous
system depression. There have been a number of reports of abuse,
impaired driving and non-fatal intoxications. There is sufficient
evidence of its abuse so as to constitute a public health problem,
and it has no known therapeutic use.
     The Committee recommended that clonazolam (Chemical
name: 6-(2-chlorophenyl)-1-methyl-8-nitro-4H-
benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine) be added to Schedule
IV of the 1971 Convention on Psychotropic Substances.

Diclazepam

Substance Identification

    Diclazepam (Chemical name: 7-chloro-5-(2-chlorophenyl)-1-methyl-
1,3-dihydro-2H-benzo[e][1,4]diazepin2-one) is a 2-chloro derivative
of the benzodiazepine diazepam. It appears as a white powder, and is
commonly sold as tablets, pellets and liquid.

WHO Review History

    Diclazepam has never been formally reviewed by WHO and is not
currently under international control. Information was brought to
WHO's attention that this substance is clandestinely manufactured,
poses a risk to public health, and has no recognized therapeutic
use.

Similarity to Known Substances and Effects on Central Nervous System

    Diclazepam is an agonist at the benzodiazepine site of the GABA-
A receptor, acting to increase the effect of the inhibitory
neurotransmitter gamma amino butyric acid (GABA). Diclazepam has
similar effects to the benzodiazepine diazepam, which is currently
controlled under the Convention on Psychotropic Substances of 1971.
It is metabolized to the benzodiazepines delorazepam, lorazepam and
lormetazepam. These metabolites are active and are also
pharmaceuticals that are included in Schedule IV of the Convention
on Psychotropic Substances of 1971.
    Diclazepam has been demonstrated to cause sedation and muscle
relaxation in animals. Central nervous systems depressant effects
are also described in humans.

Dependence Potential

    No controlled animal or human studies have examined the
dependence potential of diclazepam.
    Online user reports describe cross-tolerance with other
benzodiazepines and use to self-manage benzodiazepine withdrawal.
This evidence, along with its mechanism of action, suggests that
diclazepam has the capacity to produce dependence similar to other
benzodiazepines.

Actual Abuse and/or Evidence of Likelihood of Abuse

    No controlled animal or human studies have examined the abuse
liability of diclazepam. However, based on its mechanism of action
and effects, it would be expected to have abuse liability similar to
other benzodiazepines.
    Diclazepam has the potential to increase unintentional opioid
overdoses. Its long half-life may increase the risk of accumulation
and interactions when combined with other drugs. Fatal intoxications
with diclazepam have been reported.
    Seizures of diclazepam have been reported from multiple
countries across different regions. Diclazepam is increasingly sold
as falsified benzodiazepines, commonly as diazepam.
    Diclazepam has been implicated in cases of impaired driving,
including cases where diclazepam was identified as the main
contributor to impairment. It also has been involved in cases of
drug-facilitated sexual assault.

Therapeutic Usefulness

    Diclazepam is not known to have any therapeutic use, is not
listed on the WHO Model List of Essential Medicines and has never
been marketed as a medicinal product.

Recommendation

    Diclazepam (Chemical name: 7-chloro-5-(2-chlorophenyl)-1-methyl-
1,3-dihydro-2H-benzo[e][1,4]diazepin2-one) is a 2-chloro analogue of
the benzodiazepine diazepam that has actions and effects very
similar to those of benzodiazepines listed under Schedule IV of the
Convention on Psychotropic Substances of 1971. It can produce a
state of dependence and central nervous system depression, like
other

benzodiazepines. There have been reports of abuse, impaired driving
and fatal and nonfatal intoxications. There is sufficient evidence
of its abuse so as to constitute a significant risk to public
health, and it has no known therapeutic use.
     The Committee recommended that diclazepam (Chemical
name: 7-chloro-5-(2-chlorophenyl)-1-methyl-1,3-dihydro-2H-
benzo[e][1,4]diazepin2-one) be added to Schedule IV of the 1971
Convention on Psychotropic Substances.

Flubromazolam

Substance Identification

    Flubromazolam (Chemical name: 8-bromo-6-(2-fluorophenyl)-1-
methyl-4H-benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine) is a 1-4
triazolobenzodiazepine. Flubromazolam is a white powder, often sold
as a liquid or as tablets.

WHO Review History

    Flubromazolam has never been formally reviewed by WHO and is not
currently under international control. Information was brought to
WHO's attention that this substance is clandestinely manufactured,
poses a risk to public health and has no recognized therapeutic use.

Similarity to Known Substances and Effects on Central Nervous System

    Flubromazolam is a highly potent benzodiazepine with long
lasting depressant effects on the central nervous system.
Flubromazolam enhances the effects of the inhibitory
neurotransmitter gamma-aminobutyric acid (GABA) through binding at
the benzodiazepine site of the GABA-A receptor. This mechanism of
action, as well as its effects, are similar to those of the
benzodiazepines triazolam and alprazolam which are controlled under
Schedule IV of the 1971 Convention on Psychotropic Substances.
    A single pharmacokinetic study showed that a 0.5 mg
flubromazolam dose induced strong sedative effects that lasted more
than 10 hours, and caused partial amnesia for more than 24 hours.
The effects of flubromazolam have been effectively reversed by the
benzodiazepine antagonist flumazenil.
    Reports from online user forums describe benzodiazepine-like
effects including anxiolytic, euphoric and sedative effects.

Dependence Potential

    No controlled animal or human studies describe the dependence
potential of flubromazolam, although multiple reports from online
sources describe severe withdrawal symptoms, such as muscle aches,
sleeping disorders, severe anxiety and panic attacks, dissociative
symptoms, perceptual distortions, cramping, chills, vomiting and
risk of seizures. There are also descriptions of loss of control
over use, and rapid onset of tolerance. The latter suggests that
taking increased doses and developing physical dependence is likely.

Actual Abuse and/or Evidence of Likelihood of Abuse

    No controlled animal or human studies have assessed the abuse
potential of flubromazolam. Impaired driving with flubromazolam as
the sole intoxicant is reported. Non-fatal intoxications requiring
hospital admission, and fatal intoxications due to flubromazolam use
are documented. In these cases, central nervous system depression
and severe sedation were clinical features of presentation.
Flubromazolam has the potential to increase unintentional opioid
overdoses. Its long half-life may increase the risk of accumulation
and interactions when combined with other drugs.
    Nonmedical use and seizures of flubromazolam have been
documented in multiple countries across different regions. It is
increasingly sold as falsified pharmaceutical benzodiazepines.

Therapeutic Usefulness

    Flubromazolam is not known to have any therapeutic uses, is not
listed on the WHO Model List of Essential Medicines and has never
been marketed as a medicinal product.

Recommendation

    Flubromazolam (Chemical name: 8-bromo-6-(2-fluorophenyl)-1-
methyl-4H-benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine) is a 1-4
triazolobenzodiazepine that has actions and effects very similar to
those of benzodiazepines listed under Schedule IV in the Convention
on Psychotropic Substances of 1971. It can produce a state of
dependence and central nervous system depression, like other
benzodiazepines. There have been increasing reports of abuse,
impaired driving and fatal and non-fatal intoxications. There is
sufficient evidence of its abuse to constitute a significant risk to
public health, and it has no known therapeutic use.
    The Committee recommended that flubromazolam (Chemical name: 8-
bromo-6-(2-fluorophenyl)-1-methyl-4H-benzo[f][1,2,4]triazolo[4,3-
a][1,4]diazepine) be added to Schedule IV of the 1971 Convention on
Psychotropic Substances.

III. Discussion

    Although WHO has made specific scheduling recommendations for each
of the drug substances, the CND is not obliged to follow the WHO
recommendations. Options available to the CND for substances considered
for control under the 1971 Convention include the following: (1) Accept
the WHO recommendations; (2) accept the recommendations to control but
control the drug substance in a schedule other than that recommended;
or (3) reject the recommendations entirely.
    Isotonitazene (chemical name: N,N-diethyl-2-(2-(4-
isopropoxybenzyl)-5-nitro-1H-benzimidazol-1-yl)ethan-1-amine) is a
potent synthetic opioid that is abused similar to other synthetic
opioids. Its use has resulted in adverse health effects, including
positively identified in 49 death investigation cases in the United
States between August 2019 and April 2020. Law enforcement data
indicate that isotonitazene has appeared in the United States' illicit
drug market.
    According to the National Forensic Laboratory Information System
(NFLIS) database, there have been 53 encounters of isotonitazene in the
United States (as of June 2020). There are no commercial or approved
medical uses for isotonitazene. On August 20, 2020, the Drug
Enforcement Administration issued an order to temporarily control
isotonitazene as a Schedule I substance under the CSA. As such,
additional permanent controls will be necessary to fulfill U.S.
obligations if isotonitazene is placed in Schedule I of the 1961
Convention.
    CUMYL-PEGACLONE is a synthetic cannabinoid that has been sold
online and used to mimic the biological effects of tetrahydrocannabinol
(THC), the main psychoactive constituent in marijuana. Research and
clinical reports have demonstrated that synthetic cannabinoids are
applied onto plant material so that the material may be smoked as users
attempt to obtain a euphoric and psychoactive ``high''. Synthetic
cannabinoids have been marketed under the guise of ``herbal incense'',
and promoted by drug traffickers as legal alternatives to marijuana. In
vitro studies demonstrate that CUMYL-PEGALCONE binds to and activates
the cannabinoid one receptor. CUMYL-PEGALCONE has not been encountered
within the United States according to the NFLIS database (as of January
14, 2021). There are no commercial or approved medical uses for CUMYL-
PEGALCONE and it is not a controlled substance under the CSA. As such,
additional permanent controls will be necessary to fulfill U.S.
obligations if CUMYL-PEGALCONE is controlled under Schedule II of the
1971 Convention.
    MDMB-4en-PINACA is a synthetic cannabinoid that has been sold
online and used to mimic the biological effects of THC, the main
psychoactive constituent in marijuana. Research and clinical reports
have demonstrated that synthetic cannabinoids are applied onto plant
material so that the material may be smoked as users attempt to obtain
a euphoric and psychoactive ``high''. Synthetic cannabinoids have been
marketed under the guise of ``herbal incense'', and promoted by drug
traffickers as legal alternatives to marijuana. According to the NFLIS
database, MDMB-4en-PINACA was first encountered in the United States in
January 2019. There have been 3,331 encounters of MDMB-4en-PINACA in
the United States (as of January 14, 2021). MDMB-4en-PINACA has also
been encountered mixed with opioids including heroin and fentanyl, with
some incidents resulting in violent

behaviors, tachycardia, and hypertension. There are no commercial or
approved medical uses for MDMB-4en-PINACA and it is not a controlled
substance under the CSA. As such, additional permanent controls will be
necessary to fulfill U.S. obligations if MDMB-4en-PINACA is controlled
under Schedule II of the 1971 Convention.
    3-Methoxyphencyclidine; chemical name: 1-(1-(3-
methoxyphenyl)cyclohexyl)piperidine) is a novel N-methyl-D-aspartate
(NMDA) receptor antagonist with structural and biochemical similarities
to phencyclcycidine (PCP) and other arylcyclohexylamines. 3-
Methoxyphencyclidine is classified as an arylcyclohexylamine and
produces dissociative anesthetic and hallucinogenic effects. Use of
this substance is associated with intoxication and published case
reports of both fatal and non-fatal overdose. 3-Methoxyphencyclidine is
encountered by law enforcement in drug seizure reports. 3-
Methoxyphencyclidine is an analogue of the Schedule II hallucinogen
PCP. There is no approved medical use for 3-Methoxyphencyclidine in the
United States and is not a controlled substance under the CSA. If
intended for human consumption, 3-Methoxyphencyclidine may be treated
as a ``controlled substance analogue'' under the CSA pursuant to 21
U.S.C. 802(32)(A) and 813. As such, additional permanent controls will
be necessary to fulfill U.S. obligations if 3-Methoxyphencyclidine is
controlled under Schedule II of the 1971 Convention.
    Diphenidine (chemical name: 1-(1,2-diphenylethyl) piperidine) is a
non-competitive NMDA receptor antagonist classified as a
diarylethylamine and produces dissociative anesthetic and
hallucinogenic effects. It was originally synthesized in the 1920s but
reports of abuse started in the last decade. Use of this substance is
associated with intoxication and published case reports of both fatal
and non-fatal overdose outside of the United States. Diphenidine is
encountered by law enforcement in drug seizure reports. Diphenidine is
not approved for medical use in the United States and is not a
controlled substance under the CSA. As such, additional permanent
controls will be necessary to fulfill U.S. obligations if diphenidine
is controlled under Schedule II of the 1971 Convention.
    Flubromazolam, clonazolam, and diclazepam belong to a class of
substances known as benzodiazepines. Benzodiazepines produce central
nervous system depression and are commonly used to treat insomnia,
anxiety, and seizure disorders. Flubromazolam is a triazole analogue of
the designer benzodiazepine, flubromazepam. Flubromazolam can be
purchased on the internet and is used as a recreational substance in
the United States. Flubromazolam has been identified in an increasing
number of law enforcement seizures and has been associated with an
increasing number of drug overdose deaths. According to the NFLIS
database, in 2020 there were 1,446 clonazolam encounters (as of
December 2020). It is abused by a broad range of groups including
youths, young adults, and older adults. Clonazolam has been involved in
an increasing number of drug seizure events as well as drug overdose
deaths, alone and in combination with alcohol. As such, the NFLIS
database reported 249 encounters in 2020 (as of December 2020).
Diclazepam is a designer benzodiazepine sold on the internet and most
often found as a liquid solution, but it may be sold as a powder,
tablet, blotter paper, or pellet. In 2020, the NFLIS database reported
113 encounters of diclazepam (as of December 2020). In 2018,
flubromazolam, clonazolam, and dicalazepam were all identified by law
enforcement in driving under the influence of drugs cases in the United
States. Flubromazolam, clonazolam, and diclazepam are not approved for
medical use in the United States and are not controlled substances
under the CSA. As such, additional permanent controls will be necessary
to fulfill U.S. obligations if flubromazolam, clonazolam, and
dicalazepam are controlled under Schedule IV of the 1971 Convention.
    FDA, on behalf of the Secretary of HHS, invites interested persons
to submit comments on the notifications from the United Nations
concerning these drug substances. FDA, in cooperation with the National
Institute on Drug Abuse, will consider the comments on behalf of HHS in
evaluating the WHO scheduling recommendations. Then, under section
201(d)(2)(B) of the CSA, HHS will recommend to the Secretary of State
what position the United States should take when voting on the
recommendations for control of substances under the 1971 Convention at
the CND meeting in April 2021.
    Comments regarding the WHO recommendations for control of
isotonitazene under the 1961 Single Convention will also be forwarded
to the relevant Agencies for consideration in developing the U.S.
position regarding narcotic substances at the CND meeting.

    Dated: February 12, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03268 Filed 2-17-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 213 (Monday, November 6, 2023)]
[Rules and Regulations]
[Pages 76123-76128]
[FR Doc No: 2023-24424]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 95

[Docket No. 31516; Amdt. No. 575]

IFR Altitudes; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule

-----------------------------------------------------------------------

SUMMARY: This amendment adopts miscellaneous amendments to the required
IFR (instrument flight rules) altitudes and changeover points for
certain Federal airways, jet routes, or direct routes for which a
minimum or maximum en route authorized IFR altitude is prescribed. This
regulatory action is needed because of changes occurring in the
National Airspace System. These changes are designed to provide for the
safe and efficient use of the navigable airspace under instrument
conditions in the affected areas.

DATES: Effective 0901 UTC, November 30, 2023.

FOR FURTHER INFORMATION CONTACT: Thomas J. Nichols, Flight Procedures
and Airspace Group, Flight Technologies and Procedures Division, Flight
Standards Service, Federal Aviation Administration. Mailing Address:
FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace
Group, 6500 South MacArthur Blvd., STB Annex, Bldg 26, Room 217,
Oklahoma City, OK 73099. Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This amendment to part 95 of the Federal
Aviation Regulations (14 CFR part 95) amends, suspends, or revokes IFR
altitudes governing the operation of all aircraft in flight over a
specified route or any portion of that route, as well as the changeover
points (COPs) for Federal airways, jet routes, or direct routes as
prescribed in part 95.

The Rule

    The specified IFR altitudes, when used in conjunction with the
prescribed changeover points for those routes, ensure navigation aid
coverage that is adequate for safe flight operations and free of
frequency interference. The reasons and circumstances that create the
need for this amendment involve matters of flight safety and
operational efficiency in the National Airspace System, are related to
published aeronautical charts that are essential to the user, and
provide for the safe and efficient use of the navigable airspace. In
addition, those various reasons or circumstances require making this
amendment effective before the next scheduled charting and publication
date of the flight information to assure its timely availability to the
user. The effective date of this amendment reflects those
considerations. In view of the close and immediate relationship between
these regulatory changes and safety in air commerce, I find that notice
and public procedure before adopting this amendment are impracticable
and contrary to the public interest and that good cause exists for
making the amendment effective in less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 95

    Airspace, Navigation (air).

    Issued in Washington, DC on, October 27, 2023.
Thomas J Nichols,
Manager, Aviation Safety, Flight Standards Service, Standards Section,
Flight Procedures & Airspace Group, Flight Technologies and Procedures
Division.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me by the
Administrator, part 95 of the Federal Aviation Regulations (14 CFR part
95) is amended as follows effective at 0901 UTC, November 30, 2023.

PART 95--IFR Altitudes

0
1. The authority citation for part 95 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113 and 14 CFR
11.49(b)(2)

0
2. Part 95 is amended to read as follows:

              Revisions to IFR Altitudes & Changeover Point
            [Amendment 575 Effective Date November 30, 2023]
------------------------------------------------------------------------
             From                     To            MEA          MAA
------------------------------------------------------------------------
                Sec.   95.3000 Low Altitude RNAV Routes
                     Sec.   95.3223 RNAV Route T223
------------------------------------------------------------------------
     Is Amended by Adding

ZIKNI, AK WP.................  ROGOC, AK FIX..         4000        17500
ROGOC, AK FIX................  CEKBA, AK FIX..         4400        17500
CEKBA, AK FIX................  * DILLINGHAM,           4000        17500
                                AK VOR/DME.
    * 2400--MCA DILLINGHAM,
     AK VOR/DME, W BND
     Is Amended To Delete

CAPE NEWENHAM, AK NDB/DME....  DILLINGHAM, AK          4400        17500
                                VOR/DME.
  Is Amended To Read in Part

DILLINGHAM, AK VOR/DME.......  ZUNOS, AK FIX..         2200        17500
ZUNOS, AK FIX................  FAGIN, AK FIX..         5000        17500
------------------------------------------------------------------------
                     Sec.   95.3242 RNAV Route T242
------------------------------------------------------------------------
     Is Amended by Adding

BARROW, AK VOR/DME...........  WUPUV, AK WP...       * 1900        17500
    * 1900--MOCA
WUPUV, AK WP.................  LACIL, AK WP...       * 5900        17500
    * 3000--MOCA
LACIL, AK WP.................  KUTDE, AK WP...         9500        17500
KUTDE, AK WP.................  TADUE, AK WP...         5900        17500
TADUE, AK WP.................  * JOKAP, AK WP.      ** 4000        17500
    * 10700--MCA JOKAP, AK
     WP, SE BND
    ** 3400--MOCA
JOKAP, AK WP.................  * WEGNO, AK WP.        15300        17500
    * 12200--MCA WEGNO, AK
     WP, NW BND
WEGNO, AK WP.................  * HUMUB, AK WP.         4600        17500
    * 3100--MCA HUMUB, AK WP,
     NW BND
HUMUB, AK WP.................  TALKEETNA, AK         * 3000        17500
                                VOR/DME.
     Is Amended To Delete

* TALKEETNA, AK VOR/DME......  JOKAP, AK WP...     ** 16000        17500
    * 12100--MCA TALKEETNA,
     AK VOR/DME, N BND
    ** 15300--MOCA
* JOKAP, AK WP...............  KUTDE, AK WP...         6000        17500
    * 11500--MCA JOKAP, AK
     WP, S BND
KUTDE, AK WP.................  LACIL, AK WP...      * 15000        17500
    * 9400--MOCA
LACIL, AK WP.................  BARROW, AK VOR/       * 8000        17500
                                DME.
    * 1800--MOCA
------------------------------------------------------------------------
        Sec.   95.3356 RNAV Route T356 Is Amended To Read in Part
------------------------------------------------------------------------
REESY, PA WP.................  FOLEZ, PA WP...         2400        17500
------------------------------------------------------------------------
             Sec.   95.3447 RNAV Route T447 Is Added To Read
------------------------------------------------------------------------
SMYRNA, DE VORTAC............  CHAZR, DE WP...         1800        17500
CHAZR, DE WP.................  APEER, MD WP...         2000        17500
APEER, MD WP.................  REESY, PA WP...         2000        17500
REESY, PA WP.................  FOLEZ, PA WP...         2400        17500
FOLEZ, PA WP.................  HOSKR, PA WP...         2400        17500
HOSKR, PA WP.................  POTTSTOWN, PA           2400        17500
                                VORTAC.
POTTSTOWN, PA VORTAC.........  HIKES, PA FIX..         2800        17500
HIKES, PA FIX................  EAST TEXAS, PA          2900        17500
                                VOR/DME.
EAST TEXAS, PA VOR/DME.......  DIANO, PA FIX..       * 4200        17500
    * 3700--MOCA
DIANO, PA FIX................  WILLIAMSPORT,           4400        17500
                                PA VOR/DME.
WILLIAMSPORT, PA VOR/DME.....  DLMAR, PA WP...         4800        17500
------------------------------------------------------------------------
             Sec.   95.3449 RNAV Route T449 Is Added To Read
------------------------------------------------------------------------
KITHE, PA FIX................  GEERI, PA FIX..         2700        17500
GEERI, PA FIX................  LANCASTER, PA         * 2400        17500
                                VOR/DME.
    * 1900--MOCA
LANCASTER, PA VOR/DME........  KERYN, PA FIX..         3000        17500
KERYN, PA FIX................  JUPAS, PA FIX..         3400        17500
JUPAS, PA FIX................  CHLSE, PA FIX..         3300        17500
CHLSE, PA FIX................  MARRC, PA FIX..         3700        17500

MARRC, PA FIX................  MEGSS, PA FIX..         3700        17500
MEGSS, PA FIX................  * MEATS, PA FIX         3700        17500
    * 4100--MCA MEATS, PA
     FIX, N BND
MEATS, PA FIX................  * OYUCA, PA FIX         4900        17500
    * 4200--MCA OYUCA, PA
     FIX, S BND
OYUCA, PA FIX................  BINGHAMTON, NY          3700        17500
                                VOR/DME.
------------------------------------------------------------------------
             Sec.   95.3460 RNAV Route T460 Is Added To Read
------------------------------------------------------------------------
PHILIPSBURG, PA VORTAC.......  WILLIAMSPORT,           4900        17500
                                PA VOR/DME.
WILLIAMSPORT, PA VOR/DME.....  NOSEE, PA FIX..         4700        17500
NOSEE, PA FIX................  * HANCOCK, NY           4100        17500
                                VOR/DME.
    * 4600--MCA HANCOCK, NY
     VOR/DME, E BND
HANCOCK, NY VOR/DME..........  RIMBA, NY FIX..         5800        17500
RIMBA, NY FIX................  * SAGES, NY FIX         6400        17500
    * 6300--MCA SAGES, NY
     FIX, W BND
SAGES, NY FIX................  SASHA, MA FIX..         6100        17500
SASHA, MA FIX................  TOMES, MA FIX..       * 4100        17500
    * 3500--MOCA
TOMES, MA FIX................  BARNES, MA              3400        17500
                                VORTAC.
BARNES, MA VORTAC............  GLYDE, MA FIX..         3000        17500
------------------------------------------------------------------------
             Sec.   95.3469 RNAV Route T469 Is Added To Read
------------------------------------------------------------------------
TASEY, TX WP.................  RICH MOUNTAIN,          4300        17500
                                OK VORTAC.
------------------------------------------------------------------------
             Sec.   95.3472 RNAV Route T472 Is Added To Read
------------------------------------------------------------------------
TASEY, TX WP.................  HOT SPRINGS, AR         3000        17500
                                VOR/DME.
------------------------------------------------------------------------
             Sec.   95.3479 RNAV Route T479 Is Added To Read
------------------------------------------------------------------------
DNVIL, VA WP.................  ENTUK, VA FIX..         2800        17500
ENTUK, VA FIX................  PIGGS, VA FIX..         3500        17500
PIGGS, VA FIX................  * DEWET, VA FIX         3600        17500
    * 4300--MCA DEWET, VA
     FIX, NW BND
DEWET, VA FIX................  DBRAH, VA WP...         5300        17500
DBRAH, VA WP.................  NATTS, WV FIX..         6000        17500
NATTS, WV FIX................  VELLI, WV FIX..         7000        17500
VELLI, WV FIX................  AHCIN, WV FIX..         6900        17500
AHCIN, WV FIX................  ELKINS, WV            * 5900        17500
                                VORTAC.
    * 5300--MOCA
------------------------------------------------------------------------
                 Sec.   95.4000 High Altitude RNAV Route
           Sec.   95.4445 RNAV Route Q445 Is Amended To Delete
------------------------------------------------------------------------
PAACK, NC WP.................  JAMIE, VA FIX..      * 18000        45000
    * 18000-GNSS MEA
    * DME/DME/IRU MEA
JAMIE, VA FIX................  CONFR, MD WP...      * 18000        45000
    * 18000-GNSS MEA
    * DME/DME/IRU MEA
CONFR, MD WP.................  RADDS, DE FIX..      * 18000        45000
    * 18000-GNSS MEA
    * DME/DME/IRU MEA
RADDS, DE FIX................  WNSTN, NJ WP...      * 18000        45000
    * 18000-GNSS MEA
    * DME/DME/IRU MEA
WNSTN, NJ WP.................  AVALO, NJ FIX..      * 18000        45000
    * 18000-GNSS MEA
    * DME/DME/IRU MEA
AVALO, NJ FIX................  BRIGS, NJ FIX..      * 18000        45000
    * 18000-GNSS MEA
    * DME/DME/IRU MEA
BRIGS, NJ FIX................  SHAUP, OA WP...      * 18000        45000
    * 18000-GNSS MEA
    * DME/DME/IRU MEA
------------------------------------------------------------------------

------------------------------------------------------------------------
               From                           To                 MEA
------------------------------------------------------------------------
                    Sec.   95.6001 Victor Route--U.S.
       Sec.   95.6010 VOR Federal Airway V10 Is Amended To Delete
------------------------------------------------------------------------
YOUNGSTOWN, OH VORTAC............  VOLAN, PA FIX...........       * 5000
    * 3000--MOCA
    * 3000--GNSS MEA
VOLAN, PA FIX....................  TALLS, PA WP............       * 5000
    * 3200--MOCA
    * 3300--GNSS MEA
TALLS, PA WP.....................  * REVLOC, PA VOR/DME....
                                   SE BND..................         4200
                                   NW BND..................         5000
    * 5000--MCA REVLOC, PA VOR/
     DME, SE BND
REVLOC, PA VOR/DME...............  JUNEY, PA FIX...........       * 5000
                                                              MAA--12000
    * 5000--GNSS MEA
JUNEY, PA FIX....................  LANCASTER, PA VOR/DME...       * 5000
    * 3600--MOCA
------------------------------------------------------------------------
    Sec.   95.6020 VOR Federal Airway V20 Is Amended To Read in Part
------------------------------------------------------------------------
MONROEVILLE, AL VORTAC...........  MONTGOMERY, AL VORTAC...         2300
------------------------------------------------------------------------
    Sec.   95.6075 VOR Federal Airway V75 Is Amended To Read in Part
------------------------------------------------------------------------
BELLAIRE, OH VOR/DME.............  ATWOO, OH FIX...........       * 6000
    * 3100--MOCA
------------------------------------------------------------------------
    Sec.   95.6097 VOR Federal Airway V97 Is Amended To Read in Part
------------------------------------------------------------------------
LA BELLE, FL VORTAC..............  ROGAN, FL FIX...........
                                   SE BND..................       * 2000
                                   NW BND..................       * 5000
    * 2000--GNSS MEA
------------------------------------------------------------------------
    Sec.   95.6103 VOR Federal Airway V103 Is Amended To Read in Part
------------------------------------------------------------------------
CLARKSBURG, WV VOR/DME...........  BELLAIRE, OH VOR/DME....       * 3400
    * CLARKSBURG R-335 UNUSABLE,
     USE BELLAIR R-158
BELLAIRE, OH VOR/DME.............  ATWOO, OH FIX...........       * 6000
    * 3100--MOCA
ATWOO, OH FIX....................  AKRON, OH VOR/DME.......         3100
------------------------------------------------------------------------
    Sec.   95.6123 VOR Federal Airway V123 Is Amended To Read in Part
------------------------------------------------------------------------
ALBANY, NY VORTAC................  CAMBRIDGE, NY VOR/DME...       * 4000
    * ALBANY R-067 UNUSABLE, USE
     CAMBRIDGE R-248
------------------------------------------------------------------------
    Sec.   95.6137 VOR Federal Airway V137 Is Amended To Read in Part
------------------------------------------------------------------------
IMPERIAL, CA VORTAC..............  BRAWL, CA FIX...........       * 3700
    * 2300--MOCA
------------------------------------------------------------------------
       Sec.   95.6210 VOR Federal Airway V210 Is Amended To Delete
------------------------------------------------------------------------
REVLOC, PA VOR/DME...............  BLINK, PA FIX...........         4500
BLINK, PA FIX....................  HARRISBURG, PA VORTAC...         4000
------------------------------------------------------------------------
       Sec.   95.6314 VOR Federal Airway V314 Is Amended To Delete
------------------------------------------------------------------------
U.S. CANADIAN BORDER.............  PATTA, ME WP............       * 6000
    * 3900--MOCA
PATTA, ME WP.....................  MILLINOCKET, ME VOR/DME.       * 6000
    * 3900--MOCA
------------------------------------------------------------------------
                 Sec.   95.6388 VOR Federal Airway V388
------------------------------------------------------------------------
       Is Amended by Adding

SEAL BEACH, CA VORTAC............  AHEIM, CA FIX...........       * 3000
    * 2200--MOCA
AHEIM, CA FIX....................  DOWDD, CA FIX...........         4000
DOWDD, CA FIX....................  PARADISE, CA VORTAC.....         4400
    Is Amended To Read in Part

PARADISE, CA VORTAC..............  ACINS, CA FIX...........

                                   W BND...................       * 5300
                                   E BND...................       * 7000
    * 5300--MOCA
------------------------------------------------------------------------
    Sec.   95.6395 VOR Federal Airway V395 Is Amended To Read in Part
------------------------------------------------------------------------
NOGALES, AZ VOR/DME..............  U.S. MEXICAN BORDER.....      * 10000
    * 8000--MOCA
------------------------------------------------------------------------
       Sec.   95.6456 VOR Federal Airway V456 Is Amended To Delete
------------------------------------------------------------------------
MANKATO, MN VOR/DME..............  FLYING CLOUD, MN VOR/DME       * 2900
    * 2400--MOCA
------------------------------------------------------------------------
       Sec.   95.6469 VOR Federal Airway V469 Is Amended To Delete
------------------------------------------------------------------------
JOHNSTOWN, PA VOR/DME............  ST THOMAS, PA TACAN.....         5000
ST THOMAS, PA TACAN..............  BADDI, PA FIX...........       * 5000
    * 4000--MOCA
BADDI, PA FIX....................  HARRISBURG, PA VORTAC...         4000
------------------------------------------------------------------------
       Sec.   95.6474 VOR Federal Airway V474 Is Amended To Delete
------------------------------------------------------------------------
ST THOMAS, PA TACAN..............  NOENO, PA FIX...........       * 5000
    * 4000--MOCA
NOENO, PA FIX....................  DELRO, PA FIX...........       * 5000
    * 3400--MOCA
    * 3400--GNSS MEA
DELRO, PA FIX....................  * MODENA, PA VORTAC.....     ** 10000
    * 10000--MCA MODENA, PA
     VORTAC, W BND
    ** 4000--GNSS MEA
------------------------------------------------------------------------
    Sec.   95.6479 VOR Federal Airway V479 Is Amended To Read in Part
------------------------------------------------------------------------
MENGE, NJ FIX....................  YARDLEY, PA VOR/DME.....
                                   N BND...................         2000
                                   S BND...................         4000
------------------------------------------------------------------------
                 Sec.   95.6501 VOR Federal Airway V501
------------------------------------------------------------------------
       Is Amended by Adding

HAGERSTOWN, MD VOR...............  GGRIF, PA FIX...........         4100
GGRIF, PA FIX....................  PHILIPSBURG, PA VORTAC..         4900
       Is Amended To Delete

HAGERSTOWN, MD VOR...............  ST THOMAS, PA TACAN.....         4000
ST THOMAS, PA TACAN..............  PHILIPSBURG, PA VORTAC..       * 4500
    * 4000--MOCA
------------------------------------------------------------------------
 Sec.   95.6402 Hawaii VOR Federal Airway V2 Is Amended To Read in Part
------------------------------------------------------------------------
LANAI, HI VORTAC.................  KEIKI, HI FIX...........         5000
------------------------------------------------------------------------
 Sec.   95.6421 Hawaii VOR Federal Airway V21 Is Amended To Read in Part
------------------------------------------------------------------------
LANAI, HI VORTAC.................  KEIKI, HI FIX...........         5000
------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
              Airway Segment                                         Changeover Points
----------------------------------------------------------------------------------------------------------------
                   From                                 To                Distance               From
----------------------------------------------------------------------------------------------------------------
                              Sec.   95.8003 VOR Federal Airways Changeover Points
                                   V501 Is Amended To Delete Changeover Point
----------------------------------------------------------------------------------------------------------------
ST THOMAS, PA VORTAC.....................  PHILIPSBURG, PA VORTAC.....           22  ST THOMAS.
----------------------------------------------------------------------------------------------------------------
                                   Sec.   95.8005 JET Route Changeover Points
                                   J523 Is Amended To Modify Changeover Point
----------------------------------------------------------------------------------------------------------------
BRYCE CANYON, UT VORTAC..................  ELY, NV VOR/DME............          134  BRYCE CANYON.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2023-24424 Filed 11-3-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 28 (Friday, February 10, 2023)]
[Notices]
[Pages 8839-8841]
[FR Doc No: 2023-02892]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC23-54-000.
    Applicants: Evergy Kansas Central, Inc., Evergy, Inc., Persimmon
Creek Wind Farm 1, LLC.
    Description: Joint Application for Authorization Under Section 203
of the Federal Power Act of Evergy Kansas Central, Inc., et al.
    Filed Date: 2/6/23.
    Accession Number: 20230206-5088.
    Comment Date: 5 p.m. ET 2/27/23.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG23-80-000.
    Applicants: Lockhart ESS, LLC.
    Description: Lockhart ESS, LLC submits Notice of Self-Certification
of Exempt Wholesale Generator Status.
    Filed Date: 2/3/23.
    Accession Number: 20230203-5205.
    Comment Date: 5 p.m. ET 2/24/23.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-1841-028; ER10-1849-030; ER10-1851-018; ER10-
1852-076; ER10-1857-021; ER10-1890-025; ER10-1899-020; ER13-712-032;
ER13-752-019; ER13-1991-026; ER13-1992-026; ER15-2582-014; ER15-2676-
023; ER16-1672-021; ER17-804-004; ER17-2152-017; ER18-882-017; ER18-
1534-012; ER18-1863-015; ER18-1978-011; ER19-987-015; ER19-1003-015;
ER19-1393-015; ER19-1394-015; ER19-2269-008; ER19-2437-011; ER19-2461-
011; ER20-122-009; ER20-1769-009; ER20-1980-008; ER20-1986-007; ER20-
1987-010; ER20-2049-007; ER21-1320-005; ER21-1519-005; ER21-1682-005;
ER21-1879-006; ER21-2118-008; ER21-2293-008; ER21-2296-007; ER22-381-
006; ER22-2518-002; ER22-2634-002; ER23-71-001; ER22-2516-001.
    Applicants: Chaves County Solar II, LLC, Buena Vista Energy Center,
LLC, Buffalo Ridge Wind, LLC, Clearwater Wind I, LLC, Dunns Bridge
Solar Center, LLC, Ensign Wind Energy, LLC, Fish Springs Ranch Solar,
LLC, Dodge Flat Solar, LLC, Farmington Solar, LLC, Elora Solar, LLC,
Cool Springs Solar, LLC, Crystal Lake Wind Energy III, LLC, Cedar
Springs Wind III, LLC, Cerro Gordo Wind, LLC, Day County Wind I, LLC,
Cedar Springs Wind, LLC, Chicot Solar, LLC, Crowned Ridge
Interconnection, LLC, Crowned Ridge Wind, LLC, Emmons-Logan Wind, LLC,
Dougherty County Solar, LLC, Endeavor Wind II, LLC, Endeavor Wind I,
LLC, Crystal Lake Wind Energy II, LLC, Crystal Lake Wind Energy I, LLC,
Casa Mesa Wind, LLC, Coolidge Solar I, LLC, East Hampton Energy Storage
Center, LLC, Elk City Renewables II, LLC, Cottonwood Wind Project, LLC,
Coram California Development, L.P., Chaves County Solar, LLC, Cedar
Bluff Wind, LLC, Carousel Wind Farm, LLC, Desert Sunlight 300, LLC,
Desert Sunlight 250, LLC, Energy Storage Holdings, LLC, Cimarron Wind
Energy, LLC, FPL Energy Illinois Wind, LLC, FPL Energy Green Power
Wind, LLC, FPL Energy Cape, LLC, Florida Power & Light

Company, ESI Vansycle Partners, L.P., Elk City Wind, LLC, Butler Ridge
Wind Energy Center, LLC.
    Description: Notice of Change in Status of NextEra Companies, et
al.
    Filed Date: 1/31/23.
    Accession Number: 20230131-5515.
    Comment Date: 5 p.m. ET 2/21/23.

    Docket Numbers: ER10-1907-027; ER10-1918-028; ER10-1930-018; ER10-
1931-019; ER10-1932-021; ER10-1935-022; ER10-1950-028; ER10-1962-025;
ER11-2160-025; ER11-2642-024; ER11-3635-020; ER12-1228-031; ER13-2112-
020; ER13-2147-008; ER14-2447-002; ER15-2101-015; ER15-2477-018; ER15-
2601-012; ER16-90-018; ER16-2275-019; ER17-2340-015; ER18-1952-014;
ER18-2246-017; ER19-1392-010; ER19-2389-010; ER19-2398-013; ER20-2019-
008; ER20-2064-009; ER20-2690-009; ER21-254-007; ER21-1953-007; ER21-
2225-007; ER22-1982-004.
    Applicants: Great Prairie Wind, LLC, Irish Creek Wind, LLC,
Heartland Divide Wind II, LLC, Harmony Florida Solar, LLC, Jordan Creek
Wind Farm LLC, High Majestic Wind I, LLC, Gray County Wind, LLC,
Hancock County Wind, LLC, Grazing Yak Solar, LLC, High Lonesome Mesa
Wind, LLC, Heartland Divide Wind Project, LLC, Gulf Power Company,
Golden Hills North Wind, LLC, Kingman Wind Energy I, LLC, Golden Hills
Interconnection, LLC, Green Mountain Storage, LLC, Golden Hills Wind,
LLC, Golden West Power Partners, LLC, Granite Reliable Power, LLC,
Frontier Utilities Northeast LLC, Genesis Solar, LLC, High Majestic
Wind II, LLC, Hatch Solar Energy Center I, LLC, FPL Energy South Dakota
Wind, LLC,FPL Energy Montezuma Wind, LLC, High Winds, LLC, Garden Wind,
LLC, FPL Energy Wyman IV, LLC, FPL Energy Wyman, LLC, FPL Energy
Vansycle, L.L.C., FPL Energy Stateline II, Inc., FPL Energy North
Dakota Wind II, LLC, FPL Energy North Dakota Wind, LLC.
    Description: Notice of Change in Status of NextEra Companies, et
al.
    Filed Date: 2/1/23.
    Accession Number: 20230201-5270.
    Comment Date: 5 p.m. ET 2/22/23.

    Docket Numbers: ER10-1966-020; ER11-4462-076; ER12-895-029; ER12-
2225-019; ER12-2226-019; ER14-21-016; ER14-1630-016; ER14-2138-016;
ER14-2707-026; ER15-1375-019; ER16-1354-014; ER16-1872-018; ER16-2276-
019; ER16-2443-015; ER17-1774-010; ER18-772-010; ER18-1535-011; ER18-
1771-017; ER18-2003-015; ER18-2066-010; ER18-2182-016; ER20-1907-008;
ER20-2695-010; ER21-2117-007; ER21-2149-007; ER21-2699-008; ER22-2536-
002; ER23-489-002.
    Applicants: Neptune Energy Center, LLC, Kossuth County Wind, LLC,
Minco Wind Energy III, LLC, Minco Wind Energy II, LLC, Little Blue Wind
Project, LLC, Mohave County Wind Farm LLC, Minco Wind I, LLC, Minco IV
& V Interconnection, LLC, Minco Wind IV, LLC, Lorenzo Wind, LLC,
Langdon Renewables, LLC, Montauk Energy Storage Center, LLC, New Mexico
Wind, LLC, NextEra Energy Bluff Point, LLC, NextEra Blythe Solar Energy
Center, LLC, Kingman Wind Energy II, LLC, Marshall Solar, LLC, Live Oak
Solar, LLC, McCoy Solar, LLC, Mammoth Plains Wind Project, LLC, Limon
Wind III, LLC, Mantua Creek Solar, LLC, Mountain View Solar, LLC, Limon
Wind, LLC, Limon Wind II, LLC, Minco Wind Interconnection Services,
LLC,NEPM II, LLC, Logan Wind Energy LLC.
    Description: Notice of Change in Status of NextEra Companies, et
al.
    Filed Date: 2/1/23.
    Accession Number: 20230201-5271.
    Comment Date: 5 p.m. ET 2/22/23.

    Docket Numbers: ER10-2005-028; ER15-1418-019; ER15-1883-019; ER15-
1925-024; ER16-91-018; ER16-632-018; ER16-2190-020; ER16-2191-020;
ER16-2453-021; ER18-2118-016; ER19-1073-009; ER19-2373-011; ER19-2901-
010; ER20-819-012; ER20-820-010; ER20-2179-008; ER21-1990-006; ER21-
2294-007; ER21-2304-007; ER21-2674-006; ER22-415-006; ER23-568-001.
    Applicants: Big Cypress Solar, LLC, Arlington Energy Center III,
LLC, Borderlands Wind, LLC, Arlington Solar, LLC, Arlington Energy
Center II, LLC, Blackwell Wind Energy, LLC, Baldwin Wind Energy, LLC,
Blythe Solar IV, LLC, Blythe Solar III, LLC, Bronco Plains Wind, LLC,
Ashtabula Wind I, LLC, Alta Wind VIII, LLC, Armadillo Flats Wind
Project, LLC, Brady Interconnection, LLC, Brady Wind II, LLC, Brady
Wind, LLC, Blythe Solar II, LLC, Blythe Solar 110, LLC, Breckinridge
Wind Project, LLC, Adelanto Solar, LLC, Adelanto Solar II, LLC,
Ashtabula Wind II, LLC.
    Description: Notice of Change in Status of NextEra Companies, et
al.
    Filed Date: 1/31/23.
    Accession Number: 20230131-5514.
    Comment Date: 5 p.m. ET 2/21/23.

    Docket Numbers: ER11-2044-040; ER10-1520-011; ER10-1521-011; ER10-
1522-008; ER12-162-034; ER13-1266-045; ER15-2211-042; ER20-2493-006;
ER21-2280-004.
    Applicants: Independence Wind Energy LLC, OTCF, LLC, MidAmerican
Energy Services, LLC, CalEnergy, LLC, Bishop Hill Energy II LLC,
Occidental Chemical Corporation, Occidental Power Marketing, L.P.,
Occidental Power Services, Inc., MidAmerican Energy Company.
    Description: Notice of Non-Material Change in Status of MidAmerican
Energy Company, et al.
    Filed Date: 1/31/23.
    Accession Number: 20230131-5513.
    Comment Date: 5 p.m. ET 2/21/23.

    Docket Numbers: ER23-1051-000.
    Applicants: Southwestern Electric Power Company.
    Description: Tariff Amendment: Rate Schedule 305, System
Integration Agreement Concurrence to be effective 5/22/2022.
    Filed Date: 2/3/23.
    Accession Number: 20230203-5186.
    Comment Date: 5 p.m. ET 2/24/23.

    Docket Numbers: ER23-1052-000.
    Applicants: Union Atlantic Electricity.
    Description: Notice of Cancellation of Market Based Rate Tariff of
Union Atlantic Electricity.
    Filed Date: 2/3/23.
    Accession Number: 20230203-5239.
    Comment Date: 5 p.m. ET 2/24/23.

    Docket Numbers: ER23-1053-000.
    Applicants: Merino Solar, LLC.
    Description: Request for Limited Waiver, et al. of Merino Solar,
LLC.
    Filed Date: 2/3/23.
    Accession Number: 20230203-5246.
    Comment Date: 5 p.m. ET 2/24/23.

    Docket Numbers: ER23-1054-000.
    Applicants: PPL Electric Utilities Corporation, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: PPL Electric Utilities
Corporation submits tariff filing per 35.13(a)(2)(iii: PPL submits SA
No. 6789 Construction Service Agreement to be effective 1/9/2023.
    Filed Date: 2/6/23.
    Accession Number: 20230206-5073.
    Comment Date: 5 p.m. ET 2/27/23.

    Take notice that the Commission received the following public
utility holding company filings:

    Docket Numbers: PH23-4-000.
    Applicants: Unison Energy, LLC, AIM Universal Holdings, LLC, Hunt
Companies, Inc.
    Description: Unison Energy, LLC, et al., submits FERC 65-A
Exemption Notification.
    Filed Date: 2/6/23.
    Accession Number: 20230206-5087.
    Comment Date: 5 p.m. ET 2/27/23.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/

fercgensearch.asp) by querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: February 6, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-02892 Filed 2-9-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 70 (Tuesday, April 12, 2011)]
[Notices]
[Pages 20387-20388]
[FR Doc No: 2011-8578]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request; Copies Available From: Securities and Exchange
Commission Office of Investor Education and Advocacy Washington, DC
20549-0213.

Extension:
Form CB; OMB Control No. 3235-0518; SEC File No. 270-457.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget this request for extension of the previously approved
collection of information discussed below.
    Form CB (17 CFR 239.800) is a document filed in connection with a
tender offer for a foreign private issuer. This form is used to report
an issuer tender offer conducted in compliance with Exchange Act Rule
13e-4(h)(8) (17 CFR 240.13e-4(h)(8)) and a third-party tender offer
conducted in compliance with Exchange Act Rule 14d-1(c) (17 CFR
240.14d-1(c)). Form CB is also used by a subject company pursuant to
Exchange Act Rule 14e-2(d) (17 CFR 240.14e-2(d)). This information is
made available to the public. Information provided on Form CB is
mandatory. Form CB takes approximately 0.5 hours per response to
prepare and is filed by approximately 200 respondents annually. We
estimate that 25% of the 0.5 hours per response (0.125 hours) is
prepared by the respondent for an annual reporting burden of 25 hours
(0.125 hours per response x 200 responses).
    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 control number.
    The public may view the background documentation for this
information collection at the following Web site, http://www.reginfo.gov. Comments should be directed to: (i) Desk Officer for
the Securities and Exchange Commission, Office of Information and
Regulatory Affairs, Office of Management and Budget, Room 10102, New
Executive Office Building, Washington, DC 20503, or by sending an e-
mail to<EMAIL_ADDRESS>and (ii) Thomas Bayer, Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 6432 General Green Way, Alexandria,

VA 22312 or send an e-mail to<EMAIL_ADDRESS>Comments must be
submitted to OMB within 30 days of this notice.

    Dated: April 8, 2011.
Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-8578 Filed 4-11-11; 8:45 am]
BILLING CODE 8011-01-P