Proposed Adjustments to the Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2023, 74512-74520 [2023-23931]
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Federal Register / Vol. 88, No. 209 / Tuesday, October 31, 2023 / Notices
Limited disclosure of business
proprietary information (BPI) under an
administrative protective order (APO)
and BPI service list.—Pursuant to
§ 207.7(a) of the Commission’s rules, the
Secretary will make BPI gathered in
these investigations available to
authorized applicants representing
interested parties (as defined in 19
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the investigations, provided that the
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receive BPI under the APO.
Conference.—The Office of
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preliminary phase of these
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Requests to appear at the conference
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NOT FILE ON EDIS) on or before
November 13, 2023. Please provide an
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submitting a short statement.
Please note the Secretary’s Office will
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Written submissions.—As provided in
§§ 201.8 and 207.15 of the
Commission’s rules, any person may
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§§ 201.6, 207.3, and 207.7 of the
Commission’s rules. The Commission’s
Handbook on Filing Procedures,
available on the Commission’s website
at https://www.usitc.gov/documents/
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handbook_on_filing_procedures.pdf,
elaborates upon the Commission’s
procedures with respect to filings.
In accordance with §§ 201.16(c) and
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Certification.—Pursuant to § 207.3 of
the Commission’s rules, any person
submitting information to the
Commission in connection with these
investigations must certify that the
information is accurate and complete to
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making the certification, the submitter
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during these investigations may be
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and contract personnel (a) for
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under 5 U.S.C. Appendix 3; or (ii) by
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Authority: These investigations are
being conducted under authority of title
VII of the Tariff Act of 1930; this notice
is published pursuant to § 207.12 of the
Commission’s rules.
By order of the Commission.
Issued: October 25, 2023.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2023–23947 Filed 10–30–23; 8:45 am]
BILLING CODE 7020–02–P
INTERNATIONAL TRADE
COMMISSION
[USITC SE–23–052]
Sunshine Act Meetings
United
States International Trade Commission.
TIME AND DATE: November 3, 2023 at
11:00 a.m.
PLACE: Room 101, 500 E Street SW,
Washington, DC 20436, Telephone:
(202) 205–2000.
STATUS: Open to the public.
MATTERS TO BE CONSIDERED:
AGENCY HOLDING THE MEETING:
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1. Agendas for future meetings: none.
2. Minutes.
3. Ratification List.
4. Commission vote on Inv. No. 731–
TA–472 (Fifth Review) (Silicon Metal
from China). The Commission currently
is scheduled to complete and file its
determinations and views of the
Commission on November 14, 2023.
5. Outstanding action jackets: none.
CONTACT PERSON FOR MORE INFORMATION:
Sharon Bellamy, Supervisory Hearings
and Information Officer, 202–205–2000.
The Commission is holding the
meeting under the Government in the
Sunshine Act, 5 U.S.C. 552(b). In
accordance with Commission policy,
subject matter listed above, not disposed
of at the scheduled meeting, may be
carried over to the agenda of the
following meeting.
By order of the Commission.
Issued: October 27, 2023.
Sharon Bellamy,
Supervisory Hearings and Information
Officer.
[FR Doc. 2023–24073 Filed 10–27–23; 11:15 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1051A]
Proposed Adjustments to the
Aggregate Production Quotas for
Schedule I and II Controlled
Substances and Assessment of
Annual Needs for the List I Chemicals
Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2023
Drug Enforcement
Administration, Department of Justice.
ACTION: Notice with request for
comments.
AGENCY:
The Drug Enforcement
Administration (DEA) proposes to
adjust the 2023 aggregate production
quotas for several controlled substances
in schedules I and II of the Controlled
Substances Act (CSA) and the
assessment of annual needs for the list
I chemical phenylpropanolamine.
DATES: Interested persons may file
written comments on this notice in
accordance with 21 CFR 1303.13(c) and
1315.13(d). Electronic comments must
be submitted, and written comments
must be postmarked, on or before
November 30, 2023. 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.
SUMMARY:
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Based on comments received in
response to this notice, the
Administrator may hold a public
hearing on one or more issues raised. In
the event the Administrator decides in
her sole discretion to hold such a
hearing, the Administrator will publish
a notice of any such hearing in the
Federal Register. After consideration of
any comments or objections, or after a
hearing, if one is held, the
Administrator will publish in the
Federal Register a final order
establishing the 2023 adjusted aggregate
production quotas for schedule I and II
controlled substances, and an adjusted
assessment of annual needs for the list
I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine, as relevant.
ADDRESSES: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–1051A’’ on all
correspondence, including any
attachments. DEA 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 https://
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 that duplicate electronic
submissions 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, Attention: DEA Federal
Register Representative/DRW, 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: 571–776–3882.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments
received in response to this docket are
considered part of the public record.
The Drug Enforcement Administration
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(DEA) will make comments available for
public inspection online at https://
www.regulations.gov. Such information
includes personal or business identifiers
(such as name, address, state or Federal
identifiers, etc.) voluntarily submitted
by the commenter. Generally, all
information voluntarily submitted by
the commenter, unless clearly marked
as Confidential Information in the
method described below, will be
publicly posted. Comments may be
submitted anonymously. The Freedom
of Information Act applies to all
comments received.
Commenters submitting comments
which include personal identifying
information (PII), confidential, or
proprietary business information that
the commenter does not want made
publicly available should submit two
copies of the comment. One copy must
be marked ‘‘CONTAINS
CONFIDENTIAL INFORMATION’’ and
should clearly identify all PII or
business information the commenter
does not want to be made publicly
available, including any supplemental
materials. DEA will review this copy,
including the claimed PII and
confidential business information, in its
consideration of comments. The second
copy should be marked ‘‘TO BE
PUBLICLY POSTED’’ and must have all
claimed confidential PII and business
information already redacted. DEA will
post only the redacted comment on
https://www.regulations.gov for public
inspection.
For easy reference, an electronic copy
of this document is available at https://
www.regulations.gov.
Legal Authority and Background
Section 306 of the CSA (21 U.S.C.
826) requires the Attorney General to
establish aggregate production quotas
(APQ) for each basic class of controlled
substance listed in schedules I and II
and for the list I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine. The Attorney
General has delegated this function to
the Administrator of DEA.1
DEA established the 2023 APQ for
substances in schedules I and II and the
assessment of annual needs (AAN) for
the list I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine on December 2,
2022.2 That order stipulated that, in
accordance with 21 CFR 1303.13 and
1315.13, all APQ and AAN are subject
to adjustment.
Analysis for Proposed Adjusted 2023
Aggregate Production Quotas and
Assessment of Annual Needs
DEA proposes to adjust the
established 2023 APQ for certain
schedule I and II controlled substances
and the AAN for certain list I chemicals
to be manufactured in the United States
(U.S.) in 2023 to provide for the
estimated medical, scientific, research,
and industrial needs of the U.S., for
lawful export requirements, and for the
establishment and maintenance of
reserve stocks. These quotas do not
include imports of controlled
substances for use in industrial
processes.
Factors for Determining the Proposed
Adjustments
In determining the proposed
adjustments, the Administrator has
taken into account the factors in 21 CFR
1303.13 (adjustment of APQ for
controlled substances) and 21 CFR
1315.13 (adjustment of the AAN for
ephedrine, pseudoephedrine, and
phenylpropanolamine). The
Administrator is authorized to increase
or reduce the APQ and the AAN at any
time.3
DEA determined whether to propose
an adjustment of the APQ for 2023 by
considering the factors found at 21 CFR
1303.13(b): 4
(1) Changes in the demand for that class,
changes in the national rate of net disposal
of the class, changes in the rate of net
disposal of the class by registrants holding
individual manufacturing quotas for that
class, and changes in the extent of any
diversion in the class;
(2) Whether any increased demand for that
class, the national and/or individual rates of
net disposal of that class are temporary, short
term, or long term;
(3) Whether any increased demand for that
class can be met through existing inventories,
increased individual manufacturing quotas,
or increased importation, without increasing
the aggregate production quota, taking into
account production delays and the
probability that other individual
manufacturing quotas may be suspended
pursuant to Sec. 1303.24(b);
(4) Whether any decreased demand for that
class will result in excessive inventory
accumulation by all persons registered to
handle that class (including manufacturers,
distributors, practitioners, importers, and
3 21
1 28
CFR 0.100(b).
2 Established Aggregate Production Quotas for
Schedule I and II Controlled Substances and
Assessment of Annual Needs for the List I
Chemicals Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2023, 87 FR 74168
(December 2, 2022).
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74513
CFR 1303.13(a) and 1315.13(a).
recently adopted revisions to its
regulations for setting quotas, but that rule has not
yet taken effect and does not affect this notice
proposing some adjustments to the 2023 APQs.
Management of Quotas for Controlled Substances
and List I Chemicals, 88 FR 60117 (Aug. 31, 2023)
(effective Nov. 29, 2023).
4 DEA
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exporters), notwithstanding the possibility
that individual manufacturing quotas may be
suspended pursuant to Sec. 1303.24(b) or
abandoned pursuant to Sec. 1303.27;
(5) Other factors affecting medical,
scientific, research, and industrial needs in
the United States and lawful export
requirements, as the Administrator finds
relevant, including changes in the currently
accepted medical use in treatment with the
class or the substances which are
manufactured from it, the economic and
physical availability of raw materials for use
in manufacturing and for inventory purposes,
yield and stability problems, potential
disruptions to production (including possible
labor strikes), and recent unforeseen
emergencies such as floods and fires.
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DEA also considered updated
information obtained from 2022 yearend inventories, 2022 disposition data
submitted by quota applicants, changes
in estimates of the medical needs of the
U.S., export requirements, and other
information made available to DEA after
the initial APQ and AAN had been
established. Additional factors the
Administrator considered in calculating
the APQ, but not the AAN, include
product development requirements of
both bulk and finished dosage form
manufacturers.
After considering the changes in the
extent of diversion of all controlled
substances, as required by 21 CFR
1303.13(b)(1), DEA has determined that
any changes from the initial calculations
are slight and not statistically significant
from the estimates of diversion that DEA
applied to the initial APQ valuations.
DEA determined whether to propose
an adjustment of the AAN for 2023 by
considering the factors found at 21 CFR
1315.13(b) and summarized below:
(1) Changes in the demand for that
chemical, changes in the national rate of net
disposal of the chemical, and changes in the
rate of net disposal of the chemical by
registrants holding individual manufacturing
or import quotas for that chemical;
(2) Whether any increased demand for that
chemical, the national and/or changes in
individual rates of net disposal of that
chemical are temporary, short term, or long
term;
(3) Whether any increased demand for that
chemical can be met through existing
inventories, increased individual
manufacturing quotas, or increased
importation, without increasing the
assessment of annual needs, taking into
account production delays and the
probability that other individual
manufacturing quotas may be suspended
pursuant to Sec. 1315.24(b);
(4) Whether any decreased demand for that
chemical will result in excessive inventory
accumulation by all persons registered to
handle that chemical (including
manufacturers, distributors, importers, and
exporters), notwithstanding the possibility
that individual manufacturing quotas may be
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suspended pursuant to Sec. 1315.24(b) or
abandoned pursuant to Sec. 1315.27;
(5) Other factors affecting medical,
scientific, research, industrial, and
importation needs in the United States,
lawful export requirements, and reserve
stocks, as the Administrator finds relevant,
including changes in the currently accepted
medical use in treatment with the chemical
or the substances that are manufactured from
it, the economic and physical availability of
raw materials for use in manufacturing and
for inventory purposes, yield and stability
problems, potential disruptions to
production (including possible labor strikes),
and recent unforeseen emergencies such as
floods and fires.
In evaluating whether there is a need
for adjustment of the 2023 AAN for list
I chemicals, DEA used the calculation
methodology previously described in
the 2010 and 2011 assessment of annual
needs.5 DEA considered the total net
disposals of the list I chemicals for the
current and preceding two years, actual
and estimated inventories, projected
demand, industrial use, and export
requirements from data provided by
DEA registered manufacturers and
importers on the relevant quota
application forms.6
Additional Considerations Applicable to
Covered Controlled Substances
When setting APQ, the Administrator
must estimate the amount of diversion
of any substance that is considered a
‘‘covered controlled substance.’’ 7 The
covered controlled substances are
fentanyl, oxycodone, hydrocodone,
oxymorphone, and hydromorphone.8
DEA is required to ‘‘make appropriate
quota reductions, as determined by the
[Administrator], from the quota the
[Administrator] would have otherwise
established had such diversion not been
considered.’’ 9 When estimating
diversion, the Administrator ‘‘shall
consider information,’’ in consultation
with the Secretary of Health and Human
Services, the Administrator ‘‘determines
reliable on rates of overdose deaths and
abuse and overall public health impact
related to the covered controlled
substance in the United States;’’ and
‘‘may take into consideration’’ whatever
other sources of information they
determine reliable.10
DEA sent letters to the Centers for
Disease Control and Prevention (CDC),
and the states in February, April, and
5 74 FR 60294 (Nov. 20, 2009) and 75 FR 79407
(Dec. 20, 2010).
6 Id.
7 21 U.S.C. 826(i)(1)(A).
8 21 U.S.C. 826(i)(1)(A).
9 All functions vested in the Attorney General by
the CSA have been delegated to the Administrator
of DEA. 28 CFR 0.100(b); 21 U.S.C. 826(i)(1)(C).
10 21 U.S.C. 826(i)(1)(B).
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May 2023 requesting overdose death
and overprescribing data that could be
considered in estimating diversion. DEA
received information from the CDC in
April 2023 and received Prescription
Data Monitoring Program (PDMP) data
from the states in May and June 2023.
DEA considered this information in
developing the estimates of diversion
for the five covered controlled
substances for this proposed
adjustment.
To determine the estimates of
diversion, DEA also aggregated data for
each covered controlled substance from
the Drug Theft and Loss Reports. DEA
gathered data involving employee theft,
break-ins, armed robberies, and material
lost in transit. DEA calculated the
metric weight in grams of each active
pharmaceutical ingredient (API) of the
controlled substances being diverted as
identified in these reports. In
calculating the estimates of diversion,
DEA utilized the same methodology as
published in the Proposed APQ for
Schedule I and II Controlled Substances
and AAN for the List I Chemicals
Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2023.11
Below, DEA provides an updated chart
showing estimations of diversion for
each of the covered controlled
substances.
DIVERSION ESTIMATES FOR 2023 (g)
Fentanyl
59
Hydrocodone ..................................
Hydromorphone ..............................
Oxycodone ......................................
Oxymorphone .................................
133,004
595
174,797
109
Proposed Adjustments for the 2023
Aggregate Production Quotas and
Assessment of Annual Needs
DEA is proposing increases to the
APQ for the following schedule I
substances: all other
tetrahydrocannabinol, delta-9tetrahydrocannabinol, ibogaine,
psilocybin, and psilocyn. These
proposed increases are to support
research and clinical trials by DEAregistered schedule I researchers. These
proposed increases demonstrate DEA’s
support for research with schedule I
controlled substances.
DEA established the 2023 APQs for
substances in schedules I and II on
December 2, 2022.12 Subsequent to that
publication, DEA published in the
Federal Register final rules to
permanently schedule four synthetic
11 87
12 87
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FR 63091 (October 18, 2022).
FR 74168.
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substance methylphenidate (for sale) to
be manufactured in the United States to
provide for the estimated needs of the
United States and export requirements
in accordance with 21 U.S.C. 826(h).14
This adjustment was necessary to
ensure that the United States has an
adequate and uninterrupted supply of
methylphenidate (for sale) to meet
legitimate patient needs both
domestically and globally.
drugs under the CSA.13 The specific
synthetic substances are eutylone,
mesocarb, methiopropamine, and
zipeprol. As a result, these substances
will continue to be subject to the CSA
schedule I controls and DEA is
proposing to assign individual APQ for
each substance pursuant to 21 U.S.C.
826 and 21 CFR part 1303.
DEA previously adjusted the
established 2023 aggregate production
quota for the schedule II-controlled
The Administrator, therefore,
proposes to adjust the 2023 APQ for the
schedule I controlled substances of all
other tetrahydrocannabinol, delta-9tetrahydrocannabinol, eutylone,
ibogaine, mesocarb, methiopropamine,
psilocybin, psilocyn, and zipeprol. The
proposed adjusted APQ and AAN, as
expressed in grams of anhydrous acid or
base, are as follows:
Established
2023 quotas
(g)
Basic class
Proposed revised
2023 quotas
(g)
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Schedule I
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine ..........................................................................................................
1-(1-Phenylcyclohexyl)pyrrolidine ................................................................................................................
1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine ..........................................................................................
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) ....................................................................................
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) ...................................................................................
1-[1-(2-Thienyl)cyclohexyl]piperidine ...........................................................................................................
2′-fluoro 2-fluorofentanyl ..............................................................................................................................
1-Benzylpiperazine ......................................................................................................................................
1-Methyl-4-phenyl-4-propionoxypiperidine ...................................................................................................
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C–E) ..................................................................................
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C–D) ...............................................................................
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C–N) .................................................................................
2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C–P) .............................................................................
2-(2,5-Dimethoxyphenyl)ethanamine (2C–H) ..............................................................................................
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B–NBOMe; 2C–B–NBOMe; 25B;
Cimbi-36) ..................................................................................................................................................
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C–C) ................................................................................
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C–NBOMe; 2C–C–NBOMe;
25C; Cimbi-82) .........................................................................................................................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C–I) .....................................................................................
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I–NBOMe; 2C–I–NBOMe; 25I;
Cimbi-5) ....................................................................................................................................................
2,5-Dimethoxy-4-ethylamphetamine (DOET) ..............................................................................................
2,5-Dimethoxy-4-n-propylthiophenethylamine .............................................................................................
2,5-Dimethoxyamphetamine ........................................................................................................................
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–2) .......................................................................
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–4) ................................................................
3,4,5-Trimethoxyamphetamine ....................................................................................................................
3,4-Methylenedioxyamphetamine (MDA) ....................................................................................................
3,4-Methylenedioxymethamphetamine (MDMA) .........................................................................................
3,4-Methylenedioxy-N-ethylamphetamine (MDEA) .....................................................................................
3,4-Methylenedioxy-N-methylcathinone (methylone) ..................................................................................
3,4-Methylenedioxypyrovalerone (MDPV) ...................................................................................................
3–FMC; 3-Fluoro-N-methylcathinone ..........................................................................................................
3-Methylfentanyl ...........................................................................................................................................
3-Methylthiofentanyl .....................................................................................................................................
4-Bromo-2,5-dimethoxyamphetamine (DOB) ..............................................................................................
4-Bromo-2,5-dimethoxyphenethylamine (2–CB) .........................................................................................
4-Chloro-alpha-pyrrolidinovalerophenone (4-chloro-alpha-PVP) .................................................................
4–CN-Cumyl-Butinaca .................................................................................................................................
4,4′-Dimethylaminorex .................................................................................................................................
4-Fluoroisobutyryl fentanyl ...........................................................................................................................
4F–MDMB–BINACA ....................................................................................................................................
4–FMC; Flephedrone ...................................................................................................................................
4–MEC; 4-Methyl-N-ethylcathinone .............................................................................................................
4-Methoxyamphetamine ..............................................................................................................................
4-Methyl-2,5-dimethoxyamphetamine (DOM) ..............................................................................................
4-Methylaminorex ........................................................................................................................................
4-Methyl-N-methylcathinone (mephedrone) ................................................................................................
4-Methyl-alpha-ethylaminopentiophenone (4–MEAP) .................................................................................
4-Methyl-alpha-pyrrolidinohexiophenone (MPHP) .......................................................................................
4′-Methyl acetyl fentanyl ..............................................................................................................................
13 87 FR 70717 (November 21, 2022), 87 FR 71247
(November 22, 2022), 87 FR 20318 (April, 7 2022),
and 87 FR 32996 (June 1, 2022).
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25
10
30
30
30
30
100
PO 00000
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E:\FR\FM\31OCN1.SGM
31OCN1
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
30
30
no change.
no change.
25
30
no change.
no change.
30
25
25
25
30
30
30
12,000
12,000
40
5,200
35
25
30
30
5,100
25
25
25
30
30
30
25
25
150
25
25
45
25
25
30
14 Adjustment to the Aggregate Production Quota
for Methylphenidate (for Sale) for 2023, 88 FR
68147 (October 3, 2023).
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
74516
Federal Register / Vol. 88, No. 209 / Tuesday, October 31, 2023 / Notices
Established
2023 quotas
(g)
lotter on DSK11XQN23PROD with NOTICES1
Basic class
4-Methyl-a-pyrrolidinopropiophenone (4-MePPP) .......................................................................................
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol .................................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP–47,497 C8homolog) ..................................................................................................................................................
5F–AB–PINACA; (1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide .....
5F–ADB; 5F–MDMB–PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3dimethylbutanoate) ...................................................................................................................................
5F–CUMYL–P7AICA; 1-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine3carboximide ............................................................................................................................................
5F–CUMYL–PINACA ...................................................................................................................................
5F–EDMB–PINACA .....................................................................................................................................
5F–MDMB–PICA .........................................................................................................................................
5F–AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) ..........................
5F–APINACA; 5F–AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) ...............
5-Fluoro-PB–22; 5F–PB–22 ........................................................................................................................
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1Hindol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone ....
5-Methoxy-3,4-methylenedioxyamphetamine ..............................................................................................
5-Methoxy-N,N-diisopropyltryptamine ..........................................................................................................
5-Methoxy-N,N-dimethyltryptamine .............................................................................................................
AB–CHMINACA ...........................................................................................................................................
AB–FUBINACA ............................................................................................................................................
AB–PINACA .................................................................................................................................................
ADB–FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3carboxamide) ............................................................................................................................................
Acetorphine ..................................................................................................................................................
Acetyl Fentanyl ............................................................................................................................................
Acetyl-alpha-methylfentanyl .........................................................................................................................
Acetyldihydrocodeine ...................................................................................................................................
Acetylmethadol ............................................................................................................................................
Acryl Fentanyl ..............................................................................................................................................
ADB–PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) .............
AH–7921 ......................................................................................................................................................
All other tetrahydrocannabinol .....................................................................................................................
Allylprodine ..................................................................................................................................................
Alphacetylmethadol ......................................................................................................................................
alpha-Ethyltryptamine ..................................................................................................................................
Alphameprodine ...........................................................................................................................................
Alphamethadol .............................................................................................................................................
alpha-Methylfentanyl ....................................................................................................................................
alpha-Methylthiofentanyl ..............................................................................................................................
alpha-Methyltryptamine (AMT) ....................................................................................................................
alpha-Pyrrolidinobutiophenone (a-PBP) ......................................................................................................
alpha-pyrrolidinoheptaphenone (PV8) .........................................................................................................
alpha-pyrrolidinohexabophenone (a -PHP) .................................................................................................
alpha-Pyrrolidinopentiophenone (a-PVP) ....................................................................................................
Amineptine ...................................................................................................................................................
Aminorex ......................................................................................................................................................
Anileridine ....................................................................................................................................................
APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide) .................................................
Benzethidine ................................................................................................................................................
Benzylmorphine ...........................................................................................................................................
Betacetylmethadol .......................................................................................................................................
beta-Hydroxy-3-methylfentanyl ....................................................................................................................
beta-Hydroxyfentanyl ...................................................................................................................................
beta-Hydroxythiofentanyl .............................................................................................................................
beta-Methyl fentanyl ....................................................................................................................................
beta-Phenyl fentanyl ....................................................................................................................................
Betameprodine .............................................................................................................................................
Betamethadol ...............................................................................................................................................
Betaprodine ..................................................................................................................................................
Brorphine .....................................................................................................................................................
Bufotenine ....................................................................................................................................................
Butonitazene ................................................................................................................................................
Butylone .......................................................................................................................................................
Butyryl fentanyl ............................................................................................................................................
Cathinone .....................................................................................................................................................
Clonitazene ..................................................................................................................................................
Codeine methylbromide ...............................................................................................................................
Codeine-N-oxide ..........................................................................................................................................
Crotonyl Fentanyl .........................................................................................................................................
Cyclopentyl Fentanyl ...................................................................................................................................
Cyclopropyl Fentanyl ...................................................................................................................................
VerDate Sep<11>2014
17:18 Oct 30, 2023
Jkt 262001
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Frm 00116
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E:\FR\FM\31OCN1.SGM
31OCN1
Proposed revised
2023 quotas
(g)
25
50
no change.
no change.
40
25
no change.
no change.
25
no change.
25
25
25
25
25
25
25
25
25
25
11,000
30
50
30
no
no
no
no
no
no
no
no
no
no
no
no
no
no
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
30
25
100
30
30
25
25
50
30
15,000
25
25
25
25
25
30
30
25
25
25
25
25
30
25
20
25
25
30
25
30
30
30
30
30
25
4
25
30
15
30
25
30
40
25
30
192
25
30
20
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
350,000.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
74517
Federal Register / Vol. 88, No. 209 / Tuesday, October 31, 2023 / Notices
Established
2023 quotas
(g)
lotter on DSK11XQN23PROD with NOTICES1
Basic class
Cyprenorphine .............................................................................................................................................
d-9–THC ......................................................................................................................................................
Desomorphine ..............................................................................................................................................
Dextromoramide ..........................................................................................................................................
Diapromide ...................................................................................................................................................
Diethylthiambutene ......................................................................................................................................
Diethyltryptamine .........................................................................................................................................
Difenoxin ......................................................................................................................................................
Dihydromorphine ..........................................................................................................................................
Dimenoxadol ................................................................................................................................................
Dimepheptanol .............................................................................................................................................
Dimethylthiambutene ...................................................................................................................................
Dimethyltryptamine ......................................................................................................................................
Dioxyaphetyl butyrate ..................................................................................................................................
Dipipanone ...................................................................................................................................................
Drotebanol ...................................................................................................................................................
Ethylmethylthiambutene ...............................................................................................................................
Ethylone .......................................................................................................................................................
Etonitazene ..................................................................................................................................................
Etodesnitazene ............................................................................................................................................
Etorphine ......................................................................................................................................................
Etoxeridine ...................................................................................................................................................
Eutylone .......................................................................................................................................................
Fenethylline ..................................................................................................................................................
Fentanyl carbamate .....................................................................................................................................
Fentanyl related substances ........................................................................................................................
FUB–144 ......................................................................................................................................................
Flunitazene ..................................................................................................................................................
FUB–AKB48 .................................................................................................................................................
Fub-AMB, MMB-Fubinaca, AMB-Fubinaca .................................................................................................
Furanyl fentanyl ...........................................................................................................................................
Furethidine ...................................................................................................................................................
gamma-Hydroxybutyric acid ........................................................................................................................
Heroin ..........................................................................................................................................................
Hydromorphinol ............................................................................................................................................
Hydroxypethidine .........................................................................................................................................
Ibogaine .......................................................................................................................................................
Isobutyryl Fentanyl .......................................................................................................................................
Isotonitazine .................................................................................................................................................
JWH–018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole) .............................................................................
JWH–019 (1-Hexyl-3-(1-naphthoyl)indole) ..................................................................................................
JWH–073 (1-Butyl-3-(1-naphthoyl)indole) ...................................................................................................
JWH–081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole) ..............................................................................
JWH–122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole) ..................................................................................
JWH–200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole) ......................................................................
JWH–203 (1-Pentyl-3-(2-chlorophenylacetyl)indole) ...................................................................................
JWH–250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole) ...............................................................................
JWH–398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole) ...................................................................................
Ketobemidone ..............................................................................................................................................
Levomoramide .............................................................................................................................................
Levophenyacylmorphan ...............................................................................................................................
Lysergic acid diethylamide (LSD) ................................................................................................................
MAB–CHMINACA; ADB–CHMINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)1H-indazole-3-carboxamide) ....................................................................................................................
MDMB–CHMICA; MMB–CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3dimethylbutanoate) ...................................................................................................................................
MDMB–FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ..
MMB–CHMICA-(AMB–CHIMCA); Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3methylbutanoate .......................................................................................................................................
Marijuana .....................................................................................................................................................
Marijuana extract .........................................................................................................................................
Mecloqualone ...............................................................................................................................................
Mescaline .....................................................................................................................................................
Mesocarb .....................................................................................................................................................
Methaqualone ..............................................................................................................................................
Methcathinone .............................................................................................................................................
Methiopropamine .........................................................................................................................................
Methoxetamine ............................................................................................................................................
Methoxyacetyl fentanyl ................................................................................................................................
Methyldesorphine .........................................................................................................................................
Methyldihydromorphine ................................................................................................................................
Metodesnitazene ..........................................................................................................................................
VerDate Sep<11>2014
17:18 Oct 30, 2023
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E:\FR\FM\31OCN1.SGM
Proposed revised
2023 quotas
(g)
25
384,460
25
25
20
20
25
9,300
653,548
25
25
20
3,000
25
25
25
25
25
25
30
30
25
N/A
30
30
600
25
30
25
25
30
25
29,417,000
150
40
25
30
25
25
35
45
45
30
30
35
30
30
30
30
25
25
1,200
no change.
628,460.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
30.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
150.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
30
no change.
30
30
no change.
no change.
25
6,675,000
1,000,000
30
1,200
N/A
60
25
N/A
30
30
5
25
30
31OCN1
no
no
no
no
no
no
no
no
no
no
no
no
change.
change.
change.
change.
change.
30.
change.
change.
30.
change.
change.
change.
change.
change.
74518
Federal Register / Vol. 88, No. 209 / Tuesday, October 31, 2023 / Notices
Established
2023 quotas
(g)
lotter on DSK11XQN23PROD with NOTICES1
Basic class
Metonitazene ...............................................................................................................................................
Morpheridine ................................................................................................................................................
Morphine methylbromide .............................................................................................................................
Morphine methylsulfonate ............................................................................................................................
Morphine-N-oxide ........................................................................................................................................
MT–45 ..........................................................................................................................................................
Myrophine ....................................................................................................................................................
NM2201: Naphthalen-1-yl 1-(5-fluorpentyl)-1H-indole-3-carboxylate ..........................................................
N,N-Dimethylamphetamine ..........................................................................................................................
Naphyrone ...................................................................................................................................................
N-Ethyl-1-phenylcyclohexylamine ................................................................................................................
N-Ethyl-3-piperidyl benzilate ........................................................................................................................
N-Ethylamphetamine ...................................................................................................................................
N-Ethylhexedrone ........................................................................................................................................
N-Ethylpentylone, ephylone .........................................................................................................................
N-Hydroxy-3,4-methylenedioxyamphetamine ..............................................................................................
Nicocodeine .................................................................................................................................................
Nicomorphine ...............................................................................................................................................
N-methyl-3-piperidyl benzilate .....................................................................................................................
Noracymethadol ...........................................................................................................................................
N-Pyrrolidino Etonitazene ............................................................................................................................
Norlevorphanol .............................................................................................................................................
Normethadone .............................................................................................................................................
Normorphine ................................................................................................................................................
Norpipanone ................................................................................................................................................
Ocfentanil .....................................................................................................................................................
ortho-Fluoroacryl fentanyl ............................................................................................................................
ortho-Fluorobutyryl fentanyl .........................................................................................................................
ortho-Fluorofentanyl,2-Fluorofentanyl ..........................................................................................................
ortho-Fluoroisobutyryl fentanyl ....................................................................................................................
ortho-Methyl acetylfentanyl ..........................................................................................................................
ortho-Methyl methoxyacetyl fentanyl ...........................................................................................................
Para-Chlorisobutyrl fentanyl ........................................................................................................................
Para-flourobutyryl fentanyl ...........................................................................................................................
Para-fluorofentanyl .......................................................................................................................................
Para-Fluoro furanyl fentanyl ........................................................................................................................
Para-Methoxybutyrl fentanyl ........................................................................................................................
Para-methoxymethamphetamine .................................................................................................................
Para-Methylfentanyl .....................................................................................................................................
Parahexyl .....................................................................................................................................................
PB–22; QUPIC .............................................................................................................................................
Pentedrone ..................................................................................................................................................
Pentylone .....................................................................................................................................................
Phenadoxone ...............................................................................................................................................
Phenampromide ...........................................................................................................................................
Phenomorphan ............................................................................................................................................
Phenoperidine ..............................................................................................................................................
Phenyl fentanyl ............................................................................................................................................
Pholcodine ...................................................................................................................................................
Piritramide ....................................................................................................................................................
Proheptazine ................................................................................................................................................
Properidine ...................................................................................................................................................
Propiram ......................................................................................................................................................
Protonitazene ...............................................................................................................................................
Psilocybin .....................................................................................................................................................
Psilocyn ........................................................................................................................................................
Racemoramide .............................................................................................................................................
SR–18 and RCS–8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole) .................................................
SR–19 and RCS–4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole) ....................................................................
Tetrahydrofuranyl fentanyl ...........................................................................................................................
Thebacon .....................................................................................................................................................
Thiafentanil ..................................................................................................................................................
Thiofentanyl .................................................................................................................................................
Thiofuranyl fentanyl .....................................................................................................................................
THJ–2201 ([1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone) .............................................
Tilidine ..........................................................................................................................................................
Trimeperidine ...............................................................................................................................................
UR–144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone .............................................
U–47700 ......................................................................................................................................................
Valeryl fentanyl ............................................................................................................................................
Zipeprol ........................................................................................................................................................
VerDate Sep<11>2014
17:18 Oct 30, 2023
Jkt 262001
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Frm 00118
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E:\FR\FM\31OCN1.SGM
30
25
5
5
150
30
25
25
25
25
25
10
24
25
30
24
25
25
30
25
30
2,550
25
40
25
25
30
30
30
30
30
30
30
25
25
30
30
30
30
5
20
25
25
25
25
25
25
30
5
25
25
25
25
30
8,000
12,000
25
45
30
15
25
25
25
30
30
25
25
25
30
25
N/A
31OCN1
Proposed revised
2023 quotas
(g)
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
15,000.
24,000.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
30.
74519
Federal Register / Vol. 88, No. 209 / Tuesday, October 31, 2023 / Notices
Established
2023 quotas
(g)
Basic class
Proposed revised
2023 quotas
(g)
lotter on DSK11XQN23PROD with NOTICES1
Schedule II
1-Phenylcyclohexylamine ............................................................................................................................
1-Piperidinocyclohexanecarbonitrile ............................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) .................................................................................................
Alfentanil ......................................................................................................................................................
Alphaprodine ................................................................................................................................................
Amobarbital ..................................................................................................................................................
Amphetamine (for sale)(split) ......................................................................................................................
Bezitramide ..................................................................................................................................................
Carfentanil ....................................................................................................................................................
Cocaine ........................................................................................................................................................
Codeine (for conversion) .............................................................................................................................
Codeine (for sale) ........................................................................................................................................
D-amphetamine (for sale) ............................................................................................................................
D,l-amphetamine ..........................................................................................................................................
D-amphetamine (for conversion) .................................................................................................................
Dexmethylphenidate (for sale) .....................................................................................................................
Dexmethylphenidate (for conversion) ..........................................................................................................
Dextropropoxyphene ....................................................................................................................................
Dihydrocodeine ............................................................................................................................................
Dihydroetorphine ..........................................................................................................................................
Diphenoxylate (for conversion) ....................................................................................................................
Diphenoxylate (for sale) ...............................................................................................................................
Ecgonine ......................................................................................................................................................
Ethylmorphine ..............................................................................................................................................
Etorphine hydrochloride ...............................................................................................................................
Fentanyl .......................................................................................................................................................
Glutethimide .................................................................................................................................................
Hydrocodone (for conversion) .....................................................................................................................
Hydrocodone (for sale) ................................................................................................................................
Hydromorphone ...........................................................................................................................................
Isomethadone ..............................................................................................................................................
L-amphetamine ............................................................................................................................................
Levo-alphacetylmethadol (LAAM) ................................................................................................................
Levomethorphan ..........................................................................................................................................
Levorphanol .................................................................................................................................................
Lisdexamfetamine ........................................................................................................................................
Meperidine ...................................................................................................................................................
Meperidine Intermediate-A ..........................................................................................................................
Meperidine Intermediate-B ..........................................................................................................................
Meperidine Intermediate-C ..........................................................................................................................
Metazocine ...................................................................................................................................................
Methadone (for sale) ...................................................................................................................................
Methadone Intermediate ..............................................................................................................................
Methamphetamine .......................................................................................................................................
d-methamphetamine (for conversion) ..........................................................................................................
d-methamphetamine (for sale) ....................................................................................................................
l-methamphetamine .....................................................................................................................................
Methylphenidate (for sale) ...........................................................................................................................
Methylphenidate (for conversion) ................................................................................................................
Metopon .......................................................................................................................................................
Moramide-intermediate ................................................................................................................................
Morphine (for conversion) ............................................................................................................................
Morphine (for sale) ......................................................................................................................................
Nabilone .......................................................................................................................................................
Norfentanyl ...................................................................................................................................................
Noroxymorphone (for conversion) ...............................................................................................................
Noroxymorphone (for sale) ..........................................................................................................................
Oliceridine ....................................................................................................................................................
Opium (powder) ...........................................................................................................................................
Opium (tincture) ...........................................................................................................................................
Oripavine ......................................................................................................................................................
Oxycodone (for conversion) ........................................................................................................................
Oxycodone (for sale) ...................................................................................................................................
Oxymorphone (for conversion) ....................................................................................................................
Oxymorphone (for sale) ...............................................................................................................................
Pentobarbital ................................................................................................................................................
Phenazocine ................................................................................................................................................
Phencyclidine ...............................................................................................................................................
Phenmetrazine .............................................................................................................................................
Phenylacetone .............................................................................................................................................
VerDate Sep<11>2014
17:18 Oct 30, 2023
Jkt 262001
PO 00000
Frm 00119
Fmt 4703
Sfmt 4703
E:\FR\FM\31OCN1.SGM
15
25
937,874
5,000
25
20,100
N/A
25
20
60,492
1,085,024
21,003,397
21,200,000
21,200,000
20,000,000
6,200,000
4,200,000
35
132,658
25
14,100
770,800
60,492
30
32
731,452
25
1,250
27,239,822
1,994,125
30
30
25
30
23,010
26,500,000
681,289
30
30
30
15
25,619,700
27,673,600
150
485,020
47,000
587,229
53,283,000
15,300,000
25
25
2,458,460
21,747,625
62,000
25
22,044,741
1,000
25,100
250,000
530,837
33,010,750
437,827
53,840,608
28,204,371
516,351
33,843,337
25
35
25
100
31OCN1
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
74520
Federal Register / Vol. 88, No. 209 / Tuesday, October 31, 2023 / Notices
Established
2023 quotas
(g)
Basic class
Piminodine ...................................................................................................................................................
Racemethorphan .........................................................................................................................................
Racemorphan ..............................................................................................................................................
Remifentanil .................................................................................................................................................
Secobarbital .................................................................................................................................................
Sufentanil .....................................................................................................................................................
Tapentadol ...................................................................................................................................................
Thebaine ......................................................................................................................................................
Proposed revised
2023 quotas
(g)
25
5
5
3,000
172,100
4,000
11,941,416
57,137,944
no
no
no
no
no
no
no
no
change.
change.
change.
change.
change.
change.
change.
change.
41,100
4,136,000
14,878,320
7,990,000
1,000
174,246,000
no
no
no
no
no
no
change.
change.
change.
change.
change.
change.
List I Chemicals
Ephedrine (for conversion) ..........................................................................................................................
Ephedrine (for sale) .....................................................................................................................................
Phenylpropanolamine (for conversion) ........................................................................................................
Phenylpropanolamine (for sale) ...................................................................................................................
Pseudoephedrine (for conversion) ..............................................................................................................
Pseudoephedrine (for sale) .........................................................................................................................
The Administrator further proposes
that APQ for all other schedule I and II
controlled substances included in 21
CFR 1308.11 and 1308.12 remain at
zero. In accordance with 21 CFR
1303.13 and 21 CFR 1315.13, upon
consideration of the relevant factors, the
Administrator may adjust the 2023 APQ
and AAN as needed.
Conclusion
After consideration of any comments
or objections, or after a hearing, if one
is held, the Administrator will issue and
publish in the Federal Register a final
order establishing any adjustment of the
2023 APQ for each basic class of
controlled substances in schedules I and
II and AAN for the list I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine.15
lotter on DSK11XQN23PROD with NOTICES1
Signing Authority
This document of the Drug
Enforcement Administration was signed
on October 25, 2023, by Administrator
Anne Milgram. That document with the
original signature and date is
maintained by DEA. For administrative
purposes only, and in compliance with
requirements of the Office of the Federal
Register, the undersigned DEA Federal
Register Liaison Officer has been
authorized to sign and submit the
document in electronic format for
publication, as an official document of
DEA. This administrative process in no
way alters the legal effect of this
document upon publication in the
Federal Register.
Scott Brinks,
Federal Register Liaison Officer, Drug
Enforcement Administration.
[FR Doc. 2023–23931 Filed 10–30–23; 8:45 am]
BILLING CODE P
15 21
CFR 1303.13(c) and 1315.13(c).
VerDate Sep<11>2014
17:18 Oct 30, 2023
Jkt 262001
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Dmitry Anatolevich Shelchkov, M.D.;
Decision and Order
On July 21, 2021, the Drug
Enforcement Administration
(hereinafter, DEA or Government)
issued an Order to Show Cause
(hereinafter, OSC) to Dmitry
Anatolevich Shelchkov, M.D.
(hereinafter, Registrant). Request for
Final Agency Action (hereinafter,
RFAA), Appendix (hereinafter, RFAAX)
H, at 1, 4. The OSC proposed the
revocation of Registrant’s Certificate of
Registration No. BS8311502 at the
registered address of 1396 Myrtle
Avenue, Brooklyn, New York 11237. Id.
at 1. The OSC alleged that Registrant’s
registration should be revoked because
Registrant is ‘‘without authority to
handle controlled substances in New
York, the state in which [he is]
registered with DEA.’’ Id. at 2 (citing 21
U.S.C. 824(a)(3)).
The Agency makes the following
findings of fact based on the
uncontroverted evidence submitted by
the Government in its RFAA,1 which
was fully received on July 12, 2023.2
1 The Government’s RFAA is dated June 30, 2022.
RFAA, at 6.
2 Based on the Declaration from a DEA Diversion
Investigator, the Agency finds that the
Government’s service of the OSC on Registrant was
adequate. RFAAX F, at 1; see also RFAAX A (Form
DEA–12 signed by Registrant). Further, based on the
Government’s assertions in its RFAA, the Agency
finds that more than thirty days have passed since
Registrant was served with the OSC and Registrant
has neither requested a hearing nor submitted a
corrective action plan and therefore has waived any
such rights. RFAA, at 2; see also 21 CFR 1301.43
and 21 U.S.C. 824(c)(2).
PO 00000
Frm 00120
Fmt 4703
Sfmt 4703
Findings of Fact
On March 2, 2021, the New York State
Commissioner of Health ordered that
‘‘effective immediately, [Registrant]
shall not practice medicine in the State
of New York.’’ RFAAX B, at 1, 3. On
October 29, 2021, the New York State
Board for Professional Medical Conduct
issued a Determination and Order
revoking Registrant’s New York medical
license. RFAAX C, at 3–4, 27. According
to New York’s online records, of which
the Agency takes official notice,
Registrant’s New York medical license
is revoked.3 New York State Department
of Health Office of Professional Medical
Conduct Physician Search, https://
apps.health.ny.gov/pubdoh/
professionals/doctors/conduct/factions/
Home.action (last visited date of
signature of this Order).4 Accordingly,
3 Under the Administrative Procedure Act, an
agency ‘‘may take official notice of facts at any stage
in a proceeding—even in the final decision.’’
United States Department of Justice, Attorney
General’s Manual on the Administrative Procedure
Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint
1979). Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an
agency decision rests on official notice of a material
fact not appearing in the evidence in the record, a
party is entitled, on timely request, to an
opportunity to show the contrary.’’ Accordingly,
Registrant may dispute the Agency’s finding by
filing a properly supported motion for
reconsideration of findings of fact within fifteen
calendar days of the date of this Order. Any such
motion and response shall be filed and served by
email to the other party and to Office of the
Administrator, Drug Enforcement Administration at
dea.addo.attorneys@dea.gov.
4 The New York State Education Department
Office of the Professions lists the status of
Registrant’s New York medical license as ‘‘summary
suspension’’, but notes that because the office does
not discipline physicians, the status listed might be
impacted by New York State Department of Health
action and accordingly provides a link to the New
York State Department of Health Office of
Professional Medical Conduct Physician Search.
New York State Education Department Office of the
Professions, Verification Search, https://
www.op.nysed.gov/verification-search.
E:\FR\FM\31OCN1.SGM
31OCN1
]]>Agencies
[Federal Register Volume 88, Number 209 (Tuesday, October 31, 2023)]
[Notices]
[Pages 74512-74520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23931]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1051A]
Proposed Adjustments to the Aggregate Production Quotas for
Schedule I and II Controlled Substances and Assessment of Annual Needs
for the List I Chemicals Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2023
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice with request for comments.
-----------------------------------------------------------------------
SUMMARY: The Drug Enforcement Administration (DEA) proposes to adjust
the 2023 aggregate production quotas for several controlled substances
in schedules I and II of the Controlled Substances Act (CSA) and the
assessment of annual needs for the list I chemical phenylpropanolamine.
DATES: Interested persons may file written comments on this notice in
accordance with 21 CFR 1303.13(c) and 1315.13(d). Electronic comments
must be submitted, and written comments must be postmarked, on or
before November 30, 2023. 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.
[[Page 74513]]
Based on comments received in response to this notice, the
Administrator may hold a public hearing on one or more issues raised.
In the event the Administrator decides in her sole discretion to hold
such a hearing, the Administrator will publish a notice of any such
hearing in the Federal Register. After consideration of any comments or
objections, or after a hearing, if one is held, the Administrator will
publish in the Federal Register a final order establishing the 2023
adjusted aggregate production quotas for schedule I and II controlled
substances, and an adjusted assessment of annual needs for the list I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, as
relevant.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-1051A'' on all correspondence, including any
attachments. DEA 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
https://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 that duplicate
electronic submissions 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, Attention: DEA Federal Register Representative/DRW,
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: 571-776-3882.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received in response to this docket
are considered part of the public record. The Drug Enforcement
Administration (DEA) will make comments available for public inspection
online at https://www.regulations.gov. Such information includes
personal or business identifiers (such as name, address, state or
Federal identifiers, etc.) voluntarily submitted by the commenter.
Generally, all information voluntarily submitted by the commenter,
unless clearly marked as Confidential Information in the method
described below, will be publicly posted. Comments may be submitted
anonymously. The Freedom of Information Act applies to all comments
received.
Commenters submitting comments which include personal identifying
information (PII), confidential, or proprietary business information
that the commenter does not want made publicly available should submit
two copies of the comment. One copy must be marked ``CONTAINS
CONFIDENTIAL INFORMATION'' and should clearly identify all PII or
business information the commenter does not want to be made publicly
available, including any supplemental materials. DEA will review this
copy, including the claimed PII and confidential business information,
in its consideration of comments. The second copy should be marked ``TO
BE PUBLICLY POSTED'' and must have all claimed confidential PII and
business information already redacted. DEA will post only the redacted
comment on https://www.regulations.gov for public inspection.
For easy reference, an electronic copy of this document is
available at https://www.regulations.gov.
Legal Authority and Background
Section 306 of the CSA (21 U.S.C. 826) requires the Attorney
General to establish aggregate production quotas (APQ) for each basic
class of controlled substance listed in schedules I and II and for the
list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
The Attorney General has delegated this function to the Administrator
of DEA.\1\
---------------------------------------------------------------------------
\1\ 28 CFR 0.100(b).
---------------------------------------------------------------------------
DEA established the 2023 APQ for substances in schedules I and II
and the assessment of annual needs (AAN) for the list I chemicals
ephedrine, pseudoephedrine, and phenylpropanolamine on December 2,
2022.\2\ That order stipulated that, in accordance with 21 CFR 1303.13
and 1315.13, all APQ and AAN are subject to adjustment.
---------------------------------------------------------------------------
\2\ Established Aggregate Production Quotas for Schedule I and
II Controlled Substances and Assessment of Annual Needs for the List
I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for
2023, 87 FR 74168 (December 2, 2022).
---------------------------------------------------------------------------
Analysis for Proposed Adjusted 2023 Aggregate Production Quotas and
Assessment of Annual Needs
DEA proposes to adjust the established 2023 APQ for certain
schedule I and II controlled substances and the AAN for certain list I
chemicals to be manufactured in the United States (U.S.) in 2023 to
provide for the estimated medical, scientific, research, and industrial
needs of the U.S., for lawful export requirements, and for the
establishment and maintenance of reserve stocks. These quotas do not
include imports of controlled substances for use in industrial
processes.
Factors for Determining the Proposed Adjustments
In determining the proposed adjustments, the Administrator has
taken into account the factors in 21 CFR 1303.13 (adjustment of APQ for
controlled substances) and 21 CFR 1315.13 (adjustment of the AAN for
ephedrine, pseudoephedrine, and phenylpropanolamine). The Administrator
is authorized to increase or reduce the APQ and the AAN at any time.\3\
---------------------------------------------------------------------------
\3\ 21 CFR 1303.13(a) and 1315.13(a).
---------------------------------------------------------------------------
DEA determined whether to propose an adjustment of the APQ for 2023
by considering the factors found at 21 CFR 1303.13(b): \4\
---------------------------------------------------------------------------
\4\ DEA recently adopted revisions to its regulations for
setting quotas, but that rule has not yet taken effect and does not
affect this notice proposing some adjustments to the 2023 APQs.
Management of Quotas for Controlled Substances and List I Chemicals,
88 FR 60117 (Aug. 31, 2023) (effective Nov. 29, 2023).
(1) Changes in the demand for that class, changes in the
national rate of net disposal of the class, changes in the rate of
net disposal of the class by registrants holding individual
manufacturing quotas for that class, and changes in the extent of
any diversion in the class;
(2) Whether any increased demand for that class, the national
and/or individual rates of net disposal of that class are temporary,
short term, or long term;
(3) Whether any increased demand for that class can be met
through existing inventories, increased individual manufacturing
quotas, or increased importation, without increasing the aggregate
production quota, taking into account production delays and the
probability that other individual manufacturing quotas may be
suspended pursuant to Sec. 1303.24(b);
(4) Whether any decreased demand for that class will result in
excessive inventory accumulation by all persons registered to handle
that class (including manufacturers, distributors, practitioners,
importers, and
[[Page 74514]]
exporters), notwithstanding the possibility that individual
manufacturing quotas may be suspended pursuant to Sec. 1303.24(b) or
abandoned pursuant to Sec. 1303.27;
(5) Other factors affecting medical, scientific, research, and
industrial needs in the United States and lawful export
requirements, as the Administrator finds relevant, including changes
in the currently accepted medical use in treatment with the class or
the substances which are manufactured from it, the economic and
physical availability of raw materials for use in manufacturing and
for inventory purposes, yield and stability problems, potential
disruptions to production (including possible labor strikes), and
recent unforeseen emergencies such as floods and fires.
DEA also considered updated information obtained from 2022 year-end
inventories, 2022 disposition data submitted by quota applicants,
changes in estimates of the medical needs of the U.S., export
requirements, and other information made available to DEA after the
initial APQ and AAN had been established. Additional factors the
Administrator considered in calculating the APQ, but not the AAN,
include product development requirements of both bulk and finished
dosage form manufacturers.
After considering the changes in the extent of diversion of all
controlled substances, as required by 21 CFR 1303.13(b)(1), DEA has
determined that any changes from the initial calculations are slight
and not statistically significant from the estimates of diversion that
DEA applied to the initial APQ valuations.
DEA determined whether to propose an adjustment of the AAN for 2023
by considering the factors found at 21 CFR 1315.13(b) and summarized
below:
(1) Changes in the demand for that chemical, changes in the
national rate of net disposal of the chemical, and changes in the
rate of net disposal of the chemical by registrants holding
individual manufacturing or import quotas for that chemical;
(2) Whether any increased demand for that chemical, the national
and/or changes in individual rates of net disposal of that chemical
are temporary, short term, or long term;
(3) Whether any increased demand for that chemical can be met
through existing inventories, increased individual manufacturing
quotas, or increased importation, without increasing the assessment
of annual needs, taking into account production delays and the
probability that other individual manufacturing quotas may be
suspended pursuant to Sec. 1315.24(b);
(4) Whether any decreased demand for that chemical will result
in excessive inventory accumulation by all persons registered to
handle that chemical (including manufacturers, distributors,
importers, and exporters), notwithstanding the possibility that
individual manufacturing quotas may be suspended pursuant to Sec.
1315.24(b) or abandoned pursuant to Sec. 1315.27;
(5) Other factors affecting medical, scientific, research,
industrial, and importation needs in the United States, lawful
export requirements, and reserve stocks, as the Administrator finds
relevant, including changes in the currently accepted medical use in
treatment with the chemical or the substances that are manufactured
from it, the economic and physical availability of raw materials for
use in manufacturing and for inventory purposes, yield and stability
problems, potential disruptions to production (including possible
labor strikes), and recent unforeseen emergencies such as floods and
fires.
In evaluating whether there is a need for adjustment of the 2023
AAN for list I chemicals, DEA used the calculation methodology
previously described in the 2010 and 2011 assessment of annual
needs.\5\ DEA considered the total net disposals of the list I
chemicals for the current and preceding two years, actual and estimated
inventories, projected demand, industrial use, and export requirements
from data provided by DEA registered manufacturers and importers on the
relevant quota application forms.\6\
---------------------------------------------------------------------------
\5\ 74 FR 60294 (Nov. 20, 2009) and 75 FR 79407 (Dec. 20, 2010).
\6\ Id.
---------------------------------------------------------------------------
Additional Considerations Applicable to Covered Controlled Substances
When setting APQ, the Administrator must estimate the amount of
diversion of any substance that is considered a ``covered controlled
substance.'' \7\ The covered controlled substances are fentanyl,
oxycodone, hydrocodone, oxymorphone, and hydromorphone.\8\ DEA is
required to ``make appropriate quota reductions, as determined by the
[Administrator], from the quota the [Administrator] would have
otherwise established had such diversion not been considered.'' \9\
When estimating diversion, the Administrator ``shall consider
information,'' in consultation with the Secretary of Health and Human
Services, the Administrator ``determines reliable on rates of overdose
deaths and abuse and overall public health impact related to the
covered controlled substance in the United States;'' and ``may take
into consideration'' whatever other sources of information they
determine reliable.\10\
---------------------------------------------------------------------------
\7\ 21 U.S.C. 826(i)(1)(A).
\8\ 21 U.S.C. 826(i)(1)(A).
\9\ All functions vested in the Attorney General by the CSA have
been delegated to the Administrator of DEA. 28 CFR 0.100(b); 21
U.S.C. 826(i)(1)(C).
\10\ 21 U.S.C. 826(i)(1)(B).
---------------------------------------------------------------------------
DEA sent letters to the Centers for Disease Control and Prevention
(CDC), and the states in February, April, and May 2023 requesting
overdose death and overprescribing data that could be considered in
estimating diversion. DEA received information from the CDC in April
2023 and received Prescription Data Monitoring Program (PDMP) data from
the states in May and June 2023. DEA considered this information in
developing the estimates of diversion for the five covered controlled
substances for this proposed adjustment.
To determine the estimates of diversion, DEA also aggregated data
for each covered controlled substance from the Drug Theft and Loss
Reports. DEA gathered data involving employee theft, break-ins, armed
robberies, and material lost in transit. DEA calculated the metric
weight in grams of each active pharmaceutical ingredient (API) of the
controlled substances being diverted as identified in these reports. In
calculating the estimates of diversion, DEA utilized the same
methodology as published in the Proposed APQ for Schedule I and II
Controlled Substances and AAN for the List I Chemicals Ephedrine,
Pseudoephedrine, and Phenylpropanolamine for 2023.\11\ Below, DEA
provides an updated chart showing estimations of diversion for each of
the covered controlled substances.
---------------------------------------------------------------------------
\11\ 87 FR 63091 (October 18, 2022).
Diversion Estimates for 2023 (g)
------------------------------------------------------------------------
Fentanyl 59
------------------------------------------------------------------------
Hydrocodone................................................... 133,004
Hydromorphone................................................. 595
Oxycodone..................................................... 174,797
Oxymorphone................................................... 109
------------------------------------------------------------------------
Proposed Adjustments for the 2023 Aggregate Production Quotas and
Assessment of Annual Needs
DEA is proposing increases to the APQ for the following schedule I
substances: all other tetrahydrocannabinol, delta-9-
tetrahydrocannabinol, ibogaine, psilocybin, and psilocyn. These
proposed increases are to support research and clinical trials by DEA-
registered schedule I researchers. These proposed increases demonstrate
DEA's support for research with schedule I controlled substances.
DEA established the 2023 APQs for substances in schedules I and II
on December 2, 2022.\12\ Subsequent to that publication, DEA published
in the Federal Register final rules to permanently schedule four
synthetic
[[Page 74515]]
drugs under the CSA.\13\ The specific synthetic substances are
eutylone, mesocarb, methiopropamine, and zipeprol. As a result, these
substances will continue to be subject to the CSA schedule I controls
and DEA is proposing to assign individual APQ for each substance
pursuant to 21 U.S.C. 826 and 21 CFR part 1303.
---------------------------------------------------------------------------
\12\ 87 FR 74168.
\13\ 87 FR 70717 (November 21, 2022), 87 FR 71247 (November 22,
2022), 87 FR 20318 (April, 7 2022), and 87 FR 32996 (June 1, 2022).
---------------------------------------------------------------------------
DEA previously adjusted the established 2023 aggregate production
quota for the schedule II-controlled substance methylphenidate (for
sale) to be manufactured in the United States to provide for the
estimated needs of the United States and export requirements in
accordance with 21 U.S.C. 826(h).\14\ This adjustment was necessary to
ensure that the United States has an adequate and uninterrupted supply
of methylphenidate (for sale) to meet legitimate patient needs both
domestically and globally.
---------------------------------------------------------------------------
\14\ Adjustment to the Aggregate Production Quota for
Methylphenidate (for Sale) for 2023, 88 FR 68147 (October 3, 2023).
---------------------------------------------------------------------------
The Administrator, therefore, proposes to adjust the 2023 APQ for
the schedule I controlled substances of all other tetrahydrocannabinol,
delta-9-tetrahydrocannabinol, eutylone, ibogaine, mesocarb,
methiopropamine, psilocybin, psilocyn, and zipeprol. The proposed
adjusted APQ and AAN, as expressed in grams of anhydrous acid or base,
are as follows:
------------------------------------------------------------------------
Established 2023 Proposed revised
Basic class quotas (g) 2023 quotas (g)
------------------------------------------------------------------------
Schedule I
------------------------------------------------------------------------
1-[1-(2- 20 no change.
Thienyl)cyclohexyl]pyrrolidine...
1-(1-Phenylcyclohexyl)pyrrolidine. 30 no change.
1-(2-Phenylethyl)-4-phenyl-4- 10 no change.
acetoxypiperidine................
1-(5-Fluoropentyl)-3-(1- 30 no change.
naphthoyl)indole (AM2201)........
1-(5-Fluoropentyl)-3-(2- 30 no change.
iodobenzoyl)indole (AM694).......
1-[1-(2- 15 no change.
Thienyl)cyclohexyl]piperidine....
2'-fluoro 2-fluorofentanyl........ 30 no change.
1-Benzylpiperazine................ 25 no change.
1-Methyl-4-phenyl-4- 10 no change.
propionoxypiperidine.............
2-(2,5-Dimethoxy-4- 30 no change.
ethylphenyl)ethanamine (2C-E)....
2-(2,5-Dimethoxy-4- 30 no change.
methylphenyl)ethanamine (2C-D)...
2-(2,5-Dimethoxy-4-nitro- 30 no change.
phenyl)ethanamine (2C-N).........
2-(2,5-Dimethoxy-4-n- 30 no change.
propylphenyl)ethanamine (2C-P)...
2-(2,5-Dimethoxyphenyl)ethanamine 100 no change.
(2C-H)...........................
2-(4-Bromo-2,5-dimethoxyphenyl)-N- 30 no change.
(2-methoxybenzyl)ethanamine (25B-
NBOMe; 2C-B-NBOMe; 25B; Cimbi-36)
2-(4-Chloro-2,5- 30 no change.
dimethoxyphenyl)ethanamine (2C-C)
2-(4-Chloro-2,5-dimethoxyphenyl)-N- 25 no change.
(2-methoxybenzyl)ethanamine (25C-
NBOMe; 2C-C-NBOMe; 25C; Cimbi-82)
2-(4-Iodo-2,5- 30 no change.
dimethoxyphenyl)ethanamine (2C-I)
2-(4-Iodo-2,5-dimethoxyphenyl)-N- 30 no change.
(2-methoxybenzyl)ethanamine (25I-
NBOMe; 2C-I-NBOMe; 25I; Cimbi-5).
2,5-Dimethoxy-4-ethylamphetamine 25 no change.
(DOET)...........................
2,5-Dimethoxy-4-n- 25 no change.
propylthiophenethylamine.........
2,5-Dimethoxyamphetamine.......... 25 no change.
2-[4-(Ethylthio)-2,5- 30 no change.
dimethoxyphenyl]ethanamine (2C-T-
2)...............................
2-[4-(Isopropylthio)-2,5- 30 no change.
dimethoxyphenyl]ethanamine (2C-T-
4)...............................
3,4,5-Trimethoxyamphetamine....... 30 no change.
3,4-Methylenedioxyamphetamine 12,000 no change.
(MDA)............................
3,4-Methylenedioxymethamphetamine 12,000 no change.
(MDMA)...........................
3,4-Methylenedioxy-N- 40 no change.
ethylamphetamine (MDEA)..........
3,4-Methylenedioxy-N- 5,200 no change.
methylcathinone (methylone)......
3,4-Methylenedioxypyrovalerone 35 no change.
(MDPV)...........................
3-FMC; 3-Fluoro-N-methylcathinone. 25 no change.
3-Methylfentanyl.................. 30 no change.
3-Methylthiofentanyl.............. 30 no change.
4-Bromo-2,5-dimethoxyamphetamine 5,100 no change.
(DOB)............................
4-Bromo-2,5- 25 no change.
dimethoxyphenethylamine (2-CB)...
4-Chloro-alpha- 25 no change.
pyrrolidinovalerophenone (4-
chloro-alpha-PVP)................
4-CN-Cumyl-Butinaca............... 25 no change.
4,4'-Dimethylaminorex............. 30 no change.
4-Fluoroisobutyryl fentanyl....... 30 no change.
4F-MDMB-BINACA.................... 30 no change.
4-FMC; Flephedrone................ 25 no change.
4-MEC; 4-Methyl-N-ethylcathinone.. 25 no change.
4-Methoxyamphetamine.............. 150 no change.
4-Methyl-2,5-dimethoxyamphetamine 25 no change.
(DOM)............................
4-Methylaminorex.................. 25 no change.
4-Methyl-N-methylcathinone 45 no change.
(mephedrone).....................
4-Methyl-alpha- 25 no change.
ethylaminopentiophenone (4-MEAP).
4-Methyl-alpha- 25 no change.
pyrrolidinohexiophenone (MPHP)...
4'-Methyl acetyl fentanyl......... 30 no change.
[[Page 74516]]
4-Methyl-[alpha]- 25 no change.
pyrrolidinopropiophenone (4-
MePPP)...........................
5-(1,1-Dimethylheptyl)-2-[(1R,3S)- 50 no change.
3-hydroxycyclohexyl]-phenol......
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3- 40 no change.
hydroxycyclohexyl]-phenol
(cannabicyclohexanol or CP-47,497
C8-homolog)......................
5F-AB-PINACA; (1-Amino-3-methyl-1- 25 no change.
oxobutan-2-yl)-1-(5-fluoropentyl)-
1H-indazole-3-carboxamide........
5F-ADB; 5F-MDMB-PINACA (methyl 2- 25 no change.
(1-(5-fluoropentyl)-1H-indazole-3-
carboxamido)-3,3-
dimethylbutanoate)...............
5F-CUMYL-P7AICA; 1-(5- 25 no change.
Fluoropentyl)-N-(2-phenylpropan-2-
yl)-1H-pyrrolo[2,3-b]pyridine-
3carboximide.....................
5F-CUMYL-PINACA................... 25 no change.
5F-EDMB-PINACA.................... 25 no change.
5F-MDMB-PICA...................... 25 no change.
5F-AMB (methyl 2-(1-(5- 25 no change.
fluoropentyl)-1H-indazole-3-
carboxamido)-3-methylbutanoate)..
5F-APINACA; 5F-AKB48 (N-(adamantan- 25 no change.
1-yl)-1-(5-fluoropentyl)-1H-
indazole-3-carboxamide)..........
5-Fluoro-PB-22; 5F-PB-22.......... 25 no change.
5-Fluoro-UR144, XLR11 ([1-(5- 25 no change.
fluoro-pentyl)-1Hindol-3-
yl](2,2,3,3-
tetramethylcyclopropyl)methanone.
5-Methoxy-3,4- 25 no change.
methylenedioxyamphetamine........
5-Methoxy-N,N- 25 no change.
diisopropyltryptamine............
5-Methoxy-N,N-dimethyltryptamine.. 11,000 no change.
AB-CHMINACA....................... 30 no change.
AB-FUBINACA....................... 50 no change.
AB-PINACA......................... 30 no change.
ADB-FUBINACA (N-(1-amino-3,3- 30 no change.
dimethyl-1-oxobutan-2-yl)-1-(4-
fluorobenzyl)-1H-indazole-3-
carboxamide).....................
Acetorphine....................... 25 no change.
Acetyl Fentanyl................... 100 no change.
Acetyl-alpha-methylfentanyl....... 30 no change.
Acetyldihydrocodeine.............. 30 no change.
Acetylmethadol.................... 25 no change.
Acryl Fentanyl.................... 25 no change.
ADB-PINACA (N-(1-amino-3,3- 50 no change.
dimethyl-1-oxobutan-2-yl)-1-
pentyl-1H-indazole-3-carboxamide)
AH-7921........................... 30 no change.
All other tetrahydrocannabinol.... 15,000 350,000.
Allylprodine...................... 25 no change.
Alphacetylmethadol................ 25 no change.
alpha-Ethyltryptamine............. 25 no change.
Alphameprodine.................... 25 no change.
Alphamethadol..................... 25 no change.
alpha-Methylfentanyl.............. 30 no change.
alpha-Methylthiofentanyl.......... 30 no change.
alpha-Methyltryptamine (AMT)...... 25 no change.
alpha-Pyrrolidinobutiophenone 25 no change.
([alpha]-PBP)....................
alpha-pyrrolidinoheptaphenone 25 no change.
(PV8)............................
alpha-pyrrolidinohexabophenone 25 no change.
([alpha] -PHP)...................
alpha-Pyrrolidinopentiophenone 25 no change.
([alpha]-PVP)....................
Amineptine........................ 30 no change.
Aminorex.......................... 25 no change.
Anileridine....................... 20 no change.
APINCA, AKB48 (N-(1-adamantyl)-1- 25 no change.
pentyl-1H-indazole-3-carboxamide)
Benzethidine...................... 25 no change.
Benzylmorphine.................... 30 no change.
Betacetylmethadol................. 25 no change.
beta-Hydroxy-3-methylfentanyl..... 30 no change.
beta-Hydroxyfentanyl.............. 30 no change.
beta-Hydroxythiofentanyl.......... 30 no change.
beta-Methyl fentanyl.............. 30 no change.
beta-Phenyl fentanyl.............. 30 no change.
Betameprodine..................... 25 no change.
Betamethadol...................... 4 no change.
Betaprodine....................... 25 no change.
Brorphine......................... 30 no change.
Bufotenine........................ 15 no change.
Butonitazene...................... 30 no change.
Butylone.......................... 25 no change.
Butyryl fentanyl.................. 30 no change.
Cathinone......................... 40 no change.
Clonitazene....................... 25 no change.
Codeine methylbromide............. 30 no change.
Codeine-N-oxide................... 192 no change.
Crotonyl Fentanyl................. 25 no change.
Cyclopentyl Fentanyl.............. 30 no change.
Cyclopropyl Fentanyl.............. 20 no change.
[[Page 74517]]
Cyprenorphine..................... 25 no change.
d-9-THC........................... 384,460 628,460.
Desomorphine...................... 25 no change.
Dextromoramide.................... 25 no change.
Diapromide........................ 20 no change.
Diethylthiambutene................ 20 no change.
Diethyltryptamine................. 25 no change.
Difenoxin......................... 9,300 no change.
Dihydromorphine................... 653,548 no change.
Dimenoxadol....................... 25 no change.
Dimepheptanol..................... 25 no change.
Dimethylthiambutene............... 20 no change.
Dimethyltryptamine................ 3,000 no change.
Dioxyaphetyl butyrate............. 25 no change.
Dipipanone........................ 25 no change.
Drotebanol........................ 25 no change.
Ethylmethylthiambutene............ 25 no change.
Ethylone.......................... 25 no change.
Etonitazene....................... 25 no change.
Etodesnitazene.................... 30 no change.
Etorphine......................... 30 no change.
Etoxeridine....................... 25 no change.
Eutylone.......................... N/A 30.
Fenethylline...................... 30 no change.
Fentanyl carbamate................ 30 no change.
Fentanyl related substances....... 600 no change.
FUB-144........................... 25 no change.
Flunitazene....................... 30 no change.
FUB-AKB48......................... 25 no change.
Fub-AMB, MMB-Fubinaca, AMB- 25 no change.
Fubinaca.........................
Furanyl fentanyl.................. 30 no change.
Furethidine....................... 25 no change.
gamma-Hydroxybutyric acid......... 29,417,000 no change.
Heroin............................ 150 no change.
Hydromorphinol.................... 40 no change.
Hydroxypethidine.................. 25 no change.
Ibogaine.......................... 30 150.
Isobutyryl Fentanyl............... 25 no change.
Isotonitazine..................... 25 no change.
JWH-018 and AM678 (1-Pentyl-3-(1- 35 no change.
naphthoyl)indole)................
JWH-019 (1-Hexyl-3-(1- 45 no change.
naphthoyl)indole)................
JWH-073 (1-Butyl-3-(1- 45 no change.
naphthoyl)indole)................
JWH-081 (1-Pentyl-3-[1-(4- 30 no change.
methoxynaphthoyl)]indole)........
JWH-122 (1-Pentyl-3-(4-methyl-1- 30 no change.
naphthoyl)indole)................
JWH-200 (1-[2-(4- 35 no change.
Morpholinyl)ethyl]-3-(1-
naphthoyl)indole)................
JWH-203 (1-Pentyl-3-(2- 30 no change.
chlorophenylacetyl)indole).......
JWH-250 (1-Pentyl-3-(2- 30 no change.
methoxyphenylacetyl)indole)......
JWH-398 (1-Pentyl-3-(4-chloro-1- 30 no change.
naphthoyl)indole)................
Ketobemidone...................... 30 no change.
Levomoramide...................... 25 no change.
Levophenyacylmorphan.............. 25 no change.
Lysergic acid diethylamide (LSD).. 1,200 no change.
MAB-CHMINACA; ADB-CHMINACA (N-(1- 30 no change.
amino-3,3-dimethyl-1-oxobutan-2-
yl)-1-(cyclohexylmethyl)-1H-
indazole-3-carboxamide)..........
MDMB-CHMICA; MMB-CHMINACA(methyl 2- 30 no change.
(1-(cyclohexylmethyl)-1H-indole-3-
carboxamido)-3,3-
dimethylbutanoate)...............
MDMB-FUBINACA (methyl 2-(1-(4- 30 no change.
fluorobenzyl)-1H-indazole-3-
carboxamido)-3,3-
dimethylbutanoate)...............
MMB-CHMICA-(AMB-CHIMCA); Methyl-2- 25 no change.
(1-(cyclohexylmethyl)-1H-indole-3-
carboxamido)-3-methylbutanoate...
Marijuana......................... 6,675,000 no change.
Marijuana extract................. 1,000,000 no change.
Mecloqualone...................... 30 no change.
Mescaline......................... 1,200 no change.
Mesocarb.......................... N/A 30.
Methaqualone...................... 60 no change.
Methcathinone..................... 25 no change.
Methiopropamine................... N/A 30.
Methoxetamine..................... 30 no change.
Methoxyacetyl fentanyl............ 30 no change.
Methyldesorphine.................. 5 no change.
Methyldihydromorphine............. 25 no change.
Metodesnitazene................... 30 no change.
[[Page 74518]]
Metonitazene...................... 30 no change.
Morpheridine...................... 25 no change.
Morphine methylbromide............ 5 no change.
Morphine methylsulfonate.......... 5 no change.
Morphine-N-oxide.................. 150 no change.
MT-45............................. 30 no change.
Myrophine......................... 25 no change.
NM2201: Naphthalen-1-yl 1-(5- 25 no change.
fluorpentyl)-1H-indole-3-
carboxylate......................
N,N-Dimethylamphetamine........... 25 no change.
Naphyrone......................... 25 no change.
N-Ethyl-1-phenylcyclohexylamine... 25 no change.
N-Ethyl-3-piperidyl benzilate..... 10 no change.
N-Ethylamphetamine................ 24 no change.
N-Ethylhexedrone.................. 25 no change.
N-Ethylpentylone, ephylone........ 30 no change.
N-Hydroxy-3,4- 24 no change.
methylenedioxyamphetamine........
Nicocodeine....................... 25 no change.
Nicomorphine...................... 25 no change.
N-methyl-3-piperidyl benzilate.... 30 no change.
Noracymethadol.................... 25 no change.
N-Pyrrolidino Etonitazene......... 30 no change.
Norlevorphanol.................... 2,550 no change.
Normethadone...................... 25 no change.
Normorphine....................... 40 no change.
Norpipanone....................... 25 no change.
Ocfentanil........................ 25 no change.
ortho-Fluoroacryl fentanyl........ 30 no change.
ortho-Fluorobutyryl fentanyl...... 30 no change.
ortho-Fluorofentanyl,2- 30 no change.
Fluorofentanyl...................
ortho-Fluoroisobutyryl fentanyl... 30 no change.
ortho-Methyl acetylfentanyl....... 30 no change.
ortho-Methyl methoxyacetyl 30 no change.
fentanyl.........................
Para-Chlorisobutyrl fentanyl...... 30 no change.
Para-flourobutyryl fentanyl....... 25 no change.
Para-fluorofentanyl............... 25 no change.
Para-Fluoro furanyl fentanyl...... 30 no change.
Para-Methoxybutyrl fentanyl....... 30 no change.
Para-methoxymethamphetamine....... 30 no change.
Para-Methylfentanyl............... 30 no change.
Parahexyl......................... 5 no change.
PB-22; QUPIC...................... 20 no change.
Pentedrone........................ 25 no change.
Pentylone......................... 25 no change.
Phenadoxone....................... 25 no change.
Phenampromide..................... 25 no change.
Phenomorphan...................... 25 no change.
Phenoperidine..................... 25 no change.
Phenyl fentanyl................... 30 no change.
Pholcodine........................ 5 no change.
Piritramide....................... 25 no change.
Proheptazine...................... 25 no change.
Properidine....................... 25 no change.
Propiram.......................... 25 no change.
Protonitazene..................... 30 no change.
Psilocybin........................ 8,000 15,000.
Psilocyn.......................... 12,000 24,000.
Racemoramide...................... 25 no change.
SR-18 and RCS-8 (1-Cyclohexylethyl- 45 no change.
3-(2-methoxyphenylacetyl)indole).
SR-19 and RCS-4 (1-Pentyl-3-[(4- 30 no change.
methoxy)-benzoyl]indole).........
Tetrahydrofuranyl fentanyl........ 15 no change.
Thebacon.......................... 25 no change.
Thiafentanil...................... 25 no change.
Thiofentanyl...................... 25 no change.
Thiofuranyl fentanyl.............. 30 no change.
THJ-2201 ([1-(5-fluoropentyl)-1H- 30 no change.
indazol-3-yl](naphthalen-1-
yl)methanone)....................
Tilidine.......................... 25 no change.
Trimeperidine..................... 25 no change.
UR-144 (1-pentyl-1H-indol-3- 25 no change.
yl)(2,2,3,3-
tetramethylcyclopropyl)methanone.
U-47700........................... 30 no change.
Valeryl fentanyl.................. 25 no change.
Zipeprol.......................... N/A 30.
------------------------------------------------------------------------
[[Page 74519]]
Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine........... 15 no change.
1- 25 no change.
Piperidinocyclohexanecarbonitrile
4-Anilino-N-phenethyl-4-piperidine 937,874 no change.
(ANPP)...........................
Alfentanil........................ 5,000 no change.
Alphaprodine...................... 25 no change.
Amobarbital....................... 20,100 no change.
Amphetamine (for sale)(split)..... N/A no change.
Bezitramide....................... 25 no change.
Carfentanil....................... 20 no change.
Cocaine........................... 60,492 no change.
Codeine (for conversion).......... 1,085,024 no change.
Codeine (for sale)................ 21,003,397 no change.
D-amphetamine (for sale).......... 21,200,000 no change.
D,l-amphetamine................... 21,200,000 no change.
D-amphetamine (for conversion).... 20,000,000 no change.
Dexmethylphenidate (for sale)..... 6,200,000 no change.
Dexmethylphenidate (for 4,200,000 no change.
conversion)......................
Dextropropoxyphene................ 35 no change.
Dihydrocodeine.................... 132,658 no change.
Dihydroetorphine.................. 25 no change.
Diphenoxylate (for conversion).... 14,100 no change.
Diphenoxylate (for sale).......... 770,800 no change.
Ecgonine.......................... 60,492 no change.
Ethylmorphine..................... 30 no change.
Etorphine hydrochloride........... 32 no change.
Fentanyl.......................... 731,452 no change.
Glutethimide...................... 25 no change.
Hydrocodone (for conversion)...... 1,250 no change.
Hydrocodone (for sale)............ 27,239,822 no change.
Hydromorphone..................... 1,994,125 no change.
Isomethadone...................... 30 no change.
L-amphetamine..................... 30 no change.
Levo-alphacetylmethadol (LAAM).... 25 no change.
Levomethorphan.................... 30 no change.
Levorphanol....................... 23,010 no change.
Lisdexamfetamine.................. 26,500,000 no change.
Meperidine........................ 681,289 no change.
Meperidine Intermediate-A......... 30 no change.
Meperidine Intermediate-B......... 30 no change.
Meperidine Intermediate-C......... 30 no change.
Metazocine........................ 15 no change.
Methadone (for sale).............. 25,619,700 no change.
Methadone Intermediate............ 27,673,600 no change.
Methamphetamine................... 150 no change.
d-methamphetamine (for conversion) 485,020 no change.
d-methamphetamine (for sale)...... 47,000 no change.
l-methamphetamine................. 587,229 no change.
Methylphenidate (for sale)........ 53,283,000 no change.
Methylphenidate (for conversion).. 15,300,000 no change.
Metopon........................... 25 no change.
Moramide-intermediate............. 25 no change.
Morphine (for conversion)......... 2,458,460 no change.
Morphine (for sale)............... 21,747,625 no change.
Nabilone.......................... 62,000 no change.
Norfentanyl....................... 25 no change.
Noroxymorphone (for conversion)... 22,044,741 no change.
Noroxymorphone (for sale)......... 1,000 no change.
Oliceridine....................... 25,100 no change.
Opium (powder).................... 250,000 no change.
Opium (tincture).................. 530,837 no change.
Oripavine......................... 33,010,750 no change.
Oxycodone (for conversion)........ 437,827 no change.
Oxycodone (for sale).............. 53,840,608 no change.
Oxymorphone (for conversion)...... 28,204,371 no change.
Oxymorphone (for sale)............ 516,351 no change.
Pentobarbital..................... 33,843,337 no change.
Phenazocine....................... 25 no change.
Phencyclidine..................... 35 no change.
Phenmetrazine..................... 25 no change.
Phenylacetone..................... 100 no change.
[[Page 74520]]
Piminodine........................ 25 no change.
Racemethorphan.................... 5 no change.
Racemorphan....................... 5 no change.
Remifentanil...................... 3,000 no change.
Secobarbital...................... 172,100 no change.
Sufentanil........................ 4,000 no change.
Tapentadol........................ 11,941,416 no change.
Thebaine.......................... 57,137,944 no change.
------------------------------------------------------------------------
List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)........ 41,100 no change.
Ephedrine (for sale).............. 4,136,000 no change.
Phenylpropanolamine (for 14,878,320 no change.
conversion)......................
Phenylpropanolamine (for sale).... 7,990,000 no change.
Pseudoephedrine (for conversion).. 1,000 no change.
Pseudoephedrine (for sale)........ 174,246,000 no change.
------------------------------------------------------------------------
The Administrator further proposes that APQ for all other schedule
I and II controlled substances included in 21 CFR 1308.11 and 1308.12
remain at zero. In accordance with 21 CFR 1303.13 and 21 CFR 1315.13,
upon consideration of the relevant factors, the Administrator may
adjust the 2023 APQ and AAN as needed.
Conclusion
After consideration of any comments or objections, or after a
hearing, if one is held, the Administrator will issue and publish in
the Federal Register a final order establishing any adjustment of the
2023 APQ for each basic class of controlled substances in schedules I
and II and AAN for the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine.\15\
---------------------------------------------------------------------------
\15\ 21 CFR 1303.13(c) and 1315.13(c).
---------------------------------------------------------------------------
Signing Authority
This document of the Drug Enforcement Administration was signed on
October 25, 2023, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-23931 Filed 10-30-23; 8:45 am]
BILLING CODE P
