Schedules of Controlled Substances: Placement of Nine Specific Fentanyl-Related Substances in Schedule I, 85104-85109 [2023-26694]
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Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Rules and Regulations
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DEPARTMENT OF JUSTICE
Matthew S. Borman,
Deputy Assistant Secretary for Export
Administration.
Drug Enforcement Administration
21 CFR Part 1308
[FR Doc. 2023–26935 Filed 12–5–23; 11:15 am]
[Docket No. DEA–1036]
BILLING CODE 3510–33–P
Schedules of Controlled Substances:
Placement of Nine Specific FentanylRelated Substances in Schedule I
SOCIAL SECURITY ADMINISTRATION
20 CFR Part 404
Drug Enforcement
Administration, Department of Justice.
ACTION: Final rule.
Federal Old-Age, Survivors and
Disability Insurance (1950– )
SUMMARY:
CFR Correction
This rule is being published by the
Office of the Federal Register to correct
an editorial or technical error that
appeared in the most recent annual
revision of the Code of Federal
Regulations.
In Title 20 of the Code of Federal
Regulations, Parts 400 to 499, revised as
of April 1, 2023, in Appendix I to
Subpart P of Part 404, in Part B, section
101.00, revise the first sentence of
paragraph C.7.c. to read as follows:
■
Appendix 1 to Subpart P of Part 404—
Listing of Impairments
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Part B
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101.00
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Musculoskeletal Disorders.
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C. * * *
7. * * *
c. For 101.15, 101.16, 101.17, 101.18,
101.20C, 101.20D, 101.22, and 101.23, all of
the required criteria must be present
simultaneously, or within a close proximity
of time, to satisfy the level of severity needed
to meet the listing. * * *
[FR Doc. 2023–26983 Filed 12–6–23; 8:45 am]
BILLING CODE 0099–10–P
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AGENCY:
With the issuance of this final
rule, the Drug Enforcement
Administration places nine fentanylrelated substances, as identified in this
final rule, including their isomers,
esters, ethers, salts, and salts of isomers,
esters, and ethers whenever the
existence of such isomers, esters, ethers,
and salts is possible, in schedule I of the
Controlled Substances Act. These nine
fentanyl-related substances are currently
listed in schedule I pursuant to a
temporary scheduling order. This action
makes permanent the imposition of the
regulatory controls and administrative,
civil, and criminal sanctions applicable
to schedule I controlled substances on
persons who handle (manufacture,
distribute, import, export, engage in
research, conduct instructional
activities or chemical analysis with, or
possess), or propose to handle these
nine specific fentanyl-related controlled
substances.
DATES: Effective date: December 7, 2023.
FOR FURTHER INFORMATION CONTACT: Dr.
Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control
Division, Drug Enforcement
Administration; Telephone: (571) 362–
3249.
SUPPLEMENTARY INFORMATION: In this
rule, the Drug Enforcement
Administration (DEA) is permanently
scheduling the following nine
controlled substances including their
isomers, esters, ethers, salts, and salts of
isomers, esters, and ethers whenever the
existence of such isomers, esters, ethers,
and salts is possible, in schedule I of the
Controlled Substances Act (CSA):
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Federal Register citation
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• meta-fluorofentanyl (N-(3fluorophenyl)-N-(1-phenethylpiperidin4-yl)propionamide),
• meta-fluoroisobutyryl fentanyl (N(3-fluorophenyl)-N-(1phenethylpiperidin-4-yl)isobutyramide),
• para-methoxyfuranyl fentanyl (N(4-methoxyphenyl)-N-(1phenethylpiperidin-4-yl)furan-2carboxamide),
• 3-furanyl fentanyl (N-(1phenethylpiperidin-4-yl)-Nphenylfuran-3-carboxamide),
• 2′,5′-dimethoxyfentanyl (N-(1-(2,5dimethoxyphenethyl)piperidin-4-yl)-Nphenylpropionamide),
• isovaleryl fentanyl (3-methyl-N-(1phenethylpiperidin-4-yl)-Nphenylbutanamide),
• ortho-fluorofuranyl fentanyl (N-(2fluorophenyl)-N-(1-phenethylpiperidin4-yl)furan-2-carboxamide),
• alpha′-methyl butyryl fentanyl (2methyl-N-(1-phenethylpiperidin-4-yl)N-phenylbutanamide), and
• para-methylcyclopropyl fentanyl
(N-(4-methylphenyl)-N-(1phenethylpiperidin-4yl)cyclopropanecarboxamide).
Legal Authority
The CSA provides that proceedings
for the issuance, amendment, or repeal
of the scheduling of any drug or other
substance may be initiated by the
Attorney General (1) on his own motion;
(2) at the request of the Secretary of the
Department of Health and Human
Services (HHS); 1 or (3) on the petition
of any interested party.2 This action was
initiated on the Attorney General’s own
motion, as delegated to the
Administrator of the DEA
(Administrator), and is supported by,
inter alia, a recommendation from the
Assistant Secretary for Health of HHS
1 As discussed in a memorandum of
understanding entered into by the Food and Drug
Administration (FDA) and the National Institute on
Drug Abuse (NIDA), FDA acts as the lead agency
within HHS in carrying out the Secretary’s
scheduling responsibilities under the CSA, with the
concurrence of NIDA. 50 FR 9518, Mar. 8, 1985.
The Secretary of HHS has delegated to the Assistant
Secretary for Health of HHS the authority to make
domestic drug scheduling recommendations. 58 FR
35460, July 1, 1993.
2 21 U.S.C. 811(a).
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(Assistant Secretary) and an evaluation
of all relevant data by DEA. This action
continues the imposition of the
regulatory controls and administrative,
civil, and criminal sanctions of schedule
I controlled substances on any person
who handles or proposes to handle
meta-fluorofentanyl, metafluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2′,5′-dimethoxyfentanyl,
isovaleryl fentanyl, ortho-fluorofuranyl
fentanyl, alpha′-methyl butyryl
fentanyl, and para-methylcyclopropyl
fentanyl.
Background
On February 6, 2018, DEA published
an order in the Federal Register (FR) (83
FR 5188) amending 21 CFR 1308.11(h),
temporarily placing fentanyl-related
substances, as defined in that order, in
schedule I of the CSA based upon a
finding that these substances pose an
imminent hazard to the public safety
and pursuant to the temporary
scheduling provisions of 21 U.S.C.
811(h). The nine substances named in
this final rule meet the existing
definition of fentanyl-related
substances, as they are not otherwise
controlled in any other schedule (i.e.,
not included under another DEA
Controlled Substance Code Number)
and are structurally related to fentanyl
by one or more of the five modifications
listed under the definition. That
temporary scheduling order was
effective on the date of publication and
was based on findings by the former
Acting Administrator that the temporary
scheduling of these substances was
necessary to avoid an imminent hazard
to the public safety pursuant to 21
U.S.C. 811(h)(1). Pursuant to 21 U.S.C.
811(h)(2), the temporary control of
fentanyl-related substances, a class of
substances as defined in the order, as
well as these nine specific substances
already covered by that order, was set to
expire on February 6, 2020. However,
on February 6, 2020, as explained in
DEA’s April 10, 2020, correcting
amendment (85 FR 20155), Congress
extended that expiration date until May
6, 2021, by enacting the Temporary
Reauthorization and Study of the
Emergency Scheduling of Fentanyl
Analogues Act (Pub. L. 116–114, sec. 2,
134 Stat. 103). This temporary order was
subsequently extended multiple times,
most recently on December 29, 2022,
through the Consolidated
Appropriations Act, 2023, which
extended the order until December 31,
2024.
Comment: One commenter stated that
fentanyl and the list of related
substances is a hazard due to the
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overdose deaths that have been
occurring. This commenter also
referenced the National Institute on
Drug Abuse, stating that fentanyl-related
overdoses have been increasing in the
United States. Lastly, this commenter
stated that permanently placing fentanyl
and the list of related substances in
schedule I would improve public health
and allow for regulation of these
substances.
DEA Response: DEA appreciates the
comments in support of this
rulemaking. One clarification to note is
that fentanyl remains a schedule II
substance. This final rule only applies
to the fentanyl-related substances that
are listed in this final order.
Comment: One commenter stated the
proposed rule would make it more
difficult to produce and distribute these
dangerous fentanyl-related substances,
which would help combat the opioid
epidemic in the United States. This
commenter also referenced a news
article by National Public Radio, stating
that these nine fentanyl-related
substances are not currently classified
as controlled substances, making it easy
to produce and distribute these
substances without legal consequences.
Lastly, this commenter recognized that
this proposal could have significant
impacts on the healthcare industry,
such as increased oversight and
regulation of fentanyl-related
substances, which could prevent their
misuse and abuse.
DEA Response: DEA appreciates the
comments in support of this
rulemaking. One clarification to note
based on the comment above is that, by
temporary order on February 6, 2018,
DEA placed these nine fentanyl-related
substances under schedule I. 83 FR
5188. That temporary order defined a
fentanyl-related substance to mean any
substance not otherwise controlled in
any schedule (i.e., not listed under
another DEA Controlled Substance Code
Number), and for which no exemption
or approval is in effect under section
505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355), that is
structurally related to fentanyl by one or
more of five specified structural
modifications. Therefore, these nine
fentanyl-related substances are in fact
already schedule I controlled
substances.
The final rule being issued today
applies to nine fentanyl-related
substances that were the subject of a
February 6, 2018, temporary scheduling
order. These nine substances will now
be listed in 21 CFR 1308.11(b), as
specified in the text of the rule that
appears below. This final rule should
not have a significant impact on the
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healthcare industry because these nine
fentanyl-related substances have no
medical use and they have already been
added as schedule I controlled
substances since 2018.
Comment: One commenter discussed
the direct and indirect effects on federal
and state healthcare from this
regulation. The commenter suggested
that this regulation will boost federal
oversight of manufacturing and
disseminating harmful chemicals. In
addition, this regulation would limit
availability and expected use, ensure
protection of residents, and increases
confidence in the medical field. In
addition, the commenter stated that is
critical to restrict the use of ‘‘fentanyl
replicates’’ to those who may need them
for medical conditions. Lastly, the
commenter stated that raising awareness
of the risks of abusing these drugs
benefits their prevention.
DEA Response: DEA appreciates the
comments in support of this
rulemaking. As mentioned previously,
FDA has not approved a marketing
application for a drug product
containing any of these nine substances
for any therapeutic indication. These
substances have no medical use in the
United States.
Comment: One commenter stated that
this rule will affect federal healthcare
because many federal agencies are
trying to tackle the opioid crisis. The
commenter discussed the rising number
of pediatric deaths from fentanyl in
2021 and the surge in 2018 of fentanyl
overdoses among older adolescents as
well as in children younger than five.
The commenter agrees with this final
rule to schedule these fentanyl-related
substances. The commenter also stated
that fentanyl is highly addictive and
that while fentanyl is prescribed for
chronic pain or major surgery, it should
be a last resort.
DEA Response: DEA appreciates the
comments in support of this
rulemaking.
Comment: One commenter agreed
with this final rule to make permanent
these nine specific fentanyl-related
substances rather than continuing
multiple temporary extensions. Once
finalized, the commenter stated that the
federal government could act against
anyone handling these substances since
over 150 people die each day from a
fentanyl-related drug overdose.
DEA Response: DEA appreciates the
comments in support of this
rulemaking. Again, DEA notes that
fentanyl is a schedule II controlled
substance that can be prescribed for
approved medical uses. However, the
nine fentanyl-related substances
addressed in this rule are already
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schedule I controlled substances and
none of them have any medical use in
the United States.
Comment: One commenter stated that
fentanyl should be placed in schedule I.
The commenter compared this
substance to marijuana, which is a
schedule I drug and thought it was
mind-blowing that fentanyl was not a
schedule I substance. It was suggested
that the rising number of deaths, the risk
to public health, abuse potential, and
dependency should classify fentanyl as
a schedule I.
DEA Response: DEA appreciates this
comment. As stated previously, fentanyl
remains a schedule II substance.
Fentanyl has approved medical uses in
the United States. This final rule only
applies to the fentanyl-related
substances that are listed in this final
order.
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Scheduling Conclusion
After consideration of the relevant
matter presented through public
comments, the scientific and medical
evaluation and accompanying
recommendation of HHS, and after its
own eight-factor evaluation, DEA finds
that these facts and all other relevant
data constitute substantial evidence of
the potential for abuse of metafluorofentanyl, meta-fluoroisobutyryl
fentanyl, para-methoxyfuranyl fentanyl,
3-furanyl fentanyl, 2′,5′dimethoxyfentanyl, isovaleryl fentanyl,
ortho-fluorofuranyl fentanyl, alpha′methyl butyryl fentanyl, and paramethylcyclopropyl fentanyl. DEA is
permanently scheduling these nine
fentanyl-related substances as schedule
I controlled substances under the CSA.
Determination of Appropriate Schedule
The CSA establishes five schedules of
controlled substances known as
schedules I, II, III, IV, and V. The CSA
also specifies the findings required to
place a drug or other substance in any
particular schedule.3 After
consideration of the analysis and
recommendation of the Assistant
Secretary for HHS and review of all
other available data, the Administrator,
pursuant to 21 U.S.C. 811(a) and
812(b)(1), finds the following:
(1) The abuse potential of metafluorofentanyl, meta-fluoroisobutyryl
fentanyl, para-methoxyfuranyl fentanyl,
3-furanyl fentanyl, 2′,5′dimethoxyfentanyl, isovaleryl fentanyl,
ortho-fluorofuranyl fentanyl, alpha′methyl butyryl fentanyl, and paramethylcyclopropyl fentanyl is
associated with each substance’s
pharmacological similarity to other
3 21
U.S.C. 812(b).
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schedule I and II mu-opioid receptor
agonist substances which have a high
potential for abuse. Similar to morphine
(schedule II), fentanyl (schedule II), and
several schedule I opioid substances
that are structurally related to fentanyl,
these nine fentanyl-related substances
have been shown to bind and act as muopioid receptor agonists;
(2) meta-Fluorofentanyl, metafluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2′,5′-dimethoxyfentanyl,
isovaleryl fentanyl, ortho-fluorofuranyl
fentanyl, alpha′-methyl butyryl
fentanyl, and para-methylcyclopropyl
fentanyl, have no currently accepted
medical use in treatment in the United
States; 4 and
(3) There is a lack of accepted safety
for use of meta-fluorofentanyl, metafluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2′,5′-dimethoxyfentanyl,
isovaleryl fentanyl, ortho-fluorofuranyl
fentanyl, alpha′-methyl butyryl
fentanyl, and para-methylcyclopropyl
fentanyl under medical supervision.
Based on these findings, the
Administrator concludes that metafluorofentanyl, meta-fluoroisobutyryl
fentanyl, para-methoxyfuranyl fentanyl,
3-furanyl fentanyl, 2′,5′dimethoxyfentanyl, isovaleryl fentanyl,
ortho-fluorofuranyl fentanyl, alpha′methyl butyryl fentanyl, and paramethylcyclopropyl fentanyl, including
their isomers, esters, ethers, salts, and
salts of isomers, esters, and ethers
whenever the existence of such isomers,
esters, ethers, and salts is possible,
warrant control in schedule I of the
CSA.5
This final rule does not affect the
scheduling of fentanyl itself, which
4 Although there is no evidence suggesting that
meta-fluorofentanyl, meta-fluoroisobutyryl
fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2′,5′-dimethoxyfentanyl, isovaleryl
fentanyl, ortho-fluorofuranyl fentanyl, alpha′methyl butyryl fentanyl, and paramethylcyclopropyl fentanyl have a currently
accepted medical use in treatment in the United
States, it bears noting that a drug cannot be found
to have such medical use unless DEA concludes
that it satisfies a five-part test. Specifically, with
respect to a drug that has not been approved by
FDA, to have a currently accepted medical use in
treatment in the United States, all of the following
must be demonstrated:
i. The drug’s chemistry must be known and
reproducible;
ii. there must be adequate safety studies;
iii. there must be adequate and well-controlled
studies proving efficacy;
iv. the drug must be accepted by qualified
experts; and
v. the scientific evidence must be widely
available.
57 FR 10499 (1992).
5 21 U.S.C. 812(b)(1).
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remains a schedule II controlled
substance.
Requirements for Handling MetaFluorofentanyl, Meta-Fluoroisobutyryl
Fentanyl, Para-Methoxyfuranyl
Fentanyl, 3-Furanyl Fentanyl, 2′,5′Dimethoxyfentanyl, Isovaleryl
Fentanyl, Ortho-Fluorofuranyl
Fentanyl, Alpha′-Methyl Butyryl
Fentanyl, and Para-Methylcyclopropyl
Fentanyl
Meta-Fluorofentanyl, metafluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2′,5′-dimethoxyfentanyl,
isovaleryl fentanyl, ortho-fluorofuranyl
fentanyl, alpha′-methyl butyryl
fentanyl, and para-methylcyclopropyl
fentanyl will continue, on a permanent
basis,6 to be subject to the CSA’s
schedule I regulatory controls and
administrative, civil, and criminal
sanctions applicable to the manufacture,
distribution, dispensing, importing,
exporting, research, and conduct of
instructional activities, including the
following:
1. Registration. Any person who
handles (manufactures, distributes,
dispenses, imports, exports, engages in
research, or conducts instructional
activities or chemical analysis with, or
possesses) meta-fluorofentanyl, metafluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2′,5′-dimethoxyfentanyl,
isovaleryl fentanyl, ortho-fluorofuranyl
fentanyl, alpha′-methyl butyryl
fentanyl, and para-methylcyclopropyl
fentanyl, or who desires to handle these
nine substances, is required to be
registered with DEA to conduct such
activities pursuant to 21 U.S.C. 822,
823, 957, and 958, and in accordance
with 21 CFR parts 1301 and 1312. Retail
sales of schedule I controlled substances
to the general public are not allowed
under the CSA. Possession of any
quantity of these substances in a manner
not authorized by the CSA is unlawful
and those in possession of any quantity
of these substances may be subject to
prosecution pursuant to the CSA.
2. Disposal of stocks. metafluorofentanyl, meta-fluoroisobutyryl
fentanyl, para-methoxyfuranyl fentanyl,
3-furanyl fentanyl, 2′,5′6 meta-fluorofentanyl, meta-fluoroisobutyryl
fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2′,5′-dimethoxyfentanyl, isovaleryl
fentanyl, ortho-fluorofuranyl fentanyl, alpha′methyl butyryl fentanyl, and/or paramethylcyclopropyl fentanyl have been subject to
schedule I controls on a temporary basis, pursuant
to 21 U.S.C. 811(h), by virtue of the February 6,
2018 temporary scheduling order (83 FR 5188) and
the subsequent statutory extension of that order
through December 31, 2024 (Pub. L. 117–328,
Division O, Title VI, Sec. 601).
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dimethoxyfentanyl, isovaleryl fentanyl,
ortho-fluorofuranyl fentanyl, alpha′methyl butyryl fentanyl, and paramethylcyclopropyl fentanyl must be
disposed of in accordance with 21 CFR
part 1317, in addition to all other
applicable federal, state, local, and tribal
laws.
3. Security. meta-fluorofentanyl,
meta-fluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2′,5′-dimethoxyfentanyl,
isovaleryl fentanyl, ortho-fluorofuranyl
fentanyl, alpha′-methyl butyryl
fentanyl, and para-methylcyclopropyl
fentanyl are subject to schedule I
security requirements and must be
handled and stored pursuant to 21
U.S.C. 823, and in accordance with 21
CFR 1301.71–1301.76. Non-practitioners
handling these nine substances must
also comply with the employee
screening requirements of 21 CFR
1301.90–1301.93.
4. Labeling and Packaging. All labels
and labeling for commercial containers
of meta-fluorofentanyl, metafluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2′,5′-dimethoxyfentanyl,
isovaleryl fentanyl, ortho-fluorofuranyl
fentanyl, alpha′-methyl butyryl
fentanyl, and para-methylcyclopropyl
fentanyl, must be in compliance with 21
U.S.C. 825, and be in accordance with
21 CFR part 1302.
5. Quota. Only registered
manufacturers are permitted to
manufacture meta-fluorofentanyl, metafluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2′,5′-dimethoxyfentanyl,
isovaleryl fentanyl, ortho-fluorofuranyl
fentanyl, alpha′-methyl butyryl
fentanyl, and para-methylcyclopropyl
fentanyl in accordance with a quota
assigned pursuant to 21 U.S.C. 826 and
in accordance with 21 CFR part 1303.
6. Inventory. Any person registered
with DEA to handle metafluorofentanyl, meta-fluoroisobutyryl
fentanyl, para-methoxyfuranyl fentanyl,
3-furanyl fentanyl, 2′,5′dimethoxyfentanyl, isovaleryl fentanyl,
ortho-fluorofuranyl fentanyl, alpha′methyl butyryl fentanyl, and paramethylcyclopropyl fentanyl must have
an initial inventory of all stocks of
controlled substances (including these
substances) on hand on the date the
registrant first engages in the handling
of controlled substances pursuant to 21
U.S.C. 827 and 958(e), and in
accordance with 21 CFR 1304.03,
1304.04, and 1304.11.
After the initial inventory, every DEA
registrant must take a new inventory of
all stocks of controlled substances
(including meta-fluorofentanyl, meta-
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fluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2′,5′-dimethoxyfentanyl,
isovaleryl fentanyl, ortho-fluorofuranyl
fentanyl, alpha′-methyl butyryl
fentanyl, and para-methylcyclopropyl
fentanyl) on hand every two years
pursuant to 21 U.S.C. 827 and 958(e),
and in accordance with 21 CFR 1304.03,
1304.04, and 1304.11.
7. Records and Reports. Every DEA
registrant must maintain records and
submit reports with respect to metafluorofentanyl, meta-fluoroisobutyryl
fentanyl, para-methoxyfuranyl fentanyl,
3-furanyl fentanyl, 2′,5′dimethoxyfentanyl, isovaleryl fentanyl,
ortho-fluorofuranyl fentanyl, alpha′methyl butyryl fentanyl, and paramethylcyclopropyl fentanyl, pursuant to
21 U.S.C. 827 and 958(e), and in
accordance with 21 CFR parts
1301.74(b) and (c), 1301.76(b), 1307.11
and parts 1304, 1312, and 1317.
Manufacturers and distributors must
submit reports regarding these
substances to the Automation of Reports
and Consolidated Order System
pursuant to 21 U.S.C. 827 and in
accordance with 21 CFR parts 1304 and
1312.
8. Order Forms. Every DEA registrant
who distributes meta-fluorofentanyl,
meta-fluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2′,5′-dimethoxyfentanyl,
isovaleryl fentanyl, ortho-fluorofuranyl
fentanyl, alpha′-methyl butyryl
fentanyl, and para-methylcyclopropyl
fentanyl must continue to comply with
the order form requirements, pursuant
to 21 U.S.C. 828 and in accordance with
21 CFR part 1305.
9. Importation and Exportation. All
importation and exportation of metafluorofentanyl, meta-fluoroisobutyryl
fentanyl, para-methoxyfuranyl fentanyl,
3-furanyl fentanyl, 2′,5′dimethoxyfentanyl, isovaleryl fentanyl,
ortho-fluorofuranyl fentanyl, alpha′methyl butyryl fentanyl, and paramethylcyclopropyl fentanyl must
comply with 21 U.S.C. 952, 953, 957,
and 958, and in accordance with 21 CFR
part 1312.
10. Liability. Any activity involving
meta-fluorofentanyl, metafluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2′,5′-dimethoxyfentanyl,
isovaleryl fentanyl, ortho-fluorofuranyl
fentanyl, alpha′-methyl butyryl
fentanyl, and para-methylcyclopropyl
fentanyl not authorized by, or in
violation of, the CSA or its
implementing regulations is unlawful
and may subject the person to
administrative, civil, and/or criminal
sanctions.
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Regulatory Analyses
Executive Orders (E.O.) 12866
(Regulatory Planning and Review),
13563 (Improving Regulation and
Regulatory Review), and 14094
(Modernizing Regulatory Review)
This action is not a significant
regulatory action as defined by
Executive Order (E.O.) 12866
(Regulatory Planning and Review),
section 3(f), and the principles
reaffirmed in E.O. 13563 (Improving
Regulation and Regulatory Review);
and, accordingly, this action has not
been reviewed by the Office of
Management and Budget (OMB). This
action makes no change in the status
quo, as meta-fluorofentanyl, metafluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2′,5′-dimethoxyfentanyl,
isovaleryl fentanyl, ortho-fluorofuranyl
fentanyl, alpha′-methyl butyryl
fentanyl, and para-methylcyclopropyl
fentanyl are already listed as a schedule
I controlled substances.
Executive Order 12988, Civil Justice
Reform
This action meets the applicable
standards set forth in sections 3(a) and
3(b)(2) of E.O. 12988 to eliminate
drafting errors and ambiguity, minimize
litigation, provide a clear legal standard
for affected conduct, and promote
simplification and burden reduction.
Executive Order 13132, Federalism
This rulemaking does not have
federalism implications warranting the
application of E.O. 13132. The rule does
not have substantial direct effects on the
states, on the relationship between the
National Government and the states, or
the distribution of power and
responsibilities among the various
levels of government.
Executive Order 13175, Consultation
and Coordination With Indian Tribal
Governments
This rule does not have tribal
implications warranting the application
of E.O. 13175. It does not have
substantial direct effects on one or more
Indian tribes, on the relationship
between the Federal Government and
Indian tribes, or on the distribution of
power and responsibilities between the
Federal Government and Indian tribes.
Regulatory Flexibility Act
The Administrator, in accordance
with the Regulatory Flexibility Act, 5
U.S.C. 601–602, has reviewed this final
rule and, by approving it, certifies that
it will not have a significant economic
impact on a substantial number of small
E:\FR\FM\07DER1.SGM
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Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Rules and Regulations
ddrumheller on DSK120RN23PROD with RULES1
entities. On February 6, 2018, DEA
published an order to temporarily place
fentanyl-related substances in schedule
I of the CSA pursuant to the temporary
scheduling provisions of 21 U.S.C.
811(h). DEA estimates that all entities
handling or planning to handle metafluorofentanyl, meta-fluoroisobutyryl
fentanyl, para-methoxyfuranyl fentanyl,
3-furanyl fentanyl, 2′,5′dimethoxyfentanyl, isovaleryl fentanyl,
ortho-fluorofuranyl fentanyl, alpha′methyl butyryl fentanyl, and paramethylcyclopropyl fentanyl have
already established and implemented
the systems and processes required to
handle these substances.
As discussed in the NPRM, there are
108 registrations authorized to handle
one or more of the following substances:
meta-fluorofentanyl, metafluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2′,5′-dimethoxyfentanyl,
isovaleryl fentanyl, ortho-fluorofuranyl
fentanyl, alpha′-methyl butyryl
fentanyl, and para-methylcyclopropyl
fentanyl, as well as a number of
registered analytical labs that are
authorized to handle schedule I
controlled substances generally. These
108 registrations represent a maximum
of 95 small entities. Therefore, DEA
conservatively estimates as many as 95
small entities are affected by this rule.
A review of the 108 registrations
indicates that all entities that currently
handle meta-fluorofentanyl, metafluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2′,5′-dimethoxyfentanyl,
isovaleryl fentanyl, ortho-fluorofuranyl
fentanyl, alpha′-methyl butyryl
fentanyl, and para-methylcyclopropyl
fentanyl, also handle other schedule I
controlled substances and have
established and implemented (or
maintain) the systems and processes
required to handle these substances.
Therefore, DEA anticipates that this
final rule will impose minimal or no
economic impact on any affected
entities, and, thus, will not have a
significant economic impact on any of
the small entities. Therefore, DEA has
concluded that this final rule will not
have a significant economic impact on
a substantial number of small entities.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded
Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has
determined and certifies that this action
would not result in any federal mandate
that may result ‘‘in the expenditure by
State, local, and Tribal Governments, in
the aggregate, or by the private sector, of
$100 million or more (adjusted annually
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16:11 Dec 06, 2023
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for inflation) in any 1 year * * * .’’
Therefore, neither a Small Government
Agency Plan nor any other action is
required under UMRA of 1995.
Paperwork Reduction Act of 1995
This final rule does not impose a new
collection or modify an existing
collection of information under the
Paperwork Reduction Act of 1995. 44
U.S.C. 3501–3521. Also, this final rule
does not impose new or modify existing
recordkeeping or reporting requirements
on State or local governments,
individuals, businesses, or
organizations. However, this final rule
does require compliance with the
following existing OMB collections:
1117–0003, 1117–0004, 1117–0006,
1117–0008, 1117–0009, 1117–0010,
1117–0012, 1117–0014, 1117–0021,
1117–0023, 1117–0029, and 1117–0056.
An agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number.
Congressional Review Act
This rule is not a major rule as
defined by the Congressional Review
Act (CRA), 5 U.S.C. 804. Pursuant to the
CRA, DEA is submitting a copy of this
final rule to both Houses of Congress
and to the Comptroller General.
Determination To Make Rule Effective
Immediately
As indicated above, this rule finalizes
the schedule I control status of nine
substances that has already been in
effect. These nine substances all fall
within the definition of fentanyl-related
substances set forth in the February 6,
2018, temporary scheduling order (83
FR 5188). Through the Temporary
Reauthorization and Study of the
Emergency Scheduling of Fentanyl
Analogues Act, which became law on
February 6, 2020, Congress extended the
temporary control of fentanyl-related
substances until May 6, 2021. This
temporary order was subsequently
extended multiple times, most recently
on December 29, 2022, through the
Consolidated Appropriations Act, 2023,
which extended the order until
December 31, 2024.7 The February 2018
order was effective on the date of
publication, and was based on findings
by the then-Acting Administrator that
the temporary scheduling of the
fentanyl-related substances was
necessary to avoid an imminent hazard
to the public safety pursuant to 21
U.S.C. 811(h)(1). Because this rule
7 Public
Law 117–328, Division O, Title VI, Sec.
601.
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
finalizes the control status of nine
substances that has already been in
effect, it does not alter the legal
obligations of any person who handles
these substances. Rather, it merely
makes permanent the current
scheduling status and corresponding
legal obligations. Therefore, since this
rule does not change the current
scheduling status and corresponding
legal obligations, DEA is making the
rule effective on the date of publication
in the Federal Register, as any delay in
the effective date is unnecessary and
would be contrary to the public interest.
Signing Authority
This document of the Drug
Enforcement Administration was signed
on November 29, 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.
List of Subjects in 21 CFR Part 1308
Administrative practice and
procedure, Drug traffic control,
Reporting and recordkeeping
requirements.
For the reasons set out above, 21 CFR
part 1308 is amended as follows:
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
1. The authority citation for 21 CFR
part 1308 continues to read as follows:
■
Authority: 21 U.S.C. 811, 812, 871(b),
956(b), unless otherwise noted.
2. In § 1308.11:
a. Redesignate paragraphs (b)(10)
through (94) to read as follows:
■
■
Old paragraph
(b)(10)
(b)(34)
(b)(44)
(b)(48)
(b)(51)
(b)(67)
(b)(75)
through
through
through
through
through
through
through
(33)
(43)
(47)
(50)
(66)
(74)
(94)
New paragraph
........
........
........
........
........
........
........
(b)(11)
(b)(36)
(b)(47)
(b)(52)
(b)(57)
(b)(74)
(b)(84)
through
through
through
through
through
through
through
(34).
(45).
(50).
(54).
(72).
(81).
(103).
b. Add new paragraphs (b)(10), (35),
(46), (51), (55), (56), (73), (82), and (83);
The additions to read as follows:
■
E:\FR\FM\07DER1.SGM
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Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Rules and Regulations
§ 1308.11
*
*
Schedule I.
*
*
(b) * * *
*
*
*
*
*
*
*
*
(10) alpha′-Methyl butyryl fentanyl (2-methyl-N-(1-phenethylpiperidin-4-yl)-N-phenylbutanamide) .........................................................
9864
*
*
*
*
*
*
*
(35) 2′,5′-Dimethoxyfentanyl (N-(1-(2,5-dimethoxyphenethyl)piperidin-4-yl)-N-phenylpropionamide) ......................................................
9861
*
*
*
*
*
*
*
(46) 3-Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-3-carboxamide) ..............................................................................
9860
*
*
*
*
*
*
*
(51) Isovaleryl fentanyl (3-methyl-N-(1-phenethylpiperidin-4-yl)-N-phenylbutanamide) .............................................................................
9862
*
*
*
*
*
*
*
(55) meta-Fluorofentanyl (N-(3-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide) .......................................................................
(56) meta-Fluoroisobutyryl fentanyl (N-(3-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide) ....................................................
9857
9858
*
*
*
*
*
*
*
(73) ortho-Fluorofuranyl fentanyl (N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)furan-2-carboxamide) ..............................................
9863
*
*
*
*
*
*
*
(82) para-Methoxyfuranyl fentanyl (N-(4-methoxyphenyl)-N-(1-phenethylpiperidin-4-yl)furan-2-carboxamide ........................................
(83) para-Methylcyclopropyl fentanyl (N-(4-methylphenyl)-N-(1-phenethylpiperidin-4-yl)cyclopropanecarboxamide) ............................
9859
9865
*
*
*
*
*
[FR Doc. 2023–26694 Filed 12–6–23; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF STATE
22 CFR Part 42
[Public Notice: 12224]
RIN 1400–AE83
Immigrant Visas
Department of State.
Final rule.
AGENCY:
ACTION:
The Department of State
(‘‘Department’’) is amending its
regulation governing immigrant visas by
removing the section which allows a
consular officer to conduct an informal
evaluation of the family members of an
immigrant visa applicant to identify
potential grounds of ineligibility. The
existing regulation was promulgated in
1952, at a time when a consular officer
could more readily assess a family
member’s potential qualification for a
visa without a formal visa application.
Assessing eligibility for an immigrant
visa is now a more complex task and not
one which can be accomplished
accurately with an informal evaluation.
DATES: This final rule is effective on
January 8, 2024.
FOR FURTHER INFORMATION CONTACT:
Claire Kelly, Office of Visa Services,
Bureau of Consular Affairs, Department
of State; telephone (202) 485–7586,
VisaRegs@state.gov.
SUPPLEMENTARY INFORMATION: The
Department published a notice of
SUMMARY:
ddrumheller on DSK120RN23PROD with RULES1
85109
VerDate Sep<11>2014
16:11 Dec 06, 2023
Jkt 262001
proposed rulemaking, Public Notice
11604 at 88 FR 16384 (Mar. 17, 2023)
(hereafter ‘‘proposed rule’’), with a
request for comments, proposing to
amend Part 42 of Title 22 of the Code
of Federal Regulations. The rule will
eliminate 22 CFR 42.68 in its entirety.
The regulatory amendment was
discussed in detail in the proposed rule,
and that discussion is adopted by
reference in this final rule. The
Department received two responsive
comments, both in support of
eliminating 22 CFR 42.68. The
Department is now promulgating a final
rule with no changes from the proposed
rule. This rule results in no change for
applicants, as the authority granted by
22 CFR 42.68 was no longer used by
consular officers.1
Analysis of Comments
The proposed rule was published in
the Federal Register on March 17, 2023.
The comment period closed May 16,
2023. The Department received two
responsive comments, both in favor of
the proposed elimination of 22 CFR
42.68, and one non-responsive
comment.
One of the two responsive comments
advocated for replacing 22 CFR 42.68
with ‘‘supportive and accessible
eligibility screenings for noncitizens
seeking visas,’’ while the other comment
only expressed its support for the
proposed elimination. The Department
has considered these comments.
Considering the complexity required to
evaluate a noncitizen’s eligibility for a
visa, and limited resources to reliably
1 See
PO 00000
the proposed rule for further discussion.
Frm 00017
Fmt 4700
Sfmt 4700
assess eligibility absent a visa
application, the Department is unable to
offer any eligibility screenings.
Noncitizens who wish to receive a
nonimmigrant or immigrant visa must
formally apply for a visa to allow a
consular officer to assess their eligibility
for the visa.
Regulatory Findings
A. Administrative Procedure Act
As this rule involves amending visa
policy, which is a foreign affairs
function of the United States, it is
exempt from both the delayed effective
date and notice and comment
requirements of 5 U.S.C. 553 per
subsection (a)(1). Notwithstanding the
applicability of the foreign affairs
exception to this rule, the Department,
for its own benefit, sought public
comment on the proposed elimination
of 22 CFR 42.68. See, e.g., Hoctor v. U.S.
Dep’t of Agric., 82 F.3d 165, 171–72 (7th
Cir. 1996) (observing that there is
nothing in the APA that forbids an
agency’s use of notice-and-comment
procedures even if not required under
the APA, and that courts should attach
no weight to an agency’s varied
approaches involving similar rules).
Though this rule is not subject to 5
U.S.C. 553(d), the Department is also
choosing to delay the effective date of
this rule for 30 days.
B. Regulatory Flexibility Act
As this rulemaking is not required to
be published for notice and comment
under 5 U.S.C. 553, it is exempt from
the regulatory flexibility analysis
requirements set forth by the Regulatory
E:\FR\FM\07DER1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 234 (Thursday, December 7, 2023)]
[Rules and Regulations]
[Pages 85104-85109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26694]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1036]
Schedules of Controlled Substances: Placement of Nine Specific
Fentanyl-Related Substances in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: With the issuance of this final rule, the Drug Enforcement
Administration places nine fentanyl-related substances, as identified
in this final rule, including their isomers, esters, ethers, salts, and
salts of isomers, esters, and ethers whenever the existence of such
isomers, esters, ethers, and salts is possible, in schedule I of the
Controlled Substances Act. These nine fentanyl-related substances are
currently listed in schedule I pursuant to a temporary scheduling
order. This action makes permanent the imposition of the regulatory
controls and administrative, civil, and criminal sanctions applicable
to schedule I controlled substances on persons who handle (manufacture,
distribute, import, export, engage in research, conduct instructional
activities or chemical analysis with, or possess), or propose to handle
these nine specific fentanyl-related controlled substances.
DATES: Effective date: December 7, 2023.
FOR FURTHER INFORMATION CONTACT: Dr. Terrence L. Boos, Drug and
Chemical Evaluation Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION: In this rule, the Drug Enforcement
Administration (DEA) is permanently scheduling the following nine
controlled substances including their isomers, esters, ethers, salts,
and salts of isomers, esters, and ethers whenever the existence of such
isomers, esters, ethers, and salts is possible, in schedule I of the
Controlled Substances Act (CSA):
meta-fluorofentanyl (N-(3-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)propionamide),
meta-fluoroisobutyryl fentanyl (N-(3-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)isobutyramide),
para-methoxyfuranyl fentanyl (N-(4-methoxyphenyl)-N-(1-
phenethylpiperidin-4-yl)furan-2-carboxamide),
3-furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-
phenylfuran-3-carboxamide),
2',5'-dimethoxyfentanyl (N-(1-(2,5-
dimethoxyphenethyl)piperidin-4-yl)-N-phenylpropionamide),
isovaleryl fentanyl (3-methyl-N-(1-phenethylpiperidin-4-
yl)-N-phenylbutanamide),
ortho-fluorofuranyl fentanyl (N-(2-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)furan-2-carboxamide),
alpha'-methyl butyryl fentanyl (2-methyl-N-(1-
phenethylpiperidin-4-yl)-N-phenylbutanamide), and
para-methylcyclopropyl fentanyl (N-(4-methylphenyl)-N-(1-
phenethylpiperidin-4-yl)cyclopropanecarboxamide).
Legal Authority
The CSA provides that proceedings for the issuance, amendment, or
repeal of the scheduling of any drug or other substance may be
initiated by the Attorney General (1) on his own motion; (2) at the
request of the Secretary of the Department of Health and Human Services
(HHS); \1\ or (3) on the petition of any interested party.\2\ This
action was initiated on the Attorney General's own motion, as delegated
to the Administrator of the DEA (Administrator), and is supported by,
inter alia, a recommendation from the Assistant Secretary for Health of
HHS
[[Page 85105]]
(Assistant Secretary) and an evaluation of all relevant data by DEA.
This action continues the imposition of the regulatory controls and
administrative, civil, and criminal sanctions of schedule I controlled
substances on any person who handles or proposes to handle meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl,
and para-methylcyclopropyl fentanyl.
---------------------------------------------------------------------------
\1\ As discussed in a memorandum of understanding entered into
by the Food and Drug Administration (FDA) and the National Institute
on Drug Abuse (NIDA), FDA acts as the lead agency within HHS in
carrying out the Secretary's scheduling responsibilities under the
CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The
Secretary of HHS has delegated to the Assistant Secretary for Health
of HHS the authority to make domestic drug scheduling
recommendations. 58 FR 35460, July 1, 1993.
\2\ 21 U.S.C. 811(a).
---------------------------------------------------------------------------
Background
On February 6, 2018, DEA published an order in the Federal Register
(FR) (83 FR 5188) amending 21 CFR 1308.11(h), temporarily placing
fentanyl-related substances, as defined in that order, in schedule I of
the CSA based upon a finding that these substances pose an imminent
hazard to the public safety and pursuant to the temporary scheduling
provisions of 21 U.S.C. 811(h). The nine substances named in this final
rule meet the existing definition of fentanyl-related substances, as
they are not otherwise controlled in any other schedule (i.e., not
included under another DEA Controlled Substance Code Number) and are
structurally related to fentanyl by one or more of the five
modifications listed under the definition. That temporary scheduling
order was effective on the date of publication and was based on
findings by the former Acting Administrator that the temporary
scheduling of these substances was necessary to avoid an imminent
hazard to the public safety pursuant to 21 U.S.C. 811(h)(1). Pursuant
to 21 U.S.C. 811(h)(2), the temporary control of fentanyl-related
substances, a class of substances as defined in the order, as well as
these nine specific substances already covered by that order, was set
to expire on February 6, 2020. However, on February 6, 2020, as
explained in DEA's April 10, 2020, correcting amendment (85 FR 20155),
Congress extended that expiration date until May 6, 2021, by enacting
the Temporary Reauthorization and Study of the Emergency Scheduling of
Fentanyl Analogues Act (Pub. L. 116-114, sec. 2, 134 Stat. 103). This
temporary order was subsequently extended multiple times, most recently
on December 29, 2022, through the Consolidated Appropriations Act,
2023, which extended the order until December 31, 2024.
Comment: One commenter stated that fentanyl and the list of related
substances is a hazard due to the overdose deaths that have been
occurring. This commenter also referenced the National Institute on
Drug Abuse, stating that fentanyl-related overdoses have been
increasing in the United States. Lastly, this commenter stated that
permanently placing fentanyl and the list of related substances in
schedule I would improve public health and allow for regulation of
these substances.
DEA Response: DEA appreciates the comments in support of this
rulemaking. One clarification to note is that fentanyl remains a
schedule II substance. This final rule only applies to the fentanyl-
related substances that are listed in this final order.
Comment: One commenter stated the proposed rule would make it more
difficult to produce and distribute these dangerous fentanyl-related
substances, which would help combat the opioid epidemic in the United
States. This commenter also referenced a news article by National
Public Radio, stating that these nine fentanyl-related substances are
not currently classified as controlled substances, making it easy to
produce and distribute these substances without legal consequences.
Lastly, this commenter recognized that this proposal could have
significant impacts on the healthcare industry, such as increased
oversight and regulation of fentanyl-related substances, which could
prevent their misuse and abuse.
DEA Response: DEA appreciates the comments in support of this
rulemaking. One clarification to note based on the comment above is
that, by temporary order on February 6, 2018, DEA placed these nine
fentanyl-related substances under schedule I. 83 FR 5188. That
temporary order defined a fentanyl-related substance to mean any
substance not otherwise controlled in any schedule (i.e., not listed
under another DEA Controlled Substance Code Number), and for which no
exemption or approval is in effect under section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355), that is structurally
related to fentanyl by one or more of five specified structural
modifications. Therefore, these nine fentanyl-related substances are in
fact already schedule I controlled substances.
The final rule being issued today applies to nine fentanyl-related
substances that were the subject of a February 6, 2018, temporary
scheduling order. These nine substances will now be listed in 21 CFR
1308.11(b), as specified in the text of the rule that appears below.
This final rule should not have a significant impact on the healthcare
industry because these nine fentanyl-related substances have no medical
use and they have already been added as schedule I controlled
substances since 2018.
Comment: One commenter discussed the direct and indirect effects on
federal and state healthcare from this regulation. The commenter
suggested that this regulation will boost federal oversight of
manufacturing and disseminating harmful chemicals. In addition, this
regulation would limit availability and expected use, ensure protection
of residents, and increases confidence in the medical field. In
addition, the commenter stated that is critical to restrict the use of
``fentanyl replicates'' to those who may need them for medical
conditions. Lastly, the commenter stated that raising awareness of the
risks of abusing these drugs benefits their prevention.
DEA Response: DEA appreciates the comments in support of this
rulemaking. As mentioned previously, FDA has not approved a marketing
application for a drug product containing any of these nine substances
for any therapeutic indication. These substances have no medical use in
the United States.
Comment: One commenter stated that this rule will affect federal
healthcare because many federal agencies are trying to tackle the
opioid crisis. The commenter discussed the rising number of pediatric
deaths from fentanyl in 2021 and the surge in 2018 of fentanyl
overdoses among older adolescents as well as in children younger than
five. The commenter agrees with this final rule to schedule these
fentanyl-related substances. The commenter also stated that fentanyl is
highly addictive and that while fentanyl is prescribed for chronic pain
or major surgery, it should be a last resort.
DEA Response: DEA appreciates the comments in support of this
rulemaking.
Comment: One commenter agreed with this final rule to make
permanent these nine specific fentanyl-related substances rather than
continuing multiple temporary extensions. Once finalized, the commenter
stated that the federal government could act against anyone handling
these substances since over 150 people die each day from a fentanyl-
related drug overdose.
DEA Response: DEA appreciates the comments in support of this
rulemaking. Again, DEA notes that fentanyl is a schedule II controlled
substance that can be prescribed for approved medical uses. However,
the nine fentanyl-related substances addressed in this rule are already
[[Page 85106]]
schedule I controlled substances and none of them have any medical use
in the United States.
Comment: One commenter stated that fentanyl should be placed in
schedule I. The commenter compared this substance to marijuana, which
is a schedule I drug and thought it was mind-blowing that fentanyl was
not a schedule I substance. It was suggested that the rising number of
deaths, the risk to public health, abuse potential, and dependency
should classify fentanyl as a schedule I.
DEA Response: DEA appreciates this comment. As stated previously,
fentanyl remains a schedule II substance. Fentanyl has approved medical
uses in the United States. This final rule only applies to the
fentanyl-related substances that are listed in this final order.
Scheduling Conclusion
After consideration of the relevant matter presented through public
comments, the scientific and medical evaluation and accompanying
recommendation of HHS, and after its own eight-factor evaluation, DEA
finds that these facts and all other relevant data constitute
substantial evidence of the potential for abuse of meta-fluorofentanyl,
meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl fentanyl, ortho-
fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, and para-
methylcyclopropyl fentanyl. DEA is permanently scheduling these nine
fentanyl-related substances as schedule I controlled substances under
the CSA.
Determination of Appropriate Schedule
The CSA establishes five schedules of controlled substances known
as schedules I, II, III, IV, and V. The CSA also specifies the findings
required to place a drug or other substance in any particular
schedule.\3\ After consideration of the analysis and recommendation of
the Assistant Secretary for HHS and review of all other available data,
the Administrator, pursuant to 21 U.S.C. 811(a) and 812(b)(1), finds
the following:
---------------------------------------------------------------------------
\3\ 21 U.S.C. 812(b).
---------------------------------------------------------------------------
(1) The abuse potential of meta-fluorofentanyl, meta-
fluoroisobutyryl fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl fentanyl, ortho-
fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, and para-
methylcyclopropyl fentanyl is associated with each substance's
pharmacological similarity to other schedule I and II mu-opioid
receptor agonist substances which have a high potential for abuse.
Similar to morphine (schedule II), fentanyl (schedule II), and several
schedule I opioid substances that are structurally related to fentanyl,
these nine fentanyl-related substances have been shown to bind and act
as mu-opioid receptor agonists;
(2) meta-Fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-
methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl,
isovaleryl fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl
butyryl fentanyl, and para-methylcyclopropyl fentanyl, have no
currently accepted medical use in treatment in the United States; \4\
and
---------------------------------------------------------------------------
\4\ Although there is no evidence suggesting that meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl
fentanyl, and para-methylcyclopropyl fentanyl have a currently
accepted medical use in treatment in the United States, it bears
noting that a drug cannot be found to have such medical use unless
DEA concludes that it satisfies a five-part test. Specifically, with
respect to a drug that has not been approved by FDA, to have a
currently accepted medical use in treatment in the United States,
all of the following must be demonstrated:
i. The drug's chemistry must be known and reproducible;
ii. there must be adequate safety studies;
iii. there must be adequate and well-controlled studies proving
efficacy;
iv. the drug must be accepted by qualified experts; and
v. the scientific evidence must be widely available.
57 FR 10499 (1992).
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(3) There is a lack of accepted safety for use of meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl,
and para-methylcyclopropyl fentanyl under medical supervision.
Based on these findings, the Administrator concludes that meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl,
and para-methylcyclopropyl fentanyl, including their isomers, esters,
ethers, salts, and salts of isomers, esters, and ethers whenever the
existence of such isomers, esters, ethers, and salts is possible,
warrant control in schedule I of the CSA.\5\
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\5\ 21 U.S.C. 812(b)(1).
---------------------------------------------------------------------------
This final rule does not affect the scheduling of fentanyl itself,
which remains a schedule II controlled substance.
Requirements for Handling Meta-Fluorofentanyl, Meta-Fluoroisobutyryl
Fentanyl, Para-Methoxyfuranyl Fentanyl, 3-Furanyl Fentanyl, 2',5'-
Dimethoxyfentanyl, Isovaleryl Fentanyl, Ortho-Fluorofuranyl Fentanyl,
Alpha'-Methyl Butyryl Fentanyl, and Para-Methylcyclopropyl Fentanyl
Meta-Fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-
methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl,
isovaleryl fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl
butyryl fentanyl, and para-methylcyclopropyl fentanyl will continue, on
a permanent basis,\6\ to be subject to the CSA's schedule I regulatory
controls and administrative, civil, and criminal sanctions applicable
to the manufacture, distribution, dispensing, importing, exporting,
research, and conduct of instructional activities, including the
following:
---------------------------------------------------------------------------
\6\ meta-fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-
methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-
dimethoxyfentanyl, isovaleryl fentanyl, ortho-fluorofuranyl
fentanyl, alpha'-methyl butyryl fentanyl, and/or para-
methylcyclopropyl fentanyl have been subject to schedule I controls
on a temporary basis, pursuant to 21 U.S.C. 811(h), by virtue of the
February 6, 2018 temporary scheduling order (83 FR 5188) and the
subsequent statutory extension of that order through December 31,
2024 (Pub. L. 117-328, Division O, Title VI, Sec. 601).
---------------------------------------------------------------------------
1. Registration. Any person who handles (manufactures, distributes,
dispenses, imports, exports, engages in research, or conducts
instructional activities or chemical analysis with, or possesses) meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl,
and para-methylcyclopropyl fentanyl, or who desires to handle these
nine substances, is required to be registered with DEA to conduct such
activities pursuant to 21 U.S.C. 822, 823, 957, and 958, and in
accordance with 21 CFR parts 1301 and 1312. Retail sales of schedule I
controlled substances to the general public are not allowed under the
CSA. Possession of any quantity of these substances in a manner not
authorized by the CSA is unlawful and those in possession of any
quantity of these substances may be subject to prosecution pursuant to
the CSA.
2. Disposal of stocks. meta-fluorofentanyl, meta-fluoroisobutyryl
fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-
[[Page 85107]]
dimethoxyfentanyl, isovaleryl fentanyl, ortho-fluorofuranyl fentanyl,
alpha'-methyl butyryl fentanyl, and para-methylcyclopropyl fentanyl
must be disposed of in accordance with 21 CFR part 1317, in addition to
all other applicable federal, state, local, and tribal laws.
3. Security. meta-fluorofentanyl, meta-fluoroisobutyryl fentanyl,
para-methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-
dimethoxyfentanyl, isovaleryl fentanyl, ortho-fluorofuranyl fentanyl,
alpha'-methyl butyryl fentanyl, and para-methylcyclopropyl fentanyl are
subject to schedule I security requirements and must be handled and
stored pursuant to 21 U.S.C. 823, and in accordance with 21 CFR
1301.71-1301.76. Non-practitioners handling these nine substances must
also comply with the employee screening requirements of 21 CFR 1301.90-
1301.93.
4. Labeling and Packaging. All labels and labeling for commercial
containers of meta-fluorofentanyl, meta-fluoroisobutyryl fentanyl,
para-methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-
dimethoxyfentanyl, isovaleryl fentanyl, ortho-fluorofuranyl fentanyl,
alpha'-methyl butyryl fentanyl, and para-methylcyclopropyl fentanyl,
must be in compliance with 21 U.S.C. 825, and be in accordance with 21
CFR part 1302.
5. Quota. Only registered manufacturers are permitted to
manufacture meta-fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-
methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl,
isovaleryl fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl
butyryl fentanyl, and para-methylcyclopropyl fentanyl in accordance
with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with
21 CFR part 1303.
6. Inventory. Any person registered with DEA to handle meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl,
and para-methylcyclopropyl fentanyl must have an initial inventory of
all stocks of controlled substances (including these substances) on
hand on the date the registrant first engages in the handling of
controlled substances pursuant to 21 U.S.C. 827 and 958(e), and in
accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
After the initial inventory, every DEA registrant must take a new
inventory of all stocks of controlled substances (including meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl,
and para-methylcyclopropyl fentanyl) on hand every two years pursuant
to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR 1304.03,
1304.04, and 1304.11.
7. Records and Reports. Every DEA registrant must maintain records
and submit reports with respect to meta-fluorofentanyl, meta-
fluoroisobutyryl fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl fentanyl, ortho-
fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, and para-
methylcyclopropyl fentanyl, pursuant to 21 U.S.C. 827 and 958(e), and
in accordance with 21 CFR parts 1301.74(b) and (c), 1301.76(b), 1307.11
and parts 1304, 1312, and 1317. Manufacturers and distributors must
submit reports regarding these substances to the Automation of Reports
and Consolidated Order System pursuant to 21 U.S.C. 827 and in
accordance with 21 CFR parts 1304 and 1312.
8. Order Forms. Every DEA registrant who distributes meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl,
and para-methylcyclopropyl fentanyl must continue to comply with the
order form requirements, pursuant to 21 U.S.C. 828 and in accordance
with 21 CFR part 1305.
9. Importation and Exportation. All importation and exportation of
meta-fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-
methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl,
isovaleryl fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl
butyryl fentanyl, and para-methylcyclopropyl fentanyl must comply with
21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part
1312.
10. Liability. Any activity involving meta-fluorofentanyl, meta-
fluoroisobutyryl fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl fentanyl, ortho-
fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, and para-
methylcyclopropyl fentanyl not authorized by, or in violation of, the
CSA or its implementing regulations is unlawful and may subject the
person to administrative, civil, and/or criminal sanctions.
Regulatory Analyses
Executive Orders (E.O.) 12866 (Regulatory Planning and Review), 13563
(Improving Regulation and Regulatory Review), and 14094 (Modernizing
Regulatory Review)
This action is not a significant regulatory action as defined by
Executive Order (E.O.) 12866 (Regulatory Planning and Review), section
3(f), and the principles reaffirmed in E.O. 13563 (Improving Regulation
and Regulatory Review); and, accordingly, this action has not been
reviewed by the Office of Management and Budget (OMB). This action
makes no change in the status quo, as meta-fluorofentanyl, meta-
fluoroisobutyryl fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl fentanyl, ortho-
fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, and para-
methylcyclopropyl fentanyl are already listed as a schedule I
controlled substances.
Executive Order 12988, Civil Justice Reform
This action meets the applicable standards set forth in sections
3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and
ambiguity, minimize litigation, provide a clear legal standard for
affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism
This rulemaking does not have federalism implications warranting
the application of E.O. 13132. The rule does not have substantial
direct effects on the states, on the relationship between the National
Government and the states, or the distribution of power and
responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This rule does not have tribal implications warranting the
application of E.O. 13175. It does not have substantial direct effects
on one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.
Regulatory Flexibility Act
The Administrator, in accordance with the Regulatory Flexibility
Act, 5 U.S.C. 601-602, has reviewed this final rule and, by approving
it, certifies that it will not have a significant economic impact on a
substantial number of small
[[Page 85108]]
entities. On February 6, 2018, DEA published an order to temporarily
place fentanyl-related substances in schedule I of the CSA pursuant to
the temporary scheduling provisions of 21 U.S.C. 811(h). DEA estimates
that all entities handling or planning to handle meta-fluorofentanyl,
meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl fentanyl, ortho-
fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, and para-
methylcyclopropyl fentanyl have already established and implemented the
systems and processes required to handle these substances.
As discussed in the NPRM, there are 108 registrations authorized to
handle one or more of the following substances: meta-fluorofentanyl,
meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl fentanyl, ortho-
fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, and para-
methylcyclopropyl fentanyl, as well as a number of registered
analytical labs that are authorized to handle schedule I controlled
substances generally. These 108 registrations represent a maximum of 95
small entities. Therefore, DEA conservatively estimates as many as 95
small entities are affected by this rule.
A review of the 108 registrations indicates that all entities that
currently handle meta-fluorofentanyl, meta-fluoroisobutyryl fentanyl,
para-methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-
dimethoxyfentanyl, isovaleryl fentanyl, ortho-fluorofuranyl fentanyl,
alpha'-methyl butyryl fentanyl, and para-methylcyclopropyl fentanyl,
also handle other schedule I controlled substances and have established
and implemented (or maintain) the systems and processes required to
handle these substances. Therefore, DEA anticipates that this final
rule will impose minimal or no economic impact on any affected
entities, and, thus, will not have a significant economic impact on any
of the small entities. Therefore, DEA has concluded that this final
rule will not have a significant economic impact on a substantial
number of small entities.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has determined and certifies that this
action would not result in any federal mandate that may result ``in the
expenditure by State, local, and Tribal Governments, in the aggregate,
or by the private sector, of $100 million or more (adjusted annually
for inflation) in any 1 year * * * .'' Therefore, neither a Small
Government Agency Plan nor any other action is required under UMRA of
1995.
Paperwork Reduction Act of 1995
This final rule does not impose a new collection or modify an
existing collection of information under the Paperwork Reduction Act of
1995. 44 U.S.C. 3501-3521. Also, this final rule does not impose new or
modify existing recordkeeping or reporting requirements on State or
local governments, individuals, businesses, or organizations. However,
this final rule does require compliance with the following existing OMB
collections: 1117-0003, 1117-0004, 1117-0006, 1117-0008, 1117-0009,
1117-0010, 1117-0012, 1117-0014, 1117-0021, 1117-0023, 1117-0029, and
1117-0056. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.
Congressional Review Act
This rule is not a major rule as defined by the Congressional
Review Act (CRA), 5 U.S.C. 804. Pursuant to the CRA, DEA is submitting
a copy of this final rule to both Houses of Congress and to the
Comptroller General.
Determination To Make Rule Effective Immediately
As indicated above, this rule finalizes the schedule I control
status of nine substances that has already been in effect. These nine
substances all fall within the definition of fentanyl-related
substances set forth in the February 6, 2018, temporary scheduling
order (83 FR 5188). Through the Temporary Reauthorization and Study of
the Emergency Scheduling of Fentanyl Analogues Act, which became law on
February 6, 2020, Congress extended the temporary control of fentanyl-
related substances until May 6, 2021. This temporary order was
subsequently extended multiple times, most recently on December 29,
2022, through the Consolidated Appropriations Act, 2023, which extended
the order until December 31, 2024.\7\ The February 2018 order was
effective on the date of publication, and was based on findings by the
then-Acting Administrator that the temporary scheduling of the
fentanyl-related substances was necessary to avoid an imminent hazard
to the public safety pursuant to 21 U.S.C. 811(h)(1). Because this rule
finalizes the control status of nine substances that has already been
in effect, it does not alter the legal obligations of any person who
handles these substances. Rather, it merely makes permanent the current
scheduling status and corresponding legal obligations. Therefore, since
this rule does not change the current scheduling status and
corresponding legal obligations, DEA is making the rule effective on
the date of publication in the Federal Register, as any delay in the
effective date is unnecessary and would be contrary to the public
interest.
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\7\ Public Law 117-328, Division O, Title VI, Sec. 601.
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Signing Authority
This document of the Drug Enforcement Administration was signed on
November 29, 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.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
For the reasons set out above, 21 CFR part 1308 is amended as
follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for 21 CFR part 1308 continues to read as
follows:
Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise
noted.
0
2. In Sec. 1308.11:
0
a. Redesignate paragraphs (b)(10) through (94) to read as follows:
------------------------------------------------------------------------
Old paragraph New paragraph
------------------------------------------------------------------------
(b)(10) through (33)...................... (b)(11) through (34).
(b)(34) through (43)...................... (b)(36) through (45).
(b)(44) through (47)...................... (b)(47) through (50).
(b)(48) through (50)...................... (b)(52) through (54).
(b)(51) through (66)...................... (b)(57) through (72).
(b)(67) through (74)...................... (b)(74) through (81).
(b)(75) through (94)...................... (b)(84) through (103).
------------------------------------------------------------------------
0
b. Add new paragraphs (b)(10), (35), (46), (51), (55), (56), (73),
(82), and (83);
The additions to read as follows:
[[Page 85109]]
Sec. 1308.11 Schedule I.
* * * * *
(b) * * *
* * * * * * *
(10) alpha'-Methyl butyryl fentanyl (2-methyl-N-(1- 9864
phenethylpiperidin-4-yl)-N-phenylbutanamide)....................
* * * * * * *
(35) 2',5'-Dimethoxyfentanyl (N-(1-(2,5- 9861
dimethoxyphenethyl)piperidin-4-yl)-N-phenylpropionamide)........
* * * * * * *
(46) 3-Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- 9860
phenylfuran-3-carboxamide)......................................
* * * * * * *
(51) Isovaleryl fentanyl (3-methyl-N-(1-phenethylpiperidin-4-yl)- 9862
N-phenylbutanamide).............................................
* * * * * * *
(55) meta-Fluorofentanyl (N-(3-fluorophenyl)-N-(1- 9857
phenethylpiperidin-4-yl)propionamide)...........................
(56) meta-Fluoroisobutyryl fentanyl (N-(3-fluorophenyl)-N-(1- 9858
phenethylpiperidin-4-yl)isobutyramide)..........................
* * * * * * *
(73) ortho-Fluorofuranyl fentanyl (N-(2-fluorophenyl)-N-(1- 9863
phenethylpiperidin-4-yl)furan-2-carboxamide)....................
* * * * * * *
(82) para-Methoxyfuranyl fentanyl (N-(4-methoxyphenyl)-N-(1- 9859
phenethylpiperidin-4-yl)furan-2-carboxamide.....................
(83) para-Methylcyclopropyl fentanyl (N-(4-methylphenyl)-N-(1- 9865
phenethylpiperidin-4-yl)cyclopropanecarboxamide)................
* * * * *
[FR Doc. 2023-26694 Filed 12-6-23; 8:45 am]
BILLING CODE 4410-09-P
