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Proposed Rule2023-07576

Schedules of Controlled Substances: Placement of Nine Specific Fentanyl-Related Substances in Schedule I

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Published

April 13, 2023

Issuing agencies

Justice DepartmentDrug Enforcement Administration

Abstract

The Drug Enforcement Administration proposes placing nine substances, as identified in this proposed rule, in schedule I of the Controlled Substances Act. These nine substances fall within the definition of fentanyl-related substances set forth in the February 6, 2018, temporary scheduling order. Through the Temporary Reauthorization and Study of 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. If finalized, this action would make permanent the existing regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle these nine specific controlled substances.

Full Text

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<title>Federal Register, Volume 88 Issue 71 (Thursday, April 13, 2023)</title>
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[Federal Register Volume 88, Number 71 (Thursday, April 13, 2023)]
[Proposed Rules]
[Pages 22391-22399]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-07576]

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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: Notice of proposed rulemaking.

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SUMMARY: The Drug Enforcement Administration proposes placing nine
substances, as identified in this proposed rule, in schedule I of the
Controlled Substances Act. These nine substances fall within the
definition of fentanyl-related substances set forth in the February 6,
2018, temporary scheduling order. Through the Temporary Reauthorization
and Study of 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. If finalized, this action would make
permanent the existing regulatory controls and administrative, civil,
and criminal sanctions applicable to schedule I controlled substances
on persons who handle (manufacture, distribute, import, export, engage
in research, conduct instructional activities or chemical analysis, or
possess), or propose to handle these nine specific controlled
substances.

DATES: Comments must be submitted electronically or postmarked on or
before May 15, 2023.
Interested persons may file a request for a hearing or waiver of
hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR
1316.47 and/or 1316.49, as applicable. Requests for a hearing, and
waivers of an opportunity for a hearing or to participate in a hearing,
must be received on or before May 15, 2023.

ADDRESSES: Interested persons may file written comments on this
proposal in accordance with 21 CFR 1308.43(g). 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. To ensure proper
handling of comments, please reference ``Docket No. DEA-1036'' on all
electronic and written correspondence, including any attachments.
<bullet> Electronic comments: The Drug Enforcement Administration
(DEA) encourages commenters to submit all comments electronically
through the Federal eRulemaking Portal which provides the ability to
type short comments directly into the comment field on the web page or
to attach a file for lengthier comments. Please go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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. Submitted comments
are not instantaneously available for public view on <a href="http://Regulations.gov">Regulations.gov</a>.
If you have received a Comment Tracking Number, your comment has been
successfully submitted and there is no need to resubmit the same
comment.
<bullet> Paper comments: Paper comments that duplicate electronic
submissions are not necessary. Should you wish to mail a paper comment
in lieu of an electronic comment, it should be sent via regular or
express mail to: Drug Enforcement Administration, Attn: DEA Federal
Register Representative/DPW, 8701 Morrissette Drive, Springfield,
Virginia 22152.

[[Page 22392]]

<bullet> Hearing requests: All requests for a hearing and waivers
of participation, together with a written statement of position on the
matters of fact and law asserted in the hearing, must be filed with the
DEA Administrator, who will make the determination of whether a hearing
will be needed to address such matters of fact and law in the
rulemaking. Such requests must be sent to: Drug Enforcement
Administration, Attn: Administrator, 8701 Morrissette Drive,
Springfield, Virginia 22152. For informational purposes, a courtesy
copy of requests for hearing and waivers of participation should also
be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/
OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug
Enforcement Administration, Attn: DEA Federal Register Representative/
DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Dr. Terrence L. Boos, Drug and
Chemical Evaluation Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 362-3249.

SUPPLEMENTARY INFORMATION: In this proposed rule, the Drug Enforcement
Administration (DEA) proposes to permanently schedule the following
nine controlled substances in schedule I of the Controlled Substances
Act (CSA), 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 within the specific chemical
designation:
<bullet> meta-fluorofentanyl (N-(3-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)propionamide),
<bullet> meta-fluoroisobutyryl fentanyl (N-(3-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)isobutyramide),
<bullet> para-methoxyfuranyl fentanyl (N-(4-methoxyphenyl)-N-(1-
phenethylpiperidin-4-yl)furan-2-carboxamide),
<bullet> 3-furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-
phenylfuran-3-carboxamide),
<bullet> 2',5'-dimethoxyfentanyl (N-(1-(2,5-
dimethoxyphenethyl)piperidin-4-yl)-N-phenylpropionamide),
<bullet> isovaleryl fentanyl (3-methyl-N-(1-phenethylpiperidin-4-
yl)-N-phenylbutanamide),
<bullet> ortho-fluorofuranyl fentanyl (N-(2-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)furan-2-carboxamide),
<bullet> alpha'-methyl butyryl fentanyl (2-methyl-N-(1-
phenethylpiperidin-4-yl)-N-phenylbutanamide),
<bullet> and para-methylcyclopropyl fentanyl (N-(4-methylphenyl)-N-
(1-phenethylpiperidin-4-yl)cyclopropanecarboxamide).

Posting of Public Comments

All comments received in response to this docket are considered
part of the public record. DEA will make comments available for public
inspection online at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, unless reasonable
cause is given. Such information includes personal identifying
information (such as your name, address, etc.) voluntarily submitted by
the commenter. The Freedom of Information Act applies to all comments
received. If you want to submit personal identifying information (such
as your name, address, etc.) as part of your comment, but do not want
DEA to make it publicly available, you must include the phrase
``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your
comment. You must also place all of the personal identifying
information you do not want made publicly available in the first
paragraph of your comment and identify what information you want
redacted.
If you want to submit confidential business information as part of
your comment, but do not want DEA to make it publicly available, you
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the
first paragraph of your comment. You must also prominently identify
confidential business information to be redacted within the comment.
DEA will generally make publicly available in redacted from
comments containing personal identifying information and confidential
business information identified as directed above. If a comment has so
much confidential business information or personal identifying
information that DEA cannot redact it effectively, DEA may not make all
or part of that comment publicly available. Comments posted to <a href="https://www.regulations.gov">https://www.regulations.gov</a> may include any personal identifying information
(such as name, address, and phone number) included in the text of your
electronic submission that is not identified as confidential as
directed above.
An electronic copy of this document and supplemental information to
this proposed rule are available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> for
easy reference.

Request for Hearing or Appearance; Waiver

Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking
``on the record after opportunity for a hearing.'' Such proceedings are
conducted pursuant to the provisions of the Administrative Procedure
Act (APA), 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316,
subpart D. Interested persons, as defined in 21 CFR 1300.01(b), may
file requests for a hearing in conformity with the requirements of 21
CFR 1308.44(a) and 1316.47(a), and such requests must:
(1) state with particularity the interest of the person in the
proceeding;
(2) state with particularity the objections or issues concerning
which the person desires to be heard; and
(3) state briefly the position of the person with regarding to the
objections or issues.
Any interested person may file a waiver of an opportunity for a
hearing or to participate in a hearing in conformity with the
requirements of 21 CFR 1308.44(c), together with a written statement of
position on the matters of fact and law involved in any hearing. 21 CFR
1316.49.
All requests for a hearing and waivers of participation, together
with a written statement of position on the matters of fact and law
involved in such hearing, must be sent to DEA using the address
information provided above. The decision whether a hearing will be
needed to address such matters of fact and law in the rulemaking will
be made by the Administrator. If a hearing is needed, DEA will publish
a notice of hearing on the proposed rulemaking in the Federal Register.
21 CFR 1308.44(b), 1316.53. Further, once the Administrator determines
a hearing is needed to address such matters of fact and law in
rulemaking, she will then designate an Administrative Law Judge (ALJ)
to preside over the hearing. The ALJ's functions shall only commence
upon designation, as provided in 21 CFR 1316.52.
In accordance with 21 U.S.C. 811 and 812, the purpose of a hearing
would be to determine whether 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 meet the statutory criteria for placement in
schedule I.

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 (delegated to the Administrator of
DEA pursuant to 28 CFR 0.100) on his own motion.\1\ This proposed
action is supported by a

[[Page 22393]]

recommendation from the Assistant Secretary for Health of the
Department of Health and Human Services (Assistant Secretary for HHS or
Assistant Secretary) and an evaluation of all other relevant data by
DEA. If finalized, this action would make permanent the existing
temporary regulatory controls and administrative, civil, and criminal
sanctions of schedule I controlled substances on any person who handles
or proposes to handle these nine substances.
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\1\ 21 U.S.C. 811(a).
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Background

On February 6, 2018, pursuant to 21 U.S.C. 811(h)(1), DEA published
an order in the Federal Register (83 FR 5188) 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. As discussed below in Factor 3, the nine
substances named in this proposed 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 order was effective upon the date of publication. 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
the 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,\2\ which extended the order until December 31, 2024.
Consequently, the temporary control of these nine substances will
remain in effect until December 31, 2024, unless DEA permanently places
them in schedule I prior to that date.
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\2\ Public Law 117-328, Division O, Title VI, Sec. 601.
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Therefore, the Administrator, on her own motion pursuant to 21
U.S.C. 811(a), is initiating proceedings to permanently schedule 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 gathered and reviewed the
available information regarding the pharmacology, chemistry,
trafficking, actual abuse, pattern of abuse, and the relative potential
for abuse for these substances. On October 12, 2021, in accordance with
21 U.S.C. 811(b), the Administrator submitted a request to the
Assistant Secretary to provide DEA with a scientific and medical
evaluation of available information and a scheduling recommendation for
these nine substances.
On May 16, 2022, the Assistant Secretary submitted HHS's scientific
and medical evaluation and scheduling recommendation for 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 and their salts to the
Administrator. In accordance with 21 U.S.C. 811(c), upon receipt of the
scientific and medical evaluation and scheduling recommendation from
HHS, DEA reviewed the documents and all other relevant data, and
conducted its own eight-factor analysis of the abuse potential of these
nine substances.

Proposed Determination To Permanently Schedule Nine Specific Fentanyl-
Related Substances

As discussed in the background section, the Administrator is
initiating proceedings, pursuant to 21 U.S.C. 811(a), to permanently
add 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 to schedule I.
DEA reviewed the scientific and medical evaluation, scheduling
recommendation received from HHS, and all other relevant data and
conducted its own eight-factor analysis of the abuse potential of these
nine substances pursuant to 21 U.S.C. 811(c). Included below is a brief
summary of each factor as analyzed by HHS and DEA, and as considered by
DEA in its proposed scheduling action. Please note that both DEA and
HHS analyses are available in their entirety under ``Supporting
Documents'' of the public docket for this proposed rule at <a href="https://www.regulations.gov">https://www.regulations.gov</a> under Docket Number ``DEA-1036.''

1. The Drug's Actual or Relative Potential for Abuse

The term ``abuse'' is not defined in the CSA. However, the
legislative history of the CSA \3\ suggests that DEA consider the
following criteria when determining whether a particular drug or
substance has a potential for abuse:
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\3\ Comprehensive Drug Abuse Prevention and Control Act of 1970,
H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970); reprinted in 1970
U.S.C.C.A.N. 4566, 4603.
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(a) There is evidence that individuals are taking the drug or drugs
containing such a substance in amounts sufficient to create a hazard to
their health or to the safety of other individuals or to the community;
or
(b) There is significant diversion of the drug or drugs containing
such a substance from legitimate drug channels; or
(c) Individuals are taking the drug or drugs containing such a
substance on their own initiative rather than on the basis of medical
advice from a practitioner licensed by law to administer such drugs in
the course of his professional practice; or
(d) The drug or drugs containing such a substance are new drugs so
related in their action to a drug or drugs already listed as having a
potential for abuse to make it likely that the drug will have the same
potentiality for abuse as such drugs, thus making it reasonable to
assume that there may be significant diversions from legitimate
channels, significant use contrary to or without medical advice, or
that it has a substantial capability of creating hazards to the health
of the user or to the safety of the community.
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 their pharmacological similarity to other schedule I
and II mu-opioid receptor agonist substances which have a high
potential for abuse. Similar to schedule II substances morphine and
fentanyl and several schedule I opioid substances that are structurally
related to fentanyl, these nine substances have been shown to bind and
act as mu-opioid receptor agonists.
meta-Fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-
methoxyfuranyl fentanyl, 3-furanyl

[[Page 22394]]

fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl fentanyl, ortho-
fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, and para-
methylcyclopropyl fentanyl have no approved medical use in the United
States and have been encountered on the illicit drug market. Because
these nine substances are not Food and Drug Administration (FDA)-
approved drug products, a practitioner may not legally prescribe them
and these substances cannot be dispensed to an individual. Accordingly,
the use of these nine substances without medical advice leads to the
conclusion that they are abused for their opioid-like properties. There
are no legitimate channels for these nine substances to be marketed as
FDA-approved drug products, but they are available for purchase from
legitimate chemical companies to be used in scientific research.
However, despite the limited legitimate use of these substances,
reports from public health and law enforcement indicate 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 are being abused and taken in
amounts sufficient to create a hazard to an individual's health. Data
from forensic databases can be used as an indicator of illicit activity
with drugs and abuse \4\ within the United States. According to drug
seizure data from 2016 to 2021 from the National Forensic Laboratory
Information System (NFLIS),\5\ seven of the substances (meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl
fentanyl, 3-furanyl fentanyl, isovaleryl fentanyl, ortho-fluorofuranyl
fentanyl, and alpha'-methyl butyryl fentanyl) are being encountered in
the United States. Two substances (2',5'-dimethoxyfentanyl and para-
methylcyclopropyl fentanyl) were not listed in the NFLIS database,
however, reporting from NMS labs \6\ in 2019 show that 2',5'-
dimethoxyfentanyl and para-methylcyclopropyl fentanyl have been
positively identified in drugs seized by the Department of Homeland
Security. Consequently, the positive identification of the nine
substances in law enforcement encounters indicates that these
substances are being abused, and thus pose safety hazards to the health
of users.
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\4\ While law enforcement data is not direct evidence of abuse,
it can lead to an inference that a drug has been diverted and
abused. See 76 FR 77330, 77332, Dec. 12, 2011.
\5\ NFLIS is a DEA program and a national forensic laboratory
reporting system that systematically collects results from drug
chemistry analyses conducted by state and local forensic
laboratories in the United States. The NFLIS database also contains
Federal data from U.S. Customs and Border Protection (CBP). NFLIS
only includes drug chemistry results from completed analyses. NFLIS
data were queried July 18, 2022. NFLIS is still reporting data from
2021 due to normal lag time in reporting.
\6\ NMS Labs is an independent provider of professional
laboratory testing services, specializing in clinical toxicology and
forensic science.
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2. Scientific Evidence of the Drug's Pharmacological Effects, if Known

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
pharmacologically similar to other schedule I and schedule II mu-opioid
receptor agonist substances. Non-clinical and clinical studies
conducted on abuse potential of mu-opioid receptor agonists such as
morphine and fentanyl indicate that these substances share
discriminative stimulus effects and have reinforcing properties.
Similar to schedule I and II opioid analgesics, these nine substances
bind to and activate the mu-opioid receptor. Additionally, behavioral
studies in animals demonstrate 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 produce analgesic effects similar to
fentanyl and morphine. Further, pre-treatment with naltrexone, an
opioid antagonist, attenuated analgesic effects of these nine
substances as well as morphine. Thus, it is concluded from in vitro and
in vivo pharmacological studies that the effects of these nine
substances are similar to that of fentanyl and morphine and mediated by
mu-opioid receptor agonism.

3. The State of Current Scientific Knowledge Regarding the Drug or
Other Substance

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 synthetic
opioids in the 4-anilidopiperidine structural class which includes
fentanyl. As defined in the February 6, 2018, temporary order,
fentanyl-related substances include any substance not otherwise
controlled in any schedule (i.e., not included under any other
Administration Controlled Substance Code Number) that is structurally
related to fentanyl by one or more of the following modifications:
(A) Replacement of the phenyl portion of the phenethyl group by any
monocycle, whether or not further substituted in or on the monocycle;
(B) substitution in or on the phenethyl group with alkyl, alkenyl,
alkoxyl, hydroxyl, halo, haloalkyl, amino or nitro groups;
(C) substitution in or on the piperidine ring with alkyl, alkenyl,
alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino or nitro
groups;
(D) replacement of the aniline ring with any aromatic monocycle
whether or not further substituted in or on the aromatic monocycle;
and/or
(E) replacement of the N-propionyl group by another acyl group.

[[Page 22395]]

[GRAPHIC] [TIFF OMITTED] TP13AP23.114

According to the February 6, 2018, temporary scheduling order, the
existence of a substance with any one, or any combination, of above-
mentioned modifications (see Figure 1) would meet the structural
requirements of the definition of fentanyl-related substances. The
present nine substances fall within the definition of fentanyl-related
substances by the following modifications:
1. meta-fluorofentanyl: substitution on the aniline ring (meets
definition for modification D);
2. meta-fluoroisobutyryl fentanyl: substitution on the aniline ring
and replacement of the N-propionyl group with another acyl group (meets
definition for modifications D and E);
3. para-methoxyfuranyl fentanyl: substitution on the aniline ring
and replacement of the N-propionyl group with another acyl group (meets
definition for modifications D and E);
4. 3-furanyl fentanyl: replacement of the N-propionyl group with
another acyl group (meets definition for modification E);
5. 2',5'-dimethoxyfentanyl: substitution on the phenethyl group
with alkoxyl groups (meets definition for modification B);
6. isovaleryl fentanyl: replacement of the N-propionyl group with
another acyl group (meets definition for modification E);
7. ortho-fluorofuranyl fentanyl: substitution on the aniline ring
and replacement of the N-propionyl group with another acyl group (meets
definition for modifications D and E);
8. alpha'-methyl butyryl fentanyl: replacement of the N-propionyl
group with another acyl group (meets definition for modification E);
9. para-methylcyclopropyl fentanyl: substitution on the aniline
ring and replacement of the N-propionyl group with another acyl group
(meets definition for modifications D and E);
No study has been undertaken to evaluate the efficacy, toxicology,
and safety of the nine substances in humans. It can be inferred from
data obtained from animal studies that these nine substances have
sufficient distribution to the brain to produce depressant effects
similar to that of mu opioid receptor agonists.
There are no FDA-approved marketing applications for drug products
containing 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 for any
therapeutic indication in the United States. Moreover, there are no
clinical studies or petitioners which have claimed an accepted medical
use in the United States for these substances.

4. Its History and Current Pattern of Abuse

Evidence suggests that the pattern of 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 parallels that of prescription opioid
analgesics. Currently, the United States is in the midst of an illicit
opioid abuse epidemic. There has been a marked increase in the
encounters of synthetic opioids that are structurally related to
fentanyl that parallels to an increase in deaths related to synthetic
opioids. Thus, the recreational abuse of fentanyl-like substances
continues to be a significant concern. These substances are distributed
to users, often with unpredictable outcomes. According to HHS, the
Centers for Disease Control and Prevention (CDC) reported there were
over 68,000 deaths in 2020 associated with the use of opioids other
than methadone, but including fentanyl and fentanyl-related substances
(HHS, 2022).
Law enforcement encountered these nine substances in the United
States. According to the NFLIS \7\ database, 49 reports were registered
containing seven of the substances (meta-fluorofentanyl, meta-
fluoroisobutyryl fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl
fentanyl, isovaleryl fentanyl, ortho-fluorofuranyl fentanyl, or alpha'-
methyl butyryl fentanyl) from state or local forensic laboratories from
2016 to 2021. Two substances (2',5'-dimethoxyfentanyl and para-
methylcyclopropyl fentanyl) were not listed in the NFLIS database,
however, reporting from NMS labs in 2019 show that 2',5'-
dimethoxyfentanyl and para-methylcyclopropyl fentanyl have been
positively identified in seized drugs encountered by the Department of
Homeland Security.
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\7\ NFLIS data were queried July 18, 2022. NFLIS data reporting
is still pending for 2021 due to normal lag time.

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[[Page 22396]]

5. The Scope, Duration, and Significance of Abuse

Similar to other substances structurally related to 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 are often used as recreational
drugs. The recreational use of these nine substances and other
fentanyl-related substances continues to be of significant concern in
the United States. These substances are distributed to users often with
unpredictable outcomes.
DEA notes that the data from pharmacological testing 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 are consistent with those of other
opioids such as fentanyl and other related opioid agonists. Thus, it
can be inferred the abuse potential of these substances is similar to
mu opioid receptor agonists such as fentanyl and morphine.

6. What, if Any, Risk There Is to the Public Health

The 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
leads to the same qualitative public health risks as heroin, fentanyl,
and other opioid analgesic substances. Further, abusers of these
substances may not know the origin, identity, or purity of these
substances. This unknown information poses significant adverse health
risks when compared to abuse of pharmaceutical preparations of opioid
analgesics, such as morphine and oxycodone. Taken together, evidence
suggests that individuals experimenting with substances with unknown
potency are at high risk of adverse health outcomes.

7. Its Psychic or Physiological Dependence Liability

There are no pre-clinical or clinical studies that have evaluated
the psychic or physiologic dependence 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. Several studies have shown that due to
fentanyl's short duration of action, more frequent dosing is often
required which can lead to a fast induction of tolerance, dependence,
and opiate withdrawal syndrome. Opioid withdrawal includes nausea and
vomiting, depression, agitation, anxiety, craving, sweats,
hypertension, diarrhea, and fever. These nine substances act as
agonists at the mu opioid receptors and exhibit a full and dose-
dependent substitution for the discriminative stimulus effects produced
by morphine. Thus, the pharmacological similarity and pattern of abuse
of these nine substances to fentanyl are indicative of their potential
to possess a psychic and physiological dependence liability similar to
that of other mu opioid receptor agonist substances, such as heroin and
fentanyl.

8. Whether the Substance Is an Immediate Precursor of a Substance
Already Controlled Under the CSA

Proposed Determination of Appropriate Schedule

The CSA establishes five schedules of controlled substances known
as schedules I, II, III, IV, and V. The CSA also outlines the findings
required to place a drug or other substance in any particular schedule,
per 21 U.S.C. 812(b). After consideration of the analysis and
recommendation of the Assistant Secretary for HHS and review of all
other available data, the Administrator of DEA, pursuant to 21 U.S.C.
812(b)(1), finds that:
(1) 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 high
potential for abuse. According to HHS, these nine substances are mu-
opioid receptor agonists. These substances have analgesic effects, and
these effects are mediated by mu-opioid receptor agonism. HHS states
that substances that produce mu-opioid receptor agonist effects in the
central nervous system (e.g., morphine and fentanyl) are considered as
having a high potential for abuse. Data obtained from drug
discrimination studies indicate that these nine substances fully
substituted for the discriminative stimulus effects of morphine.
(2) FDA has not approved a marketing application for a drug product
containing 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 for any
therapeutic indication. In addition, DEA and HHS know of no clinical
studies or petitioners claiming an accepted medical use in the United
States. Therefore, these nine substances have no currently accepted
medical use in the United States.\8\
---------------------------------------------------------------------------

\8\ 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), pet. for rev. denied, Alliance for Cannabis
Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994).
---------------------------------------------------------------------------

(3) There is a lack of accepted safety for use of meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl
fentanyl, 3-furanyl

[[Page 22397]]

fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl fentanyl, ortho-
fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, and para-
methylcyclopropyl fentanyl under medical supervision. Because these
nine substances have no FDA-approved medical use and have not been
investigated as new drugs, their safety for use under medical
supervision is has not been determined. Therefore, there is a lack of
accepted safety for use of these nine substances under medical
supervision.
Based on these findings, the Administrator of DEA 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 within the specific chemical designation, warrant
continued control in schedule I of the CSA.\9\
---------------------------------------------------------------------------

\9\ 21 U.S.C. 812(b)(1).
---------------------------------------------------------------------------

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

As discussed above, these nine fentanyl-related substances are
currently subject to a temporary scheduling order adding them to
schedule I. If this rule is finalized as proposed, 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 would be subject, on a permanent basis, 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, 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 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.
2. 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. 821, 823, and in accordance with 21 CFR
1301.71-1301.76. Non-practitioners handling these nine substances also
must comply with the screening requirements of 21 CFR 1301.90-1301.93.
3. 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 comply with 21 U.S.C. 825, and be in accordance with 21 CFR part
1302.
4. 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.
5. 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 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 in accordance with 21 CFR 1304.03, 1304.04, and
1304.11.
6. 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 832(a), and
in accordance with 21 CFR 1301.74(b) and (c) and 1301.76(b) and parts
1304, 1312, and 1317.
7. 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 comply with the order form
requirements, pursuant to 21 U.S.C. 828 and 21 CFR part 1305.
8. 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 be in
compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance
with 21 CFR part 1312.
9. 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 12866 and 13563, Regulatory Planning and Review, and
Improving Regulation and Regulatory Review

In accordance with 21 U.S.C. 811(a), this proposed scheduling
action is

[[Page 22398]]

subject to formal rulemaking procedures done ``on the record after
opportunity for a hearing,'' which are conducted pursuant to the
provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for
scheduling a drug or other substance. Such actions are exempt from
review by the Office of Management and Budget (OMB) pursuant to section
3(d)(1) of Executive Order (E.O.) 12866 and the principles reaffirmed
in E.O. 13563.

Executive Order 12988, Civil Justice Reform

This proposed regulation meets the applicable standards set forth
in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors
and ambiguity, minimize litigation, provide a clear legal standard for
affected conduct, and promote simplification and burden reduction.

Executive Order 13132, Federalism

This proposed rulemaking does not have federalism implications
warranting the application of E.O. 13132. The proposed 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 proposed 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. 601-612, has reviewed this rule and by approving it,
certifies that it will not have a significant economic impact on a
substantial number of small entities. On February 6, 2018, DEA
published an order to temporarily place fentanyl-related substances, as
defined in the order, in schedule I of the CSA pursuant to the
temporary scheduling provisions of 21 U.S.C. 811(h). However, 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) (Feb.
6, 2020). This temporary order was subsequently extended multiple
times, most recently on December 29, 2022, through the Consolidated
Appropriations Act, 2023 (Pub. L. 117-328, Division O, Title VI, Sec.
601), which extended the order until December 31, 2024. 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
systems and processes required to handle these substances which meet
the definition of fentanyl-related substances.
There are currently 108 registrations authorized to specifically
handle the fentanyl-related substances as a class, which include 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. Some of these entities are likely to be large entities.
However, since DEA does not have information of registrant size and the
majority of DEA registrants are small entities, DEA estimates a maximum
of 95 are small entities. Therefore, DEA conservatively estimates as
many as 95 small entities are affected by this proposed 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 maintained) systems and processes required to
handle these substances. Therefore, DEA anticipates this proposed 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 95
affected small entities. Therefore, DEA has concluded that this
proposed 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 $100,000,000 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.

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, DEA proposes to amend 21 CFR part
1308 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)(73) through (92) as paragraphs (b)(82)
through (101);
0
b. Redesignate paragraphs (b)(65) through (b)(72) as paragraphs (b)(72)
through (79);
0
c. Redesignate paragraphs (b)(50) through (64) as paragraphs (b)(56)
through (70);
0
d. Redesignate paragraphs (b)(47) through (49) as paragraphs (b)(51)
through (53);
0
e. Redesignate paragraphs (b)(43) through (46) as paragraphs (b)(46)
through (49);
0
f. Redesignate paragraphs (b)(33) through (42) as paragraphs (b)(35)
through (44);
0
g. Redesignate paragraphs (b)(10) through (32) as paragraphs (b)(11)
through (33); and
0
h. Add new paragraphs (b)(10), (34), (45), (50), (54), (55), (71),
(80), and (81).
The additions read as follows:

Sec. 1308.11 Schedule I.

* * * * *
(b) * * *

(10) alpha'-Methyl butyryl fentanyl (2-methyl-N-(1- 9864
phenethylpiperidin-4-yl)-N-phenylbutanamide)..................

[[Page 22399]]

* * * * *
(34) 2',5'-Dimethoxyfentanyl (N-(1-(2,5- 9861
dimethoxyphenethyl)piperidin-4-yl)-N-phenylpropionamide)......

* * * * *
(45) 3-Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- 9860
phenylfuran-3-carboxamide)....................................

* * * * *
(50) Isovaleryl fentanyl (3-methyl-N-(1-phenethylpiperidin-4- 9862
yl)-N-phenylbutanamide).......................................

* * * * *
(54) meta-Fluorofentanyl (N-(3-fluorophenyl)-N-(1- 9857
phenethylpiperidin-4-yl)propionamide).........................
(55) meta-Fluoroisobutyryl fentanyl (N-(3-fluorophenyl)-N-(1- 9858
phenethylpiperidin-4-yl)isobutyramide)........................

* * * * *
(71) ortho-Fluorofuranyl fentanyl (N-(2-fluorophenyl)-N-(1- 9863
phenethylpiperidin-4-yl)furan-2-carboxamide)..................

* * * * *
(80) para-Methoxyfuranyl fentanyl (N-(4-methoxyphenyl)-N-(1- 9859
phenethylpiperidin-4-yl)furan-2-carboxamide...................
(81) para-Methylcyclopropyl fentanyl (N-(4-methylphenyl)-N-(1- 9865
phenethylpiperidin-4-yl)cyclopropanecarboxamide)..............

* * * * *

Signing Authority

This document of the Drug Enforcement Administration was signed on
April 3, 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. 2023-07576 Filed 4-12-23; 8:45 am]
BILLING CODE 4410-09-P

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