Schedules of Controlled Substances: Placement of Nine Specific Fentanyl-Related Substances in Schedule I, 22391-22399 [2023-07576]

Agencies

• Drug Enforcement Administration
• Department of Justice

[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 [www.gpo.gov]
[FR Doc No: 2023-07576]


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

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.

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

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.
     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 https://www.regulations.gov and follow the online instructions at that site for 
submitting comments. Upon completion of your submission you will 
receive a Comment Tracking Number for your comment. Submitted comments 
are not instantaneously available for public view on Regulations.gov. 
If you have received a Comment Tracking Number, your comment has been 
successfully submitted and there is no need to resubmit the same 
comment.
     Paper comments: Paper comments that duplicate 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]]

     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:
     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).

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 https://www.regulations.gov, 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 https://www.regulations.gov may include any personal identifying information 
(such as name, address, and phone number) included in the text of your 
electronic submission that is not identified as confidential as 
directed above.
    An electronic copy of this document and supplemental information to 
this proposed rule are available at https://www.regulations.gov for 
easy reference.

Request for Hearing or Appearance; Waiver

    Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking 
``on the record after opportunity for a hearing.'' Such proceedings are 
conducted pursuant to the provisions of the Administrative Procedure 
Act (APA), 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316, 
subpart D. Interested persons, 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.
---------------------------------------------------------------------------

    \1\ 21 U.S.C. 811(a).
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \2\ Public Law 117-328, Division O, Title VI, Sec. 601.
---------------------------------------------------------------------------

    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 https://www.regulations.gov 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:
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    (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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \7\ NFLIS data were queried July 18, 2022. NFLIS data reporting 
is still pending for 2021 due to normal lag time.

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

[[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

    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 not immediate 
precursors of any controlled substance of the CSA as defined by 21 
U.S.C. 802(23).
    Conclusion: Based on consideration of the scientific and medical 
evaluation and accompanying recommendation of HHS, and on DEA's own 
eight-factor analysis, DEA finds that these facts and all relevant data 
constitute substantial evidence of 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. As such, DEA proposes to 
permanently schedule these nine substances as controlled substances 
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