Proposed Rule2025-10372
Schedules of Controlled Substances: Placement of Three Specific Fentanyl-Related Substances in Schedule I
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Published
June 10, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration proposes placing three fentanyl-related substances, as identified in this proposed rule, in schedule I of the Controlled Substances Act. These three 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 March 15, 2025, which extended the order until September 30, 2025. 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 three specific controlled substances.
Full Text
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<title>Federal Register, Volume 90 Issue 110 (Tuesday, June 10, 2025)</title>
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[Federal Register Volume 90, Number 110 (Tuesday, June 10, 2025)]
[Proposed Rules]
[Pages 24362-24370]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10372]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1484]
Schedules of Controlled Substances: Placement of Three 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 three
fentanyl-related substances, as identified in this proposed rule, in
schedule I of the Controlled Substances Act. These three 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 March 15, 2025, which extended the order until September
30, 2025. 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 three specific controlled substances.
DATES: Comments must be submitted electronically or postmarked on or
before July 10, 2025.
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
[[Page 24363]]
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 July 10, 2025
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-1484'' 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="http://www.regulations.gov">http://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. Commenters should be aware that the electronic Federal Docket
Management System will not accept comments after 11:59 p.m. Eastern
Time on the last day of the comment period.
<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.
<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.
<bullet> Paperwork Reduction Act comments: All comments concerning
collections of information under the Paperwork Reduction Act must be
submitted to the Office of Information and Regulatory Affairs, OMB,
Attention: Desk Officer for DOJ, Washington, DC 20503. Please state
that your comment refers to Docket No. DEA-1484.
FOR FURTHER INFORMATION CONTACT: Dr. Terrence L. Boos, Drug and
Chemical Evaluation Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 362-3249.
As required by 5 U.S.C. 553(b)(4), a summary of this proposed rule
may be found in the docket for this rulemaking at <a href="http://www.regulations.gov">www.regulations.gov</a>.
SUPPLEMENTARY INFORMATION: In this proposed rule, the Drug Enforcement
Administration (DEA) proposes to permanently schedule the following
three 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> para-bromofentanyl (N-(4-bromophenyl)-N-(1-
phenethylpiperidin-4-yl)propionamide),
<bullet> para-fluoroacetyl fentanyl (N-(4-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)acetamide),
<bullet> para-methyl acetyl fentanyl (N-(4-methylphenyl)-N-(1-
phenethylpiperidin-4-yl)acetamide).
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="http://www.regulations.gov">http://www.regulations.gov</a>, unless reasonable
cause is given. Such information includes personal or business
identifiers (such as name, address, state of federal identifiers, etc.)
voluntarily submitted by the commenter.
Commenters submitting comments which include personal identifying
information (PII), confidential, or proprietary business information
that the commenter does not want made publicly available should submit
two copies of the comment. One copy must be marked ``CONTAINS
CONFIDENTIAL INFORMATION'' and should clearly identify all PII or
business information the commenter does not want to be made publicly
available, including any supplemental materials. DEA will review this
copy, including the claimed PII and confidential business information,
in its consideration of comments. The second copy should be marked ``TO
BE PUBLICLY POSTED'' and must have all claimed confidential PII and
business information already redacted. DEA will post only the redacted
comment on <a href="https://www.regulations.gov">https://www.regulations.gov</a> for public inspection. DEA
generally will not redact additional information contained in the
comment marked ``TO BE PUBLICLY POSTED.'' The Freedom of Information
Act applies to all comments received.
For easy reference, an electronic copy of this document and
supplemental information to this proposed scheduling action are
available at <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
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.\1\ 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:
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\1\ 21 CFR 1308.41-1308.45; 21 CFR part 1316, subpart D.
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(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 regard 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.\2\
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\2\ 21 CFR 1316.49.
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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
[[Page 24364]]
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.\3\ Further, once the Administrator
determines a hearing is needed to address such matters of fact and law
in rulemaking, he 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.
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\3\ 21 CFR 1308.44(b), 1316.53.
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In accordance with 21 U.S.C. 811 and 812, the purpose of a hearing
would be to determine whether para-bromofentanyl, para-fluoroacetyl
fentanyl, and para-methyl acetyl fentanyl meet the statutory criteria
for placement in schedule I, as proposed in this rule.
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, at the request of the
Secretary of Health and Human Services (HHS), or on the petition of an
interested party.\4\ This proposed action is initiated on the Acting
Administrator's own motion and supported by, inter alia, a
recommendation from the Assistant Secretary for Health of HHS
(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 three
substances.
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\4\ 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.\5\ As discussed below in Factor 3, the
three 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 three 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,\6\
Congress extended that expiration date until May 6, 2021, by enacting
the Temporary Reauthorization and Study of the Emergency Scheduling of
Fentanyl Analogues Act.\7\ This temporary order was subsequently
extended multiple times, most recently on March 15, 2025,\8\ which
extended the order until September 30, 2025. Consequently, the
temporary control of these three substances will remain in effect until
September 30, 2025, unless it is extended.
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\5\ Schedules of Controlled Substances: Temporary Placement of
Fentanyl-Related Substances in Schedule I, 83 FR 5188 (Feb. 6,
2018).
\6\ Schedules of Controlled Substances: Temporary Placement of
Fentanyl-Related Substances in Schedule I; Correction, 85 FR 20155
(Apr. 10, 2020).
\7\ Public Law 116-114, sec. 2, 134 Stat. 103.
\8\ Public Law 119-4, sec. 3105, 139 Stat. 9.
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The Acting Administrator, on his own motion pursuant to 21 U.S.C.
811(a), is initiating proceedings to permanently schedule para-
bromofentanyl, para-fluoroacetyl fentanyl, and para-methyl acetyl
fentanyl in schedule I of the CSA. Pursuant to 21 U.S.C. 811(b), DEA
gathered the necessary data 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 March 15, 2024, in accordance with 21 U.S.C. 811(b), the
then-Administrator submitted a request to the then-Assistant Secretary
to provide DEA with a scientific and medical evaluation of available
information and a scheduling recommendation for these three substances.
On December 27, 2024, the then-Assistant Secretary submitted HHS's
scientific and medical evaluation and scheduling recommendation for
para-bromofentanyl, para-fluoroacetyl fentanyl, and para-methyl acetyl
fentanyl and their salts to the Administrator. The Secretary
recommended placing these three fentanyl-related substances in schedule
I of the CSA. 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
three substances.
Proposed Determination to Permanently Schedule Three Specific Fentanyl-
Related Substances
As discussed in the background section, the Acting Administrator is
initiating proceedings, pursuant to 21 U.S.C. 811(a), to permanently
add para-bromofentanyl, para-fluoroacetyl fentanyl, and para-methyl
acetyl fentanyl to schedule I. DEA reviewed the scientific and medical
evaluation and scheduling recommendation received from HHS, and all
other relevant data and conducted its own eight-factor analysis of the
abuse potential of these three 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.
Readers should refer to the full eight-factor analyses prepared by HHS
and by DEA in support of this proposal, which are available in their
entirety under ``Supporting Documents'' of the public docket for this
proposed rule at <a href="http://www.regulations.gov">http://www.regulations.gov</a> under Docket Number ``DEA-
1484.''
1. The Drug's Actual or Relative Potential for Abuse
In addition to considering the information HHS provided in its
scientific and medical evaluation document for these three fentanyl-
related substances, DEA also considered all other relevant data
regarding actual or relative potential for abuse of these three
substances. The term ``abuse'' is not defined in the CSA; however, the
legislative history of the CSA suggests that DEA consider the following
criteria when determining whether a particular drug or substance has a
potential for abuse: \9\
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\9\ 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
[[Page 24365]]
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.
Law enforcement seizure data indicate that individuals have and are
using para-bromofentanyl, para-fluoroacetyl fentanyl, and para-methyl
acetyl fentanyl 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, especially since
there is no currently accepted medical use for these three substances.
According to the National Forensic Laboratory Information System
(NFLIS-Drug) \10\ database, which collects drug identification results
from drug cases submitted to and analyzed by Federal, State, and local
forensic laboratories, there have been 112 reports for para-
fluoroacetyl fentanyl and para-methyl acetyl fentanyl between 2022 and
2024. Although para-bromofentanyl is yet to be reported to the NFLIS
database, this substance has been positively identified in two drug
paraphernalia cases, which is indicative of its illicit use. para-
Fluoroacetyl fentanyl has been positively identified in six toxicology
cases, two of which involved drug paraphernalia reported in overdose
deaths, while the other four were in post-mortem cases.\11\
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\10\ The National Forensic Laboratory Information System (NFLIS)
represents an important resource in monitoring illicit drug
trafficking, including the diversion of legally manufactured
pharmaceuticals into illegal markets. NFLIS is a comprehensive
information system that includes data from forensic laboratories
that handle more than 96% of an estimated 1.0 million distinct
annual State and local drug analysis cases. NFLIS includes drug
chemistry results from completed analyses only. While NFLIS data is
not direct evidence of abuse, it can lead to an inference that a
drug has been diverted and abused. See Schedules of Controlled
Substances: Placement of Carisoprodol Into Schedule IV, 76 FR 77330,
77332 (Dec. 12, 2011). NFLIS data were queried January 6, 2025.
\11\ The Drug Enforcement Administration's Toxicology Testing
Program (DEA TOX) began in May 2019 as a surveillance program aimed
at detecting new psychoactive substances (NPS) within the United
States.
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According to HHS, para-bromofentanyl, para-fluoroacetyl fentanyl,
and para-methyl acetyl fentanyl are not legally marketed as drugs in
the United States or anywhere else in the world. These substances have
no approved medical use other than their limited use in scientific
research. As such, the legal sources of the substances are limited to
legitimate chemical companies supplying them for scientific research.
para-Bromofentanyl, para-fluoroacetyl fentanyl, and para-methyl
acetyl fentanyl are not approved for medical use and are not formulated
or approved for clinical use. As such, all use is on an individual's
own initiative, rather than on the basis of medical advice from a
practitioner licensed by law to administer drugs. Law enforcement
seizures and case reports demonstrate that individuals are taking these
three fentanyl-related substances on their own initiative, rather than
on the basis of medical advice from a licensed practitioner.
Similar to fentanyl and other structurally related synthetic
opioids, fentanyl-related substances namely para-bromofentanyl, para-
fluoroacetyl fentanyl, and para-methyl acetyl fentanyl have been shown
to bind to the mu-opioid receptors with varying affinities. Based on
available data, para-bromofentanyl, para-fluoroacetyl fentanyl, and
para-methyl acetyl fentanyl, are related in their effects to the
actions of other mu-opioid receptor (MOR) agonists,\12\ such as
fentanyl, that are already listed as having potential for abuse.
Because high doses of MOR agonists can produce respiratory depression
leading to death, these fentanyl-related substances at high doses have
substantial capability of creating hazards to the health of the user or
to the safety of the community. According to HHS, these three fentanyl-
related substances exert their actions at least in part through the MOR
and thus have a high likelihood of having substantially similar
potential for abuse as other schedule I opioids. Both DEA's and HHS's
eight-factor analyses found that the abuse potential of these
substances is similar to other schedule I opioids and presents a hazard
to the health and safety of individuals and the community.
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\12\ Drug Enforcement Administration--Veterans Affairs (DEA-VA)
Interagency Agreement. Binding and Functional Activity at Delta,
Kappa and Mu Opioid Receptors. In Vitro Receptor and Transporter
Assays for Abuse Liability Testing for the DEA by the VA. 2024
(unpublished data).
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2. Scientific Evidence of the Drug's Pharmacological Effects, if Known
According to DEA and HHS, the pharmacological activity of these
substances in humans is unknown. Data obtained from preclinical studies
show that these fentanyl-related substances (para-bromofentanyl, para-
fluoroacetyl fentanyl, and para-methyl acetyl fentanyl) exhibit a
pharmacological profile similar to that of fentanyl, morphine, and
several schedule I opioid substances that are structurally related to
fentanyl. Similar to fentanyl and other structurally related synthetic
opioids, fentanyl-related substances namely para-bromofentanyl, para-
fluoroacetyl fentanyl, and para-methyl acetyl fentanyl have been shown
to bind to the mu-opioid receptors with varying affinities.\13\ Also,
similar to fentanyl and other structurally related synthetic opioids,
these three fentanyl-related substances behave as agonists at the MOR
sites in in vitro functional studies.
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\13\ In Vitro Pharmacology data was collected through DEA--
Veterans Affairs interagency agreement: ``in vitro Receptor and
Transporter Assays for Abuse Liability Testing for the DEA by the
VA''.
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Studies conducted to examine the antinociceptive effect of the
three fentanyl-related substances in a warm water tail-withdrawal assay
and their mediation by opioid receptors as determined by naltrexone
antagonism showed these three fentanyl-related substances, similar to
fentanyl and morphine, produced antinociceptive effects as measured by
an increase in tail withdrawal latency.\14\ Pre-treatment with
naltrexone, an opioid receptor antagonist, attenuated antinociceptive
effects of the three-fentanyl related substances. These data
demonstrate that similar to morphine and fentanyl, para-bromofentanyl,
para-fluoroacetyl fentanyl, and para-methyl acetyl fentanyl produced
dose-dependent antinociception in the warm-water tail-withdrawal assay
that can be attenuated by naltrexone pre-treatment.
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\14\ Gatch MB. (2024). Test of analgesic effects alone and in
combination with naltrexone. 15DDHQ19F00001173, ``Evaluation of
Abuse Potential of Synthetic Opioids Using In Vivo Pharmacological
Studies'' (unpublished data).
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There is a strong correlation between the discriminative stimulus
effects of a given drug in animals and its subjective effects in
humans.\15\ Data from drug discrimination studies \16\ show that the
three fentanyl-related substances dose-dependently substitute for the
discriminative stimulus effects produced by morphine in Sprague Dawley
rats trained to discriminate 3.2
[[Page 24366]]
mg/kg morphine from saline.\17\ para-Bromofentanyl partially
substituted for morphine in the drug discrimination study. According to
HHS, the failure of para-bromofentanyl to fully-substitute for morphine
may be due to its significant kappa-opioid receptor activity as
demonstrated in vitro assay; however, the drug is still likely to have
pharmacological effects similar to other fentanyl-related substances or
fentanyl. These data demonstrate para-bromofentanyl, para-fluoroacetyl
fentanyl, and para-methyl acetyl fentanyl, similar to morphine
(schedule II) and fentanyl (schedule II), are mu-opioid receptor
agonists.
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\15\ Solinas M, Panlilio LV, Justinova Z, Yasar S, Goldberg SR.
(2006). Using drug-discrimination techniques to study the abuse-
related effects of psychoactive drugs in rats. Nat Protoc,1(3):1194-
206.
\16\ Drug discrimination is widely used to determine whether a
new test drug or substance is pharmacologically similar to a known
drug of abuse.
\17\ DEA-Synthetic Opioids Purchase Agreement (2022-2024).
Evaluation of synthetic opioid substances using analgesia and the
drug discrimination assay. In Vivo Testing for the DEA by Gatch
(Univ. of North Texas).
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3. The State of Current Scientific Knowledge Regarding the Drug or
Other Substance
para-Bromofentanyl, para-fluoroacetyl fentanyl, and para-methyl
acetyl fentanyl are synthetic opioids in the 4-anilidopiperidine
structural class which includes fentanyl. As defined in the February 6,
2018, temporary scheduling 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.
[GRAPHIC] [TIFF OMITTED] TP10JN25.000
Figure 1: Regions of the Chemical Structure of Fentanyl Described in
the Definition of a Fentanyl-Related Substance
According to the February 6, 2018 temporary scheduling order, the
existence of a substance with anyone, or any combination, of above-
mentioned modifications (see Figure 1) would meet the structural
requirements of the definition of fentanyl-related substances. The
present three substances fall within the definition of fentanyl-related
substances by the following modifications:
1. para-bromofentanyl: replacement of the aniline ring with any
aromatic monocycle whether or not further substituted in or on the
aromatic monocycle (meets definition for modification D);
2. para-fluoroacetyl fentanyl: replacement of the aniline ring with
any aromatic monocycle whether or not further substituted in or on the
aromatic monocycle and replacement of the N-propionyl group with
another acyl group (meets definition for modification D and E);
3. para-methyl acetyl fentanyl: replacement of the aniline ring
with any aromatic monocycle whether or not further substituted in or on
the aromatic monocycle and replacement of the N-propionyl group with
another acyl group (meets definition for modifications D and E).
4. Its History and Current Pattern of Abuse
Evidence suggests that the pattern of abuse of para-bromofentanyl,
para-fluoroacetyl fentanyl, and para-methyl acetyl 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 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. para-
Fluoroacetyl fentanyl and para-methyl acetyl fentanyl have been
encountered by law enforcement officials. para-Bromofentanyl and para-
fluoroacetyl fentanyl have been positively identified in drug
paraphernalia cases.
According to the NFLIS \18\ database, 110 reports were registered
for para-fluoroacetyl fentanyl and two reports of para-methyl acetyl
fentanyl from state or local forensic laboratories from 2022 to 2024.
Although para-bromofentanyl was not specifically listed in the NFLIS
database as of the date of query, between 2022 and 2023, it has been
identified in at least two cases \19\ involving drug paraphernalia of
decedents who were suspected to have died from acute fentanyl
intoxication.
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\18\ NFLIS data were queried on January 6, 2025. NFLIS data
reporting is still pending for 2023 and 2024 due to normal lag time.
\19\ DEA-TOX is a DEA-run program whereby unused biological
samples from victims of drug overdoses can be extensively tested for
the presence of novel psychoactive substances, in addition to other
drugs of abuse.
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5. The Scope, Duration, and Significance of Abuse
The rapid appearance of fentanyl-related substances presents
numerous challenges for forensic and toxicology laboratories. The
identification of a new substance requires full structural elucidation,
sometimes requiring specialized instrumentation not available to all
forensic laboratories. Laboratories are required to quickly adapt
testing procedures to identify new substances. It remains likely that
the prevalence of these substances in opioid related emergency room
admissions and deaths is underreported as standard immunoassays may not
differentiate fentanyl from substances structurally related to
fentanyl.
The population likely to abuse fentanyl-related substances overlaps
with the population abusing prescription opioid analgesics, heroin,
fentanyl, and other synthetic opioid substances. Because abusers of
fentanyl-related substances are likely to obtain these substances
through unregulated sources, the identity, purity, and quantity are
uncertain and inconsistent, thus posing significant adverse health
risks to the end user. The misuse and abuse of opioids have been
demonstrated and are well characterized. According to the most recent
data from the National Survey on
[[Page 24367]]
Drug Use and Health (NSDUH) \20\ of the Substance Abuse and Mental
Health Services Administration (SAMHSA),\21\ in 2023, an estimated 8.9
million people aged 12 or older misused opioids in the past year,
including 8.6 million prescription pain reliever misusers and 660,000
heroin users. In 2023, among people aged 12 or older, 828,000 people
misused fentanyl in the past year. NSDUH data show that among people
aged 12 or older in 2023, 627,000 people used illicitly manufactured
fentanyl in the past year. This population is likely to be at risk of
abusing fentanyl-related substances. Individuals who initiate (i.e.,
use a drug for the first time) use of fentanyl-related substances are
likely to be at risk of developing substance use disorder, overdose,
and death, similar to the risks of other opioid analgesics (e.g.,
fentanyl, morphine, etc.).
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\20\ The National Survey on Drug Use and Health, formerly known
as the National Household Survey on Drug Abuse (NHSDA), is conducted
annually by the Department of Health and Human Services Substance
Abuse and Mental Health Services Administration (SAMHSA). It is the
primary source of estimates of the prevalence and incidence of
nonmedical use of pharmaceutical drugs, illicit drugs, alcohol, and
tobacco use in the United States. The survey is based on a
nationally representative sample of the civilian, non-
institutionalized population 12 years of age and older. The survey
excludes homeless people who do not use shelters, active military
personnel, and residents of institutional group quarters such as
jails and hospitals. The NSDUH provides yearly national and state
level estimates of drug abuse, and includes prevalence estimates by
lifetime (i.e., ever used), past year and past month abuse or
dependence.
\21\ The Substance Abuse and Mental Health Services
Administration (SAMHSA) is a branch of the U.S. Department of Health
and Human Services (HHS). It is charged with improving the quality
and availability of prevention, treatment, and rehabilitative
services in order to reduce illness, death disability, and cost to
society resulting from substance abuse and mental illness.
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According to HHS, it is highly likely that the prevalence of these
fentanyl-related substances in emergency room admissions and fatalities
is under reported because standard immunoassays may not be sufficient
to distinguish between fentanyl and substances that are structurally
related to fentanyl. Law enforcement and toxicology reports demonstrate
para-bromofentanyl, para-fluoroacetyl fentanyl, and para-methyl acetyl
fentanyl are being illicitly distributed and abused. The use of these
three fentanyl-related substances is likely to increase the scope,
duration, and significance of abuse based on their pharmacological
similarity to drugs that are abused in the current opioid epidemic
(e.g., fentanyl).
6. What, if Any, Risk There Is to the Public Health
The increase in opioid overdose deaths in the United States has
been exacerbated by the availability of potent synthetic opioids such
as fentanyl and numerous other structurally related substances in the
illicit drug market.\22\ These substances have a history of being
trafficked as replacements for other opioids, such as heroin and other
synthetic opioids. Fentanyl is a potent synthetic opioid that is
primarily prescribed for acute and chronic pain and is approximately
100 times more potent than morphine. As such, fentanyl has a high risk
of abuse, dependence and overdose that can lead to death. Because
fentanyl-related substances have a similar chemical structure to
fentanyl, these substances are expected to have similar biological
effects. Indeed, these three fentanyl-related substances produced
pharmacological effects similar to fentanyl. The adverse effects of
substances structurally related to fentanyl on humans are largely
identical to those of fentanyl and other opioid analgesics. These
fentanyl-related substances pose the same qualitative public health
risks as heroin, fentanyl, and other opioid analgesic substances. The
DEA Toxicology Testing Program (DEA-Tox) \23\ between 2022 and 2023
identified para-fluoroacetyl fentanyl in six cases and para-
bromofentanyl in two cases. Of the para-fluoroacetyl fentanyl cases,
two involved drug paraphernalia reported in overdose deaths and the
other four were in post-mortem cases. para-Bromofentanyl cases were
positive identification in drug paraphernalia. As the data demonstrate,
the potential for overdoses exists for these substances and these
substances pose risk to public health.
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\22\ Centers for Disease Control and Prevention (2024, April).
Understanding the opioid overdose epidemic. <a href="https://www.cdc.gov/overdose-prevention/about/understanding-the-opioid-overdoseepidemic.html">https://www.cdc.gov/overdose-prevention/about/understanding-the-opioid-overdoseepidemic.html</a>; Spencer, M.R., Warner, M., Cisewski, J.A.,
Mini[ntilde]o, A., Dodds, D., Perera, J., & Ahmad, F.B., Estimates
of drug overdose deaths involving fentanyl, methamphetamine,
cocaine, heroin, and oxycodone: United States, 2021. Vital
Statistics Rapid Release (Report No. 27). National Center for Health
Statistics; Zibbell, J.E., Aldridge, A., Grabenauer, M., Heller, D.,
Duhart Clarke, S., Pressley, D., & Smiley-McDonald, H. (2023).
Associations between opioid overdose deaths and drugs confiscated by
law enforcement and submitted to crime laboratories for analysis,
United States, 2014-2019: An observational study. The Lancet
Regional Health-Americas, 25.
\23\ DEA-TOX is a DEA-run program whereby unused biological
samples from victims of drug overdoses can be extensively tested for
the presence of novel psychoactive substances, in addition to other
drugs of abuse.
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7. Its Psychic or Physiological Dependence Liability
According to HHS, the psychic or physiologic dependence of these
three fentanyl-related substances has not been studied in clinical
studies and is therefore unknown. HHS notes that pharmacology data for
these substances as MOR agonists with known abuse potential
demonstrates their property of producing physical and psychic
dependence similar to other MOR agonists. The discontinuation of the
use of MOR agonists, such as morphine and fentanyl (Schedule II drugs),
is associated with withdrawal symptoms indicative of physical
dependence. Opioid withdrawal syndrome is characterized by central
nervous system irritability, gastrointestinal dysfunction, yawning,
diaphoresis, and fever.\24\ Thus, the pharmacological similarity and
pattern of abuse of para-bromofentanyl, para-fluoroacetyl fentanyl, and
para-methyl acetyl 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.
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\24\ Katz R, Kelly W, Hsi A. (1994). Prospective-study on the
occurrence of withdrawal in critically ill children who receive
fentanyl by continuous-infusion. Critical Care Medicine 16:763-767.
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8. Whether the Substance Is an Immediate Precursor of a Substance
Already Controlled Under the CSA
para-Bromofentanyl, para-fluoroacetyl fentanyl, and para-methyl
acetyl 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 para-
bromofentanyl, para-fluoroacetyl fentanyl, and para-methyl acetyl
fentanyl. As such, DEA proposes to permanently schedule these three
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.\25\ After consideration of the analysis and
[[Page 24368]]
recommendation of the Assistant Secretary for HHS and review of all
other available data, the Acting Administrator of DEA, pursuant to 21
U.S.C. 811(a) and 812(b)(1), finds that:
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\25\ See 21 U.S.C. 812(b).
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(1) para-Bromofentanyl, para-fluoroacetyl fentanyl, and para-methyl
acetyl fentanyl, similar to fentanyl, are mu-opioid receptor agonists.
The three fentanyl-related substances have analgesic effects, and these
effects are mediated by [mu]-opioid receptor agonism. These substances
that produce mu-opioid receptor agonist effects in the CNS are
considered as having a high potential for abuse (e.g. morphine and
fentanyl). Data obtained from drug discrimination studies indicate that
para-bromofentanyl, para-fluoroacetyl fentanyl, and para-methyl acetyl
fentanyl substituted for the discriminative stimulus effects of
morphine. Thus, these substances have a high potential for abuse.
(2) There is no Food and Drug Administration (FDA)-approved drug
application for para-bromofentanyl, para-fluoroacetyl fentanyl, and
para-methyl acetyl fentanyl in the United States. Further, there are no
adequate and well-controlled clinical studies for any of these
substances, and there are no well-defined finished dosage forms for any
of these fentanyl-related substances. There are no known therapeutic
applications for these three fentanyl-related substances, and thus they
have no currently accepted medical use in the United States.\26\
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\26\ Pursuant to 21 U.S.C 812(b)(1)(B), when placing a drug or
substance in schedule I of the CSA, DEA must consider whether the
substance has a currently accepted medical use in treatment in the
United States. First, DEA looks to whether the drug or substance has
FDA approval. When no FDA approval exists, DEA has traditionally
applied a five-part test to a drug or substance to determine whether
a drug or substance has a currently medical use: 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.
Marijuana Scheduling Petition; Denial of Petition; Remand, 57 FR
10499 (Mar. 26, 1992), pet. for rev. denied, Alliance for Cannabis
Therapeutics v. Drug Enforcement Admin., 15 F.3d 1131, 1135 (D.C.
Cir. 1994). DEA applied the traditional five-part test and concluded
the test was not satisfied. In a recent published letter in a
different context, HHS applied an additional two-part test to
determine currently accepted medical use for substances that do not
satisfy the five-part test: (1) whether there exists widespread,
current experience with medical use of the substance by licensed
health care providers operating in accordance with implemented
jurisdiction-authorized programs, where medical use is recognized by
entities that regulate the practice of medicine, and, if so, (2)
whether there exists some credible scientific support for at least
one of the medical conditions for which part (1) is satisfied. On
April 11, 2024, the Department of Justice's Office of Legal Counsel
(OLC) issued an opinion, which, among other things, concluded that
HHS's two-part test would be sufficient to establish that a drug has
a currently accepted medical use. Office of Legal Counsel,
Memorandum for Merrick B. Garland Attorney General Re: Questions
Related to the Potential Rescheduling of Marijuana at 3 (April 11,
2024). In its eight-factor assessment, HHS determined that these
three fentanyl-related substances did not satisfy this two-part
test. Therefore, since both DEA and HHS have determined that these
three fentanyl-related substances do not satisfy the five-part test,
and HHS has determined that these three fentanyl-related substances
do not satisfy the additional two-part test, DEA concludes that
para-bromofentanyl, para-fluoro acetylfentanyl, and para-methyl
acetylfentanyl do not have a currently accepted medical use.
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(3) There is a lack of accepted safety for use of para-
bromofentanyl, para-fluoroacetyl fentanyl, and para-methyl acetyl
fentanyl under medical supervision. Because these three substances have
no FDA-approved medical use and have not been investigated as new
drugs, their safety for use under medical supervision has not been
determined. Therefore, there is a lack of accepted safety for use of
these three substances under medical supervision.
Based on these findings, the Acting Administrator of DEA concludes
that para-bromofentanyl, para-fluoroacetyl fentanyl, and para-methyl
acetyl 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.\27\
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\27\ 21 U.S.C. 812(b)(1).
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Requirements for Handling para-Bromofentanyl, para-Fluoroacetyl
Fentanyl, and para-Methyl Acetyl Fentanyl
As discussed above, these three fentanyl-related substances are
currently subject to a temporary scheduling order, which added them to
schedule I. If this rule is finalized as proposed, para-bromofentanyl,
para-fluoroacetyl fentanyl, and para-methyl acetyl 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) para-
bromofentanyl, para-fluoroacetyl fentanyl, and para-methyl acetyl
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. para-Bromofentanyl, para-fluoroacetyl fentanyl, and
para-methyl acetyl 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 through 1301.76. Non-
practitioners handling these three substances also must comply with the
screening requirements of 21 CFR 1301.90 through 1301.93.
3. Labeling and Packaging. All labels and labeling for commercial
containers of para-bromofentanyl, para-fluoroacetyl fentanyl, and para-
methyl acetyl fentanyl must comply with 21 U.S.C. 825 and 958(e) and be
in accordance with 21 CFR part 1302.
4. Quota. Only registered manufacturers are permitted to
manufacture para-bromofentanyl, para-fluoroacetyl fentanyl, and para-
methyl acetyl 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 para-
bromofentanyl, para-fluoroacetyl fentanyl, and para-methyl acetyl
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 para-
bromofentanyl, para-fluoroacetyl fentanyl, and para-methyl acetyl
fentanyl) on hand every two years pursuant to 21 U.S.C. 827 and 958(e)
and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
6. Records and Reports. Every DEA registrant must maintain records
and submit reports with respect to para-bromofentanyl, para-fluoroacety
lfentanyl, and para-methyl acetyl fentanyl, pursuant to 21 U.S.C. 827,
832(a), and 958(e), and in accordance with 21 CFR 1301.74(b) and (c)
and 1301.76(b) and parts 1304, 1312, and 1317. Manufacturers and
distributors would be required to submit reports regarding para-
bromofentanyl, para-fluoroacetyl fentanyl, and para-methyl acetyl
fentanyl to the Automation of Reports and Consolidated Order System
pursuant 21 U.S.C. 827, and in accordance with 21 CFR parts 1304 and
1312.
[[Page 24369]]
7. Order Forms. Every DEA registrant who distributes para-
bromofentanyl, para-fluoroacetyl fentanyl, and para-methyl acetyl
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
para-bromofentanyl, para-fluoroacetyl fentanyl, and para-methyl acetyl
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 para-bromofentanyl, para-
fluoroacetyl fentanyl, and para-methyl acetyl 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, 13563, and 14192 (Regulatory Review)
In accordance with 21 U.S.C. 811(a), this proposed scheduling
action is 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. DEA scheduling actions are not subject to E.O. 14192,
Unleashing Prosperity Through Deregulation.
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 Acting Administrator, in accordance with the Regulatory
Flexibility Act, 5 U.S.C. 601-612, has reviewed this proposed 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,\28\ Congress
extended that expiration date until May 6, 2021, by enacting the
Temporary Reauthorization and Study of the Emergency Scheduling of
Fentanyl Analogues Act.\29\ This temporary order was subsequently
extended multiple times, most recently on March 15, 2025, which
extended the order until September 30, 2025.\30\ DEA estimates that all
entities handling or planning to handle para-bromofentanyl, para-
fluoroacetyl fentanyl, and para-methyl acetyl fentanyl have already
established and implemented systems and processes required to handle
these substances which meet the definition of fentanyl-related
substances.
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\28\ Schedules of Controlled Substances: Temporary Placement of
Fentanyl-Related Substances in Schedule I; Correction, 85 FR 20155
(Apr. 10, 2020).
\29\ Public Law 116-114, sec. 2, 134 Stat. 103.
\30\ Public Law 119-4, sec. 3105, 139 Stat. 9.
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There are currently 173 registrations authorized to specifically
handle the fentanyl-related substances as a class, which include one or
more of the following substances: para-bromofentanyl, para-fluoroacetyl
fentanyl, and para-methyl acetyl 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, DEA conservatively assumes all of 173 registrants
affected by this rulemaking are small entities.
A review of the 173 registrations indicates that all entities that
currently handle para-bromofentanyl, para-fluoroacetyl fentanyl, and
para-methyl acetyl 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 that 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 173 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 the UMRA
of 1995.
Paperwork Reduction Act of 1995
This proposed rule would not impose a new collection or modify an
existing collection of information under the Paperwork Reduction Act of
1995.\31\ Also, this proposed rule would not impose new or modify
existing recordkeeping or reporting requirements on state or local
governments, individuals, businesses, or organizations. However, this
proposed rule would require compliance with the following existing OMB
collections: 1117-0003, 1117-0004, 1117-0006, 1117-0008, 1117-0009,
1117-0010, 1117-0012, 1117-0014, 1117-0021, 1117-0023, 1117-0029, and
1117-0056. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.
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\31\ 44 U.S.C. 3501-3521.
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List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
[[Page 24370]]
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)(89) through (110) as (b)(92) through
(113);
0
b. Redesignate paragraphs (b)(84) through (b)(88) as (b)(86) through
(90);
0
c. Redesignate paragraphs (b)(83) as (b)(84); and
0
d. Add new paragraphs (b)(83), (b)(85), and (b)(91);
The additions to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(b) * * *
------------------------------------------------------------------------
------------------------------------------------------------------------
* * * * * * *
(83) para-bromofentanyl (N-(4-bromophenyl)-N-(1- 9872
phenethylpiperidin-4-yl)propionamide).........................
* * * * * * *
(85) para-fluoroacetyl fentanyl (N-(4-fluorophenyl)-N-(1- 9874
phenethylpiperidin-4-yl)acetamide)............................
* * * * * * *
(91) para-methyl acetyl fentanyl (N-(4-methylphenyl)-N-(1- 9875
phenethylpiperidin-4-yl)acetamide)............................
* * * * * * *
------------------------------------------------------------------------
* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed on
June 2, 2025, by Acting Administrator Robert J. Murphy. 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.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2025-10372 Filed 6-9-25; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on June 10, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.