Schedules of Controlled Substances: Temporary Placement of N-Pyrrolidino Metonitazene and N-Pyrrolidino Protonitazene in Schedule I, 75979-75984 [2024-21058]
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Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Proposed Rules
The Proposed Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the FAA proposes to amend 14 CFR part
39 as follows:
PART 39—AIRWORTHINESS
DIRECTIVES
1. The authority citation for part 39
continues to read as follows:
■
Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. The FAA amends § 39.13 by adding
the following new airworthiness
directive:
■
Embraer S.A. (Type Certificate Previously
Held by Yaborã Indústria Aeronáutica
S.A.; Embraer S.A.): Docket No. FAA–
2024–2140; Project Identifier MCAI–
2024–00242–T.
(a) Comments Due Date
The FAA must receive comments on this
airworthiness directive (AD) by November 1,
2024.
(b) Affected ADs
None.
(c) Applicability
This AD applies to all Embraer S.A. (Type
Certificate previously held by Yaborã
Indústria Aeronáutica S.A.; Embraer S.A.)
Model EMB–120, –120ER, –120FC, –120QC,
and –120RT airplanes, certificated in any
category.
(d) Subject
Air Transport Association (ATA) of
America Code 53, Fuselage.
(e) Unsafe Condition
This AD was prompted by a structural
assessment that indicated the fuselage center
I longitudinal skin splice and panel between
frames 22 and 23 is susceptible to cracking.
The FAA is issuing this AD to address
undetected cracks in the fuselage center I
longitudinal skin splice and panel between
frames 22 and 23. The unsafe condition, if
not addressed, could result in undetected
fuselage crack propagation, and reduced
structural integrity of the airplane.
ddrumheller on DSK120RN23PROD with PROPOSALS1
(f) Compliance
Comply with this AD within the
compliance times specified, unless already
done.
(g) Requirements
Except as specified in paragraph (h) of this
AD: Comply with all required actions and
compliance times specified in, and in
accordance with, Agência Nacional de
Aviação Civil (ANAC) AD 2024–04–02R01,
effective May 31, 2024 (ANAC AD 2024–04–
02R01).
(h) Exceptions to ANAC AD 2024–04–02R01
(1) Where ANAC AD 2024–04–02R01 refers
to its effective date, this AD requires using
the effective date of this AD.
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(2) Where paragraphs (b)(1) and (2) of
ANAC AD 2024–04–02R01 specify the initial
compliance time for the high-frequency eddy
current inspection of the fuselage center I
longitudinal skin splice—frames 22 and 23,
from the internal and external side of the
fuselage, for this AD, the initial compliance
time for doing the high-frequency eddy
current inspection is prior to the
accumulation of 50,000 total flight cycles, or
within 800 flight cycles after the effective
date of this AD, whichever occurs later.
(3) Where paragraphs (d)(1) and (2) of
ANAC AD 2024–04–02R01 specify the initial
compliance time for the high-frequency eddy
current inspection of the fuselage center I
skin panel—frames 22 and 23, from the
external side of the fuselage, for this AD, the
initial compliance time for doing the highfrequency eddy current inspection is prior to
the accumulation of 50,000 total flight cycles,
or within 800 flight cycles after the effective
date of this AD, whichever occurs later.
(4) Where paragraphs (b)(3) and (d)(3) of
ANAC AD 2024–04–02R01 specify corrective
actions, for this AD, if any discrepancy
including cracking is detected during any
inspection required by this AD, the
discrepancy must be repaired before further
flight using a method approved by the
Manager, International Validation Branch,
FAA; or ANAC; or Embraer’s ANAC Design
Organization Approval (DOA). If approved by
the DOA, the approval must include the
DOA-authorized signature.
(5) Paragraph (f) of ANAC AD 2024–04–
02R01 specifies to report inspection results to
ANAC and Embraer within a certain
compliance time. For this AD, report
inspection results at the applicable time
specified in paragraph (h)(5)(i) or (ii) of this
AD.
(i) If the inspection was done on or after
the effective date of this AD: Submit the
report within 30 days after the inspection.
(ii) If the inspection was done before the
effective date of this AD: Submit the report
within 30 days after the effective date of this
AD.
(6) This AD does not adopt paragraph (g)
of ANAC AD 2024–04–02R01.
(i) Additional AD Provisions
The following provisions also apply to this
AD:
(1) Alternative Methods of Compliance
(AMOCs): The Manager, International
Validation Branch, FAA, has the authority to
approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19.
In accordance with 14 CFR 39.19, send your
request to your principal inspector or
responsible Flight Standards Office, as
appropriate. If sending information directly
to the manager of the International Validation
Branch, mail it to the address identified in
paragraph (j) of this AD. Information may be
emailed to: 9-AVS-AIR-730-AMOC@faa.gov.
Before using any approved AMOC, notify
your appropriate principal inspector, or
lacking a principal inspector, the manager of
the responsible Flight Standards Office.
(2) Contacting the Manufacturer: For any
requirement in this AD to obtain instructions
from a manufacturer, the instructions must
be accomplished using a method approved
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by the Manager, International Validation
Branch, FAA; or ANAC; or ANAC’s
authorized Designee. If approved by the
ANAC Designee, the approval must include
the Designee’s authorized signature.
(j) Additional Information
For more information about this AD,
contact Hassan Ibrahim, Aviation Safety
Engineer, FAA, 1600 Stewart Avenue, Suite
410, Westbury, NY 11590; phone: 206–231–
3653; email: Hassan.M.Ibrahim@faa.gov.
(k) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference
(IBR) of the material listed in this paragraph
under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this material as
applicable to do the actions required by this
AD, unless this AD specifies otherwise.
(i) Agência Nacional de Aviação Civil
(ANAC) AD 2024–04–02R01, effective May
31, 2024.
(ii) [Reserved]
(3) For ANAC material identified in this
AD, contact ANAC, Aeronautical Products
Certification Branch (GGCP), Rua Dr. Orlando
Feirabend Filho, 230—Centro Empresarial
Aquarius—Torre B—Andares 14 a 18, Parque
Residencial Aquarius, CEP 12.246–190—São
José dos Campos—SP, Brazil; phone 55 (12)
3203–6600; email pac@anac.gov.br; website
anac.gov.br/en/. You may find this ANAC
AD on the ANAC website
sistemas.anac.gov.br/certificacao/DA/
DAE.asp.
(4) You may view this material at the FAA,
Airworthiness Products Section, Operational
Safety Branch, 2200 South 216th Street, Des
Moines, WA. For information on the
availability of this material at the FAA, call
206–231–3195.
(5) You may view this material at the
National Archives and Records
Administration (NARA). For information on
the availability of this material at NARA,
visit www.archives.gov/federal-register/cfr/
ibr-locations or email fr.inspection@nara.gov.
Issued on September 10, 2024.
Victor Wicklund,
Deputy Director, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2024–20991 Filed 9–16–24; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–1337]
Schedules of Controlled Substances:
Temporary Placement of N-Pyrrolidino
Metonitazene and N-Pyrrolidino
Protonitazene in Schedule I
Drug Enforcement
Administration, Department of Justice.
ACTION: Proposed amendment; notice of
intent.
AGENCY:
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Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Proposed Rules
The Administrator of the Drug
Enforcement Administration is issuing
this notice of intent to publish a
temporary order to schedule two
synthetic benzimidazole-opioid
substances, N-pyrrolidino metonitazene
and N-pyrrolidino protonitazene,
including their isomers, esters, ethers,
salts, and salts of isomers, esters, and
ethers whenever the existence of such
isomers, esters, ethers, and salts is
possible, in schedule I of the Controlled
Substances Act. When it is issued, the
temporary scheduling order will impose
the regulatory controls and
administrative, civil, and criminal
sanctions applicable to schedule I
controlled substances on persons who
handle (manufacture, distribute, reverse
distribute, import, export, engage in
research, conduct instructional
activities or chemical analysis, or
possess) or propose to handle these two
specified substances.
DATES: This notice of intent is effective
September 17, 2024.
FOR FURTHER INFORMATION CONTACT:
Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control
Division, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone: (571) 362–3249.
SUPPLEMENTARY INFORMATION: The notice
of intent contained in this document is
issued pursuant to the temporary
scheduling provisions of 21 U.S.C.
811(h). The Drug Enforcement
Administration (DEA) intends to issue a
temporary scheduling order 1 (in the
form of a temporary amendment) to add
the two synthetic benzimidazole-opioid
substances, including their isomers,
esters, ethers, salts, and salts of isomers,
esters, and ethers whenever the
existence of such isomers, esters, ethers,
and salts is possible, to schedule I under
the Controlled Substances Act (CSA):
• 2-(4-methoxybenzyl)-5-nitro-1-(2(pyrrolidin-1-yl)ethyl)-1Hbenzimidazole (commonly known as, Npyrrolidino metonitazene or
metonitazepyne), and
• 5-nitro-2-(4-propoxybenzyl)-1-(2(pyrrolidin-1-yl)ethyl)-1Hbenzimidazole (commonly known as, Npyrrolidino protonitazene or
protonitazepyne).
The temporary scheduling order will
be published in the Federal Register on
or after October 17, 2024.
ddrumheller on DSK120RN23PROD with PROPOSALS1
SUMMARY:
Legal Authority
Under 21 U.S.C. 811(h)(1), the CSA
provides the Attorney General (as
delegated to the Administrator of DEA
(Administrator) pursuant to 28 CFR
0.100) has the authority to temporarily
place a substance in schedule I of the
CSA for two years without regard to the
evaluation requirements of 21 U.S.C.
811(b), if he finds that such action is
necessary to avoid an imminent hazard
to the public safety.2 In addition, if
proceedings to control a substance are
initiated under 21 U.S.C. 811(a)(1) while
the substance is temporarily controlled
under section 811(h), the Attorney
General may extend the temporary
scheduling for up to one year.3
Where the necessary findings are
made, a substance may be temporarily
scheduled if it is not listed in any other
schedule under 21 U.S.C. 812, or if there
is no exemption or approval in effect for
the substance under section 505 of the
Federal Food, Drug, and Cosmetic Act,
21 U.S.C. 355.4
Background
7 21
The CSA requires the Administrator
to notify the Secretary of the
Department of Health and Human
Services (HHS) of an intent to
temporarily place a substance in
schedule I of the CSA (i.e., to issue a
temporary scheduling order).5 By letter
dated December 15, 2023, the
Administrator transmitted the required
notice to place N-pyrrolidino
metonitazene and N-pyrrolidino
protonitazene in schedule I on a
temporary basis to the Assistant
Secretary for Health of HHS (Assistant
Secretary).6 On December 22, 2023, the
Assistant Secretary responded to this
notice and advised DEA that based on
a review by the Food and Drug
Administration (FDA), there are
currently no investigational new drug
applications (IND) or approved new
drug applications (NDA) for Npyrrolidino metonitazene or Npyrrolidino protonitazene. The
Assistant Secretary also stated that HHS
had no objection to the temporary
placement of these substances in
schedule I of the CSA. N-Pyrrolidino
metonitazene and N-pyrrolidino
protonitazene currently are not listed in
any schedule under the CSA, and no
exemptions or approvals under 21
2 21
U.S.C. 811(h)(1).
U.S.C. 811(h)(2).
4 21 U.S.C. 811(h)(1); 21 CFR part 1308.
5 21 U.S.C. 811(h)(4).
6 The Secretary of HHS has delegated to the
Assistant Secretary for Health of HHS the authority
to make domestic drug scheduling
recommendations. 58 FR 35460 (July 1, 1993).
3 21
1 Though DEA has used the term ‘‘final order’’
with respect to temporary scheduling orders in the
past, this notice of intent adheres to the statutory
language of 21 U.S.C. 811(h), which refers to a
‘‘temporary scheduling order.’’ No substantive
change is intended.
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U.S.C. 355 are in effect for these
substances.
To find that temporarily placing a
substance in schedule I of the CSA is
necessary to avoid an imminent hazard
to the public safety, the Administrator
must consider three of the eight factors
set forth in 21 U.S.C. 811(c): the
substance’s history and current pattern
of abuse; the scope, duration, and
significance of abuse; and what, if any,
risk there is to the public health.7 This
consideration includes any information
indicating actual abuse, diversion from
legitimate channels, and clandestine
importation, manufacture, or
distribution of N-Pyrrolidino
metonitazene and N-pyrrolidino
protonitazene.8
Substances meeting the statutory
requirements for temporary scheduling
may only be placed in schedule I.9
Substances in schedule I have high
potential for abuse, no currently
accepted medical use in treatment in the
United States,10 and a lack of accepted
Fmt 4702
Sfmt 4702
U.S.C. 811(h)(3).
U.S.C. 811(h)(3).
9 21 U.S.C. 811(h)(1).
10 When finding schedule I placement on a
temporary basis is necessary to avoid imminent
hazard to the public, 21 U.S.C. 811(h) does not
require DEA to consider whether the substance has
a currently accepted medical use in treatment in the
United States. Nonetheless, there is no evidence
suggesting that N-pyrrolidino metonitazene or Npyrrolidino protonitazene have a currently accepted
medical use in treatment in the United States. To
determine whether a drug or other substance has a
currently accepted medical use, DEA has
traditionally applied a five-part test to a drug or
substance that has not been approved by the FDA:
i. The drug’s chemistry must be known and
reproducible; ii. there must be adequate safety
studies; iii. there must be adequate and wellcontrolled studies proving efficacy; iv. the drug
must be accepted by qualified experts; and v. the
scientific evidence must be widely available. See
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 and HHS applied the traditional fivepart test for currently accepted medical use in this
matter. 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 jurisdictionauthorized 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). For purposes of this notice of intent,
there is no evidence that health care providers have
8 21
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safety for use under medical
supervision.11
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Two Benzimidazole-Opioids: Npyrrolidino metonitazene and Npyrrolidino protonitazene
The continued encounter of novel
synthetic opioids on the recreational
drug market poses a threat to public
safety. Beginning in 2019, a new class
of synthetic opioids known as
benzimidazole-opioids, commonly
referred to as ‘‘nitazenes,’’ emerged on
the recreational drug market. This class
of substances has a similar
pharmacological profile to fentanyl,
morphine, and other mu-opioid receptor
agonists. Between August 2020 and
March 2024, DEA temporarily
controlled ten benzimidazole-opioids
because they posed a threat to public
safety.12 N-Pyrrolidino metonitazene and
N-pyrrolidino protonitazene are some of
the recently encountered ‘‘nitazene’’
synthetic opioids identified on the illicit
drug market.
The continued trafficking and
identification of benzimidazole-opioids
in toxicology cases poses a significant
threat to public health and safety.
Adverse health effects associated with
the misuse and abuse of synthetic
opioids have led to devastating
consequences including death.
Preclinical pharmacology data
demonstrate that N-pyrrolidino
metonitazene and N-pyrrolidino
protonitazene have pharmacological
profiles similar to those of the potent
benzimidazole-opioids metonitazene
and protonitazene, schedule I opioid
substances. N-Pyrrolidino metonitazene
and N-pyrrolidino protonitazene have
been positively identified in at least 26
toxicology cases. As the United States
continues to experience a high number
of opioid-involved overdoses and
mortalities, the introduction of new
designer opioids further exacerbates the
current opioid epidemic.
Available data and information for Npyrrolidino metonitazene and Nwidespread experience with medical use of Npyrrolidino metonitazene and N-pyrrolidino
protonitazene or that the use of N-pyrrolidino
metonitazene or N-pyrrolidino protonitazene is
recognized by entities that regulate the practice of
medicine under either the traditional five-part test
or the two-part test.
11 21 U.S.C. 812(b)(1).
12 Schedules of Controlled Substances:
Temporary Placement of Butonitazene,
Etodesnitazene, Flunitazene, Metodesnitazene,
Metonitazene, N-Pyrrolidino etonitazene, and
Protonitazene in Schedule I, 87 FR 21556 (Apr. 12,
2022); Schedules of Controlled Substances:
Temporary Placement of Isotonitazene in Schedule
I, 85 FR 51342 (Aug. 20, 2020); Schedules of
Controlled Substances: Temporary Placement of NDesethyl Isotonitazene and N-Piperidinyl
Etonitazene in Schedule I, 89 FR 60817 (Jul. 29,
2024).
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16:52 Sep 16, 2024
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pyrrolidino protonitazene, summarized
below, indicate that these substances
have high potentials for abuse, no
currently accepted medical uses in
treatment in the United States, and a
lack of accepted safety for use under
medical supervision. DEA’s three-factor
analysis is available in its entirety under
‘‘Supporting and Related Material’’ of
the public docket for this action at
www.regulations.gov under Docket
Number DEA–1337.
Factor 4. History and Current Pattern of
Abuse
Since 2019, there has been an
emergence of benzimidazole-opioid
compounds on the illicit drug market,
which have been positively identified in
numerous cases of fatal overdose events.
The benzimidazole-opioids were
originally synthesized and studied in
the 1950s by the pharmaceutical
research laboratories of the Swiss
chemical company Chemical Industries
Basel. The research produced a group of
structurally unique benzimidazole
derivatives with analgesic properties;
however, the research effort did not
produce any medically approved
analgesic products. These
benzimidazole derivatives include
schedule I substances, such as synthetic
opioids clonitazene, etonitazene, and
isotonitazene.
In August 2020, isotonitazene was
placed in schedule I of the CSA (85 FR
51342). Subsequently, nine additional
benzimidazole-opioids 13 have been
placed in schedule I of the CSA (87 FR
21556 and 89 FR 60817). Recently, Npyrrolidino metonitazene and Npyrrolidino protonitazene have emerged
on the illicit drug market. Law
enforcement officers have encountered
N-pyrrolidino metonitazene and Npyrrolidino protonitazene in several
solid forms (e.g., powder and tablets).
These substances are not approved
pharmaceutical products and are not
approved for medical use anywhere in
the world. The Assistant Secretary in a
letter to DEA dated December 22, 2023,
stated that there are no FDA-approved
NDAs or IND applications for Npyrrolidino metonitazene and Npyrrolidino protonitazene in the United
States; hence, there are no legitimate
channels for these substances as
marketed drug products.
The appearance of benzimidazoleopioids on the illicit drug market is
similar to other designer opioid drugs
that are trafficked for their psychoactive
13 Butonitazene, etodesnitazene, flunitazene,
metodesnitazene, metonitazene, N-pyrrolidino
etonitazene, and protonitazene (87 FR 21556, Apr.
12, 2022). N-desethyl isotonitazene and Npiperidinyl etonitazene (89 FR 60817, Jul. 29 2024).
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75981
effects. These substances are likely to be
abused in the same manner as schedule
I opioids, such as etonitazene,
isotonitazene, and heroin. In 2023, Npyrrolidino metonitazene and Npyrrolidino protonitazene emerged on
the illicit synthetic drug market as
evidenced by their identification in
forensic drug seizures and in biological
samples.14 Based on NFLIS-Drug data,
law enforcement encounters of Npyrrolidino metonitazene and Npyrrolidino protonitazene were found in
combination with other substances of
abuse such as heroin, designer
benzodiazepines, cocaine, fentanyl,
methamphetamine, and xylazine.
Factor 5. Scope, Duration and
Significance of Abuse
N-Pyrrolidino metonitazene and Npyrrolidino protonitazene, similar to
etonitazene, metonitazene and
protonitazene (schedule I substances),
have been described as potent synthetic
opioids, and evidence suggests they are
abused for their opioidergic effects (see
Factor 6). The abuse of these
benzimidazole-opioids, similar to other
synthetic opioids, has resulted in
serious adverse health effects.
According to a public alert report 15
published in August 2023, Npyrrolidino protonitazene has been
positively confirmed in 20 medicolegal
death investigation cases in the United
States (n =16) and United Kingdom (n
= 4). The cases that occurred in the
United States originated from seven
States including California, Illinois,
Maine, Massachusetts, Minnesota,
Wisconsin, and Wyoming. NPyrrolidino metonitazene has been
identified in six toxicology cases as of
June 2023 in the United States. The
cases occurred in at least three States
including Ohio, Illinois, and West
Virginia.16
Data from law enforcement suggest
that N-pyrrolidino metonitazene and N14 NMS Labs, in collaboration with the Center for
Forensic Science Research and Education at the
Fredric Rieders Family Foundation and the
Organized Crime Drug Enforcement Task Force at
the United States Department of Justice, has
received funding from the Centers for Disease
Control and Prevention to develop systems for the
early identification and notification of novel
psychoactive substances in the drug supply within
the United States.
15 Krotulski, AJ; Walton, SE; Papsun, DM;
DeBord, J; Fogarty, MF; Logan, BK. (2023) New
Nitazene Analogue N-Pyrrolidino Protonitazene
Impacting Drug Markets In North America and
Europe, Center for Forensic Science Research and
Education, United States. CSFRE Public Alert.
August 2023.
16 Krotulski, AJ; Horton, KB; Walton, SE; Papsun,
DM; DeBord, J; Fogarty, MF; Logan, BK. (2023) NPyrrolidino Metonitazene—NPS Discovery New
Drug Monograph, Center for Forensic Science
Research and Education, United States.
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pyrrolidino protonitazene are being
abused in the United States as
recreational drugs.17 Since 2023, there
have been 37 exhibits reported to the
NFLIS-Drug (Federal, State and local
laboratories) database pertaining to the
trafficking, distribution, and abuse of
these substances. There were seven
encounters of N-pyrrolidino
metonitazene from two States in NFLISDrug: Missouri (n = 2) and Ohio (n = 5).
N-Pyrrolidino protonitazene has been
identified in 30 exhibits in NFLIS-Drug
from five States: Florida (n = 4), Iowa (n
= 10), Missouri (n = 1), Ohio (n = 13),
and Texas (n = 2).18
Because abusers of N-pyrrolidino
metonitazene and N-pyrrolidino
protonitazene are likely to obtain these
substances through unregulated sources,
the identity, purity, and quantity of
these substances 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 wellcharacterized.19 Individuals who
initiate (i.e., use a drug for the first time)
use of these benzimidazole-opioids are
likely to be at risk of developing
substance use disorder, an overdose
event, or death, similar to that of other
opioid analgesics (e.g., fentanyl,
morphine, etc.). Law enforcement and
toxicology reports demonstrate that Npyrrolidino metonitazene and Npyrrolidino protonitazene are being
illicitly distributed and abused.
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Factor 6. What, if Any, Risk There Is to
the Public Health
The increase in opioid overdose
deaths in the United States has been
exacerbated recently by the availability
of potent synthetic opioids on the illicit
drug market. Data obtained from preclinical studies demonstrate that Npyrrolidino metonitazene and Npyrrolidino protonitazene exhibit
pharmacological profiles similar to that
of etonitazene, metonitazene,
protonitazene, and other mu-opioid
receptor agonists. These two
benzimidazole-opioids bind to and act
as agonists at the mu-opioid receptors.20
17 While law enforcement data are not direct
evidence of abuse, they can lead to an inference that
a drug has been diverted and abused. See 76 FR
77330, 77332 (Dec. 12, 2011).
18 NFLIS-Drug was queried on July 17, 2024.
19 Jones CM, Logan J, Gladden RM, Bohm MK.
Vital Signs: Demographic and Substance Use
Trends Among Heroin Users—United States, 2002–
2013. MMWR Morb Mortal Wkly Rep. 2015 Jul
10;64(26):719–25.
20 DEA–VA Interagency Agreement. ‘‘In Vitro
Receptor and Transporter Assays for Abuse
Liability Testing for the DEA by the VA’’. Binding
and Functional Activity at Delta, Kappa and Mu
Opioid Receptors. 2022.
VerDate Sep<11>2014
16:52 Sep 16, 2024
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It is well established that substances
that act as mu-opioid receptor agonists
have a high potential for addiction and
can induce dose-dependent respiratory
depression.21
Consistent with any mu-opioid
receptor agonist, the potential health
and safety risks for users of Npyrrolidino metonitazene and Npyrrolidino protonitazene are high. NPyrrolidino metonitazene and Npyrrolidino protonitazene have been
positively identified in forensic
toxicology and post mortem cases.
According to a public alert, Npyrrolidino protonitazene has been
positively identified in 20 medicolegal
death investigations in the United States
and United Kingdom as of August 2023.
Of the cases, 16 occurred across seven
States in the United States. Decedent
ages ranged from mid-20s to mid-70s. NPyrrolidino protonitazene was coidentified with additional novel
psychoactive substances (70 percent),
quinine (60 percent), other
benzimidazole-opioids (55 percent),
methamphetamine/cocaine (55 percent),
fentanyl (55 percent), xylazine (35
percent) and designer benzodiazepines
(30 percent).22 Also, N-pyrrolidino
metonitazene has been identified in six
toxicology cases in the United States as
of June 2023. The introduction of potent
synthetic opioids such as N-pyrrolidino
metonitazene and N-pyrrolidino
protonitazene into the illicit market may
serve as a portal to problematic opioid
use for those seeking these powerful
opioids. As documented by toxicology
reports, polysubstance abuse remains
common in fatalities associated with the
abuse of some of these benzimidazoleopioids.
The United States is currently
experiencing an opioid epidemic, and
the presence of synthetic opioids on the
illicit drug market further exacerbates
the problem. The trafficking and abuse
of new synthetic opioids are deadly
trends which pose imminent hazard to
the public safety. Adverse health effects
associated with the abuse of synthetic
opioids and the continued evolution
and increased popularity of these
substances have been a serious concern
in recent years. Because of the
pharmacological similarities of Npyrrolidino metonitazene and N21 Fox LM, Hoffman RS, Vlahov D, Manini AF.
Risk factors for severe respiratory depression from
prescription opioid overdose. Addiction. 2018
Jan;113(1):59–66.
22 Krotulski, AJ; Walton, SE; Papsun, DM;
DeBord, J; Fogarty, MF; Logan, BK. (2023) New
Nitazene Analogue N-Pyrrolidino Protonitazene
Impacting Drug Markets In North America and
Europe, Center for Forensic Science Research and
Education, United States. CSFRE Public Alert.
August 2023.
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pyrrolidino protonitazene to
metonitazene and protonitazene, the use
of these substances presents high risk of
abuse and may negatively affect users
and communities. The positive
identification of these substances in
toxicology cases is of serious concern to
the public safety. Thus, N-pyrrolidino
metonitazene and N-pyrrolidino
protonitazene pose imminent hazard to
public safety.
Finding of Necessity of Schedule I
Placement To Avoid Imminent Hazard
to Public Safety
In accordance with 21 U.S.C.
811(h)(3), based on the available data
and information summarized above, the
uncontrolled manufacture, distribution,
reverse distribution, importation,
exportation, conduct of research and
chemical analysis, possession, and
abuse of N-pyrrolidino metonitazene
and N-pyrrolidino protonitazene pose
imminent hazards to public safety. DEA
is not aware of any currently accepted
medical uses for these substances in the
United States. A substance meeting the
statutory requirements for temporary
scheduling, found in 21 U.S.C.
811(h)(1), may only be placed in
schedule I. Substances in schedule I
must have a high potential for abuse, no
currently accepted medical use in
treatment in the United States, and a
lack of accepted safety for use under
medical supervision. Available data and
information for N-pyrrolidino
metonitazene and N-pyrrolidino
protonitazene indicate that these
substances meet the three statutory
criteria. As required by 21 U.S.C.
811(h)(4), the Administrator transmitted
to the Assistant Secretary, via letter
dated December 15, 2023, notice of her
intent to place N-pyrrolidino
metonitazene and N-pyrrolidino
protonitazene in schedule I on a
temporary basis. HHS had no objection
to the temporary placement of these
substances in schedule I.
Conclusion
This notice of intent provides the 30day notice pursuant to 21 U.S.C.
811(h)(1) of DEA’s intent to issue a
temporary scheduling order. In
accordance with 21 U.S.C. 811(h)(1) and
(3), the Administrator considered
available data and information, herein
set forth the grounds for her
determination that it is necessary to
temporarily schedule N-pyrrolidino
metonitazene and N-pyrrolidino
protonitazene in schedule I of the CSA,
and finds that placement of these
substances in schedule I is necessary to
avoid an imminent hazard to the public
safety.
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ddrumheller on DSK120RN23PROD with PROPOSALS1
The temporary placement of Npyrrolidino metonitazene and Npyrrolidino protonitazene in schedule I
of the CSA will take effect pursuant to
a temporary scheduling order, which
will not be issued before October 17,
2024. Because the Administrator hereby
finds this temporary scheduling order
necessary to avoid an imminent hazard
to the public safety, it will take effect on
the date the order is published in the
Federal Register and remain in effect for
two years, with a possible extension of
one year, pending completion of the
regular (permanent) scheduling
process.23 The Administrator intends to
issue a temporary scheduling order as
soon as possible after the expiration of
30 days from the date of publication of
this document. Upon the temporary
order’s publication, N-pyrrolidino
metonitazene and N-pyrrolidino
protonitazene will then be subject to the
CSA’s schedule I regulatory controls
and to administrative, civil, and
criminal sanctions applicable to their
manufacture, distribution, reverse
distribution, importation, exportation,
research, conduct of instructional
activities and chemical analysis, and
possession.
The CSA sets forth specific criteria for
scheduling drugs or other substances.
Regular scheduling actions in
accordance with 21 U.S.C. 811(a) are
subject to formal rulemaking procedures
‘‘on the record after opportunity for a
hearing’’ conducted pursuant to the
provisions of 5 U.S.C. 556 and 557.24
The regular scheduling process of
formal rulemaking affords interested
parties appropriate process and the
government any additional relevant
information needed to make a
determination. Final decisions that
conclude the regular scheduling process
of formal rulemaking are subject to
judicial review.25 Temporary
scheduling orders are not subject to
judicial review.26
Regulatory Analyses
The CSA provides for expedited
temporary scheduling actions where
necessary to avoid an imminent hazard
to the public safety. Under 21 U.S.C.
811(h)(1), the Administrator, as
delegated by the Attorney General, may,
by order, temporarily place substances
in schedule I. Such orders may not be
issued before the expiration of 30 days
from: (1) The publication of a notice in
the Federal Register of the intent to
issue such order and the grounds upon
23 21
U.S.C. 811(h)(1) and (2).
U.S.C. 811.
25 21 U.S.C. 877.
26 21 U.S.C. 811(h)(6).
which such order is to be issued, and (2)
the date that notice of the proposed
temporary scheduling order is
transmitted to the Assistant Secretary,
as delegated by the Secretary of HHS.27
Inasmuch as section 811(h) directs
that temporary scheduling actions be
issued by order and sets forth the
procedures by which such orders are to
be issued, including the requirement to
publish in the Federal Register a notice
of intent, the notice-and-comment
requirements of section 553 of the
Administrative Procedure Act (APA), 5
U.S.C. 553, do not apply to this notice
of intent. The APA expressly
differentiates between orders and rules,
as it defines an ‘‘order’’ to mean a ‘‘final
disposition, whether affirmative,
negative, injunctive, or declaratory in
form, of an agency in a matter other
than rule making.’’ 28 (Emphasis added).
This contrasts with permanent
scheduling actions, which are subject to
formal rulemaking procedures done ‘‘on
the record after opportunity for a
hearing,’’ and final decisions that
conclude the scheduling process and are
subject to judicial review. 21 U.S.C.
811(a) and 877. The specific language
chosen by Congress indicates its intent
that DEA issue orders instead of
proceeding by rulemaking when
temporarily scheduling substances.
Given that Congress specifically
requires the Administrator (as delegated
by the Attorney General) to follow
rulemaking procedures for other kinds
of scheduling actions, see 21 U.S.C.
811(a), it is noteworthy that, in section
811(h)(1), Congress authorized the
issuance of temporary scheduling
actions by order rather than by rule.
Even assuming that this notice of
intent is subject to section 553 of the
APA, the Administrator finds that there
is good cause to forgo its notice-andcomment requirements, as any further
delays in the process for issuing
temporary scheduling orders would be
impracticable and contrary to the public
interest given the manifest urgency to
avoid an imminent hazard to the public
safety.
Although DEA believes this notice of
intent to issue a temporary scheduling
order is not subject to the notice-andcomment requirements of section 553 of
the APA, DEA notes that in accordance
with 21 U.S.C. 811(h)(4), the
Administrator took into consideration
comments submitted by the Assistant
Secretary in response to the notices that
DEA transmitted to the Assistant
Secretary pursuant to such subsection.
16:52 Sep 16, 2024
27 21
U.S.C. 811(h)(1).
28 5 U.S.C. 551(6).
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Further, DEA believes that this
temporary scheduling action is not a
‘‘rule’’ as defined by 5 U.S.C. 601(2),
and, accordingly, is not subject to the
requirements of the Regulatory
Flexibility Act (RFA). The requirements
for the preparation of an initial
regulatory flexibility analysis in 5 U.S.C.
603(a) are not applicable where, as here,
DEA is not required by section 553 of
the APA or any other law to publish a
general notice of proposed rulemaking.
As discussed above, DEA is issuing this
notice of intent pursuant to DEA’s
authority to issue a temporary
scheduling order. 21 U.S.C. 811(h)(1).
Therefore, in this instance, since DEA
believes this temporary scheduling
action is not a ‘‘rule,’’ it is not subject
to the requirements of the RFA when
issuing this temporary action.
In accordance with the principles of
Executive Orders (E.O.) 12866 and
13563, this action is not a significant
regulatory action. E.O. 12866 directs
agencies to assess all costs and benefits
of available regulatory alternatives and,
if regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health,
and safety effects; distributive impacts;
and equity). E.O. 13563 is supplemental
to and reaffirms the principles,
structures, and definitions governing
regulatory review as established in E.O.
12866. E.O. 12866, sec. 3(f), as amended
by E.O. 14094, sec. 1(b), provides the
definition of a ‘‘significant regulatory
action,’’ requiring review by the Office
of Management and Budget. Because
this is not a rulemaking action, this is
not a significant regulatory action as
defined in section 3(f) of E.O. 12866.
This action will not have substantial
direct effects on the States, on the
relationship between the National
Government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Therefore, in
accordance with E.O. 13132, it is
determined that this action does not
have sufficient federalism implications
to warrant the preparation of a
Federalism Assessment.
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:
24 21
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Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Proposed Rules
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
Authority: 21 U.S.C. 811, 812, 871(b),
956(b), unless otherwise noted.
1. The authority citation for part 1308
continues to read as follows:
■
■
2. In § 1308.11, add paragraphs (h)(70)
and (71) to read as follows:
§ 1308.11
*
Schedule I
*
*
(h) * * *
*
*
*
*
*
*
*
*
*
(70) 2-(4-methoxybenzyl)-5-nitro-1-(2-(pyrrolidin-1-yl)ethyl)-1H-benzimidazole, its isomers, esters, ethers, salts, and salts of isomers,
esters and ethers (Other names: N-pyrrolidino metonitazene; metonitazepyne) ........................................................................................
(71) 5-nitro-2-(4-propoxybenzyl)-1-(2-(pyrrolidin-1-yl)ethyl)-1H-benzimidazole, its isomers, esters, ethers, salts, and salts of isomers,
esters and ethers (Other names: N-pyrrolidino protonitazene; protonitazepyne) .......................................................................................
Signing Authority
This document of the Drug
Enforcement Administration was signed
on September 11, 2024, 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.
Heather Achbach,
Federal Register Liaison Officer, Drug
Enforcement Administration.
BILLING CODE 4410–09–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[REG–102161–23]
RIN 1545–BQ89
Identification of Basket Contract
Transactions as Listed Transactions;
Hearing Cancellation
Internal Revenue Service (IRS),
Treasury.
ACTION: Cancellation of a notice of
public hearing on a proposed
rulemaking and notice of public
hearing.
ddrumheller on DSK120RN23PROD with PROPOSALS1
AGENCY:
This document cancels a
public hearing on proposed regulations
that would identify transactions that are
the same as, or substantially similar to,
certain basket contract transactions as
listed transactions, a type of reportable
transaction.
SUMMARY:
16:52 Sep 16, 2024
DEPARTMENT OF THE TREASURY
Public comments submitted
for the proposed rule can be viewed
electronically via the Federal
eRulemaking Portal at https://
www.regulations.gov by searching REG–
102161–23. The public hearing
scheduled to be held in the Auditorium
at the Internal Revenue Building, 1111
Constitution Avenue NW, Washington,
DC is cancelled.
26 CFR Part 1
Jkt 262001
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Oluwafunmilayo Taylor, Section Chief,
the Publications and Regulations
Section at (202) 317–6901 (not a toll-free
number).
A notice
of proposed rulemaking and a notice of
public hearing that appeared in the
Federal Register on July 12, 2024 (89 FR
57111), announced that a public hearing
being held in person and by
teleconference was scheduled for
September 26, 2024, at 10 a.m. ET. The
subject of the public hearing is under 26
CFR part 1.
The public comment period for these
regulations expired on September 10,
2024. The notice of proposed
rulemaking and notice of public hearing
instructed those interested in testifying
at the public hearing to submit a request
to testify and an outline of the topics to
be addressed. We did not receive a
request to testify at the Public Hearing.
Therefore, the public hearing scheduled
for September 26, 2024, at 10 a.m. ET
is cancelled.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2024–21058 Filed 9–16–24; 8:45 am]
VerDate Sep<11>2014
The public hearing scheduled for
September 26, 2024, at 10 a.m. ET is
cancelled.
DATES:
Kalle L. Wardlow,
Federal Register Liaison, Publications and
Regulations, Associate Chief Counsel,
(Procedure & Administration).
[FR Doc. 2024–21039 Filed 9–16–24; 8:45 am]
BILLING CODE 4830–01–P
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9762
9763
Internal Revenue Service
[REG–116787–23]
RIN 1545–BR31
Definition of the Term ‘‘Coverage
Month’’ for Computing the Premium
Tax Credit
Internal Revenue Service (IRS),
Treasury.
ACTION: Notice of proposed rulemaking
and public hearing.
AGENCY:
This document contains
proposed regulations that would amend
the definition of ‘‘coverage month’’ and
amend certain other rules in existing
income tax regulations regarding the
computation of an individual taxpayer’s
premium tax credit (PTC). The proposed
coverage month amendment generally
would provide that, in computing a
PTC, a month may be a coverage month
for an individual if the amount of the
premium paid, including by advance
payments of the PTC (APTC), for the
month for the individual’s coverage is
sufficient to avoid termination of the
individual’s coverage for that month.
The proposal also would amend the
existing regulations relating to the
amount of enrollment premiums used in
computing the taxpayer’s monthly PTC
if a portion of the monthly enrollment
premium for a coverage month is
unpaid. Finally, the proposed
regulations would clarify when an
individual is considered to be ineligible
for coverage under a State’s Basic Health
Program (BHP). The proposed
regulations would affect taxpayers who
enroll themselves, or enroll a family
member, in individual health insurance
coverage through a Health Insurance
Exchange (Exchange) and may be
allowed a PTC for the coverage. This
document also provides a notice of a
public hearing on these proposed
regulations.
SUMMARY:
E:\FR\FM\17SEP1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 180 (Tuesday, September 17, 2024)]
[Proposed Rules]
[Pages 75979-75984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21058]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1337]
Schedules of Controlled Substances: Temporary Placement of N-
Pyrrolidino Metonitazene and N-Pyrrolidino Protonitazene in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Proposed amendment; notice of intent.
-----------------------------------------------------------------------
[[Page 75980]]
SUMMARY: The Administrator of the Drug Enforcement Administration is
issuing this notice of intent to publish a temporary order to schedule
two synthetic benzimidazole-opioid substances, N-pyrrolidino
metonitazene and N-pyrrolidino protonitazene, including their isomers,
esters, ethers, salts, and salts of isomers, esters, and ethers
whenever the existence of such isomers, esters, ethers, and salts is
possible, in schedule I of the Controlled Substances Act. When it is
issued, the temporary scheduling order will impose the regulatory
controls and administrative, civil, and criminal sanctions applicable
to schedule I controlled substances on persons who handle (manufacture,
distribute, reverse distribute, import, export, engage in research,
conduct instructional activities or chemical analysis, or possess) or
propose to handle these two specified substances.
DATES: This notice of intent is effective September 17, 2024.
FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control Division, Drug Enforcement
Administration; Mailing Address: 8701 Morrissette Drive, Springfield,
Virginia 22152; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION: The notice of intent contained in this
document is issued pursuant to the temporary scheduling provisions of
21 U.S.C. 811(h). The Drug Enforcement Administration (DEA) intends to
issue a temporary scheduling order \1\ (in the form of a temporary
amendment) to add the two synthetic benzimidazole-opioid substances,
including their isomers, esters, ethers, salts, and salts of isomers,
esters, and ethers whenever the existence of such isomers, esters,
ethers, and salts is possible, to schedule I under the Controlled
Substances Act (CSA):
---------------------------------------------------------------------------
\1\ Though DEA has used the term ``final order'' with respect to
temporary scheduling orders in the past, this notice of intent
adheres to the statutory language of 21 U.S.C. 811(h), which refers
to a ``temporary scheduling order.'' No substantive change is
intended.
---------------------------------------------------------------------------
2-(4-methoxybenzyl)-5-nitro-1-(2-(pyrrolidin-1-yl)ethyl)-
1H-benzimidazole (commonly known as, N-pyrrolidino metonitazene or
metonitazepyne), and
5-nitro-2-(4-propoxybenzyl)-1-(2-(pyrrolidin-1-yl)ethyl)-
1H-benzimidazole (commonly known as, N-pyrrolidino protonitazene or
protonitazepyne).
The temporary scheduling order will be published in the Federal
Register on or after October 17, 2024.
Legal Authority
Under 21 U.S.C. 811(h)(1), the CSA provides the Attorney General
(as delegated to the Administrator of DEA (Administrator) pursuant to
28 CFR 0.100) has the authority to temporarily place a substance in
schedule I of the CSA for two years without regard to the evaluation
requirements of 21 U.S.C. 811(b), if he finds that such action is
necessary to avoid an imminent hazard to the public safety.\2\ In
addition, if proceedings to control a substance are initiated under 21
U.S.C. 811(a)(1) while the substance is temporarily controlled under
section 811(h), the Attorney General may extend the temporary
scheduling for up to one year.\3\
---------------------------------------------------------------------------
\2\ 21 U.S.C. 811(h)(1).
\3\ 21 U.S.C. 811(h)(2).
---------------------------------------------------------------------------
Where the necessary findings are made, a substance may be
temporarily scheduled if it is not listed in any other schedule under
21 U.S.C. 812, or if there is no exemption or approval in effect for
the substance under section 505 of the Federal Food, Drug, and Cosmetic
Act, 21 U.S.C. 355.\4\
---------------------------------------------------------------------------
\4\ 21 U.S.C. 811(h)(1); 21 CFR part 1308.
---------------------------------------------------------------------------
Background
The CSA requires the Administrator to notify the Secretary of the
Department of Health and Human Services (HHS) of an intent to
temporarily place a substance in schedule I of the CSA (i.e., to issue
a temporary scheduling order).\5\ By letter dated December 15, 2023,
the Administrator transmitted the required notice to place N-
pyrrolidino metonitazene and N-pyrrolidino protonitazene in schedule I
on a temporary basis to the Assistant Secretary for Health of HHS
(Assistant Secretary).\6\ On December 22, 2023, the Assistant Secretary
responded to this notice and advised DEA that based on a review by the
Food and Drug Administration (FDA), there are currently no
investigational new drug applications (IND) or approved new drug
applications (NDA) for N-pyrrolidino metonitazene or N-pyrrolidino
protonitazene. The Assistant Secretary also stated that HHS had no
objection to the temporary placement of these substances in schedule I
of the CSA. N-Pyrrolidino metonitazene and N-pyrrolidino protonitazene
currently are not listed in any schedule under the CSA, and no
exemptions or approvals under 21 U.S.C. 355 are in effect for these
substances.
---------------------------------------------------------------------------
\5\ 21 U.S.C. 811(h)(4).
\6\ The Secretary of HHS has delegated to the Assistant
Secretary for Health of HHS the authority to make domestic drug
scheduling recommendations. 58 FR 35460 (July 1, 1993).
---------------------------------------------------------------------------
To find that temporarily placing a substance in schedule I of the
CSA is necessary to avoid an imminent hazard to the public safety, the
Administrator must consider three of the eight factors set forth in 21
U.S.C. 811(c): the substance's history and current pattern of abuse;
the scope, duration, and significance of abuse; and what, if any, risk
there is to the public health.\7\ This consideration includes any
information indicating actual abuse, diversion from legitimate
channels, and clandestine importation, manufacture, or distribution of
N-Pyrrolidino metonitazene and N-pyrrolidino protonitazene.\8\
---------------------------------------------------------------------------
\7\ 21 U.S.C. 811(h)(3).
\8\ 21 U.S.C. 811(h)(3).
---------------------------------------------------------------------------
Substances meeting the statutory requirements for temporary
scheduling may only be placed in schedule I.\9\ Substances in schedule
I have high potential for abuse, no currently accepted medical use in
treatment in the United States,\10\ and a lack of accepted
[[Page 75981]]
safety for use under medical supervision.\11\
---------------------------------------------------------------------------
\9\ 21 U.S.C. 811(h)(1).
\10\ When finding schedule I placement on a temporary basis is
necessary to avoid imminent hazard to the public, 21 U.S.C. 811(h)
does not require DEA to consider whether the substance has a
currently accepted medical use in treatment in the United States.
Nonetheless, there is no evidence suggesting that N-pyrrolidino
metonitazene or N-pyrrolidino protonitazene have a currently
accepted medical use in treatment in the United States. To determine
whether a drug or other substance has a currently accepted medical
use, DEA has traditionally applied a five-part test to a drug or
substance that has not been approved by the FDA: 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.
See 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 and HHS applied the traditional five-part test for
currently accepted medical use in this matter. 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). For purposes of this notice of intent, there is no
evidence that health care providers have widespread experience with
medical use of N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene or that the use of N-pyrrolidino metonitazene or N-
pyrrolidino protonitazene is recognized by entities that regulate
the practice of medicine under either the traditional five-part test
or the two-part test.
\11\ 21 U.S.C. 812(b)(1).
---------------------------------------------------------------------------
Two Benzimidazole-Opioids: N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene
The continued encounter of novel synthetic opioids on the
recreational drug market poses a threat to public safety. Beginning in
2019, a new class of synthetic opioids known as benzimidazole-opioids,
commonly referred to as ``nitazenes,'' emerged on the recreational drug
market. This class of substances has a similar pharmacological profile
to fentanyl, morphine, and other mu-opioid receptor agonists. Between
August 2020 and March 2024, DEA temporarily controlled ten
benzimidazole-opioids because they posed a threat to public safety.\12\
N-Pyrrolidino metonitazene and N-pyrrolidino protonitazene are some of
the recently encountered ``nitazene'' synthetic opioids identified on
the illicit drug market.
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\12\ Schedules of Controlled Substances: Temporary Placement of
Butonitazene, Etodesnitazene, Flunitazene, Metodesnitazene,
Metonitazene, N-Pyrrolidino etonitazene, and Protonitazene in
Schedule I, 87 FR 21556 (Apr. 12, 2022); Schedules of Controlled
Substances: Temporary Placement of Isotonitazene in Schedule I, 85
FR 51342 (Aug. 20, 2020); Schedules of Controlled Substances:
Temporary Placement of N-Desethyl Isotonitazene and N-Piperidinyl
Etonitazene in Schedule I, 89 FR 60817 (Jul. 29, 2024).
---------------------------------------------------------------------------
The continued trafficking and identification of benzimidazole-
opioids in toxicology cases poses a significant threat to public health
and safety. Adverse health effects associated with the misuse and abuse
of synthetic opioids have led to devastating consequences including
death. Preclinical pharmacology data demonstrate that N-pyrrolidino
metonitazene and N-pyrrolidino protonitazene have pharmacological
profiles similar to those of the potent benzimidazole-opioids
metonitazene and protonitazene, schedule I opioid substances. N-
Pyrrolidino metonitazene and N-pyrrolidino protonitazene have been
positively identified in at least 26 toxicology cases. As the United
States continues to experience a high number of opioid-involved
overdoses and mortalities, the introduction of new designer opioids
further exacerbates the current opioid epidemic.
Available data and information for N-pyrrolidino metonitazene and
N-pyrrolidino protonitazene, summarized below, indicate that these
substances have high potentials for abuse, no currently accepted
medical uses in treatment in the United States, and a lack of accepted
safety for use under medical supervision. DEA's three-factor analysis
is available in its entirety under ``Supporting and Related Material''
of the public docket for this action at www.regulations.gov under
Docket Number DEA-1337.
Factor 4. History and Current Pattern of Abuse
Since 2019, there has been an emergence of benzimidazole-opioid
compounds on the illicit drug market, which have been positively
identified in numerous cases of fatal overdose events. The
benzimidazole-opioids were originally synthesized and studied in the
1950s by the pharmaceutical research laboratories of the Swiss chemical
company Chemical Industries Basel. The research produced a group of
structurally unique benzimidazole derivatives with analgesic
properties; however, the research effort did not produce any medically
approved analgesic products. These benzimidazole derivatives include
schedule I substances, such as synthetic opioids clonitazene,
etonitazene, and isotonitazene.
In August 2020, isotonitazene was placed in schedule I of the CSA
(85 FR 51342). Subsequently, nine additional benzimidazole-opioids \13\
have been placed in schedule I of the CSA (87 FR 21556 and 89 FR
60817). Recently, N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene have emerged on the illicit drug market. Law enforcement
officers have encountered N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene in several solid forms (e.g., powder and tablets). These
substances are not approved pharmaceutical products and are not
approved for medical use anywhere in the world. The Assistant Secretary
in a letter to DEA dated December 22, 2023, stated that there are no
FDA-approved NDAs or IND applications for N-pyrrolidino metonitazene
and N-pyrrolidino protonitazene in the United States; hence, there are
no legitimate channels for these substances as marketed drug products.
---------------------------------------------------------------------------
\13\ Butonitazene, etodesnitazene, flunitazene, metodesnitazene,
metonitazene, N-pyrrolidino etonitazene, and protonitazene (87 FR
21556, Apr. 12, 2022). N-desethyl isotonitazene and N-piperidinyl
etonitazene (89 FR 60817, Jul. 29 2024).
---------------------------------------------------------------------------
The appearance of benzimidazole-opioids on the illicit drug market
is similar to other designer opioid drugs that are trafficked for their
psychoactive effects. These substances are likely to be abused in the
same manner as schedule I opioids, such as etonitazene, isotonitazene,
and heroin. In 2023, N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene emerged on the illicit synthetic drug market as evidenced
by their identification in forensic drug seizures and in biological
samples.\14\ Based on NFLIS-Drug data, law enforcement encounters of N-
pyrrolidino metonitazene and N-pyrrolidino protonitazene were found in
combination with other substances of abuse such as heroin, designer
benzodiazepines, cocaine, fentanyl, methamphetamine, and xylazine.
---------------------------------------------------------------------------
\14\ NMS Labs, in collaboration with the Center for Forensic
Science Research and Education at the Fredric Rieders Family
Foundation and the Organized Crime Drug Enforcement Task Force at
the United States Department of Justice, has received funding from
the Centers for Disease Control and Prevention to develop systems
for the early identification and notification of novel psychoactive
substances in the drug supply within the United States.
---------------------------------------------------------------------------
Factor 5. Scope, Duration and Significance of Abuse
N-Pyrrolidino metonitazene and N-pyrrolidino protonitazene, similar
to etonitazene, metonitazene and protonitazene (schedule I substances),
have been described as potent synthetic opioids, and evidence suggests
they are abused for their opioidergic effects (see Factor 6). The abuse
of these benzimidazole-opioids, similar to other synthetic opioids, has
resulted in serious adverse health effects. According to a public alert
report \15\ published in August 2023, N-pyrrolidino protonitazene has
been positively confirmed in 20 medicolegal death investigation cases
in the United States (n =16) and United Kingdom (n = 4). The cases that
occurred in the United States originated from seven States including
California, Illinois, Maine, Massachusetts, Minnesota, Wisconsin, and
Wyoming. N-Pyrrolidino metonitazene has been identified in six
toxicology cases as of June 2023 in the United States. The cases
occurred in at least three States including Ohio, Illinois, and West
Virginia.\16\
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\15\ Krotulski, AJ; Walton, SE; Papsun, DM; DeBord, J; Fogarty,
MF; Logan, BK. (2023) New Nitazene Analogue N-Pyrrolidino
Protonitazene Impacting Drug Markets In North America and Europe,
Center for Forensic Science Research and Education, United States.
CSFRE Public Alert. August 2023.
\16\ Krotulski, AJ; Horton, KB; Walton, SE; Papsun, DM; DeBord,
J; Fogarty, MF; Logan, BK. (2023) N-Pyrrolidino Metonitazene--NPS
Discovery New Drug Monograph, Center for Forensic Science Research
and Education, United States.
---------------------------------------------------------------------------
Data from law enforcement suggest that N-pyrrolidino metonitazene
and N-
[[Page 75982]]
pyrrolidino protonitazene are being abused in the United States as
recreational drugs.\17\ Since 2023, there have been 37 exhibits
reported to the NFLIS-Drug (Federal, State and local laboratories)
database pertaining to the trafficking, distribution, and abuse of
these substances. There were seven encounters of N-pyrrolidino
metonitazene from two States in NFLIS-Drug: Missouri (n = 2) and Ohio
(n = 5). N-Pyrrolidino protonitazene has been identified in 30 exhibits
in NFLIS-Drug from five States: Florida (n = 4), Iowa (n = 10),
Missouri (n = 1), Ohio (n = 13), and Texas (n = 2).\18\
---------------------------------------------------------------------------
\17\ While law enforcement data are not direct evidence of
abuse, they can lead to an inference that a drug has been diverted
and abused. See 76 FR 77330, 77332 (Dec. 12, 2011).
\18\ NFLIS-Drug was queried on July 17, 2024.
---------------------------------------------------------------------------
Because abusers of N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene are likely to obtain these substances through unregulated
sources, the identity, purity, and quantity of these substances 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.\19\ Individuals who initiate
(i.e., use a drug for the first time) use of these benzimidazole-
opioids are likely to be at risk of developing substance use disorder,
an overdose event, or death, similar to that of other opioid analgesics
(e.g., fentanyl, morphine, etc.). Law enforcement and toxicology
reports demonstrate that N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene are being illicitly distributed and abused.
---------------------------------------------------------------------------
\19\ Jones CM, Logan J, Gladden RM, Bohm MK. Vital Signs:
Demographic and Substance Use Trends Among Heroin Users--United
States, 2002-2013. MMWR Morb Mortal Wkly Rep. 2015 Jul
10;64(26):719-25.
---------------------------------------------------------------------------
Factor 6. What, if Any, Risk There Is to the Public Health
The increase in opioid overdose deaths in the United States has
been exacerbated recently by the availability of potent synthetic
opioids on the illicit drug market. Data obtained from pre-clinical
studies demonstrate that N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene exhibit pharmacological profiles similar to that of
etonitazene, metonitazene, protonitazene, and other mu-opioid receptor
agonists. These two benzimidazole-opioids bind to and act as agonists
at the mu-opioid receptors.\20\ It is well established that substances
that act as mu-opioid receptor agonists have a high potential for
addiction and can induce dose-dependent respiratory depression.\21\
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\20\ DEA-VA Interagency Agreement. ``In Vitro Receptor and
Transporter Assays for Abuse Liability Testing for the DEA by the
VA''. Binding and Functional Activity at Delta, Kappa and Mu Opioid
Receptors. 2022.
\21\ Fox LM, Hoffman RS, Vlahov D, Manini AF. Risk factors for
severe respiratory depression from prescription opioid overdose.
Addiction. 2018 Jan;113(1):59-66.
---------------------------------------------------------------------------
Consistent with any mu-opioid receptor agonist, the potential
health and safety risks for users of N-pyrrolidino metonitazene and N-
pyrrolidino protonitazene are high. N-Pyrrolidino metonitazene and N-
pyrrolidino protonitazene have been positively identified in forensic
toxicology and post mortem cases. According to a public alert, N-
pyrrolidino protonitazene has been positively identified in 20
medicolegal death investigations in the United States and United
Kingdom as of August 2023. Of the cases, 16 occurred across seven
States in the United States. Decedent ages ranged from mid-20s to mid-
70s. N-Pyrrolidino protonitazene was co-identified with additional
novel psychoactive substances (70 percent), quinine (60 percent), other
benzimidazole-opioids (55 percent), methamphetamine/cocaine (55
percent), fentanyl (55 percent), xylazine (35 percent) and designer
benzodiazepines (30 percent).\22\ Also, N-pyrrolidino metonitazene has
been identified in six toxicology cases in the United States as of June
2023. The introduction of potent synthetic opioids such as N-
pyrrolidino metonitazene and N-pyrrolidino protonitazene into the
illicit market may serve as a portal to problematic opioid use for
those seeking these powerful opioids. As documented by toxicology
reports, polysubstance abuse remains common in fatalities associated
with the abuse of some of these benzimidazole-opioids.
---------------------------------------------------------------------------
\22\ Krotulski, AJ; Walton, SE; Papsun, DM; DeBord, J; Fogarty,
MF; Logan, BK. (2023) New Nitazene Analogue N-Pyrrolidino
Protonitazene Impacting Drug Markets In North America and Europe,
Center for Forensic Science Research and Education, United States.
CSFRE Public Alert. August 2023.
---------------------------------------------------------------------------
The United States is currently experiencing an opioid epidemic, and
the presence of synthetic opioids on the illicit drug market further
exacerbates the problem. The trafficking and abuse of new synthetic
opioids are deadly trends which pose imminent hazard to the public
safety. Adverse health effects associated with the abuse of synthetic
opioids and the continued evolution and increased popularity of these
substances have been a serious concern in recent years. Because of the
pharmacological similarities of N-pyrrolidino metonitazene and N-
pyrrolidino protonitazene to metonitazene and protonitazene, the use of
these substances presents high risk of abuse and may negatively affect
users and communities. The positive identification of these substances
in toxicology cases is of serious concern to the public safety. Thus,
N-pyrrolidino metonitazene and N-pyrrolidino protonitazene pose
imminent hazard to public safety.
Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard
to Public Safety
In accordance with 21 U.S.C. 811(h)(3), based on the available data
and information summarized above, the uncontrolled manufacture,
distribution, reverse distribution, importation, exportation, conduct
of research and chemical analysis, possession, and abuse of N-
pyrrolidino metonitazene and N-pyrrolidino protonitazene pose imminent
hazards to public safety. DEA is not aware of any currently accepted
medical uses for these substances in the United States. A substance
meeting the statutory requirements for temporary scheduling, found in
21 U.S.C. 811(h)(1), may only be placed in schedule I. Substances in
schedule I must have a high potential for abuse, no currently accepted
medical use in treatment in the United States, and a lack of accepted
safety for use under medical supervision. Available data and
information for N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene indicate that these substances meet the three statutory
criteria. As required by 21 U.S.C. 811(h)(4), the Administrator
transmitted to the Assistant Secretary, via letter dated December 15,
2023, notice of her intent to place N-pyrrolidino metonitazene and N-
pyrrolidino protonitazene in schedule I on a temporary basis. HHS had
no objection to the temporary placement of these substances in schedule
I.
Conclusion
This notice of intent provides the 30-day notice pursuant to 21
U.S.C. 811(h)(1) of DEA's intent to issue a temporary scheduling order.
In accordance with 21 U.S.C. 811(h)(1) and (3), the Administrator
considered available data and information, herein set forth the grounds
for her determination that it is necessary to temporarily schedule N-
pyrrolidino metonitazene and N-pyrrolidino protonitazene in schedule I
of the CSA, and finds that placement of these substances in schedule I
is necessary to avoid an imminent hazard to the public safety.
[[Page 75983]]
The temporary placement of N-pyrrolidino metonitazene and N-
pyrrolidino protonitazene in schedule I of the CSA will take effect
pursuant to a temporary scheduling order, which will not be issued
before October 17, 2024. Because the Administrator hereby finds this
temporary scheduling order necessary to avoid an imminent hazard to the
public safety, it will take effect on the date the order is published
in the Federal Register and remain in effect for two years, with a
possible extension of one year, pending completion of the regular
(permanent) scheduling process.\23\ The Administrator intends to issue
a temporary scheduling order as soon as possible after the expiration
of 30 days from the date of publication of this document. Upon the
temporary order's publication, N-pyrrolidino metonitazene and N-
pyrrolidino protonitazene will then be subject to the CSA's schedule I
regulatory controls and to administrative, civil, and criminal
sanctions applicable to their manufacture, distribution, reverse
distribution, importation, exportation, research, conduct of
instructional activities and chemical analysis, and possession.
---------------------------------------------------------------------------
\23\ 21 U.S.C. 811(h)(1) and (2).
---------------------------------------------------------------------------
The CSA sets forth specific criteria for scheduling drugs or other
substances. Regular scheduling actions in accordance with 21 U.S.C.
811(a) are subject to formal rulemaking procedures ``on the record
after opportunity for a hearing'' conducted pursuant to the provisions
of 5 U.S.C. 556 and 557.\24\ The regular scheduling process of formal
rulemaking affords interested parties appropriate process and the
government any additional relevant information needed to make a
determination. Final decisions that conclude the regular scheduling
process of formal rulemaking are subject to judicial review.\25\
Temporary scheduling orders are not subject to judicial review.\26\
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\24\ 21 U.S.C. 811.
\25\ 21 U.S.C. 877.
\26\ 21 U.S.C. 811(h)(6).
---------------------------------------------------------------------------
Regulatory Analyses
The CSA provides for expedited temporary scheduling actions where
necessary to avoid an imminent hazard to the public safety. Under 21
U.S.C. 811(h)(1), the Administrator, as delegated by the Attorney
General, may, by order, temporarily place substances in schedule I.
Such orders may not be issued before the expiration of 30 days from:
(1) The publication of a notice in the Federal Register of the intent
to issue such order and the grounds upon which such order is to be
issued, and (2) the date that notice of the proposed temporary
scheduling order is transmitted to the Assistant Secretary, as
delegated by the Secretary of HHS.\27\
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\27\ 21 U.S.C. 811(h)(1).
---------------------------------------------------------------------------
Inasmuch as section 811(h) directs that temporary scheduling
actions be issued by order and sets forth the procedures by which such
orders are to be issued, including the requirement to publish in the
Federal Register a notice of intent, the notice-and-comment
requirements of section 553 of the Administrative Procedure Act (APA),
5 U.S.C. 553, do not apply to this notice of intent. The APA expressly
differentiates between orders and rules, as it defines an ``order'' to
mean a ``final disposition, whether affirmative, negative, injunctive,
or declaratory in form, of an agency in a matter other than rule
making.'' \28\ (Emphasis added). This contrasts with permanent
scheduling actions, which are subject to formal rulemaking procedures
done ``on the record after opportunity for a hearing,'' and final
decisions that conclude the scheduling process and are subject to
judicial review. 21 U.S.C. 811(a) and 877. The specific language chosen
by Congress indicates its intent that DEA issue orders instead of
proceeding by rulemaking when temporarily scheduling substances. Given
that Congress specifically requires the Administrator (as delegated by
the Attorney General) to follow rulemaking procedures for other kinds
of scheduling actions, see 21 U.S.C. 811(a), it is noteworthy that, in
section 811(h)(1), Congress authorized the issuance of temporary
scheduling actions by order rather than by rule.
---------------------------------------------------------------------------
\28\ 5 U.S.C. 551(6).
---------------------------------------------------------------------------
Even assuming that this notice of intent is subject to section 553
of the APA, the Administrator finds that there is good cause to forgo
its notice-and-comment requirements, as any further delays in the
process for issuing temporary scheduling orders would be impracticable
and contrary to the public interest given the manifest urgency to avoid
an imminent hazard to the public safety.
Although DEA believes this notice of intent to issue a temporary
scheduling order is not subject to the notice-and-comment requirements
of section 553 of the APA, DEA notes that in accordance with 21 U.S.C.
811(h)(4), the Administrator took into consideration comments submitted
by the Assistant Secretary in response to the notices that DEA
transmitted to the Assistant Secretary pursuant to such subsection.
Further, DEA believes that this temporary scheduling action is not
a ``rule'' as defined by 5 U.S.C. 601(2), and, accordingly, is not
subject to the requirements of the Regulatory Flexibility Act (RFA).
The requirements for the preparation of an initial regulatory
flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as
here, DEA is not required by section 553 of the APA or any other law to
publish a general notice of proposed rulemaking. As discussed above,
DEA is issuing this notice of intent pursuant to DEA's authority to
issue a temporary scheduling order. 21 U.S.C. 811(h)(1). Therefore, in
this instance, since DEA believes this temporary scheduling action is
not a ``rule,'' it is not subject to the requirements of the RFA when
issuing this temporary action.
In accordance with the principles of Executive Orders (E.O.) 12866
and 13563, this action is not a significant regulatory action. E.O.
12866 directs agencies to assess all costs and benefits of available
regulatory alternatives and, if regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health, and safety effects;
distributive impacts; and equity). E.O. 13563 is supplemental to and
reaffirms the principles, structures, and definitions governing
regulatory review as established in E.O. 12866. E.O. 12866, sec. 3(f),
as amended by E.O. 14094, sec. 1(b), provides the definition of a
``significant regulatory action,'' requiring review by the Office of
Management and Budget. Because this is not a rulemaking action, this is
not a significant regulatory action as defined in section 3(f) of E.O.
12866.
This action will not have substantial direct effects on the States,
on the relationship between the National Government and the States, or
on the distribution of power and responsibilities among the various
levels of government. Therefore, in accordance with E.O. 13132, it is
determined that this action does not have sufficient federalism
implications to warrant the preparation of a Federalism Assessment.
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:
[[Page 75984]]
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for 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, add paragraphs (h)(70) and (71) to read as
follows:
Sec. 1308.11 Schedule I
* * * * *
(h) * * *
------------------------------------------------------------------------
------------------------------------------------------------------------
* * * * * * *
(70) 2-(4-methoxybenzyl)-5-nitro-1-(2-(pyrrolidin-1-yl)ethyl)- 9762
1H-benzimidazole, its isomers, esters, ethers, salts, and
salts of isomers, esters and ethers (Other names: N-
pyrrolidino metonitazene; metonitazepyne).....................
(71) 5-nitro-2-(4-propoxybenzyl)-1-(2-(pyrrolidin-1-yl)ethyl)- 9763
1H-benzimidazole, its isomers, esters, ethers, salts, and
salts of isomers, esters and ethers (Other names: N-
pyrrolidino protonitazene; protonitazepyne)...................
------------------------------------------------------------------------
Signing Authority
This document of the Drug Enforcement Administration was signed on
September 11, 2024, 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.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2024-21058 Filed 9-16-24; 8:45 am]
BILLING CODE 4410-09-P
