Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Proposed Rules 75979 

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 Yabora ̃ Indu ́ stria Aerona ́utica 

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 Yabora ̃

Indu ́ stria Aerona ́utica 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. 

(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, Ageˆncia Nacional de 

Aviac ̧a ̃o 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. 

(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 

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) Ageˆncia Nacional de Aviac ̧a ̃o 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—Sa ̃o 

Jose ́ 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 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Proposed amendment; notice of 

intent. 


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75980 Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Proposed Rules 

1Though 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 21 U.S.C. 811(h)(1). 

3 21 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). 

6The 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). 

7 21 U.S.C. 811(h)(3). 

8 21 U.S.C. 811(h)(3). 

9 21 U.S.C. 811(h)(1). 

10When 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 

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): 

• 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. 

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 

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 

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 


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Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Proposed Rules 75981 

widespread 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). 12Schedules 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). 

13Butonitazene, 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). 

14NMS 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. 

safety for use under medical 

supervision.11

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 Npyrrolidino 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 

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 NVerDate Sep<11>2014 16:52 Sep 16, 2024 Jkt 262001 PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 E:\FR\FM\17SEP1.SGM 17SEP1

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17While 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). 

18NFLIS-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. 

21Fox 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. 

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. 

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

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 Npyrrolidino 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. 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Proposed Rules 75983 

23 21 U.S.C. 811(h)(1) and (2). 

24 21 U.S.C. 811. 

25 21 U.S.C. 877. 

26 21 U.S.C. 811(h)(6). 

27 21 U.S.C. 811(h)(1). 

28 5 U.S.C. 551(6). 

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 

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. 

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: 


ddrumheller on DSK120RN23PROD with PROPOSALS1
75984 Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Proposed Rules 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 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. 

■ 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) ........................................................................................ 9762 

(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) ....................................................................................... 9763 

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 

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 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Cancellation of a notice of 

public hearing on a proposed 

rulemaking and notice of public 

hearing. 

SUMMARY: 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. 

DATES: The public hearing scheduled for 

September 26, 2024, at 10 a.m. ET is 

cancelled. 

ADDRESSES: 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. 

FOR FURTHER INFORMATION CONTACT: 

Oluwafunmilayo Taylor, Section Chief, 

the Publications and Regulations 

Section at (202) 317–6901 (not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: 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. 

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 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[REG–116787–23] 

RIN 1545–BR31 

Definition of the Term ‘‘Coverage 

Month’’ for Computing the Premium 

Tax Credit 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Notice of proposed rulemaking 

and public hearing. 

SUMMARY: 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. 


ddrumheller on DSK120RN23PROD with PROPOSALS1