65330 Federal Register / Vol. 88, No. 183 / Friday, September 22, 2023 / Proposed Rules 

(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, EASA AD 2023–0132. 

(h) Exceptions to EASA AD 2023–0132 

(1) Where EASA AD 2023–0132 refers to its 

effective date, this AD requires using the 

effective date of this AD. 

(2) Where paragraph (2) of EASA AD 2023– 

0132 specifies if ‘‘any crack is detected, 

before next flight, contact Airbus for 

approved instructions and, within the 

compliance time(s) specified in those 

instructions, accomplish those instructions 

accordingly,’’ this AD requires replacing 

those word with ‘‘if any cracking is detected, 

the cracking must be repaired before further 

flight using a method approved by the 

Manager, International Validation Branch, 

FAA; or EASA; or Airbus SAS’s EASA 

Design Organization Approval (DOA). If 

approved by the DOA, the approval must 

include the DOA-authorized signature.’’ 

(3) This AD does not adopt the ‘‘Remarks’’ 

section of EASA AD 2023–0132. 

(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 International Validation Branch, send 

it to the attention of the person 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 EASA; or Airbus SAS’s 

EASA Design Organization Approval (DOA). 

If approved by the DOA, the approval must 

include the DOA-authorized signature. 

(3) Required for Compliance (RC): Except 

as required by paragraph (i)(2) of this AD, if 

any service information contains procedures 

or tests that are identified as RC, those 

procedures and tests must be done to comply 

with this AD; any procedures or tests that are 

not identified as RC are recommended. Those 

procedures and tests that are not identified 

as RC may be deviated from using accepted 

methods in accordance with the operator’s 

maintenance or inspection program without 

obtaining approval of an AMOC, provided 

the procedures and tests identified as RC can 

be done and the airplane can be put back in 

an airworthy condition. Any substitutions or 

changes to procedures or tests identified as 

RC require approval of an AMOC. 

(j) Additional Information 

For more information about this AD, 

contact Dat Le, Aviation Safety Engineer, 

FAA, 1600 Stewart Avenue, Suite 410, 

Westbury, NY 11590; telephone: 516–228– 

7300; email: 9-avs-nyaco-cos@faa.gov. 

(k) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference 

(IBR) of the service information listed in this 

paragraph under 5 U.S.C. 552(a) and 1 CFR 

part 51. 

(2) You must use this service information 

as applicable to do the actions required by 

this AD, unless this AD specifies otherwise. 

(i) European Union Aviation Safety Agency 

(EASA) AD 2023–0132, dated July 3, 2023. 

(ii) [Reserved] 

(3) For EASA AD 2023–0132, contact 

EASA, Konrad-Adenauer-Ufer 3, 50668 

Cologne, Germany; telephone +49 221 8999 

000; email ADs@easa.europa.eu; website 

easa.europa.eu. You may find this EASA AD 

on the EASA website ad.easa.europa.eu. 

(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 that is 

incorporated by reference at the National 

Archives and Records Administration 

(NARA). For information on the availability 

of this material at NARA, email 

fr.inspection@nara.gov, or go to: 

www.archives.gov/federal-register/cfr/ibrlocations.html. 

Issued on September 15, 2023. 

Victor Wicklund, 

Deputy Director, Compliance & Airworthiness 

Division, Aircraft Certification Service. 

[FR Doc. 2023–20407 Filed 9–21–23; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–1142] 

Schedules of Controlled Substances: 

Placement of Ethylphenidate in 

Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Drug Enforcement 

Administration proposes placing the 

substance ethylphenidate (chemical 

name: ethyl 2-phenyl-2-(piperidin-2- 

yl)acetate), including its salts, isomers, 

and salts of isomers, in schedule I of the 

Controlled Substances Act. This action 

is being taken, in part, to enable the 

United States to meet its obligations 

under the 1971 Convention on 

Psychotropic Substances. If finalized, 

this action would 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 ethylphenidate. 

DATES: Comments must be submitted 

electronically or postmarked on or 

before November 21, 2023. 

Interested persons may file a request 

for a hearing or waiver of hearing 

pursuant to 21 CFR 1308.44 and in 

accordance with 21 CFR 1316.45 and/or 

1316.47, as applicable. Requests for a 

hearing and waivers of an opportunity 

for a hearing or to participate in a 

hearing, together with a written 

statement of position on the matters of 

fact and law asserted in the hearing, 

must be received on or before October 

23, 2023. 

ADDRESSES: Interested persons may file 

written comments on this proposal in 

accordance with 21 CFR 1308.43(g). The 

electronic Federal Docket Management 

System will not accept comments after 

11:59 p.m. Eastern Time on the last day 

of the comment period. To ensure 

proper handling of comments, please 

reference ‘‘Docket No. DEA–1142’’ on 

all electronic and written 

correspondence, including any 

attachments. 

• Electronic comments: The Drug 

Enforcement Administration (DEA) 

encourages commenters to submit 

comments electronically through the 

Federal eRulemaking Portal, which 

provides the ability to type short 

comments directly into the comment 

field on the web page or attach a file for 

lengthier comments. Please go to http:// 

www.regulations.gov and follow the 

online instructions at that site for 

submitting comments. Upon completion 

of your submission you will receive a 

Comment Tracking Number for your 

comment. Please be aware that 

submitted comments are not 

instantaneously available for public 

view on regulations.gov. If you have 

received a Comment Tracking Number, 

your comment has been successfully 

submitted and there is no need to 

resubmit the same comment. 

Commenters should be aware that the 

electronic Federal Docket Management 

System will not accept comments after 

11:59 p.m. Eastern Time on the last day 

of the comment period. 


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Federal Register / Vol. 88, No. 183 / Friday, September 22, 2023 / Proposed Rules 65331 

1 5 U.S.C. 551–559. 21 CFR 1308.41–1308.45; 21 

CFR part 1316, subpart D. 

2 21 CFR 1316.49. 

3 21 CFR 1308.44(b), 1316.53. 

4 21 U.S.C. 811(a). 

5As discussed in a memorandum of 

understanding entered into by the FDA and the 

National Institute on Drug Abuse (NIDA), FDA acts 

as the lead agency within HHS in carrying out the 

Secretary’s scheduling responsibilities under the 

CSA, with the concurrence of NIDA. 50 FR 9518 

(March 8, 1985). The Secretary has delegated to the 

Assistant Secretary for Health of HHS the authority 

to make domestic drug scheduling 

recommendations. 58 FR 35460 (July 1, 1993). 

• Paper comments: Paper comments 

that duplicate the electronic 

submissions are not necessary and are 

discouraged. Should you wish to mail a 

paper comment, in lieu of an electronic 

comment, it should be sent via regular 

or express mail to: Drug Enforcement 

Administration, Attn: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. 

• Hearing requests: All requests for a 

hearing and waivers of participation, 

together with a written statement of 

position on the matters of fact and law 

asserted in the hearing, must be sent to: 

Drug Enforcement Administration, Attn: 

Administrator, 8701 Morrissette Drive, 

Springfield, Virginia 22152. All requests 

for hearing and waivers of participation 

should also be sent to: (1) Drug 

Enforcement Administration, Attn: 

Hearing Clerk/OALJ, 8701 Morrissette 

Drive, Springfield, Virginia 22152; and 

(2) Drug Enforcement Administration, 

Attn: DEA Federal Register 

Representative/DPW, 8701 Morrissette 

Drive, Springfield, Virginia 22152. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Terrence L. Boos, Drug and Chemical 

Evaluation Section, Diversion Control 

Division, Drug Enforcement 

Administration; Telephone: (571) 362– 

3249. 

SUPPLEMENTARY INFORMATION: In this 

proposed rule, the Drug Enforcement 

Administration (DEA) intends to place 

ethyl 2-phenyl-2-(piperidin-2-yl)acetate 

(ethylphenidate) including its salts, 

isomers, and salts of isomers in 

schedule I of the Controlled Substances 

Act (CSA). 

Posting of Public Comments 

All comments received in response to 

this docket are considered part of the 

public record. DEA will make comments 

available, unless reasonable cause is 

given, for public inspection online at 

http://www.regulations.gov. Such 

information includes personal 

identifying information (such as your 

name, address, etc.) voluntarily 

submitted by the commenter. The 

Freedom of Information Act applies to 

all comments received. If you want to 

submit personal identifying information 

(such as your name, address, etc.) as 

part of your comment, but do not want 

DEA to make it publicly available, you 

must include the phrase ‘‘PERSONAL 

IDENTIFYING INFORMATION’’ in the 

first paragraph of your comment. You 

must also place all of the personal 

identifying information you do not want 

made publicly available in the first 

paragraph of your comment and identify 

what information you want redacted. 

If you want to submit confidential 

business information as part of your 

comment, but do not want it to be made 

publicly available, you must include the 

phrase ‘‘CONFIDENTIAL BUSINESS 

INFORMATION’’ in the first paragraph 

of your comment. You must also 

prominently identify the confidential 

business information to be redacted 

within the comment. 

DEA will make available publicly in 

redacted form comments containing 

personal identifying information or 

confidential business information 

identified as directed above. If a 

comment has so much confidential 

business information that DEA cannot 

effectively redact it, DEA may not make 

available publicly all or part of that 

comment. Comments posted to http://

www.regulations.gov may include any 

personal identifying information (such 

as name, address, and phone number) 

included in the text of your electronic 

submission that is not identified as 

confidential as directed above. 

An electronic copy of this document 

and supplemental information to this 

proposed rule are available at http://

www.regulations.gov for easy reference. 

Request for Hearing or Appearance; 

Waiver 

Pursuant to 21 U.S.C. 811(a), this 

action is a formal rulemaking ‘‘on the 

record after opportunity for a hearing.’’ 

Such proceedings are conducted 

pursuant to the provisions of the 

Administrative Procedure Act (APA).1

Interested persons, as defined in 21 CFR 

1300.01(b), may file requests for a 

hearing in conformity with the 

requirements of 21 CFR 1308.44(a) and 

1316.47(a), and such requests must: 

(1) state with particularity the interest 

of the person in the proceeding; 

(2) state with particularity the 

objections or issues concerning which 

the person desires to be heard; and 

(3) state briefly the position of the 

person with regarding to the objections 

or issues. 

Any interested person may file a 

waiver of an opportunity for a hearing 

or to participate in a hearing in 

conformity with the requirements of 21 

CFR 1308.44(c), together with a written 

statement of position on the matters of 

fact and law involved in any hearing.2

All requests for a hearing and waivers 

of participation, together with a written 

statement of position on the matters of 

fact and law involved in such hearing, 

must be sent to DEA using the address 

information provided above. The 

decision whether a hearing will be 

needed to address such matters of fact 

and law in the rulemaking will be made 

by the Administrator. If a hearing is 

needed, DEA will publish a notice of 

hearing on the proposed rulemaking in 

the Federal Register.3 Further, once the 

Administrator determines a hearing is 

needed to address such matters of fact 

and law in rulemaking, she will then 

designate an Administrative Law Judge 

(ALJ) to preside over the hearing. The 

ALJ’s functions shall only commence 

upon designation, as provided in 21 

CFR 1316.52. 

In accordance with 21 U.S.C. 811 and 

812, the purpose of a hearing would be 

to determine whether ethylphenidate 

meets the statutory criteria for 

placement in schedule I. 

Legal Authority 

The CSA provides that proceedings 

for the issuance, amendment, or repeal 

of the scheduling of any drug or other 

substance may be initiated by the 

Attorney General (delegated to the 

Administrator of DEA pursuant to 28 

CFR 0.100) on his own motion.4 This 

proposed action is supported by a 

recommendation from the Assistant 

Secretary for Health of the Department 

of Health and Human Services (HHS). 

In addition, the United States is a 

party to the 1971 United Nations 

Convention on Psychotropic Substances 

(1971 Convention), February 21, 1971, 

32 U.S.T. 543, 1019 U.N.T.S. 175, as 

amended. Procedures respecting 

changes in drug schedules under the 

1971 Convention are governed 

domestically by 21 U.S.C. 811(d)(2)–(4). 

When the United States receives 

notification of a scheduling decision 

pursuant to Article 2 of the 1971 

Convention indicating that a drug or 

other substance has been added to a 

schedule specified in the notification, 

the Secretary of HHS (Secretary),5 after 

consultation with the Attorney General, 

shall first determine whether existing 

legal controls under subchapter I of the 

Controlled Substances Act (CSA) and 

the Federal Food, Drug, and Cosmetic 

Act meet the requirements of the 

schedule specified in the notification 

with respect to the specific drug or 


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65332 Federal Register / Vol. 88, No. 183 / Friday, September 22, 2023 / Proposed Rules 

6 21 U.S.C. 811(d)(3). 

7Comprehensive Drug Abuse Prevention and 

Control Act of 1970, H.R. Rep. No. 91–1444, 91st 

Cong., Sess. 1 (1970); reprinted in 1970 

U.S.C.C.A.N. 4566, 4603. 

substance.6 In the event that the 

Secretary did not so consult with the 

Attorney General, and the Attorney 

General did not issue a temporary order, 

as provided under 21 U.S.C. 811(d)(4), 

the procedures for permanent 

scheduling set forth in 21 U.S.C. 811(a) 

and (b) control. Pursuant to 21 U.S.C. 

811(a)(1), the Attorney General (as 

delegated to the Administrator of DEA) 

may, by rule, add to such a schedule or 

transfer between such schedules any 

drug or other substance, if he finds that 

such drug or other substance has a 

potential for abuse, and makes with 

respect to such drug or other substance 

the findings prescribed by 21 U.S.C. 

812(b) for the schedule in which such 

drug or other substance is to be placed. 

Background 

Ethylphenidate is a central nervous 

system (CNS) stimulant and shares 

structural and pharmacological 

similarities with other schedule II 

stimulants such as methylphenidate. On 

April 21, 2017, the Secretary-General of 

the United Nations advised the 

Secretary of State of the United States 

that during its 60th session, on March 

16, 2017, the Commission on Narcotic 

Drugs voted to place ethyl 2-phenyl-2- 

(piperidin-2-yl)acetate (ethylphenidate) 

in Schedule II of the 1971 Convention 

(CND Dec/60/7). Because the procedures 

in 21 U.S.C. 811(d)(3) and (4) for 

consultation and issuance of a 

temporary order for ethylphenidate, 

discussed in the above legal authority 

section, were not followed, DEA is 

utilizing the procedures for permanent 

scheduling set forth in 21 U.S.C. 811(a) 

and (b) to control ethylphenidate. Such 

scheduling would satisfy the United 

States’ international obligations. 

Article 2, paragraph 7(b), of the 1971 

Convention sets forth the minimum 

requirements that the United States 

must meet when a substance has been 

added to Schedule II of the 1971 

Convention. Pursuant to the 1971 

Convention, the United States must 

require licenses for the manufacture, 

export and import, and distribution of 

ethylphenidate. This license 

requirement is accomplished by the 

CSA’s registration requirement as set 

forth in 21 U.S.C. 822, 823, 957, 958 and 

in ance with 21 CFR parts 1301 and 

1312. In addition, the United States 

must adhere to specific export and 

import provisions set forth in the 1971 

Convention. This requirement is 

accomplished by the CSA’s export and 

import provisions established in 21 

U.S.C. 952, 953, 957, 958 and in 

accordance with 21 CFR part 1312. 

Likewise, under Article 13, paragraphs 

1 and 2, of the 1971 Convention, a party 

to the 1971 Convention may notify 

through the UN Secretary-General 

another party that it prohibits the 

importation of a substance in Schedule 

II, III, or IV of the 1971 Convention. If 

such notice is presented to the United 

States, the United States shall take 

measures to ensure that the named 

substance is not exported to the 

notifying country. This requirement is 

also accomplished by the CSA’s export 

provisions mentioned above. Under 

Article 16, paragraph 4, of the 1971 

Convention, the United States is 

required to provide annual statistical 

reports to the International Narcotics 

Control Board (INCB). Using INCB Form 

P, the United States shall provide the 

following information: (1) in regard to 

each substance in Schedule I and II of 

the 1971 Convention, quantities 

manufactured in, exported to, and 

imported from each country or region as 

well as stocks held by manufacturers; 

(2) in regard to each substance in 

Schedule II and III of the 1971 

Convention, quantities used in the 

manufacture of exempt preparations; 

and (3) in regard to each substance in 

Schedule II–IV of the 1971 Convention, 

quantities used for the manufacture of 

non-psychotropic substances or 

products. Lastly, under Article 2 of the 

1971 Convention, the United States 

must adopt measures in accordance 

with Article 22 to address violations of 

any statutes or regulations that are 

adopted pursuant to its obligations 

under the 1971 Convention. Persons 

acting outside the legal framework 

established by the CSA are subject to 

administrative, civil, and/or criminal 

action; therefore, the United States 

complies with this provision. 

DEA notes that there are differences 

between the schedules of substances in 

the 1971 Convention and the CSA. The 

CSA has five schedules (schedules I–V) 

with specific criteria set forth for each 

schedule. Schedule I is the only 

possible schedule in which a drug or 

other substance may be placed if it has 

high potential for abuse and no 

currently accepted medical use in 

treatment in the United States. See 21 

U.S.C. 812(b). In contrast, the 1971 

Convention has four schedules 

(Schedules I–IV) but does not have 

specific criteria for each schedule. The 

1971 Convention simply defines its four 

schedules, in Article 1, to mean the 

correspondingly numbered lists of 

psychotropic substances annexed to the 

Convention, and altered in accordance 

with Article 2. 

Proposed Determination To Schedule 

Ethylphenidate 

On April 3, 2019, the Drug 

Enforcement Administration (DEA) 

requested that the Department of Health 

and Human Services (HHS) conduct a 

scientific and medical evaluation and 

provide a scheduling recommendation 

for ethylphenidate. On October 26, 

2020, HHS provided DEA a scientific 

and medical evaluation (dated August 

25, 2020) entitled ‘‘Basis for the 

recommendation to place 

ethylphenidate in schedule I of the 

Controlled Substances Act’’ and a 

scheduling recommendation. Pursuant 

to 21 U.S.C. 811(b), following 

consideration of the eight-factors and 

findings related to the substance’s abuse 

potential, legitimate medical use, safety, 

and dependence liability, HHS 

recommended that ethylphenidate be 

controlled in schedule I of the CSA 

under 21 U.S.C. 812(b). Upon receipt of 

the scientific and medical evaluation 

and scheduling recommendation from 

HHS, DEA reviewed the documents and 

all other relevant data and conducted its 

own eight-factor analysis in accordance 

with 21 U.S.C. 811(c). Included below is 

a brief summary of each factor as 

analyzed by HHS and DEA, and as 

considered by DEA in its proposed 

scheduling action. Please note that both 

DEA and HHS eight-factor analyses are 

available in their entirety under the tab 

‘‘Supporting Documents’’ of the public 

docket of this rulemaking action at 

http://www.regulations.gov, under 

docket number ‘‘DEA–1142.’’ 

1. The Drug’s Actual or Relative 

Potential for Abuse: The term ‘‘abuse’’ is 

not defined in the CSA. However, the 

legislative history of the CSA suggests 

that DEA consider the following criteria 

when determining whether a particular 

drug or substance has a potential for 

abuse: 7

(a) There is evidence that individuals 

are taking the drug or drugs containing 

such a substance in amounts sufficient 

to create a hazard to their health or to 

the safety of other individuals or to the 

community; or 

(b) There is significant diversion of 

the drug or drugs containing such a 

substance from legitimate drug 

channels; or 

(c) Individuals are taking the drug or 

drugs containing such a substance on 

their own initiative rather than on the 

basis of medical advice from a 

practitioner licensed by law to 


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Federal Register / Vol. 88, No. 183 / Friday, September 22, 2023 / Proposed Rules 65333 

8NFLIS represents an important resource in 

monitoring illicit drug trafficking, including the 

diversion of legally manufactured pharmaceuticals 

into illegal markets. NFLIS-Drug is a comprehensive 

information system that includes data from forensic 

laboratories that handle the nation’s drug analysis 

cases. NFLIS-Drug participation rate, defined as the 

percentage of the national drug caseload 

represented by laboratories that have joined NFLISDrug, is currently 98.5 percent. NFLIS-Drug 

includes drug chemistry results from completed 

analyses only. While NFLIS-Drug data is not direct 

evidence of abuse, it can lead to an inference that 

a drug has been diverted and abused. See 76 FR 

77330, 77332, December 12, 2011. NFLIS data were 

queried on January 20, 2023. 

administer such drugs in the course of 

his professional practice; or 

(d) The drug or drugs containing such 

a substance are new drugs so related in 

their action to a drug or drugs already 

listed as having a potential for abuse to 

make it likely that the drug will have the 

same potentiality for abuse as such 

drugs, thus making it reasonable to 

assume that there may be significant 

diversions from legitimate channels, 

significant use contrary to or without 

medical advice, or that it has a 

substantial capability of creating 

hazards to the health of the user or to 

the safety of the community. 

Both DEA and HHS eight-factor 

analyses found that ethylphenidate has 

abuse potential associated with its 

abilities to produce psychoactive effects 

that are similar to those produced by 

schedule II stimulants such as 

methylphenidate that have a high 

potential for abuse. In particular, the 

responses in humans to ethylphenidate 

are stimulant-like and include 

tachycardia, anxiety, hallucinations, 

impaired thinking, paranoia and 

hypertension. 

Ethylphenidate does not have an 

approved medical use in the United 

States. Thus, because this substance is 

not an approved drug product, a 

practitioner may not legally prescribe it, 

and it cannot be dispensed to an 

individual. DEA and HHS conclude that 

ethylphenidate is being abused for its 

psychoactive properties because it is 

being used without medical advice. 

Reports from the public health sector 

and law enforcement suggest that 

ethylphenidate is being abused and 

taken in amounts sufficient to create a 

hazard to an individual’s health. This 

hazard is evidenced by deaths 

associated with ethylphenidate use 

which represents a safety issue for those 

in the community. Further, 

ethylphenidate was first reported to the 

National Forensic Laboratory 

Information System (NFLIS-Drug) 8

database in 2013; a January 2023 query 

of this database for ethylphenidate 

reports indicated a total of 191 such 

reports through 2022 from 23 states by 

participating Federal, State, and local 

forensic laboratories. Consequently, the 

data indicate that ethylphenidate is 

being abused, and presents safety 

hazards to the health of individuals who 

consume it due to its stimulant 

properties, making it a hazard to the 

safety of the community. 

2. Scientific Evidence of the Drug’s 

Pharmacological Effects, if Known: As 

described by HHS, studies show that 

ethylphenidate produces 

pharmacological effects that are similar 

to those produced by methylphenidate, 

a schedule II substance. Similar to these 

schedule II substances, ethylphenidate 

binds to monoamine transporters for 

dopamine and norepinephrine and 

blocks the uptake of these 

neurotransmitters at their transporters. 

Functionally, ethylphenidate, similar to 

methylphenidate and cocaine, inhibits 

norepinephrine and dopamine uptake. 

The potency of ethylphenidate in 

inhibiting norepinephrine uptake is 

about 6.75-fold less than that of 

methylphenidate and 1.7-fold less than 

cocaine. With respect to behavioral data, 

according to HHS, while ethylphenidate 

is pharmacodynamically similar to 

methylphenidate, it is less potent than 

methylphenidate in the locomotor 

activity assay. Specifically, 

ethylphenidate is approximately 80% as 

effective as methylphenidate in 

producing locomotor effect. Self-reports 

by users of ethylphenidate demonstrate 

that the drug produces typical 

stimulant-like effects, including 

euphoria and psychological and 

psychomotor stimulation. Overall, these 

data indicate that ethylphenidate 

produces stimulant-like 

pharmacological effects and behaviors 

that are similar to those of schedule II 

substances methylphenidate and 

methamphetamine. 

3. The State of Current Scientific 

Knowledge Regarding the Drug or Other 

Substance: Ethylphenidate is 

structurally similar to the schedule II 

substance methylphenidate. As stated in 

the HHS review, ethylphenidate is 

chemically known as ethyl 2-phenyl-2- 

piperidin-2-ylacetate, (RS)-ethyl 2- 

phenyl-2-(piperidin-2-yl)acetate and dlethylphenidate. Another name for 

ethylphenidate is EPH. 

Ethylphenidate user reports suggest 

that following insufflation, the 

pharmacokinetics of the drug are 

relatively rapid, with the onset of effects 

occurring approximately 13 minutes 

after administration (with a range of 0 

to 35 minutes). Additionally, following 

oral ingestion, the mean onset of action 

is 23 minutes (ranging from 5 to 31 

minutes). According to published 

scientific literature, the mean duration 

of action of ethylphenidate is 

approximately 2 hours. 

As stated by HHS, there are no 

published clinical or nonclinical 

toxicology studies using ethylphenidate. 

Furthermore, the only evidence of the 

toxicological effects of ethylphenidate 

come from anecdotal user reports and 

fatal overdoses that implicated its role 

in a death. 

Neither DEA nor HHS is aware of any 

currently accepted medical use for 

ethylphenidate. According to HHS’s 

August 2020 scientific and medical 

evaluation and scheduling 

recommendation, the Food and Drug 

Administration (FDA) has not approved 

a marketing application for a drug 

product containing ethylphenidate for 

any therapeutic indication, nor is HHS 

aware of any reports of clinical studies 

or claims of an accepted medical use for 

ethylphenidate in the United States. 

Although there is no evidence to 

suggest ethylphenidate has a currently 

accepted medical use in treatment in the 

United States, it bears noting that a drug 

cannot be found to have such medical 

use unless DEA concludes that it 

satisfies a five-part test. Specifically, 

with respect to a drug that has not been 

approved by FDA, all of the following 

must be demonstrated: the drug’s 

chemistry is known and reproducible; 

there are adequate safety studies; there 

are adequate and well-controlled studies 

proving efficacy; the drug is accepted by 

qualified experts; and the scientific 

evidence is widely available. 57 FR 

10499 (1992), pet. for rev. denied, 

Alliance for Cannabis Therapeutics v. 

DEA, 15 F.3d 1131, 1135 (D.C. Cir. 

1994). Based on this analysis, 

ethylphenidate has no currently 

accepted medical use in the United 

States. Furthermore, DEA has not found 

any references regarding clinical testing 

of ethylphenidate in the scientific and 

medical literature. Taken together with 

HHS’s conclusion, DEA finds that there 

is no legitimate medical use for 

ethylphenidate in the United States. 

4. History and Current Pattern of 

Abuse: As described by DEA and HHS, 

ethylphenidate is a stimulant and is 

structurally and pharmacologically 

similar to the schedule II substance, 

methylphenidate. Ethylphenidate has 

been trafficked and abused in North 

America and Europe since its first report 

of abuse in 2011. In addition, 

ethylphenidate has been identified in 

law enforcement seizures in the United 

States since 2013 and has persisted 

through 2020 (There were no 

ethylphenidate-related NFLIS-Drug 

reports in 2021 and 2022). Thus, 

ethylphenidate abuse occurs worldwide. 


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5. Scope, Duration and Significance 

of Abuse: Forensic laboratories have 

confirmed the presence of 

ethylphenidate in drug exhibits received 

from State, local, and Federal law 

enforcement agencies. Law enforcement 

data show that ethylphenidate first 

appeared in the illicit drug market in 

2013 with 10 encounters. Overall, from 

2013 through 2022, NFLIS registered 

191 reports from Federal, State and local 

forensic laboratories identifying this 

substance in drug-related exhibits from 

23 states. Thus, ethylphenidate abuse is 

wide-spread. 

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

Public Health: Based on the review of 

both HHS and DEA, public health risks 

of ethylphenidate result from its ability 

to induce stimulant-like responses, 

which may lead to adverse events that 

include psychological and cognitive 

impairment. Furthermore, risk to the 

public health is associated with adverse 

reactions in humans, which include 

hallucinations, impaired thinking, and 

paranoia. Nineteen deaths in the United 

Kingdom involving ethylphenidate have 

occurred between July 2013 and 

December 2014. A majority of these 

deaths involved males from East of 

Scotland with a history of current or 

previous heroin abuse. Additionally, 

according to the 2016 WHO Critical 

Review, these cases were almost 

exclusively associated with poly-drug 

use, with benzodiazepines, methadone, 

and other opioids being the most 

commonly detected drugs. Thus, the 

public health risks associated with 

ethylphenidate are confirmed by the 

pharmacological profile along with the 

fatalities associated with ethylphenidate 

use. 

7. Its Psychic or Physiological 

Dependence Liability: According to 

HHS, the psychic or physiological 

dependence liability of ethylphenidate 

can be inferred based on case reports 

and from data on substances that have 

similar pharmacological actions. As 

noted by HHS, scientific literature of 

published case reports demonstrate the 

propensity of ethylphenidate re-dosing 

by its users. Furthermore, according to 

self-reports users of ethylphenidate 

typically experience stimulant-like 

behavioral effects. In addition, DEA 

notes that because ethylphenidate 

shares pharmacological properties with 

schedule II stimulant substances such as 

methylphenidate and 

methamphetamine, ethylphenidate 

likely has a dependence profile similar 

to these substances, which are known to 

cause substance dependence. 

In summary, data suggests that 

ethylphenidate produces behavioral 

effects in animals and humans similar to 

those of schedule II stimulants. 

Although there are no clinical studies 

evaluating dependence liabilities 

specific for ethylphenidate, the 

pharmacological profile of this 

substance suggests that it possesses 

dependence liabilities qualitatively 

similar to schedule II substances such as 

methylphenidate and 

methamphetamine. 

8. Whether the Substance is an 

Immediate Precursor of a Substance 

Already Controlled Under the CSA: 

Ethylphenidate is not an immediate 

precursor of any controlled substance 

under the CSA as defined by 21 U.S.C. 

802(23). 

Conclusion: After considering the 

scientific and medical evaluation 

conducted by HHS, HHS’s scheduling 

recommendation, and DEA’s own eightfactor analysis, DEA finds that the facts 

and all relevant data constitute 

substantial evidence of the potential for 

abuse of ethylphenidate. As such, DEA 

hereby proposes to permanently 

schedule ethylphenidate as a schedule I 

controlled substance under the CSA. 

Proposed Determination of Appropriate 

Schedule 

The CSA establishes five schedules of 

controlled substances known as 

schedules I, II, III, IV, and V. The CSA 

also outlines the findings required to 

place a drug or other substance in any 

particular schedule. 21 U.S.C. 812(b). 

After consideration of the analysis and 

recommendation of the Assistant 

Secretary for Health of HHS and review 

of all other available data, the 

Administrator of DEA, pursuant to 21 

U.S.C. 811(a) and 812(b)(1), finds that: 

1. Ethylphenidate has a high potential 

for abuse. 

Ethylphenidate, similar to the 

schedule II stimulants methylphenidate 

and methamphetamine, is a stimulant 

with a high potential for abuse. In 

animals, behavioral locomotor studies 

show that ethylphenidate produces 

stimulation similar to that of 

methylphenidate. Additionally, typical 

stimulant effects such as euphoria, 

psychomotor stimulation, and anxiety 

have been described from self-reports of 

ethylphenidate abusers. These effects 

are similar to those of schedule II 

stimulant such as methylphenidate and 

methamphetamine. These data 

collectively indicate that ethylphenidate 

has a high potential for abuse similar to 

other substances in schedule II such as 

methylphenidate and 

methamphetamine. 

2. Ethylphenidate currently has no 

accepted medical use in treatment in the 

United States. 

According to HHS, FDA has not 

approved a marketing application for a 

drug product containing ethylphenidate 

for any therapeutic indication. As HHS 

states, there are also no clinical studies 

or petitioners that claim an accepted 

medical use in the United States. In 

addition, as discussed above in the 

Factor 3 analysis, ethylphenidate does 

not satisfy DEA’s five-part test for 

having a currently accepted medical use 

in treatment in the United States. 

3. There is a lack of accepted safety 

for use of ethylphenidate under medical 

supervision. 

Currently, ethylphenidate does not 

have an accepted medical use as noted 

by HHS. Because ethylphenidate has no 

approved medical use in treatment in 

the United States and has not been 

investigated as a new drug, its safety for 

use under medical supervision has not 

been determined. Thus, there is a lack 

of accepted safety for use of 

ethylphenidate under medical 

supervision. 

Although the first finding shows 

ethylphenidate to have similar effects to 

schedule II substances such as 

methylphenidate and 

methamphetamine, it bears reiterating 

that there is only one possible schedule 

in the CSA—schedule I—to place 

ethylphenidate since it has no currently 

accepted medical use in treatment in the 

United States. See the background 

section for additional discussion. 

Based on these findings, the 

Administrator concludes that 

ethylphenidate (chemical name: ethyl 2- 

phenyl-2-(piperidin-2-yl)acetate), 

including its salts, isomers, and salts of 

isomers, warrants control in schedule I 

of the CSA. 21 U.S.C. 812(b)(1). More 

precisely, because of its stimulant-like 

effects, DEA is proposing to place 

ethylphenidate in 21 CFR 1308.11(f) 

(the stimulants category of schedule I). 

As such, the proposed control of 

ethylphenidate also includes its salts, 

isomers, and salts of isomers. 

Requirements for Handling 

Ethylphenidate 

If this rule is finalized as proposed, 

ethylphenidate would be subject to the 

CSA’s schedule I regulatory controls 

and administrative, civil, and criminal 

sanctions applicable to the manufacture, 

distribution, reverse distribution, 

importation, exportation, engagement in 

research, and conduct of instructional 

activities or chemical analysis with, and 

possession of schedule I controlled 

substances including the following: 

1. Registration. Any person who 

handles (manufactures, distributes, 

reverse distributes, imports, exports, 

engages in research, or conducts 


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instructional activities or chemical 

analysis with, or possesses) 

ethylphenidate, or who desires to 

handle ethylphenidate, is required to be 

registered with DEA to conduct such 

activities pursuant to 21 U.S.C. 822, 

823, 957, and 958, and in accordance 

with 21 CFR parts 1301 and 1312 as of 

the effective date of a final scheduling 

action. Any person who currently 

handles ethylphenidate, and is not 

registered with DEA, would need to 

submit an application for registration 

and may not continue to handle 

ethylphenidate as of the effective date of 

a final scheduling action, unless DEA 

has approved that application for 

registration pursuant to 21 U.S.C. 822, 

823, 957, 958, and in accordance with 

21 CFR parts 1301 and 1312. 

2. Disposal of stocks. Any person who 

does not desire or is not able to obtain 

a schedule I registration would be 

required to surrender all quantities of 

currently held ethylphenidate or to 

transfer all quantities of currently held 

ethylphenidate to a person registered 

with DEA before the effective date of a 

final scheduling action, in accordance 

with all applicable Federal, State, local, 

and Tribal laws. As of the effective date 

of a final scheduling action, 

ethylphenidate would be required to be 

disposed of in accordance with 21 CFR 

part 1317, in addition to all other 

applicable Federal, State, local, and 

Tribal laws. 

3. Security. Ethylphenidate would be 

subject to schedule I security 

requirements and would need to be 

handled and stored pursuant to 21 

U.S.C. 821, 823, 871(b) and in 

accordance with 21 CFR 1301.71– 

1301.93 as of the effective date of a final 

scheduling action. Non-practitioners 

handling ethylphenidate would also 

need to comply with the employee 

screening requirements of 21 CFR 

1301.90 –1301.93. 

4. Labeling and Packaging. All labels, 

labeling, and packaging for commercial 

containers of ethylphenidate would 

need to be in compliance with 21 U.S.C. 

825 and 958(e) and be in accordance 

with 21 CFR part 1302 as of the effective 

date of a final scheduling action. 

5. Quota. Only registered 

manufacturers would be permitted to 

manufacture ethylphenidate in 

accordance with a quota assigned 

pursuant to 21 U.S.C. 826 and in 

accordance with 21 CFR part 1303 as of 

the effective date of a final scheduling 

action. 

6. Inventory. Every DEA registrant 

who possesses any quantity of 

ethylphenidate on the effective date of 

a final scheduling action would be 

required to take an inventory of 

ethylphenidate on hand at that time, 

pursuant to 21 U.S.C. 827 and 958 and 

in accordance with 21 CFR 1304.03, 

1304.04, and 1304.11(a) and (d). 

Any person who becomes registered 

with DEA to handle ethylphenidate on 

or after the effective date of a final 

scheduling action would be required to 

have an initial inventory of all stocks of 

controlled substances (including 

ethylphenidate) on hand on the date the 

registrant first engages in the handling 

of controlled substances pursuant to 21 

U.S.C. 827 and 958, and in accordance 

with 21 CFR 1304.03, 1304.04, and 

1304.11(a) and (b). 

After the initial inventory, every DEA 

registrant must take an inventory of all 

controlled substances (including 

ethylphenidate) on hand every two 

years, pursuant to 21 U.S.C. 827 and 

958, and in accordance with 21 CFR 

1304.03, 1304.04, and 1304.11. 

7. Records and Reports. Every DEA 

registrant would be required to maintain 

records and submit reports with respect 

to ethylphenidate pursuant to 21 U.S.C. 

827 and 958(e) and in accordance with 

21 CFR parts 1304 and 1312, as of the 

effective date of a final scheduling 

action. Manufacturers and distributors 

would be required to submit reports 

regarding ethylphenidate to the 

Automation of Reports and 

Consolidated Order System pursuant to 

21 U.S.C. 827 and in accordance with 21 

CFR parts 1304 and 1312, as of the 

effective date of a final scheduling 

action. 

8. Order Forms. Every DEA registrant 

who distributes ethylphenidate would 

be required to comply with the order 

form requirements, pursuant to 21 

U.S.C. 828 and in accordance with 21 

CFR part 1305, as of the effective date 

of a final scheduling action. 

9. Importation and Exportation. All 

importation and exportation of 

ethylphenidate would need to be in 

compliance with 21 U.S.C. 952, 953, 

957, and 958, and in accordance with 21 

CFR part 1312, as of the effective date 

of a final scheduling action. 

10. Liability. Any activity involving 

ethylphenidate not authorized by, or in 

violation of, the CSA or its 

implementing regulations would be 

unlawful, and may subject the person to 

administrative, civil, and/or criminal 

sanctions. 

Regulatory Analyses 

Executive Orders 12866 (Regulatory 

Planning and Review) and 13563 

(Improving Regulation and Regulatory 

Review) 

In accordance with 21 U.S.C. 811(a), 

this proposed scheduling action is 

subject to formal rulemaking procedures 

performed ‘‘on the record after 

opportunity for a hearing,’’ which are 

conducted pursuant to the provisions of 

5 U.S.C. 556 and 557. The CSA sets 

forth the criteria for scheduling a drug 

or other substance. Such actions are 

exempt from review by the Office of 

Management and Budget (OMB) 

pursuant to section 3(d)(1) of Executive 

Order (E.O.) 12866 and the principles 

reaffirmed in E.O. 13563. 

Executive Order 12988, Civil Justice 

Reform 

This proposed regulation meets the 

applicable standards set forth in 

sections 3(a) and 3(b)(2) of E.O. 12988 

to eliminate drafting errors and 

ambiguity, minimize litigation, provide 

a clear legal standard for affected 

conduct, and promote simplification 

and burden reduction. 

Executive Order 13132, Federalism 

This proposed rulemaking does not 

have federalism implications warranting 

the application of E.O. 13132. The 

proposed rule does not have substantial 

direct effects on the States, on the 

relationship between the national 

government and the States, or the 

distribution of power and 

responsibilities among the various 

levels of government. 

Executive Order 13175, Consultation 

and Coordination With Indian Tribal 

Governments 

This proposed rule does not have 

tribal implications warranting the 

application of E.O. 13175. It does not 

have substantial direct effects on one or 

more Indian tribes, on the relationship 

between the Federal government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal government and Indian tribes. 

Regulatory Flexibility Act 

The Administrator, in accordance 

with the Regulatory Flexibility Act, 5 

U.S.C. 601–602, has reviewed this 

proposed rule and by approving it 

certifies that it will not have a 

significant economic impact on a 

substantial number of small entities. 

DEA proposes placing the substance 

ethylphenidate (chemical name: ethyl 2- 

phenyl-2-(piperidin-2-yl)acetate), 

including its salts, isomers, and salts of 

isomers, in schedule I of the CSA. This 

action is being taken to enable the 

United States to meet its obligations 

under the 1971 Convention on 

Psychotropic Substances. If finalized, 

this action would impose the regulatory 

controls and administrative, civil, and 

criminal sanctions applicable to 


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schedule I controlled substances on 

persons who handle (manufacture, 

distribute, reverse distribute, import, 

export, engage in research, conduct 

instructional activities or chemical 

analysis with, or possess), or propose to 

handle, ethylphenidate. 

According to HHS, ethylphenidate 

has a high potential for abuse, has no 

currently accepted medical use in 

treatment in the United States, and lacks 

accepted safety for use under medical 

supervision. DEA’s research confirms 

that there is no legitimate commercial 

market for ethylphenidate in the United 

States. Therefore, DEA estimates that no 

United States entity currently handles 

ethylphenidate and does not expect any 

United States entity to handle 

ethylphenidate in the foreseeable future. 

DEA concludes that no legitimate 

United States entity would be affected 

by this rule if finalized. As such, the 

proposed rule will not have a significant 

effect on a substantial number of small 

entities. 

Unfunded Mandates Reform Act of 1995 

In accordance with the Unfunded 

Mandates Reform Act (UMRA) of 1995, 

2 U.S.C. 1501 et seq., DEA has 

determined and certifies that this action 

would not result in any Federal 

mandate that may result ‘‘in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100 million or more 

(adjusted annually for inflation) in any 

1 year * * *.’’ Therefore, neither a 

Small Government Agency Plan nor any 

other action is required under UMRA of 

1995. 

Paperwork Reduction Act of 1995 

This action does not impose a new 

collection of information under the 

Paperwork Reduction Act of 1995. 44 

U.S.C. 3501–3521. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on September 7, 2023, by Administrator 

Anne Milgram. That document with the 

original signature and date is 

maintained by DEA. For administrative 

purposes only, and in compliance with 

requirements of the Office of the Federal 

Register, the undersigned DEA Federal 

Register Liaison Officer has been 

authorized to sign and submit the 

document in electronic format for 

publication, as an official document of 

DEA. This administrative process in no 

way alters the legal effect of this 

document upon publication in the 

Federal Register. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

For the reasons set out above, DEA 

proposes to amend 21 CFR part 1308 as 

follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 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. Amend § 1308.11 by: 

■ a. Redesignating paragraph (f)(6) 

through (12) as (f)(7) through (13); and 

■ b. Adding a new paragraph (f)(6) 

The addition reads as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(f) * * * 

*******

(6) Ethylphenidate (ethyl 2-phenyl-2-(piperidin-2-yl)acetate) .............................................................................................................. 1727 

* * * * * * * 

* * * * * 

Scott Brinks, 

Federal Register Liaison Officer, Drug 

Enforcement Administration. 

[FR Doc. 2023–20439 Filed 9–21–23; 8:45 am] 

BILLING CODE 4410–09–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2023–0267; FRL–10958– 

01–R9] 

Second 10-Year Maintenance Plan for 

the 24-Hour PM10 Standards; 

Sacramento County Planning Area, 

California 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve 

the ‘‘Second 10-Year PM10 Maintenance 

Plan for Sacramento County’’ (‘‘Second 

10-Year Maintenance Plan’’ or ‘‘Plan’’) 

as a revision to the state implementation 

plan (SIP) for the State of California 

(‘‘State’’). The Second 10-Year 

Maintenance Plan includes, among 

other elements, a base year emissions 

inventory, a maintenance 

demonstration, contingency provisions, 

and motor vehicle emissions budgets for 

use in transportation conformity 

determinations, to ensure the continued 

maintenance of the national ambient air 

quality standards (NAAQS) for 

particulate matter of 10 microns or less 

(PM10). With this proposed rulemaking, 

the EPA is beginning the adequacy 

process for the 2024, 2027, and 2033 

motor vehicle emissions budgets. 

Additionally, as part of the technical 

basis for this approval, the EPA is taking 

comment on our August 1, 2022 

concurrence on the wildfire exceptional 

events demonstration submitted by the 

California Air Resources Board (CARB) 

on April 26, 2021. 

DATES: Written comments must arrive 

on or before October 23, 2023. 

ADDRESSES: Submit your comments 

identified by Docket ID No. EPA–R09– 

OAR–2023–0267 at https://

www.regulations.gov. For comments 

submitted at Regulations.gov, follow the 

online instructions for submitting 

comments. Once submitted, comments 

cannot be edited or removed from 

Regulations.gov. The EPA may publish 

any comment received to its public 

docket. Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. Multimedia 

submissions (audio, video, etc.) must be 

accompanied by a written comment. 

The written comment is considered the 

official comment and should include 

discussion of all points you wish to 

make. The EPA will generally not 

consider comments or comment 

contents located outside of the primary 

submission (i.e., on the web, cloud, or 

other file sharing system). For 

additional submission methods, please 

contact the person identified in the FOR

FURTHER INFORMATION CONTACT section. 

For the full EPA public comment policy, 

information about CBI or multimedia 

submissions, and general guidance on 

making effect comments, please visit 


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