Federal Register / Vol. 89, No. 204 / Tuesday, October 22, 2024 / Rules and Regulations 84281 

4Security-Based Swap Execution and Registration 

and Regulation of Security-Based Swap Execution 

Facilities, Release No. 34–98845 (Nov. 2, 2023) [88 

FR 87156 (Dec. 15, 2023)]. 

5Cybersecurity Risk Management, Strategy, 

Governance, and Incident Disclosure, Release No. 

33–11216 (July 26, 2023) [88 FR 51896 (Aug. 4, 

2023)]. 

6 5 U.S.C. 553(b)(A). 

7 5 U.S.C. 601 through 612. 

8 5 U.S.C. 804(3)(c). 

9 5 U.S.C. 553(d)(3). 

10 15 U.S.C. 77f, 77g, 77h, 77j, and 77s(a). 

11 15 U.S.C. 78c, 78l, 78m, 78n, 78o, 78o–4, 78w, 

and 78ll. 

12 15 U.S.C. 77sss. 

13 15 U.S.C. 80a–8, 80a–29, 80a–30, and 80a–37. 

as SBSEF–FIN–QTR, SBSEF–FIN–QTR/ 

A, SBSEF–FIN–REQ, and SBSEF–FIN– 

REQ/A submissions, respectively.4

Addition of XBRL Taxonomy for 

Cybersecurity Disclosures 

EDGAR will be updated to allow filers 

to use the appropriate XBRL Taxonomy 

for cybersecurity disclosures required to 

be included in Forms 6–K, 8–K, 10–K, 

and 20–F (and the variants 10–KT, 10– 

K/A, 10–KT/A, 20–F/A, 8–K/A, and 6– 

K/A).5

Removal of the Index From Volume II of 

the EDGAR Filer Manual 

Volume II of the Filer Manual will be 

updated to remove the Index. Filers may 

continue to use the Table of Contents 

which links directly to chapters and 

topics, and the document search 

function of this online manual. 

III. Amendments to Rule 301 of 

Regulation S–T 

Along with the adoption of the 

updated Filer Manual, we are amending 

Rule 301 of Regulation S–T to provide 

for the incorporation by reference into 

the Code of Federal Regulations of the 

current revisions. This incorporation by 

reference was approved by the Director 

of the Federal Register in accordance 

with 5 U.S.C. 552(a) and 1 CFR part 51. 

The updated EDGAR Filer Manual is 

available at https://www.sec.gov/edgar/ 

filerinformation/current-edgar-filermanual. 

IV. Administrative Law Matters 

Because the Filer Manual and rule 

amendments relate solely to agency 

procedures or practice and do not 

substantially alter the rights and 

obligations of non-agency parties, 

publication for notice and comment is 

not required under the Administrative 

Procedure Act (‘‘APA’’).6 It follows that 

the amendments do not require analysis 

under requirements of the Regulatory 

Flexibility Act 7 or a report to Congress 

under the Small Business Regulatory 

Enforcement Fairness Act of 1996.8

The effective date for the updated 

Filer Manual and related rule 

amendments is October 22, 2024. In 

accordance with the APA,9 we find that 

there is good cause to establish an 

effective date less than 30 days after 

publication of these rules. The 

Commission believes that establishing 

an effective date less than 30 days after 

publication of these rules is necessary to 

coordinate the effectiveness of the 

updated Filer Manual with the related 

system upgrades. 

V. Statutory Basis 

We are adopting the amendments to 

Regulation S–T under the authority in 

sections 6, 7, 8, 10, and 19(a) of the 

Securities Act of 1933,10 sections 3, 12, 

13, 14, 15, 15B, 23, and 35A of the 

Securities Exchange Act of 1934,11

section 319 of the Trust Indenture Act 

of 1939,12 and sections 8, 30, 31, and 38 

of the Investment Company Act of 

1940.13

List of Subjects in 17 CFR Part 232 

Incorporation by reference, Reporting 

and recordkeeping requirements, 

Securities. 

Text of the Amendments 

In accordance with the foregoing, title 

17, chapter II of the Code of Federal 

Regulations is amended as follows: 

PART 232—REGULATION S–T— 

GENERAL RULES AND REGULATIONS 

FOR ELECTRONIC FILINGS 

■ 1. The general authority citation for 

part 232 continues to read as follows: 

Authority: 15 U.S.C. 77c, 77f, 77g, 77h, 77j, 

77s(a), 77z–3, 77sss(a), 78c(b), 78l, 78m, 78n, 

78n–1,78o(d), 78w(a), 78ll, 80a–6(c), 80a–8, 

80a–29, 80a–30, 80a–37, 7201 et seq.; and 18 

U.S.C. 1350, unless otherwise noted. 

* * * * * 

■ 2. Section 232.301 is revised to read 

as follows: 

§ 232.301 EDGAR Filer Manual. 

Filers must prepare electronic filings 

in the manner prescribed by the EDGAR 

Filer Manual, promulgated by the 

Commission, which sets forth the 

technical formatting requirements for 

electronic submissions. The 

requirements for becoming an EDGAR 

Filer and updating company data are set 

forth in the EDGAR Filer Manual, 

Volume I: ‘‘General Information,’’ 

Version 41 (December 2022). The 

requirements for filing on EDGAR are 

set forth in the updated EDGAR Filer 

Manual, Volume II: ‘‘EDGAR Filing,’’ 

Version 71 (September 2024). All of 

these provisions have been incorporated 

by reference into the Code of Federal 

Regulations, which action was approved 

by the Director of the Federal Register 

in accordance with 5 U.S.C. 552(a) and 

1 CFR part 51. You must comply with 

these requirements in order for 

documents to be timely received and 

accepted. The EDGAR Filer Manual is 

available for inspection at the 

Commission and at the National 

Archives and Records Administration 

(NARA). The EDGAR Filer Manual is 

available for website viewing and 

printing in the Commission’s Public 

Reference Room, 100 F Street NE, 

Washington, DC 20549, on official 

business days between the hours of 10 

a.m. and 3 p.m. Operating conditions 

may limit access to the Commission’s 

Public Reference Room. For information 

on the availability of the EDGAR Filer 

Manual at NARA, visit 

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

ibr-locations.html or email 

fr.inspection@nara.gov. The EDGAR 

Filer Manual may also be obtained from 

https://www.sec.gov/edgar/ 

filerinformation/current-edgar-filermanual. 

By the Commission. 

Dated: September 16, 2024. 

Vanessa A. Countryman, 

Secretary. 

[FR Doc. 2024–24355 Filed 10–21–24; 8:45 am] 

BILLING CODE 8011–01–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: Final rule. 

SUMMARY: With the issuance of this final 

rule, the Drug Enforcement 

Administration places 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. When 

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, 


ddrumheller on DSK120RN23PROD with RULES1
84282 Federal Register / Vol. 89, No. 204 / Tuesday, October 22, 2024 / Rules and Regulations 

1As 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 

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

Assistant Secretary for Health of HHS the authority 

to make domestic drug scheduling 

recommendations. Comprehensive Drug Abuse 

Prevention and Control Act of 1970, Public Law 91– 

513, As Amended; Delegation of Authority, 58 FR 

35460 (July 1, 1993). 

2 21 U.S.C. 811(d)(3). 

3Schedules of Controlled Substances: Placement 

of Ethylphenidate in Schedule I, 88 FR 65330 (Sept. 

22, 2023). 

export, engage in research, conduct 

instructional activities or chemical 

analysis with, or possess) or propose to 

handle ethylphenidate. 

DATES: Effective date: November 21, 

2024. 

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: 

Legal Authority 

The United States is a party to the 

1971 United Nations Convention on 

Psychotropic Substances (1971 

Convention), Feb. 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 Health and Human 

Services (Secretary),1 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 

substance.2 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) and 

(2), the Attorney General (as delegated 

to the Administrator of the Drug 

Enforcement Administration (DEA) 

pursuant to 28 CFR 0.100) may, by rule, 

and upon the recommendation of the 

Secretary, 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 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 (CND) 

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 

were not followed, as discussed above 

in the legal authority section, DEA is 

utilizing the procedures for permanent 

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

and (b) to control ethylphenidate. 

Permanently scheduling ethylphenidate 

satisfies the United States’ international 

obligations. 

DEA and HHS Eight Factor Analyses 

In a letter dated October 26, 2020, in 

accordance with 21 U.S.C. 811(b), and 

in response to DEA’s April 3, 2019 

request, HHS provided to DEA a 

scientific and medical evaluation and 

scheduling recommendation for 

ethylphenidate. DEA reviewed the 

scientific and medical evaluation and 

scheduling recommendation for 

schedule I placement provided by HHS, 

and all other relevant data, pursuant to 

21 U.S.C. 811(b) and (c), and conducted 

its own analysis under the eight factors 

stipulated in 21 U.S.C. 811(c). DEA 

found, under 21 U.S.C. 811(b)(1), that 

this substance warrants control in 

schedule I. Both DEA and HHS EightFactor analyses are available in their 

entirety under the tab Supporting 

Documents of the public docket for this 

action at https://www.regulations.gov 

under docket number DEA–1142. 

Notice of Proposed Rulemaking To 

Schedule Ethylphenidate 

On September 22, 2023, DEA 

published a notice of proposed 

rulemaking (NPRM) to permanently 

control ethylphenidate in schedule I.3

Specifically, DEA proposed to add 

ethylphenidate to the list of stimulant 

substances under 21 CFR 1308.11(f). 

The NPRM provided an opportunity for 

interested persons to file a request for 

hearing in accordance with DEA 

regulations on or before October 23, 

2023. DEA did not receive any requests 

for such a hearing. The NPRM also 

provided an opportunity for interested 

persons to submit comments on or 

before November 21, 2023. 

Comments Received 

DEA received ten comments in 

response to the notice of proposed 

rulemaking for the placement of 

ethylphenidate into schedule I of the 

CSA. The submissions were from 

individuals or anonymous commenters. 

Five commenters provided support for 

the notice of proposed rulemaking, four 

commenters were against the placement 

of ethylphenidate in schedule I of the 

CSA, and one commenter expressed 

statements that were neither for nor 

against the proposed rule. 

DEA received five comments in 

support of the placement of 

ethylphenidate in schedule I. 

DEA Response: DEA appreciates these 

comments in support of this 

rulemaking. 

DEA received four comments against 

the placement of ethylphenidate in 

schedule I of the CSA. The following are 

DEA’s responses to the individual 

comments against the proposed 

rulemaking. 

DEA received a comment asserting 

that methylphenidate is already 

controlled under schedule II of the CSA, 

thus, ethylphenidate is considered 

controlled under the Controlled 

Substances Analogue Act due to their 

similarities. This commenter concluded 

that the government should not dictate 

what researchers may study for 

legitimate scientific use. 

DEA Response: DEA appreciates this 

comment and would like to provide 

further clarification regarding the 

control of ethylphenidate. 

Ethylphenidate has been placed under 

international control. In order to comply 

with treaty obligations, DEA must place 

ethylphenidate under the most 

appropriate schedule, taking into 

consideration all appropriate scientific 

data. This is true even if this substance 

could be treated under the Controlled 

Substances Analogue provision. 

Additionally, as set forth in the NPRM, 

ethylphenidate has no currently 

accepted medical use in treatment in the 

United States. Therefore, ethylphenidate 

must be placed in schedule I of the CSA 

along with other substances which have 

no currently accepted medical use, lack 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 89, No. 204 / Tuesday, October 22, 2024 / Rules and Regulations 84283 

4https://apps.deadiversion.usdoj.gov/webforms2/ 

spring/main?execution=e1s2. 

accepted safety for use under medical 

supervision, and possess a high 

potential for abuse. With respect to 

scientific research, the placement of 

substances in schedule I of the CSA 

does not preclude academic research on 

these substances. DEA registrants 

wishing to conduct research on 

schedule I substances may apply for 

permission to do so through the 

schedule I researcher registration 

program.4

DEA received a comment comparing 

ethylphenidate to methylphenidate. The 

commenter questioned the reasonable 

nature of placing ethylphenidate in 

schedule I of the CSA considering it is 

a weaker substance when compared to 

methylphenidate, a schedule II 

substance. 

DEA Response: DEA appreciates this 

comment and asserts the following: 

Ethylphenidate belongs to the stimulant 

class of drugs and possesses abuse 

liability similar to that of 

methylphenidate; however, unlike 

methylphenidate, ethylphenidate has no 

currently accepted medical use in 

treatment in the United States. A 

qualification for placing substances in 

schedules II thorough IV of the CSA is 

that they must have a currently accepted 

medical use in treatment in the United 

States. Thus, DEA asserts that the 

placement of ethylphenidate in 

schedule I of the CSA is warranted. 

DEA received a comment with 

statements against the NPRM placing 

ethylphenidate in schedule I of the CSA. 

The commenter stated that, in the 

NPRM, DEA failed to provide a reason 

for the placement of ethylphenidate in 

a more restrictive schedule (here, 

schedule I) than methylphenidate, 

considering the two drugs share 

significant pharmacological similarities 

and are considered analogues of one 

another. The commenter further stated 

that because ethylphenidate is an analog 

of methylphenidate, it may be possible 

in the future for ethylphenidate to be 

marketed as an alternative to 

methylphenidate. In particular, the 

commenter stated the placement of 

ethylphenidate in schedule I of the CSA 

would completely hamper future 

legitimate research regarding its medical 

efficacy. Thus, the commenter states, by 

imposing criminal sanctions on those 

who engage in research or chemical 

analysis of the drug, DEA would prevent 

the future discovery of its possible 

medical use. 

DEA Response: DEA appreciates this 

comment and asserts the following: As 

stated above, ethylphenidate has been 

placed under international control. In 

order to comply with treaty obligations, 

DEA must place ethylphenidate under 

the most appropriate schedule, taking 

into consideration all appropriate 

scientific data. Additionally, a 

qualification for placing substances in 

schedules II thorough IV of the CSA is 

that they must have a currently accepted 

medical use in treatment in the United 

States. Ethylphenidate has no currently 

accepted medical use in treatment in the 

United States, lacks accepted safety for 

use under medical supervision, and 

possesses a high potential for abuse. 

Thus, DEA asserts that the placement of 

ethylphenidate in schedule I of the CSA 

is warranted. With respect to research, 

the placement of substances in schedule 

I of the CSA does not preclude research 

into this substance. DEA registrants 

wishing to conduct research on 

schedule I substances, including 

ethylphenidate, may apply for 

permission to do so through the 

schedule I researcher registration 

program. 

DEA received a comment expressing 

that ethylphenidate should be 

categorized as a schedule II drug ‘‘until 

further research has been conducted to 

prove its viability.’’ 

DEA Response: DEA appreciates this 

comment and asserts the following: 

According to the CSA, schedule I 

substances are defined as drugs that 

have no known medical use in 

treatment in the United States, and have 

a high potential for abuse. Additionally, 

according to the CSA, schedule II 

substances also have a high potential for 

abuse but have a currently accepted 

medical use in treatment. Accordingly, 

DEA proposed to place ethylphenidate 

in schedule I of the CSA, due to its lack 

of a currently accepted medical use in 

treatment in the United States, its lack 

of accepted safety for use under medical 

supervision, and its high potential for 

abuse. 

DEA received one comment that 

provided statements that were neither 

explicitly for nor against the proposed 

rule. 

In this comment, the commenter 

suggested that instead of creating a new 

rule for the control of ethylphenidate, 

DEA should simply clarify the existing 

rule which controlled methylphenidate. 

According to this commenter, this 

suggested amendment would extend 

control to all derivatives of 

methylphenidate. The commenter also 

expressed an understanding of DEA’s 

intent to schedule ethylphenidate but 

questioned whether a standard noticeand-comment procedure was needed for 

an action that could be addressed by 

clarifying existing rulemaking. 

DEA Response: DEA appreciates this 

suggestion and asserts the following: 

Ethylphenidate was placed under 

international control on March 16, 2017, 

during the CND’s 60th session. As a 

signatory to the 1971 Convention on 

Psychotropic Substances, it is 

incumbent upon DEA to place 

ethylphenidate in its most appropriate 

schedule under the CSA. Therefore, 

DEA proposed to place ethylphenidate 

in schedule I of the CSA because it has 

no currently accepted medical use in 

treatment in the United States, lacks 

accepted safety for use under medical 

supervision, and has an abuse potential 

similar to that of methylphenidate. As 

explained in the NPRM, because the 

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

(4) for consultation and issuance of a 

temporary order for ethylphenidate 

were not followed, DEA utilized the 

procedures for permanent scheduling 

set forth in 21 U.S.C. 811(a) and (b) to 

control ethylphenidate, which required 

notice and an opportunity for hearing. 

Scheduling Conclusion 

After consideration of the public 

comments, scientific and medical 

evaluation and accompanying 

scheduling recommendation from HHS, 

and after its own eight-factor evaluation, 

DEA finds that these facts and all 

relevant data constitute substantial 

evidence of potential for abuse of 

ethylphenidate. As such, DEA is 

permanently scheduling ethylphenidate 

as a controlled substance under 

schedule I of the CSA. The permanent 

scheduling of ethylphenidate will fulfill 

the United States’ obligations as a party 

to the 1971 Convention. 

Determination of Appropriate Schedule 

The CSA establishes five schedules of 

controlled substances known as 

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

also specifies the findings requires 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 Acting Assistant 

Secretary for Health of HHS and review 

of all other available data, the 

Administrator of DEA, pursuant to 21 

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

(1) Ethylphenidate has a high potential for 

abuse that is comparable to other scheduled 

substances, such as methylphenidate (a 

schedule II substance); 

(2) Ethylphenidate has no currently 

accepted medical use in treatment in the 

United States. In HHS’ 2020 recommendation 

to control ethylphenidate, it was noted there 

are no approved New Drug Applications for 

ethylphenidate and no known therapeutic 

applications for ethylphenidate in the United 

States. DEA is not aware of any other 

evidence suggesting that ethylphenidate has 


ddrumheller on DSK120RN23PROD with RULES1
84284 Federal Register / Vol. 89, No. 204 / Tuesday, October 22, 2024 / Rules and Regulations 

5When placing a substance in schedule I, DEA 

must consider whether the substance has a 

currently accepted medical use in treatment in the 

United States. 21 U.S.C. 812(b)(1)(B) There is no 

evidence suggesting that ethylphenidate has 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 practitioners 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 final rule, there is 

no evidence that health care providers have 

widespread experience with medical use of 

ethylphenidate or that the use of ethylphenidate is 

recognized by entities that regulate the practice of 

medicine under either the traditional five-part test 

or the two-part test. 

a currently accepted medical use in treatment 

in the United States.5

(3) There is a lack of accepted safety for use 

of ethylphenidate under medical supervision. 

Because ethylphenidate has no approved 

medical use and has not been investigated as 

a new drug, its safety for use under medical 

supervision has not been determined. 

Based on these findings, the 

Administrator of DEA concludes that 

ethylphenidate, as well as its salts, 

isomers, and salts of isomers whenever 

the existence of such salts, isomers, and 

salts of isomers is possible, warrants 

control in schedule I of the CSA. 

Requirements for Handling 

Ethylphenidate 

Ethylphenidate is subject to the CSA’s 

schedule I regulatory controls and 

administrative, civil, and criminal 

sanctions applicable to the manufacture, 

distribution, reverse distribution, 

import, export, engagement in research, 

conduct 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 

instructional activities or chemical 

analysis with, or possesses), or who 

desires to handle, ethylphenidate must 

register 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. Any 

person who currently handles 

ethylphenidate and is not registered 

with DEA must submit an application 

for registration and may not continue to 

handle ethylphenidate, 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. Retail sales 

of schedule I controlled substances to 

the general public are not allowed under 

the CSA. Possession of any quantity in 

a manner not authorized by the CSA is 

unlawful and those in possession of any 

quantity may be subject to prosecution 

pursuant to the CSA. 

2. Disposal of stocks. Any person 

unwilling or unable to obtain a schedule 

I registration must surrender or 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. Ethylphenidate must 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 is subject 

to schedule I security requirements and 

must be handled and stored pursuant to 

21 U.S.C. 823, and in accordance with 

21 CFR 1301.71–1301.76, as of the 

effective date of this final scheduling 

action. Non-practitioners handling 

ethylphenidate must 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 must 

comply with 21 U.S.C. 825, and be in 

accordance with 21 CFR part 1302. 

5. Quota. Only registered 

manufacturers are 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. 

6. Inventory. Every DEA registrant 

who possesses any quantity of 

ethylphenidate must take an inventory 

of ethylphenidate on hand, pursuant to 

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

CFR 1304.03, 1304.04, and 1304.11(a) 

and (d). 

Any person who registers with DEA 

must take 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 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 in 

accordance with 21 CFR 1304.03, 

1304.04, and 1304.11. 

7. Records and Reports. Every DEA 

registrant must maintain records and 

submit reports for ethylphenidate, or 

products containing ethylphenidate, 

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

accordance with 21 CFR 1301.74(b) and 

(c), 1301.76(b), and parts 1304, 1312 and 

1317. Manufacturers and distributors 

must 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. 

8. Order Forms. Every DEA registrant 

who distributes ethylphenidate must 

comply with the order form 

requirements, pursuant to 21 U.S.C. 828 

and 21 CFR part 1305. 

9. Importation and Exportation. All 

importation and exportation of 

ethylphenidate must comply with 21 

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

accordance with 21 CFR parts 1304 and 

1312. 

10. Liability. Any activity involving 

ethylphenidate not authorized by, or in 

violation of, the CSA or its 

implementing regulations, is unlawful, 

and may subject the person to 

administrative, civil, and/or criminal 

sanctions. 

Regulatory Analyses 

Executive Orders 12866 (Regulatory 

Planning and Review), 13563 

(Improving Regulation and Regulatory 

Review), and 14094 (Modernizing 

Regulatory Review) 

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

this final 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 procedures and criteria for 

scheduling a drug or other substance. 

Such actions are exempt from review by 

the Office of Management and Budget 

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

Order (E.O.) 12866 and the principles 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 89, No. 204 / Tuesday, October 22, 2024 / Rules and Regulations 84285 

6 44 U.S.C. 3501–3521. 

reaffirmed in E.O. 13563. E.O. 14094 

modernizes the regulatory review 

process to advance policies that 

promote the public interest and address 

national priorities. 

Executive Order 12988, Civil Justice 

Reform 

This 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 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 on the distribution of 

power and responsibilities among the 

various levels of government. 

Executive Order 13175, Consultation 

and Coordination With Indian Tribal 

Governments 

This 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. 

Paperwork Reduction Act of 1995 

This action does not impose a new 

collection of information requirement 

under the Paperwork Reduction Act of 

1995.6 Also, this proposed rule would 

not impose new or modify existing 

recordkeeping or reporting requirements 

on state or local governments, 

individuals, businesses, or 

organizations. However, this proposed 

rule would require compliance with the 

following existing OMB collections: 

1117–0003, 1117–0004, 1117–0006, 

1117–0008, 1117–0009, 1117–0010, 

1117–0012, 1117–0014, 1117–0021, 

1117–0023, 1117–0029, and 1117–0056. 

An agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. 

Regulatory Flexibility Act 

The Administrator of DEA, in 

accordance with the Regulatory 

Flexibility Act, 5 U.S.C. 601–612, has 

reviewed this final rule, and by 

approving it, certifies that it will not 

have a significant economic impact on 

a substantial number of small entities. 

DEA is 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 to 

enable the United States to meet its 

obligations under the 1971 Convention. 

This action imposes 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 with, or possess) or propose to 

handle ethylphenidate. 

Based on the review of HHS’s 

scientific and medical evaluation and 

all other relevant data, DEA determined 

that ethylphenidate has 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, this final rule will not have 

a significant economic impact on a 

substantial number of small entities. 

Unfunded Mandates Reform Act of 1995 

On the basis of information contained 

in the ‘‘Regulatory Flexibility Act’’ 

section above, DEA has determined 

pursuant to the Unfunded Mandates 

Reform Act (UMRA) of 1995 (2 U.S.C. 

1501 et seq.) that this final rule would 

not result in any Federal mandate that 

may result ‘‘in the expenditure by State, 

local, and tribal governments, in the 

aggregate, or by the private sector, of 

$100,000,000 or more (adjusted 

annually for inflation) in any 1 year 

. . . .’’ Therefore, neither a Small 

Government Agency Plan nor any other 

action is required under UMRA of 1995. 

Congressional Review Act 

This rule is not a major rule as 

defined by the Congressional Review 

Act (CRA), 5 U.S.C. 804. However, 

pursuant to the CRA, DEA is submitting 

a copy of the final rule to both Houses 

of Congress and to the Comptroller 

General. 

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, 21 CFR 

part 1308 is amended 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. In § 1308.11: 

■ a. Redesignate paragraphs (f)(6) 

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

and 

■ b. Add 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 

* * * * * * * 

* * * * * 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on October 10, 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. 


ddrumheller on DSK120RN23PROD with RULES1
84286 Federal Register / Vol. 89, No. 204 / Tuesday, October 22, 2024 / Rules and Regulations 

Heather Achbach, 

Federal Register Liaison Officer, Drug 

Enforcement Administration. 

[FR Doc. 2024–24083 Filed 10–21–24; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2024–0924] 

Safety Zone: Fireworks Displays 

Within the Fifth Coast Guard District; 

The Wharf, Washington, DC 

AGENCY: Coast Guard, DHS. 

ACTION: Notification of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

a safety zone for a fireworks display at 

‘‘The Wharf DC,’’ in Washington, DC, to 

provide for the safety of life on 

navigable waterways during this event. 

Our regulation, ‘‘Safety Zones; 

Fireworks Displays within the Fifth 

Coast Guard District,’’ identifies the 

precise location. During the 

enforcement period, vessels may not 

enter, remain in, or transit through the 

safety zone unless authorized to do so 

by the COTP or his representative, and 

vessels in the vicinity must comply with 

directions from the Patrol Commander 

or any Official Patrol displaying a Coast 

Guard ensign. 

DATES: The regulation in 33 CFR 

165.506 will be enforced for the location 

identified in line no. 1 of table 2 to 33 

CFR 165.506(h)(2) from 8 p.m. until 9:30 

p.m. on December 7, 2024, or if 

necessary, due to inclement weather, 

from 8 p.m. until 9:30 p.m. on December 

8, 2024. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this 

notification of enforcement, call or 

email LCDR Kate M. Newkirk, Sector 

Maryland-NCR, Waterways Management 

Division, U.S. Coast Guard: telephone 

410–576–2596, email 

MDNCRMarineEvents@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce the safety zone 

regulation for a fireworks display at The 

Wharf DC from 8 p.m. to 9:30 p.m. on 

December 7, 2024, or, if necessary due 

to inclement weather, from 8 p.m. until 

9:30 p.m. on December 8, 2024. This 

action is being taken to provide for the 

safety of life on navigable waterways 

during this event. Our regulation, 

‘‘Safety Zones; Fireworks Displays 

within the Fifth Coast Guard District,’’ 

§ 165.506, specifies the location of the 

safety zone for the fireworks show, 

which encompasses portions of the 

Washington Channel in the Upper 

Potomac River. As reflected in 33 CFR 

165.23, vessels in the vicinity of the 

safety zone may not enter, remain in, or 

transit through the safety zone during 

the enforcement period unless 

authorized to do so by the COTP or his 

representative, and they must comply 

with directions from the Patrol 

Commander or any Official Patrol 

displaying a Coast Guard ensign. 

In addition to this notification of 

enforcement in the Federal Register, the 

Coast Guard plans to provide 

notification of this enforcement period 

via the Local Notice to Mariners and 

marine information broadcasts. 

Dated: October 7, 2024. 

Patrick C. Burkett, 

Captain, U.S. Coast Guard, Captain of the 

Port, Sector Maryland-National Capital 

Region. 

[FR Doc. 2024–24284 Filed 10–21–24; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 51 and 52 

[EPA–HQ–OAR–2024–0234; FRL–11945–01– 

OAR] 

Prevention of Significant Deterioration 

(PSD): Paragraph Designation 

Corrections 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is amending its 

Prevention of Significant Deterioration 

(PSD) regulations to correct the fourthlevel paragraph designations to conform 

with the Office of the Federal Register 

(OFR) requirements. This is a 

ministerial final rule action that 

involves minor technical corrections. 

DATES: This rule is effective October 22, 

2024. 

ADDRESSES: The EPA has established a 

docket for this action under Docket ID 

No. EPA–HQ–OAR–2024–0234. All 

documents in the docket are listed on 

the https://www.regulations.gov 

website. Publicly available docket 

materials are available either 

electronically through https://

www.regulations.gov or in hard copy at 

the EPA Docket Center, WJC West 

Building, Room 3334, 1301 Constitution 

Avenue NW, Washington, DC 20004. 

The Public Reading Room is open from 

8:30 a.m. to 4:30 p.m., Monday through 

Friday, excluding federal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the Office of 

Air and Radiation Docket is (202) 566– 

1742. 

FOR FURTHER INFORMATION CONTACT: 

Questions concerning this final rule 

should be addressed to Mr. Peter Keller, 

Air Quality Policy Division, Office of 

Air Quality Planning and Standards 

(C539–04), U.S. Environmental 

Protection Agency, Post Office Box 

12055, Research Triangle Park, NC 

27711; telephone number: (919) 541– 

2065; email address: keller.peter@

epa.gov. 

SUPPLEMENTARY INFORMATION: The 

information presented in this preamble 

is organized as follows: 

I. Does this action apply to me? 

II. Background and Rationale for This Action 

III. Final Action 

IV. Statutory and Executive Order Reviews 

V. Statutory Authority 

VI. Judicial Review 

I. Does this action apply to me? 

No entities will be affected by this 

final action. The EPA is amending its 

PSD regulations to correct the fourthlevel paragraph designations from the 

Code of Federal Regulations (CFR) to 

conform with the OFR requirements. 

The EPA is responsible for making the 

required paragraph codification 

corrections in the EPA PSD regulations 

and communicating those corrections to 

stakeholders, including state, local, and 

Tribal (SLT) permitting authorities and 

regulated entities. SLT permitting 

authorities are not required to make 

corresponding corrections to any of 

their regulations implementing the PSD 

program including those approved by 

the EPA into a State Implementation 

Plan (SIP). 

II. Background and Rationale for This 

Action 

Part C of title I of the Clean Air Act 

(CAA), 42 U.S.C. 7470 et seq., contains 

the requirements for a component of the 

major New Source Review (NSR) 

program known as the PSD program. 

This program sets forth procedures for 

the preconstruction review and 

permitting of new and modified 

stationary sources of air pollution 

located in areas meeting the National 

Ambient Air Quality Standards 

(NAAQS) (‘‘attainment’’ areas) and areas 

for which there is insufficient 

information to classify an area as either 

attainment or nonattainment 

(‘‘unclassifiable’’ areas). The EPA’s PSD 

regulations are contained in 40 CFR 


ddrumheller on DSK120RN23PROD with RULES1