[Federal Register Volume 89, Number 204 (Tuesday, October 22, 2024)]
[Rules and Regulations]
[Pages 84281-84286]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24083]


=======================================================================
-----------------------------------------------------------------------

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,

[[Page 84282]]

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.
---------------------------------------------------------------------------

    \1\ As 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).
---------------------------------------------------------------------------

    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 Eight-Factor 
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.
---------------------------------------------------------------------------

    \3\ Schedules of Controlled Substances: Placement of 
Ethylphenidate in Schedule I, 88 FR 65330 (Sept. 22, 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

[[Page 84283]]

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\
---------------------------------------------------------------------------

    \4\ https://apps.deadiversion.usdoj.gov/webforms2/spring/main?execution=e1s2.
---------------------------------------------------------------------------

    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 notice-and-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

[[Page 84284]]

a currently accepted medical use in treatment in the United 
States.\5\
---------------------------------------------------------------------------

    \5\ When 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 well-controlled studies 
proving efficacy; iv. the drug must be accepted by qualified 
experts; and v. the scientific evidence must be widely available. 
See Marijuana Scheduling Petition; Denial of Petition; Remand, 57 FR 
10499 (Mar. 26, 1992), pet. for rev. denied, Alliance for Cannabis 
Therapeutics v. Drug Enforcement Admin., 15 F.3d 1131, 1135 (D.C. 
Cir. 1994). DEA and HHS applied the traditional five-part test for 
currently accepted medical use in this matter. In a recent published 
letter in a different context, HHS applied an additional two-part 
test to determine currently accepted medical use for substances that 
do not satisfy the five-part test: (1) whether there exists 
widespread, current experience with medical use of the substance by 
licensed health care practitioners operating in accordance with 
implemented jurisdiction-authorized programs, where medical use is 
recognized by entities that regulate the practice of medicine, and, 
if so, (2) whether there exists some credible scientific support for 
at least one of the medical conditions for which part (1) is 
satisfied. On April 11, 2024, the Department of Justice's Office of 
Legal Counsel (OLC) issued an opinion, which, among other things, 
concluded that HHS's two-part test would be sufficient to establish 
that a drug has a currently accepted medical use. Office of Legal 
Counsel, Memorandum for Merrick B. Garland Attorney General Re: 
Questions Related to the Potential Rescheduling of Marijuana at 3 
(April 11, 2024). For purposes of this 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.
---------------------------------------------------------------------------

    (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

[[Page 84285]]

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.
---------------------------------------------------------------------------

    \6\ 44 U.S.C. 3501-3521.
---------------------------------------------------------------------------

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

0
1. The authority citation for part 1308 continues to read as follows:

    Authority:  21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise 
noted.


0
2. In Sec.  1308.11:
0
a. Redesignate paragraphs (f)(6) through (f)(12) as (f)(7) through 
(f)(13); and
0
b. Add a new paragraph (f)(6)
    The addition reads as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (f) * * *

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

* * * * *

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.


[[Page 84286]]


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