[Federal Register Volume 86, Number 112 (Monday, June 14, 2021)]
[Rules and Regulations]
[Pages 31427-31429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12261]



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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 

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Federal Register / Vol. 86, No. 112 / Monday, June 14, 2021 / Rules 
and Regulations

[[Page 31427]]



DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-482]


Schedules of Controlled Substances: Placement of N-Ethylpentylone 
in Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: The Drug Enforcement Administration places 1-(1,3-benzodioxol-
5-yl)-2-(ethylamino)pentan-1-one (known as N-ethylpentylone or 
ephylone) and its optical, positional, and geometric isomers, salts, 
and salts of isomers whenever the existence of such salts, isomers, and 
salts of isomers is possible, in schedule I of the Controlled 
Substances Act. This action makes permanent the current imposition of 
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 N-ethylpentylone.

DATES: Effective date: June 14, 2021.

FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical 
Evaluation Section, Diversion Control Division, Drug Enforcement 
Administration; Telephone: (571) 362-8207.

SUPPLEMENTARY INFORMATION:

Legal Authority

    The Controlled Substances Act (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 (1) on his own 
motion; (2) at the request of the Secretary of the Department of Health 
and Human Services (HHS); \1\ or (3) on the petition of any interested 
party. 21 U.S.C. 811(a). This action was initiated on the Attorney 
General's own motion, as delegated to the Administrator of the Drug 
Enforcement Administration (DEA), and it is supported by a 
recommendation from the Assistant Secretary for Health of HHS 
(Assistant Secretary) and an evaluation of all other relevant data by 
DEA. This action makes permanent the current, temporary imposition of 
regulatory controls and administrative, civil, and criminal sanctions 
for schedule I controlled substances on any person who handles or 
proposes to handle N-ethylpentylone.
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    \1\ As discussed in a memorandum of understanding entered into 
by the Food and Drug Administration (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 of HHS has delegated to the Assistant Secretary for Health 
of HHS the authority to make domestic drug scheduling 
recommendations. 58 FR 35460, July 1, 1993.
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Background

    On August 31, 2018, DEA published an order in the Federal Register 
amending 21 CFR 1308.11(h) to temporarily place 1-(1,3-benzodioxol-5-
yl)-2-(ethylamino)pentan-1-one (known as N-ethylpentylone or ephylone) 
in schedule I of the CSA pursuant to the temporary scheduling 
provisions of 21 U.S.C. 811(h). 83 FR 44474. That temporary scheduling 
order was effective on the date of publication, and was based on 
findings by the Acting Administrator of DEA that the temporary 
scheduling of this synthetic cathinone was necessary to avoid an 
imminent hazard to the public safety pursuant to section 811(h)(1). On 
August 27, 2020, DEA published an order to extend the temporary 
scheduling of N-ethylpentylone by one year, or until August 31, 2021, 
pursuant to section 811(h)(2). 85 FR 52915. Also, on that same date and 
in the same issue of the Federal Register, DEA simultaneously published 
a notice of proposed rulemaking (NPRM) to permanently control N-
ethylpentylone in schedule I of the CSA. 85 FR 52935. Specifically, DEA 
proposed to add N-ethylpentylone to the hallucinogenic substances list 
under 21 CFR 1308.11(d).

DEA and HHS Eight Factor Analyses

    On July 15, 2020, HHS provided DEA with a scientific and medical 
evaluation document prepared by the Food and Drug Administration (FDA) 
entitled ``Basis for the Recommendation to Control N-ethylpentylone and 
Its Optical, Geometric, and Positional Isomers, Salts, and Salts of 
Isomers in Schedule I of the Controlled Substances Act.'' After 
considering the eight factors in 21 U.S.C. 811(c) pursuant to 21 U.S.C. 
811(b), and N-ethylpentylone's abuse potential, lack of legitimate 
medical use in the United States, and lack of accepted safety for use 
under medical supervision pursuant to 21 U.S.C. 812(b), the Assistant 
Secretary recommended that N-ethylpentylone be controlled in schedule I 
of the CSA.
    In response, DEA conducted its own eightfactor analysis of N-
ethylpentylone under 21 U.S.C. 811(c), and concluded that this 
substance warrants control in schedule I of the CSA, as it meets the 
findings prescribed by 21 U.S.C. 812(b)(1). Both DEA and HHS eight-
factor analyses are available in their entirety in the public docket 
for this rule (Docket Number DEA-482) at http://www.regulations.gov 
under ``Supporting Documents.''

Determination to Schedule N-Ethylpentylone

    After a review of the available data, including the scientific and 
medical evaluation and the scheduling recommendation from HHS, DEA 
published an NPRM entitled ``Schedules of Controlled Substances: 
Placement of N-ethylpentylone in Schedule I.'' This rule proposed to 
control N-ethylpentylone, and its optical, positional, and geometric 
isomers, salts, and salts of isomers in schedule I of the CSA. 85 FR 
52935, August 27, 2020. The NPRM provided an opportunity for interested 
persons to file a request for hearing in accordance with DEA 
regulations on or before September 28, 2020. No requests for such a 
hearing were received by DEA. The NPRM also provided an opportunity for 
interested persons to submit comments on the proposed rule on or before 
September 28, 2020.

Comment Received

    DEA received one anonymous comment on the proposed rule to control 
N-ethylpentylone in schedule I

[[Page 31428]]

of the CSA. However, this comment was not related to the rule; 
therefore, DEA does not respond to the comment.

Scheduling Conclusion

    After consideration of the relevant matter presented through the 
scientific and medical evaluation and the accompanying scheduling 
recommendation of HHS, and after its own eight-factor evaluation, DEA 
finds that these facts and all other relevant data constitute 
substantial evidence of potential for abuse of N-ethylpentylone. 
Accordingly, DEA is permanently scheduling N-ethylpentylone as a 
controlled substance under the CSA.

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 and review of all other 
available data, the Acting Administrator, pursuant to 21 U.S.C. 811(a) 
and 812(b)(1), finds that:
    (1) N-Ethylpentylone has a high potential for abuse;
    (2) N-Ethylpentylone has no currently accepted medical use in 
treatment in the United States; \2\ and
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    \2\ Although there is no evidence suggesting that N-
ethylpentylone 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, to have a currently accepted medical use in 
treatment in the United States, all of the following must be 
demonstrated:
    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.
    57 FR 10499 (1992), pet. for rev. denied, Alliance for Cannabis 
Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994).
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    (3) There is a lack of accepted safety for use of N-ethylpentylone 
under medical supervision.
    Based on these findings, the Acting Administrator concludes that 1-
(1,3-benzodioxol-5-yl)-2-(ethylamino)pentan-1-one (known as N-
ethylpentylone or ephylone) and its optical, positional, and geometric 
isomers, including its salts, isomers, and salts of isomers, whenever 
the existence of such salts, isomers, and salts of isomers is possible, 
warrants continued control in schedule I of the CSA. 21 U.S.C. 
812(b)(1).

Requirements for Handling N-Ethylpentylone

    N-Ethylpentylone will continue \3\ to 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:
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    \3\ N-Ethylpentylone has been subject to schedule I controls on 
a temporary basis, pursuant to 21 U.S.C. 811(h), by virtue of the 
August 31, 2018 temporary scheduling order (83 FR 44474) and the 
subsequent one-year extension of that order (August 27, 2020, 85 FR 
52915).
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    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) N-
ethylpentylone, or who desires to handle N-ethylpentylone, must 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.
    2. Security. N-Ethylpentylone is subject to schedule I security 
requirements and must be handled and stored pursuant to 21 U.S.C. 821, 
823, 871(b), and in accordance with 21 CFR 1301.71-1301.76. Non-
practitioners handling this substance must also comply with the 
employee screening requirements of 21 CFR 1301.90-1301.93.
    3. Labeling and Packaging. All labels, labeling, and packaging for 
commercial containers of N-ethylpentylone must be in compliance with 21 
U.S.C. 825 and 958(e), and be in accordance with 21 CFR part 1302.
    4. Quota. Only registered manufacturers are permitted to 
manufacture N-ethylpentylone in accordance with a quota assigned 
pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.
    5. Inventory. Any person registered with DEA to handle N-
ethylpentylone must have an initial inventory of all stocks of 
controlled substances (including N-ethylpentylone) on hand on the date 
the registrant first engages in the handling of the controlled 
substances pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 
CFR 1304.03, 1304.04, and 1304.11. After the initial inventory, every 
DEA registrant must take a new inventory of all stocks of controlled 
substances (including N-ethylpentylone) 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.
    6. Records and Reports. Every DEA registrant must maintain records 
and submit reports with respect to N-ethylpentylone pursuant to 21 
U.S.C. 827 and 958(e), and in accordance with 21 CFR 1301.74(b) and (c) 
and parts 1304, 1312, and 1317.
    7. Order Forms. Every DEA registrant who distributes N-
ethylpentylone must continue to comply with the order form 
requirements, pursuant to 21 U.S.C. 828 and 21 CFR part 1305.
    8. Importation and Exportation. All importation and exportation of 
N-ethylpentylone must be in compliance with 21 U.S.C. 952, 953, 957, 
and 958, and in accordance with 21 CFR part 1312.
    9. Liability. Any activity involving N-ethylpentylone 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) and 13563 
(Improving Regulation and 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 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 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 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.

[[Page 31429]]

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.

Regulatory Flexibility Act

    The Acting Administrator, in accordance with the Regulatory 
Flexibility Act (RFA), 5 U.S.C. 601-602, 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. On August 
31, 2018, DEA published an order to temporarily place N-ethylpentylone 
in schedule I of the CSA pursuant to the temporary scheduling 
provisions of 21 U.S.C. 811(h). On August 27, 2020, DEA published a 
temporary scheduling order extending the temporary scheduling of N-
ethylpentylone for up to one year pursuant to 21 U.S.C. 811(h)(2). 
Accordingly, all entities that currently handle or plan to handle N-
ethylpentylone have already been required to establish and implement 
the systems and processes required to specifically handle N-
ethylpentylone. There are currently 31 unique registrations authorized 
to handle N-ethylpentylone specifically, as well as a number of 
registered analytical labs that are authorized to handle schedule I 
controlled substances generally. Some of these entities are likely to 
be large entities. However, since DEA does not have information of 
registrant size and the majority of DEA registrants are small entities 
or are employed by small entities, DEA estimates a maximum of 26 
entities are small entities. Therefore, DEA conservatively estimates as 
many as 26 small entities are affected by this rule.
    A review of the 31 registrations indicates that all entities that 
currently handle N-ethylpentylone also handle other schedule I 
controlled substances, and thus they have established and implemented 
(or maintain) the systems and processes required to handle N-
ethylpentylone as a schedule I substance. Therefore, DEA anticipates 
that this rule will impose minimal or no economic impact on any 
affected entities, and, thus, will not have a significant economic 
impact on any of the 26 affected small entities. Therefore, DEA has 
concluded that this rule will not have a significant economic impact on 
a substantial number of small entities.

Unfunded Mandates Reform Act of 1995 (UMRA)

    In accordance with 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 
$100,000,000 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.

Determination To Make Rule Effective Immediately

    As indicated above, this rule finalizes the schedule I control 
status of N-ethylpentylone that has already been in effect since the 
publication of an order in the Federal Register amending 21 CFR 
1308.11(h) to temporarily place N-ethylpentylone in schedule I of the 
CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 
811(h). 83 FR 44474. The August 2018 order was effective on the date of 
publication, and was based on findings by the then-Acting Administrator 
that the temporary scheduling of N-ethylpentylone was necessary to 
avoid an imminent hazard to the public safety pursuant to 21 U.S.C. 
811(h)(1). Because this rule finalizes the control status of N-
ethylpentylone that has already been in effect for over two and half 
years, it does not alter the legal obligations of any person who 
handles this substance. Rather, it merely makes permanent the current 
scheduling status and corresponding legal obligations. Therefore, DEA 
is making the rule effective on the date of publication in the Federal 
Register, as any delay in the effective date is unnecessary and would 
be contrary to the public interest.

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. This action 
would not impose recordkeeping or reporting requirements on State or 
local governments, individuals, businesses, or organizations. 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.

Congressional Review Act (CRA)

    This rule is not a major rule as defined by the CRA, 5 U.S.C. 804. 
However, pursuant to the CRA, DEA is submitting a copy of this 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. Add paragraph (d)(86); and
0
b. Remove and reserve paragraph (h)(36).
    The addition reads as follows:


Sec.  1308.11   Schedule I.

* * * * *
    (d) * * *

(86) N-ethylpentylone (Other names: ephylone, 1-(1,3-benzodioxol-   7543
 5-yl)-2-(ethylamino)pentan-1-one)..............................
 

* * * * *

D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-12261 Filed 6-11-21; 8:45 am]
BILLING CODE 4410-09-P