[Federal Register Volume 87, Number 189 (Friday, September 30, 2022)]
[Rules and Regulations]
[Pages 59296-59298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21253]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-949]


Schedules of Controlled Substances: Placement of Daridorexant in 
Schedule IV

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: This final rule adopts without change an interim final rule 
with request for comments published in the Federal Register on April 7, 
2022, placing daridorexant ([(S)-2-(5-chloro-4-methyl-1H-
benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl](5-methoxy-2-(2H-1,2,3-
triazol-2-yl)phenyl)methanone), including its salts, isomers, and salts 
of isomers whenever the existence of such salts, isomers, and salts of 
such isomers is possible, in schedule IV of the Controlled Substances 
Act (CSA). With the issuance of this final rule, the Drug Enforcement 
Administration maintains daridorexant in schedule IV of the CSA.

DATES: The effective date of this rulemaking is October 31, 2022.

FOR FURTHER INFORMATION CONTACT: Dr. Terrence L. Boos, Drug & Chemical 
Evaluation Section, Diversion Control Division, Drug Enforcement 
Administration; Telephone: (571) 362-3249.

SUPPLEMENTARY INFORMATION: 

Background and Legal Authority

    Under the Controlled Substances Act (CSA), as amended in 2015 by 
the Improving Regulatory Transparency for New Medical Therapies Act 
(section 2(b) of Pub. L. 114-89), when the Drug Enforcement 
Administration (DEA) receives notification from the Department of 
Health and Human Services (HHS) that the Secretary has approved a 
certain new drug and HHS recommends control in the CSA schedule II-V, 
DEA is required to issue an interim final rule (IFR), with opportunity 
for public comment and to request a hearing, controlling the drug 
within a specified 90-day timeframe and to subsequently issue a final 
rule. 21 U.S.C. 811(j). When controlling a drug pursuant to subsection 
(j), DEA must apply the scheduling criteria of 21 U.S.C. 811 (b) 
through (d) and 812(b). 21 U.S.C. 811(j)(3).
    On January 7, 2022, DEA received notification that the United 
States Food and Drug Administration (FDA) approved, on the same date, a 
new drug application (NDA) for QUVIVIQ (daridorexant) tablets for use 
as a treatment of adult patients with insomnia, characterized by 
difficulties with sleep onset and/or sleep maintenance. Daridorexant, 
chemically known as [(S)-2-(5-chloro-4-methyl-1H-benzo[d]imidazol-2-
yl)-2-methylpyrrolidin-1-yl](5-methoxy-2-(2H-1,2,3-triazol-2-
yl)phenyl)methanone, is a new molecular entity (NME) with central 
nervous system activity. Previously, on December 22, 2021, DEA received 
HHS's recommendation that DEA place daridorexant and ``its salts'' in 
schedule IV of the CSA, in the event that FDA approves the NDA for 
daridorexant. On April 7, 2022, DEA, pursuant to 21 U.S.C. 811(j), 
published an IFR (87 FR 20313) to place daridorexant (including its 
salts, isomers, and salts of isomers) in schedule IV of the CSA; the 
regulatory text only listed the chemical name for daridorexant. In the 
preamble of the IFR, DEA incorrectly misspelled the proprietary name 
for daridorexant's approved drug product as ``QUIVIVIQ.'' The preamble 
of this final rule now correctly uses ``QUVIVIQ.'' It bears emphasis 
that the regulatory text used in this final rule remains unchanged from 
that used in the IFR.
    The IFR provided an opportunity for interested persons to submit 
comments, as well as to file a request for hearing or waiver of 
hearing, on or before May 9, 2022. DEA did not receive any requests for 
hearing or waivers of hearing.

Comment Received

    In response to the IFR, DEA received one comment. The submission 
was from an anonymous commenter. The commenter supported the placement 
of daridorexant in schedule IV of the CSA, and noted its safety, 
effectiveness, and approved indication for use as a treatment of 
patients with insomnia.
    DEA Response: DEA appreciates the support for this rulemaking.

Requirements for Handling Daridorexant

    As indicated above, daridorexant has been a schedule IV controlled 
substance by virtue of an IFR issued by DEA on April 7, 2022. Thus, 
this final rule does not alter the regulatory requirements applicable 
to handlers of daridorexant that have been in place since that time. 
Nonetheless, for informational purposes, DEA restates here those 
requirements. Daridorexant is subject to the CSA's schedule IV 
regulatory controls and administrative, civil, and criminal sanctions 
applicable to the

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manufacture, distribution, reverse distribution, dispensing, importing, 
exporting, research, and conduct of instructional activities and 
chemical analysis with, and possession involving schedule IV 
substances, including the following:
    1. Registration. Any person who handles (manufactures, distributes, 
reverse distributes, dispenses, imports, exports, engages in research, 
or conducts instructional activities or chemical analysis with, or 
possesses) daridorexant, or who desires to handle daridorexant, 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. Any person who intends to handle daridorexant and is not 
registered with DEA must submit an application for registration and may 
not handle daridorexant unless DEA has approved that application, 
pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 
CFR parts 1301 and 1312. These registration requirements, however, are 
not applicable to patients (end users) who possess daridorexant 
pursuant to a lawful prescription.
    2. Disposal of stocks. Any person who obtains a schedule IV 
registration to handle daridorexant but who subsequently does not 
desire or is not able to maintain such registration must surrender all 
quantities of daridorexant, or may transfer all quantities of 
daridorexant to a person registered with DEA in accordance with 21 CFR 
part 1317, in addition to all other applicable Federal, State, local, 
and tribal laws.
    3. Security. Daridorexant is subject to schedule III-V security 
requirements for DEA registrants and must be handled and stored in 
accordance with 21 CFR 1301.71-1301.77. Non-practitioners handling 
daridorexant must also comply with the employee screening requirements 
of 21 CFR 1301.90-1301.93. These requirements, however, are not 
applicable to patients (end users) who possess daridorexant pursuant to 
a lawful prescription.
    4. Labeling and Packaging. All labels, labeling, and packaging for 
commercial containers of daridorexant must comply with 21 U.S.C. 825 
and be in accordance with 21 CFR part 1302.
    5. Inventory. Every DEA registrant who possesses any quantity of 
daridorexant was required to keep an inventory of daridorexant on hand, 
as of April 7, 2022, pursuant to 21 U.S.C. 827 and in accordance with 
21 CFR 1304.03, 1304.04, and 1304.11. These requirements, however, are 
not applicable to patients (end users) who possess daridorexant 
pursuant to a lawful prescription.
    6. Records and Reports. DEA registrants must maintain records and 
submit reports for daridorexant, pursuant to 21 U.S.C. 827 and 832(a), 
and in accordance with 21 CFR 1301.74(b) and (c) and 1301.76(b) and 
parts 1304, 1312, and 1317.
    7. Prescriptions. All prescriptions for daridorexant, or products 
containing daridorexant, must comply with 21 U.S.C. 829, and be issued 
in accordance with 21 CFR parts 1306 and 1311, subpart C.
    8. Manufacturing and Distributing. In addition to the general 
requirements of the CSA and DEA regulations that are applicable to 
manufacturers and distributors of schedule IV controlled substances, 
such registrants should be advised that (consistent with the foregoing 
considerations) any manufacturing or distribution of daridorexant may 
only be for the legitimate purposes consistent with the drug's 
labeling, or for research activities authorized by the Federal Food, 
Drug, and Cosmetic Act (FDCA), as applicable, and the CSA.
    9. Importation and Exportation. All importation and exportation of 
daridorexant must comply with 21 U.S.C. 952, 953, 957, and 958, and be 
in accordance with 21 CFR part 1312.
    10. Liability. Any activity involving daridorexant 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

Administrative Procedure Act

    This final rule adopts, without change, the amendment made by the 
IFR that is already in effect. Section 553 of the Administrative 
Procedure Act (APA) (5 U.S.C. 553) generally requires notice and 
comment for rulemakings. However, 21 U.S.C. 811(j) provides that in 
cases where a certain new drug is (1) approved by HHS, under section 
505(c) of the FDCA and (2) HHS recommends control in CSA schedule II-V, 
DEA shall issue an IFR scheduling the drug within 90 days. 
Additionally, subsection (j) specifies that the rulemaking shall become 
immediately effective as an IFR without requiring DEA to demonstrate 
good cause. DEA issued an IFR on April 7, 2022, and solicited public 
comments on that rule. Subsection (j) further states that after giving 
interested persons the opportunity to comment and to request a hearing, 
the Attorney General, as delegated to the Administrator of DEA, shall 
issue a final rule in accordance with the scheduling criteria of 21 
U.S.C. 811(b) through (d) and 812(b). DEA is now responding to the 
comment submitted by the public and issuing the final rule, in 
accordance with 21 U.S.C. 811(j).

Executive Orders 12866 (Regulatory Planning and Review) and 13563 
(Improving Regulation and Regulatory Review)

    In accordance with 21 U.S.C. 811(a) and (j), this 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 
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 on the distribution of power and 
responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This final 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 Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to 
rules that are subject to notice and comment under section 553(b) of 
the APA. As noted in the above discussion regarding the applicability 
of the APA, DEA was not required to publish a general notice

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of proposed rulemaking. Consequently, the RFA does not apply.

Unfunded Mandates Reform Act of 1995

    In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 
2 U.S.C. 1501 et seq., DEA has determined 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.

Paperwork Reduction Act of 1995

    This action does not impose a new collection of information 
requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-
3521.

Congressional Review Act

    This final 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 this final rule to the Government Accountability 
Office, the House, and the Senate under the CRA.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
September 26, 2022, by Administrator Anne Milgram. That document with 
the original signature and date is maintained by DEA. For 
administrative purposes only, and in compliance with requirements of 
the Office of the Federal Register, the undersigned DEA Federal 
Register Liaison Officer has been authorized to sign and submit the 
document in electronic format for publication, as an official document 
of DEA. This administrative process in no way alters the legal effect 
of this document upon publication in the Federal Register.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Reporting and recordkeeping requirements.

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
Accordingly, the interim final rule (87 FR 20313) amending 21 CFR part 
1308, which published on April 7, 2022, is adopted as a final rule 
without change.

Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2022-21253 Filed 9-29-22; 8:45 am]
BILLING CODE 4410-09-P