[Federal Register Volume 85, Number 4 (Tuesday, January 7, 2020)]
[Rules and Regulations]
[Pages 643-645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27955]



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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-504]


Schedules of Controlled Substances: Placement of Solriamfetol 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 June 17, 
2019, placing solriamfetol (2-amino-3-phenylpropyl carbamate), 
including its salts, isomers, and salts of isomers whenever the 
existence of such salts, isomers, and salts of isomers is possible, in 
schedule IV of the Controlled Substances Act. With the issuance of this 
final rule, the Drug Enforcement Administration maintains solriamfetol, 
including its salts, isomers, and salts of isomers whenever the 
existence of such salts, isomers, and salts of isomers is possible, in 
schedule IV of the CSA.

DATES: The effective date of this final rulemaking is January 7, 2020.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.

SUPPLEMENTARY INFORMATION: 

Background and Legal Authority

    The Improving Regulatory Transparency for New Medical Therapies Act 
(Pub. L. 114-89) was signed into law on November 25, 2015. This law 
amended the Controlled Substances Act (CSA) and states that in cases 
where the Drug Enforcement Administration (DEA) receives notification 
from The Department of Health and Human Services (HHS) that the 
Secretary has approved an application under section 505(c) of the 
Federal Food, Drug, and Cosmetic Act (FDCA), the DEA is required to 
issue an interim final rule, with opportunity for public comment and to 
request a hearing, controlling the drug not later than 90 days after 
receiving such notification from HHS and subsequently to issue a final 
rule. 21 U.S.C. 811(j). When controlling a drug pursuant to section 
811(j), the DEA must apply the scheduling criteria of subsections 
811(b), (c), and (d) and section 812(b). 21 U.S.C. 811(j)(3).
    Solriamfetol (2-amino-3-phenylpropyl carbamate) is a new molecular 
entity with central nervous system (CNS) stimulant properties. 
Solriamfetol primarily acts as a dopamine and norepinephrine reuptake 
inhibitor and does not bind to any other receptors that are typically 
associated with abuse, such as opioid or cannabinoid receptors, 
GABAergic, and other ion channels. On December 20, 2017, Jazz 
Pharmaceuticals, Inc. (Sponsor) submitted a new drug application (NDA) 
to the Food and Drug Administration (FDA) for SUNOSI (solriamfetol) 75 
and 150 mg oral tablets. On March 19, 2019, DEA received from HHS a 
scientific and medical evaluation document (dated March 8, 2019) 
prepared by the FDA related to solriamfetol. Pursuant to 21 U.S.C. 
811(b), this document contained an eight-factor analysis of the abuse 
potential of solriamfetol, along with HHS' recommendation to control 
solriamfetol under schedule IV of the CSA. Subsequently, on March 20, 
2019, the DEA received notification that the FDA, on that same date, 
approved the NDA for SUNOSI (solriamfetol), under section 505(c) of the 
FDCA, to improve wakefulness in adult patients with excessive daytime 
sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).
    On June 17, 2019, the DEA published an interim final rule [84 FR 
27943] to make solriamfetol (including its salts, isomers, and salts of 
isomers whenever the existence of such salts, isomers, and salts of 
isomers is possible) a schedule IV controlled substance. Interested 
persons were provided a 30 day comment period in which to submit 
comments on this rulemaking in accordance with 21 U.S.C. 811(j)(3) and 
21 CFR 1308.43(g). In addition, interested persons were provided an 
opportunity to file a request for hearing or waiver of hearing pursuant 
to 21 U.S.C. 811(j)(3) and 21 CFR 1308.44. The deadline for submitting 
comments or requests for hearing/waiver of hearing was July 17, 2019. 
The DEA received one comment and did not receive any requests for 
hearing or waiver of hearing.

Comments Received

    In response to the interim final rule, the DEA received one 
comment. The commenter indicated that all clinical studies on 
solriamfetol are supported by the sponsor of the NDA for solriamfetol 
and thus subject to conflicts of interests. This commenter further 
stated that long-term adverse health effects (including adverse effects 
on the cardiovascular system) of solriamfetol have not been studied and 
such effects need to be considered.
    DEA Response: The comment relating to the alleged conflicts of 
interests as a result of financial support of the clinical studies by 
the sponsor of the NDA and the long-term toxicity of solriamfetol are 
related to the FDA approval process (such as weighing the benefits 
versus risks of approving the drug for the proposed indication) and are 
outside of the scope of this rulemaking because they do not relate to 
the factors determinative of control of a substance (21 U.S.C. 811(c)). 
The DEA notes that the FDA approved an NDA for solriamfetol and 
provided the DEA with a scheduling recommendation for solriamfetol. The 
scheduling recommendation by HHS and its notification to DEA regarding 
the FDA approval of the NDA initiated the DEA review and scheduling 
action. As stated in the interim final rule, after careful 
consideration of data from preclinical and clinical studies, the DEA 
concurred with the HHS recommendation that solriamfetol has abuse 
potential comparable to other schedule IV stimulants and therefore 
supported--and continues to support through this final rule--placement 
of solriamfetol in schedule IV under the CSA.
    Based on the rationale set forth in the interim final rule, the DEA 
adopts the interim final rule, without change.

Requirements for Handling Solriamfetol

    As indicated above, solriamfetol has been a schedule IV controlled 
substance by virtue of the interim final rule issued by DEA in June 
2019. Thus, this final rule does not alter the regulatory requirements 
applicable to handlers of solriamfetol that have been in place since 
that time. Nonetheless, for informational purposes, we restate here 
those requirements. Solriamfetol is subject to the CSA's schedule IV 
regulatory controls and administrative, civil, and criminal sanctions 
applicable to the manufacture, distribution, reverse distribution, 
dispensing, importing, exporting, research, and conduct of 
instructional activities and chemical analysis with, and possession 
involving schedule IV substances, including, but not limited to, 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) solriamfetol, or who desires to handle solriamfetol, must be 
registered with the DEA to conduct such activities pursuant to 21 
U.S.C. 822, 823, 957, and 958 and

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in accordance with 21 CFR parts 1301 and 1312. Any person who intends 
to handle solriamfetol, and is not registered with the DEA, must submit 
an application for registration and may not handle solriamfetol, unless 
the DEA approves that application for registration, pursuant to 21 
U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 
and 1312.
    2. Disposal of stocks. Any person who obtains a schedule IV 
registration to handle solriamfetol but who subsequently does not 
desire or is not able to maintain such registration must surrender all 
quantities of solriamfetol, or may transfer all quantities of 
solriamfetol to a person registered with the DEA in accordance with 21 
CFR part 1317, in addition to all other applicable federal, state, 
local, and tribal laws.
    3. Security. Solriamfetol is subject to schedule III-V security 
requirements and must be handled and stored in accordance with 21 CFR 
1301.71-1301.93.
    4. Labeling and Packaging. All labels, labeling, and packaging for 
commercial containers of solriamfetol must comply with 21 U.S.C. 825 
and 958(e), and be in accordance with 21 CFR part 1302.
    5. Inventory. Every DEA registrant who possesses any quantity of 
solriamfetol was required to keep an inventory of solriamfetol on hand, 
as of June 17, 2019, pursuant to 21 U.S.C. 827 and 958(e), and in 
accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    6. Records and Reports. DEA registrants must maintain records and 
submit reports for solriamfetol, or products containing solriamfetol, 
pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR 
parts 1304, 1312, and 1317.
    7. Prescriptions. All prescriptions for solriamfetol or products 
containing solriamfetol 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 solriamfetol 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 and the CSA.
    9. Importation and Exportation. All importation and exportation of 
solriamfetol must be in compliance with 21 U.S.C. 952, 953, 957, and 
958, and in accordance with 21 CFR part 1312.
    10. Liability. Any activity involving solriamfetol 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, without change, affirms the amendment made by the 
interim final rule 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 provides 
that in cases where a new drug is (1) approved by HHS and (2) HHS 
recommends control in CSA schedule II-V, the DEA shall issue an interim 
final rule scheduling the drug within 90 days. Additionally, the law 
specifies that the rulemaking shall become immediately effective as an 
interim final rule without requiring the DEA to demonstrate good cause. 
The DEA issued an interim final rule on June 17, 2019 and solicited 
public comments on that rule. Section 811 further states that after 
giving interested persons the opportunity to comment and to request a 
hearing, ``the Attorney General shall issue a final rule in accordance 
with the scheduling criteria of subsections (b), (c), and (d) of this 
section and section 812(b) of'' the CSA. 21 U.S.C. 811(j)(3). The DEA 
is now responding to the comment submitted by the public and issuing 
the final rule, in conformity with the APA and the procedure required 
by 21 U.S.C. 811.

Executive Orders 12866, 13563, and 13771, Regulatory Planning and 
Review, Improving Regulation and Regulatory Review, and Reducing 
Regulatory and Controlling Regulatory Costs

    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 (OMB) 
pursuant to section 3(d)(1) of Executive Order 12866 and the principles 
reaffirmed in Executive Order 13563.
    This final rule is not an Executive Order 13771 regulatory action 
pursuant to Executive Order 12866 and OMB guidance.\1\
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    \1\ Office of Mgmt. & Budget, Exec. Office of The President, 
Interim Guidance Implementing Section 2 of the Executive Order of 
January 30, 2017 Titled ``Reducing Regulation and Controlling 
Regulatory Costs'' (Feb. 2, 2017).
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Executive Order 12988, Civil Justice Reform

    This regulation meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 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 final rule does not have federalism implications warranting 
the application of Executive Order 13132. The final 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 Executive Order 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. Under 21 U.S.C. 811(j), the DEA was not required to publish a 
general notice of proposed rulemaking prior to this final rule. 
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., the 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 for 
inflation) in any one year.'' Therefore, neither a Small Government 
Agency Plan nor any other action is required under UMRA of 1995.

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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. 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

    This final rule is not a major rule as defined by the Congressional 
Review Act (CRA), 5 U.S.C. 804. This rule will not result in an annual 
effect on the economy of $100,000,000 or more; a major increase in 
costs or prices for consumers, individual industries, Federal, State, 
or local government agencies, or geographic regions; or significant 
adverse effects on competition, employment, investment, productivity, 
innovation, or on the ability of U.S.-based companies to compete with 
foreign based companies in domestic and export markets. However, 
pursuant to the CRA, the DEA has submitted 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.

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
Accordingly, the interim final rule amending 21 CFR part 1308, which 
published on June 17, 2019 (84 FR 27943), is adopted as a final rule 
without change.

    Dated: December 17, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-27955 Filed 1-6-20; 8:45 am]
 BILLING CODE 4410-09-P