Schedules of Controlled Substances: Placement of Solriamfetol in Schedule IV
| Published date | 07 January 2020 |
| Citation | 85 FR 643 |
| Record Number | 2019-27955 |
| Section | Rules and Regulations |
| Court | Drug Enforcement Administration,Justice Department |
Federal Register, Volume 85 Issue 4 (Tuesday, January 7, 2020)
[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]
[[Page 643]]
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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
[[Page 644]]
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.
[[Page 645]]
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
