Schedules of Controlled Substances: Placement of Cenobamate in Schedule V
| Published date | 20 August 2020 |
| Citation | 85 FR 51340 |
| Record Number | 2020-17357 |
| Section | Rules and Regulations |
| Court | Drug Enforcement Administration |
Federal Register, Volume 85 Issue 162 (Thursday, August 20, 2020)
[Federal Register Volume 85, Number 162 (Thursday, August 20, 2020)]
[Rules and Regulations]
[Pages 51340-51342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17357]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-581]
Schedules of Controlled Substances: Placement of Cenobamate in
Schedule V
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 March
10, 2020, placing cenobamate [(1R)-1-(2-chlorophenyl)-2-(tetrazol-2-
yl)ethyl] carbamate, including its salts, in schedule V of the
Controlled Substances Act (CSA). With the issuance of this final rule,
the Drug Enforcement Administration maintains cenobamate, including its
salts, in schedule V of the CSA.
DATES: The effective date of this rulemaking is August 20, 2020.
FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting
and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone: (571) 362-3261.
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
(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, with opportunity for public comment and to
request a hearing, controlling the drug within a specified 90-day
timeframe and subsequently to 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 March 10, 2020, DEA published an interim final rule in the
Federal Register to make cenobamate (including its salts) a schedule V
controlled substance. 85 FR 13741. The interim final rule provided an
opportunity for interested persons to submit comments, as well as file
a request for hearing or waiver of hearing, on or before April 9, 2020.
DEA received two comments and did not receive any requests for hearing
or waiver of hearing.
Comments Received
In response to the interim final rule, DEA received two comments.
One comment was blank and the second comment was not related to the
scheduling of cenobamate. Therefore, DEA has no responses to those
comments.
Based on the rationale set forth in the interim final rule, DEA
adopts the interim final rule, without change.
Requirements for Handling Cenobamate
As indicated above, cenobamate has been a schedule V controlled
substance by virtue of an interim final rule issued by DEA in March
2020. Thus, this final rule does not alter the regulatory requirements
applicable to handlers of cenobamate that have been in place since that
time. Nonetheless, for informational purposes, we restate here those
requirements. Cenobamate is subject to the CSA's schedule V 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 V
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) cenobamate, or who desires to handle cenobamate, 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 cenobamate, and is not
registered with DEA, must submit an application for registration and
may not continue to handle cenobamate, unless DEA has approved 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 V
registration to handle cenobamate and subsequently determines they are
no longer willing or able to maintain such registration must surrender
all quantities of currently held cenobamate, or may transfer all
quantities of cenobamate 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. Cenobamate is subject to schedule III-V security
requirements and must be handled and stored in accordance with 21 CFR
1301.71-1301.93. Non-practitioners handling cenobamate must also 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 cenobamate must comply with 21 U.S.C. 825 and
958(e), and be in accordance with 21 CFR part 1302.
5. Inventory. Since March 10, 2020, every DEA registrant who
possesses any quantity of cenobamate was required to keep an inventory
of cenobamate on hand, pursuant to 21 U.S.C. 827 and 958(e), and in
accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
[[Page 51341]]
6. Records and Reports. DEA registrants must maintain records and
submit reports for cenobamate, or products containing cenobamate,
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 cenobamate, or products
containing cenobamate, 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 V controlled substances,
such registrants should be advised that (consistent with the foregoing
considerations) any manufacturing or distribution of cenobamate 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
cenobamate 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 cenobamate 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 rulemaking. However, 21 U.S.C. 811(j) provides
that in cases where a certain new drug is: (1) Approved by HHS and (2)
HHS recommends control in CSA schedule II-V, DEA shall issue an interim
final rule scheduling the drug within 90 days. Additionally, subsection
(j) specifies that the rulemaking shall become immediately effective as
an interim final rule without requiring DEA to demonstrate good cause.
DEA issued an interim final rule on March 10, 2020, and solicited
public comments on that rule. Subsection (j) further provides 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). As
stated above, the two public comments DEA received to the interim final
rule did not necessitate any response. DEA is now issuing the final
rule in accordance with subsection (j).
Executive Orders (E.O.) 12866, 13563, and 13771, Regulatory Planning
and Review, Improving Regulation and Regulatory Review, and Reducing
Regulation 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 E.O. 12866 and the principles reaffirmed
in E.O. 13563.
This final rule is not an E.O. 13771 regulatory action pursuant to
E.O. 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 Regulating and Controlling
Regulatory Costs'' (Feb. 2, 2017).
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E.O. 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.
E.O. 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.
E.O. 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 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 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 million 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. This action does 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 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, 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.
0
Accordingly, the interim final rule amending 21 CFR part 1308, which
[[Page 51342]]
published on March 10, 2020 (85 FR 13741), is adopted as final without
change.
Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-17357 Filed 8-19-20; 8:45 am]
BILLING CODE 4410-09-P
