Schedules of Controlled Substances: Placement of Cenobamate in Schedule V, 13741-13746 [2020-04963]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 85, Number 47 (Tuesday, March 10, 2020)]
[Rules and Regulations]
[Pages 13741-13746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04963]


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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: Interim final rule, with request for comments.

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SUMMARY: On November 21, 2019, the U.S. Food and Drug Administration 
(FDA) approved a new drug application for XCOPRI (cenobamate) tablets. 
Cenobamate is chemically known as [(1R)-1-(2-chlorophenyl)-2-(tetrazol-
2-yl)ethyl] carbamate. Thereafter, the Department of Health and Human 
Services provided the Drug Enforcement Administration (DEA) with a 
scheduling recommendation to place cenobamate in schedule V of the 
Controlled Substances Act (CSA). In accordance with the CSA, as revised 
by the Improving Regulatory Transparency for New Medical Therapies Act, 
DEA is hereby issuing an interim final rule placing cenobamate, 
including its salts, in schedule V of the CSA.

DATES: The effective date of this rulemaking is March 10, 2020. 
Interested persons may file written comments on this rulemaking in 
accordance with 21 U.S.C. 811(j)(3) and 21 CFR 1308.43(g). Electronic 
comments must be submitted, and written comments must be postmarked, on 
or before April 9, 2020. Commenters should be aware that the electronic 
Federal Docket Management System will not accept comments after 11:59 
p.m. Eastern Time on the last day of the comment period.
    Interested persons may file a request for hearing or waiver of 
hearing pursuant to 21 U.S.C. 811(j)(3) and 21 CFR 1308.44. Requests 
for hearing and waivers of an opportunity for a hearing or to 
participate in a hearing must be received on or before April 9, 2020.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-581'' on all correspondence, including any 
attachments.
     Electronic comments: The Drug Enforcement Administration 
encourages that all comments be submitted electronically through the 
Federal eRulemaking Portal, which provides the ability to type short 
comments directly into the comment field on the web page or attach a 
file for lengthier comments. Please go to https://www.regulations.gov 
and follow the online instructions at that site for submitting 
comments. Upon completion of your submission, you will receive a 
Comment Tracking Number for your comment. Please be aware that 
submitted comments are not instantaneously available for public view on 
Regulations.gov. If you have received a Comment Tracking Number, your 
comment has been successfully submitted and there is no need to 
resubmit the same comment.
     Paper comments: Paper comments that duplicate the 
electronic submission are not necessary and are discouraged. Should you 
wish to mail a paper comment in lieu of an electronic comment, it 
should be sent via regular or express mail to: Drug Enforcement 
Administration, Attn: DEA Federal Register Representative/DPW, 8701 
Morrissette Drive, Springfield, VA 22152.
     Hearing requests: All requests for hearing and waivers of 
participation must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for hearing and waivers of participation should also be sent 
to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 
Morrissette Drive, Springfield, Virginia 22152; and (2) Drug 
Enforcement Administration, Attn: DEA Federal Register Representative/
DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Scott Brinks, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 362-
3261.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received are considered part of the 
public record. They will, unless reasonable cause is given, be made 
available by the Drug Enforcement Administration (DEA) for public 
inspection online at https://www.regulations.gov. Such information 
includes personal identifying information (such as your name, address, 
etc.) voluntarily submitted by the commenter. The Freedom of 
Information Act (FOIA) applies to all comments received. If you want to

[[Page 13742]]

submit personal identifying information (such as your name, address, 
etc.) as part of your comment, but do not want it to be made publicly 
available, you must include the phrase ``PERSONAL IDENTIFYING 
INFORMATION'' in the first paragraph of your comment. You must also 
place all of the personal identifying information you do not want made 
publicly available in the first paragraph of your comment and identify 
what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify the 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information and 
confidential business information identified as directed above will 
generally be made publicly available in redacted form. If a comment has 
so much confidential business information or personal identifying 
information that it cannot be effectively redacted, all or part of that 
comment may not be made publicly available. Comments posted to https://www.regulations.gov may include any personal identifying information 
(such as name, address, and phone number) included in the text of your 
electronic submission that is not identified as directed above as 
confidential.
    An electronic copy of this document and supplemental information, 
including the complete Department of Health and Human Services (HHS) 
and DEA eight-factor analyses, to this interim final rule are available 
at https://www.regulations.gov for easy reference.

Request for Hearing, Notice of Appearance at Hearing, or Waiver of 
Participation in Hearing

    Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking 
``on the record after opportunity for a hearing.'' Such proceedings are 
conducted pursuant to the provisions of the Administrative Procedure 
Act (APA), 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316, 
subpart D. Interested persons may file requests for a hearing, or 
notices of intent to participate in a hearing, in conformity with the 
requirements of 21 CFR 1308.44(a) or (b), and include a statement of 
interest in the proceeding and the objections or issues, if any, 
concerning which the person desires to be heard. Any interested person 
may file a waiver of an opportunity for a hearing or to participate in 
a hearing together with a written statement regarding the interested 
person's position on the matters of fact and law involved in any 
hearing as set forth in 21 CFR 1308.44(c).
    All requests for a hearing and waivers of participation must be 
sent to DEA using the address information provided above.

Background and Legal Authority

    Under the Improving Regulatory Transparency for New Medical 
Therapies Act (Pub. L. 114-89), which was signed into law on November 
25, 2015, DEA is required to commence an expedited scheduling action 
with respect to certain new drugs approved by the United States Food 
and Drug Administration (FDA). As provided in 21 U.S.C. 811(j), this 
expedited scheduling is required where both of the following conditions 
apply: (1) The Secretary of the Department of Health and Human Services 
(Secretary of HHS or the Secretary) has advised DEA that a New Drug 
Application (NDA) has been approved for a drug that has a stimulant, 
depressant, or hallucinogenic effect on the central nervous system 
(CNS), and that it appears that such drug has an abuse potential; and, 
(2) the Secretary recommends that DEA control the drug in schedule II, 
III, IV, or V pursuant to 21 U.S.C. 811(a) and (b). In these 
circumstances, DEA is required to issue an interim final rule 
controlling the drug within 90 days.
    The law further states that the 90-day timeframe starts the later 
of: (1) The date DEA receives HHS' scientific and medical evaluation/
scheduling recommendation or (2) the date DEA receives notice of the 
NDA approval by HHS. In addition, the law specifies that the rulemaking 
shall become immediately effective as an interim final rule without 
requiring DEA to demonstrate good cause therefor. Thus, the purpose of 
subsection (j) is to speed the process by which DEA schedules newly 
approved drugs that are currently either in schedule I or not 
controlled (but which have sufficient abuse potential to warrant 
control) so that such drugs may be marketed without undue delay 
following FDA approval.\1\
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    \1\ Given the parameters of subsection (j), in DEA's view, it 
would not apply to a reformulation of a drug containing a substance 
currently in schedules II through V for which an NDA has recently 
been approved.
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    Subsection (j) further provides that the interim final rule shall 
give interested persons the opportunity to comment and to request a 
hearing. After the conclusion of such proceedings, DEA must issue a 
final rule in accordance with the scheduling criteria of subsections 21 
U.S.C. 811(b), (c), and (d) and 21 U.S.C. 812(b).
    Cenobamate is a new molecular entity with CNS depressant 
properties, and is chemically known as [(1R)-1-(2-chlorophenyl)-2-
(tetrazol-2-yl)ethyl] carbamate. Cenobamate is a voltage-gated sodium 
channel (NaV) blocker that also has gamma-aminobutyric acid 
(GABA)-A channel positive allosteric modulator (PAM) activity. On 
November 21, 2018, SK Life Science (Sponsor) submitted an NDA to FDA 
for XCOPRI (cenobamate) 12.5, 25, 50, 100, 150, and 200 mg oral 
tablets. On November 22, 2019, DEA received notification from HHS that 
FDA, on November 21, 2019, approved the NDA for XCOPRI (cenobamate) 
under section 505(c) of the Federal Food, Drug, and Cosmetic Act 
(FDCA), for the treatment of partial-onset seizures in adult patients.

Determination to Schedule Cenobamate

    Pursuant to 21 U.S.C. 811(a)(1), proceedings to add a drug or 
substance to those controlled under the CSA may be initiated by request 
of the Secretary of HHS.\2\ On December 10, 2019, DEA received from HHS 
a scientific and medical evaluation document (dated December 3, 2019) 
prepared by FDA, titled ``Basis for the Recommendation to Control 
Cenobamate and Its Salts in Schedule V of the Controlled Substances 
Act.'' Pursuant to 21 U.S.C. 811(b) and (c), this document contained an 
eight-factor analysis of the abuse potential of cenobamate, along with 
HHS' recommendation to control cenobamate under schedule V of the CSA.
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    \2\ As set forth in a memorandum of understanding entered into 
by HHS, 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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    On January 15, 2020, DEA received from HHS a supplemental letter 
(dated January 15, 2020) clarifying factors 6 and 7 listed in 21 U.S.C. 
811(c), as well as the third finding under 21 U.S.C. 812(b)(5), to 
control cenobamate in schedule V. This letter did not change HHS' 
overall recommendation to place cenobamate in schedule V.
    In response, DEA reviewed the scientific and medical evaluation and 
scheduling recommendation provided by HHS, along with all other 
relevant data, and completed its own eight-factor review document 
pursuant to 21 U.S.C. 811(c). DEA concluded that cenobamate

[[Page 13743]]

met the 21 U.S.C. 812(b)(5) criteria for placement in schedule V of the 
CSA.
    Pursuant to subsection 811(j), and based on HHS recommendation, NDA 
approval by HHS/FDA, and DEA's determination, DEA is issuing this 
interim final rule to schedule cenobamate as a schedule V controlled 
substance under the CSA.
    Included below is a brief summary of each factor as analyzed by HHS 
and DEA, and as considered by DEA in its scheduling action. Please note 
that both DEA and HHS analyses are available in their entirety under 
``Supporting Documents'' in the public docket for this interim final 
rule at https://www.regulations.gov, under Docket Number ``DEA-581.'' 
Full analysis of, and citations to, the information referenced in the 
summary may also be found in the supporting and related material.
    1. Its Actual or Relative Potential for Abuse: Cenobamate is a new 
molecular entity and is not currently available or marketed in any 
country. Evidence regarding its diversion, illicit manufacturing, or 
deliberate ingestions is currently lacking. However, as reported by 
HHS, preclinical studies show that cenobamate shares similar mechanisms 
of action as substances in schedules IV or V. Cenobamate, like the 
schedule V substance lacosamide, is a voltage-gated sodium channel 
(Nav) blocker. In addition, cenobamate, like the schedule IV 
substances alprazolam, chlordiazepoxide, and midazolam, has gamma-
aminobutyric acid (GABA)-A channel positive allosteric modulator (PAM) 
activity and increases the effects of the inhibitory neurotransmitter, 
GABA. Data obtained from general behavioral studies demonstrate that 
cenobamate produces abuse-related CNS activity. In a preclinical drug 
discrimination study in rats, cenobamate mimicked the discriminative 
stimulus effects of the schedule IV substance chlordiazepoxide. 
However, in a separate drug discrimination study, cenobamate only 
partially mimicked the discriminative stimulus effects of the schedule 
IV substance midazolam. In addition, cenobamate, like midazolam, 
produced reinforcing effects in a rat self-administration assay by 
significantly increasing the number of infusions compared to saline 
infusions. In human abuse potential (HAP) studies, cenobamate produced 
drug-liking visual analog scale scores that were significantly higher 
compared to placebo but significantly lower than the schedule IV 
substance alprazolam. Thus, these studies demonstrate that cenobamate 
produced behavioral effects in rats comparable to that of schedule IV 
substances (i.e., similar to chlordiazepoxide but less than midazolam); 
whereas in humans, cenobamate produced drug-liking effects that were 
significantly less than that of the schedule IV substance alprazolam. 
Thus, cenobamate likely has abuse potential less than that of schedule 
IV substances but similar to that of schedule V substances of the CSA. 
Based on the totality of the available scientific data, HHS concluded 
that cenobamate has an abuse potential similar to that of substances in 
schedule V of the CSA.
    2. Scientific Evidence of Its Pharmacological Effects, if Known: 
Cenobamate shares similar mechanisms of action to substances in 
schedule IV or V and has anti-epileptic activity in humans. Cenobamate, 
like the schedule V substance lacosamide, is a voltage-gated sodium 
channel blocker. In addition, cenobamate, like the schedule IV 
benzodiazepines chlordiazepoxide, midazolam, and alprazolam, is a GABA-
A channel positive allosteric modulator. Cenobamate and other GABAergic 
substances interact directly with the GABA-A receptor which is a 
ligand-gated chloride ion channel consisting of five subunits and a 
central chloride channel to enhance the opening of the ligand-gated 
chloride channel and the influx of chloride. Cenobamate's ability to 
bind to GABA-A receptors and sodium channel sites is consistent with 
the action of anti-epileptic or sedative drugs, such as 
chlordiazepoxide, midazolam, alprazolam, and lacosamide (schedule IV or 
V substances).
    As described in HHS' review document, studies evaluating 
cenobamate's effect in these general behavioral studies showed that 
cenobamate mimicked or partially mimicked substances such as 
chlordiazepoxide, alprazolam, or midazolam (schedule IV substances) in 
producing behaviors that are associated with abuse. In an in vivo drug 
discrimination study in rats, cenobamate produced chlordiazepoxide-like 
(schedule IV) discriminative stimulus effects. In a separate drug 
discrimination study, cenobamate produced discriminative stimulus 
effects that partially mimicked the effects of the schedule IV 
substance midazolam. In self-administration studies, cenobamate was 
self-administered by rodents, but the self-administration (i.e., number 
of infusions) of cenobamate was lower than that of midazolam, a 
schedule IV substance. In HAP studies, cenobamate produced drug-liking 
scores higher than placebo but less than that of the schedule IV 
substance alprazolam. Based on these studies, HHS concluded that 
cenobamate has mechanisms of actions that are similar to that of 
substances in schedule IV or V but the abuse potential of cenobamate is 
less than that of alprazolam, a schedule IV substance.
    3. The State of Current Scientific Knowledge Regarding the Drug or 
Other Substance: Cenobamate is a new molecular entity. It is chemically 
known as [(1R)-1-(2-chlorophenyl)-2-(tetrazol-2-yl)ethyl] carbamate. 
Other chemical names for cenobamate include: 2H-tetrazole-2-ethanol, 
alpha-(2-chlorophenyl)-, carbamate (ester), (alphaR)-; and carbamic 
acid (R)-(+)-1-(2-chlorophenyl)-2-(2H-tetrazol-2-yl)ethyl ester. It has 
a molecular formula of 
C10H10ClN5O2 and a 
molecular weight of 267.67 g/mol. Cenobamate is a white to off-white 
crystalline solid that has a melting point between 96.8-98.3 [deg]C. It 
is partially soluble in water at a pH between 2 and 12. Pharmacokinetic 
data indicate that cenobamate is rapidly absorbed, has good 
bioavailability, and has a long half-life. Additional studies in humans 
show that cenobamate is not extensively metabolized and does not 
produce any major circulating metabolites. On November 21, 2019, FDA 
approved an NDA for XCOPRI (cenobamate) for the treatment of partial-
onset seizures in adult patients. Thus, cenobamate has an accepted 
medical use in the United States.
    4. Its History and Current Pattern of Abuse: There is no 
information on the history and current pattern of abuse for cenobamate, 
since it has not been marketed, legally or illegally, in any country.
    On December 19, 2019, DEA conducted a search on the National 
Forensic Laboratory Information System (NFLIS) \3\ and the STARLiMS \4\ 
databases for cenobamate's encounters. Consistent with the fact that 
cenobamate is a new molecular entity, these databases had no records of 
encounters by law enforcement.
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    \3\ NFLIS is a national forensic laboratory reporting system 
that systematically collects results from drug chemistry analyses 
conducted by Federal, State, and local forensic laboratories in the 
United States.
    \4\ STARLiMS is a laboratory information management system that 
systematically collects results from drug chemistry analyses 
conducted by DEA laboratories. On October 1, 2014, STARLiMS replaced 
STRIDE as the DEA laboratory drug evidence data system of record.
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    The pharmacological activity of cenobamate, like schedule IV or V 
GABAergic or anti-epileptic substances, at sodium channels and GABA-A 
receptors suggests that cenobamate's pattern of abuse would be less 
than that

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of schedule IV substances but similar to that of schedule V anti-
epileptic drugs.
    5. The Scope, Duration, and Significance of Abuse: Cenobamate is 
not marketed, legally or illegally, in any country. However, HHS stated 
that based on the preclinical and clinical study data of cenobamate, 
the scope, duration, and significance of cenobamate abuse would likely 
be similar to that of schedule V substances.
    6. What, if any, Risk There is to the Public Health: According to 
HHS, the public health risk associated with cenobamate is due to its 
abuse potential. Thus, HHS concluded that the data from preclinical and 
clinical studies (see Factor 2, above) showed that cenobamate has abuse 
potential and physical or psychological dependence (Factor 7) similar 
to that of substances in schedule V.
    7. Its Psychic or Physiological Dependence Liability: The psychic 
or physiological dependence liability of drugs can be demonstrated by 
abuse-related animal and human studies (see Factor 2, above). In animal 
studies, there were no significant alterations in the withdrawal phase 
of the study in the measured parameters at either of the tested doses. 
However, in human studies, cenobamate led to a mild withdrawal syndrome 
characterized by insomnia, decreased appetite, depressed mood, tremor, 
and amnesia. Based on these studies, HHS concluded that cenobamate has 
a psychic or physiological dependence liability similar to that of 
substances in schedule V.
    8. Whether the Substance is an Immediate Precursor of a Substance 
Already Controlled under the CSA: Cenobamate is not an immediate 
precursor of any substance already controlled in the CSA.
    Conclusion: After considering the scientific and medical evaluation 
conducted by HHS, HHS' recommendation, and its own eight-factor 
analysis, DEA has determined that these facts and all relevant data 
constitute substantial evidence of a potential for abuse of cenobamate. 
As such, DEA hereby schedules cenobamate as a controlled substance 
under the CSA.

Determination of Appropriate Schedule

    The CSA lists the findings required to place a drug or other 
substance in any particular schedule (I, II, III, IV, or V). 21 U.S.C. 
812(b). After consideration of the analysis and recommendation of the 
Assistant Secretary for Health of HHS and review of all available data, 
the Acting Administrator of DEA, pursuant to 21 U.S.C. 812(b)(5), finds 
that:
    (1) Cenobamate has a low potential for abuse relative to the drugs 
or other substances in schedule IV.
    Cenobamate, similar to the schedule IV substance lacosamide, is a 
voltage-gated sodium channel blocker that also has GABA-A channel PAM 
activity similar to schedule IV benzodiazepines. In drug discrimination 
studies, cenobamate partially generalized to the discriminative 
stimulus effects of midazolam (schedule IV) but fully generalized to 
the discriminative stimulus effects of chlordiazepoxide (schedule IV) 
in rats. In self-administration studies, cenobamate was self-
administered by rodents, but the self-administration (i.e., number of 
infusions) of cenobamate was lower than that of midazolam. In the HAP 
studies, cenobamate produced drug-liking scores higher than placebo but 
less than that of alprazolam, a schedule IV substance. Based on all of 
these studies, HHS concluded that cenobamate has an abuse potential 
similar to that of substances in schedule V of the CSA. Thus, DEA finds 
that the potential for abuse of cenobamate is less than that of 
schedule IV benzodiazepines but similar to that of substances in 
schedule V of the CSA.
    (2) Cenobamate has a currently accepted medical use in the United 
States.
    FDA recently approved an NDA for cenobamate as a treatment for 
partial-onset seizures in adult patients. Thus, cenobamate has a 
currently accepted medical use in treatment in the United States.
    (3) Abuse of Cenobamate may lead to limited physical dependence or 
psychological dependence relative to the drugs or other substances in 
schedule IV.
    HHS reported in Factor 7 that cenobamate may lead to mild 
withdrawal syndromes characterized by insomnia, decreased appetite, and 
amnesia in humans. Thus, based on clinical study and preclinical data, 
HHS concluded in Factor 6 that cenobamate has a physical or 
psychological dependence liability similar to that of substances 
controlled in schedule V. In a separate letter, dated January 15, 2020, 
HHS further stated that based on the totality of available scientific 
data, cenobamate may lead to physical or psychological dependence that 
is low relative to substances in schedule IV of the CSA and similar to 
that of substances in schedule V. Based on these data, DEA finds that 
the abuse of cenobamate may lead to limited physical or psychological 
dependence relative to the drugs or other substances in schedule IV.
    Based on these findings, the Acting Administrator of DEA concludes 
that cenobamate warrants control in schedule V of the CSA. 21 U.S.C. 
812(b)(5).

Requirements for Handling Cenobamate

    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 currently handles or 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 does not desire or is not 
able to maintain a schedule V 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.
    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. Every DEA registrant who possesses any quantity of 
cenobamate must take an inventory of cenobamate on hand, pursuant to 21 
U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 
1304.11.
    Any person who becomes registered with DEA to handle cenobamate 
must take an initial inventory of all stocks of controlled substances 
(including

[[Page 13745]]

cenobamate) on hand on the date the registrant first engages in the 
handling of controlled substances, pursuant to 21 U.S.C. 827 and 
958(e), 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 cenobamate) 
on hand every two years, 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 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 FDCA 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

    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 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, the law specifies that the rulemaking shall become 
immediately effective as an interim final rule without requiring DEA to 
demonstrate good cause.

Executive Orders 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 Executive Order 12866 and the principles 
reaffirmed in Executive Order 13563.
    This interim final rule is not an Executive Order 13771 regulatory 
action pursuant to Executive Order 12866 and OMB guidance.\5\
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    \5\ 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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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 rulemaking does not have federalism implications warranting 
the application of Executive Order 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 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), DEA is not required to publish a 
general notice of proposed rulemaking. Consequently, the RFA does not 
apply to this interim final rule.

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. 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 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 interim 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, DEA amends 21 CFR part 1308 as 
follows:

[[Page 13746]]

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), unless otherwise noted.

0
2. Amend Sec.  1308.15 by:
0
a. Redesignating paragraphs (e)(2) through (5) as (e)(3) through (6), 
respectively;
0
b. Adding new paragraph (e)(2).
    The addition reads as follows:


Sec.  1308.15  Schedule V.

* * * * *
    (e) * * *

(2) Cenobamate ([(1R)-1-(2-chlorophenyl)-2-(tetrazol-2-             2720
 yl)ethyl] carbamate; 2H-tetrazole-2-ethanol, alpha-(2-
 chlorophenyl)-, carbamate (ester), (alphaR)-; carbamic
 acid (R)-(+)-1-(2-chlorophenyl)-2-(2H-tetrazol-2-yl)ethyl
 ester)....................................................
 

* * * * *

    Dated: March 5, 2020.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020-04963 Filed 3-9-20; 8:45 am]
 BILLING CODE 4410-09-P