Schedules of Controlled Substances: Placement of Solriamfetol in Schedule IV, 27943-27947 [2019-12723]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 84, Number 116 (Monday, June 17, 2019)]
[Rules and Regulations]
[Pages 27943-27947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12723]


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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: Interim final rule, with request for comments.

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SUMMARY: On March 20, 2019, the U.S. Food and Drug Administration 
approved a new drug application for SUNOSI, a drug product consisting 
of solriamfetol ((R)-2-amino-3-phenylpropyl carbamate hydrochloride) 
tablets for oral use. Thereafter, the Department of Health and Human 
Services provided the Drug Enforcement Administration (DEA) with a 
scheduling recommendation to place solriamfetol in schedule IV 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 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 rulemaking is June 17, 2019. 
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 July 17, 2019. 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 in accordance with 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 July 17, 2019.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-504'' 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: Lynnette M. Wingert, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.

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 
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.

[[Page 27944]]

    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 and Drug 
Enforcement Administration eight-factor analyses, to this interim final 
rule are available at https://www.regulations.gov for easy reference.

Request for 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.

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, the DEA is required to commence an expedited scheduling 
action with respect to certain new drugs approved by the U.S. 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 submitted for a drug that has a stimulant, 
depressant, or hallucinogenic effect on the central nervous system, 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 the 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).

Background

    On December 20, 2017, Jazz Pharmaceuticals, Inc. (Sponsor) 
submitted an NDA to FDA for SUNOSI (solriamfetol) 75 and 150 mg oral 
tablets. FDA determined that solriamfetol is a new molecular entity, 
and HHS determined that solriamfetol has a stimulant effect on the 
central nervous system. On March 20, 2019, FDA approved the NDA for 
SUNOSI (solriamfetol) to improve wakefulness in adult patients with 
excessive daytime sleepiness associated with narcolepsy or obstructive 
sleep apnea (OSA).

Determination To Schedule Solriamfetol

    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, DEA received notification 
from HHS that the FDA had approved an NDA for SUNOSI (solriamfetol).
    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 solriamfetol met the 
21 U.S.C. 812(b)(4) criteria for placement in schedule IV of the CSA.
    Pursuant to subsection 811(j)--and based on the HHS recommendation, 
NDA approval by HHS/FDA, and DEA's determination--the DEA is issuing 
this interim final rule to schedule solriamfetol as a schedule IV 
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 the 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-
504.'' 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: Solriamfetol is a 
new molecular entity that has not been marketed in the United States or 
any other country. Thus, information about the diversion and actual 
abuse of solriamfetol is limited. Solriamfetol is currently not 
available for medical treatment, has not been diverted from legitimate 
sources, and individuals have not taken this substance in amounts 
sufficient to create a hazard to public health and safety. The DEA 
notes that there are no reports for solriamfetol in the National 
Forensic Laboratory Information System (NFLIS),\2\ which collects drug

[[Page 27945]]

identification results from drug cases submitted to and analyzed by 
state and local forensic laboratories. There were also no reports in 
STARLiMS,\3\ DEA's laboratory drug evidence data system of record.
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    \2\ The National Forensic Laboratory Information System (NFLIS) 
represents an important resource in monitoring illicit drug 
trafficking, including the diversion of legally manufactured 
pharmaceuticals into illegal markets. NFLIS is a comprehensive 
information system that includes data from forensic laboratories 
that handle more than 96% of an estimated 1.0 million distinct 
annual state and local drug analysis cases. NFLIS includes drug 
chemistry results from completed analyses only. While NFLIS data is 
not direct evidence of abuse, it can lead to an inference that a 
drug has been diverted and abused. See 76 FR 77330, 77332, Dec. 12, 
2011. NFLIS data were queried 04/02/2019.
    \3\ On October 1, 2014, the DEA implemented STARLiMS (a web-
based, commercial laboratory information management system) to 
replace the System to Retrieve Information from Drug Evidence 
(STRIDE) as its laboratory drug evidence data system of record. DEA 
laboratory data submitted after September 30, 2014, are reposited in 
STARLiMS. STARLiMS data were queried on 04/02/2019.
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    As stated by HHS, solriamfetol is a stimulant that has low affinity 
for the human dopamine, serotonin, and norepinephrine transporters. In 
a clinical study investigating the abuse potential of solriamfetol, HHS 
concluded that solriamfetol produced subjective responses that were 
similar to those for the schedule IV stimulant phentermine.
    2. Scientific Evidence of Its Pharmacological Effects, if Known: 
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. According to HHS, general behavioral 
studies in animals indicate that solriamfetol produces stimulant 
effects such as an increase in locomotor activity and anorexic effects. 
However, in drug discrimination studies used to predict subjective 
effects in humans, solriamfetol at doses that do not severely impact 
motor responses did not mimic stimulus effects of schedule II 
substances amphetamine or cocaine. In a human abuse potential study, 
therapeutic doses of solriamfetol produced feelings of relaxation, 
hypervigilance, elevated mood, insomnia, and hyperhidrosis. These 
adverse events (AEs) are consistent with those of stimulant drugs and 
are also seen with phentermine, a schedule IV substance. In other 
clinical studies, adverse events such as anxiety, insomnia, and 
agitation were seen in subjects treated with solriamfetol. HHS 
concluded that the results from animal and human studies indicate that 
solriamfetol has low abuse potential similar to phentermine.
    3. The State of Current Scientific Knowledge Regarding the Drug or 
Other Substance: Solriamfetol is a new molecular entity, chemically 
known as (R)-2-amino-3-phenylpropyl carbamate. It has a molecular 
formula of C10H14N2O2. 
Solriamfetol is a white to off-white solid that has a melting point 
between 183-189 [deg]C. It is highly soluble in water at a pH between 
one and seven. On March 20, 2019, the FDA approved an NDA for 
solriamfetol for medical use to improve wakefulness in adult patients 
with excessive daytime sleepiness associated with narcolepsy or OSA. 
Thus, solriamfetol has an accepted medical use in the United States. 
Solriamfetol will be marketed as a once daily tablet and is available 
in strengths of 75 and 150 mg. The 75 mg tablet is functionally scored 
to permit a starting dose for patients with OSA of 37.5 mg once 
daily.\4\
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    \4\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf, accessed May 6, 2019.
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    4. Its History and Current Pattern of Abuse: There is no 
information available relating to the history and current pattern of 
abuse of solriamfetol, since this drug is not currently marketed in any 
country. HHS notes that solriamfetol produces abuse-related signals and 
abuse potential similar to that of schedule IV controlled substance 
phentermine.
    The DEA conducted a search on the NFLIS and STARLiMS databases for 
solriamfetol encounters. Consistent with the fact that solriamfetol is 
a new molecular entity, these databases had no records of encounters of 
solriamfetol by law enforcement.
    5. The Scope, Duration, and Significance of Abuse: Solriamfetol as 
a single active ingredient in a drug product is currently not marketed 
in any country. Thus, information on the scope, duration, and 
significance of abuse for solriamfetol is lacking. However, as HHS 
notes, data from preclinical and clinical studies summarized in factor 
2 and epidemiological data indicate that the scope, duration, and 
significance of abuse for solriamfetol would be similar to those of 
phentermine, a schedule IV substance. As stated by HHS, data from 
animal and human studies indicate that solriamfetol has abuse potential 
similar to phentermine.
    6. What, if any, Risk There is to the Public Health: The extent of 
abuse potential of a drug is an indication of its public health risk. 
Data from the preclinical and clinical studies suggest that the abuse 
potential and physical or psychological dependence of solriamfetol are 
similar to schedule IV substances such as phentermine.
    7. Its Psychic or Physiological Dependence Liability: Physical 
dependence for solriamfetol was tested in animal toxicity studies and 
during Phase 3 clinical trials. According to HHS, animal toxicity 
studies in rats and dogs demonstrated no symptoms of withdrawal from 
discontinuation of the solriamfetol. In clinical studies, sudden 
cessation of solriamfetol produced a low percentage of adverse events 
that HHS concluded did not exhibit a consistent pattern of withdrawal 
symptoms. Based on these studies, HHS stated that solriamfetol does not 
appear to cause physical dependence.
    8. Whether the Substance is an Immediate Precursor of a Substance 
Already Controlled under the CSA: Solriamfetol is not an immediate 
precursor of any controlled substance, as defined in 21 U.S.C. 802(23).
    Conclusion: After considering the scientific and medical evaluation 
conducted by HHS, HHS' recommendation, and its own eight-factor 
analysis, the DEA has determined that these facts and all relevant data 
constitute substantial evidence of a potential for abuse of 
solriamfetol. As such, DEA hereby schedules solriamfetol as a 
controlled substance under the CSA.

Determination of Appropriate Schedule

    The CSA outlines 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 the DEA, pursuant to 21 U.S.C. 812(b)(4), 
finds that:
    1. Solriamfetol has a low potential for abuse relative to the drugs 
or other substances in schedule III.
    Receptor binding and functional studies demonstrate that 
solriamfetol acts as a dopamine and norepinephrine reuptake inhibitor 
that does not appear to bind to other receptors typically associated 
with abuse (e.g., opioid, cannabinoid, GABAergic, and other ion 
channels). Results from animal behavioral studies (using solriamfetol 
treated animals) demonstrated increases in locomotor activity, 
increases in awake time in the sleep-wake cycle, and anorexia, all of 
which may be indicative of abuse potential of solriamfetol. However, in 
drug discrimination studies used to predict subjective effects in 
humans, solriamfetol did not produce full generalization to cocaine or 
amphetamine. In a human abuse potential study, subjects treated with 
solriamfetol experienced adverse events

[[Page 27946]]

that were similar to that of the schedule IV stimulant phentermine. In 
phase 1 through 3 clinical trials, solriamfetol treated subjects 
exhibited low rates of adverse effects including insomnia, anxiety, and 
agitation. The data from preclinical and clinical studies indicate that 
solriamfetol has a low potential for abuse relative to other substances 
in schedule III. Solriamfetol has abuse potential similar to 
phentermine.
    2. Solriamfetol has a currently accepted medical use in the United 
States.
    The FDA recently approved solriamfetol to improve wakefulness in 
adult patients with excessive daytime sleepiness associated with 
narcolepsy or obstructive sleep apnea. Thus, solriamfetol has a 
currently accepted medical use in the United States.
    3. Solriamfetol may lead to limited physical dependence or 
psychological dependence relative to the drugs or other substances in 
schedule III.
    In animal toxicology studies, rats or dogs exposed to solriamfetol 
demonstrated no indication of physical dependence after abrupt 
discontinuation of the drug. This is consistent with the effects of 
amphetamine-like stimulant drugs, which produce psychological 
dependence, but little or no physical dependence. In clinical studies, 
subjects receiving solriamfetol reported an array of adverse events 
after discontinuation from the drug. However, there was no consistent 
pattern of withdrawal symptoms that would indicate physical dependence. 
In a human abuse potential study, solriamfetol increased drug liking 
scores that are significantly greater than that of placebo and are 
similar to or less than that of phentermine. These data collectively 
suggest that solriamfetol abuse may lead to limited psychological 
dependence relative to drugs in schedule III and largely similar to 
that of schedule IV stimulants.
    Based on these findings, the Acting Administrator of DEA concludes 
that solriamfetol warrants control in schedule IV of the CSA. 21 U.S.C. 
812(b)(4).

Requirements for Handling Solriamfetol

    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 in accordance with 21 CFR parts 1301 
and 1312. Any person who currently handles or intends to handle 
solriamfetol, and is not registered with DEA, must submit an 
application for registration and may not continue to handle 
solriamfetol, unless DEA has approved the 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 IV registration must surrender all 
quantities of currently held solriamfetol, or may transfer all 
quantities of currently held solriamfetol to a person registered with 
DEA in accordance with 21 CFR part 1317, in additional 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 
1301.71-93.
    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 must take an inventory of all stocks of solriamfetol 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.
    Any person who becomes registered with the DEA to handle 
solriamfetol must take an initial inventory of all stocks of controlled 
substances containing solriamfetol 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 
solriamfetol) 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. Every DEA registrant must maintain records 
and submit reports for 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

    Public Law 114-89 was signed into law, amending 21 U.S.C. 811. This 
amendment provides that in cases where a 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. Therefore, DEA has determined that the notice 
and comment requirements of section 553 of the APA, 5 U.S.C. 553, do 
not apply to this scheduling action.

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 Public Law 114-89, 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.

[[Page 27947]]

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 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 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

    In accordance with 5 U.S.C. 603(a), ``[w]henever an agency is 
required by [5 U.S.C. 553], or any other law, to publish general notice 
of proposed rulemaking for any proposed rule, or publishes a notice of 
proposed rulemaking for an interpretive rule involving the internal 
revenue laws of the United States, the agency shall prepare and make 
available for public comment an initial regulatory flexibility 
analysis.'' As noted in the above discussion regarding applicability of 
the APA, the DEA has determined that the notice and comment 
requirements of section 553 of the APA, 5 U.S.C. 553, do not apply to 
this scheduling action. Consequently, the Regulatory Flexibility Act 
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 for inflation) in any 
one 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 does 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:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for 21 CFR part 1308 continues to read as 
follows:

    Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.


0
2. Amend Sec.  1308.14 by:
0
a. Redesignating paragraph (f)(12) as (f)(13);
0
b. Adding new paragraph (f)(12).
    The addition to read as follows:


Sec.  1308.14   Schedule IV.

* * * * *
    (f) * * *

(12) Solriamfetol (2-amino-3-phenylpropyl car-bamate;               1650
 benzenepropanol, beta-amino-, carbamate (ester))...............
 

* * * * *

    Dated: June 10, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-12723 Filed 6-14-19; 8:45 am]
BILLING CODE 4410-09-P