[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 http://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 http://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 http://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 http://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 http://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