Schedules of Controlled Substances: Placement of Oliceridine in Schedule II, 68749-68753 [2020-22762]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 85, Number 211 (Friday, October 30, 2020)]
[Rules and Regulations]
[Pages 68749-68753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22762]



[[Page 68749]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-715]


Schedules of Controlled Substances: Placement of Oliceridine in 
Schedule II

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Interim final rule, with request for comments.

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SUMMARY: On August 7, 2020, the U.S. Food and Drug Administration 
approved a new drug application for oliceridine, chemically known as N-
[(3-methoxythiophen-2-yl)methyl] ({2-[(9R)-9-(pyridin-2-yl)-6-oxaspiro 
[4.5]decan-9-yl]ethyl{time} )amine fumarate. The Department of Health 
and Human Services provided the Drug Enforcement Administration (DEA) 
with a scheduling recommendation to place oliceridine in schedule II 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 
oliceridine, including its isomers, esters, ethers, salts and salts of 
isomers, esters and ethers whenever the existence of such isomers, 
esters, ethers and salts is possible, in schedule II of the CSA.

DATES: The effective date of this rulemaking is October 30, 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 November 30, 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 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 November 30, 
2020.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-715'' 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 A. Brinks, Regulatory Drafting 
and Policy Support Section, Diversion Control Division, Drug 
Enforcement Administration; Mailing Address: 8701 Morrissette Drive, 
Springfield, Virginia 22152; Telephone: (571) 362-3261.

SUPPLEMENTARY INFORMATION:

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 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.
    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 (IFR) are 
available at https://www.regulations.gov for easy reference.

Request for Hearing or Appearance; Waiver

    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

[[Page 68750]]

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, Public Law 114-89, 2(b), 129 Stat. 698, 700 (2015), 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 (the 
Secretary) has advised DEA that an application for a new drug 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 IFR 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 
application approval by HHS. In addition, the law specifies that the 
rulemaking shall become immediately effective as an IFR 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 IFR 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).
    On November 2, 2017, Trevena, Inc. (Sponsor) submitted an initial 
New Drug Application (NDA) to FDA for oliceridine that was subsequently 
resubmitted on February 7, 2020. FDA determined that oliceridine is a 
new molecular entity, and HHS determined that oliceridine has a 
depressant effect on the central nervous system. On August 7, 2020, FDA 
approved the NDA for oliceridine for medical use as an intravenous drug 
for the management of acute pain severe enough to require an 
intravenous opioid analgesic and for patients for whom alternative 
treatments are inadequate.

Determination To Schedule Oliceridine

    On July 27, 2020, DEA received a scientific and medical evaluation 
document from HHS prepared by FDA related to oliceridine, titled: 
``Basis for the Recommendation to Control Oliceridine and its Salts in 
Schedule II of the Controlled Substances Act.'' Pursuant to 21 U.S.C. 
811(b), this document contained an eight-factor analysis of the abuse 
potential of oliceridine, along with HHS's recommendation to control 
oliceridine under schedule II of the CSA. Subsequently, on August 7, 
2020, DEA received notification from HHS that FDA had approved an NDA 
for oliceridine (OLINVYK).
    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 oliceridine met the 21 
U.S.C. 812(b)(2) criteria for placement in schedule II of the CSA.
    Pursuant to subsection 811(j), and based on HHS's recommendation, 
the NDA approval by HHS/FDA, and DEA's determination, DEA is issuing 
this IFR to schedule oliceridine as a schedule II 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 IFR at 
https://www.regulations.gov, under Docket Number ``DEA-715.'' 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: Oliceridine 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 oliceridine is limited. Oliceridine 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. DEA notes that there are 
no reports for oliceridine in the National Forensic Laboratory 
Information System (NFLIS),\2\ which collects drug identification 
results from drug cases submitted to and analyzed by Federal, State, 
and local forensic laboratories. There were also no reports in DEA's 
laboratory drug evidence data system of record, STARLiMS.\3\
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    \2\ 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 percent 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 on July 28, 2020.
    \3\ On October 1, 2014, 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 July 28, 2020.
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    According to the legislative history of the CSA, one of the 
criteria by which DEA should assess actual or relative potential for 
abuse is whether the substance in question ``is so related in its 
action to a substance already listed as having a potential for abuse to 
make it likely that it will have the same potential for abuse as such 
substance, thus making it reasonable to assume that there may be 
significant diversions from legitimate channels, significant use 
contrary to or without medical advice, or that it has a substantial 
capability of creating hazards to the health of the user or to the 
safety of the community.'' \4\ As stated by HHS, oliceridine is a high-
affinity mu opioid agonist that produces behavioral effects similar to 
other mu opioid agonists, such as the schedule II opioid morphine. 
Moreover, in a rat drug discrimination study, oliceridine generalized 
to morphine, showing that oliceridine has opioid-like properties. In a 
clinical study investigating the abuse potential of oliceridine, HHS 
concluded that oliceridine produced subjective responses that were 
similar to those for morphine. Specifically, like morphine, oliceridine 
produced positive subjective responses and euphoria-related adverse 
events in clinical studies. Together, this

[[Page 68751]]

evidence demonstrates that oliceridine is related in action and effect 
to the schedule II substance morphine, and can therefore be expected to 
have a similar potential for abuse.
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    \4\ Comprehensive Drug Abuse Prevention and Control Act of 1970, 
H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970), reprinted in 
U.S.C.C.A.N. 4566, 4603.
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    2. Scientific Evidence of Its Pharmacological Effects, if Known: 
Oliceridine has high affinity for the mu-opioid receptor and does not 
bind to any other receptors that are typically associated with abuse, 
such as kappa and delta opioid receptors, cannabinoid receptors, 
GABAergic receptors, or other ion channels. According to HHS, general 
behavioral studies in animals indicate that oliceridine produces 
behavioral and motor effects similar to those of morphine, a schedule 
II substance. Additionally, oliceridine produces self-administration in 
rats. Furthermore, in a drug discrimination study used to predict 
subjective effects in humans, oliceridine mimicked the stimulus effects 
of morphine. In a human abuse potential (HAP) study, therapeutic and 
supratherapeutic doses of oliceridine produced euphoria, somnolence, 
and paresthesia. These adverse events are consistent with those of 
other schedule II opioids such as morphine. In other clinical studies, 
adverse events such as somnolence, sedation, anxiety, restlessness, and 
paresthesia were seen in subjects treated with oliceridine. As 
concluded by HHS, results from preclinical and clinical studies 
indicate that oliceridine has abuse potential similar to morphine.
    3. The State of Current Scientific Knowledge Regarding the Drug or 
Other Substance: Oliceridine is a new molecular entity, chemically 
known as N-[(3-methoxythiophen-2-yl)methyl] ({2-[(9R)-9-(pyridin-2-yl)-
6-oxaspiro [4.5]decan-9-yl]ethyl{time} )amine fumarate. It has a 
molecular formula of 
C22H30N2O2S.C4H4
O4. Oliceridine is a white to lightly-colored solid that is 
sparingly soluble in water. On August 7, 2020, FDA approved an NDA for 
oliceridine for medical use to manage acute pain severe enough to 
require an intravenous opioid analgesic and for which alternative 
treatments are inadequate. Thus, oliceridine has an accepted medical 
use in the United States. Oliceridine will be marketed as an 
intravenous medication formulated in vials containing 1, 2, or 30 mg of 
oliceridine.
    4. Its History and Current Pattern of Abuse: There is no 
information available relating to the history and current pattern of 
abuse of oliceridine, since this drug is not currently marketed in any 
country. HHS notes that oliceridine produces abuse-related signals, 
such as euphoria and somnolence, and abuse potential similar to that of 
schedule II controlled substance morphine. DEA searched NFLIS and 
STARLiMS databases for oliceridine encounters. Consistent with the fact 
that oliceridine is a new molecular entity, these databases had no 
records of encounters of oliceridine by law enforcement.
    5. The Scope, Duration, and Significance of Abuse: Oliceridine is 
currently not marketed in any country. Thus, information on the scope, 
duration, and significance of abuse for oliceridine is lacking. 
However, as stated by HHS, data from animal and human studies indicate 
that oliceridine has abuse potential similar to morphine. Therefore, 
upon marketing, oliceridine scope of abuse is expected to be similar to 
morphine.
    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 potential of 
oliceridine are similar to the schedule II substance morphine. Thus, 
oliceridine upon its availability for marketing would be expected to 
create a public health risk.
    7. Its Psychic or Physiological Dependence Liability: Physical 
dependence for oliceridine was tested in an animal toxicity study. 
According to HHS, the animal toxicity study using rats demonstrated 
dose-dependent decreases in food consumption and body weight as well as 
classic opioid withdrawal signs from discontinuation of oliceridine. In 
a rat self-administration study as well as in clinical studies, 
oliceridine produced rewarding effects similar to morphine. Based on 
these studies, HHS stated that oliceridine may produce physical and 
psychological dependence.
    8. Whether the Substance is an Immediate Precursor of a Substance 
Already Controlled under the CSA: Oliceridine 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's scheduling 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 
oliceridine. As such, DEA hereby schedules oliceridine 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 DEA, pursuant to 21 U.S.C. 812(b)(2), finds 
that:

1. Oliceridine Has a High Potential for Abuse

    Oliceridine is a mu-opioid receptor agonist and produces behavioral 
effects that are similar to those of morphine (schedule II opioid 
substance) in animals and humans. A self-administration study in 
animals demonstrated that oliceridine produced self-administration that 
was comparable to morphine. Additionally, a drug-discrimination study 
in animals demonstrated that oliceridine generalized to morphine, 
indicating that it has mu-opioid receptor agonist properties. Results 
from a HAP study showed that oliceridine produces positive subjective 
effects as well as adverse events such as euphoria, similar to that of 
morphine, a schedule II substance with a high potential for abuse. 
Lastly, clinical studies in healthy individuals indicate that 
oliceridine produces abuse-related adverse events such as euphoria and 
sedation. These data collectively indicate that oliceridine has a high 
potential for abuse similar to the schedule II substance morphine.

2. Oliceridine Has a Currently Accepted Medical Use in the United 
States

    FDA recently approved a NDA for oliceridine for the management of 
acute pain severe enough to require an intravenous opioid analgesic and 
for patients for whom alternative treatments are inadequate. Thus, 
oliceridine has a currently accepted medical use in treatment in the 
United States.

3. Abuse of Oliceridine May Lead To Severe Psychological or Physical 
Dependence

    Chronic administration of oliceridine in rats followed by drug 
discontinuation produced classic opioid withdrawal signs, similar to 
that of schedule II drug morphine. This study would indicate 
oliceridine's potential to cause physical dependence similar to that of 
morphine. Oliceridine also produces self-administration in rats and 
positive subjective responses in a HAP study. These results parallel 
those produced by morphine and suggest that oliceridine can also 
produce psychological dependence. These data collectively suggest that 
oliceridine abuse may lead to psychological and physical

[[Page 68752]]

dependence similar to that of schedule II opioids.
    Based on these findings, the Acting Administrator of DEA concludes 
that oliceridine warrants control in schedule II of the CSA. 21 U.S.C. 
812(b)(2).

Requirements for Handling Oliceridine

    Oliceridine is subject to the CSA's schedule II 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 II 
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) oliceridine, or who desires to handle oliceridine, 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 
oliceridine, and is not registered with DEA, must submit an application 
for registration and may not continue to handle oliceridine, 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. Quota. Only registered manufacturers are permitted to 
manufacture oliceridine in accordance with a quota assigned pursuant to 
21 U.S.C. 826 and in accordance with 21 CFR part 1303.
    3. Disposal of stocks. Any person who does not desire or is not 
able to maintain a schedule II registration must surrender all 
quantities of currently held oliceridine, or may transfer all 
quantities of currently held oliceridine 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.
    4. Security. Oliceridine is subject to schedule II security 
requirements and must be handled and stored pursuant to 21 U.S.C. 821 
and 823 and in accordance with 21 CFR 1301.71-1301.93.
    5. Labeling and Packaging. All labels, labeling, and packaging for 
commercial containers of oliceridine must comply with 21 U.S.C. 825 and 
958(e) and be in accordance with 21 CFR part 1302.
    6. Inventory. Every DEA registrant who possesses any quantity of 
oliceridine must take an inventory of oliceridine 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 DEA to handle oliceridine 
must take an initial inventory of all stocks of controlled substances 
containing oliceridine 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 
oliceridine) 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.
    7. Records and Reports. Every DEA registrant must maintain records 
and submit reports for oliceridine, pursuant to 21 U.S.C. 827 and 
958(e), and in accordance with 21 CFR parts 1304, 1312, and 1317.
    8. Orders for oliceridine. Every DEA registrant who distributes 
oliceridine is required to comply with order form requirements, 
pursuant to 21 U.S.C. 828, and in accordance with 21 CFR part 1305.
    9. Prescriptions. All prescriptions for oliceridine or products 
containing oliceridine must comply with 21 U.S.C. 829, and be issued in 
accordance with 21 CFR parts 1306 and 1311, subpart C.
    10. Manufacturing and Distributing. In addition to the general 
requirements of the CSA and DEA regulations that are applicable to 
manufacturers and distributors of schedule II controlled substances, 
such registrants should be advised that (consistent with the foregoing 
considerations) any manufacturing or distribution of oliceridine 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, as applicable, and the CSA.
    11. Importation and Exportation. All importation and exportation of 
oliceridine must be in compliance with 21 U.S.C. 952, 953, 957, and 
958, and in accordance with 21 CFR part 1312.
    12. Liability. Any activity involving oliceridine 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 IFR scheduling the drug within 90 days. Additionally, the law 
specifies that the rulemaking shall become immediately effective as an 
IFR 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 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 (E.O.) 12866 and the 
principles reaffirmed in E.O. 13563.
    This IFR is not an E.O. 13771 regulatory action pursuant to E.O. 
12866 and OMB guidance.\5\
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    \5\ Office of Management and Budget, Executive 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 E.O. 12988 to eliminate drafting errors 
and ambiguity, minimize litigation, provide a clear legal standard for 
affected conduct, and promote simplification and burden reduction.

Executive Order 13132, Federalism

    This rulemaking does not have federalism implications warranting 
the application of E.O. 13132. The rule does not have substantial 
direct effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.

[[Page 68753]]

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This rule does not have tribal implications warranting the 
application of E.O. 13175. It does not have substantial direct effects 
on one or more Indian tribes, on the relationship between the Federal 
government and Indian tribes, or on the distribution of power and 
responsibilities between the Federal government and Indian tribes.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to 
rules that are subject to notice and comment under section 553(b) of 
the APA. 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 IFR.

Unfunded Mandates Reform Act of 1995

    In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 
2 U.S.C. 1501 et seq., DEA has determined that this action would not 
result in any Federal mandate that may result ``in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted 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 million 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 IFR to both 
Houses of Congress and to the Comptroller General.

List of Subjects

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), 956(b), unless otherwise 
noted.


0
2. Amend Sec.  1308.12 by:
0
a. Redesignating paragraph (c)(18) through (c)(29) as (c)(19) through 
(c)(30);
0
b. Adding new paragraph (c)(18).
    The addition to read as follows:


Sec.  1308.12  Schedule II.

* * * * *
    (c) * * *

(18) Oliceridine (N-[(3-methoxythiophen-2-yl)methyl] ({2-[(9R)-     9245
 9-(pyridin-2-yl)-6-oxaspiro [4.5]decan-9-yl]ethyl{time}
 )amine fumarate).............................................
 

* * * * *

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-22762 Filed 10-29-20; 8:45 am]
BILLING CODE 4410-09-P