[Federal Register Volume 85, Number 16 (Friday, January 24, 2020)]
[Rules and Regulations]
[Pages 4215-4217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00664]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-492]


Schedules of Controlled Substances: Removal of 6[beta]-Naltrexol 
From Control

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: With the issuance of this final rule, the Acting Administrator 
of the Drug Enforcement Administration removes (5[alpha],6[beta])-17-
(cyclopropylmethyl)-4,5-epoxymorphinan-3,6,14-triol (6[beta]-naltrexol) 
and its salts from the schedules of the Controlled Substances Act 
(CSA). This scheduling action is pursuant to the CSA which requires 
that such actions be made on the record after opportunity for a hearing 
through formal rulemaking. Prior to the effective date of this rule, 
6[beta]-naltrexol was a schedule II controlled substance because it can 
be derived from opium alkaloids. This action removes the regulatory 
controls and administrative, civil, and criminal sanctions applicable 
to controlled substances, including those specific to schedule II 
controlled substances, on persons who handle (manufacture, distribute, 
reverse distribute, dispense, conduct research, import, export, or 
conduct chemical analysis) or propose to handle 6[beta]-naltrexol.

DATES: Effective Date: January 24, 2020.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting 
and Policy Support Section, Diversion Control Division, Drug 
Enforcement Administration; Mailing Address: 8701 Morrissette Drive, 
Springfield, Virginia 22152; Telephone: (571) 362-8209.

SUPPLEMENTARY INFORMATION:

Legal Authority

    Under the Controlled Substances Act (CSA), each controlled 
substance is classified into one of five schedules based upon its 
potential for abuse, its currently accepted medical use in treatment in 
the United States, and the degree of dependence the drug or other 
substance may cause. 21 U.S.C. 812. The initial schedules of controlled 
substances established by Congress are found at 21 U.S.C. 812(c) and 
the current list of scheduled substances is published at 21 CFR part 
1308.
    Pursuant to 21 U.S.C. 811(a)(2), the Attorney General may, by rule, 
``remove any drug or other substance from the schedules if he finds 
that the drug or other substance does not meet the requirements for 
inclusion in any schedule.'' The Attorney General has delegated 
scheduling authority under 21 U.S.C. 811 to the Acting Administrator of 
the Drug Enforcement Administration (DEA). 28 CFR 0.100.
    The CSA provides that proceedings for the issuance, amendment, or 
repeal of the scheduling of any drug or other substance may be 
initiated by the Attorney General (1) on his own motion, (2) at the 
request of the Secretary of the Department of Health and Human Services 
(HHS),\1\ or (3) on the petition of any interested party. 21 U.S.C. 
811(a). This action was initiated by two citizen petitions to remove 
6[beta]-naltrexol from the list of scheduled controlled substances of 
the CSA, and is supported by, inter alia, a recommendation from the 
Assistant Secretary of the HHS and an evaluation of all relevant data 
by the DEA. This action removes the regulatory controls and 
administrative, civil, and criminal sanctions applicable to controlled 
substances, including those specific to schedule II controlled 
substances, on persons who handle or propose to handle 6[beta]-
naltrexol.
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    \1\ As discussed in a memorandum of understanding entered into 
by the Food and Drug Administration (FDA) and the National Institute 
on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS 
in carrying out the Secretary's scheduling responsibilities under 
the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The 
Secretary of the HHS has delegated to the Assistant Secretary for 
Health of the HHS the authority to make domestic drug scheduling 
recommendations. 58 FR 35460, July 1, 1993.
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Background

    6[beta]-Naltrexol is the major metabolite of naltrexone. Naltrexone 
and 6[beta]-naltrexol are reversible opioid receptor antagonists. 
Opioid receptor antagonists are commonly used in the treatment of 
opioid addiction and overdose. On December 24, 1974, naloxone, an 
opioid receptor antagonist that works similarly to naltrexone, was 
removed from all schedules for control under the CSA. Effective on 
March 6, 1975, title 21 of the Code of Federal Regulations was amended 
to remove naltrexone from all schedules for control under the CSA. The 
Administrator of the DEA found that both naltrexone and naloxone and 
their salts have an accepted medical use for treatment in the United 
States and that they do not have a potential for abuse to justify 
continued control in any schedule under the CSA. In June 2003 and April 
2008, the DEA received two separate citizen petitions to initiate 
proceedings to amend 21 CFR 1308.12(b)(1) to decontrol 6[beta]-
naltrexol from schedule II of the CSA. These petitions complied with 
the requirements of 21 CFR 1308.44(b) and were accepted for filing. 
Both petitioners argue that 6[beta]-naltrexol has been characterized as 
an opioid receptor

[[Page 4216]]

antagonist, a class of drugs with no abuse potential.

DEA and HHS Eight Factor Analyses

    Pursuant to 21 U.S.C. 811(b), the DEA gathered the necessary data 
on 6[beta]-naltrexol and forwarded the data, the sponsors' petitions, 
and a request for scheduling recommendation on 6[beta]-naltrexol to HHS 
on August 11, 2009.
    On July 21, 2017, HHS provided to DEA a scientific and medical 
evaluation entitled ``Basis for the Recommendation to Remove 
(5[alpha],6[beta])-17-(cyclopro pylmethyl)-4,5-epoxymorphinan-3,6,14-
triol (6[beta]-naltrexol) and Its Salts from All Schedules of Control 
Under the Controlled Substances Act'' and a scheduling recommendation. 
Following consideration of the eight factors and findings related to 
the substance's abuse potential, legitimate medical use, and dependence 
liability, HHS recommended that 6[beta]-naltrexol and its salts be 
removed from all schedules of control of the CSA.
    In response, DEA conducted its own eight factor analysis of 
6[beta]-naltrexol pursuant to 21 U.S.C. 811(c). Both the DEA and HHS 
analyses are available in their entirety in the public docket of this 
rule (Docket Number DEA-492) at http://www.regulations.gov under 
``Supporting and Related Material.''

Determination To Decontrol 6[beta]-Naltrexol

    After a review of the available data, including the scientific and 
medical evaluation and the recommendation to decontrol 6[beta]-
naltrexol from HHS, the Acting Administrator of DEA published in the 
Federal Register a notice of proposed rulemaking (NPRM) entitled 
``Schedules of Controlled Substances: Removal of 6[beta]-naltrexol from 
Control'' which proposed removal of 6[beta]-naltrexol and its salts 
from the schedules of the CSA. 84 FR 43530, August 21, 2019. The 
proposed rule provided an opportunity for interested persons to file a 
request for a hearing in accordance with DEA regulations by September 
20, 2019. No requests for such a hearing were received by DEA. The NPRM 
also provided an opportunity for interested persons to submit written 
comments on the proposal on or before September 20, 2019.

Comments Received

    DEA received four comments on the proposed rule to remove 6[beta]-
naltrexol from control. Two commenters supported decontrol of 6[beta]-
naltrexol. Two commenters submitted comments not related to the 
proposed action.

Support

    One commenter supported decontrolling 6[beta]-naltrexol and 
expressed agreement with DEA's findings that 6[beta]-naltrexol does not 
possess abuse or dependence potential. Another commenter was also in 
support of this decontrol action although the commenter mentioned the 
drug names as ``6-naltrexol'' and ``naltrexone'' and appears to have 
used these two names interchangeably. DEA assumes that the commenter's 
reference to ``naltrexone'' or ``6-naltrexol'' is actually in reference 
to 6[beta]-naltrexol.
    DEA Response: DEA appreciates the comments in support of this 
rulemaking.

Unrelated Comments

    One commenter stated that DEA should spend more time in combating 
drugs that are readily available to public and are highly prescribed by 
physicians rather than putting efforts on drugs with no abuse potential 
and are limited to research labs.
    DEA Response: DEA's mission is to enforce the controlled substance 
laws and regulations. The CSA contains specific mandates pertaining to 
the scheduling of controlled substances. Pursuant to 21 U.S.C. 
811(a)(2), the Attorney General through formal rulemaking may remove 
any drug or other substance from the schedules if it is found that the 
drug or other substance does not meet the requirement for inclusion in 
any schedule under the CSA. Proceedings for the issuance, amendment, or 
repeal of such rules may be initiated by the Attorney General (1) on 
his own motion, (2) at the request of the Secretary, or (3) on the 
petition of any interested party. DEA, under authority delegated by the 
Attorney General, has initiated the current scheduling action in 
response to two petitions requesting decontrol of 6[beta]-naltrexol. 
Pursuant to CSA, DEA has followed all of those mandates regarding the 
current decontrol of 6[beta]-naltrexol, including receiving from the 
Secretary of HHS a scientific and medical evaluation, and 
recommendation, regarding control (21 U.S.C. 811(b)); considering the 
factors enumerated in 21 U.S.C. 811(c); determining, based on the 
above, appropriate scheduling for 6[beta]-naltrexol (21 U.S.C. 812(b)); 
and conducting a formal rulemaking to decontrol 6[beta]-naltrexol (21 
U.S.C. 811(a)(2)). 6[beta]-Naltrexol satisfies the CSA's criteria for 
removal from controls.
    Another commenter mentioned that a majority of states have 
legalized the use of cannabis for medical and recreational purposes and 
there are reports of medical benefits for cannabis. This commenter 
further stated that ``removing cannabis from being Schedule I drug is 
long over due . . .''
    DEA Response: Because the current rule involves 6[beta]-naltrexol, 
but not cannabis, this comment is unrelated and is outside the scope of 
the current scheduling action.

Scheduling Conclusion

    Based on the consideration of all comments, the scientific and 
medical evaluation and accompanying recommendation of HHS, and based on 
DEA's consideration of its own eight-factor analysis, the Acting 
Administrator finds that these facts and all relevant data demonstrate 
that 6[beta]-naltrexol does not meet the requirements for inclusion in 
any schedule, and will be removed from control under the CSA.

Regulatory Analyses

Executive Orders 12866 and 13563

    In accordance with 21 U.S.C. 811(a), this scheduling action is 
subject to formal rulemaking procedures done ``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 criteria for 
scheduling a drug or other substance. Such actions are exempt from 
review by the Office of Management and Budget (OMB) pursuant to section 
3(d)(1) of Executive Order 12866 and the principles reaffirmed in 
Executive Order 13563.

Executive Order 12988

    This regulation meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform 
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

    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 Federal Government and the States, or the distribution of power and 
responsibilities among the various levels of government.

Executive Order 13175

    This rule does not have tribal implications warranting the 
application of Executive Order 13175. This rule does not have 
substantial direct effects on one or more Indian tribes, on the

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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 Acting Administrator, in accordance with the Regulatory 
Flexibility Act (5 U.S.C. 601-612) (RFA), has reviewed this rule and by 
approving it certifies that it will not have a significant economic 
impact on a substantial number of small entities. The purpose of this 
rule is to remove 6[beta]-naltrexol from the list of schedules of the 
CSA. This action removes regulatory controls and administrative, civil, 
and criminal sanctions applicable to controlled substances for handlers 
and proposed handlers of 6[beta]-naltrexol. Accordingly, it has the 
potential for some economic impact in the form of cost savings.
    This rule will affect all persons who would handle, or propose to 
handle, 6[beta]-naltrexol. 6[beta]-Naltrexol is the major metabolite of 
naltrexone and is not currently available or marketed in any country. 
Due to the wide variety of unidentifiable and unquantifiable variables 
that potentially could influence the distribution and dispensing rates, 
if any, of 6[beta]-naltrexol, DEA is unable to determine the number of 
entities and small entities which might handle 6[beta]-naltrexol. In 
some instances where a controlled pharmaceutical drug is removed from 
the schedules of the CSA, DEA is able to quantify the estimated number 
of affected entities and small entities because the handling of the 
drug is expected to be limited to DEA registrants even after removal 
from the schedules. In such instances, DEA's knowledge of its 
registrant population forms the basis for estimating the number of 
affected entities and small entities. However, the DEA does not have a 
basis to estimate whether 6[beta]-naltrexol is expected to be handled 
by persons who hold DEA registrations, by persons who are not currently 
registered with DEA to handle controlled substances, or both. 
Therefore, the DEA is unable to estimate the number of entities and 
small entities who plan to handle 6[beta]-naltrexol.
    Although DEA does not have a reliable basis to estimate the number 
of affected entities and quantify the economic impact of this final 
rule, a qualitative analysis indicates that this rule is likely to 
result in some cost savings. Any person planning to handle 6[beta]-
naltrexol will realize cost savings in the form of saved DEA 
registration fees, and the elimination of physical security, 
recordkeeping, and reporting requirements. Because of these factors, 
DEA projects that this rule will not result in a significant economic 
impact on a substantial number of small entities.

Unfunded Mandates Reform Act of 1995

    On the basis of information contained in the ``Regulatory 
Flexibility Act'' section above, DEA has determined and certifies 
pursuant to the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 
1501 et seq., 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 provisions of UMRA.

Paperwork Reduction Act

    This action does not impose a new collection of information 
requirement under the Paperwork Reduction Act, 44 U.S.C. 3501-3521. 
This action would not impose recordkeeping or reporting requirements on 
State or local governments, individuals, businesses, or organizations. 
An agency may not conduct or sponsor, and a person is not required to 
respond to, a collection of information unless it displays a currently 
valid OMB control number.

Congressional Review Act

    This rule is not a major rule as defined by section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996 
(Congressional Review Act (CRA)). This rule will not result in: An 
annual effect on the economy of $100,000,000 or more; a major increase 
in costs or prices for consumers, individual industries, Federal, 
State, or local government agencies, or geographic regions; or 
significant adverse effects on competition, employment, investment, 
productivity, innovation, or on the ability of United States-based 
companies to compete with foreign-based companies in domestic and 
export markets. However, pursuant to the CRA, DEA has submitted a copy 
of this final rule to both Houses of Congress and to the Comptroller 
General.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Reporting and recordkeeping requirements.

    For the reasons set out above, 21 CFR part 1308 is amended to read 
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. In Sec.  1308.12, revise the introductory text of paragraph (b)(1) 
to read as follows:


Sec.  1308.12  Schedule II.

* * * * *
    (b) * * *
    (1) Opium and opiate, and any salt, compound, derivative, or 
preparation of opium or opiate excluding apomorphine, thebaine-derived 
butorphanol, dextrorphan, nalbuphine, naldemedine, nalmefene, 
naloxegol, naloxone, 6[beta]-naltrexol and naltrexone, and their 
respective salts, but including the following:
* * * * *

    Dated: December 19, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020-00664 Filed 1-23-20; 8:45 am]
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