[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
[[Page 4217]]
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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