Schedules of Controlled Substances: Removal of 6β-Naltrexol From Control, 4215-4217 [2020-00664]

Download as PDF Federal Register / Vol. 85, No. 16 / Friday, January 24, 2020 / Rules and Regulations List of Subjects in 21 CFR Part 1308 PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements. 1. The authority citation for 21 CFR part 1308 continues to read as follows: ■ For the reasons set out above, 21 CFR part 1308 is amended as follows: Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted. ■ 2. In § 1308.11, 4215 a. Add paragraphs (d)(73) through (78); and ■ b. Remove and reserve paragraphs (h)(6) through (11); The additions read as follows: ■ § 1308.11 * Schedule I. * * (d) * * * * * (73) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate (Other names: 5F-ADB; 5F-MDMB-PINACA) (74) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate (Other names: 5F-AMB) ......................................... (75) N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide (Other names: 5F-APINACA, 5F-AKB48) ............................... (76) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (Other names: ADB-FUBINACA) ...... (77) methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate (Other names: MDMB-CHMICA, MMBCHMINACA) ................................................................................................................................................................................................ (78) methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate (Other names: MDMB-FUBINACA) ................ * * * * * 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: Dated: January 3, 2020. Uttam Dhillon, Acting Administrator. [FR Doc. 2020–00665 Filed 1–23–20; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Legal Authority Drug Enforcement Administration 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 21 CFR Part 1308 [Docket No. DEA–492] Schedules of Controlled Substances: Removal of 6β-Naltrexol From Control Drug Enforcement Administration, Department of Justice. ACTION: Final rule. AGENCY: With the issuance of this final rule, the Acting Administrator of the Drug Enforcement Administration removes (5a,6b)-17(cyclopropylmethyl)-4,5epoxymorphinan-3,6,14-triol (6bnaltrexol) 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, 6b-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 6bnaltrexol. lotter on DSKBCFDHB2PROD with RULES SUMMARY: DATES: Effective Date: January 24, 2020. VerDate Sep<11>2014 15:58 Jan 23, 2020 Jkt 250001 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 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 7034 7033 7049 7010 7042 7020 of any interested party. 21 U.S.C. 811(a). This action was initiated by two citizen petitions to remove 6b-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 6b-naltrexol. Background 6b-Naltrexol is the major metabolite of naltrexone. Naltrexone and 6b-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 6b-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 6b-naltrexol has been characterized as an opioid receptor authority to make domestic drug scheduling recommendations. 58 FR 35460, July 1, 1993. E:\FR\FM\24JAR1.SGM 24JAR1 4216 Federal Register / Vol. 85, No. 16 / Friday, January 24, 2020 / Rules and Regulations Support 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 6bnaltrexol and forwarded the data, the sponsors’ petitions, and a request for scheduling recommendation on 6bnaltrexol 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 (5a,6b)-17-(cyclopro pylmethyl)-4,5-epoxymorphinan-3,6,14triol (6b-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 6b-naltrexol and its salts be removed from all schedules of control of the CSA. In response, DEA conducted its own eight factor analysis of 6b-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 6bNaltrexol After a review of the available data, including the scientific and medical evaluation and the recommendation to decontrol 6b-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 6b-naltrexol from Control’’ which proposed removal of 6b-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. lotter on DSKBCFDHB2PROD with RULES Comments Received DEA received four comments on the proposed rule to remove 6b-naltrexol from control. Two commenters supported decontrol of 6b-naltrexol. Two commenters submitted comments not related to the proposed action. VerDate Sep<11>2014 15:58 Jan 23, 2020 Jkt 250001 One commenter supported decontrolling 6b-naltrexol and expressed agreement with DEA’s findings that 6b-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 6b-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 6bnaltrexol. Pursuant to CSA, DEA has followed all of those mandates regarding the current decontrol of 6b-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 6b-naltrexol (21 U.S.C. 812(b)); and conducting a formal rulemaking to decontrol 6b-naltrexol (21 U.S.C. 811(a)(2)). 6b-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 PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 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 6b-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 eightfactor analysis, the Acting Administrator finds that these facts and all relevant data demonstrate that 6bnaltrexol 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 E:\FR\FM\24JAR1.SGM 24JAR1 Federal Register / Vol. 85, No. 16 / Friday, January 24, 2020 / Rules and Regulations lotter on DSKBCFDHB2PROD with RULES 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 6bnaltrexol 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 6b-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, 6bnaltrexol. 6b-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 6b-naltrexol, DEA is unable to determine the number of entities and small entities which might handle 6b-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 6bnaltrexol 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 6b-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 6b-naltrexol will realize cost savings in the form of saved DEA registration fees, and the elimination of physical security, VerDate Sep<11>2014 15:58 Jan 23, 2020 Jkt 250001 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. 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 foreignbased 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. Frm 00027 Fmt 4700 Sfmt 4700 For the reasons set out above, 21 CFR part 1308 is amended to read as follows: PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES 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. 2. In § 1308.12, revise the introductory text of paragraph (b)(1) to read as follows: ■ § 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, 6b-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] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 Congressional Review Act PO 00000 4217 [Docket No. DEA–503] Schedules of Controlled Substances: Placement of Brexanolone in Schedule IV Drug Enforcement Administration, Department of Justice. ACTION: Final rule. AGENCY: This final rule adopts without change an interim final rule with request for comments published in the Federal Register on June 17, 2019. That interim final rule placed the substance brexanolone (3a-hydroxy-5a-pregnan20-one), 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 Controlled Substances Act. With the issuance of this final rule, the Drug Enforcement Administration maintains brexanolone in schedule IV of the Controlled Substances Act. DATES: Effective January 24, 2020. FOR FURTHER INFORMATION CONTACT: Scott Brinks, Diversion Control Division, Drug Enforcement SUMMARY: E:\FR\FM\24JAR1.SGM 24JAR1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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]
BILLING CODE 4410-09-P