83 FR 4411 - Schedules of Controlled Substances: Extension of Temporary Placement of MAB-CHMINACA in Schedule I of the Controlled Substances Act
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 20 (January 30, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 20 (January 30, 2018)
| Page Range | 4411-4412 | |
| FR Document | 2018-01746 |
[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)] [Rules and Regulations] [Pages 4411-4412] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01746] Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Rules and Regulations [[Page 4411]] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-421] Schedules of Controlled Substances: Extension of Temporary Placement of MAB-CHMINACA in Schedule I of the Controlled Substances Act AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Temporary rule; temporary scheduling order; extension. ----------------------------------------------------------------------- SUMMARY: The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to extend the temporary schedule I status of a synthetic cannabinoid, N-(1-amino-3,3-dimethyl- 1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (other names: MAB-CHMINACA; ADB-CHMINACA), including its optical, positional and geometric isomers, salts, and salts of isomers. The schedule I status of MAB-CHMINACA currently is in effect through February 4, 2018. This temporary order will extend the temporary scheduling of MAB- CHMINACA for one year, or until the permanent scheduling action for this substance is completed, whichever occurs first. DATES: This temporary scheduling order, which extends the final order (81 FR 6171, February 5, 2016), is effective February 5, 2018 and expires on February 5, 2019. If DEA publishes a final rule making this scheduling action permanent, this order will expire on the effective date of that rule, if the effective date is earlier than February 5, 2019. FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598- 6812. SUPPLEMENTARY INFORMATION: Background and Legal Authority On February 5, 2016, the Acting Administrator of the Drug Enforcement Administration (DEA) published a final order in the Federal Register (81 FR 6171) temporarily placing N-(1-amino-3,3-dimethyl-1- oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (other names: MAB-CHMINACA; ADB-CHMINACA), a synthetic cannabinoid (SC) substance, in schedule I of the Controlled Substances Act (CSA) pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). That final order was effective on the date of publication, and was based on findings by the Acting Administrator of the DEA that the temporary scheduling of this SC was necessary to avoid an imminent hazard to the public safety pursuant to 21 U.S.C. 811(h)(1). Section 201(h)(2) of the CSA, 21 U.S.C. 811(h)(2), requires that the temporary control of this substance expires two years from the effective date of the scheduling order, or on February 5, 2018. However, the CSA also provides that during the pendency of proceedings under 21 U.S.C. 811(a)(1) with respect to the substance, the temporary scheduling \1\ of that substance could be extended for up to one year. Proceedings for the scheduling of a substance under 21 U.S.C. 811(a) may be initiated by the Attorney General (delegated to the Administrator of the DEA pursuant to 28 CFR 0.100) on his own motion, at the request of the Secretary of Health and Human Services,\2\ or on the petition of any interested party. --------------------------------------------------------------------------- \1\ Though DEA has used the term ``final order'' with respect to temporary scheduling orders in the past, this notice adheres to the statutory language of 21 U.S.C. 811(h), which refers to a ``temporary scheduling order.'' No substantive change is intended. \2\ Because the Secretary of the Department of Health and Human Services (HHS) has delegated to the Assistant Secretary for Health of the HHS the authority to make domestic drug scheduling recommendations, for purposes of this temporary scheduling order, all subsequent references to ``Secretary'' have been replaced with ``Assistant Secretary.'' --------------------------------------------------------------------------- The Acting Administrator of the DEA, on his own motion pursuant to 21 U.S.C. 811(a), has initiated proceedings under 21 U.S.C. 811(a)(1) to permanently schedule MAB-CHMINACA. The DEA has gathered and reviewed the available information regarding the pharmacology, chemistry, trafficking, actual abuse, pattern of abuse, and the relative potential for abuse for this SC. On May 18, 2016, the DEA submitted a request to the HHS to provide the DEA with a scientific and medical evaluation of available information and a scheduling recommendation for MAB-CHMINACA, and in accordance with 21 U.S.C. 811(b) and (c). Upon evaluating the scientific and medical evidence, on January 19, 2018, the HHS submitted to the Acting Administrator of the DEA its scientific and medical evaluation for MAB-CHMINACA. Upon receipt of the scientific and medical evaluation and scheduling recommendation from the HHS, the DEA reviewed the documents and all other relevant data, and conducted its own eight- factor analysis of the abuse potential of MAB-CHMINACA in accordance with 21 U.S.C. 811(c). The DEA published a notice of proposed rulemaking for the placement of MAB-CHMINACA in schedule I elsewhere in this issue of the Federal Register. If this order is made permanent, the Drug Enforcement Administration will publish a final rule in the Federal Register. Pursuant to 21 U.S.C. 811(h)(2), the Acting Administrator of the DEA orders that the temporary scheduling of MAB-CHMINACA, including its optical, positional and geometric isomers, salts, and salts of isomers, be extended for one year, or until the permanent scheduling proceeding is completed, whichever occurs first. In accordance with this temporary scheduling order, the schedule I requirements for handling MAB-CHMINACA, including its optical, positional and geometric isomers, salts, and salts of isomers, will remain in effect for one year, or until the permanent scheduling proceeding is completed, whichever occurs first. Regulatory Matters The CSA provides for an expedited temporary scheduling action where such action is necessary to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h). The Attorney General may, by order, schedule a substance in schedule I on a temporary basis. Id. 21 U.S.C. 811(h) also provides that the temporary scheduling of a substance shall expire at the end of two years from the date of the issuance of the order scheduling such substance, except that the Attorney General may, during the pendency of proceedings to permanently schedule the substance, extend the temporary scheduling for up to one year. To the extent that 21 U.S.C. 811(h) directs that temporary scheduling actions be issued by order and sets forth the procedures by which such orders are to be issued and extended, the DEA believes that the notice and comment requirements of section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553, do not apply to this extension of the temporary scheduling action. In the alternative, even assuming that this action might be subject to section 553 of the APA, the Acting Administrator finds that there is good cause to forgo the notice and comment requirements of section 553, as any further delays in the process for extending the temporary scheduling order would be impracticable and contrary to the public interest in view of the manifest urgency to avoid an imminent hazard to the public safety. Further, the DEA believes that this order [[Page 4412]] extending the temporary scheduling action is not a ``rule'' as defined by 5 U.S.C. 601(2), and, accordingly, is not subject to the requirements of the Regulatory Flexibility Act (RFA). The requirements for the preparation of an initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as here, the DEA is not required by section 553 of the APA or any other law to publish a general notice of proposed rulemaking. Additionally, this action is not a significant regulatory action as defined by Executive Order 12866 (Regulatory Planning and Review), section 3(f), and, accordingly, this action has not been reviewed by the Office of Management and Budget (OMB). This action will 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. Therefore, in accordance with Executive Order 13132 (Federalism) it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. As noted above, this action is an order, not a rule. Accordingly, the Congressional Review Act (CRA) is inapplicable, as it applies only to rules. However, if this were a rule, pursuant to the CRA, ``any rule for which an agency for good cause finds that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest, shall take effect at such time as the federal agency promulgating the rule determines.'' 5 U.S.C. 808(2). It is in the public interest to maintain the temporary placement of MAB-CHMINACA in schedule I because it poses a public health risk. The temporary scheduling action was taken pursuant to 21 U.S.C. 811(h), which is specifically designed to enable the DEA to act in an expeditious manner to avoid an imminent hazard to the public safety. Under 21 U.S.C. 811(h), temporary scheduling orders are not subject to notice and comment rulemaking procedures. The DEA understands that the CSA frames temporary scheduling actions as orders rather than rules to ensure that the process moves swiftly, and this extension of the temporary scheduling order continues to serve that purpose. For the same reasons that underlie 21 U.S.C. 811(h), that is, the need to place this substance in schedule I because it poses an imminent hazard to public safety, it would be contrary to the public interest to delay implementation of this extension of the temporary scheduling order. Therefore, in accordance with section 808(2) of the CRA, this order extending the temporary scheduling order shall take effect immediately upon its publication. The DEA has submitted a copy of this temporary scheduling order to both Houses of Congress and to the Comptroller General, although such filing is not required under the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801-808 because, as noted above, this action is an order, not a rule. Dated: January 24, 2018. Robert W. Patterson, Acting Administrator. [FR Doc. 2018-01746 Filed 1-29-18; 8:45 am] BILLING CODE 4410-09-P
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DEPARTMENT OF JUSTICE U.S.C. 811(h). That final order was CHMINACA in accordance with 21
effective on the date of publication, and U.S.C. 811(c). The DEA published a
Drug Enforcement Administration was based on findings by the Acting notice of proposed rulemaking for the
Administrator of the DEA that the placement of MAB–CHMINACA in
21 CFR Part 1308 temporary scheduling of this SC was schedule I elsewhere in this issue of the
[Docket No. DEA–421]
necessary to avoid an imminent hazard Federal Register. If this order is made
to the public safety pursuant to 21 permanent, the Drug Enforcement
Schedules of Controlled Substances: U.S.C. 811(h)(1). Section 201(h)(2) of the Administration will publish a final rule
Extension of Temporary Placement of CSA, 21 U.S.C. 811(h)(2), requires that in the Federal Register.
MAB–CHMINACA in Schedule I of the the temporary control of this substance Pursuant to 21 U.S.C. 811(h)(2), the
Controlled Substances Act expires two years from the effective date Acting Administrator of the DEA orders
of the scheduling order, or on February that the temporary scheduling of MAB–
AGENCY: Drug Enforcement 5, 2018. However, the CSA also CHMINACA, including its optical,
Administration, Department of Justice. provides that during the pendency of positional and geometric isomers, salts,
ACTION: Temporary rule; temporary proceedings under 21 U.S.C. 811(a)(1) and salts of isomers, be extended for one
scheduling order; extension. with respect to the substance, the year, or until the permanent scheduling
temporary scheduling 1 of that substance proceeding is completed, whichever
SUMMARY: The Administrator of the Drug could be extended for up to one year. occurs first.
Enforcement Administration is issuing Proceedings for the scheduling of a In accordance with this temporary
this temporary scheduling order to substance under 21 U.S.C. 811(a) may scheduling order, the schedule I
extend the temporary schedule I status be initiated by the Attorney General requirements for handling MAB–
of a synthetic cannabinoid, N-(1-amino- (delegated to the Administrator of the CHMINACA, including its optical,
3,3-dimethyl-1-oxobutan-2-yl)-1- DEA pursuant to 28 CFR 0.100) on his positional and geometric isomers, salts,
(cyclohexylmethyl)-1H-indazole-3- own motion, at the request of the and salts of isomers, will remain in
carboxamide (other names: MAB– Secretary of Health and Human effect for one year, or until the
CHMINACA; ADB–CHMINACA), Services,2 or on the petition of any permanent scheduling proceeding is
including its optical, positional and interested party. completed, whichever occurs first.
geometric isomers, salts, and salts of The Acting Administrator of the DEA, Regulatory Matters
isomers. The schedule I status of MAB– on his own motion pursuant to 21
CHMINACA currently is in effect U.S.C. 811(a), has initiated proceedings The CSA provides for an expedited
through February 4, 2018. This under 21 U.S.C. 811(a)(1) to temporary scheduling action where
temporary order will extend the permanently schedule MAB– such action is necessary to avoid an
temporary scheduling of MAB– CHMINACA. The DEA has gathered and imminent hazard to the public safety. 21
CHMINACA for one year, or until the reviewed the available information U.S.C. 811(h). The Attorney General
permanent scheduling action for this regarding the pharmacology, chemistry, may, by order, schedule a substance in
substance is completed, whichever trafficking, actual abuse, pattern of schedule I on a temporary basis. Id. 21
occurs first. abuse, and the relative potential for U.S.C. 811(h) also provides that the
abuse for this SC. On May 18, 2016, the temporary scheduling of a substance
DATES: This temporary scheduling
DEA submitted a request to the HHS to shall expire at the end of two years from
order, which extends the final order (81 the date of the issuance of the order
FR 6171, February 5, 2016), is effective provide the DEA with a scientific and
scheduling such substance, except that
February 5, 2018 and expires on medical evaluation of available
the Attorney General may, during the
February 5, 2019. If DEA publishes a information and a scheduling
pendency of proceedings to
final rule making this scheduling action recommendation for MAB–CHMINACA,
permanently schedule the substance,
permanent, this order will expire on the and in accordance with 21 U.S.C. 811(b)
extend the temporary scheduling for up
effective date of that rule, if the effective and (c). Upon evaluating the scientific
to one year.
date is earlier than February 5, 2019. and medical evidence, on January 19, To the extent that 21 U.S.C. 811(h)
FOR FURTHER INFORMATION CONTACT: 2018, the HHS submitted to the Acting directs that temporary scheduling
Michael J. Lewis, Diversion Control Administrator of the DEA its scientific actions be issued by order and sets forth
Division, Drug Enforcement and medical evaluation for MAB– the procedures by which such orders are
Administration; Mailing Address: 8701 CHMINACA. Upon receipt of the to be issued and extended, the DEA
Morrissette Drive, Springfield, Virginia scientific and medical evaluation and believes that the notice and comment
22152; Telephone: (202) 598–6812. scheduling recommendation from the requirements of section 553 of the
HHS, the DEA reviewed the documents Administrative Procedure Act (APA), 5
SUPPLEMENTARY INFORMATION:
and all other relevant data, and U.S.C. 553, do not apply to this
Background and Legal Authority conducted its own eight-factor analysis extension of the temporary scheduling
of the abuse potential of MAB– action. In the alternative, even assuming
On February 5, 2016, the Acting
Administrator of the Drug Enforcement 1 Though DEA has used the term ‘‘final order’’
that this action might be subject to
Administration (DEA) published a final with respect to temporary scheduling orders in the section 553 of the APA, the Acting
order in the Federal Register (81 FR past, this notice adheres to the statutory language Administrator finds that there is good
6171) temporarily placing N-(1-amino- of 21 U.S.C. 811(h), which refers to a ‘‘temporary cause to forgo the notice and comment
3,3-dimethyl-1-oxobutan-2-yl)-1- scheduling order.’’ No substantive change is requirements of section 553, as any
intended.
daltland on DSKBBV9HB2PROD with RULES2
(cyclohexylmethyl)-1H-indazole-3- 2 Because the Secretary of the Department of further delays in the process for
carboxamide (other names: MAB– Health and Human Services (HHS) has delegated to extending the temporary scheduling
CHMINACA; ADB–CHMINACA), a the Assistant Secretary for Health of the HHS the order would be impracticable and
synthetic cannabinoid (SC) substance, authority to make domestic drug scheduling contrary to the public interest in view
recommendations, for purposes of this temporary
in schedule I of the Controlled scheduling order, all subsequent references to
of the manifest urgency to avoid an
Substances Act (CSA) pursuant to the ‘‘Secretary’’ have been replaced with ‘‘Assistant imminent hazard to the public safety.
temporary scheduling provisions of 21 Secretary.’’ Further, the DEA believes that this order
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![4412 Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Rules and Regulations
extending the temporary scheduling federalism implications to warrant the process moves swiftly, and this
action is not a ‘‘rule’’ as defined by 5 preparation of a Federalism Assessment. extension of the temporary scheduling
U.S.C. 601(2), and, accordingly, is not As noted above, this action is an order continues to serve that purpose.
subject to the requirements of the order, not a rule. Accordingly, the For the same reasons that underlie 21
Regulatory Flexibility Act (RFA). The Congressional Review Act (CRA) is U.S.C. 811(h), that is, the need to place
requirements for the preparation of an inapplicable, as it applies only to rules. this substance in schedule I because it
initial regulatory flexibility analysis in 5 However, if this were a rule, pursuant poses an imminent hazard to public
U.S.C. 603(a) are not applicable where, to the CRA, ‘‘any rule for which an safety, it would be contrary to the public
as here, the DEA is not required by agency for good cause finds that notice interest to delay implementation of this
section 553 of the APA or any other law and public procedure thereon are extension of the temporary scheduling
to publish a general notice of proposed impracticable, unnecessary, or contrary order. Therefore, in accordance with
rulemaking. to the public interest, shall take effect at section 808(2) of the CRA, this order
such time as the federal agency extending the temporary scheduling
Additionally, this action is not a promulgating the rule determines.’’ 5
significant regulatory action as defined order shall take effect immediately upon
U.S.C. 808(2). It is in the public interest its publication. The DEA has submitted
by Executive Order 12866 (Regulatory to maintain the temporary placement of
Planning and Review), section 3(f), and, a copy of this temporary scheduling
MAB–CHMINACA in schedule I order to both Houses of Congress and to
accordingly, this action has not been because it poses a public health risk.
reviewed by the Office of Management the Comptroller General, although such
The temporary scheduling action was filing is not required under the Small
and Budget (OMB). taken pursuant to 21 U.S.C. 811(h), Business Regulatory Enforcement
This action will not have substantial which is specifically designed to enable Fairness Act of 1996 (Congressional
direct effects on the States, on the the DEA to act in an expeditious manner Review Act), 5 U.S.C. 801–808 because,
relationship between the national to avoid an imminent hazard to the as noted above, this action is an order,
government and the States, or on the public safety. Under 21 U.S.C. 811(h), not a rule.
distribution of power and temporary scheduling orders are not
responsibilities among the various subject to notice and comment Dated: January 24, 2018.
levels of government. Therefore, in rulemaking procedures. The DEA Robert W. Patterson,
accordance with Executive Order 13132 understands that the CSA frames Acting Administrator.
(Federalism) it is determined that this temporary scheduling actions as orders [FR Doc. 2018–01746 Filed 1–29–18; 8:45 am]
action does not have sufficient rather than rules to ensure that the BILLING CODE 4410–09–P
daltland on DSKBBV9HB2PROD with RULES2
VerDate Sep<11>2014 20:29 Jan 29, 2018 Jkt 244001 PO 00000 Frm 00002 Fmt 4701 Sfmt 9990 E:\FR\FM\30JAR2.SGM 30JAR2](https://thefederalregister.org/doc/83_FR_4431/page/2.svg)
Document Created: 2018-10-26 10:10:58
Document Modified: 2018-10-26 10:10:58
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Temporary rule; temporary scheduling order; extension. | |
| Dates | This temporary scheduling order, which extends the final order (81 FR 6171, February 5, 2016), is effective February 5, 2018 and expires on February 5, 2019. If DEA publishes a final rule making this scheduling action permanent, this order will expire on the effective date of that rule, if the effective date is earlier than February 5, 2019. | |
| Contact | Michael J. Lewis, Diversion Control | |
| FR Citation | 83 FR 4411 |
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