Schedules of Controlled Substances: Extension of Temporary Placement of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA in Schedule I of the Controlled Substances Act, 13796-13798 [2019-06851]

Download as PDF 13796 Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Rules and Regulations than an assessment every two years) due to concerns not meeting several VWP requirements. In 2016, DHS extended Greece’s VWP designation on a provisional basis through March 31, 2017, to address concerns over migrant vetting, information-sharing gaps, and passport-issuance practices. Additionally, DHS reduced Greece’s ESTA validity period from two years to one year and committed Greece to implement five lines of effort specified in a Joint Statement in order to remove Greece from a provisional VWP status. In 2017, DHS sent correspondence to Greece defining a set of actions that would justify ESTA normalization. Greece has made successful progress in all five lines of effort and has completed all of the elements required for ESTA normalization that had been communicated in 2017. Greece has enacted necessary legislation to authorize issuance and replacement of national identification cards (biometric chip), expanded systematic refugee vetting at all migrant processing centers, and enacted Passenger Name Recognition (PNR) legislation to implement the EU PNR Directive. For these reasons, DHS is publishing this document announcing that it is increasing Greece’s ESTA validity period to two years. Claire Grady, Senior Official Performing the Duties of the Deputy Secretary, Department of Homeland Security. [FR Doc. 2019–06750 Filed 4–5–19; 8:45 am] BILLING CODE P SECURITIES AND EXCHANGE COMMISSION 17 CFR Parts 229, 230, 232, 239, 240, 249, 270, 274, and 275 [Release No. 33–10618; 34–85381; IA–5206; IC–33426; File No. S7–08–17] RIN 3235–AM00 FAST Act Modernization and Simplification of Regulation S–K jbell on DSK30RV082PROD with RULES Correction In rule document 2019–05695, appearing on pages 12674 through 12738, in the issue of Tuesday, April 2, 2019, make the following corrections: 1. On page 12675, in the table, in the second column, in the tenth line from the top of the page, the text entry that reads ‘‘§ 249.218’’ should read ‘‘§ 249.220f’’. VerDate Sep<11>2014 15:49 Apr 05, 2019 Jkt 247001 PART 249—FORMS, SECURITIES EXCHANGE ACT OF 1934 [Corrected] 2. On page 12729, in the second column, five asterisks (* * * * *) indicating the existence of text not listed and unchanged should appear above the text reading ‘‘INSTRUCTIONS AS TO EXHIBITS’’. ■ [FR Doc. C1–2019–05695 Filed 4–5–19; 8:45 am] BILLING CODE 1301–00–D DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA–446] Schedules of Controlled Substances: Extension of Temporary Placement of 5F–ADB, 5F–AMB, 5F–APINACA, ADB– FUBINACA, MDMB–CHMICA and MDMB–FUBINACA in Schedule I of the Controlled Substances Act Drug Enforcement Administration, Department of Justice. ACTION: Temporary rule; temporary scheduling order; extension. AGENCY: The Acting Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to extend the temporary schedule I status of six synthetic cannabinoids (SC). The substances are: methyl 2-(1-(5fluoropentyl)-1H-indazole-3carboxamido)-3,3-dimethylbutanoate [5F–ADB; 5F–MDMB–PINACA]; methyl 2-(1-(5-fluoropentyl)-1H-indazole-3carboxamido)-3-methylbutanoate [5F– AMB]; N-(adamantan-1-yl)-1-(5fluoropentyl)-1H-indazole-3carboxamide [5F–APINACA, 5F– AKB48]; N-(1-amino-3,3-dimethyl-1oxobutan-2-yl)-1-(4-fluorobenzyl)-1Hindazole-3-carboxamide [ADB– FUBINACA]; methyl 2-(1(cyclohexylmethyl)-1H-indole-3carboxamido)-3,3-dimethylbutanoate [MDMB–CHMICA, MMB–CHMINACA] and methyl 2-(1-(4-fluorobenzyl)-1Hindazole-3-carboxamido)-3,3dimethylbutanoate [MDMB– FUBINACA], including their optical, positional and geometric isomers, salts, and salts of isomers. The schedule I status of 5F–ADB, 5F–AMB, 5F– APINACA, ADB–FUBINACA, MDMB– CHMICA and MDMB–FUBINACA will expire on April 10, 2019. This temporary order will extend the temporary scheduling of 5F–ADB, 5F– AMB, 5F–APINACA, ADB–FUBINACA, MDMB–CHMICA and MDMB– FUBINACA for one year or until the permanent scheduling action for these SUMMARY: PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 six substances is completed, whichever occurs first. DATES: This temporary scheduling order, which extends the order (82 FR 17119, April 10, 2017), is effective April 10, 2019 and expires on April 10, 2020. 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 April 10, 2020. FOR FURTHER INFORMATION CONTACT: Lynnette M. Wingert, 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 April 10, 2017, the Acting Administrator of the Drug Enforcement Administration (DEA) published an order in the Federal Register (82 FR 17119) temporarily placing methyl 2-(1(5-fluoropentyl)-1H-indazole-3carboxamido)-3,3-dimethylbutanoate [5F–ADB; 5F–MDMB–PINACA], methyl 2-(1-(5-fluoropentyl)-1H-indazole-3carboxamido)-3-methylbutanoate [5F– AMB], N-(adamantan-1-yl)-1-(5fluoropentyl)-1H-indazole-3carboxamide [5F–APINACA, 5F– AKB48], N-(1-amino-3,3-dimethyl-1oxobutan-2-yl)-1-(4-fluorobenzyl)-1Hindazole-3-carboxamide [ADB– FUBINACA], methyl 2-(1(cyclohexylmethyl)-1H-indole-3carboxamido)-3,3-dimethylbutanoate [MDMB–CHMICA, MMB–CHMINACA] and methyl 2-(1-(4-fluorobenzyl)-1Hindazole-3-carboxamido)-3,3dimethylbutanoate [MDMB– FUBINACA], synthetic cannabinoid (SC) substances, in schedule I of the Controlled Substances Act (CSA) pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). That 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 these SCs 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 these substances expires two years from the effective date of the scheduling order, or on April 10, 2019. 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 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 E:\FR\FM\08APR1.SGM 08APR1 Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Rules and Regulations jbell on DSK30RV082PROD with RULES 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 (HHS),2 or on the petition of any interested party. The Acting Administrator of the DEA (Acting Administrator), 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 5F– ADB, 5F–AMB, 5F–APINACA, ADB– FUBINACA, MDMB–CHMICA and MDMB–FUBINACA. 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 these six SCs. On September 27, 2017, 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 5F–ADB, 5F–AMB, 5F–APINACA, ADB–FUBINACA, MDMB–CHMICA and MDMB– FUBINACA, and in accordance with 21 U.S.C. 811 (b) and (c). Upon evaluating the scientific and medical evidence, on March 21, 2019, the HHS submitted to the Acting Administrator its scientific and medical evaluation for these six substances. Upon receipt of the scientific and medical evaluation and scheduling recommendations 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 5F–ADB, 5F– AMB, 5F–APINACA, ADB–FUBINACA, MDMB–CHMICA and MDMB– FUBINACA in accordance with 21 U.S.C. 811(c). The DEA published a notice of proposed rulemaking for the placement of 5F–ADB, 5F–AMB, 5F– APINACA, ADB–FUBINACA, MDMB– CHMICA and MDMB–FUBINACA in schedule I elsewhere in this issue of the Federal Register. If the scheduling of these substances is made permanent, the DEA will publish a final rule in the Federal Register. Pursuant to 21 U.S.C. 811(h)(2), the Acting Administrator orders that the temporary scheduling of 5F–ADB, 5F– AMB, 5F–APINACA, ADB–FUBINACA, MDMB–CHMICA and MDMB– FUBINACA, including their optical, scheduling order.’’ No substantive change is intended. 2 The Secretary of HHS has delegated to the Assistant Secretary for Health of the HHS the authority to make domestic drug scheduling recommendations. VerDate Sep<11>2014 15:49 Apr 05, 2019 Jkt 247001 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 5F–ADB, 5F– AMB, 5F–APINACA, ADB–FUBINACA, MDMB–CHMICA and MDMB– FUBINACA, including their 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. The specific language chosen by Congress indicates an intention for the DEA to proceed through the issuance of an order instead of proceeding by rulemaking. Given that Congress specifically requires the Attorney General to follow rulemaking procedures for other kinds of scheduling actions, see section 201(a) of the CSA, 21 U.S.C. 811(a), it is noteworthy that, in section 201(h), Congress authorized the issuance of temporary scheduling actions by order rather than by rule. 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 and the delayed effective date 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 PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 13797 imminent hazard to the public safety. Further, the DEA believes that this order 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. 5 U.S.C. 808(2). It is in the public interest to maintain the temporary placement of 5F–ADB, 5F–AMB, 5F– APINACA, ADB–FUBINACA, MDMB– CHMICA and MDMB–FUBINACA in schedule I because they pose 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 these substances in schedule I because they pose 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 E:\FR\FM\08APR1.SGM 08APR1 13798 Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Rules and Regulations its publication. The DEA has submitted a copy of this order to both Houses of Congress and to the Comptroller General, although such filing is not required under the Congressional Review Act, 5 U.S.C. 801–808 because, as noted above, this action is an order, not a rule. Dated: April 2, 2019. Uttam Dhillon, Acting Administrator. [FR Doc. 2019–06851 Filed 4–5–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Bureau of Alcohol, Tobacco, Firearms, and Explosives 27 CFR Part 555 [Docket No. ATF 2017R–21; AG Order No. 4425–2019] Removal of Expired Regulations Bureau of Alcohol, Tobacco, Firearms, and Explosives, Department of Justice. ACTION: Final rule. AGENCY: This final rule makes technical amendments to the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) regulations in the Code of Federal Regulations (CFR). These technical changes are being made to remove expired, obsolete, or unnecessary regulations; correct dates, titles, addresses, and telephone numbers; and to reflect changes to nomenclature resulting from the transfer of ATF to the Department of Justice from the Department of the Treasury pursuant to the Homeland Security Act of 2002. The changes are designed to update and provide clarity throughout these regulations. DATES: This rule is effective April 8, 2019. SUMMARY: FOR FURTHER INFORMATION CONTACT: jbell on DSK30RV082PROD with RULES Shermaine Kenner, Office of Regulatory Affairs, Enforcement Programs and Services, Bureau of Alcohol, Tobacco, Firearms, and Explosives, U.S. Department of Justice, 99 New York Avenue NE, Washington, DC 20226; telephone: (202) 648–7070 (this is not a toll-free number). SUPPLEMENTARY INFORMATION: I. Backgrounds ATF administers regulations published in 27 CFR part 555, concerning commerce in explosives. ATF identified several technical amendments that are needed to update VerDate Sep<11>2014 16:38 Apr 05, 2019 Jkt 247001 and to provide clarity to these regulations. Rather than make substantive changes to the regulations, these amendments focus on improving the clarity and accuracy of the regulations. Many of the technical changes reflect the removal of expired or obsolete regulations; removal of regulations that are no longer necessary; and the correction of dates, titles, addresses, and telephone numbers. Additionally, technical changes to § 555.11 reflect a change in nomenclature resulting from the transfer of ATF to the Department of Justice from the Department of the Treasury pursuant to the Homeland Security Act of 2002. Section 555.11 is being amended to remove paragraph (a) and revise paragraph (b) in the definitions of ‘‘ATF’’, ‘‘ATF Officer’’, ‘‘Bureau’’, and ‘‘Director’’ as the information in the regulations is obsolete, to revise the definition of ‘‘Director, Industry Operations’’ for accuracy, and to replace ‘‘Bureau of Alcohol, Tobacco and Firearms’’ with ‘‘Bureau of Alcohol, Tobacco, Firearms, and Explosives, Department of Justice’’ in the definition of ‘‘Region’’ as the current definition references the name of the agency under the Department of the Treasury, prior to the Homeland Security Act of 2002. Section 555.27 is being removed and reserved as the requirement in the statute that this regulation implemented is expired and obsolete. Section 555.30 is being amended to reflect the correct nationwide toll-free telephone number, and the reference to Form 4712 is being removed as this information is no longer necessary and is obsolete. Sections 555.33, 555.142, and 555.165 are being amended to remove the effective dates, which are no longer necessary. Sections 555.41, 555.49, 555.51, 555.103, and 555.125 are being amended to remove and reserve paragraph (a) in each of these sections as the information in those paragraphs is obsolete. Section 555.45 is being amended to remove and reserve paragraphs (a) and (b) as the information in those paragraphs is obsolete. Section 555.57 is being amended to remove ‘‘For all licenses or permits issued on and after May 24, 2003’’ as this delineation is no longer necessary. Section 555.102 is being amended to remove paragraph (b)(1) and revise paragraph (b)(2) as the information in those paragraphs is obsolete. Section 555.105 is being amended to remove the reference to nonlicensees and nonpermittees in the heading of the PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 section, and to remove and reserve paragraph (a) as the information in the regulation is obsolete. Section 555.126 is being amended to revise the heading of the section, and to remove and reserve paragraph (a) as the information in the regulation is obsolete. Section 555.201 is being amended to remove and reserve paragraph (e) as the application of this paragraph is obsolete. Section 555.202 is being amended to remove ‘‘See also § 555.201(e).’’ as the referenced sentence is obsolete. Section 555.218 is being amended to remove the date ‘‘July, 1991’’ from the table title and replace it with ‘‘June 1991’’, the correct date. Section 555.219 is being amended to add the title of the table, as the title was incorrectly added to the table in 555.220 when published in the Federal Register. Section 555.220 is being amended to remove the title above the table and remove the address for the Fertilizer Institute, as this information is incorrect. Section 555.224 is being amended to remove ‘‘(30 days from the date of publication of the final rule in the Federal Register)’’ and to add the effective date in the third footnote. II. Statutory Orders and Executive Review A. Executive Orders 12866, 13563, and 13771 This rule has been drafted and reviewed in accordance with Executive Order 12866, ‘‘Regulatory Planning and Review,’’ section 1(b), The Principles of Regulation; Executive Order 13563, ‘‘Improving Regulation and Regulatory Review,’’ section 1(b), General Principles of Regulation; and Executive Order 13771, ‘‘Reducing Regulation and Controlling Regulatory Costs.’’ The rule makes technical corrections to eliminate outdated and incorrect terminology and improve the clarity of the regulations, and makes no substantive changes. The Department has determined that this final rule is not a ‘‘significant regulatory action’’ as defined in Executive Order 12866, section 3(f). Accordingly, this final rule has not been reviewed by the Office of Management and Budget. Finally, because this rule is not a significant regulatory action, it is not subject to the requirements of Executive Order 13771. There are no costs associated with this regulation; however, it benefits the industry in that it removes numerous outdated regulations and provides clarity for the regulated industry. Because there are no costs associated with this final rule, E:\FR\FM\08APR1.SGM 08APR1

Agencies

[Federal Register Volume 84, Number 67 (Monday, April 8, 2019)]
[Rules and Regulations]
[Pages 13796-13798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06851]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-446]


Schedules of Controlled Substances: Extension of Temporary 
Placement of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and 
MDMB-FUBINACA in Schedule I of the Controlled Substances Act

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Temporary rule; temporary scheduling order; extension.

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

SUMMARY: The Acting Administrator of the Drug Enforcement 
Administration is issuing this temporary scheduling order to extend the 
temporary schedule I status of six synthetic cannabinoids (SC). The 
substances are: methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-
carboxamido)-3,3-dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2-
(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate [5F-
AMB]; N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide 
[5F-APINACA, 5F-AKB48]; N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-
fluorobenzyl)-1H-indazole-3-carboxamide [ADB-FUBINACA]; methyl 2-(1-
(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate 
[MDMB-CHMICA, MMB-CHMINACA] and methyl 2-(1-(4-fluorobenzyl)-1H-
indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA], 
including their optical, positional and geometric isomers, salts, and 
salts of isomers. The schedule I status of 5F-ADB, 5F-AMB, 5F-APINACA, 
ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA will expire on April 10, 
2019. This temporary order will extend the temporary scheduling of 5F-
ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA 
for one year or until the permanent scheduling action for these six 
substances is completed, whichever occurs first.

DATES: This temporary scheduling order, which extends the order (82 FR 
17119, April 10, 2017), is effective April 10, 2019 and expires on 
April 10, 2020. 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 April 10, 2020.

FOR FURTHER INFORMATION CONTACT: Lynnette M. Wingert, 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 April 10, 2017, the Acting Administrator of the Drug Enforcement 
Administration (DEA) published an order in the Federal Register (82 FR 
17119) temporarily placing methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-
carboxamido)-3,3-dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA], methyl 2-
(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate [5F-
AMB], N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide 
[5F-APINACA, 5F-AKB48], N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-
fluorobenzyl)-1H-indazole-3-carboxamide [ADB-FUBINACA], methyl 2-(1-
(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate 
[MDMB-CHMICA, MMB-CHMINACA] and methyl 2-(1-(4-fluorobenzyl)-1H-
indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA], 
synthetic cannabinoid (SC) substances, in schedule I of the Controlled 
Substances Act (CSA) pursuant to the temporary scheduling provisions of 
21 U.S.C. 811(h). That 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 these SCs 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 these substances expires two years from the 
effective date of the scheduling order, or on April 10, 2019. 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

[[Page 13797]]

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 (HHS),\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\ The Secretary of HHS has delegated to the Assistant 
Secretary for Health of the HHS the authority to make domestic drug 
scheduling recommendations.
---------------------------------------------------------------------------

    The Acting Administrator of the DEA (Acting Administrator), 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 5F-ADB, 5F-AMB, 5F-
APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA. 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 these six SCs. On September 
27, 2017, 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 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, 
MDMB-CHMICA and MDMB-FUBINACA, and in accordance with 21 U.S.C. 811 (b) 
and (c). Upon evaluating the scientific and medical evidence, on March 
21, 2019, the HHS submitted to the Acting Administrator its scientific 
and medical evaluation for these six substances. Upon receipt of the 
scientific and medical evaluation and scheduling recommendations 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 
5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA 
in accordance with 21 U.S.C. 811(c). The DEA published a notice of 
proposed rulemaking for the placement of 5F-ADB, 5F-AMB, 5F-APINACA, 
ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA in schedule I elsewhere in 
this issue of the Federal Register. If the scheduling of these 
substances is made permanent, the DEA will publish a final rule in the 
Federal Register.
    Pursuant to 21 U.S.C. 811(h)(2), the Acting Administrator orders 
that the temporary scheduling of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-
FUBINACA, MDMB-CHMICA and MDMB-FUBINACA, including their 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 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, 
MDMB-CHMICA and MDMB-FUBINACA, including their 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. The specific language 
chosen by Congress indicates an intention for the DEA to proceed 
through the issuance of an order instead of proceeding by rulemaking. 
Given that Congress specifically requires the Attorney General to 
follow rulemaking procedures for other kinds of scheduling actions, see 
section 201(a) of the CSA, 21 U.S.C. 811(a), it is noteworthy that, in 
section 201(h), Congress authorized the issuance of temporary 
scheduling actions by order rather than by rule. 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 and the delayed effective date 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 
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. 5 U.S.C. 808(2). It is in the public interest to maintain the 
temporary placement of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-
CHMICA and MDMB-FUBINACA in schedule I because they pose 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 these substances in schedule I because they pose 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

[[Page 13798]]

its publication. The DEA has submitted a copy of this order to both 
Houses of Congress and to the Comptroller General, although such filing 
is not required under the Congressional Review Act, 5 U.S.C. 801-808 
because, as noted above, this action is an order, not a rule.

    Dated: April 2, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-06851 Filed 4-5-19; 8:45 am]
BILLING CODE 4410-09-P