```

[Federal Register Volume 80, Number 94 (Friday, May 15, 2015)]
[Rules and Regulations]
[Pages 27854-27856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11765]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-414]

Schedules of Controlled Substances: Extension of Temporary 
Placement of UR-144, XLR11, and AKB48 in Schedule I of the Controlled 
Substances Act

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

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

SUMMARY: The Administrator of the Drug Enforcement Administration (DEA) 
is

[[Page 27855]]

issuing this final order to extend the temporary placement of (1-
pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-
144), [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-
tetramethylcyclopropyl)methanone (5-fluoro-UR-144, XLR11) and N-(1-
adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA, AKB48), 
including their salts, isomers, and salts of isomers whenever the 
existence of such salts, isomers, and salts of isomers is possible, in 
schedule I of the Controlled Substances Act. The current final order 
temporarily placing UR-144, XLR11, and AKB48 in schedule I is due to 
expire on May 15, 2015. This final order will extend the temporary 
scheduling of UR-144, XLR11, and AKB48 to May 15, 2016, or until the 
permanent scheduling action for these three substances is completed, 
whichever occurs first.

DATES: This final order is effective May 15, 2015.

FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, Office of 
Diversion Control, Drug Enforcement Administration; Mailing Address: 
8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 
598-6812.

SUPPLEMENTARY INFORMATION: On May 16, 2013, the Deputy Administrator of 
the Drug Enforcement Administration published a Final Order in the 
Federal Register (78 FR 28735) amending 21 CFR 1308.11(h) to 
temporarily place three synthetic cannabinoids, namely (1-pentyl-1H-
indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144), [1-(5-
fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone 
(5-fluoro-UR-144, XLR11), and N-(1-adamantyl)-1-pentyl-1H-indazole-3-
carboxamide (APINACA, AKB48), 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, which became effective on the date 
of publication, was based on findings by the Deputy Administrator of 
the DEA that the temporary scheduling of these three synthetic 
cannabinoids was necessary to avoid an imminent hazard to the public 
safety pursuant to 21 U.S.C. 811(h)(1). At the time the final order 
took effect, section 201(h)(2) of the CSA, 21 U.S.C. 811(h)(2), 
required that the temporary scheduling of a substance expires at the 
end of two years from the date of issuance of the order scheduling the 
substance, except that the Attorney General may, during the pendency of 
proceedings under 21 U.S.C. 811(a)(1) with respect to the substance, 
extend the temporary scheduling of that substance for up to one year. 
Proceedings for the permanent 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 or her own 
motion, at the request of the Secretary of Health and Human 
Services,\1\ or on the petition of any interested party.
---------------------------------------------------------------------------

    \1\ Because the Secretary of the Department of Health and Human 
Services has delegated to the Assistant Secretary for Health of the 
Department of Health and Human Services the authority to make 
domestic drug scheduling recommendations, for purposes of this Final 
Order, all subsequent references to ``Secretary'' have been replaced 
with ``Assistant Secretary.''
---------------------------------------------------------------------------

    In this case, the DEA initiated permanent scheduling proceedings on 
its own motion pursuant to 21 U.S.C. 811(a). 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 three synthetic cannabinoids. On 
August 31, 2013, 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 UR-144, XLR11, and AKB48, pursuant 
to 21 U.S.C. 811(b) and (c). Upon evaluating the scientific and medical 
evidence, the HHS on May 12, 2015, submitted to the Administrator of 
the DEA its three scientific and medical evaluations entitled, ``Basis 
For the Recommendation to Place 1-pentyl-1H-indol-3-yl 2,2,3,3-
tetramethylcyclopropyl methanone (UR-144) and its Salts in schedule I 
of the Controlled Substances Act (CSA),'' ``Basis For the 
Recommendation to Place 1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-
tetramethylcyclopropyl methanone (XLR11) and its Salts in schedule I of 
the Controlled Substances Act (CSA),'' and ``Basis For the 
Recommendation to Place N-(1-adamantyl)-1-pentyl-1H-indazole-3-
carboxamide (AKB48) and its Salts in schedule I of the Controlled 
Substances Act (CSA).'' 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 UR-144, XLR11, and 
AKB48 pursuant to 21 U.S.C. 811(c). The DEA is publishing a Notice of 
Proposed Rulemaking for the Placement of UR-144, XLR11, and AKB48 into 
schedule I. The Administrator thereby has initiated proceedings 
regarding UR-144, XLR11, and AKB48 in accordance with 21 U.S.C. 
811(a)(1). Therefore, pursuant to 21 U.S.C. 811(h)(2), the 
Administrator of the DEA hereby orders that the temporary scheduling of 
UR-144, XLR11, and AKB48, including their salts, isomers, and salts of 
isomers whenever the existence of such salts, isomers, and salts of 
isomers is possible, be extended to May 15, 2016, or until the 
proceedings to permanently schedule these three substances is 
completed, whichever occurs first.
    In accordance with this final order, the schedule I requirements 
for handling UR-144, XLR11, and AKB48, including their salts, isomers, 
and salts of isomers whenever the existence of such salts, isomers, and 
salts of isomers is possible, will remain in effect until May 15, 2016, 
or until the permanent scheduling proceeding is completed, whichever 
occurs first.

Regulatory Matters

    Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for an 
expedited temporary scheduling action where such action is necessary to 
avoid an imminent hazard to the public safety. As provided in this 
subsection, the Attorney General may, by order, schedule a substance in 
schedule I on a temporary basis. Section 201(h) of the CSA, 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.
    Inasmuch as section 201(h) of the CSA 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 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 final order extending the temporary

[[Page 27856]]

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.
    Pursuant to section 808(2) of the Congressional Review Act (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 UR-
144, XLR11, and AKB48 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. 21 
U.S.C. 811(h) exempted the temporary scheduling order from standard 
notice and comment rulemaking procedures to ensure that the process 
moved 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 DEA's 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 final order extending 
the temporary scheduling order shall take effect immediately upon its 
publication. Pursuant to the Small Business Regulatory Enforcement 
Fairness Act of 1996 (Congressional Review Act) (5 U.S.C. 801-808), the 
DEA has submitted a copy of this final order to both Houses of Congress 
and to the Comptroller General.

    Dated: May 12, 2015.
Michele M. Leonhart,
Administrator.
[FR Doc. 2015-11765 Filed 5-14-15; 8:45 am]
 BILLING CODE 4410-09-P
```