[Federal Register Volume 77, Number 202 (Thursday, October 18, 2012)]
[Rules and Regulations]
[Pages 64032-64033]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-25510]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-357]


Schedules of Controlled Substances: Extension of Temporary 
Placement of Methylone Into Schedule I of the Controlled Substances Act

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

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SUMMARY: This Final Order is issued by the Administrator of the Drug 
Enforcement Administration (DEA) to extend the temporary scheduling of 
methylone (3,4-methylenedioxy-N-methylcathinone) including its salts,

[[Page 64033]]

isomers, and salts of isomers whenever the existence of such salts, 
isomers, and salts of isomers is possible, into Schedule I of the 
Controlled Substances Act (CSA). The temporary scheduling of methylone 
is due to expire on October 20, 2012. This document will extend the 
temporary scheduling of methylone to April 20, 2013, or until 
rulemaking proceedings are completed, whichever occurs first.

DATES: Effective Date: October 18, 2012.

FOR FURTHER INFORMATION CONTACT: Alan G. Santos, Associate Deputy 
Assistant Administrator, Office of Diversion Control, Drug Enforcement 
Administration; Mailing Address: 8701 Morrissette Drive, Springfield, 
Virginia 22152; Telephone: (202) 307-7165.

SUPPLEMENTARY INFORMATION: On October 21, 2011, the Administrator of 
the DEA published a Final Order in the Federal Register (76 FR 65371) 
amending 21 CFR 1308.11(g) to temporarily place three synthetic 
cathinones, namely mephedrone (4-methyl-N-methylcathinone), MDPV (3,4-
methylenedioxypyrovalerone) and methylone, into Schedule I of the 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 Administrator of the DEA that the 
temporary scheduling of these three synthetic cathinones 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) (2011)) required that the temporary 
scheduling of a substance expire at the end of one year from the date 
of issuance of the order and that during the pendency of proceedings 
under 21 U.S.C. 811(a)(1) with respect to the substance, the temporary 
scheduling of that substance could be extended for up to six months.\1\ 
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.
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    \1\ On July 9, 2012, President Obama signed the Food and Drug 
Administration Safety and Innovation Act (Pub. L. 112-144) (FDASIA), 
which amended section 201(h)(2) of the CSA to extend the timeframes 
applicable to temporary scheduling.
    \2\ 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.''
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    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 cathinones. On March 30, 2012, the Administrator of the DEA 
submitted a letter to the Assistant Secretary for Health of the 
Department of Health and Human Services, requesting scientific and 
medical evaluations and scheduling recommendations for these three 
synthetic cathinones. In response to this letter, on August 14, 2012, 
the Assistant Secretary provided to DEA a scientific and medical 
evaluation and recommendation that methylone be placed in Schedule 
I.\3\ Proceedings regarding methylone have been initiated 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 methylone, including its salts, isomers, and salts of 
isomers whenever the existence of such salts, isomers, and salts of 
isomers is possible, is extended to April 20, 2013, or until rulemaking 
proceedings are completed, whichever occurs first.
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    \3\ Section 1152 of FDASIA controlled mephedrone and MDPV as 
Schedule I controlled substances, but it did not similarly control 
methylone. Accordingly, HHS provided a Scientific and Medical 
Evaluation and Scheduling Recommendation for methylone, recommending 
that methylone be placed in Schedule I.
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    In accordance with this Final Order, the Schedule I requirements 
for handling methylone including its salts, isomers, and salts of 
isomers whenever the existence of such salts, isomers, and salts of 
isomers is possible, will remain in effect until April 20, 2013, or 
until rulemaking proceedings are completed, whichever occurs first.
    Pursuant to the Small Business Regulatory Enforcement Fairness Act 
of 1996 (Congressional Review Act) (5 U.S.C. 801-808), DEA has 
submitted a copy of this Final Order to both Houses of Congress and to 
the Comptroller General.

     Dated: October 10, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-25510 Filed 10-17-12; 8:45 am]
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