Rules - 2012
[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]
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.
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]
BILLING CODE 4410-09-P
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