[Federal Register Volume 78, Number 126 (Monday, July 1, 2013)]
[Notices]
[Page 39338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-15589]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Registration; 
Alkermes Gainesville, LLC

    By Notice dated January 16, 2013, and published in the Federal 
Register on January 29, 2013, 78 FR 6132, Alkermes Gainesville, LLC, 
1300 Gould Drive, Gainesville, Georgia 30504, made application to the 
Drug Enforcement Administration (DEA) to be registered as an importer 
of Noroxymorphone (9668), a basic class of controlled substance listed 
in schedule II.
    The company plans to import the listed controlled substance for 
analytical research and testing.
    The import of the above listed basic class of controlled substance 
would be granted only for analytical testing and clinical trials. This 
authorization does not extend to the import of a finished FDA approved 
or non-approved dosage form for commercial distribution in the United 
States.
    No comments or objections have been received. DEA has considered 
the factors in 21 U.S.C. 823(a) and 952(a) and determined that the 
registration of Alkermes Gainesville, LLC, to import the basic class of 
controlled substance is consistent with the public interest and with 
United States obligations under international treaties, conventions, or 
protocols in effect on May 1, 1971.
    DEA has investigated Alkermes Gainesville, LLC, to ensure that the 
company's registration is consistent with the public interest. The 
investigation has included inspection and testing of the company's 
physical security systems, verification of the company's compliance 
with state and local laws, and a review of the company's background and 
history.
    Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in 
accordance with 21 CFR 1301.34, the above named company is granted 
registration as an importer of the basic class of controlled substance 
listed.

    Dated: June 18, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-15589 Filed 6-28-13; 8:45 am]
BILLING CODE 4410-09-P