[Federal Register Volume 78, Number 19 (Tuesday, January 29, 2013)]
[Notices]
[Page 6132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-01837]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


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

    Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this 
is notice that on October 11, 2012, Alkermes Gainesville, LLC., 1300 
Gould Drive, Gainesville, Georgia 30504, made application to the Drug 
Enforcement Administration (DEA) for registration as an importer of 
noroxymorphone (9668), a basic class of controlled substance listed in 
schedule II.
    The company plans to import the listed substance for analytical 
research and testing.
    The import of the above listed basic class of controlled substance 
will 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.
    Any bulk manufacturer who is presently, or is applying to be, 
registered with DEA to manufacture such basic classes of controlled 
substances listed in schedules I or II, which fall under the authority 
of section 1002(a)(2)(B) of the Act 21 U.S.C. 952 (a)(2)(B) may, in the 
circumstances set forth in 21 U.S.C. 958(i), file comments or 
objections to the issuance of the proposed registration and may, at the 
same time, file a written request for a hearing on such application 
pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 
1316.47.
    Any such written comments or objections should be addressed, in 
quintuplicate, to the Drug Enforcement Administration, Office of 
Diversion Control, Federal Register Representative (ODL), 8701 
Morrissette Drive, Springfield, Virginia 22152; and must be filed no 
later than February 28, 2013.
    This procedure is to be conducted simultaneously with, and 
independent of, the procedures described in 21 CFR 1301.34(b), (c), 
(d), (e), and (f). As noted in a previous notice published in the 
Federal Register on September 23, 1975, 40 FR 43745-46, all applicants 
for registration to import a basic class of any controlled substance in 
schedules I or II are, and will continue to be, required to demonstrate 
to the Deputy Assistant Administrator, Office of Diversion Control, 
Drug Enforcement Administration, that the requirements for such 
registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 21 CFR 
1301.34(b), (c), (d), (e), and (f) are satisfied.

    Dated: January 16, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-01837 Filed 1-28-13; 8:45 am]
BILLING CODE 4410-09-P