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