Notice of Application - 2013
[Federal Register Volume 78, Number 35 (Thursday, February 21, 2013)]
[Notices]
[Page 12101]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03905]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Application; Meda
Pharmaceuticals, Inc.
Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this
is notice that on December 4, 2012, Meda Pharmaceuticals, Inc., 705
Eldorado Street, Decatur, Illinois 62523, made application by renewal
to the Drug Enforcement Administration (DEA) to be registered as an
importer of Nabilone (7379), a basic class of controlled substance
listed in schedule II.
The company plans to import the listed controlled substance as a
finished drug product in dosage form for distribution to its customers.
Any bulk manufacturer who is presently, or is applying to be,
registered with DEA to manufacture such basic classes of controlled
substances listed in schedule II, which falls 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 March 25, 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 classes of any controlled substances
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: February 8, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2013-03905 Filed 2-20-13; 8:45 am]
BILLING CODE 4410-09-P
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