Notice of Application - 2012
[Federal Register Volume 77, Number 219 (Tuesday, November 13, 2012)]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27570]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Application; Watson
Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this
is notice that on August 28, 2012, Watson Pharma, Inc., 2455 Wardlow
Road, Corona, California 92880-2882, made application to the Drug
Enforcement Administration (DEA) for registration as an importer of the
following basic classes of controlled substances:
The company plans to import the listed controlled substances for
analytical testing and clinical trials.
The import of the above listed basic classes of controlled
substances 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
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 December 13, 2012.
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: November 5, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
[FR Doc. 2012-27570 Filed 11-9-12; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).