Notice of Application - 2013
[Federal Register Volume 78, Number 25 (Wednesday, February 6, 2013)]
[Notices]
[Pages 8583-8584]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02682]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Application; GE
Healthcare
Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this
is notice that on July 28, 2011, GE Healthcare, 3350 North Ridge
Avenue, Arlington Heights, Illinois 60004-1412, made application by
renewal to the Drug Enforcement Administration (DEA) for registration
as an importer of Cocaine (9041), a basic class of controlled substance
listed in schedule II.
The company plans to import small quantities of ioflupane, in the
form of three separate analogues of Cocaine, to validate production and
quality control systems, for a reference standard, and for producing
material for a future investigational new drug (IND) submission.
Any bulk manufacturer who is presently, or is applying to be,
registered with DEA to manufacture such basic class of controlled
substance listed in schedule 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
[[Page 8584]]
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 8, 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
schedule 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 31, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2013-02682 Filed 2-5-13; 8:45 am]
BILLING CODE 4410-09-P
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