[Federal Register Volume 74, Number 172 (Tuesday, September 8, 2009)]
[Notices]
[Pages 46228-46229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21540]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Application
Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to
issuing a registration under this Section to a bulk manufacturer of a
controlled substance in schedule I or II and prior to issuing a
regulation under 21 U.S.C. 952(a)(2) authorizing the importation of
such a substance, provide manufacturers holding registrations for the
bulk manufacture of the substance an opportunity for a hearing.
Therefore, in accordance with Title 21 Code of Federal Regulations
(CFR), 1301.34(a), this is notice that on July 2, 2009, GE Healthcare,
3350 North Ridge Avenue, Arlington Heights, Illinois 60004-1412, made
application by renewal to the Drug Enforcement Administration (DEA) to
be registered 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 may 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 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, VA. 22152; and must be filed no later
than October 8, 2009.
[[Page 46229]]
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: August 21, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. E9-21540 Filed 9-4-09; 8:45 am]
BILLING CODE 4410-09-P