Importer of Controlled Substances; Notice of Application, 73358 [E7-25042]
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73358
Federal Register / Vol. 72, No. 247 / Thursday, December 27, 2007 / Notices
this is notice that on November 22,
2007, Cambrex Charles City, Inc., 1205
11th Street, Charles City, Iowa 50616,
made application by renewal to the
Drug Enforcement Administration
(DEA) to be registered as a bulk
manufacturer of the basic classes of
controlled substances listed in schedule
II:
Drug
Schedule
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Phenylacetone (8501) ..................
Codeine (9050) .............................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Dextropropoxyphene, bulk (nondosage forms) (9273).
Morphine (9300) ...........................
Thebaine (9333) ...........................
Sufentanil (9740) ..........................
Fentanyl (9801) ............................
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for sale to its customers.
Any other such applicant and any
person who is presently registered with
DEA to manufacture such substances
may file comments or objections to the
issuance of the proposed registration
pursuant to 21 CFR 1301.33(a).
Any such written comments or
objections being sent via regular mail
should be addressed, in quintuplicate,
to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), Washington, DC 20537, or any
being sent via express mail should be
sent to Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, VA 22152; and must be
filed no later than February 25, 2008.
Dated: December 17, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E7–25111 Filed 12–26–07; 8:45 am]
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DEPARTMENT OF JUSTICE
mstockstill on PROD1PC66 with NOTICES
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
VerDate Aug<31>2005
19:40 Dec 26, 2007
Jkt 214001
bulk manufacturer of a controlled
substance in schedule I or II and prior
to issuing a registration 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 October
19, 2007, GE Healthcare, 3350 North
Ridge Avenue, Arlington Heights,
Illinois 60004–1412, made application
to the Drug Enforcement Administration
(DEA) to be registered as an importer of
a substance controlled under the basic
class of Cocaine (9041), a schedule II
controlled substance.
The company plans to import small
quantities of ioflupane, in the form of
three separate analogues of Cocaine, to
validate production and QC systems; for
a reference standard; and for producing
material for 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
being sent via regular mail should be
addressed, in quintuplicate, to the Drug
Enforcement Administration, Office of
Diversion Control, Federal Register
Representative (ODL), Washington, DC
20537, or any being sent via express
mail should be sent to Drug
Enforcement Administration, Office of
Diversion Control, Federal Register
Representative (ODL), 8701 Morrissette
Drive, Springfield, VA 22152; and must
be filed no later than January 28, 2008.
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 substances 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
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
CFR 1301.34(b), (c), (d), (e), and (f) are
satisfied.
Dated: December 17, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E7–25042 Filed 12–26–07; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application
Pursuant to § 1301.33(a) of Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on July 20, 2007, GE
Healthcare, 3350 North Ridge Avenue,
Arlington Heights, Illinois 60004–1412,
made application to the Drug
Enforcement Administration (DEA) to
be registered as a bulk manufacturer of
a substance controlled under the basic
class of Cocaine (9041), a schedule II
controlled substance.
The company plans to manufacture a
radioactive product used in diagnostic
imaging in the diagnosis of Parkinson’s
Disease and for manufacture in bulk for
investigational new drug (IND)
submission and clinical trials.
Any other such applicant and any
person who is presently registered with
DEA to manufacture such a substance
may file comments or objections to the
issuance of the proposed registration
pursuant to 21 CFR 1301.33(a).
Any such written comments or
objections being sent via regular mail
should be addressed, in quintuplicate,
to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), Washington, DC 20537, or any
being sent via express mail should be
sent to Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, VA 22152; and must be
filed no later than February 25, 2008.
Dated: December 17, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control Drug Enforcement
Administration.
[FR Doc. E7–25051 Filed 12–26–07; 8:45 am]
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E:\FR\FM\27DEN1.SGM
27DEN1
Agencies
[Federal Register Volume 72, Number 247 (Thursday, December 27, 2007)]
[Notices]
[Page 73358]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-25042]
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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
registration 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 October 19, 2007, GE
Healthcare, 3350 North Ridge Avenue, Arlington Heights, Illinois 60004-
1412, made application to the Drug Enforcement Administration (DEA) to
be registered as an importer of a substance controlled under the basic
class of Cocaine (9041), a schedule II controlled substance.
The company plans to import small quantities of ioflupane, in the
form of three separate analogues of Cocaine, to validate production and
QC systems; for a reference standard; and for producing material for
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 being sent via regular mail should
be addressed, in quintuplicate, to the Drug Enforcement Administration,
Office of Diversion Control, Federal Register Representative (ODL),
Washington, DC 20537, or any being sent via express mail should be sent
to Drug Enforcement Administration, Office of Diversion Control,
Federal Register Representative (ODL), 8701 Morrissette Drive,
Springfield, VA 22152; and must be filed no later than January 28,
2008.
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
substances 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: December 17, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. E7-25042 Filed 12-26-07; 8:45 am]
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