Importer of Controlled Substances; Notice of Application, 46228-46229 [E9-21540]
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46228
Federal Register / Vol. 74, No. 172 / Tuesday, September 8, 2009 / Notices
Schedule
Drug
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Benzoylecgonine (9180) ...............
Ethylmorphine (9190) ...................
Meperidine (9230) ........................
Methadone (9250) ........................
Dextropropoxyphene, bulk (nondosage forms).
(9273) ...........................................
Morphine (9300) ...........................
Oripavine (9330) ...........................
Thebaine (9333) ...........................
Levo-alphacetylmethadol (9648) ..
Oxymorphone (9652) ...................
Poppy Straw Concentrate (9670)
Fentanyl (9801) ............................
DEPARTMENT OF JUSTICE
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Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application
II
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jlentini on DSKJ8SOYB1PROD with NOTICES
The company plans to import small
quantities of the listed controlled
substances for the manufacture of
analytical reference standards.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic classes of controlled
substances 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, Virginia 22152; and must be
filed no later than October 8, 2009.
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 listed 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 28, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–21543 Filed 9–4–09; 8:45 am]
BILLING CODE 4410–09–P
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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 8,
2009, Clinical Supplies Management,
Inc., 342 42nd Street South, Fargo,
North Dakota 58103, made application
by renewal to the Drug Enforcement
Administration (DEA) to be registered as
an importer of Sufentanil (9740), a basic
class of controlled substance listed in
schedule II.
The company plans to import the
listed controlled substance with the sole
purpose of packaging, labeling, and
distributing to customers which are
qualified clinical sites conducting
clinical trials under the auspices of an
FDA-approved clinical study.
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.
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
PO 00000
Frm 00149
Fmt 4703
Sfmt 4703
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 28, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–21541 Filed 9–4–09; 8:45 am]
BILLING CODE 4410–09–P
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.
E:\FR\FM\08SEN1.SGM
08SEN1
46229
Federal Register / Vol. 74, No. 172 / Tuesday, September 8, 2009 / Notices
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
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application; Correction
By Notice dated June 24, 2009, and
published in the Federal Register on
July 9, 2009, (74 FR 32954), the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, provided notice of
application by Rhodes Technologies,
498 Washington Street, Coventry, Rhode
Island 02816, to be registered as an
importer of basic classes of controlled
substances listed in schedule II. The
Notice of Application should be
corrected by adding the following
information: ‘‘The company plans to
import the listed controlled substances
to manufacture bulk active
pharmaceutical ingredients.’’
Dated: August 21, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–21539 Filed 9–4–09; 8:45 am]
BILLING CODE 4410–09–P
jlentini on DSKJ8SOYB1PROD with NOTICES
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration
By Notice dated April 17, 2009, and
published in the Federal Register on
VerDate Nov<24>2008
17:32 Sep 04, 2009
Jkt 217001
April 29, 2009 (74 FR 19595), Almac
Clinical Services, Inc., (ASCI), 2661
Audubon Road, Audubon, Pennsylvania
19403, made application by renewal to
the Drug Enforcement Administration
(DEA) to be registered as an importer of
the basic classes of controlled
substances listed in schedule II:
Drug
Schedule
Oxycodone (9143) ........................
Fentanyl (9801) ............................
II
II
The company plans to import small
quantities of the listed controlled
substances in dosage form to conduct
clinical trials.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and 952(a),
and determined that the registration of
Almac Clinical Services Inc. to import
the basic classes of controlled
substances is consistent with the public
interest, and with United States
obligations under international treaties,
conventions, or protocols in effect on
May 1, 1971, at this time. DEA has
investigated Almac Clinical Services
Inc. to ensure that the company’s
registration is consistent with the public
interest. The investigation has included
inspection and testing of the company’s
physical security systems, verification
of the company’s compliance with State
and local laws, and a review of the
company’s background and history.
Therefore, pursuant to 21 U.S.C. 952(a)
and 958(a), and in accordance with 21
CFR 1301.34, the above named company
is granted registration as an importer of
the basic classes of controlled
substances listed.
Dated: August 21, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–21538 Filed 9–4–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration
By Notice dated April 17, 2009, and
published in the Federal Register on
April 29, 2009 (74 FR 19594), Meridian
Medical Technologies, 2555 Hermelin
Drive, St. Louis, Missouri 63144, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of
Morphine (9300), a basic class of
PO 00000
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Fmt 4703
Sfmt 4703
controlled substance listed in schedule
II.
The company plans to import
products for research experimentation
or clinical use and analytical testing.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and 952(a),
and determined that the registration of
Meridian Medical Technologies to
import the basic class of controlled
substance is consistent with the public
interest, and with United States
obligations under international treaties,
conventions, or protocols in effect on
May 1, 1971, at this time. DEA has
investigated Meridian Medical
Technologies to ensure that the
company’s registration is consistent
with the public interest. The
investigation has included inspection
and testing of the company’s physical
security systems, verification of the
company’s compliance with state and
local laws, and a review of the
company’s background and history.
Therefore, pursuant to 21 U.S.C. 952(a)
and § 958(a), and in accordance with 21
CFR 1301.34, the above named company
is granted registration as an importer of
the basic class of controlled substance
listed.
Dated: August 21, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–21537 Filed 9–4–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration
By Notice dated April 17, 2009 and
published in the Federal Register on
April 29, 2009, (74 FR 19594), Penick
Corporation, 33 Industrial Park Road,
Pennsville, New Jersey 08070, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the basic
classes of controlled substances listed in
schedule II:
Drug
Coca Leaves (9040) .....................
Opium, raw (9600) .......................
Poppy Straw (9650) .....................
Concentrate of Poppy Straw
(9670).
Schedule
II
II
II
II
The company plans to import the
listed controlled substances to
E:\FR\FM\08SEN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 172 (Tuesday, September 8, 2009)]
[Notices]
[Pages 46228-46229]
From the Federal Register Online via the Government Printing 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
