Importer of Controlled Substances; Notice of Registration, 76755-76756 [2010-30897]
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Federal Register / Vol. 75, No. 236 / Thursday, December 9, 2010 / Notices
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addition, Defendants will abate leadbased paint hazards on friction and
impact surfaces, stabilize other leadbased paint hazards, and pay an
administrative penalty of $7,500.
The Department of Justice will receive
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date of this publication comments
relating to the Proposed Consent Decree.
Comments should be addressed to the
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Environment and Natural Resources
Division, and either e-mailed to
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mailed to U.S. Department of Justice,
Washington, DC 20044–7611 P.O. Box
7611, U.S. Department of Justice,
Washington, DC 20044–7611, and
should refer to United States v.
Combined Development Co. I, LLC, et
al., D.J. Ref. # 90–5–1–1–09435.
The Proposed Consent Decree may be
examined at the Department of Housing
and Urban Development, Office of
General Counsel, 451 7th St. NW., Room
9262, Washington, DC 20410; at the
office of the United States Attorney for
the Southern District of Ohio, 303
Marconi Blvd., Suite 200, Columbus,
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at U.S. EPA Region 5, 77 W. Jackson
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public comment period, the Consent
Decree may also be examined on the
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Consent_Decrees.html. A copy of the
Consent Decree may also be obtained by
mail from the Consent Decree Library,
P.O. Box 7611, U.S. Department of
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by faxing or e-mailing a request to Tonia
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Maureen Katz,
Assistant Chief, Environmental Enforcement
Section, Environment and Natural Resources
Division.
[FR Doc. 2010–30900 Filed 12–8–10; 8:45 am]
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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 21 CFR
1301.34(a), this is notice that on October
19, 2010, Mylan Pharmaceuticals, Inc.,
781 Chestnut Ridge Road, Morgantown,
West Virginia 26505, 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
Methylphenidate (1724) ................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Fentanyl (9801) ............................
II
II
II
II
The company plans to import the
listed controlled substances in finished
dosage form (FDF) from foreign sources
for analytical testing and clinical trials
in which the foreign FDF will be
compared to the company’s own
domestically-manufactured FDF. This
analysis is required to allow the
company to export domesticallymanufactured FDF to foreign markets.
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, Virginia 22152; and must be
filed no later than January 10, 2011.
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
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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: November 29, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2010–30901 Filed 12–8–10; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration
By Notice dated August 3, 2010, and
published in the Federal Register on
September 1, 2010, (75 FR 53719),
Alltech Associates, Inc., 2051 Waukegan
Road, Deerfield, Illinois 60015, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the basic
classes of controlled substances:
Drug
Gamma
Hydroxybutyric
Acid
(2010).
Heroin (9200) ...............................
Cocaine (9041) .............................
Codeine (9050) .............................
Hydrocodone (9193) .....................
Meperidine (9230) ........................
Methadone (9250) ........................
Morphine (9300) ...........................
Schedule
I
I
II
II
II
II
II
II
The company plans to import these
controlled substances for the
manufacture of reference standards.
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
Alltech Associates, 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. DEA
has investigated Alltech Associates, 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
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Federal Register / Vol. 75, No. 236 / Thursday, December 9, 2010 / Notices
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: November 29, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
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. 823(a),
and in accordance with 21 CFR 1301.33,
the above named company is granted
registration as a bulk manufacturer of
the basic classes of controlled
substances listed.
Dated: November 29, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2010–30897 Filed 12–8–10; 8:45 am]
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[FR Doc. 2010–30904 Filed 12–8–10; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
DEPARTMENT OF JUSTICE
Manufacturer of Controlled
Substances; Notice of Registration
Drug Enforcement Administration
By Notice dated July 19, 2010, and
published in the Federal Register on
July 28, 2010, (75 FR 44285), Johnson
Matthey Pharmaceutical Materials, Inc.,
Pharmaceuticals Service, 25 Patton
Road, Devens, Massachusetts 01434,
made application by letter to the Drug
Enforcement Administration (DEA) to
be registered as a bulk manufacturer of
the basic classes of controlled
substances:
Drug
Manufacturer of Controlled
Substances; Notice of Registration
By Notice dated March 16, 2010, and
published in the Federal Register on
March 24, 2010, (75 FR 14189), Norac
Inc., 405 S. Motor Avenue, P.O. Box
577, Azusa, California 91702–3232,
made application by renewal to the
Drug Enforcement Administration
(DEA) to be registered as a bulk
manufacturer of the basic classes of
controlled substances:
Schedule
Drug
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Amphetamine (1100) ....................
Methylphenidate (1724) ................
Nabilone (7379) ............................
Alfentanil (9737) ...........................
Sufentanil (9740) ..........................
Remifentanil (9739) ......................
Hydrocodone (9193) .....................
II
II
II
II
II
II
II
Gamma
Hydroxybutyric
Acid
(2010).
Tetrahydrocannabinols (7370) .....
Methamphetamine (1105) ............
Nabilone (7379) ............................
The company plans to utilize this
facility to manufacture small quantities
of the listed controlled substances in
bulk and to conduct analytical testing in
support of the company’s primary
manufacturing facility in West Deptford,
New Jersey. The controlled substances
manufactured in bulk at this facility will
be distributed to the company’s
customers.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and
determined that the registration of
Johnson Matthey Pharmaceutical
Materials, Inc. to manufacture the listed
basic classes of controlled substances is
consistent with the public interest at
this time. DEA has investigated Johnson
Matthey Pharmaceutical Materials, Inc.
to ensure that the company’s
registration is consistent with the public
interest. The investigation has included
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Schedule
I
I
II
II
With regard to Gamma
Hydroxybutyric Acid (2010),
Tetrahydrocannabinols (7370), and
Methamphetamine (1105) only, the
company manufactures these controlled
substances in bulk solely for domestic
distribution within the United States to
customers engaged in dosage-form
manufacturing.
With regard to Nabilone (7379) only,
the company presently manufactures a
small amount of this controlled
substance in bulk solely to conduct
manufacturing process development
internally within the company. It is the
company’s intention that, when the
manufacturing process is refined to the
point that its Nabilone bulk product is
available for commercial use, the
company will export the controlled
substance in bulk solely to customers
engaged in dosage-form manufacturing
outside the United States. The company
is aware of the requirement to obtain a
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DEA registration as an exporter to
conduct this activity.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and
determined that the registration of
Norac, Inc. to manufacture the listed
basic classes of controlled substances is
consistent with the public interest at
this time. DEA has investigated Norac,
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. 823(a),
and in accordance with 21 CFR 1301.33,
the above named company is granted
registration as a bulk manufacturer of
the basic classes of controlled
substances listed.
Dated: November 29, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2010–30903 Filed 12–8–10; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Registration
By Notice dated July 23, 2010, and
published in the Federal Register on
August 4, 2010, (75 FR 47029), Johnson
Matthey Pharma Services, 70 Flagship
Drive, North Andover, Massachusetts
01845, made application by letter to the
Drug Enforcement Administration
(DEA) to be registered as a bulk
manufacturer of the basic classes of
controlled substances:
Drug
Amphetamine (1100) ....................
Methylphenidate (1724) ................
Hydrocodone (9193) .....................
Schedule
II
II
II
The company plans to utilize this
facility to manufacture small quantities
of the listed controlled substances in
bulk and to conduct analytical testing in
support of the company’s primary
manufacturing facility in West Deptford,
New Jersey. The controlled substances
manufactured in bulk at this facility will
be distributed to the company’s
customers.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and
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[Federal Register Volume 75, Number 236 (Thursday, December 9, 2010)]
[Notices]
[Pages 76755-76756]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30897]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Registration
By Notice dated August 3, 2010, and published in the Federal
Register on September 1, 2010, (75 FR 53719), Alltech Associates, Inc.,
2051 Waukegan Road, Deerfield, Illinois 60015, made application by
renewal to the Drug Enforcement Administration (DEA) to be registered
as an importer of the basic classes of controlled substances:
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)........... I
Heroin (9200).............................. I
Cocaine (9041)............................. II
Codeine (9050)............................. II
Hydrocodone (9193)......................... II
Meperidine (9230).......................... II
Methadone (9250)........................... II
Morphine (9300)............................ II
------------------------------------------------------------------------
The company plans to import these controlled substances for the
manufacture of reference standards.
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 Alltech Associates, 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. DEA has investigated Alltech
Associates, 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
[[Page 76756]]
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: November 29, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2010-30897 Filed 12-8-10; 8:45 am]
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