Importer of Controlled Substances; Notice of Registration; Catalent CTS, LLC, 69131-69132 [2013-27482]
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69131
Federal Register / Vol. 78, No. 222 / Monday, November 18, 2013 / Notices
Schedule
Drug
mstockstill on DSK4VPTVN1PROD with NOTICES
1-Phenylcyclohexylamine (7460)
1-Piperidinocyclohexane
carbonitrile (8603).
Alphaprodine (9010) .....................
Hydrocodone (9193) .....................
Levomethorphan (9210) ...............
Levorphanol (9220) ......................
Noroxymorphone (9668) ..............
Racemethorphan (9732) ..............
Remifentanil (9739) ......................
Carfentanil (9743) .........................
Tapentadol (9780) ........................
DEPARTMENT OF JUSTICE
II
II
Drug Enforcement Administration
Importer of Controlled Substances,
Notice of Registration, Chattem
Chemicals, Inc.
Dated: November 5, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–27481 Filed 11–15–13; 8:45 am]
II
II
II
II
II
II
II
II
II
The company plans to import the
listed controlled substances for
manufacture and distribution to their
research and forensic customers
conducting drug testing and analysis.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic classes of controlled
substance listed in schedules I and 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 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
(ODW), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than December 18, 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 classes of
any controlled substances in schedules
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 5, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–27454 Filed 11–15–13; 8:45 am]
By Notice dated August 15, 2013, and
published in the Federal Register on
August 26, 2013, 78 FR 52801, Chattem
Chemicals, Inc., 3801 St. Elmo Avenue,
Chattanooga, Tennessee 37409, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the
following basic classes of controlled
substances:
Drug
Schedule
Methamphetamine (1105) ............
4-Anilino-N-phenethyl-4-piperidine
(8333).
Phenylacetone (8501) ..................
Opium, raw (9600) .......................
Poppy Straw Concentrate (9670)
Tapentadol (9780) ........................
17:33 Nov 15, 2013
Jkt 232001
II
II
II
II
The company plans to import the
listed controlled substances to
manufacture bulk controlled substances
for sale to its customers. The company
plans to import an intermediate form of
Tapentadol (9780); and then to bulk
manufacture Tapentadol for distribution
to its customers.
Comments and requests for hearings
on applications to import narcotic raw
material are not appropriate. 72 FR 3417
(2007).
DEA has considered the factors in 21
U.S.C. 823(a) and 952(a) and determined
that the registration of Chattem
Chemicals, 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 Chattem Chemicals,
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.
BILLING CODE 4410–09–P
VerDate Mar<15>2010
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II
PO 00000
Frm 00092
Fmt 4703
Sfmt 4703
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; Catalent CTS,
LLC
By Notice dated August 15, 2013, and
published in the Federal Register on
August 26, 2013, 78 FR 53800, Catalent
CTS, LLC., 10245 Hickman Mills Drive,
Kansas City, Missouri 64137, made
application to the Drug Enforcement
Administration (DEA) to be registered as
an importer of the following classes of
controlled substances:
Drug
Marihuana (7360) .........................
Poppy Straw Concentrate (9670)
Schedule
I
II
The company plans to import a
finished pharmaceutical product
containing cannabis extracts in dosage
form for a clinical trial study. In
addition, the company plans to import
an ointment for the treatment of wounds
which contains trace amounts of the
controlled substances normally found in
poppy straw concentrate for packaging
and labeling to be used in clinical trials.
Comments and requests for any
hearings on applications to import
narcotic raw material are not
appropriate. 72 FR 3417 (2007).
DEA has considered the factors in 21
U.S.C. 823(a) and 952(a) and determined
that the registration of Catalent CTS,
LLC., 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 Catalent CTS, LLC., 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.
E:\FR\FM\18NON1.SGM
18NON1
69132
Federal Register / Vol. 78, No. 222 / Monday, November 18, 2013 / Notices
Dated: November 5, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–27482 Filed 11–15–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; Noramco, Inc.
By Notice dated August 14, 2013, and
published in the Federal Register on
August 21, 2013, 78 FR 51747,
Noramco, Inc., 1440 Olympic Drive,
Athens, Georgia 30601, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the
following basic classes of controlled
substances:
Drug
mstockstill on DSK4VPTVN1PROD with NOTICES
[FR Doc. 2013–27457 Filed 11–15–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
II
II
II
II
Drug Enforcement Administration
The company plans to import
Thebaine (9333) analytical standards for
distribution to its customers. The
company plans to import an
intermediate form of Tapentadol (9780)
to bulk manufacture Tapentadol for
distribution to its customers. The
company plans to import the
Phenylacetone (8501) in bulk for the
manufacture of a controlled substance.
Comments and requests for hearings
on applications to import narcotic raw
material are not appropriate. 72 FR
3417(2007).
In reference to the non-narcotic raw
material, any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic classes of controlled
substances listed in schedules 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 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.
DEA has considered the factors in 21
U.S.C. 823(a) and 952(a) and determined
that the registration of Noramco, Inc., to
import the basic classes of controlled
substances is consistent with the public
interest and with United States
17:33 Nov 15, 2013
Dated: November 5, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
Schedule
Phenylacetone (8501) ..................
Thebaine (9333) ...........................
Poppy Straw Concentrate (9670)
Tapentadol (9780) ........................
VerDate Mar<15>2010
obligations under international treaties,
conventions, or protocols in effect on
May 1, 1971. DEA has investigated
Noramco, 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.
Jkt 232001
Manufacturer of Controlled
Substances, Notice of Application,
National Center for Natural Products
Research (NIDA MProject)
Pursuant to § 1301.33(a), Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on September 6, 2013,
National Center for Natural Products
Research—NIDA MProject, University of
Mississippi, 135 Coy Waller Complex,
University, Mississippi 38677, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as a bulk manufacturer of
the following basic classes of controlled
substances:
Drug
Schedule
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
I
I
The company plans to cultivate
marihuana in support of the National
Institute on Drug Abuse for research
approved by the Department of Health
and Human Services.
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 should be addressed, in
quintuplicate, to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
PO 00000
Frm 00093
Fmt 4703
Sfmt 4703
(ODW), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than January 17, 2014.
Dated: November 5, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–27491 Filed 11–15–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application;
Johnson Matthey, Inc.
Pursuant to § 1301.33(a), Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on September 5, 2013,
Johnson Matthey Inc., Custom
Pharmaceuticals Department, 2003
Nolte Drive, West Deptford, New Jersey
08066–1742, made application by
renewal to the Drug Enforcement
Administration (DEA) to be registered as
a bulk manufacturer of the following
basic classes of controlled substances:
Drug
Gamma
Hydroxybutyric
Acid
(2010).
Tetrahydrocannabinols (7370) .....
Dihydromorphine (9145) ...............
Difenoxin (9168) ...........................
Propiram (9649) ...........................
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Nabilone (7379) ............................
Cocaine (9041) .............................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Diphenoxylate (9170) ...................
Ecgonine (9180) ...........................
Hydrocodone (9193) .....................
Meperidine (9230) ........................
Methadone (9250) ........................
Methadone intermediate (9254) ...
Morphine (9300) ...........................
Thebaine (9333) ...........................
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Alfentanil (9737) ...........................
Remifentanil (9739) ......................
Sufentanil (9740) ..........................
Tapentadol (9780) ........................
Fentanyl (9801) ............................
Schedule
I
I
I
I
I
II
II
II
II
II
II
II
II
II
II
II
II
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
E:\FR\FM\18NON1.SGM
18NON1
]]>Agencies
[Federal Register Volume 78, Number 222 (Monday, November 18, 2013)]
[Notices]
[Pages 69131-69132]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27482]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Registration;
Catalent CTS, LLC
By Notice dated August 15, 2013, and published in the Federal
Register on August 26, 2013, 78 FR 53800, Catalent CTS, LLC., 10245
Hickman Mills Drive, Kansas City, Missouri 64137, made application to
the Drug Enforcement Administration (DEA) to be registered as an
importer of the following classes of controlled substances:
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Marihuana (7360)........................... I
Poppy Straw Concentrate (9670)............. II
------------------------------------------------------------------------
The company plans to import a finished pharmaceutical product
containing cannabis extracts in dosage form for a clinical trial study.
In addition, the company plans to import an ointment for the treatment
of wounds which contains trace amounts of the controlled substances
normally found in poppy straw concentrate for packaging and labeling to
be used in clinical trials.
Comments and requests for any hearings on applications to import
narcotic raw material are not appropriate. 72 FR 3417 (2007).
DEA has considered the factors in 21 U.S.C. 823(a) and 952(a) and
determined that the registration of Catalent CTS, LLC., 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 Catalent CTS, LLC., 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.
[[Page 69132]]
Dated: November 5, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2013-27482 Filed 11-15-13; 8:45 am]
BILLING CODE 4410-09-P
