Importer of Controlled Substances; Notice of Registration; Mylan Pharmaceuticals, Inc., 1888-1889 [2014-00206]
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1888
Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / 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 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: December 23, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2014–00202 Filed 1–9–14; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application; Cody
Laboratories, Inc.
Pursuant to 21 CFR 1301.34(a), this is
notice that on June 12, 2013, Cody
Laboratories Inc., 601 Yellowstone
Avenue, Cody, Wyoming 82414–9321,
made application by renewal to the
Drug Enforcement Administration
(DEA) for registration as an importer of
the following basic classes of controlled
substances:
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.
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 February 10, 2014.
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 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: December 31, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic class of controlled substance
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.
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 February 10, 2014.
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 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.
Schedule
mstockstill on DSK4VPTVN1PROD with NOTICES
Phenylacetone (8501) ..................
Poppy Straw Concentrate (9670)
Tapentadol (9780) ........................
BILLING CODE 4410–09–P
II
II
II
DEPARTMENT OF JUSTICE
[FR Doc. 2014–00197 Filed 1–9–14; 8:45 am]
Drug Enforcement Administration
Drug
Dated: December 31, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
BILLING CODE 4410–09–P
The company plans to import narcotic
raw materials for manufacturing and
further distribution to its customers.
The company is registered with DEA as
a manufacturer of several controlled
substances that are manufactured from
poppy straw concentrate.
The company plans to import an
intermediate form of Tapentadol (9780)
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, (January 25, 2007)
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic classes of controlled
VerDate Mar<15>2010
19:00 Jan 09, 2014
Jkt 232001
[FR Doc. 2014–00203 Filed 1–9–14; 8:45 am]
Importer of Controlled Substances;
Notice of Application; Fresenius Kabi
USA, LLC.
Pursuant to 21 CFR 1301.34(a), this is
notice that on November 2, 2012,
Fresenius Kabi USA, LLC., 3159 Stanley
Road, Grand Island, New York 14072,
made application to the Drug
Enforcement Administration (DEA) for
registration as an importer of
Remifentanil (9739), a basic class of
controlled substance listed in schedule
II.
The company plans to import this
controlled substance for product
development and preparation of
stability batches.
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; Mylan
Pharmaceuticals, Inc.
By Notice dated June 18, 2013, and
published in the Federal Register on
July 1, 2013, 78 FR 39336, Mylan
Pharmaceuticals, Inc., 3711 Collins
Ferry Road, Morgantown, West Virginia
26505, made application to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the
following basic classes of controlled
substances:
E:\FR\FM\10JAN1.SGM
10JAN1
1889
Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Notices
Drug
Schedule
Amphetamine (1100) ....................
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Pentobarbital (2270) .....................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Levorphanol (9220) ......................
Morphine (9300) ...........................
Oxymorphone (9652) ...................
Remifentanil (9739) ......................
Fentanyl (9801) ............................
II
II
II
II
II
II
II
II
II
II
II
II
Drug
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.
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
Mylan Pharmaceuticals, 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
Mylan Pharmaceuticals, 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: December 31, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2014–00206 Filed 1–9–14; 8:45 am]
Schedule
Methyphendiate (1724) ................
Levorphanol (9220) ......................
Noroxymorphone (9668) ..............
Tapentadol (9780) ........................
II
II
II
II
The company plans to import the
listed controlled substances for clinical
trials, analytical research and testing.
The import of the above listed basic
classes of controlled substances will be
granted only for analytical testing and
clinical trials. This authorization does
not extend to the import of a finished
FDA approved or non-approved dosage
form for commercial distribution in the
United States.
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
Fisher 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. DEA has investigated
Fisher 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: December 31, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
mstockstill on DSK4VPTVN1PROD with NOTICES
on September 25, 2013, 78 FR 59064,
Fisher Clinical Services, Inc., 7554
Schantz Road, Allentown, Pennsylvania
18106, 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 Enforcement Administration
[FR Doc. 2014–00179 Filed 1–9–14; 8:45 am]
Importer of Controlled Substances;
Notice of Registration; Fisher Clinical
Services, Inc.
BILLING CODE 4410–09–P
By Notice dated September 16, 2013,
and published in the Federal Register
VerDate Mar<15>2010
16:40 Jan 09, 2014
Jkt 232001
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application;
Cayman Chemical Company
Pursuant to 21 CFR 1301.33(a), this is
notice that on June 27, 2013, Cayman
Chemical Company, 1180 East Ellsworth
Road, Ann Arbor, Michigan 48108,
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
Cathinone (1235) ..........................
Methcathinone (1237) ..................
4-Methyl-N-methylcathinone
(1248).
N-Ethylamphetamine (1475) ........
N,N-Dimethylamphetamine (1480)
Aminorex (1585) ...........................
4-Methylaminorex (cis isomer)
(1590).
Gamma
Hydroxybutyric
Acid
(2010).
JWH–250 (6250) ..........................
SR–18 also known as RCS–8
(7008).
XLR11 (7011) ...............................
JWH–019 (7019) ..........................
AKB48 (7048) ...............................
JWH–081 (7081) ..........................
SR–19 also known as RCS–4
(7104).
1-Pentyl-3-(1-naphthoyl)indole
(7118).
JWH–122 (7122) ..........................
UR–144 (7144) .............................
1-Butyl-3-(1-naphthoyl)indole
(7173).
1-[2-(4-Morpholinyl)ethyl]-3- .........
(1-naphthoyl) indole (7200) ..........
AM–2201 (7201) ...........................
JWH–203 (7203) ..........................
Alpha-ethyltryptamine (7249) .......
5-(1,1-Dimethylheptyl)-2-[(1R,3S)3-hydroxycyclohexyl]-phenol
(7297).
5-(1,1-Dimethyloctyl)-2-[(1R,3S)3-hydroxycyclohexyl]-phenol
(7298).
Lysergic acid diethylamide (7315)
2,5-Dimethoxy-4-(n)propylthiophenethylamine
(7348).
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
Mescaline (7381) ..........................
2C–T–2 (7385) .............................
3,4,5-Trimethoxyamphetamine
(7390).
4-Bromo-2,5dimethoxyamphetamine (7391).
4-Bromo-2,5dimethoxyphenethylamine
(7392).
4-Methyl-2,5dimethoxyamphetamine (7395).
E:\FR\FM\10JAN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Notices]
[Pages 1888-1889]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00206]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Registration; Mylan
Pharmaceuticals, Inc.
By Notice dated June 18, 2013, and published in the Federal
Register on July 1, 2013, 78 FR 39336, Mylan Pharmaceuticals, Inc.,
3711 Collins Ferry Road, Morgantown, West Virginia 26505, made
application to the Drug Enforcement Administration (DEA) to be
registered as an importer of the following basic classes of controlled
substances:
[[Page 1889]]
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Amphetamine (1100)......................... II
Lisdexamfetamine (1205).................... II
Methylphenidate (1724)..................... II
Pentobarbital (2270)....................... II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Hydrocodone (9193)......................... II
Levorphanol (9220)......................... II
Morphine (9300)............................ II
Oxymorphone (9652)......................... II
Remifentanil (9739)........................ II
Fentanyl (9801)............................ 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 domestically-manufactured FDF to foreign
markets.
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 Mylan Pharmaceuticals, 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 Mylan Pharmaceuticals, 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: December 31, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2014-00206 Filed 1-9-14; 8:45 am]
BILLING CODE 4410-09-P
