Importer of Controlled Substances; Notice Of Registration; Mallinckrodt, LLC., 39337-39338 [2013-15603]
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Federal Register / Vol. 78, No. 126 / Monday, July 1, 2013 / Notices
substances listed in schedule II, which
falls 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
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than July 31, 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: June 18, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
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
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than July 31, 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 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.
[FR Doc. 2013–15587 Filed 6–28–13; 8:45 am]
Dated: June 18, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
BILLING CODE 4410–09–P
[FR Doc. 2013–15600 Filed 6–28–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
BILLING CODE 4410–09–P
mstockstill on DSK4VPTVN1PROD with NOTICES
Pursuant to Title 21 Code of Federal
Regulations 1301.34(a), this is notice
that on May 9, 2013, Akorn, Inc., 1222
W. Grand Avenue, Decatur, Illinois
62522, made application by renewal 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
Remifentanil in bulk for use in dosageform manufacturing.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
22:39 Jun 28, 2013
Jkt 229001
Dated: June 18, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application; Akorn, Inc.
VerDate Mar<15>2010
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic class of controlled substance
listed in schedule II, which falls 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
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than July 31, 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 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.
[FR Doc. 2013–15602 Filed 6–28–13; 8:45 am]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
39337
Importer of Controlled Substances,
Notice of Application, Boehringer
Ingelheim Chemicals
DEPARTMENT OF JUSTICE
Pursuant to Title 21 Code of Federal
Regulations 1301.34(a), this is notice
that on May 31, 2013, Boehringer
Ingelheim Chemicals, 2820 N.
Normandy Drive, Petersburg, Virginia
23805, made application by renewal to
the Drug Enforcement Administration
(DEA) for registration as an importer of
Phenylacetone (8501), a basic class of
controlled substance listed in schedule
II.
The company plans to import the
listed controlled substance to bulk
manufacture amphetamine.
Importer of Controlled Substances;
Notice Of Registration; Mallinckrodt,
LLC.
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
Drug Enforcement Administration
By Notice dated February 8, 2013, and
published in the Federal Register on
February 21, 2013, 78 FR 12101,
Mallinckrodt, LLC., 3600 North Second
Street, St. Louis, Missouri 63147, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the
following basic classes of controlled
substances:
E:\FR\FM\01JYN1.SGM
01JYN1
39338
Federal Register / Vol. 78, No. 126 / Monday, July 1, 2013 / Notices
Drug
Schedule
Phenylacetone (8501) ..................
Coca Leaves (9040) .....................
Opium, raw (9600) .......................
Poppy Straw Concentrate (9670)
II
II
II
II
The company plans to import the
listed controlled substances for the
manufacture of controlled substances in
bulk for distribution to its customers.
Comments and requests for hearings
on applications to import narcotic raw
material are not appropriate, 72 FR 3417
(2007). Regarding Phenylacetone (8501),
a basic class of controlled substance, 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
Mallinckrodt, 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 Mallinckrodt, LLC., 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: June 18, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
The company plans to import the
listed controlled substance for analytical
research and testing.
The import of the above listed basic
class of controlled substance would 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
Alkermes Gainesville, LLC, 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.
DEA has investigated Alkermes
Gainesville, LLC, 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: June 18, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–15589 Filed 6–28–13; 8:45 am]
BILLING CODE 4410–09–P
The company plans to import a
finished pharmaceutical product
containing cannabis extracts in dosage
form, to package for a clinical trial
study. In addition, the company also
plans to import an ointment for the
treatment of wounds, which contains
trace amounts of the controlled
substance normally found in poppy
straw concentrate for packaging and
labeling for clinical trials.
Comments and requests for any
hearings on applications to import
narcotic raw material are not
appropriate. 72 FR 3417(2007).
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
Catalent CTS., Inc., to import the basic
classes 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.
DEA has investigated Catalent CTS.,
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: June 18, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–15588 Filed 6–28–13; 8:45 am]
DEPARTMENT OF JUSTICE
BILLING CODE 4410–09–P
[FR Doc. 2013–15603 Filed 6–28–13; 8:45 am]
BILLING CODE 4410–09–P
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; Catalent CTS.,
Inc.
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
By Notice dated April 10, 2013, and
published in the Federal Register on
April 19, 2013, 78 FR 23594, Catalent
CTS., Inc., 10245 Hickman Mills Drive,
Kansas City, Missouri 64137, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the
following basic classes of controlled
substances:
Importer of Controlled Substances;
Notice of Registration; Lipomed
Drug Enforcement Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
Importer of Controlled Substances;
Notice of Registration; Alkermes
Gainesville, LLC
By Notice dated January 16, 2013, and
published in the Federal Register on
January 29, 2013, 78 FR 6132, Alkermes
Gainesville, LLC, 1300 Gould Drive,
Gainesville, Georgia 30504, made
application to the Drug Enforcement
Administration (DEA) to be registered as
an importer of Noroxymorphone (9668),
a basic class of controlled substance
listed in schedule II.
VerDate Mar<15>2010
21:38 Jun 28, 2013
Jkt 229001
Drug
Schedule
Marihuana (7360) .........................
Poppy Straw Concentrate (9670)
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
I
II
Drug Enforcement Administration
By Notice dated April 16, 2013, and
published in the Federal Register on
April 23, 2013, 78 FR 23957, Lipomed,
One Broadway, Cambridge,
Massachusetts 02142, made application
by letter to the Drug Enforcement
Administration (DEA) to be registered as
an importer of the following basic
classes of controlled substances:
Drug
JWH–250 (6250) ..........................
E:\FR\FM\01JYN1.SGM
01JYN1
Schedule
I
]]>Agencies
[Federal Register Volume 78, Number 126 (Monday, July 1, 2013)]
[Notices]
[Pages 39337-39338]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15603]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice Of Registration;
Mallinckrodt, LLC.
By Notice dated February 8, 2013, and published in the Federal
Register on February 21, 2013, 78 FR 12101, Mallinckrodt, LLC., 3600
North Second Street, St. Louis, Missouri 63147, made application by
renewal to the Drug Enforcement Administration (DEA) to be registered
as an importer of the following basic classes of controlled substances:
[[Page 39338]]
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Phenylacetone (8501)....................... II
Coca Leaves (9040)......................... II
Opium, raw (9600).......................... II
Poppy Straw Concentrate (9670)............. II
------------------------------------------------------------------------
The company plans to import the listed controlled substances for
the manufacture of controlled substances in bulk for distribution to
its customers.
Comments and requests for hearings on applications to import
narcotic raw material are not appropriate, 72 FR 3417 (2007). Regarding
Phenylacetone (8501), a basic class of controlled substance, no
comments or objections have been received. DEA has considered the
factors in 21 U.S.C. 823(a) and Sec. 952(a), and determined that the
registration of Mallinckrodt, 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 Mallinckrodt,
LLC., 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 Sec. 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: June 18, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2013-15603 Filed 6-28-13; 8:45 am]
BILLING CODE 4410-09-P
