Importer of Controlled Substances, Notice of Application, Almac Clinical Services, Inc., (ACSI), 23594-23595 [2013-09302]
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23594
Federal Register / Vol. 78, No. 76 / Friday, April 19, 2013 / Notices
applicants for registration to import
basic classes of any controlled substance
in schedules I or II are, and will
By email .. pubcommentcontinue to be, required to demonstrate
ees.enrd@usdoj.gov.
to the Deputy Assistant Administrator,
By mail .... Assistant Attorney General, U.S.
Office of Diversion Control, Drug
DOJ—ENRD, P.O. Box 7611,
Enforcement Administration, that the
Washington, DC 20044–7611.
requirements for such registration
pursuant to 21 U.S.C. 958(a); 21 U.S.C.
During the public comment period,
823(a); and 21 CFR 1301.34(b), (c), (d),
the proposed Decree may be examined
(e), and (f) are satisfied.
and downloaded at this Justice
Department Web site: https://
Dated: April 10, 2013.
www.usdoj.gov/enrd/
Joseph T. Rannazzisi,
Consent_Decrees.html. We will provide Deputy Assistant Administrator, Office of
a paper copy of the proposed Decree
Diversion Control, Drug Enforcement
Administration.
upon written request and payment of
reproduction costs. Please mail your
[FR Doc. 2013–09305 Filed 4–18–13; 8:45 am]
request and payment to:
BILLING CODE 4410–09–P
Consent Decree Library, U.S. DOJ—
ENRD, P.O. Box 7611, Washington,
DEPARTMENT OF JUSTICE
DC 20044–7611.
Please enclose a check or money order
Drug Enforcement Administration
for $13.25 (.25 cents per page
reproduction cost) payable to the United Importer of Controlled Substances;
States Treasury.
Notice of Application; Catalent CTS.,
Inc.
Robert Brook,
To submit
comments:
Send them to:
Assistant Section Chief, Environmental
Enforcement Section, Environment and
Natural Resources Division.
Pursuant to Title 21, of the Code of
Federal Regulations 1301.34(a), this is
notice that on August 6, 2012, Catalent
Cts., Inc., 10245 Hickman Mills Drive,
Kansas City, Missouri 64137, made
application by renewal to the Drug
Enforcement Administration (DEA) for
registration as an importer of the
following basic classes of controlled
substances:
[FR Doc. 2013–09203 Filed 4–18–13; 8:45 am]
BILLING CODE 4410–15–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application; Rhodes
Technologies
Drug
This is notice that on March 6, 2013,
Rhodes Technologies, 498 Washington
Street, Coventry, Rhode Island 02816,
made application by renewal to the
Drug Enforcement Administration
(DEA) for registration as an importer of
the following basic classes of controlled
substances:
Drug
Schedule
mstockstill on DSK4VPTVN1PROD with NOTICES
Opium, Raw (9600) ......................
Poppy Straw Concentrate (9670)
II
II
The company plans to import the
listed controlled substances in order to
bulk manufacture controlled substances
in Active Pharmaceutical Ingredient
(API) form. The company distributes the
manufactured APIs in bulk to its
customers.
Comments and requests for hearings
on applications to import narcotic raw
material are not appropriate. 72 FR 3417
(2007).
As noted in a previous notice
published in the Federal Register on
September 23, 1975, 40 FR 43745, all
VerDate Mar<15>2010
17:11 Apr 18, 2013
Jkt 229001
I
II
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 contain
trace amounts of the controlled
substances 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).
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic classes of controlled
substances listed in schedule 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
Frm 00058
Fmt 4703
Dated: April 10, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–09293 Filed 4–18–13; 8:45 am]
BILLING CODE 4410–09–P
Schedule
Marihuana (7360) .........................
Poppy Straw Concentrate (9670)
PO 00000
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, VA 22152; and must be
filed no later than May 20, 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 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.
Sfmt 4703
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances,
Notice of Application, Almac Clinical
Services, Inc., (ACSI)
Pursuant to Title 21 Code of Federal
Regulations 1301.34(a), this is notice
that on March 5, 2013, Almac Clinical
Services, Inc., (ACSI), 25 Fretz Road,
Souderton, Pennsylvania 18964, 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
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Tapentadol (9780) ........................
Fentanyl (9801) ............................
Schedule
II
II
II
II
The company plans to import small
quantities of the listed controlled
substances in dosage form to conduct
clinical trials.
E:\FR\FM\19APN1.SGM
19APN1
23595
Federal Register / Vol. 78, No. 76 / Friday, April 19, 2013 / Notices
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
forms for commercial distribution in the
United States.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic classes of controlled
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 May 20, 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: April 10, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
mstockstill on DSK4VPTVN1PROD with NOTICES
BILLING CODE 4410–09–P
Importer of Controlled Substances;
Notice of Registration
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; GE Healthcare
By Notice dated January 31, 2013, and
published in the Federal Register on
February 6, 2013, 78 FR 8583, GE
Healthcare, 3350 North Ridge Avenue,
Jkt 229001
[FR Doc. 2013–09290 Filed 4–18–13; 8:45 am]
Drug Enforcement Administration
BILLING CODE 4410–09–P
17:11 Apr 18, 2013
Dated: April 10, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
DEPARTMENT OF JUSTICE
[FR Doc. 2013–09302 Filed 4–18–13; 8:45 am]
VerDate Mar<15>2010
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.
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
GE Healthcare 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 GE Healthcare 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.
By Notice dated January 16, 2013, and
published in the Federal Register on
January 25, 2013, 78 FR 5497, Nebraska
State Penitentiary, 4201 South 14th
Street, Lincoln, Nebraska 68502, made
application to the Drug Enforcement
Administration (DEA) to be registered as
an importer of Pentobarbital (2270), a
basic class of controlled substance listed
in schedule II.
The facility intends to import the
above listed controlled substance for
legitimate use. Supplies of this
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
particular controlled substance are
inadequate and are not available in the
form needed within the current
domestic supply of 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
Nebraska State Penitentiary 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 Nebraska State
Penitentiary to ensure that its
registration is consistent with the public
interest. The investigation has included
inspection and testing of the Nebraska
State Penitentiary facility’s physical
security systems, verification of its
compliance with state and local laws,
and a review of its 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
facility is granted registration as an
importer of the basic class of controlled
substance listed.
Dated: April 11, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–09299 Filed 4–18–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application;
Penick Corporaton
Pursuant to § 1301.33(a), Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on March 1, 2013,
Penick Corporation, 33 Industrial Park
Road, Pennsville, New Jersey 08070,
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
Cocaine (9041) .............................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Ecgonine (9180) ...........................
Hydrocodone (9193) .....................
Morphine (9300) ...........................
Oripavine (9330) ...........................
Thebaine (9333) ...........................
E:\FR\FM\19APN1.SGM
19APN1
Schedule
II
II
II
II
II
II
II
II
II
II
]]>Agencies
[Federal Register Volume 78, Number 76 (Friday, April 19, 2013)]
[Notices]
[Pages 23594-23595]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09302]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances, Notice of Application, Almac
Clinical Services, Inc., (ACSI)
Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this
is notice that on March 5, 2013, Almac Clinical Services, Inc., (ACSI),
25 Fretz Road, Souderton, Pennsylvania 18964, 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
------------------------------------------------------------------------
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Tapentadol (9780).......................... II
Fentanyl (9801)............................ II
------------------------------------------------------------------------
The company plans to import small quantities of the listed
controlled substances in dosage form to conduct clinical trials.
[[Page 23595]]
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 forms for commercial distribution
in the United States.
Any bulk manufacturer who is presently, or is applying to be,
registered with DEA to manufacture such basic classes of controlled
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 May 20, 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: April 10, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2013-09302 Filed 4-18-13; 8:45 am]
BILLING CODE 4410-09-P
