Importer of Controlled Substances; Notice of Application; Almac Clinical Services, Inc., (ACSI), 24985 [2012-10053]
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Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices
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 17, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2012–10043 Filed 4–25–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application; Almac Clinical
Services, Inc., (ACSI)
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 March
5, 2012, 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
tkelley on DSK3SPTVN1PROD with NOTICES
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Tapentadol (9780) ........................
Fentanyl (9801) ............................
II
II
II
II
The company plans to import small
quantities of the listed controlled
substances in dosage form to conduct
clinical trials.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic classes of controlled
substances 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.
VerDate Mar<15>2010
17:51 Apr 25, 2012
Jkt 226001
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 29, 2012.
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 the 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: April 17, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2012–10053 Filed 4–25–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; Hospira Inc.
By Notice dated December 5, 2011,
and published in the Federal Register
on December 12, 2011, 76 FR 77253,
Hospira Inc., 1776 North Centennial
Drive, McPherson, Kansas 67460–1247,
made application by renewal to the
Drug Enforcement Administration
(DEA) to be registered as an importer of
Remifentanil (9739), a basic class of
controlled substance listed in schedule
II.
The company plans to import
Remifentanil for use in dosage form
manufacturing.
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
Hospira Inc. 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, at this time. DEA
has investigated Hospira Inc. to ensure
that the company’s registration is
consistent with the public interest. The
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
24985
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: April 17, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2012–10048 Filed 4–25–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; ISP Freetown
Fine Chemicals
By Notice dated October 8, 2010, and
published in the Federal Register on
October 20, 2010, 75 FR 64743, ISP
Freetown Fine Chemicals, 238 South
Main Street, Assonet, Massachusetts
02702, made application by renewal to
the Drug Enforcement Administration
(DEA) to be registered as an importer of
Phenylacetone (8501), a basic class of
controlled substance listed in schedule
II.
The company plans to import the
controlled substance to manufacture
amphetamine.
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
ISP Freetown Fine Chemicals 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, at
this time. DEA has investigated ISP
Freetown Fine Chemicals 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.
E:\FR\FM\26APN1.SGM
26APN1
]]>Agencies
[Federal Register Volume 77, Number 81 (Thursday, April 26, 2012)]
[Notices]
[Page 24985]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10053]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Application; Almac
Clinical Services, Inc., (ACSI)
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 March 5, 2012, 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.
Any bulk manufacturer who is presently, or is applying to be,
registered with DEA to manufacture such basic classes of controlled
substances 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 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 29, 2012.
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 the 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: April 17, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2012-10053 Filed 4-25-12; 8:45 am]
BILLING CODE 4410-09-P
