Importer of Controlled Substances; Notice of Registration, 77253 [2011-31776]
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77253
Federal Register / Vol. 76, No. 238 / Monday, December 12, 2011 / Notices
The assessment of annual needs may be
adjusted at a later date pursuant to 21
CFR 1315.13.
Dated: December 1, 2011.
Michele M. Leonhart,
Administrator.
Dated: December 5, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2011–31776 Filed 12–9–11; 8:45 am]
BILLING CODE 4410–09–P
[FR Doc. 2011–31777 Filed 12–9–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application
Importer of Controlled Substances;
Notice of Registration
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 October
17, 2011, 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.
Any bulk manufacturers who are
presently, or are applying to be,
registered with DEA to manufacture
such basic class of controlled substance
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 January 11, 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, 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
By Notice dated September 27, 2011,
and published in the Federal Register
on October 7, 2011, 76 FR 62446, 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
Schedule
jlentini on DSK4TPTVN1PROD with NOTICES
Noroxymorphone (9668) ..............
Sufentanil (9740) ..........................
Tapentadol (9780) ........................
II
II
II
The company plans to import the
listed substances for analytical research
and clinical trials.
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.
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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 5, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2011–31766 Filed 12–9–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application
Pursuant to Title 21 Code of Federal
Regulations 1301.34(a), this is notice
that on September 12, 2011, Johnson
Matthey, Inc., Pharmaceutical Materials,
2003 Nolte Drive, West Deptford, New
Jersey 08066–1742, made application by
renewal to the Drug Enforcement
Administration (DEA) for registration as
an importer of the following basic
classes of controlled substances listed in
schedule II:
Drug
Coca Leaves (9040) .....................
Thebaine (9333) ...........................
Opium, raw (9600) .......................
Noroxymorphone (9668) ..............
Poppy Straw Concentrate (9670)
Schedule
II
II
II
II
II
The company plans to import the
listed controlled substances as raw
materials, to be used in the manufacture
of bulk controlled substances, for
distribution to its customers.
No comments, objections, or requests
for any hearings will be accepted on any
application for registration or reregistration to import crude opium,
poppy straw, concentrate of poppy
straw, and coca leaves. Comments and
requests for hearings on applications to
import narcotic raw material are not
appropriate, in accordance with 72 FR
3417 (2007).
In regards to the non-narcotic raw
material, the company plans to import
gram amounts to be used as reference
standards for sale to its customers. 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.
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]]>Agencies
[Federal Register Volume 76, Number 238 (Monday, December 12, 2011)]
[Notices]
[Page 77253]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-31776]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Registration
By Notice dated September 27, 2011, and published in the Federal
Register on October 7, 2011, 76 FR 62446, 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 Schedule
------------------------------------------------------------------------
Noroxymorphone (9668)...................... II
Sufentanil (9740).......................... II
Tapentadol (9780).......................... II
------------------------------------------------------------------------
The company plans to import the listed substances for analytical
research and clinical trials.
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 5, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2011-31776 Filed 12-9-11; 8:45 am]
BILLING CODE 4410-09-P
