Bulk Manufacturer of Controlled Substances Application: Siemens Healthcare Diagnostics, Inc., 3982 [2015-01315]
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3982
Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Notices
(other than final orders in connection
with suspension, denial, or revocation
of registration) has been redelegated to
the Deputy Assistant Administrator of
the DEA Office of Diversion Control
(‘‘Deputy Assistant Administrator’’)
pursuant to section 7 of 28 CFR pt. 0,
subpt. R, App.
In accordance with 21 CFR
1301.33(a), this is notice that on August
14, 2014, IRIX Manufacturing, Inc., 309
Delaware Street, Building 1106,
Greenville, South Carolina 29605,
applied to be registered as a bulk
manufacturer of noroxymorphone
(9668), a basic class of controlled
substance listed in schedule II.
The company plans to manufacture
the listed controlled substance as API
for clinical trials.
Dated: January 9, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
with suspension, denial, or revocation
of registration) has been redelegated to
the Deputy Assistant Administrator of
the DEA Office of Diversion Control
(‘‘Deputy Assistant Administrator’’)
pursuant to section 7 of 28 CFR pt. 0,
subpart. R, App.
In accordance with 21 CFR
1301.33(a), this is notice that on
November 19, 2014, Siemens Healthcare
Diagnostics, Inc., Attn: RA, 100 GBC
Drive, Mailstop 514, Newark, Delaware
19702, applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
Controlled substance
Schedule
Tetrahydrocannabinols (7370) ......
Ecgonine (9180) ...........................
Morphine (9300) ...........................
Thebaine (9333) ...........................
I
II
II
II
[Docket No. DEA–392]
The company plans to produce the
listed controlled substances in bulk to
be used in the manufacture of reagents
and drug calibrator controls which are
DEA exempt products.
In reference to drug code 7370 the
company plans to bulk manufacture a
synthetic tetrahydrocannabinol. No
other activity for this drug code is
authorized for this registration.
Bulk Manufacturer of Controlled
Substances Application: Siemens
Healthcare Diagnostics, Inc.
Dated: January 9, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–01314 Filed 1–23–15; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
ACTION:
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Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration in
accordance with 21 CFR 1301.33(a) on
or before March 27, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearings should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his
authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, and
dispensers of controlled substances
(other than final orders in connection
emcdonald on DSK67QTVN1PROD with NOTICES
18:48 Jan 23, 2015
Jkt 235001
[FR Doc. 2015–01298 Filed 1–23–15; 8:45 am]
BILLING CODE P
Drug Enforcement Administration
[Docket No. DEA–392]
DATES:
VerDate Sep<11>2014
Dated: January 9, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
DEPARTMENT OF JUSTICE
[FR Doc. 2015–01315 Filed 1–23–15; 8:45 am]
Notice of application.
the factors in 21 U.S.C. 823(a) and
determined that the registration of
Pharmacore, Inc. to manufacture this
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. The
DEA investigated the company’s
maintenance of effective controls
against diversion by inspecting and
testing the company’s physical security
systems, verifying the company’s
compliance with state and local laws,
and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the above-named company is
granted registration as a bulk
manufacturer of Noroxymorphone
(9668), a basic class of controlled
substance listed in schedule II.
The company plans to manufacture
the listed controlled substance as an
active pharmaceutical ingredient (API)
for clinical trials.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances Registration: Lin Zhi
International, Inc.
[Docket No. DEA–392]
ACTION:
Manufacturer of Controlled
Substances Registration: Pharmacore,
Inc.
SUMMARY:
ACTION:
Notice of registration.
Pharmacore, Inc. applied to
be registered as a manufacturer of a
basic class of controlled substance. The
DEA grants Pharmacore, Inc. registration
as a manufacturer of this controlled
substance.
SUPPLEMENTARY INFORMATION: By notice
dated May 28, 2014, and published in
the Federal Register on June 3, 2014, 79
FR 31987, Pharmacore, Inc., 4180
Mendenhall Oaks Parkway, High Point,
North Carolina 27265, applied to be
registered as a manufacturer of a certain
basic class of controlled substance. No
comments or objections were submitted
to this notice.
The Drug Enforcement
Administration (DEA) has considered
SUMMARY:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Notice of registration.
Lin Zhi International, Inc.,
applied to be registered as a
manufacturer of certain basic classes of
controlled substances. The DEA grants
Lin Zhi International, Inc. registration as
a manufacturer of those controlled
substances.
By notice
dated May 28, 2014, and published in
the Federal Register on June 4, 2014, 79
FR 32321, Lin Zhi International, Inc.,
670 Almanor Avenue, Sunnyvale,
California 94085, applied to be
registered as a manufacturer of certain
basic classes of controlled substances.
No comments or objections were
submitted to this notice.
The Drug Enforcement
Administration (DEA) has considered
the factors in 21 U.S.C. 823(a) and
determined that the registration of Lin
Zhi International, Inc. to manufacture
the basic classes of controlled
SUPPLEMENTARY INFORMATION:
E:\FR\FM\26JAN1.SGM
26JAN1
]]>Agencies
[Federal Register Volume 80, Number 16 (Monday, January 26, 2015)]
[Notices]
[Page 3982]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01315]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Siemens
Healthcare Diagnostics, Inc.
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic classes, and
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration in accordance with 21 CFR
1301.33(a) on or before March 27, 2015.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODW,
8701 Morrissette Drive, Springfield, Virginia 22152. Request for
hearings should be sent to: Drug Enforcement Administration, Attention:
Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The Attorney General has delegated his
authority under the Controlled Substances Act to the Administrator of
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority
to exercise all necessary functions with respect to the promulgation
and implementation of 21 CFR part 1301, incident to the registration of
manufacturers, distributors, and dispensers of controlled substances
(other than final orders in connection with suspension, denial, or
revocation of registration) has been redelegated to the Deputy
Assistant Administrator of the DEA Office of Diversion Control
(``Deputy Assistant Administrator'') pursuant to section 7 of 28 CFR
pt. 0, subpart. R, App.
In accordance with 21 CFR 1301.33(a), this is notice that on
November 19, 2014, Siemens Healthcare Diagnostics, Inc., Attn: RA, 100
GBC Drive, Mailstop 514, Newark, Delaware 19702, applied to be
registered as a bulk manufacturer of the following basic classes of
controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols (7370)................................. I
Ecgonine (9180).............................................. II
Morphine (9300).............................................. II
Thebaine (9333).............................................. II
------------------------------------------------------------------------
The company plans to produce the listed controlled substances in
bulk to be used in the manufacture of reagents and drug calibrator
controls which are DEA exempt products.
In reference to drug code 7370 the company plans to bulk
manufacture a synthetic tetrahydrocannabinol. No other activity for
this drug code is authorized for this registration.
Dated: January 9, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-01315 Filed 1-23-15; 8:45 am]
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