Manufacturer of Controlled Substances Registration: Halo Pharmaceutical, Inc., 15567-15568 [2016-06532]
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15567
Federal Register / Vol. 81, No. 56 / Wednesday, March 23, 2016 / Notices
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/ODW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
Comments and requests for hearing on
applications to import narcotic raw
material are not appropriate. 72 FR 3417
(January 25, 2007).
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated her
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, dispensers,
importers, and exporters 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 part 0, appendix to subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on
December 22, 2015, Mallinckrodt LLC,
3600 North Second Street, Saint Louis,
Missouri 63147 applied to be registered
as an importer of the following basic
classes of controlled substances:
Controlled substance
Schedule
Phenylacetone (8501) ..................
Coca Leaves (9040) .....................
Opium, raw (9600) .......................
Poppy Straw Concentrate (9670)
II
II
II
II
[FR Doc. 2016–06543 Filed 3–22–16; 8:45 am]
BILLING CODE 4410–09–P
jstallworth on DSK7TPTVN1PROD with NOTICES
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Siegfried
USA, LLC
ACTION:
Notice of application.
VerDate Sep<11>2014
15:26 Mar 22, 2016
Jkt 238001
Dated: March 14, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DEPARTMENT OF JUSTICE
ADDRESSES:
The
Attorney General has delegated her
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, dispensers,
importers, and exporters 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 part 0, appendix to subpart R.
In accordance with 21 CFR
1301.33(a), this is notice that on
November 12, 2015, Siegfried USA,
LLC, 33 Industrial Park Road,
Pennsville, New Jersey 08070 applied to
be registered as a bulk manufacturer the
following basic classes of controlled
substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
The company plans to import the
listed controlled substances to bulk
manufacture into Active Pharmaceutical
Ingredients for distribution to its
customers.
Dated: March 14, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
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 May 23, 2016.
DATES:
Gamma
Hydroxybutyric
Acid
(2010).
Dihydromorphine (9145) ...............
Hydromorphinol (9301) .................
Methylphenidate (1724) ................
Amobarbital (2125) .......................
Pentobarbital (2270) .....................
Secobarbital (2315) ......................
Codeine (9050) .............................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Methadone (9250) ........................
Methadone intermediate (9254) ...
Dextropropoxyphene, bulk (nondosage forms) (9273).
Morphine (9300) ...........................
Oripavine (9330) ...........................
Thebaine (9333) ...........................
Opium tincture (9630) ..................
Oxymorphone (9652) ...................
Schedule
I
I
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for distribution to its customers.
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[FR Doc. 2016–06537 Filed 3–22–16; 8:45 am]
BILLING CODE 4410–09–P
Drug Enforcement Administration
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: Halo
Pharmaceutical, Inc.
ACTION:
Notice of registration.
Halo Pharmaceutical, Inc.
applied to be registered as a
manufacturer of certain basic classes of
controlled substances. The Drug
Enforcement Administration (DEA)
grants Halo Pharmaceutical, Inc.
registration as a manufacturer of those
controlled substances.
SUPPLEMENTARY INFORMATION: By notice
dated October 13, 2015, and published
in the Federal Register on October 21,
2015, 80 FR 63838, Halo
Pharmaceutical, Inc., 30 North Jefferson
Road, Whippany, New Jersey 07981
applied to be registered as a
manufacturer of certain basic classes of
controlled substances. No comments or
objections were submitted for this
notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Halo Pharmaceutical,
Inc. to manufacture 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. 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 the following basic
classes of controlled substances:
SUMMARY:
Controlled substance
Dihydromorphine (9145) ...............
Hydromorphone (9150) ................
Schedule
I
II
The company plans to manufacture
Hydromorphone HCl for sale to other
manufacturers and to manufacture other
controlled substances for distribution to
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15568
Federal Register / Vol. 81, No. 56 / Wednesday, March 23, 2016 / Notices
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 the following basic
classes of controlled substances:
its customers. Dihydromorphine is an
intermediate in the manufacture of
Hydromorphone and is not for
commercial distribution.
Dated: March 14, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–06532 Filed 3–22–16; 8:45 am]
BILLING CODE 4410–09–P
Controlled substance
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: Cambrex
Charles City
ACTION:
Notice of registration.
Cambrex Charles City applied
to be registered as a manufacturer of
certain basic classes of controlled
substances. The Drug Enforcement
Administration (DEA) grants Cambrex
Charles City registration as a
manufacturer of those controlled
substances.
SUPPLEMENTARY INFORMATION: By notice
dated October 13, 2015, and published
in the Federal Register on October 21,
2015, 80 FR 63835, Cambrex Charles
City, 1205 11th Street, Charles City,
Iowa 50616 applied to be registered as
a manufacturer of certain basic classes
of controlled substances. No other
comments or objections were submitted
for this notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Cambrex Charles City
to manufacture 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. The DEA
investigated the company’s maintenance
of effective controls against diversion by
inspecting and testing the company’s
physical security systems, verifying the
SUMMARY:
Amphetamine (1100) ....................
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
4-Anilino-N-phenethyl-4-piperidine
(ANPP) (8333).
Phenylacetone (8501) ..................
Cocaine (9041) .............................
Codeine (9050) .............................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Morphine (9300) ...........................
Oripavine (9330) ...........................
Thebaine (9333) ...........................
Opium extracts (9610) ..................
Opium fluid extract (9620) ............
Opium tincture (9630) ..................
Opium, powdered (9639) .............
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Fentanyl (9801) ............................
Schedule
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for sale to its customers, for dosage form
development, for clinical trials, and for
use in stability qualification studies.
Dated: March 14, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–06536 Filed 3–22–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Cerilliant Corporation applied
to be registered as an importer of certain
basic classes of controlled substances.
The Drug Enforcement Administration
(DEA) grants Cerilliant Corporation
registration as an importer of those
controlled substances.
SUMMARY:
By notice
dated October 13, 2015, and published
in the Federal Register on October 21,
2015, 80 FR 63836, Cerilliant
Corporation, 811 Paloma Drive, Suite A,
Round Rock, Texas 78665–2402 applied
to be registered as an importer of certain
basic classes of controlled substances.
Comments and requests for hearing on
applications to import narcotic raw
material are not appropriate. 72 FR
3417, (January 25, 2007). No comments
or objections were submitted for this
notice.
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and
determined that the registration of
Cerilliant Corporation 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. 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.
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 following basic classes
of controlled substances:
SUPPLEMENTARY INFORMATION:
[Docket No. DEA–392]
Importer of Controlled Substances
Registration: Cerilliant Corporation
ACTION:
Notice of registration.
jstallworth on DSK7TPTVN1PROD with NOTICES
Controlled substance
Schedule
3-Fluoro-N-methylcathinone (3–FMC) (1233) .............................................................................................................................................
Cathinone (1235) .........................................................................................................................................................................................
Methcathinone (1237) ..................................................................................................................................................................................
4-Fluoro-N-methylcathinone (4–FMC) (1238) .............................................................................................................................................
Pentedrone (a-methylaminovalerophenone) (1246) ....................................................................................................................................
Mephedrone (4-Methyl-N-methylcathinone) (1248) ....................................................................................................................................
4-Methyl-N-ethylcathinone (4–MEC) (1249) ................................................................................................................................................
Naphyrone (1258) ........................................................................................................................................................................................
N-Ethylamphetamine (1475) ........................................................................................................................................................................
N,N-Dimethylamphetamine (1480) ..............................................................................................................................................................
Fenethylline (1503) ......................................................................................................................................................................................
Methaqualone (2565) ..................................................................................................................................................................................
JWH–250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole) (6250) ...................................................................................................................
SR–18 (Also known as RCS–8) (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole) (7008) .................................................................
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]]>Agencies
[Federal Register Volume 81, Number 56 (Wednesday, March 23, 2016)]
[Notices]
[Pages 15567-15568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06532]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Manufacturer of Controlled Substances Registration: Halo
Pharmaceutical, Inc.
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: Halo Pharmaceutical, Inc. applied to be registered as a
manufacturer of certain basic classes of controlled substances. The
Drug Enforcement Administration (DEA) grants Halo Pharmaceutical, Inc.
registration as a manufacturer of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice dated October 13, 2015, and
published in the Federal Register on October 21, 2015, 80 FR 63838,
Halo Pharmaceutical, Inc., 30 North Jefferson Road, Whippany, New
Jersey 07981 applied to be registered as a manufacturer of certain
basic classes of controlled substances. No comments or objections were
submitted for this notice.
The DEA has considered the factors in 21 U.S.C. 823(a) and
determined that the registration of Halo Pharmaceutical, Inc. to
manufacture 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. 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 the following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Dihydromorphine (9145)..................... I
Hydromorphone (9150)....................... II
------------------------------------------------------------------------
The company plans to manufacture Hydromorphone HCl for sale to
other manufacturers and to manufacture other controlled substances for
distribution to
[[Page 15568]]
its customers. Dihydromorphine is an intermediate in the manufacture of
Hydromorphone and is not for commercial distribution.
Dated: March 14, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-06532 Filed 3-22-16; 8:45 am]
BILLING CODE 4410-09-P
