Importer of Controlled Substances Application: Mallinckrodt LLC, 15566-15567 [2016-06543]
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15566
Federal Register / Vol. 81, No. 56 / Wednesday, March 23, 2016 / Notices
used in the manufacture of DEA exempt
products.
Dated: March 14, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–06540 Filed 3–22–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: R & D Systems, Inc.
ACTION:
Notice of application.
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 1301.34(a) on
or before April 22, 2016. Such persons
may also file a written request for a
DATES:
hearing on the application pursuant to
21 CFR 1301.43 on or before April 22,
2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152. All request for hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All request for hearing
should also be sent to: (1) Drug
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
February 25, 2015, R & D Systems, Inc.,
614 McKinley Place NE., Minneapolis,
Minnesota 55413 applied to be
registered as an importer of the
following basic classes of controlled
substances:
Controlled substance
Schedule
jstallworth on DSK7TPTVN1PROD with NOTICES
Mephedrone (4-Methyl-N-methylcathinone) (1248) ....................................................................................................................................
JWH–018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl)indole) (7118) ..............................................................................................
CP–47,497 (5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl-phenol) (7297) .................................................................................
Marihuana (7360) ........................................................................................................................................................................................
Tetrahydrocannabinols (7370) .....................................................................................................................................................................
4-Bromo-2,5-dimethoxyamphetamine (7391) ..............................................................................................................................................
3,4-Methylenedioxymethamphetamine (7405) ............................................................................................................................................
Dimethyltryptamine (7435) ..........................................................................................................................................................................
Psilocyn (7438) ............................................................................................................................................................................................
Amphetamine (1100) ...................................................................................................................................................................................
Methylphenidate (1724) ...............................................................................................................................................................................
Pentobarbital (2270) ....................................................................................................................................................................................
Phencyclidine (7471) ...................................................................................................................................................................................
Cocaine (9041) ............................................................................................................................................................................................
Oxycodone (9143) .......................................................................................................................................................................................
Morphine (9300) ..........................................................................................................................................................................................
Thebaine (9333) ..........................................................................................................................................................................................
Fentanyl (9801) ...........................................................................................................................................................................................
The company plans to import the
listed controlled substances in dosage
form to distribute to researchers.
In reference to drug codes 7360 and
7370, the company plans to import a
synthetic cannabidiol and a synthetic
tetrahydrocannabinol. No other activity
for these drug codes is authorized for
this registration.
The import of the above listed basic
classes of controlled substances would
be granted only for analytical testing
and clinical trials. This authorization
does not extend to the import of a
finished Food and Drug Administration
approved or non-approved dosage form
for commercial distribution in the
United States.
VerDate Sep<11>2014
15:26 Mar 22, 2016
Jkt 238001
Dated: March 14, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
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DEPARTMENT OF JUSTICE
comments on or objections to the
issuance of the proposed registration in
accordance with 21 CFR 1301.34(a) on
or before April 22, 2016. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before April 22,
2016.
Drug Enforcement Administration
ADDRESSES:
[FR Doc. 2016–06542 Filed 3–22–16; 8:45 am]
BILLING CODE 4410–09–P
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Mallinckrodt LLC
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
DATES:
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152. All request for hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All request for hearing
should also be sent to: (1) Drug
E:\FR\FM\23MRN1.SGM
23MRN1
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)
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[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
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The company plans to manufacture
the listed controlled substances in bulk
for distribution to its customers.
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
[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
E:\FR\FM\23MRN1.SGM
23MRN1
]]>Agencies
[Federal Register Volume 81, Number 56 (Wednesday, March 23, 2016)]
[Notices]
[Pages 15566-15567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06543]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Mallinckrodt LLC
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
1301.34(a) on or before April 22, 2016. Such persons may also file a
written request for a hearing on the application pursuant to 21 CFR
1301.43 on or before April 22, 2016.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODW,
8701 Morrissette Drive, Springfield, Virginia 22152. All request for
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
request for hearing should also be sent to: (1) Drug
[[Page 15567]]
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)....................... II
Coca Leaves (9040)......................... II
Opium, raw (9600).......................... II
Poppy Straw Concentrate (9670)............. II
------------------------------------------------------------------------
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.
[FR Doc. 2016-06543 Filed 3-22-16; 8:45 am]
BILLING CODE 4410-09-P
