Bulk Manufacturer of Controlled Substances Application: Siemens Healthcare Diagnostics, Inc., 15565-15566 [2016-06540]
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Federal Register / Vol. 81, No. 56 / Wednesday, March 23, 2016 / Notices
concentrate (9670), a basic class of
controlled substance listed in schedule
II.
The company plans to import the
listed controlled substance to bulk
manufacture into other controlled
substances for sale to its customers.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Pharmacore
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic class, 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
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, dispenser,
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 January
26, 2016, Pharmacore, 4180 Mendenhall
Oaks Parkway, High Point, North
Carolina 27265 applied to be registered
as an importer of poppy straw
jstallworth on DSK7TPTVN1PROD with NOTICES
DATES:
VerDate Sep<11>2014
15:26 Mar 22, 2016
Jkt 238001
Dated: March 14, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
15565
The company plans to manufacture
the listed controlled substance as an
intermediate in the manufacture of an
active pharmaceutical ingredient to sell
to its customers.
Dated: March 14, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–06534 Filed 3–22–16; 8:45 am]
BILLING CODE 4410–09–P
[FR Doc. 2016–06541 Filed 3–22–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
[Docket No. DEA–392]
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Siemens
Healthcare Diagnostics, Inc.
Manufacturer of Controlled
Substances Registration: Cody
Laboratories, Inc.
ACTION:
Notice of registration.
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
Notice of application.
Registered bulk manufacturers of
the affected basic class, 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.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
Cody Laboratories, Inc.
applied to be registered as a
manufacturer of a certain basic class of
controlled substance. The Drug
Enforcement Administration (DEA)
grants Cody Laboratories, Inc.
registration as a manufacturer of this
controlled substance.
SUPPLEMENTARY INFORMATION: By notice
dated October 13, 2015, and published
in the Federal Register on October 21,
2015, 80 FR 63835, Cody Laboratories,
Inc., Steven Hartman—Vice President of
Compliance, 601 Yellowstone Avenue,
Cody, Wyoming 82414 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 Cody Laboratories,
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 methadone
intermediate (9254), a basic class of
controlled substance listed in schedule
II.
SUMMARY:
ACTION:
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
December 14, 2015, Siemens Healthcare
Diagnostics, Inc., 100 GBC Drive,
Mailstop 514, Newark, Delaware 19702
applied to be registered as a bulk
manufacturer of ecgonine (9180) a basic
class of controlled substance listed in
schedule II.
The company plans to produce the
listed controlled substance in bulk to be
SUPPLEMENTARY INFORMATION:
E:\FR\FM\23MRN1.SGM
23MRN1
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.
I
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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
]]>Agencies
[Federal Register Volume 81, Number 56 (Wednesday, March 23, 2016)]
[Notices]
[Pages 15565-15566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06540]
-----------------------------------------------------------------------
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 class, 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.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODW,
8701 Morrissette Drive, Springfield, Virginia 22152.
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 1301.33(a), this is notice that on
December 14, 2015, Siemens Healthcare Diagnostics, Inc., 100 GBC Drive,
Mailstop 514, Newark, Delaware 19702 applied to be registered as a bulk
manufacturer of ecgonine (9180) a basic class of controlled substance
listed in schedule II.
The company plans to produce the listed controlled substance in
bulk to be
[[Page 15566]]
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
