Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City, 63835-63836 [2015-26669]
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Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
DEPARTMENT OF JUSTICE
Controlled substance
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Chattem
Chemicals, 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 1301.33(a) on
or before December 21, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 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 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 July 22, 2015,
Chattem Chemicals, Inc., 3801 St Elmo
Avenue, Chattanooga, Tennessee 37409
applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
DATES:
tkelley on DSK3SPTVN1PROD with NOTICES
Controlled substance
Schedule
Gamma
Hydroxybutyric
Acid
(2010).
4-Methoxyamphetamine (7411) ...
Dihydromorphine (9145) ...............
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Pentobarbital (2270) .....................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
VerDate Sep<11>2014
22:39 Oct 20, 2015
I
I
I
II
II
II
II
II
II
II
II
Jkt 238001
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Meperidine (9230) ........................
Meperidine intermediate-A (9232)
Meperidine intermediate-B (9233)
Meperidine intermediate-C (9234)
Methadone (9250) ........................
Methadone intermediate (9254) ...
Morphine (9300) ...........................
Oripavine (9330) ...........................
Thebaine (9333) ...........................
Opium tincture (9630) ..................
Opium, powdered (9639) .............
Opium, granulated (9640) ............
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Alfentanil (9737) ...........................
Remifentanil (9739) ......................
Sufentanil (9740) ..........................
Tapentadol (9780) ........................
Fentanyl (9801) ............................
Schedule
II
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 distribution and sale to its
customers.
Dated: October 13, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015–26682 Filed 10–20–15; 8:45 am]
BILLING CODE 4410–09–P
63835
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 March
17, 2015, Cody Laboratories, Inc., Steve
Hartman—Vice President of
Compliance, 601 Yellowstone Avenue,
Cody, Wyoming applied to be registered
as a bulk manufacturer of methadone
intermediate (9254), a basic class of
controlled substance listed in schedule
II.
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: October 13, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015–26670 Filed 10–20–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
DEPARTMENT OF JUSTICE
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Cody
Laboratories, Inc.
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 1301.33(a) on or before
December 21, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 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 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
DATES:
PO 00000
Frm 00099
Fmt 4703
Sfmt 4703
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Cambrex
Charles City
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 1301.33(a) on
or before December 21, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 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. Comments
and requests for hearings on
applications to import raw material are
not appropriate. 72 FR 3417 (January 25,
2007).
DATES:
E:\FR\FM\21OCN1.SGM
21OCN1
63836
Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
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 exporter 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 August
21, 2015, Cambrex Charles City, 1205
11th Street, Charles City, Iowa 50616
applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Schedule
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) ............
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
Controlled substance
Opium tincture (9630) ..................
Opium, powdered (9639) .............
Opium, granulated (9640) ............
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Alfentanil (9737) ...........................
Remifentanil (9739) ......................
Sufentanil (9740) ..........................
Fentanyl (9801) ............................
Schedule
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: October 13, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015–26669 Filed 10–20–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Cerilliant Corporation
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 November 20, 2015. Such
persons may also file a written request
for a hearing on the application
pursuant to 21 CFR 1301.43 on or before
November 20, 2015.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 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. Comments
and requests for hearing on applications
to import narcotic raw material are not
appropriate. 72 FR 3417 (January 25,
2007).
ADDRESSES:
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 July 2,
2015, Cerilliant Corporation, 811
Paloma Drive, Suite A, Round Rock,
Texas 78665–2402, applied to be
registered as an importer of the
following basic classes of controlled
substances:
tkelley on DSK3SPTVN1PROD 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) ..................................................................
5-Fluoro-UR-144 and XLR11 [1-(5-Flouro-pentyl) 1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl) methanone (7011) ...............................
AB-FUBINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) (7012) ......................................
JWH-019 (1-Hexyl-3-(1-naphthoyl) (7019) ..................................................................................................................................................
AB-PINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (7023) ............................................................
THJ-2201 [1-(5-fluoropentyl)-1H-indazol-3-yl] (naphthalene-1-yl)methanone (7024) .................................................................................
AB-CHIMINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohenxylmethyl)-1H-indazole-3-carboxamide (7031) ...............................
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) (7035) ..................................................
APINACA and AKB48 N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide (7048) ...............................................................................
JWH-081 (1-Pentyl-3-(1-(4-methoxynaphthoyl) indole) (7081) ...................................................................................................................
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl] indole (7104) ..........................................................................................................
VerDate Sep<11>2014
22:39 Oct 20, 2015
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]]>Agencies
[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Notices]
[Pages 63835-63836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26669]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Cambrex
Charles City
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 December 21, 2015.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODXL,
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.
Comments and requests for hearings on applications to import raw
material are not appropriate. 72 FR 3417 (January 25, 2007).
[[Page 63836]]
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 exporter 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 August
21, 2015, Cambrex Charles City, 1205 11th Street, Charles City, Iowa
50616 applied to be registered as a bulk manufacturer of the following
basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Amphetamine (1100)......................... II
Lisdexamfetamine (1205).................... II
Methylphenidate (1724)..................... II
4-Anilino-N-phenethyl-4-piperidine (ANPP) II
(8333).
Phenylacetone (8501)....................... II
Cocaine (9041)............................. II
Codeine (9050)............................. II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Hydrocodone (9193)......................... II
Morphine (9300)............................ II
Oripavine (9330)........................... II
Thebaine (9333)............................ II
Opium extracts (9610)...................... II
Opium fluid extract (9620)................. II
Opium tincture (9630)...................... II
Opium, powdered (9639)..................... II
Opium, granulated (9640)................... II
Oxymorphone (9652)......................... II
Noroxymorphone (9668)...................... II
Alfentanil (9737).......................... II
Remifentanil (9739)........................ II
Sufentanil (9740).......................... II
Fentanyl (9801)............................ 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: October 13, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-26669 Filed 10-20-15; 8:45 am]
BILLING CODE 4410-09-P
