Bulk Manufacturer of Controlled Substances Application: Navinta LLC, 95640-95641 [2016-31282]
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95640
Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices
Controlled substance
Drug code
Codeine ...........................................................................................................................................................................
Oxycodone .......................................................................................................................................................................
Hydromorphone ...............................................................................................................................................................
Hydrocodone ...................................................................................................................................................................
Morphine ..........................................................................................................................................................................
The company plans to manufacture
bulk controlled substances for use in
product development and for
distribution to its customers.
Dated: December 20, 2016.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2016–31284 Filed 12–27–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Noramco, 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
DATES:
or before January 27, 2017. Such
persons may also file a written request
for a hearing on the application
pursuant to 21 CFR 1301.43 on or before
January 27, 2017.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests 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/DRW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
Comments and request for hearing on
applications to import narcotic raw
material are not appropriate. 72 FR 3417
(January 25, 2007).
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 Assistant
Administrator of the DEA Diversion
Control Division (‘‘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 October
14, 2016, Noramco, Inc., 1440 Olympic
Drive, Athens, Georgia 30601 applied to
be registered as an importer of the
following basic classes of controlled
substances:
Drug code
Phenylacetone .................................................................................................................................................................
Thebaine ..........................................................................................................................................................................
Poppy Straw Concentrate ...............................................................................................................................................
Tapentadol .......................................................................................................................................................................
sradovich on DSK3GMQ082PROD with NOTICES
[FR Doc. 2016–31281 Filed 12–27–16; 8:45 am]
BILLING CODE 4410–09–P
18:54 Dec 27, 2016
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Navinta LLC
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 February 27, 2017.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
Dated: December 19, 2016.
Louis J. Milione,
Assistant Administrator.
VerDate Sep<11>2014
Drug Enforcement Administration
ACTION:
Jkt 241001
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
8501
9333
9670
9780
Schedule
II
II
II
II
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
September 19, 2016, Navinta LLC, 1499
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF JUSTICE
II
II
II
II
II
SUPPLEMENTARY INFORMATION:
Controlled substance
The company plans to import
thebaine derivatives (9333) as reference
standards. The company plans to import
an intermediate form of tapentadol
(9780) to bulk manufacture tapentadol
for distribution to its customers. The
company plans to import phenylacetone
(8501) and poppy straw concentrate
(9670) to manufacture other controlled
substances.
9050
9143
9150
9193
9300
Schedule
E:\FR\FM\28DEN1.SGM
28DEN1
95641
Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices
Lower Ferry Road, Ewing, New Jersey
08618–1414 applied to be registered as
a bulk manufacturer of the following
basic classes controlled substances:
Controlled substance
Drug code
Pentobarbital ....................................................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) .....................................................................................................................
Remifentanil .....................................................................................................................................................................
Fentanyl ...........................................................................................................................................................................
The company plans to initially to
manufacture API quantities of the listed
controlled substances for validation
purposes and FDA approval, then
eventually up FDA approval to produce
commercial size batches for distribution
to dosage form manufacturers.
Dated: December 19, 2016.
Louis J. Milione,
Assistant Administrator.
Drug Enforcement Administration
[Docket No. DEA–392]
SUPPLEMENTARY INFORMATION:
Bulk Manufacturer of Controlled
Substances Registration
Notice of registration.
Registrants listed below have
applied for and been granted
registration by the Drug Enforcement
Company
FR docket
National Center for Natural Products Research (NIDA MPROJECT) ..............
Cambrex Charles City .......................................................................................
Chemtos, LLC ....................................................................................................
Stepan Company ...............................................................................................
Chattem Chemicals ...........................................................................................
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of these registrants to
manufacture the applicable 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 each of the company’s
maintenance of effective controls
against diversion by inspecting and
testing each company’s physical
security systems, verifying each
company’s compliance with state and
local laws, and reviewing each
company’s background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the DEA has granted a
registration as a bulk manufacturer to
the above listed persons.
Dated: December 19, 2016.
Louis J. Milione,
Assistant Administrator.
80
81
81
81
81
FR
FR
FR
FR
FR
78766
46956
54604
54849
57932
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Synthcon,
LLC
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 February 27, 2017.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
BILLING CODE 4410–09–P
The Attorney General has delegated
her authority under the Controlled
Published
............................................
............................................
............................................
............................................
............................................
DEPARTMENT OF JUSTICE
SUPPLEMENTARY INFORMATION:
[FR Doc. 2016–31280 Filed 12–27–16; 8:45 am]
sradovich on DSK3GMQ082PROD with NOTICES
The
companies listed below applied to be
registered as manufacturers of various
basic classes of controlled substances.
Information on previously published
notices is listed in the table below. No
comments or objections were submitted
for these notices.
SUMMARY:
BILLING CODE 4410–09–P
Drug code
3-Fluoro-N-methylcathinone (3–FMC) .............................................................................................................................
Cathinone ........................................................................................................................................................................
Methcathinone .................................................................................................................................................................
4-Fluoro-N-methylcathinone (4–FMC) .............................................................................................................................
Pentedrone (a-methylaminovalerophenone) ...................................................................................................................
18:54 Dec 27, 2016
Jkt 241001
PO 00000
Frm 00087
Fmt 4703
December 17, 2015.
July 19, 2016.
August 16, 2016.
August 17, 2016.
August 24, 2016.
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 Assistant
Administrator of the DEA Diversion
Control Division (‘‘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 16, 2015, Synthcon, LLC, 770
Wooten Road, Unit 101, Colorado
Springs, Colorado 80915 applied to be
registered as a bulk manufacturer of the
following basic classes of controlled
substances:
Controlled substance
VerDate Sep<11>2014
II
II
II
II
Administration (DEA) as bulk
manufacturers of various classes of
controlled substances.
DEPARTMENT OF JUSTICE
ACTION:
[FR Doc. 2016–31282 Filed 12–27–16; 8:45 am]
2270
8333
9739
9801
Schedule
Sfmt 4703
E:\FR\FM\28DEN1.SGM
28DEN1
1233
1235
1237
1238
1246
Schedule
I
I
I
I
I
]]>Agencies
[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)]
[Notices]
[Pages 95640-95641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31282]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Navinta
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
1301.33(a) on or before February 27, 2017.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DRW,
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
September 19, 2016, Navinta LLC, 1499
[[Page 95641]]
Lower Ferry Road, Ewing, New Jersey 08618-1414 applied to be registered
as a bulk manufacturer of the following basic classes controlled
substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Pentobarbital...................... 2270 II
4-Anilino-N-phenethyl-4-piperidine 8333 II
(ANPP).
Remifentanil....................... 9739 II
Fentanyl........................... 9801 II
------------------------------------------------------------------------
The company plans to initially to manufacture API quantities of the
listed controlled substances for validation purposes and FDA approval,
then eventually up FDA approval to produce commercial size batches for
distribution to dosage form manufacturers.
Dated: December 19, 2016.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2016-31282 Filed 12-27-16; 8:45 am]
BILLING CODE 4410-09-P
