Bulk Manufacturer of Controlled Substances Application: Navinta, LLC, 20418-20419 [2016-07948]
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20418
Federal Register / Vol. 81, No. 67 / Thursday, April 7, 2016 / 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 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 12, 2016, Stepan Company,
Natural Products Dept., 100 W. Hunter
Avenue, Maywood, New Jersey 07607
applied to be registered as an importer
of coca leaves (9040), a basic class of
controlled substance listed in schedule
II.
The company plans to import the
listed controlled substance in bulk for
the manufacture of controlled substance
for distribution to its customers.
SUPPLEMENTARY INFORMATION:
Dated: March 28, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–07944 Filed 4–6–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration: Fisher Clinical Services,
Inc.
ACTION:
Notice of registration.
Fisher Clinical Services, Inc.
applied to be registered as an importer
of certain basic classes of controlled
substances. The Drug Enforcement
Administration (DEA) grants Fisher
Clinical Services, Inc. registration as an
importer of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice
dated December 9, 2015, and published
in the Federal Register on December 17,
2015, 80 FR 78766, Fisher Clinical
Services, Inc., 7554 Schantz Road,
Allentown, Pennsylvania 18106 applied
to be registered as an importer of certain
basic classes of controlled substances.
No comments or objections were
submitted for this notice.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
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The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and
determined that the registration of
Fisher Clinical Services, Inc. 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:
Controlled substance
Methylphenidate (1724) .............
Levorphanol (9220) ...................
Noroxymorphone (9668) ............
Tapentadol (9780) .....................
Schedule
II
II
II
II
The company plans to import the
listed substances for analytical research,
testing, and clinical trials. This
authorization does not extend to the
import of a finished FDA approved or
non-approved dosage form for
commercial distribution in the United
States.
The company plans to import an
intermediate form of tapentadol (9780)
to bulk manufacture tapentadol for
distribution to its customers. Placement
of these (this) drug code (s) onto the
company’s registration does not
translate into automatic approval of
subsequent permit applications to
import controlled substances. Approval
of permit applications will occur only
when the registrant’s business activity is
consistent with what is authorized
under to 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of FDA approved or nonapproved finished dosage forms for
commercial sale.
Dated: March 28, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–07945 Filed 4–6–16; 8:45 am]
BILLING CODE 4410–09–P
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Navinta, 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 June 6, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
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 10, 2015, Navinta, LLC, 1499
Lower Ferry Road, Ewing, New Jersey
08618–1414 applied to be registered as
a bulk manufacturer of the following
basic classes of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Pentobarbital (2270) ...............
4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333).
Remifentanil (9739) .................
Fentanyl (9801) .......................
Schedule
II
II
II
II
The company plans initially to
manufacture API quantities of the listed
controlled substances for validation
purposes and FDA approval, then
eventually upon FDA approval to
produce commercial size batches for
distribution to dosage form
manufacturers.
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07APN1
20419
Federal Register / Vol. 81, No. 67 / Thursday, April 7, 2016 / Notices
Dated: March 28, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
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:
[FR Doc. 2016–07948 Filed 4–6–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Controlled substance
[Docket No. DEA–392]
Importer of Controlled Substances
Registration: Mylan Pharmaceuticals,
Inc.
ACTION:
Notice of registration.
Mylan Pharmaceuticals, Inc.
applied to be registered as an importer
of certain basic classes of controlled
substances. The Drug Enforcement
Administration (DEA) grants Mylan
Pharmaceuticals, Inc. registration as an
importer of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice
dated December 4, 2015, and published
in the Federal Register on December 10,
2015, 80 FR 76709, Mylan
Pharmaceuticals, Inc., 3711 Collins
Ferry Road, Morgantown, West Virginia
26505 applied to be registered as an
importer 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, 952(a) and 958(a) and
determined that the registration of
Mylan Pharmaceuticals, Inc. 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
SUMMARY:
Amphetamine (1100) ....................
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Pentobarbital (2270) .....................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Levorphanol (9220) ......................
Morphine (9300) ...........................
Oxymorphone (9652) ...................
Remifentanil (9739) ......................
Fentanyl (9801) ............................
Schedule
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to import the
listed controlled substances in finished
dosage form (FDF) from foreign sources
for analytical testing and clinical trials
in which the foreign FDF will be
compared to the company’s own
domestically-manufactured FDF. This
analysis is required to allow the
company to export domesticallymanufactured FDF to foreign markets.
Dated: March 28, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–07946 Filed 4–6–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
VHG Labs DBA LGC
Standards Warehouse applied to be
registered as an importer of certain basic
classes of controlled substances. The
Drug Enforcement Administration
(DEA) grants VHG Labs DBA LGC
Standards Warehouse registration as an
importer of those controlled substances.
SUMMARY:
By notice
dated November 19, 2015, and
published in the Federal Register on
November 25, 2015, 80 FR 73830, VHG
Labs DBA LGC Standards Warehouse 3
Perimeter Road, Manchester, New
Hampshire 03103 applied to be
registered as an importer 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, 952(a) and 958(a) and
determined that the registration of VHG
Labs DBA LGC Standards Warehouse 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:
Importer of Controlled Substances
Registration: VHG Labs DBA LGC
Standards Warehouse
ACTION:
Notice of registration.
mstockstill on DSK4VPTVN1PROD 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) ......................................................................................................................................................................................
4-Methylaminorex (cis isomer) (1590) .........................................................................................................................................................
Gamma Hydroxybutyric Acid (2010) ...........................................................................................................................................................
Methaqualone (2565) ..................................................................................................................................................................................
Mecloqualone (2572) ...................................................................................................................................................................................
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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[Federal Register Volume 81, Number 67 (Thursday, April 7, 2016)]
[Notices]
[Pages 20418-20419]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07948]
-----------------------------------------------------------------------
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 June 6, 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
September 10, 2015, Navinta, LLC, 1499 Lower Ferry Road, Ewing, New
Jersey 08618-1414 applied to be registered as a bulk manufacturer of
the following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Pentobarbital (2270)..................... II
4-Anilino-N-phenethyl-4-piperidine (ANPP) II
(8333).
Remifentanil (9739)...................... II
Fentanyl (9801).......................... II
------------------------------------------------------------------------
The company plans initially to manufacture API quantities of the
listed controlled substances for validation purposes and FDA approval,
then eventually upon FDA approval to produce commercial size batches
for distribution to dosage form manufacturers.
[[Page 20419]]
Dated: March 28, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-07948 Filed 4-6-16; 8:45 am]
BILLING CODE 4410-09-P
