Bulk Manufacturer of Controlled Substances Application: Navinta LLC, 8901-8902 [2015-03489]
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8901
Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices
The Department of Justice will accept
written comments relating to this
proposed Consent Decree for thirty (30)
days from the date of publication of this
Notice. Please address comments to
Friedrich A. P. Siekert, AUSA, United
States Attorney’s Office, United States
Courthouse, 300 South Fourth Street,
Suite 600, Minneapolis, MN 55415 and
refer to United States v. Mlaskoch, et al.,
USAO File No. 2009V00565, DJ# 90–5–
1–1–18624.
The proposed Consent Decree may be
examined at the Clerk’s Office, United
States District Court for the District of
Minnesota, United States Courthouse,
300 South Fourth Street, Suite 202,
Minneapolis, MN 55415. In addition,
the proposed Consent Decree may be
examined electronically at https://
www.justice.gov/enrd/Consent_
Decrees.html.
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 3, 2014, Johnson Matthey,
Inc., Custom Pharmaceuticals
Department, 2003 Nolte Drive, West
Deptford, New Jersey 08066–1742,
applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
Cherie L. Rogers,
Assistant Section Chief, Environmental
Defense Section, Environment and Natural
Resources Division.
Gamma
Hydroxybutyric
Acid
(2010).
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
Dihydromorphine (9145) ...............
Difenoxin (9168) ...........................
Propiram (9649) ...........................
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Nabilone (7379) ............................
Cocaine (9041) .............................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Diphenoxylate (9170) ...................
Ecgonine (9180) ...........................
Hydrocodone (9193) .....................
Meperidine (9230) ........................
Methadone (9250) ........................
Methadone intermediate (9254) ...
Morphine (9300) ...........................
Thebaine (9333) ...........................
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Alfentanil (9737) ...........................
Remifentanil (9739) ......................
Sufentanil (9740) ..........................
Tapentadol (9780) ........................
Fentanyl (9801) ............................
[FR Doc. 2015–03409 Filed 2–18–15; 8:45 am]
BILLING CODE 4410–15–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Johnson
Matthey, 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 April 20, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 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 his
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
emcdonald on DSK67QTVN1PROD with NOTICES
DATES:
VerDate Sep<11>2014
16:58 Feb 18, 2015
Jkt 235001
Controlled substance
Schedule
I
I
I
I
I
I
II
II
II
II
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 sale to its customers.
Dated: February 11, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–03492 Filed 2–18–15; 8:45 am]
BILLING CODE 4410–09–P
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
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 April 20, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 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 his
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 5, 2014, 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:
DATES:
Controlled substance
Pentobarbital (2270) .....................
Remifentanil (9739) ......................
Schedule
II
II
The company plans to initially to
manufacture API quantities of the listed
controlled substances for validation
purposes and FDA approval, then to
produce commercial size batches for
distribution to dosage form
manufacturers upon FDA approval.
E:\FR\FM\19FEN1.SGM
19FEN1
8902
Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices
Dated: February 11, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
Controlled substance
Amphetamine (1100) ....................
Methylphenidate (1724) ................
Codeine (9050) .............................
Oxycodone (9143) ........................
Diphenoxylate (9170) ...................
Hydrocodone (9193) .....................
Meperidine (9230) ........................
Methadone (9250) ........................
Methadone intermediate (9254) ...
Morphine (9300) ...........................
Thebaine (9333) ...........................
[FR Doc. 2015–03489 Filed 2–18–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Johnson
Matthey, 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 April 20, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 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 his
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 3, 2014, Johnson Matthey,
Inc., Pharmaceuticals Materials, 900
River Road, Conshohocken,
Pennsylvania 19428, applied to be
registered as a bulk manufacturer of the
following basic classes of controlled
substances:
emcdonald on DSK67QTVN1PROD with NOTICES
DATES:
Controlled substance
Gamma
(2010).
Hydroxybutyric
VerDate Sep<11>2014
Schedule
Acid
16:58 Feb 18, 2015
I
Jkt 235001
Schedule
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.
The Thebaine (9333) will be used to
manufacture other controlled substances
for sale in bulk to its customers.
Dated: February 11, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Mylan Technologies, Inc.
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 March 23, 2015. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before March 23,
2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 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 his
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
DATES:
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
Controlled substance
Methylphenidate (1724) ................
Fentanyl (9801) ............................
[FR Doc. 2015–03491 Filed 2–18–15; 8:45 am]
ACTION:
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
November 13, 2014, Mylan
Technologies, Inc., 110 Lake Street,
Saint Albans, Vermont 05478, applied
to be registered as an importer of the
following basic classes of controlled
substances:
Schedule
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: February 11, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–03493 Filed 2–18–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration: United States
Pharmacopeial Convention
ACTION:
Notice of registration.
United States Pharmacopeial
Convention applied to be registered as
an importer of certain basic classes of
controlled substances. The DEA grants
United States Pharmacopeial
Convention registration as an importer
of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice
dated August 11, 2014, and published in
the Federal Register on August 20,
2014, 79 FR 49341, United States
Pharmacopeial Convention, 12601
Twinbrook Parkway, Rockville,
Maryland 20852, applied to be
registered as an importer of certain basic
classes of controlled substances. No
SUMMARY:
E:\FR\FM\19FEN1.SGM
19FEN1
]]>Agencies
[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)]
[Notices]
[Pages 8901-8902]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03489]
-----------------------------------------------------------------------
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 April 20, 2015.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODW,
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 his
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 5, 2014, 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
Remifentanil (9739)........................ II
------------------------------------------------------------------------
The company plans to initially to manufacture API quantities of the
listed controlled substances for validation purposes and FDA approval,
then to produce commercial size batches for distribution to dosage form
manufacturers upon FDA approval.
[[Page 8902]]
Dated: February 11, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-03489 Filed 2-18-15; 8:45 am]
BILLING CODE 4410-09-P
