Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc., 3980 [2015-01310]
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3980
Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Notices
Controlled substance
Schedule
Methylphenidate (1724) ................
Levorphanol (9220) ......................
Noroxymorphone (9668) ..............
Tapentadol (9780) ........................
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.
Controlled substance
Dated: January 9, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
Amphetamine (1100) ....................
Methylphenidate (1724) ................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Methadone (9250) ........................
Morphine (9300) ...........................
Fentanyl (9801) ............................
[FR Doc. 2015–01309 Filed 1–23–15; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Mylan Pharmaceuticals,
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 February 25, 2015. Such
persons may also file a written request
for a hearing on the application
pursuant to 21 CFR 1301.43 on or before
February 25, 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
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DATES:
VerDate Sep<11>2014
18:48 Jan 23, 2015
Jkt 235001
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 pt. 0, subpt. R, App.
In accordance with 21 CFR
1301.34(a), this is notice that on October
6, 2014, Mylan Pharmaceuticals, Inc.,
781 Chestnut Ridge Road, Morgantown,
West Virginia 26505, applied to be
registered as an importer of the
following basic classes of controlled
substances:
Schedule
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: January 9, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
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. Comments
and request for hearings on applications
to import narcotic raw material are not
appropriate. 72 FR 3417 (January 27,
2007).
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 pt. 0, subpt. R, App.
In accordance with 21 CFR
1301.34(a), this is notice that on August
26, 2014, Noramco, Inc., 500 Swedes
Landing Road, Wilmington, Delaware
19801–4417, applied to be registered as
an importer of the following basic
classes of controlled substances:
SUPPLEMENTARY INFORMATION:
[FR Doc. 2015–01310 Filed 1–23–15; 8:45 am]
Controlled substance
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Phenylacetone (8501) ..................
Opium, raw (9600) .......................
Poppy Straw Concentrate (9670)
Tapentadol (9780) ........................
Schedule
II
II
II
II
[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
or before February 25, 2015. Such
persons may also file a written request
for a hearing on the application
pursuant to 21 CFR 1301.43 on or before
February 25, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
DATES:
PO 00000
Frm 00041
Fmt 4703
Sfmt 9990
The company plans to import raw
Opium (9600) and Poppy Straw
concentrate (9670) to bulk manufacture
other controlled substances for
distribution to its customers. The
company plans to import an
intermediate form of tapentadol (9780)
to bulk manufacture tapentadol (9780)
for distribution to its customers. The
company plans to import Phenylacetone
(8501) in bulk for the manufacture of a
controlled substance.
Dated: January 9, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–01311 Filed 1–23–15; 8:45 am]
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E:\FR\FM\26JAN1.SGM
26JAN1
]]>Agencies
[Federal Register Volume 80, Number 16 (Monday, January 26, 2015)]
[Notices]
[Page 3980]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01310]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Mylan
Pharmaceuticals, Inc.
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
1301.34(a) on or before February 25, 2015. Such persons may also file a
written request for a hearing on the application pursuant to 21 CFR
1301.43 on or before February 25, 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 pt. 0, subpt. R, App.
In accordance with 21 CFR 1301.34(a), this is notice that on
October 6, 2014, Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Road,
Morgantown, West Virginia 26505, applied to be registered as an
importer of the following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Amphetamine (1100)......................... II
Methylphenidate (1724)..................... II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Methadone (9250)........................... II
Morphine (9300)............................ II
Fentanyl (9801)............................ 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 domestically-manufactured FDF to foreign
markets.
Dated: January 9, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-01310 Filed 1-23-15; 8:45 am]
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