Importer of Controlled Substances; Notice of Registration; Mylan Pharmaceuticals Inc., 12621 [2012-4994]
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Federal Register / Vol. 77, No. 41 / Thursday, March 1, 2012 / Notices
a registration under this Section to a
bulk manufacturer of a controlled
substance in schedule I or II, and prior
to issuing a regulation under 21 U.S.C.
952(a)(2) authorizing the importation of
such a substance, provide
manufacturers holding registrations for
the bulk manufacture of the substance
an opportunity for a hearing.
Therefore, in accordance with 21 CFR
1301.34(a), this is notice that on
December 30, 2011, Mylan
Pharmaceuticals, Inc., 781 Chestnut
Ridge Road, Morgantown, West Virginia
26505, made application by letter to the
Drug Enforcement Administration
(DEA) to be registered as an importer of
the following basic classes of controlled
substances:
Drug
Schedule
mstockstill on DSK4VPTVN1PROD with NOTICES
Amphetamine (1100) ....................
Methadone (9250) ........................
Morphine (9300) ...........................
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.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic classes of controlled
substances may file comments or
objections to the issuance of the
proposed registration and may, at the
same time, file a written request for a
hearing on such application pursuant to
21 CFR 1301.43, and in such form as
prescribed by 21 CFR 1316.47.
Any such written comments or
objections should be addressed, in
quintuplicate, to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than April 2, 2012.
This procedure is to be conducted
simultaneously with, and independent
of, the procedures described in 21 CFR
1301.34(b), (c), (d), (e), and (f). As noted
in a previous notice published in the
Federal Register on September 23, 1975,
40 FR 43745–46, all applicants for
registration to import a basic class of
any controlled substance in schedule I
or II are, and will continue to be,
required to demonstrate to the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, that the requirements
VerDate Mar<15>2010
17:25 Feb 29, 2012
Jkt 226001
for such registration pursuant to 21
U.S.C. 958(a); 21 U.S.C. 823(a); and 21
CFR 1301.34(b), (c), (d), (e), and (f) are
satisfied.
Dated: February 23, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
12621
and 958(a), and in accordance with 21
CFR 1301.34, the above named company
is granted registration as an importer of
the basic classes of controlled
substances listed.
[FR Doc. 2012–4992 Filed 2–29–12; 8:45 am]
Dated: February 23, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
BILLING CODE 4410–09–P
[FR Doc. 2012–4994 Filed 2–29–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; Mylan
Pharmaceuticals Inc.
By Notice dated December 22, 2011,
and published in the Federal Register
on December 29, 2011, 76 FR 81978,
Mylan Pharmaceuticals, Inc., 781
Chestnut Ridge Road, Morgantown,
West Virginia 26505, made application
by renewal to the Drug Enforcement
Administration (DEA) to be registered as
an importer of the following basic
classes of controlled substances:
Drug
Schedule
Methylphenidate (1724) ................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Fentanyl (9801) ............................
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.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and 952(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. DEA has investigated
Mylan Pharmaceuticals, Inc. to ensure
that the company’s registration is
consistent with the public interest. The
investigation has included inspection
and testing of the company’s physical
security systems, verification of the
company’s compliance with state and
local laws, and a review of the
company’s background and history.
Therefore, pursuant to 21 U.S.C. 952(a)
PO 00000
Frm 00069
Fmt 4703
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DEPARTMENT OF JUSTICE
Parole Commission
Sunshine Act Meeting
1:30 p.m., Thursday,
March 8, 2012.
PLACE: U.S. Parole Commission, 90 K
Street NE., 3rd Floor, Washington, DC.
STATUS: Closed.
MATTERS TO BE CONSIDERED:
Consideration of two original
jurisdiction cases pursuant to 28 CFR
2.27.
TIME AND DATE:
CONTACT PERSON FOR MORE INFORMATION:
Patricia W. Moore, Staff Assistant to the
Chairman, U.S. Parole Commission, 90
K Street NE., 3rd Floor, Washington, DC
20530, (202) 346–7001.
Dated: February 27, 2012.
Rockne Chickinell,
General Counsel, U.S. Parole Commission.
[FR Doc. 2012–5183 Filed 2–28–12; 4:15 pm]
BILLING CODE 4410–31–P
MISSISSIPPI RIVER COMMISSION
Sunshine Act Meetings
Agency Holding the Meetings:
Mississippi River Commission.
AGENCY:
Time and Date: 9 a.m., March 26,
2012.
Place: On board MISSISSIPPI V at
River Park, Tiptonville, TN.
Status: Open to the public.
Matters To Be Considered: (1)
Summary report by President of the
Commission on national and regional
issues affecting the U.S. Army Corps of
Engineers and Commission programs
and projects on the Mississippi River
and its tributaries; (2) District
Commander’s overview of current
project issues within the Memphis
District; and (3) Presentations by local
organizations and members of the
public giving views or comments on any
issue affecting the programs or projects
of the Commission and the Corps of
Engineers.
DATES:
E:\FR\FM\01MRN1.SGM
01MRN1
]]>Agencies
[Federal Register Volume 77, Number 41 (Thursday, March 1, 2012)]
[Notices]
[Page 12621]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4994]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Registration; Mylan
Pharmaceuticals Inc.
By Notice dated December 22, 2011, and published in the Federal
Register on December 29, 2011, 76 FR 81978, Mylan Pharmaceuticals,
Inc., 781 Chestnut Ridge Road, Morgantown, West Virginia 26505, made
application by renewal to the Drug Enforcement Administration (DEA) to
be registered as an importer of the following basic classes of
controlled substances:
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Methylphenidate (1724)..................... II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... 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.
No comments or objections have been received. DEA has considered
the factors in 21 U.S.C. 823(a) and 952(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. DEA has
investigated Mylan Pharmaceuticals, Inc. to ensure that the company's
registration is consistent with the public interest. The investigation
has included inspection and testing of the company's physical security
systems, verification of the company's compliance with state and local
laws, and a review of 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 basic classes of controlled substances listed.
Dated: February 23, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2012-4994 Filed 2-29-12; 8:45 am]
BILLING CODE 4410-09-P
