Importer of Controlled Substances; Notice Of Registration; Mylan Pharmaceuticals, Inc., 30326 [2012-12382]
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Federal Register / Vol. 77, No. 99 / Tuesday, May 22, 2012 / Notices
Summary of Information Collection
DEPARTMENT OF JUSTICE
(1) Type of Information Collection:
Extension of a currently approved
collection.
(2) Title of the Form/Collection:
Notification of Change of Mailing or
Premise Address.
(3) Agency form number, if any, and
the applicable component of the
Department of Justice sponsoring the
collection: Form Number: None. Bureau
of Alcohol, Tobacco, Firearms and
Explosives.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: Not-for-profitinstitutions. Other: Business or other
for-profit.
Drug Enforcement Administration
Need for Collection
Amphetamine (1100) ....................
Methadone (9250) ........................
Morphine (9300) ...........................
Licensees and permittees whose
mailing address will change must notify
the Chief, Federal Explosives Licensing
Center, at least 10 days before the
change. The information is used by ATF
to identify correct locations of storage of
explosives licensees/permittees and
location of storage of explosive
materials for purposes of inspection, as
well as to notify permittee/licensees of
any change in regulations or laws that
may affect their business activities.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: It is estimated that 1,000
respondents will take 10 minutes to
respond via letter to the Federal
Explosives Licensing Center.
(6) An estimate of the total public
burden (in hours) associated with the
collection: There are an estimated 170
annual total burden hours associated
with this collection.
If additional information is required
contact: Jerri Murray, Department
Clearance Officer, Policy and Planning
Staff, Justice Management Division,
Department of Justice, Two Constitution
Square, Room 2E–508, 145 N Street NE.,
Washington, DC 20530.
Jerri Murray,
Department Clearance Officer, PRA, U.S.
Department of Justice.
[FR Doc. 2012–12346 Filed 5–21–12; 8:45 am]
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Importer of Controlled Substances;
Notice Of Registration; Mylan
Pharmaceuticals, Inc.
Dated: May 15, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2012–12382 Filed 5–21–12; 8:45 am]
BILLING CODE 4410–09–P
By Notice dated February 23, 2012,
and published in the Federal Register
on March 1, 2012, 77 FR 12620, 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
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) 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.
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application; Lin
Zhi International Inc.
Pursuant to § 1301.33(a), Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on April 19, 2012, Lin
Zhi International Inc., 670 Almanor
Avenue, Sunnyvale, California 94085,
made application by renewal to the
Drug Enforcement Administration
(DEA) to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
Drug
Tetrahydrocannabinols (7370) .....
3,4–
Methylenedioxymethamphetamine (7405).
Cocaine (9041) .............................
Oxycodone (9143) ........................
Hydrocodone (9193) .....................
Methadone (9250) ........................
Dextropropoxyphene, bulk (nondosage forms) (9273).
Morphine (9300) ...........................
Schedule
I
I
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances as bulk
reagents for use in drug abuse testing.
Any other such applicant, and any
person who is presently registered with
DEA to manufacture such substances,
may file comments or objections to the
issuance of the proposed registration
pursuant to 21 CFR 1301.33(a).
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 July 23, 2012.
E:\FR\FM\22MYN1.SGM
22MYN1
]]>Agencies
[Federal Register Volume 77, Number 99 (Tuesday, May 22, 2012)]
[Notices]
[Page 30326]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12382]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice Of Registration; Mylan
Pharmaceuticals, Inc.
By Notice dated February 23, 2012, and published in the Federal
Register on March 1, 2012, 77 FR 12620, 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
------------------------------------------------------------------------
Amphetamine (1100)......................... II
Methadone (9250)........................... II
Morphine (9300)............................ 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: May 15, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2012-12382 Filed 5-21-12; 8:45 am]
BILLING CODE 4410-09-P
