Importer of Controlled Substances; Notice of Application, 81978-81979 [2011-33402]
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81978
Federal Register / Vol. 76, No. 250 / Thursday, December 29, 2011 / Notices
Acquirer(s), and any other potential
Acquirer. Defendants and the trustee shall
furnish any additional information requested
within fifteen (15) calendar days of the
receipt of the request, unless the parties shall
otherwise agree.
C. Within thirty (30) calendar days after
receipt of the notice or within twenty (20)
calendar days after the United States has
been provided the additional information
requested from defendants, the proposed
Acquirer(s), any third party, and the trustee,
whichever is later, the United States shall
provide written notice to defendants and the
trustee, if there is one, stating whether or not
it objects to the proposed divestiture. If the
United States provides written notice that it
does not object, the divestiture may be
consummated, subject only to defendants’
limited right to object to the sale under
Section VII.B of this Final Judgment. Absent
written notice that the United States does not
object to the proposed Acquirer(s) or upon
objection by the United States, a divestiture
proposed under Section V or Section VII
shall not be consummated. Upon objection
by defendants under Section VII.B, a
divestiture proposed under Section VII shall
not be consummated unless approved by the
Court.
wreier-aviles on DSK3TPTVN1PROD with NOTICES
IX. Financing
Defendants shall not finance all or any part
of any purchase made pursuant to this Final
Judgment.
X. Compliance Inspection
A. For the purpose of determining or
securing compliance with this Final
Judgment, or determining whether the Final
Judgment should be modified or vacated, and
subject to any legally recognized privilege,
duly authorized representatives of the United
States Department of Justice, including
consultants and other persons retained by the
United States, shall, upon written request of
a duly authorized representative of the
Assistant Attorney General in charge of the
Antitrust Division, and on reasonable notice
to defendants, be permitted:
1. access during defendants’ office hours to
inspect and copy, or at the option of the
United States, to require defendants to
provide hard copies or electronic copies of,
all books, ledgers, accounts, records, data,
and documents in the possession, custody, or
control of defendants, relating to any matters
contained in this Final Judgment; and
2. to interview, either informally or on the
record, defendants’ officers, employees, or
agents, who may have their individual
counsel present, regarding such matters. The
interviews shall be subject to the reasonable
convenience of the interviewee and without
restraint or interference by defendants.
B. Upon written request of a duly
authorized representative of the Assistant
Attorney General in charge of the Antitrust
Division, defendants shall submit written
reports or responses to written
interrogatories, under oath if requested,
relating to any of the matters contained in
this Final Judgment as may be requested.
C. No information or documents obtained
by the means provided in this section shall
be divulged by the United States to any
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person other than an authorized
representative of the executive branch of the
United States, except in the course of legal
proceedings to which the United States is a
party (including grand jury proceedings), or
for the purpose of securing compliance with
this Final Judgment, or as otherwise required
by law.
D. If, at the time information or documents
are furnished by defendants to the United
States, defendants represent and identify in
writing the material in any such information
or documents to which a claim of protection
may be asserted under Rule 26(c)(1)(G) of the
Federal Rules of Civil Procedure, and
defendants mark each pertinent page of such
material, ‘‘Subject to claim of protection
under Rule 26(c)(1)(G) of the Federal Rules
of Civil Procedure,’’ then the United States
shall give defendants ten (10) calendar days
notice prior to divulging such material in any
legal proceeding (other than a grand jury
proceeding).
XI. No Reacquisition
Defendants may not reacquire any part of
the Divestiture Assets or any other equity
interest in Direct Edge during the term of this
Final Judgment.
XII. Retention of Jurisdiction
This Court retains jurisdiction to enable
any party to this Final Judgment to apply to
this Court at any time for such further orders
and directions as may be necessary or
appropriate to carry out or construe this Final
Judgment, to modify or terminate any of its
provisions, to enforce compliance, and to
punish any violations of its provisions.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application
Pursuant to 21 U.S.C. 958(i), the
Attorney General shall, prior to issuing
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 October
5, 2011, 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
Methylphenidate (1724) ................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Fentanyl (9801) ............................
Schedule
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
XIII. Expiration of Final Judgment
compared to the company’s own
domestically-manufactured FDF. This
Unless extended by this Court, this Final
Judgment shall expire ten (10) years from the analysis is required to allow the
company to export domesticallydate of its entry.
manufactured FDF to foreign markets.
XIV. Public Interest Determination
Any bulk manufacturer who is
Entry of this Final Judgment is in the
presently, or is applying to be,
public interest. The parties have complied
registered with DEA to manufacture
with the requirements of the Antitrust
such basic classes of controlled
Procedures and Penalties Act, 15 U.S.C. § 16, substances may file comments or
including making copies available to the
objections to the issuance of the
public of this Final Judgment, the
proposed registration and may, at the
Competitive Impact Statement, and any
same time, file a written request for a
comments thereon and the United States’s
hearing on such application pursuant to
responses to comments. Based upon the
21 CFR 1301.43, and in such form as
record before the Court, which includes the
prescribed by 21 CFR 1316.47.
Competitive Impact Statement and any
Any such written comments or
comments and response to comments filed
objections should be addressed, in
with the Court, entry of this Final Judgment
quintuplicate, to the Drug Enforcement
is in the public interest.
Administration, Office of Diversion
DATED:
llllllllllllllll Control, Federal Register Representative
Court approval subject to the Antitrust
(ODL), 8701 Morrissette Drive,
Procedures and Penalties Act, 15 U.S.C.
Springfield, Virginia 22152; and must be
§ 16.
filed no later than January 30, 2012.
lllllllllllllllllllll
This procedure is to be conducted
United States District Judge
simultaneously with, and independent
[FR Doc. 2011–33413 Filed 12–28–11; 8:45 am]
of, the procedures described in 21 CFR
1301.34(b), (c), (d), (e), and (f). As noted
BILLING CODE 4410–11–P
in a previous notice published in the
Federal Register on September 23, 1975,
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Federal Register / Vol. 76, No. 250 / Thursday, December 29, 2011 / Notices
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
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: December 22, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
States. The company is aware of the
requirement to obtain a DEA registration
as an exporter to conduct this activity.
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 February 27, 2012.
Dated: December 20, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2011–33402 Filed 12–28–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
81979
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. 823(a),
and in accordance with 21 CFR 1301.33,
the above named company is granted
registration as a bulk manufacturer of
the basic classes of controlled
substances listed.
Dated: December 20, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2011–33400 Filed 12–28–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[FR Doc. 2011–33421 Filed 12–28–11; 8:45 am]
Manufacturer of Controlled
Substances; Notice of Registration
Drug Enforcement Administration
BILLING CODE 4410–09–P
Manufacturer of Controlled
Substances; Notice of Application
DEPARTMENT OF JUSTICE
Pursuant to § 1301.33(a), Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on October 10, 2011,
Norac Inc., 405 S. Motor Avenue, Azusa,
California 91702–3232, 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
Schedule
wreier-aviles on DSK3TPTVN1PROD with NOTICES
Gamma
Hydroxybutyric
Acid
(2010).
Tetrahydrocannabinols (7370) .....
Methamphetamine (1105) ............
Pentobarbital (2270) .....................
Nabilone (7379) ............................
I
I
II
II
II
15:12 Dec 28, 2011
Jkt 226001
Manufacturer of Controlled
Substances; Notice of Registration
By Notice dated May 25, 2011, and
published in the Federal Register on
June 3, 2011, 76 FR 32225, AMPAC Fine
Chemicals LLC., Highway 50 and Hazel
Avenue Building 05011, Rancho
Cordova, California 95670, made
application to the Drug Enforcement
Administration (DEA) as a bulk
manufacturer of the following basic
classes of controlled substances:
Drug
Schedule
Thebaine (9333) ...........................
Poppy Straw Concentrate (9670)
With regard to Gamma
Hydroxybutyric Acid (2010),
Tetrahydrocannabinols (7370), and
Methamphetamine (1105) only, the
company manufactures these controlled
substances in bulk solely for
distribution within the United States to
customers engaged in dosage-form
manufacturing.
With regard to Nabilone (7379), the
company presently manufactures a
small amount of this controlled
substance in bulk solely to conduct
manufacturing internal process
development. It is the company’s
intention that, when the manufacturing
process is refined to the point that its
Nabilone bulk product is available for
commercial use, the company will
export the controlled substance in bulk
solely to customers engaged in dosageform manufacturing outside the United
VerDate Mar<15>2010
Drug Enforcement Administration
II
II
The company is a contract
manufacturer. In reference to Poppy
Straw Concentrate the company will
manufacture Thebaine intermediates for
sale to its customers for further
manufacture. No other activity for this
drug code is authorized for registration.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and
determined that the registration of
AMPAC Fine Chemicals LLC., to
manufacture the listed basic classes of
controlled substances is consistent with
the public interest at this time. DEA has
investigated AMPAC Fine Chemicals
LLC., 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
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By Notice dated September 9, 2011,
and published in the Federal Register
on September 15, 2011, 76 FR 57080,
Chemic Laboratories, Inc., 480 Neponset
Street, Building 7, Canton,
Massachusetts 02021, made application
by renewal to the Drug Enforcement
Administration (DEA) to be registered as
a bulk manufacturer of Cocaine (9041),
a basic class of controlled substance
listed in schedule II.
The company plans to manufacture
small quantities of the above listed
controlled substance for distribution to
its customers for the purpose of
research.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and
determined that the registration of
Chemic Laboratories, to manufacture the
listed basic class of controlled substance
is consistent with the public interest at
this time. DEA has investigated Chemic
Laboratories 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. 823(a),
and in accordance with 21 CFR 1301.33,
the above named company is granted
registration as a bulk manufacturer of
the basic class of controlled substance
listed.
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]]>Agencies
[Federal Register Volume 76, Number 250 (Thursday, December 29, 2011)]
[Notices]
[Pages 81978-81979]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33402]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Application
Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to
issuing 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 October 5, 2011, 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.
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 January 30, 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,
[[Page 81979]]
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 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: December 22, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2011-33402 Filed 12-28-11; 8:45 am]
BILLING CODE 4410-09-P
