Manufacturer of Controlled Substances Registration: Insys Therapeutics, Inc., 37302 [2015-16030]
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37302
Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices
validation of legitimate actors. These
standards will be voluntary and
auditable.
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Patricia A. Brink,
Director of Civil Enforcement, Antitrust
Division.
[Docket No. DEA–392]
Notice of Lodging of Proposed
Consent Decree Under the Clean Air
Act
Manufacturer of Controlled
Substances Registration: Insys
Therapeutics, Inc.
[FR Doc. 2015–16026 Filed 6–29–15; 8:45 am]
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ACTION:
Insys Therapeutics, Inc.
applied to be registered as a
manufacturer of certain basic classes of
controlled substances. The Drug
Enforcement Administration (DEA)
grants Insys Therapeutics, Inc.
registration as a manufacturer of those
controlled substances.
SUPPLEMENTARY INFORMATION: By notice
dated February 5, 2015, and published
in the Federal Register on February 11,
2015, 80 FR 7635, Insys Therapeutics,
Inc., 2700 Oakmont, Round Rock, Texas
78665 applied to be registered as a
manufacturer of certain basic classes of
controlled substances. No comments or
objections were submitted to this notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Insys Therapeutics,
Inc. to manufacture 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. The DEA
investigated the company’s maintenance
of effective controls against diversion by
inspecting and testing the company’s
physical security systems, verifying the
company’s compliance with state and
local laws, and reviewing 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:
SUMMARY:
DEPARTMENT OF JUSTICE
Antitrust Division
Notice Pursuant to the National
Cooperative Research and Production
Act of 1993—American Society of
Mechanical Engineers
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Notice of registration.
Notice is hereby given that, on May
20, 2015, pursuant to section 6(a) of the
National Cooperative Research and
Production Act of 1993, 15 U.S.C. 4301
et seq. (‘‘the Act’’), the American
Society of Mechanical Engineers
(‘‘ASME’’) has filed written notifications
simultaneously with the Attorney
General and the Federal Trade
Commission disclosing additions or
changes to its standards development
activities. The notifications were filed
for the purpose of extending the Act’s
provisions limiting the recovery of
antitrust plaintiffs to actual damages
under specified circumstances.
Specifically, since August 16, 2013
ASME has published four new
standards and initiated one new
standard activity, and withdrawn three
published standards within the general
nature and scope of ASME’s standards
development activities, as specified in
its original notification. More detail
regarding these changes can be found at
www.asme.org.
On September 15, 2004, ASME filed
its original notification pursuant to
section 6(a) of the Act. The Department
of Justice published a notice in the
Federal Register pursuant to section
6(b) of the Act on October 13, 2004 (69
FR 60895).
The last notification was filed with
the Department on November 6, 2014. A
notice was published in the Federal
Register pursuant to section 6(b) of the
Act on December 16, 2014 (79 FR
74767).
Patricia A. Brink,
Director of Civil Enforcement, Antitrust
Division.
Controlled substance
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
Schedule
I
I
The company plans to manufacture
bulk synthetic active pharmaceutical
ingredients (APIs) for product
development and distribution to its
customers. No other activity for this
drug code is authorized for this
registration.
[FR Doc. 2015–16025 Filed 6–29–15; 8:45 am]
Dated: June 24, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
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[FR Doc. 2015–16030 Filed 6–29–15; 8:45 am]
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On June 24, 2015, the Department of
Justice lodged a proposed Consent
Decree with the United States District
Court for the District of New Mexico in
the lawsuit entitled United States v.
Arizona Public Service Company, et al.,
Civil Case No. 1:15–cv–00537 (D. N.M.).
In this civil enforcement action under
the federal Clean Air Act (‘‘Act’’), the
United States alleges that Arizona
Public Service Company, El Paso
Electric Company, Public Service
Company of New Mexico, Salt River
Project Agricultural Improvement and
Power District, Tucson Electric Power
Company, and Southern California
Edison Company (collectively the
‘‘Defendants’’), failed to comply with
certain requirements of the Act intended
to protect air quality at the Four Corners
Power Plant located near Shiprock, New
Mexico. The complaint seeks injunctive
relief and civil penalties for violations
of the Clean Air Act’s Prevention of
Significant Deterioration (‘‘PSD’’)
provisions, 42 U.S.C. 7470–92, and
various Clean Air Act implementing
regulations. The complaint alleges that
Defendants failed to obtain appropriate
permits and failed to install and operate
required pollution control devices to
reduce emissions of sulfur dioxide
(‘‘SO2’’) and/or nitrogen oxides (‘‘NOX’’)
at the Four Corners Power Plant.
The proposed Consent Decree would
resolve violations for certain provisions
of the Act at the Four Corners Power
Plant, and would require the Defendants
to reduce harmful SO2, NOX, and
particulate matter emissions through the
installation and operation of pollution
controls. The Defendants will also
spend $6,700,000 to fund environmental
mitigation projects that will further
reduce emissions and benefit
communities adversely affected by the
pollution from the plant, and pay a civil
penalty of $1,500,000.
The publication of this notice opens
a period for public comment on the
proposed Consent Decree. Comments
should be addressed to the Assistant
Attorney General, Environment and
Natural Resources Division, and should
refer to United States v. Arizona Public
Service Company, et al., Civil Case No.
1:15–cv–00537 (D. N.M.), D.J. Ref. No.
90–5–2–1–10300. All comments must be
submitted no later than thirty (30) days
after the publication date of this notice.
Comments may be submitted either by
email or by mail:
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]]>Agencies
[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Page 37302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16030]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Manufacturer of Controlled Substances Registration: Insys
Therapeutics, Inc.
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: Insys Therapeutics, Inc. applied to be registered as a
manufacturer of certain basic classes of controlled substances. The
Drug Enforcement Administration (DEA) grants Insys Therapeutics, Inc.
registration as a manufacturer of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice dated February 5, 2015, and
published in the Federal Register on February 11, 2015, 80 FR 7635,
Insys Therapeutics, Inc., 2700 Oakmont, Round Rock, Texas 78665 applied
to be registered as a manufacturer of certain basic classes of
controlled substances. No comments or objections were submitted to this
notice.
The DEA has considered the factors in 21 U.S.C. 823(a) and
determined that the registration of Insys Therapeutics, Inc. to
manufacture 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. The DEA investigated the company's maintenance of effective
controls against diversion by inspecting and testing the company's
physical security systems, verifying the company's compliance with
state and local laws, and reviewing 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:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Marihuana (7360)........................... I
Tetrahydrocannabinols (7370)............... I
------------------------------------------------------------------------
The company plans to manufacture bulk synthetic active
pharmaceutical ingredients (APIs) for product development and
distribution to its customers. No other activity for this drug code is
authorized for this registration.
Dated: June 24, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-16030 Filed 6-29-15; 8:45 am]
BILLING CODE 4410-09-P
