80 FR 37302 - Manufacturer of Controlled Substances Registration: Insys Therapeutics, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 125 (June 30, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 125 (June 30, 2015)
| Page Range | 37302-37302 | |
| FR Document | 2015-16030 |
[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)] [Notices] [Page 37302] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-16030] ----------------------------------------------------------------------- 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
![37302 Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices
validation of legitimate actors. These DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE
standards will be voluntary and
auditable. Drug Enforcement Administration Notice of Lodging of Proposed
Consent Decree Under the Clean Air
Patricia A. Brink, [Docket No. DEA–392]
Act
Director of Civil Enforcement, Antitrust
Manufacturer of Controlled On June 24, 2015, the Department of
Division.
Substances Registration: Insys Justice lodged a proposed Consent
[FR Doc. 2015–16026 Filed 6–29–15; 8:45 am]
Therapeutics, Inc. Decree with the United States District
BILLING CODE P
ACTION: Notice of registration. Court for the District of New Mexico in
the lawsuit entitled United States v.
DEPARTMENT OF JUSTICE SUMMARY: Insys Therapeutics, Inc. Arizona Public Service Company, et al.,
applied to be registered as a Civil Case No. 1:15–cv–00537 (D. N.M.).
Antitrust Division manufacturer of certain basic classes of In this civil enforcement action under
controlled substances. The Drug the federal Clean Air Act (‘‘Act’’), the
Notice Pursuant to the National Enforcement Administration (DEA) United States alleges that Arizona
Cooperative Research and Production grants Insys Therapeutics, Inc. Public Service Company, El Paso
Act of 1993—American Society of registration as a manufacturer of those Electric Company, Public Service
Mechanical Engineers controlled substances. Company of New Mexico, Salt River
SUPPLEMENTARY INFORMATION: By notice Project Agricultural Improvement and
Notice is hereby given that, on May dated February 5, 2015, and published Power District, Tucson Electric Power
20, 2015, pursuant to section 6(a) of the in the Federal Register on February 11, Company, and Southern California
National Cooperative Research and 2015, 80 FR 7635, Insys Therapeutics, Edison Company (collectively the
Production Act of 1993, 15 U.S.C. 4301 Inc., 2700 Oakmont, Round Rock, Texas ‘‘Defendants’’), failed to comply with
et seq. (‘‘the Act’’), the American 78665 applied to be registered as a certain requirements of the Act intended
Society of Mechanical Engineers manufacturer of certain basic classes of to protect air quality at the Four Corners
(‘‘ASME’’) has filed written notifications controlled substances. No comments or Power Plant located near Shiprock, New
simultaneously with the Attorney objections were submitted to this notice. Mexico. The complaint seeks injunctive
General and the Federal Trade The DEA has considered the factors in relief and civil penalties for violations
Commission disclosing additions or 21 U.S.C. 823(a) and determined that of the Clean Air Act’s Prevention of
changes to its standards development the registration of Insys Therapeutics, Significant Deterioration (‘‘PSD’’)
activities. The notifications were filed Inc. to manufacture the basic classes of provisions, 42 U.S.C. 7470–92, and
for the purpose of extending the Act’s controlled substances is consistent with various Clean Air Act implementing
provisions limiting the recovery of the public interest and with United regulations. The complaint alleges that
States obligations under international Defendants failed to obtain appropriate
antitrust plaintiffs to actual damages
treaties, conventions, or protocols in permits and failed to install and operate
under specified circumstances.
effect on May 1, 1971. The DEA required pollution control devices to
Specifically, since August 16, 2013 reduce emissions of sulfur dioxide
investigated the company’s maintenance
ASME has published four new (‘‘SO2’’) and/or nitrogen oxides (‘‘NOX’’)
of effective controls against diversion by
standards and initiated one new at the Four Corners Power Plant.
inspecting and testing the company’s
standard activity, and withdrawn three physical security systems, verifying the The proposed Consent Decree would
published standards within the general company’s compliance with state and resolve violations for certain provisions
nature and scope of ASME’s standards local laws, and reviewing the company’s of the Act at the Four Corners Power
development activities, as specified in background and history. Plant, and would require the Defendants
its original notification. More detail Therefore, pursuant to 21 U.S.C. to reduce harmful SO2, NOX, and
regarding these changes can be found at 823(a), and in accordance with 21 CFR particulate matter emissions through the
www.asme.org. 1301.33, the above-named company is installation and operation of pollution
On September 15, 2004, ASME filed granted registration as a bulk controls. The Defendants will also
its original notification pursuant to manufacturer of the basic classes of spend $6,700,000 to fund environmental
section 6(a) of the Act. The Department controlled substances listed: mitigation projects that will further
of Justice published a notice in the reduce emissions and benefit
Controlled substance Schedule communities adversely affected by the
Federal Register pursuant to section
6(b) of the Act on October 13, 2004 (69 pollution from the plant, and pay a civil
Marihuana (7360) ......................... I
FR 60895). penalty of $1,500,000.
Tetrahydrocannabinols (7370) ..... I
The publication of this notice opens
The last notification was filed with
The company plans to manufacture a period for public comment on the
the Department on November 6, 2014. A
bulk synthetic active pharmaceutical proposed Consent Decree. Comments
notice was published in the Federal
ingredients (APIs) for product should be addressed to the Assistant
Register pursuant to section 6(b) of the Attorney General, Environment and
Act on December 16, 2014 (79 FR development and distribution to its
Natural Resources Division, and should
asabaliauskas on DSK5VPTVN1PROD with NOTICES
74767). customers. No other activity for this
drug code is authorized for this refer to United States v. Arizona Public
Patricia A. Brink, registration. Service Company, et al., Civil Case No.
Director of Civil Enforcement, Antitrust
1:15–cv–00537 (D. N.M.), D.J. Ref. No.
Dated: June 24, 2015.
Division. 90–5–2–1–10300. All comments must be
Joseph T. Rannazzisi, submitted no later than thirty (30) days
[FR Doc. 2015–16025 Filed 6–29–15; 8:45 am] Deputy Assistant Administrator. after the publication date of this notice.
BILLING CODE P [FR Doc. 2015–16030 Filed 6–29–15; 8:45 am] Comments may be submitted either by
BILLING CODE 4410–09–P email or by mail:
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Document Created: 2018-02-22 11:16:39
Document Modified: 2018-02-22 11:16:39
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of registration. | |
| FR Citation | 80 FR 37302 |
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