Manufacturer of Controlled Substances; Notice of Registration; Apertus Pharmaceuticals, LLC, 60145-60146 [2012-24194]

Download as PDF 60145 Federal Register / Vol. 77, No. 191 / Tuesday, October 2, 2012 / Notices DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Sigma Aldrich Research Biochemicals, Inc. Pursuant to 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on August 2, 2012, Sigma Aldrich Research Biochemicals, Inc., 1– 3 Strathmore Road, Natick, Massachusetts 01760–2447, made application by letter to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances: Drug Schedule 4-Methyl-2,5dimethoxyamphetamine (7395). Dimethyltryptamine (7435) ........... I I Dated: September 20, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; AMPAC Fine Chemicals, LLC wreier-aviles on DSK5TPTVN1PROD with NOTICES DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances ISP, Inc.; Notice of Registration By Notice dated June 18, 2012, and published in the Federal Register on June 26, 2012, 77 FR 38087, ISP, Inc., 238 South Main Street, Assonet, Massachusetts 02702, 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: Schedule 2,5-Dimethoxyamphetamine (7396). Amphetamine (1100) .................... Phenylacetone (8501) .................. BILLING CODE 4410–09–P Pursuant to 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on July 10, 2012, AMPAC Fine Chemicals, LLC., Highway 50 and Hazel Avenue, Building 05001, Rancho Cordova, California 95670, made application by letter to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of Tapentadol (9780), a basic class of Jkt 229001 BILLING CODE 4410–09–P Drug [FR Doc. 2012–24186 Filed 10–1–12; 8:45 am] 15:04 Oct 01, 2012 Dated: September 20, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2012–24189 Filed 10–1–12; 8:45 am] The company plans to manufacture reference standards. 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 December 3, 2012. VerDate Mar<15>2010 controlled substance listed in schedule II. The company plans to manufacture the listed controlled substance for distribution to its customers. Any other such applicant, and any person who is presently registered with DEA to manufacture such substance, 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 December 3, 2012. I II II The company plans to manufacture bulk API, for distribution to its customers. The bulk 2,5Dimethoxyamphetamine will be used for conversion into non-controlled substances. 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 ISP, Inc., to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated ISP, Inc., to ensure that the company’s registration is consistent with the public interest. PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 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 classes of controlled substances listed. Dated: September 25, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2012–24193 Filed 10–1–12; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration; Apertus Pharmaceuticals, LLC By Notice dated June 4, 2012, and published in the Federal Register on June 12, 2012, 77 FR 35058, Apertus Pharmaceuticals, LLC., 331 Consort Drive, St Louis, Missouri 63011, made application to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances: Drug Alfentanil (9737) ........................... Remifentanil (9739) ...................... Sufentanil (9740) .......................... Fentanyl (9801) ............................ Schedule II II II II The company plans to manufacture small quantities of the listed controlled substances to make reference standards for distribution to their customers. 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 Apertus Pharmaceuticals, LLC., to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Apertus Pharmaceuticals, 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 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, and in accordance with 21 CFR 1301.33, E:\FR\FM\02OCN1.SGM 02OCN1 60146 Federal Register / Vol. 77, No. 191 / Tuesday, October 2, 2012 / Notices the above named company is granted registration as a bulk manufacturer of the basic classes of controlled substances listed. NATIONAL TRANSPORTATION SAFETY BOARD SES Performance Review Board Dated: September 25, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [NRC–2012–0226] AGENCY: National Transportation Safety Board. ACTION: [FR Doc. 2012–24194 Filed 10–1–12; 8:45 am] Notice. Notice is hereby given of the appointment of members of the National Transportation Safety Board, Performance Review Board (PRB). SUMMARY: BILLING CODE 4410–09–P FOR FURTHER INFORMATION CONTACT: NATIONAL LABOR RELATIONS BOARD Sunshine Act Meetings TIME AND DATES: NUCLEAR REGULATORY COMMISSION All meetings are held at 2:30 p.m. Emily T. Carroll, Chief, Human Resources Division, Office of Administration, National Transportation Safety Board, 490 L’Enfant Plaza SW., Washington, DC 20594–0001, (202) 314– 6233. Tuesday, October 2; Wednesday, October 3; Thursday, October 4; Tuesday, October 9; Wednesday, October 10; Thursday, October 11; Tuesday, October 16; Wednesday, October 17; Thursday, October 18; Tuesday, October 23; Wednesday, October 24; Thursday, October 25; Tuesday, October 30; Wednesday, October 31. SUPPLEMENTARY INFORMATION: Board Agenda Room, No. 11820, 1099 14th St. NW., Washington DC 20570. The Honorable Christopher A. Hart, Vice Chairman, National Transportation Safety Board; PRB Chair The Honorable Earl F. Weener, Member, National Transportation Safety Board David K. Tochen, General Counsel, National Transportation Safety Board Florence Carr, Deputy Managing Director, Federal Maritime Commission Dr. John Cavolowsky, Director, Airspace Systems Program Office, Aeronautics Research Mission Directorate, National Aeronautics and Space Administration David L. Mayer, Managing Director, National Transportation Safety Board (substitute only for Mr. Tochen’s rating review) Sarah Bonilla, Deputy Chief Human Capital Officer, Department of Energy (Alternate) Jerold Gidner, Deputy Director, Office of Strategic Employee and Organizational Development, Department of the Interior (Alternate) Section 4314(c)(1) through (5) of Title 5, United States Code requires each agency to establish, in accordance with regulations prescribed by the Office of Personnel Management, one or more SES Performance Review Boards. The board reviews and evaluates the initial appraisal of a senior executive’s performance by the supervisor and considers recommendations to the appointing authority regarding the performance of the senior executive. The following have been designated as members of the Performance Review Board of the National Transportation Safety Board: Background Pursuant to Section 189a. (2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (the Commission or NRC) is publishing this regular biweekly notice. The Act requires the Commission publish notice of any amendments issued, or proposed to be issued and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person. This biweekly notice includes all notices of amendments issued, or proposed to be issued from September 6, 2012, to September 19, 2012. The last biweekly notice was published on September 14, 2012 (77 FR 56877). Dated: September 28, 2012. Lester A. Heltzer, Executive Secretary. Dated: September 26, 2012. Candi Bing, Federal Register Coordinator. [FR Doc. 2012–24399 Filed 9–28–12; 4:15 pm] [FR Doc. 2012–24168 Filed 10–1–12; 8:45 am] You may access information and comment submissions related to this document, which the NRC possesses and are publicly available, by searching on https://www.regulations.gov under Docket ID NRC–2012–0226. You may submit comments by any of the following methods: • Federal rulemaking Web site: Go to https://www.regulations.gov and search for Docket ID NRC–2012–0226. Address questions about NRC dockets to Carol Gallagher; telephone: 301–492–3668; email: Carol.Gallagher@nrc.gov. • Mail comments to: Cindy Bladey, Chief, Rules, Announcements, and Directives Branch (RADB), Office of Administration, Mail Stop: TWB–05– B01M, U.S. Nuclear Regulatory Commission, Washington, DC 20555– 0001. • Fax comments to: RADB at 301– 492–3446. For additional direction on accessing information and submitting comments, see ‘‘Accessing Information and Submitting Comments’’ in the SUPPLEMENTARY INFORMATION section of this document. BILLING CODE 7545–01–P BILLING CODE P SUPPLEMENTARY INFORMATION: PLACE: STATUS: Closed. Pursuant to 102.139(a) of the Board’s Rules and Regulations, the Board or a panel thereof will consider ‘‘the issuance of a subpoena, the Board’s participation in a civil action or proceeding or an arbitration, or the initiation, conduct, or disposition * * * of particular representation or unfair labor practice proceedings under section 8, 9, or 10 of the [National Labor Relations] Act, or any court proceedings collateral or ancillary thereto.’’ See also 5 U.S.C. 552b(c)(10). MATTERS TO BE CONSIDERED: wreier-aviles on DSK5TPTVN1PROD with NOTICES Biweekly Notice: Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations CONTACT PERSON FOR MORE INFORMATION: Lester A. Heltzer, Executive Secretary, (202) 273–1067. VerDate Mar<15>2010 15:04 Oct 01, 2012 Jkt 229001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 ADDRESSES: E:\FR\FM\02OCN1.SGM 02OCN1

Agencies

[Federal Register Volume 77, Number 191 (Tuesday, October 2, 2012)]
[Notices]
[Pages 60145-60146]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24194]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Registration; 
Apertus Pharmaceuticals, LLC

    By Notice dated June 4, 2012, and published in the Federal Register 
on June 12, 2012, 77 FR 35058, Apertus Pharmaceuticals, LLC., 331 
Consort Drive, St Louis, Missouri 63011, made application to the Drug 
Enforcement Administration (DEA) to be registered as a bulk 
manufacturer of the following basic classes of controlled substances:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Alfentanil (9737)..........................  II
Remifentanil (9739)........................  II
Sufentanil (9740)..........................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to manufacture small quantities of the listed 
controlled substances to make reference standards for distribution to 
their customers.
    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 Apertus Pharmaceuticals, LLC., to manufacture the listed basic 
classes of controlled substances is consistent with the public interest 
at this time.
    DEA has investigated Apertus Pharmaceuticals, 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 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, and in accordance with 21 CFR 
1301.33,

[[Page 60146]]

the above named company is granted registration as a bulk manufacturer 
of the basic classes of controlled substances listed.

    Dated: September 25, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2012-24194 Filed 10-1-12; 8:45 am]
BILLING CODE 4410-09-P

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