Importer of Controlled Substances Registration: Actavis Pharma, Inc., 22561-22562 [2015-09349]

Download as PDF 22561 Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices Controlled substance Schedule Cocaine (9041) ............................. Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Diphenoxylate (9170) ................... Ecgonine (9180) ........................... Hydrocodone (9193) ..................... Meperidine (9230) ........................ Methadone (9250) ........................ Morphine (9300) ........................... Thebaine (9333) ........................... Oxymorphone (9652) ................... Alfentanil (9737) ........................... Remifentanil (9739) ...................... Sufentanil (9740) .......................... Fentanyl (9801) ............................ II II II II II II II II II II II II II II II II II The company plans to manufacture the listed controlled substances in bulk for sale to its customers. Dated: April 14, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–09326 Filed 4–21–15; 8:45 am] BILLING CODE 4410–09–P Dated: April 14, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. DEPARTMENT OF JUSTICE Drug Enforcement Administration Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before May 22, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before May 22, 2015. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and request for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007). The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of of the Drug Enforcement Administration SUPPLEMENTARY INFORMATION: Jkt 235001 Opium, raw (9600) ....................... Poppy Straw Concentrate (9670) [Docket No. DEA–392] The company plans to import the listed controlled substances to bulk manufacture API’s for distribution to its customer. Importer of Controlled Substances Application: Siegfried USA, LLC Dated: April 14, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. Drug Enforcement Administration DATES: asabaliauskas on DSK5VPTVN1PROD with NOTICES Schedule DEPARTMENT OF JUSTICE Notice of application. 18:00 Apr 21, 2015 Controlled substance BILLING CODE 4410–09–P Importer of Controlled Substances Application: Stepan Company VerDate Sep<11>2014 material are not appropriate. 72 FR 3417 (January 25, 2007). SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on November 17, 2014, Siegfried USA, LLC, 33 Industrial Park Road, Pennsville, New Jersey 08070 applied to be registered as an importer of the following basic classes of controlled substances: [FR Doc. 2015–09342 Filed 4–21–15; 8:45 am] [Docket No. DEA–392] ACTION: (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on February 9, 2015, Stepan Company, Natural Products Dept., 100 W. Hunter Avenue, Maywood, New Jersey 07607 applied to be registered as an importer of coca leaves (9040), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance to manufacture bulk controlled substances for distribution to its customers. ACTION: II II [FR Doc. 2015–09336 Filed 4–21–15; 8:45 am] Notice of application. BILLING CODE 4410–09–P Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before May 22, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before May 22, 2015. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearings on applications to import narcotic raw DATES: PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration: Actavis Pharma, Inc. ACTION: Notice of registration. Actavis Pharma, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Actavis Pharma, Inc., registration as an importer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated May 28, 2014, and published in the Federal Register on June 4, 2014, FR 79 32315, Actavis Pharma, Inc., 2455 Wardlow Road, Corona, California SUMMARY: E:\FR\FM\22APN1.SGM 22APN1 22562 Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 92880–2882 applied to be registered as an importer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Actavis Pharma, 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. 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. 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: Controlled substance Schedule Amphetamine (1100) .................... Methylphenidate (1724) ................ Oxycodone (9143) ........................ Hydromorphone (9150) ................ II II II II The company plans to import the listed controlled substances for analytical testing and clinical trials. The import of the above listed basic classes of controlled substances will be granted only for analytical testing and clinical trials. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial distribution in the United States. Dated: April 14, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. DEPARTMENT OF JUSTICE asabaliauskas on DSK5VPTVN1PROD with NOTICES Antitrust Division Notice Pursuant to the National Cooperative Research and Production Act of 1993—IMS Global Learning Consortium, Inc. Notice is hereby given that, on March 24, 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’’), IMS Global Learning Consortium, Inc. (‘‘IMS Global’’) has filed written notifications Jkt 235001 locations in Pennsylvania, Maryland, and Virginia, including: the discharge of pollutants in storm water without a permit in violation of CWA Section 301, 33 U.S.C. 1311; failure to timely submit the information required to obtain coverage under an applicable permit for the discharge of storm water associated with its construction activities in violation of CWA Section 308, 33 U.S.C. 1318; and for failure to comply with the conditions of permits (including various state general permits) issued pursuant to CWA Section 402, 33 U.S.C. 1342. The Consent Decree obligates the Defendants to pay a $455,000 civil penalty and requires the Defendants to implement a company-wide Stormwater Compliance Program that includes strict training, management, and reporting requirements to improve future compliance. 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. Allan Myers, Inc., et al, Civil Action No. 15–1992, D.J. Ref. No. 90–5–1–1–09042. 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: To submit comments: Send them to: By email ....... pubcomment-ees.enrd@ usdoj.gov. Assistant Attorney General, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044–7611. By mail ......... [FR Doc. 2015–09316 Filed 4–21–15; 8:45 am] BILLING CODE P Notice of Lodging of Proposed Consent Decree Under the Clean Water Act BILLING CODE 4410–09P 18:00 Apr 21, 2015 Patricia A. Brink, Director of Civil Enforcement, Antitrust Division. DEPARTMENT OF JUSTICE [FR Doc. 2015–09349 Filed 4–21–15; 8:45 am] VerDate Sep<11>2014 simultaneously with the Attorney General and the Federal Trade Commission disclosing changes in its membership. 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, Bill & Melinda Gates Foundation, Seattle, WA; Microsoft, Redmond, WA; PARCC, Inc., Washington, DC; State of Michigan Department of Education, Lansing, MI; and University of Wisconsin, Madison, WI, have been added as parties to this venture. Also, Jenzabar, Cambridge, MA; SungKyunKwan University, Gyeonggido, REPUBLIC OF KOREA; and McGraw-Hill CTB, Nashville, TN, have withdrawn as parties to this venture. No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and IMS Global intends to file additional written notifications disclosing all changes in membership. On April 7, 2000, IMS Global 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 September 13, 2000 (65 FR 55283). The last notification was filed with the Department on December 8, 2014. A notice was published in the Federal Register pursuant to Section 6(b) of the Act on January 5, 2015 (80 FR 259). On April 16, 2015, the Department of Justice filed a Complaint and simultaneously lodged a proposed Consent Decree with the United States District Court for the Eastern District of Pennsylvania in the lawsuit entitled United States, et al, v. Allan Myers, Inc., et al, Civil Action No. 15–1992. This action involves the claim of the United States for civil penalties and injunctive relief brought pursuant to Section 309(b) and (d) of the Clean Water Act (‘‘CWA’’), 33 U.S.C. 1319(b) and (d), against Defendants for violations of the CWA at fourteen PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 During the public comment period, the proposed Consent Decree and Stipulated Judgment and Permanent Injunction may be examined and downloaded at this Justice Department Web site: https://www.usdoj.gov/enrd/ Consent_Decrees.html. We will provide a paper copy of the proposed Consent Decree and Stipulated Judgment and Permanent Injunction upon written request and payment of reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044–7611. Please enclose a check or money order for $13.75 (25 cents per page E:\FR\FM\22APN1.SGM 22APN1

Agencies

[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Pages 22561-22562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09349]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Registration: Actavis Pharma, 
Inc.

ACTION: Notice of registration.

-----------------------------------------------------------------------

SUMMARY: Actavis Pharma, Inc. applied to be registered as an importer 
of certain basic classes of controlled substances. The Drug Enforcement 
Administration (DEA) grants Actavis Pharma, Inc., registration as an 
importer of those controlled substances.

SUPPLEMENTARY INFORMATION: By notice dated May 28, 2014, and published 
in the Federal Register on June 4, 2014, FR 79 32315, Actavis Pharma, 
Inc., 2455 Wardlow Road, Corona, California

[[Page 22562]]

92880-2882 applied to be registered as an importer of certain basic 
classes of controlled substances. No comments or objections were 
submitted for this notice.
    The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 
958(a) and determined that the registration of Actavis Pharma, 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. 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. 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:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Amphetamine (1100).........................  II
Methylphenidate (1724).....................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
analytical testing and clinical trials.
    The import of the above listed basic classes of controlled 
substances will be granted only for analytical testing and clinical 
trials. This authorization does not extend to the import of a finished 
FDA approved or non-approved dosage form for commercial distribution in 
the United States.

    Dated: April 14, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-09349 Filed 4-21-15; 8:45 am]
 BILLING CODE 4410-09P

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