80_FR_22638 80 FR 22561 - Importer of Controlled Substances Registration: Actavis Pharma, Inc.

80 FR 22561 - Importer of Controlled Substances Registration: Actavis Pharma, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 77 (April 22, 2015)

Page Range22561-22562
FR Document2015-09349

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.

Federal Register, Volume 80 Issue 77 (Wednesday, April 22, 2015) 
[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Pages 22561-22562]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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

Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 22561 Controlled substance Schedule (DEA), 28 CFR 0.100(b). Authority to material are not appropriate. 72 FR 3417 exercise all necessary functions with (January 25, 2007). Cocaine (9041) ............................. II respect to the promulgation and SUPPLEMENTARY INFORMATION: The Codeine (9050) ............................. II implementation of 21 CFR part 1301, Attorney General has delegated his Dihydrocodeine (9120) ................. II incident to the registration of authority under the Controlled Oxycodone (9143) ........................ II manufacturers, distributors, dispensers, Hydromorphone (9150) ................ II Substances Act to the Administrator of Diphenoxylate (9170) ................... II importers, and exporters of controlled the Drug Enforcement Administration Ecgonine (9180) ........................... II substances (other than final orders in (DEA), 28 CFR 0.100(b). Authority to Hydrocodone (9193) ..................... II connection with suspension, denial, or exercise all necessary functions with Meperidine (9230) ........................ II revocation of registration) has been respect to the promulgation and Methadone (9250) ........................ II redelegated to the Deputy Assistant implementation of 21 CFR part 1301, Morphine (9300) ........................... II Administrator of the DEA Office of incident to the registration of Thebaine (9333) ........................... II Diversion Control (‘‘Deputy Assistant manufacturers, distributors, dispensers, Oxymorphone (9652) ................... II Administrator’’) pursuant to section 7 of importers, and exporters of controlled Alfentanil (9737) ........................... II 28 CFR part 0, appendix to subpart R. substances (other than final orders in Remifentanil (9739) ...................... II In accordance with 21 CFR Sufentanil (9740) .......................... II connection with suspension, denial, or Fentanyl (9801) ............................ II 1301.34(a), this is notice that on revocation of registration) has been February 9, 2015, Stepan Company, redelegated to the Deputy Assistant The company plans to manufacture Natural Products Dept., 100 W. Hunter Administrator of the DEA Office of the listed controlled substances in bulk Avenue, Maywood, New Jersey 07607 Diversion Control (‘‘Deputy Assistant for sale to its customers. applied to be registered as an importer Administrator’’) pursuant to section 7 of of coca leaves (9040), a basic class of 28 CFR part 0, appendix to subpart R. Dated: April 14, 2015. controlled substance listed in schedule In accordance with 21 CFR Joseph T. Rannazzisi, II. 1301.34(a), this is notice that on Deputy Assistant Administrator. The company plans to import the November 17, 2014, Siegfried USA, [FR Doc. 2015–09326 Filed 4–21–15; 8:45 am] listed controlled substance to LLC, 33 Industrial Park Road, BILLING CODE 4410–09–P manufacture bulk controlled substances Pennsville, New Jersey 08070 applied to for distribution to its customers. be registered as an importer of the Dated: April 14, 2015. following basic classes of controlled DEPARTMENT OF JUSTICE Joseph T. Rannazzisi, substances: Drug Enforcement Administration Deputy Assistant Administrator. Controlled substance Schedule [FR Doc. 2015–09342 Filed 4–21–15; 8:45 am] [Docket No. DEA–392] BILLING CODE 4410–09–P Opium, raw (9600) ....................... II Poppy Straw Concentrate (9670) II Importer of Controlled Substances Application: Stepan Company The company plans to import the DEPARTMENT OF JUSTICE ACTION: Notice of application. listed controlled substances to bulk Drug Enforcement Administration manufacture API’s for distribution to its DATES: Registered bulk manufacturers of [Docket No. DEA–392] customer. the affected basic class, and applicants Dated: April 14, 2015. therefore, may file written comments on Importer of Controlled Substances Joseph T. Rannazzisi, or objections to the issuance of the Application: Siegfried USA, LLC Deputy Assistant Administrator. proposed registration in accordance [FR Doc. 2015–09336 Filed 4–21–15; 8:45 am] ACTION: Notice of application. with 21 CFR 1301.34(a) on or before BILLING CODE 4410–09–P May 22, 2015. Such persons may also DATES: Registered bulk manufacturers of file a written request for a hearing on the affected basic classes, and the application pursuant to 21 CFR applicants therefore, may file written DEPARTMENT OF JUSTICE 1301.43 on or before May 22, 2015. comments on or objections to the ADDRESSES: Written comments should issuance of the proposed registration in Drug Enforcement Administration be sent to: Drug Enforcement accordance with 21 CFR 1301.34(a) on [Docket No. DEA–392] Administration, Attention: DEA Federal or before May 22, 2015. Such persons Register Representative/ODXL, 8701 may also file a written request for a Importer of Controlled Substances Morrissette Drive, Springfield, Virginia hearing on the application pursuant to Registration: Actavis Pharma, Inc. 22152. Request for hearings should be 21 CFR 1301.43 on or before May 22, sent to: Drug Enforcement ACTION: Notice of registration. 2015. Administration, Attention: Hearing ADDRESSES: Written comments should SUMMARY: Actavis Pharma, Inc. applied Clerk/LJ, 8701 Morrissette Drive, be sent to: Drug Enforcement to be registered as an importer of certain Springfield, Virginia 22152. Comments Administration, Attention: DEA Federal basic classes of controlled substances. and request for hearings on applications Register Representative/ODXL, 8701 The Drug Enforcement Administration asabaliauskas on DSK5VPTVN1PROD with NOTICES to import narcotic raw material are not Morrissette Drive, Springfield, Virginia (DEA) grants Actavis Pharma, Inc., appropriate. 72 FR 3417 (January 25, 22152. Request for hearings should be registration as an importer of those 2007). sent to: Drug Enforcement controlled substances. SUPPLEMENTARY INFORMATION: The Administration, Attention: Hearing SUPPLEMENTARY INFORMATION: By notice Attorney General has delegated his Clerk/LJ, 8701 Morrissette Drive, dated May 28, 2014, and published in authority under the Controlled Springfield, Virginia 22152. Comments the Federal Register on June 4, 2014, FR Substances Act to the Administrator of and requests for hearings on 79 32315, Actavis Pharma, Inc., 2455 of the Drug Enforcement Administration applications to import narcotic raw Wardlow Road, Corona, California VerDate Sep<11>2014 18:00 Apr 21, 2015 Jkt 235001 PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 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 simultaneously with the Attorney locations in Pennsylvania, Maryland, an importer of certain basic classes of General and the Federal Trade and Virginia, including: the discharge of controlled substances. No comments or Commission disclosing changes in its pollutants in storm water without a objections were submitted for this membership. The notifications were permit in violation of CWA Section 301, notice. filed for the purpose of extending the 33 U.S.C. 1311; failure to timely submit The DEA has considered the factors in Act’s provisions limiting the recovery of the information required to obtain 21 U.S.C. 823, 952(a) and 958(a) and antitrust plaintiffs to actual damages coverage under an applicable permit for determined that the registration of under specified circumstances. the discharge of storm water associated Actavis Pharma, Inc. to import the basic Specifically, Bill & Melinda Gates with its construction activities in classes of controlled substances is Foundation, Seattle, WA; Microsoft, violation of CWA Section 308, 33 U.S.C. consistent with the public interest and Redmond, WA; PARCC, Inc., with United States obligations under 1318; and for failure to comply with the Washington, DC; State of Michigan international treaties, conventions, or Department of Education, Lansing, MI; conditions of permits (including various protocols in effect on May 1, 1971. The and University of Wisconsin, Madison, state general permits) issued pursuant to DEA investigated the company’s WI, have been added as parties to this CWA Section 402, 33 U.S.C. 1342. The maintenance of effective controls venture. Consent Decree obligates the Defendants against diversion by inspecting and Also, Jenzabar, Cambridge, MA; to pay a $455,000 civil penalty and testing the company’s physical security SungKyunKwan University, Gyeonggi- requires the Defendants to implement a systems, verifying the company’s do, REPUBLIC OF KOREA; and company-wide Stormwater Compliance compliance with state and local laws, McGraw-Hill CTB, Nashville, TN, have Program that includes strict training, and reviewing the company’s withdrawn as parties to this venture. management, and reporting background and history. No other changes have been made in requirements to improve future Therefore, pursuant to 21 U.S.C. either the membership or planned compliance. 952(a) and 958(a), and in accordance activity of the group research project. The publication of this notice opens with 21 CFR 1301.34, the above-named Membership in this group research company is granted registration as an a period for public comment on the project remains open, and IMS Global importer of the basic classes of intends to file additional written proposed Consent Decree. Comments controlled substances: notifications disclosing all changes in should be addressed to the Assistant membership. Attorney General, Environment and Controlled substance Schedule On April 7, 2000, IMS Global filed its Natural Resources Division, and should original notification pursuant to Section refer to United States v. Allan Myers, Amphetamine (1100) .................... II 6(a) of the Act. The Department of Inc., et al, Civil Action No. 15–1992, D.J. Methylphenidate (1724) ................ II Justice published a notice in the Federal Ref. No. 90–5–1–1–09042. All Oxycodone (9143) ........................ II Hydromorphone (9150) ................ II Register pursuant to Section 6(b) of the comments must be submitted no later Act on September 13, 2000 (65 FR than thirty (30) days after the The company plans to import the 55283). publication date of this notice. listed controlled substances for The last notification was filed with Comments may be submitted either by analytical testing and clinical trials. the Department on December 8, 2014. A email or by mail: The import of the above listed basic notice was published in the Federal classes of controlled substances will be Register pursuant to Section 6(b) of the To submit Send them to: granted only for analytical testing and Act on January 5, 2015 (80 FR 259). comments: clinical trials. This authorization does Patricia A. Brink, not extend to the import of a finished By email ....... pubcomment-ees.enrd@ Director of Civil Enforcement, Antitrust usdoj.gov. FDA approved or non-approved dosage Division. By mail ......... Assistant Attorney General, form for commercial distribution in the [FR Doc. 2015–09316 Filed 4–21–15; 8:45 am] U.S. DOJ—ENRD, P.O. United States. Box 7611, Washington, DC BILLING CODE P Dated: April 14, 2015. 20044–7611. Joseph T. Rannazzisi, Deputy Assistant Administrator. DEPARTMENT OF JUSTICE During the public comment period, [FR Doc. 2015–09349 Filed 4–21–15; 8:45 am] the proposed Consent Decree and Notice of Lodging of Proposed Stipulated Judgment and Permanent BILLING CODE 4410–09P Consent Decree Under the Clean Water Injunction may be examined and Act downloaded at this Justice Department DEPARTMENT OF JUSTICE On April 16, 2015, the Department of Web site: http://www.usdoj.gov/enrd/ Justice filed a Complaint and Consent_Decrees.html. We will provide Antitrust Division simultaneously lodged a proposed a paper copy of the proposed Consent Notice Pursuant to the National Consent Decree with the United States Decree and Stipulated Judgment and Cooperative Research and Production District Court for the Eastern District of Permanent Injunction upon written Act of 1993—IMS Global Learning Pennsylvania in the lawsuit entitled request and payment of reproduction United States, et al, v. Allan Myers, Inc., asabaliauskas on DSK5VPTVN1PROD with NOTICES Consortium, Inc. costs. Please mail your request and et al, Civil Action No. 15–1992. payment to: Consent Decree Library, Notice is hereby given that, on March This action involves the claim of the U.S. DOJ—ENRD, P.O. Box 7611, 24, 2015, pursuant to Section 6(a) of the United States for civil penalties and Washington, DC 20044–7611. National Cooperative Research and injunctive relief brought pursuant to Production Act of 1993, 15 U.S.C. 4301 Section 309(b) and (d) of the Clean Please enclose a check or money order et seq. (‘‘the Act’’), IMS Global Learning Water Act (‘‘CWA’’), 33 U.S.C. 1319(b) for $13.75 (25 cents per page Consortium, Inc. (‘‘IMS Global’’) has and (d), against Defendants for filed written notifications violations of the CWA at fourteen VerDate Sep<11>2014 18:00 Apr 21, 2015 Jkt 235001 PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 E:\FR\FM\22APN1.SGM 22APN1


Document Created: 2015-12-16 08:28:26
Document Modified: 2015-12-16 08:28:26
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of registration.
FR Citation80 FR 22561 
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