Importer of Controlled Substances; Notice of Application; Mylan Technologies, Inc., 6131-6132 [2013-01835]

Download as PDF 6131 srobinson on DSK4SPTVN1PROD with Federal Register / Vol. 78, No. 19 / Tuesday, January 29, 2013 / Notices (‘‘the ’949 patent’’); RE 41,922 (‘‘the ’922 patent’’); 7,863,533 (‘‘the ’533 patent’’); 7,789,697 (‘‘the ’697 patent’’); 7,912,501 (‘‘the ’501 patent’’); D558,757 (‘‘the D’757 patent’’); and D618,678 (‘‘the D’678 patent’’) (collectively, ‘‘the Asserted Patents’’). The complaint further alleges the existence of a domestic industry. The respondents named in the Commission’s notice of investigation are Samsung Electronics Co, Ltd. of Korea; Samsung Electronics America, Inc. of Ridgefield Park, New Jersey; and Samsung Telecommunications America, LLC of Richardson, Texas (collectively, ‘‘Samsung’’). A Commission investigative attorney (‘‘IA’’) participated in the investigation. On May 3, 2012, the ALJ issued an ID partially terminating the investigation with respect to all claims of the ’533 patent; claims 1–3, 11, 12, 15, 16 and 21–27 of the ’697 patent; and claim 3 of the ’949 patent (Order No. 17) (not reviewed by the Commission, May 3, 2012). On October 24, 2012, the ALJ issued his final ID in this investigation finding a violation of section 337 in connection with the claim of the D’678 patent; claims 1, 4–6 and 10–20 of the ’949 patent; claims 29, 30 and 33–35 of the ’922 patent; and claims 1–4 and 8 of the ’501 patent. The ALJ found no violation of section 337 in connection with the claim of the D’757 patent; claims 31 and 32 of the ’922 patent; and claims 13 and 14 of the ’697 patent. The ALJ also found that the asserted claims of the Asserted Patents were not shown to be invalid. The ALJ further found that a domestic industry in the United States exists that practices the Asserted Patents, except for the ’697 patent. On November 7, 2012, the ALJ issued his recommended determination on remedy and bonding. Apple and Samsung filed timely petitions for review of various portions of the final ID, as well as timely responses to the petitions. The IA filed only a response to the petitions for review. On December 3, 2012, Apple and Samsung filed public interest comments pursuant to Commission rule 210.50(a)(4). That same day, non-party Google filed submissions in response to the Notice of Request for Statements on the Public Interest. See 77 FR 68829–30 (Nov. 16, 2012). Having examined the record of this investigation, including the ALJ’s final ID, the petitions for review, and the responses thereto, the Commission has determined to review the final ID in its entirety. The Commission does not seek further briefing at this time. Rather, the Commission remands the investigation VerDate Mar<15>2010 16:47 Jan 28, 2013 Jkt 229001 to the ALJ with respect to certain issues related to the ’922 patent and the ’501 patent, as set forth in the accompanying Remand Order. In light of the remand, the ALJ shall set a new target date within thirty days of this notice consistent with the Remand Order. The current target date for this investigation is March 27, 2013. Briefing, if any, on remanded and reviewed issues, and on remedy, bonding, and the public interest will follow Commission consideration of the remand ID. The authority for the Commission’s determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in sections 210.42–46 of the Commission’s Rules of Practice and Procedure (19 CFR 210.42–46). By order of the Commission. Issued: January 23, 2013. Lisa R. Barton, Acting Secretary to the Commission. [FR Doc. 2013–01771 Filed 1–28–13; 8:45 am] BILLING CODE 7020–02–P the federal trustees), to complete two restoration projects selected by the trustees valued at approximately $800,000.00, and to reimburse the trustees for any further monitoring or corrective action obligations after completion of construction of the restoration project. The Settlement includes a covenant not to sue under Section 107(a) of CERCLA. The publication of this notice opens a period for public comment on the consent decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to United States and State of Texas v. GB Biosciences Corp., et al., D.J. Ref. No. 90–5–1–1–09071. 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: By e-mail By mail ..... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act On January 22, 2013, the Department of Justice lodged a proposed Consent Decree in the United States District Court for the Southern District of Texas in the lawsuit entitled, United States and State of Texas v. GB Biosciences Corp., et al., Civil Action No. 4:13–CV– 00151. In this action the United States, on behalf of the National Oceanic and Atmospheric Administration (‘‘NOAA’’) and the U.S. Department of Interior (‘‘DOI’’), as federal trustees, together with the State of Texas, seeks natural resource damages pursuant to Section 107(a) of the Comprehensive Environmental Response, Compensation, and Liability Act (‘‘CERCLA’’), in connection with the Greens Bayou Site located in Houston, Texas (the ‘‘Site’’). The United States and the State have negotiated a consent decree with GB Biosciences Corp., ISK Magnetics, Inc., and Occidental Chemical Corp. (collectively ‘‘Settlors’’) to resolve the CERCLA claims, as well as the state law claims. Under the Consent Decree, the Settlors agree to reimburse the United States and the State for natural resource damage assessment costs ($31,060.00 to PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 Send them to: pubcommentees.enrd@usdoj.gov. Assistant Attorney General U.S. DOJ—ENRD P.O. Box 7611, Washington, D.C. 20044–7611. During the public comment period, the consent decree may be examined and downloaded at this Justice Department Web site: http:// www.usdoj.gov/enrd/ Consent_Decrees.html. We will provide a paper copy of the consent decree 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 $54.75 (25 cents per page reproduction cost) payable to the United States Treasury. For a paper copy without the exhibits, the cost is $17.50. Maureen Katz, Assistant Section Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc. 2013–01761 Filed 1–28–13; 8:45 am] BILLING CODE 4410–15–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Mylan Technologies, Inc. Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this is notice that on December 7, 2012, Mylan E:\FR\FM\29JAN1.SGM 29JAN1 6132 Federal Register / Vol. 78, No. 19 / Tuesday, January 29, 2013 / Notices Dated: January 15, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Technologies, Inc., 110 Lake Street, Saint Albans, Vermont 05478, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances: Drug BILLING CODE 4410–09–P Schedule Methylphenidate (1724) ................ Fentanyl (9801) ............................ srobinson on DSK4SPTVN1PROD with [FR Doc. 2013–01835 Filed 1–28–13; 8:45 am] II II Drug Enforcement Administration The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company’s own domestically-manufactured FDF. This analysis is required to allow the company to export domesticallymanufactured FDF to foreign markets. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances listed in schedule II, which falls under the authority of section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)) may, in the circumstances set forth in 21 U.S.C. 958(i), file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47. 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 February 28, 2013. This procedure is to be conducted simultaneously with, and independent of, the procedures described in 21 CFR § 1301.34(b), (c), (d), (e), and (f). As noted in a previous notice published in the Federal Register on September 23, 1975, 40 FR 43745–46, all applicants for registration to import a basic class of any controlled substances in schedules I or II are, and will continue to be, required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied. VerDate Mar<15>2010 16:47 Jan 28, 2013 Jkt 229001 DEPARTMENT OF JUSTICE Importer of Controlled Substances; Notice of Application; Alkermes Gainesville, LLC Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this is notice that on October 11, 2012, Alkermes Gainesville, LLC., 1300 Gould Drive, Gainesville, Georgia 30504, made application to the Drug Enforcement Administration (DEA) for registration as an importer of noroxymorphone (9668), a basic class of controlled substance listed in schedule II. The company plans to import the listed substance for analytical research and testing. The import of the above listed basic class of controlled substance 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. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances listed in schedules I or II, which fall under the authority of section 1002(a)(2)(B) of the Act 21 U.S.C. 952 (a)(2)(B) may, in the circumstances set forth in 21 U.S.C. 958(i), file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47. 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 February 28, 2013. This procedure is to be conducted simultaneously with, and independent of, the procedures described in 21 CFR 1301.34(b), (c), (d), (e), and (f). As noted in a previous notice published in the Federal Register on September 23, 1975, 40 FR 43745–46, all applicants for registration to import a basic class of any controlled substance in schedules I PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 or II are, and will continue to be, required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied. Dated: January 16, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–01837 Filed 1–28–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Petition Requirements and Investigative Data Collection: Trade Act of 1974, as Amended ACTION: Notice. The Department of Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored information collection request (ICR) revision titled, ‘‘Petition Requirements and Investigative Data Collection: Trade Act of 1974, as Amended,’’ to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.). DATES: Submit comments on or before February 28, 2013. ADDRESSES: A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained from the RegInfo.gov Web site, http://www.reginfo.gov/ public/do/PRAMain, on the day following publication of this notice or by contacting Michel Smyth by telephone at 202–693–4129 (this is not a toll-free number) or sending an email to DOL_PRA_PUBLIC@dol.gov. Submit comments about this request to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL–ETA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503, Fax: 202–395–6881 (this is not a toll-free number), email: OIRA_submission@omb.eop.gov. SUMMARY: E:\FR\FM\29JAN1.SGM 29JAN1

Agencies

[Federal Register Volume 78, Number 19 (Tuesday, January 29, 2013)]
[Notices]
[Pages 6131-6132]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01835]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Application; Mylan 
Technologies, Inc.

    Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this 
is notice that on December 7, 2012, Mylan

[[Page 6132]]

Technologies, Inc., 110 Lake Street, Saint Albans, Vermont 05478, made 
application by renewal to the Drug Enforcement Administration (DEA) to 
be registered as an importer of the following basic classes of 
controlled substances:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Methylphenidate (1724).....................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances in 
finished dosage form (FDF) from foreign sources for analytical testing 
and clinical trials in which the foreign FDF will be compared to the 
company's own domestically-manufactured FDF. This analysis is required 
to allow the company to export domestically-manufactured FDF to foreign 
markets.
    Any bulk manufacturer who is presently, or is applying to be, 
registered with DEA to manufacture such basic classes of controlled 
substances listed in schedule II, which falls under the authority of 
section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)) may, in the 
circumstances set forth in 21 U.S.C. 958(i), file comments or 
objections to the issuance of the proposed registration and may, at the 
same time, file a written request for a hearing on such application 
pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 
1316.47.
    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 February 28, 2013.
    This procedure is to be conducted simultaneously with, and 
independent of, the procedures described in 21 CFR Sec.  1301.34(b), 
(c), (d), (e), and (f). As noted in a previous notice published in the 
Federal Register on September 23, 1975, 40 FR 43745-46, all applicants 
for registration to import a basic class of any controlled substances 
in schedules I or II are, and will continue to be, required to 
demonstrate to the Deputy Assistant Administrator, Office of Diversion 
Control, Drug Enforcement Administration, that the requirements for 
such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 
21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied.

    Dated: January 15, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-01835 Filed 1-28-13; 8:45 am]
BILLING CODE 4410-09-P