Importer of Controlled Substances; Notice of Application, 21660 [2010-9564]

Download as PDF 21660 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Notices Finding of No Significant Impact are available by request at the above address. Electronic copies are available from the USIBWC homepage at https:// www.ibwc.gov/Organization/ Environmental/ EIS_EA_Public_Comment.html. Dated: April 19, 2010. Pamela L. Barber, Attorney/Advisor. [FR Doc. 2010–9426 Filed 4–23–10; 8:45 am] BILLING CODE 7010–01–P DEPARTMENT OF JUSTICE sroberts on DSKD5P82C1PROD with NOTICES Notice of Lodging of Consent Decree Under the Residential Lead-Based Paint Hazard Reduction Act Notice is hereby given that on April 19, 2010 a proposed Consent Decree in United States v. Kogan Realty Enterprises, LLC, Civil Action No. 1:10– cv–249 was lodged with the United States District Court for the Southern District of Ohio. The consent decree settles claims against the owner of 128 housing units in twenty-two separate properties located in or near Cincinnati, Ohio. The claims were brought on behalf of the Environmental Protection Agency (‘‘U.S. EPA’’) and the Department of Housing and Urban Development (‘‘HUD’’) under the Residential Lead-Based Paint Hazard Reduction Act, 42 U.S.C. 4851 et seq. (‘‘Lead Hazard Reduction Act’’). The United States alleged in the complaint that the Defendant failed to make one or more of the disclosures or to complete one or more of the disclosure activities required by the Lead Hazard Reduction Act. Under the Consent Decree, the Defendant will certify that it is complying with residential lead paint notification requirements. The Defendant will submit a plan for window replacement work and will replace all windows known to or believed to contain lead-based paint in all residential properties owned by Defendant that are not certified leadbased paint free. In addition, Defendant will abate lead-based paint hazards on friction and impact surfaces, stabilize other lead-based paint hazards, and pay an administrative penalty of $5,000. The Department of Justice will receive for a period of thirty (30) days from the date of this publication comments relating to the Proposed Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and either e-mailed to pubcomment-ees.enrd@usdoj.gov or VerDate Nov<24>2008 16:56 Apr 23, 2010 Jkt 220001 mailed to U.S. Department of Justice, P.O. Box 7611, Washington, DC 20044– 7611, and should refer to United States v. Kogan Realty Enterprises, LLC, D.J. Ref. #90–5–1–1–09574. The Proposed Consent Decree may be examined at the Department of Housing and Urban Development, Office of General Counsel, 451 7th St. NW, Room 9262, Washington, DC 20410; at the office of the United States Attorney for the Southern District of Ohio, 303 Marconi Blvd., Suite 200, Columbus, Ohio 43215 (Attn. Assistant United States Attorney Andrew M. Malek); and at U.S. EPA Region 5, 77 W. Jackson Blvd., Chicago, IL 60604. During the public comment period, the Consent Decree may also be examined on the following Department of Justice Web site, to https://www.usdoj.gov/enrd/ Consent_Decrees.html. A copy of the Consent Decree may also be obtained by mail from the Consent Decree Library, P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044–7611 or by faxing or e-mailing a request to Tonia Fleetwood (tonia.fleetwood@usdoj.gov), fax no. (202) 514–0097, phone confirmation number (202) 514–1547. In requesting a copy from the Consent Decree Library, please enclose a check in the amount of $8.75 (25 cents per page reproduction cost) payable to the U.S. Treasury or, if by e-mail or fax, forward a check in that amount to the Consent Decree Library at the stated address. Maureen Katz, Assistant Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc. 2010–9524 Filed 4–23–10; 8:45 am] BILLING CODE 4410–15–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to issuing a registration under this Section to a bulk manufacturer of a controlled substance in schedule I or II, and prior to issuing a regulation under 21 U.S.C. 952(a)(2) authorizing the importation of such a substance, provide manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing. Therefore, in accordance with 21 CFR 1301.34(a), this is notice that on November 10, 2009, Mylan Pharmaceuticals Inc., 781 Chestnut Ridge Road, Morgantown, West Virginia PO 00000 Frm 00084 Fmt 4703 Sfmt 9990 26505, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the basic classes of controlled substances listed in schedule II: Drug Methylphenidate (1724) ................ Fentanyl (9801) ............................ Oxycodone (9143) ........................ Hydromorphone (9150) ................ Schedule II II II 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 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 may 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 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 May 26, 2010. 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 schedule 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: April 20, 2010. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2010–9564 Filed 4–23–10; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\26APN1.SGM 26APN1

Agencies

[Federal Register Volume 75, Number 79 (Monday, April 26, 2010)]
[Notices]
[Page 21660]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9564]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Application

    Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to 
issuing a registration under this Section to a bulk manufacturer of a 
controlled substance in schedule I or II, and prior to issuing a 
regulation under 21 U.S.C. 952(a)(2) authorizing the importation of 
such a substance, provide manufacturers holding registrations for the 
bulk manufacture of the substance an opportunity for a hearing.
    Therefore, in accordance with 21 CFR 1301.34(a), this is notice 
that on November 10, 2009, Mylan Pharmaceuticals Inc., 781 Chestnut 
Ridge Road, Morgantown, West Virginia 26505, made application by 
renewal to the Drug Enforcement Administration (DEA) to be registered 
as an importer of the basic classes of controlled substances listed in 
schedule II:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Methylphenidate (1724).....................  II
Fentanyl (9801)............................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  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 may 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 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 May 26, 2010.
    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 schedule 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: April 20, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2010-9564 Filed 4-23-10; 8:45 am]
BILLING CODE 4410-09-P
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