Importer of Controlled Substances; Notice of Application; Mylan Pharmaceuticals, Inc., 69447 [2013-27660]

Download as PDF Federal Register / Vol. 78, No. 223 / Tuesday, November 19, 2013 / Notices that Applicant’s pending application be denied. Order Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well as 28 CFR 0.100(b) and 28 CFR 0.104, I order that the application of Wheatland Pharmacy, for a DEA Certificate of Registration as a retail pharmacy, be, and it hereby is, denied. This order is effective immediately. Dated: November 8, 2013. Thomas M. Harrigan, Deputy Administrator. [FR Doc. 2013–27700 Filed 11–18–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Mylan Pharmaceuticals, Inc. Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this is notice that on October 7, 2013, 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 following basic classes of controlled substances: Drug 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 (ODW), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than December 19, 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 basic classes 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: November 12, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–27660 Filed 11–18–13; 8:45 am] BILLING CODE 4410–09–P Schedule DEPARTMENT OF JUSTICE TKELLEY on DSK3SPTVN1PROD with NOTICES Amphetamine (1100) .................... Methylphenidate (1724) ................ Oxycodone (9143) ........................ Hydromorphone (9150) ................ Methadone (9250) ........................ Morphine (9300) ........................... Fentanyl (9801) ............................ II II II II II II II Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; GE Healthcare 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 VerDate Mar<15>2010 18:20 Nov 18, 2013 Jkt 232001 Pursuant to Title 21, Code of Federal Regulations 1301.34(a), this is notice that on September 18, 2013, GE Healthcare, 3350 North Ridge Avenue, Arlington Heights, Illinois 60004–1412, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Cocaine (9041), a basic class of controlled substance listed in schedule II. The company plans to import small quantities of ioflupane, in the form of three separate analogues of Cocaine that will be used for the support and manufacture of DaTSCAN (ioflupane 1–123) injection for distribution as a radioactive diagnostic imaging agent utilized in the diagnosis of Parkinson’s disease. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic class of controlled substance PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 69447 listed in schedules I and 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 (ODW), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than December 19, 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 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: November 5, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–27661 Filed 11–18–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Federal Bureau of Investigation [OMB Number 1110–0046] Agency Information Collection Activities; Existing Collection, Comments Requested: Friction Ridge Cards: Arrest and Institution; Applicant; Personal Identification; FBI Standard Palm Print; Supplemental Finger and Palm Print 30-day Notice of Information Collection for Reinstatement. ACTION: The Department of Justice (DOJ), Federal Bureau of Investigation (FBI), Criminal Justice Information Services (CJIS) Division will be submitting the following information collection renewal to the Office of Management and Budget (OMB) for review in E:\FR\FM\19NON1.SGM 19NON1

Agencies

[Federal Register Volume 78, Number 223 (Tuesday, November 19, 2013)]
[Notices]
[Page 69447]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27660]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


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

    Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this 
is notice that on October 7, 2013, 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 following basic classes of controlled 
substances:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Amphetamine (1100).........................  II
Methylphenidate (1724).....................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Methadone (9250)...........................  II
Morphine (9300)............................  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 (ODW), 8701 
Morrissette Drive, Springfield, Virginia 22152; and must be filed no 
later than December 19, 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 basic classes 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: November 12, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-27660 Filed 11-18-13; 8:45 am]
BILLING CODE 4410-09-P