Importer of Controlled Substances; Notice of Registration; Mylan Pharmaceuticals, Inc., 1888-1889 [2014-00206]

Download as PDF 1888 Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Notices 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: December 23, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2014–00202 Filed 1–9–14; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Cody Laboratories, Inc. Pursuant to 21 CFR 1301.34(a), this is notice that on June 12, 2013, Cody Laboratories Inc., 601 Yellowstone Avenue, Cody, Wyoming 82414–9321, made application by renewal to the Drug Enforcement Administration (DEA) for registration as an importer of the following basic classes of controlled substances: 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 (ODW), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than February 10, 2014. 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. Dated: December 31, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic class of controlled substance 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 (ODW), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than February 10, 2014. 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. Schedule mstockstill on DSK4VPTVN1PROD with NOTICES Phenylacetone (8501) .................. Poppy Straw Concentrate (9670) Tapentadol (9780) ........................ BILLING CODE 4410–09–P II II II DEPARTMENT OF JUSTICE [FR Doc. 2014–00197 Filed 1–9–14; 8:45 am] Drug Enforcement Administration Drug Dated: December 31, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. BILLING CODE 4410–09–P The company plans to import narcotic raw materials for manufacturing and further distribution to its customers. The company is registered with DEA as a manufacturer of several controlled substances that are manufactured from poppy straw concentrate. The company plans to import an intermediate form of Tapentadol (9780) to bulk manufacture Tapentadol for distribution to its customers. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417, (January 25, 2007) Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled VerDate Mar<15>2010 19:00 Jan 09, 2014 Jkt 232001 [FR Doc. 2014–00203 Filed 1–9–14; 8:45 am] Importer of Controlled Substances; Notice of Application; Fresenius Kabi USA, LLC. Pursuant to 21 CFR 1301.34(a), this is notice that on November 2, 2012, Fresenius Kabi USA, LLC., 3159 Stanley Road, Grand Island, New York 14072, made application to the Drug Enforcement Administration (DEA) for registration as an importer of Remifentanil (9739), a basic class of controlled substance listed in schedule II. The company plans to import this controlled substance for product development and preparation of stability batches. PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration; Mylan Pharmaceuticals, Inc. By Notice dated June 18, 2013, and published in the Federal Register on July 1, 2013, 78 FR 39336, Mylan Pharmaceuticals, Inc., 3711 Collins Ferry Road, Morgantown, West Virginia 26505, made application to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances: E:\FR\FM\10JAN1.SGM 10JAN1 1889 Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Notices Drug Schedule Amphetamine (1100) .................... Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Pentobarbital (2270) ..................... Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Levorphanol (9220) ...................... Morphine (9300) ........................... Oxymorphone (9652) ................... Remifentanil (9739) ...................... Fentanyl (9801) ............................ II II II II II II II II II II II II Drug 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. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and 952(a) and determined that the registration of Mylan Pharmaceuticals, 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. DEA has investigated Mylan Pharmaceuticals, Inc., to ensure that the company’s registration is consistent with the public interest. The investigation has included inspection and testing of the company’s physical security systems, verification of the company’s compliance with state and local laws, and a review of 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 listed. Dated: December 31, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2014–00206 Filed 1–9–14; 8:45 am] Schedule Methyphendiate (1724) ................ Levorphanol (9220) ...................... Noroxymorphone (9668) .............. Tapentadol (9780) ........................ II II II II The company plans to import the listed controlled substances for clinical trials, analytical research and testing. 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. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and 952(a), and determined that the registration of Fisher Clinical Services, 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. DEA has investigated Fisher Clinical Services, Inc., to ensure that the company’s registration is consistent with the public interest. The investigation has included inspection and testing of the company’s physical security systems, verification of the company’s compliance with state and local laws, and a review of 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 listed. Dated: December 31, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE mstockstill on DSK4VPTVN1PROD with NOTICES on September 25, 2013, 78 FR 59064, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown, Pennsylvania 18106, 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 Enforcement Administration [FR Doc. 2014–00179 Filed 1–9–14; 8:45 am] Importer of Controlled Substances; Notice of Registration; Fisher Clinical Services, Inc. BILLING CODE 4410–09–P By Notice dated September 16, 2013, and published in the Federal Register VerDate Mar<15>2010 16:40 Jan 09, 2014 Jkt 232001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Cayman Chemical Company Pursuant to 21 CFR 1301.33(a), this is notice that on June 27, 2013, Cayman Chemical Company, 1180 East Ellsworth Road, Ann Arbor, Michigan 48108, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances: Drug Cathinone (1235) .......................... Methcathinone (1237) .................. 4-Methyl-N-methylcathinone (1248). N-Ethylamphetamine (1475) ........ N,N-Dimethylamphetamine (1480) Aminorex (1585) ........................... 4-Methylaminorex (cis isomer) (1590). Gamma Hydroxybutyric Acid (2010). JWH–250 (6250) .......................... SR–18 also known as RCS–8 (7008). XLR11 (7011) ............................... JWH–019 (7019) .......................... AKB48 (7048) ............................... JWH–081 (7081) .......................... SR–19 also known as RCS–4 (7104). 1-Pentyl-3-(1-naphthoyl)indole (7118). JWH–122 (7122) .......................... UR–144 (7144) ............................. 1-Butyl-3-(1-naphthoyl)indole (7173). 1-[2-(4-Morpholinyl)ethyl]-3- ......... (1-naphthoyl) indole (7200) .......... AM–2201 (7201) ........................... JWH–203 (7203) .......................... Alpha-ethyltryptamine (7249) ....... 5-(1,1-Dimethylheptyl)-2-[(1R,3S)3-hydroxycyclohexyl]-phenol (7297). 5-(1,1-Dimethyloctyl)-2-[(1R,3S)3-hydroxycyclohexyl]-phenol (7298). Lysergic acid diethylamide (7315) 2,5-Dimethoxy-4-(n)propylthiophenethylamine (7348). Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... Mescaline (7381) .......................... 2C–T–2 (7385) ............................. 3,4,5-Trimethoxyamphetamine (7390). 4-Bromo-2,5dimethoxyamphetamine (7391). 4-Bromo-2,5dimethoxyphenethylamine (7392). 4-Methyl-2,5dimethoxyamphetamine (7395). E:\FR\FM\10JAN1.SGM 10JAN1 Schedule I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I

Agencies

[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Notices]
[Pages 1888-1889]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00206]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


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

    By Notice dated June 18, 2013, and published in the Federal 
Register on July 1, 2013, 78 FR 39336, Mylan Pharmaceuticals, Inc., 
3711 Collins Ferry Road, Morgantown, West Virginia 26505, made 
application to the Drug Enforcement Administration (DEA) to be 
registered as an importer of the following basic classes of controlled 
substances:

[[Page 1889]]



 
------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Amphetamine (1100).........................  II
Lisdexamfetamine (1205)....................  II
Methylphenidate (1724).....................  II
Pentobarbital (2270).......................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II
Levorphanol (9220).........................  II
Morphine (9300)............................  II
Oxymorphone (9652).........................  II
Remifentanil (9739)........................  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.
    No comments or objections have been received. DEA has considered 
the factors in 21 U.S.C. 823(a) and 952(a) and determined that the 
registration of Mylan Pharmaceuticals, 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. DEA has 
investigated Mylan Pharmaceuticals, Inc., to ensure that the company's 
registration is consistent with the public interest.
    The investigation has included inspection and testing of the 
company's physical security systems, verification of the company's 
compliance with state and local laws, and a review of 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 listed.

    Dated: December 31, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2014-00206 Filed 1-9-14; 8:45 am]
BILLING CODE 4410-09-P
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