Importer of Controlled Substances, Notice of Application, Myoderm, 1887-1888 [2014-00202]

Download as PDF 1887 Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Notices at least 68 underground storage tanks (‘‘USTs’’) containing gasoline and waste oil throughout Suffolk County. The complaint seeks civil penalties and injunctive relief for Suffolk’s violations of Resource Conservation and Recovery Act regulations governing USTs, set forth at 40 CFR Part 280. The complaint also alleges violation of federally enforceable New York State hazardous waste regulations set forth at 6 N.Y.C.R.R. § 372.2(a)(2) governing disposal of spent fluorescent lamps. The Consent Judgment requires Suffolk: (a) to pay a civil penalty of $500,000; (b) to fund a Supplemental Environmental Project in the amount of $1,500,000 to acquire an interest in land, and to manage such land and any associated ecological resources, into perpetuity, to protect and/or enhance groundwater; (c) to maintain compliance with RCRA requirements for all of its underground storage tanks and with NYS regulations in its handling of spent fluorescent lamps; and (d) to submit regular reports to EPA for four years to demonstrate that they are in compliance. The publication of this notice opens a period for public comment on the Consent Judgment. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to United States v. County of Suffolk, D.J. Ref. No. 90–7–1–09883. 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: Send them to: By e-mail ...... pubcomment-ees.enrd@ usdoj.gov. Assistant Attorney General, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044–7611. mstockstill on DSK4VPTVN1PROD with NOTICES By mail ......... During the public comment period, the Consent Judgment may be examined and downloaded at this Justice Department Web site: https:// www.usdoj.gov/enrd/Consent_ Decrees.html. We will provide a paper copy of the Consent Judgment 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 $15.75 (25 cents per page VerDate Mar<15>2010 16:40 Jan 09, 2014 Jkt 232001 reproduction cost) payable to the United States Treasury. DEPARTMENT OF JUSTICE Maureen Katz, Assistant Section Chief, Environmental Enforcement Section, Environment and Natural Resources Division. Importer of Controlled Substances, Notice of Application, Myoderm [FR Doc. 2014–00182 Filed 1–9–14; 8:45 am] BILLING CODE 4410–15–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Siegfried USA, LLC. Pursuant to 21 CFR 1301.34 (a), this is notice that on November 19, 2013, Siegfried USA, LLC., 33 Industrial Park Road, Pennsville, New Jersey 08070, made application by renewal to the Drug Enforcement Administration (DEA) for registration as an importer of the basic classes of controlled substances: Drug Schedule Opium, raw (9600) ....................... Poppy Straw Concentrate (9670) II II The company plans to import the listed controlled substances to bulk manufacture API’S for distribution to its customer. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (2007) As noted in a previous notice published in the Federal Register on September 23, 1975, 40 FR 43745, all applicants for registration to import a basic classes of any controlled substances 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: December 23, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2014–00201 Filed 1–9–14; 8:45 am] BILLING CODE 4410–09–P PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 Drug Enforcement Administration Pursuant to 21 CFR 1301.34 (a), this is notice that on October 28, 2013, Myoderm, 48 East Main Street, Norristown, Pennsylvania 19401, made application by renewal to the Drug Enforcement Administration (DEA) for registration as an importer of the following basic classes of controlled substances: Drug Amphetamine (1100) .................... Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Pentobarbital (2270) ..................... Nabilone (7379) ............................ Codeine (9050) ............................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Levomethorphan (9210) ............... Meperidine (9230) ........................ Methadone (9250) ........................ Methadone intermediate (9254) ... Morphine (9300) ........................... Oxymorphone (9652) ................... Fentanyl (9801) ............................ Schedule II II II II II II II II II II II II II II II II The company plans to import the listed controlled substances in finished dosage form for clinical trials, and research. 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. 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 (ODW), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than February 10, 2014. E:\FR\FM\10JAN1.SGM 10JAN1 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

Agencies

[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Notices]
[Pages 1887-1888]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00202]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances, Notice of Application, Myoderm

    Pursuant to 21 CFR 1301.34 (a), this is notice that on October 28, 
2013, Myoderm, 48 East Main Street, Norristown, Pennsylvania 19401, 
made application by renewal to the Drug Enforcement Administration 
(DEA) for registration as an importer of the following basic classes of 
controlled substances:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Amphetamine (1100).........................  II
Lisdexamfetamine (1205)....................  II
Methylphenidate (1724).....................  II
Pentobarbital (2270).......................  II
Nabilone (7379)............................  II
Codeine (9050).............................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II
Levomethorphan (9210)......................  II
Meperidine (9230)..........................  II
Methadone (9250)...........................  II
Methadone intermediate (9254)..............  II
Morphine (9300)............................  II
Oxymorphone (9652).........................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances in 
finished dosage form for clinical trials, and research.
    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.
    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 (ODW), 8701 
Morrissette Drive, Springfield, Virginia 22152; and must be filed no 
later than February 10, 2014.

[[Page 1888]]

    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
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