Manufacturer of Controlled Substances; Notice of Application; Mallinckrodt, LLC, 12102 [2013-03892]

Download as PDF 12102 Federal Register / Vol. 78, No. 35 / Thursday, February 21, 2013 / Notices 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 class of controlled substance 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 March 25, 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: February 8, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–03902 Filed 2–20–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration erowe on DSK2VPTVN1PROD with NOTICES Manufacturer of Controlled Substances; Notice of Application; Mallinckrodt, LLC Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on November 30, 2012, Mallinckrodt, LLC, 3600 North Second Street, St. Louis, Missouri 63147, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk VerDate Mar<15>2010 14:47 Feb 20, 2013 Jkt 229001 manufacturer of the following basic classes of controlled substances: Drug Schedule Tetrahydrocannabinols (7370) ..... Codeine-N-oxide (9053) ............... Dihydromorphine (9145) ............... Difenoxin (9168) ........................... Morphine-N-oxide (9307) ............. Normorphine (9313) ..................... Norlevorphanol (9634) .................. Amphetamine (1100) .................... Methamphetamine (1105) ............ Methylphenidate (1724) ................ Nabilone (7379) ............................ 4-Anilino-N-phenethyl-4-piperidine (8333). Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Diphenoxylate (9170) ................... Ecgonine (9180) ........................... Hydrocodone (9193) ..................... Levorphanol (9220) ...................... Meperidine (9230) ........................ Methadone (9250) ........................ Methadone intermediate (9254) ... Dextropropoxyphene, bulk (nondosage forms) (9273). Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Opium tincture (9630) .................. Opium, powdered (9639) ............. Oxymorphone (9652) ................... Noroxymorphone (9668) .............. Alfentanil (9737) ........................... Remifentanil (9739) ...................... Sufentanil (9740) .......................... Fentanyl (9801) ............................ I I I I I I I II II II II II II II II II II II II II II II II II II II II II II II II II II II II The firm plans to manufacture the listed controlled substances for internal use and for sale to other companies. Any other such applicant, and any person who is presently registered with DEA to manufacture such substances, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). 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 April 22, 2013. Dated: February 8, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–03892 Filed 2–20–13; 8:45 am] BILLING CODE 4410–09–P PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Pharmagra Labs, Inc. Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on December 3, 2012, Pharmagra Labs, Inc., 158 McLean Road, Brevard, North Carolina 28712, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of pentobarbital (2270), a basic class of controlled substance listed in schedule II. The company plans to manufacture the listed substance for analytical research and clinical trials. Any other such applicant, and any person who is presently registered with DEA to manufacture such substance, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). 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 April 22, 2013. Dated: February 8, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–03888 Filed 2–20–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Sigma Aldrich Research Biochemicals, Inc. Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on November 21, 2012, Sigma Aldrich Research Biochemicals, Inc., 1–3 Strathmore Road, Natick, Massachusetts 01760– 2447, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following classes of controlled substances: Drug Cathinone (1235) .......................... Methcathinone (1237) .................. E:\FR\FM\21FEN1.SGM 21FEN1 Schedule I I

Agencies

[Federal Register Volume 78, Number 35 (Thursday, February 21, 2013)]
[Notices]
[Page 12102]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03892]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Application; 
Mallinckrodt, LLC

    Pursuant to Sec.  1301.33(a), Title 21 of the Code of Federal 
Regulations (CFR), this is notice that on November 30, 2012, 
Mallinckrodt, LLC, 3600 North Second Street, St. Louis, Missouri 63147, 
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                               Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols (7370)...............  I
Codeine-N-oxide (9053).....................  I
Dihydromorphine (9145).....................  I
Difenoxin (9168)...........................  I
Morphine-N-oxide (9307)....................  I
Normorphine (9313).........................  I
Norlevorphanol (9634)......................  I
Amphetamine (1100).........................  II
Methamphetamine (1105).....................  II
Methylphenidate (1724).....................  II
Nabilone (7379)............................  II
4-Anilino-N-phenethyl-4-piperidine (8333)..  II
Codeine (9050).............................  II
Dihydrocodeine (9120)......................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Diphenoxylate (9170).......................  II
Ecgonine (9180)............................  II
Hydrocodone (9193).........................  II
Levorphanol (9220).........................  II
Meperidine (9230)..........................  II
Methadone (9250)...........................  II
Methadone intermediate (9254)..............  II
Dextropropoxyphene, bulk (non-dosage forms)  II
 (9273).
Morphine (9300)............................  II
Oripavine (9330)...........................  II
Thebaine (9333)............................  II
Opium tincture (9630)......................  II
Opium, powdered (9639).....................  II
Oxymorphone (9652).........................  II
Noroxymorphone (9668)......................  II
Alfentanil (9737)..........................  II
Remifentanil (9739)........................  II
Sufentanil (9740)..........................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The firm plans to manufacture the listed controlled substances for 
internal use and for sale to other companies.
    Any other such applicant, and any person who is presently 
registered with DEA to manufacture such substances, may file comments 
or objections to the issuance of the proposed registration pursuant to 
21 CFR 1301.33(a).
    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 April 22, 2013.

    Dated: February 8, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-03892 Filed 2-20-13; 8:45 am]
BILLING CODE 4410-09-P