Bulk Manufacturer of Controlled Substances Application: MALLINCKRODT, LLC, 31986-31987 [2014-12794]

Download as PDF 31986 Federal Register / Vol. 79, No. 106 / Tuesday, June 3, 2014 / Notices Suite D, Windsor, Colorado 80550, applied to be registered as a bulk manufacturer of Carfentanil (9743), a basis class of narcotic controlled substance listed in schedule II. The company plans to manufacture the above listed controlled substance for sale to veterinary pharmacies, zoos, and other animal and wildlife applications. Dated: May 28, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–12792 Filed 6–2–14; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE [Docket No. DEA–392] Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before July 3, 2014. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before July 3, 2014. Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, and dispensers of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to sec. 7(g) of 28 CFR pt. 0, subpt. R, App. In accordance with 21 CFR 1301.34(a), this is notice that on March 5, 2014, Alltech Associates, Inc., 2051 Waukegan Road, Deerfield, Illinois sroberts on DSK4SPTVN1PROD with NOTICES Jkt 232001 I I II II II II II II with 21 CFR 1301.34, the above named company is granted registration as an importer of the basic class of controlled substance listed. Dated: May 28, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2014–12795 Filed 6–2–14; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: MALLINCKRODT, LLC ACTION: Notice of application. BILLING CODE 4410–09–P DATES: 17:35 Jun 02, 2014 I [FR Doc. 2014–12793 Filed 6–2–14; 8:45 am] Notice of application. VerDate Mar<15>2010 Gamma Hydroxybutyric Acid (2010). Lysergic acid diethylamide (7315) Heroin (9200) ............................... Cocaine (9041) ............................. Codeine (9050) ............................. Hydrocodone (9193) ..................... Meperidine (9230) ........................ Methadone (9250) ........................ Morphine (9300) ........................... Schedule Dated: May 28, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. Importer of Controlled Substances Application: Alltech Associates, Inc. SUPPLEMENTARY INFORMATION: Controlled substance The company plans to import these controlled substances for the manufacture of reference standards. Drug Enforcement Administration ACTION: 60015, applied to be registered as an importer of the following basic classes of narcotic or non-narcotic controlled substances: Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before August 4, 2014. DATES: DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration; Hospira By Notice dated December 16, 2013, and published in the Federal Register on January 2, 2014, 79 FR 151, Hospira, 1776 North Centennial Drive, McPherson, Kansas 67460–1247, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Remifentanil (9739), a basic class of controlled substance listed in schedule II. The company plans to import Remifentanil for use in dosage form manufacturing. No comments or objections have been received. The DEA has considered the factors in 21 U.S.C. 823(a) and 952(a) and determined that the registration of Hospira to import the basic class of controlled substance is consistent with the public interest and in accordance with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA has investigated Hospira 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 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, and dispensers of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to sec. 7(g) of 28 CFR pt. 0, subpt. R, App. In accordance with 21 CFR 1301.33(a), this is notice that on January 16, 2014, Mallinckrodt, LLC., 3600 North Second Street, St. Louis, Missouri 63147, applied to be registered as a bulk manufacturer of the following basic classes of narcotic or nonnarcotic controlled substances: SUPPLEMENTARY INFORMATION: E:\FR\FM\03JNN1.SGM 03JNN1 31987 Federal Register / Vol. 79, No. 106 / Tuesday, June 3, 2014 / Notices Controlled substance Schedule Tetrahydrocannabinols (7370) ..... Codeine-N-oxide (9053) ............... Dihydromorphine (9145) ............... Difenoxin (9168) ........................... Morphine-N-oxide (9307) ............. Normorphine (9313) ..................... Norlevorphanol (9634) .................. Amphetamine (1100) .................... Methamphetamine (1105) ............ Phenylacetone (8501) .................. 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) ........................... 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 company plans to manufacture the listed controlled substances for internal use and for distribution to other companies. Dated: May 28, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. Drug Enforcement Administration [Docket No. DEA–392] DEPARTMENT OF JUSTICE Manufacturer of Controlled Substances Registration: Cody Laboratories, Inc. Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Pharmacore, Inc. Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before August 4, 2014. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal sroberts on DSK4SPTVN1PROD with NOTICES DATES: 17:35 Jun 02, 2014 [FR Doc. 2014–12797 Filed 6–2–14; 8:45 am] DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P VerDate Mar<15>2010 Dated: May 28, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. BILLING CODE 4410–09–P [FR Doc. 2014–12794 Filed 6–2–14; 8:45 am] ACTION: Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, and dispensers of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to sec. 7(g) of 28 CFR part 0, subpart R, App. In accordance with 21 CFR 1301.33(a), this is notice that on March 20, 2014, Pharmacore, Inc., 4180 Mendenhall Oaks Parkway, High Point, North Carolina 27265, applied to be registered as a bulk manufacturer of Noroxymorphone (9668), a basic class of narcotic controlled substance listed in schedule II. The company plans to manufacture the listed controlled substance as an active pharmaceutical ingredient (API) for clinical trials. Jkt 232001 ACTION: Notice of registration. Cody Laboratories, Inc. applied to be registered as a manufacturer of certain basic classes of narcotic or non-narcotic controlled substances. The DEA grants Cody Laboratories, Inc. registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated December 31, 2013, and published in the Federal Register on January 10, 2014, 79 FR 1890, Cody Laboratories, Inc., 601 Yellowstone Avenue, Cody, Wyoming 82414–9321, SUMMARY: PO 00000 Frm 00072 Fmt 4703 Sfmt 9990 applied to be registered as a manufacturer of certain basic classes of narcotic or non-narcotic controlled substances. The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Cody Laboratories, Inc. to manufacture 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. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verified the company’s compliance with state and local laws, and reviewed the company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of the basic classes of narcotic or non-narcotic controlled substances listed: Controlled Substance Dihydromorphine (9145) ............... Amphetamine (1100) .................... Methamphetamine (1105) ............ Methylphenidate (1724) ................ Amobarbital (2125) ....................... Pentobarbital (2270) ..................... Secobarbital (2315) ...................... 4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333). Phenylacetone (8501) .................. Cocaine (9041) ............................. Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Diphenoxylate (9170) ................... Ecgonine (9180) ........................... Hydrocodone (9193) ..................... Meperidine (9230) ........................ Methadone (9250) ........................ Morphine (9300) ........................... Thebaine (9333) ........................... Oxymorphone (9652) ................... Alfentanil (9737) ........................... Remifentanil (9739) ...................... Sufentanil (9740) .......................... Tapentadol (9780) ........................ Fentanyl (9801) ............................ Schedule 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 The company plans to manufacture the listed controlled substances in bulk for sale to its customers. No comments or objections have been received. Dated: May 27, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–12799 Filed 6–2–14; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\03JNN1.SGM 03JNN1

Agencies

[Federal Register Volume 79, Number 106 (Tuesday, June 3, 2014)]
[Notices]
[Pages 31986-31987]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12794]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: 
MALLINCKRODT, LLC

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration in accordance with 21 CFR 
1301.33(a) on or before August 4, 2014.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 
authority under the Controlled Substances Act to the Administrator of 
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, and dispensers of controlled substances 
(other than final orders in connection with suspension, denial, or 
revocation of registration) has been redelegated to the Deputy 
Assistant Administrator of the DEA Office of Diversion Control 
(``Deputy Assistant Administrator'') pursuant to sec. 7(g) of 28 CFR 
pt. 0, subpt. R, App.
    In accordance with 21 CFR 1301.33(a), this is notice that on 
January 16, 2014, Mallinckrodt, LLC., 3600 North Second Street, St. 
Louis, Missouri 63147, applied to be registered as a bulk manufacturer 
of the following basic classes of narcotic or nonnarcotic controlled 
substances:

[[Page 31987]]



------------------------------------------------------------------------
            Controlled substance                       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
Phenylacetone (8501).......................  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
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 company plans to manufacture the listed controlled substances 
for internal use and for distribution to other companies.

    Dated: May 28, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014-12794 Filed 6-2-14; 8:45 am]
BILLING CODE 4410-09-P