Importer of Controlled Substances; Notice Of Registration; Mallinckrodt, LLC., 39337-39338 [2013-15603]

Download as PDF Federal Register / Vol. 78, No. 126 / Monday, July 1, 2013 / Notices 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 (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than July 31, 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 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: June 18, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. 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 (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than July 31, 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. [FR Doc. 2013–15587 Filed 6–28–13; 8:45 am] Dated: June 18, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. BILLING CODE 4410–09–P [FR Doc. 2013–15600 Filed 6–28–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P mstockstill on DSK4VPTVN1PROD with NOTICES Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this is notice that on May 9, 2013, Akorn, Inc., 1222 W. Grand Avenue, Decatur, Illinois 62522, made application by renewal 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 Remifentanil in bulk for use in dosageform manufacturing. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture 22:39 Jun 28, 2013 Jkt 229001 Dated: June 18, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Akorn, Inc. VerDate Mar<15>2010 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 July 31, 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 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. [FR Doc. 2013–15602 Filed 6–28–13; 8:45 am] DEPARTMENT OF JUSTICE Drug Enforcement Administration 39337 Importer of Controlled Substances, Notice of Application, Boehringer Ingelheim Chemicals DEPARTMENT OF JUSTICE Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this is notice that on May 31, 2013, Boehringer Ingelheim Chemicals, 2820 N. Normandy Drive, Petersburg, Virginia 23805, made application by renewal to the Drug Enforcement Administration (DEA) for registration as an importer of Phenylacetone (8501), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance to bulk manufacture amphetamine. Importer of Controlled Substances; Notice Of Registration; Mallinckrodt, LLC. PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 Drug Enforcement Administration By Notice dated February 8, 2013, and published in the Federal Register on February 21, 2013, 78 FR 12101, Mallinckrodt, LLC., 3600 North Second Street, St. Louis, Missouri 63147, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances: E:\FR\FM\01JYN1.SGM 01JYN1 39338 Federal Register / Vol. 78, No. 126 / Monday, July 1, 2013 / Notices Drug Schedule Phenylacetone (8501) .................. Coca Leaves (9040) ..................... Opium, raw (9600) ....................... Poppy Straw Concentrate (9670) II II II II The company plans to import the listed controlled substances for the manufacture of controlled substances in bulk for distribution to its customers. Comments and requests for hearings on applications to import narcotic raw material are not appropriate, 72 FR 3417 (2007). Regarding Phenylacetone (8501), a basic class of controlled substance, 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 Mallinckrodt, LLC., 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 Mallinckrodt, LLC., 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: June 18, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. The company plans to import the listed controlled substance for analytical research and testing. The import of the above listed basic class of controlled substance would 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 Alkermes Gainesville, LLC, to import the basic class of controlled substance 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 Alkermes Gainesville, LLC, 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 class of controlled substance listed. Dated: June 18, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–15589 Filed 6–28–13; 8:45 am] BILLING CODE 4410–09–P The company plans to import a finished pharmaceutical product containing cannabis extracts in dosage form, to package for a clinical trial study. In addition, the company also plans to import an ointment for the treatment of wounds, which contains trace amounts of the controlled substance normally found in poppy straw concentrate for packaging and labeling for clinical trials. Comments and requests for any hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417(2007). 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 Catalent CTS., Inc., to import the basic classes of controlled substance 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 Catalent CTS., 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: June 18, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–15588 Filed 6–28–13; 8:45 am] DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P [FR Doc. 2013–15603 Filed 6–28–13; 8:45 am] BILLING CODE 4410–09–P Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration; Catalent CTS., Inc. DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE By Notice dated April 10, 2013, and published in the Federal Register on April 19, 2013, 78 FR 23594, Catalent CTS., Inc., 10245 Hickman Mills Drive, Kansas City, Missouri 64137, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances: Importer of Controlled Substances; Notice of Registration; Lipomed Drug Enforcement Administration mstockstill on DSK4VPTVN1PROD with NOTICES Importer of Controlled Substances; Notice of Registration; Alkermes Gainesville, LLC By Notice dated January 16, 2013, and published in the Federal Register on January 29, 2013, 78 FR 6132, Alkermes Gainesville, LLC, 1300 Gould Drive, Gainesville, Georgia 30504, made application to the Drug Enforcement Administration (DEA) to be registered as an importer of Noroxymorphone (9668), a basic class of controlled substance listed in schedule II. VerDate Mar<15>2010 21:38 Jun 28, 2013 Jkt 229001 Drug Schedule Marihuana (7360) ......................... Poppy Straw Concentrate (9670) PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 I II Drug Enforcement Administration By Notice dated April 16, 2013, and published in the Federal Register on April 23, 2013, 78 FR 23957, Lipomed, One Broadway, Cambridge, Massachusetts 02142, made application by letter to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances: Drug JWH–250 (6250) .......................... E:\FR\FM\01JYN1.SGM 01JYN1 Schedule I

Agencies

[Federal Register Volume 78, Number 126 (Monday, July 1, 2013)]
[Notices]
[Pages 39337-39338]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15603]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice Of Registration; 
Mallinckrodt, LLC.

    By Notice dated February 8, 2013, and published in the Federal 
Register on February 21, 2013, 78 FR 12101, Mallinckrodt, LLC., 3600 
North Second Street, St. Louis, Missouri 63147, made application by 
renewal to the Drug Enforcement Administration (DEA) to be registered 
as an importer of the following basic classes of controlled substances:

[[Page 39338]]



------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Phenylacetone (8501).......................  II
Coca Leaves (9040).........................  II
Opium, raw (9600)..........................  II
Poppy Straw Concentrate (9670).............  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
the manufacture of controlled substances in bulk for distribution to 
its customers.
    Comments and requests for hearings on applications to import 
narcotic raw material are not appropriate, 72 FR 3417 (2007). Regarding 
Phenylacetone (8501), a basic class of controlled substance, no 
comments or objections have been received. DEA has considered the 
factors in 21 U.S.C. 823(a) and Sec.  952(a), and determined that the 
registration of Mallinckrodt, LLC., 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 Mallinckrodt, 
LLC., 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 Sec.  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: June 18, 2013.
 Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-15603 Filed 6-28-13; 8:45 am]
BILLING CODE 4410-09-P