Importer of Controlled Substances, Notice of Registration, Noramco, Inc., 17230-17231 [2013-06321]

Download as PDF 17230 Federal Register / Vol. 78, No. 54 / Wednesday, March 20, 2013 / Notices DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances, Notice of Application, Noramco Inc. Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this is notice that on July 22, 2011, Noramco Inc., 1440 Olympic Drive, Athens, Georgia 30601, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the basic classes of controlled substances listed in schedule II: Drug Schedule srobinson on DSK4SPTVN1PROD with NOTICES Phenylacetone (8501) .................. Thebaine (9333) ........................... Noroxymorphone (9668) .............. Poppy Straw Concentrate (9670) Tapentadol (9780) ........................ 18:04 Mar 19, 2013 Jkt 229001 Dated: March 12, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–06330 Filed 3–19–13; 8:45 am] II II II II II BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE The company plans to import Thebaine (9333) analytical reference standards for distribution to its customers. The company plans to import an intermediate form of Tapentadol (9780) to bulk manufacture Tapentadol for distribution to its customers. The company plans to import Phenylacetone (8501) and Poppy Straw Concentrate (9670) to manufacture other controlled substances. Comments and request for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (2007). Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances listed in schedule 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 April 19, 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, VerDate Mar<14>2013 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. Drug Enforcement Administration Importer of Controlled Substances, Notice of Application, United States Pharmacopeial Convention Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this is notice that on January 21, 2013, United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852, made application to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances: Drug Schedule Norlevorphanol (9634) .................. Levomethorphan (9210) ............... Difenoxin (9168) ........................... I II II The company plans to import the listed controlled substances in bulk powder form from foreign sources for the manufacture of analytical reference standards for sale to their customers. 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 and 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 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than April 19, 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: March 12, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–06318 Filed 3–19–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances, Notice of Registration, Noramco, Inc. By Notice dated October 9, 2012, and published in the Federal Register on October 18, 2012, 77 FR 64142, Noramco, Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801– 4417, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the basic classes of controlled substances: Drug Phenylacetone (8501) .................. Opium, raw (9600) ....................... Poppy Straw Concentrate (9670) Tapentadol (9780) ........................ Schedule II II II II The company plans to import raw Opium (9600) and Poppy Straw concentrate (9670) to manufacture other controlled substances. The company plans to import Tapentadol (9780) in intermediate form for the bulk manufacture of Tapentadol (9780) for distribution to its customers. The company plans to import Phenylacetone (8501) in bulk for the manufacture of a controlled substance. Comments and requests for hearings on applications to import narcotic raw E:\FR\FM\20MRN1.SGM 20MRN1 17231 Federal Register / Vol. 78, No. 54 / Wednesday, March 20, 2013 / Notices material are not appropriate. 72 FR 3417 (2007). DEA has considered the factors in 21 U.S.C. 823(a) and 952(a), and determined that the registration of Noramco 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, at this time. DEA has investigated Noramco, 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: March 12, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–06321 Filed 3–19–13; 8:45 am] BILLING CODE 4410–09–P FDA approved or non-approved dosage form for commercial distribution in the United States. One comment objecting to the granting of registration as an importer of the basic class of controlled substance listed to this applicant and a request for a hearing were received on December 31, 2012. The objection and request for a hearing were withdrawn. DEA has considered the factors in 21 U.S.C. 823(a) and § 952(a) and determined that the registration of Watson Pharma, 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 Watson Pharma, 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: March 12, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances, Notice of Registration, Watson Pharma, Inc. [FR Doc. 2013–06328 Filed 3–19–13; 8:45 am] By Notice dated November 5, 2012, and published in the Federal Register on November 13, 2012, 77 FR 67675, Watson Pharma, Inc., 2455 Wardlow Road, Corona, California 92880–2882, made application to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances: DEPARTMENT OF JUSTICE Drug Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application: Morton Grove Pharmaceuticals Schedule Amphetamine (1100) .................... Methylphenidate (1724) ................ Oxycodone (9143) ........................ Hydromorphone (9150) ................ srobinson on DSK4SPTVN1PROD with NOTICES BILLING CODE 4410–09–P II II II II The company plans to import the listed controlled substances for analytical testing and clinical trials. 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 VerDate Mar<14>2013 18:04 Mar 19, 2013 Jkt 229001 Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on December 14, 2012, Morton Grove Pharmaceuticals, 6451 Main Street, Morton Grove, Illinois 60053–2633, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of Gamma Hydroxybutyric Acid (2010), a basic class of controlled substance listed in schedule I. The company plans to manufacture the listed controlled substance for distribution to its customers. Any other such applicant, and any person who is presently registered with DEA to manufacture such substance, PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 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 May 20, 2013. Dated: March 12, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–06332 Filed 3–19–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration: Noramco, Inc. By Notice dated November 1, 2012, and published in the Federal Register on November 9, 2012, 77 FR 67397, Noramco, Inc., 1440 Olympic Drive, Athens, Georgia 30601, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the basic classes of controlled substances: Drug Gamma Hydroxybutyric Acid (2010). Codeine-N-Oxide (9053) .............. Dihydromorphine (9145) ............... Morphine-N-oxide (9307) ............. Amphetamine (1100) .................... Methylphenidate (1724) ................ Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Oxymorphone (9652) ................... Noroxymorphone (9668) .............. Alfentanil (9737) ........................... Sufentanil (9740) .......................... Carfentanil (9743) ......................... Tapentadol (9780) ........................ Fentanyl (9801) ............................ Schedule I I I I 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 distribution to its customers. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Noramco, Inc., to manufacture the listed E:\FR\FM\20MRN1.SGM 20MRN1

Agencies

[Federal Register Volume 78, Number 54 (Wednesday, March 20, 2013)]
[Notices]
[Pages 17230-17231]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06321]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances, Notice of Registration, 
Noramco, Inc.

    By Notice dated October 9, 2012, and published in the Federal 
Register on October 18, 2012, 77 FR 64142, Noramco, Inc., 500 Swedes 
Landing Road, Wilmington, Delaware 19801-4417, made application by 
renewal to the Drug Enforcement Administration (DEA) to be registered 
as an importer of the basic classes of controlled substances:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Phenylacetone (8501).......................  II
Opium, raw (9600)..........................  II
Poppy Straw Concentrate (9670).............  II
Tapentadol (9780)..........................  II
------------------------------------------------------------------------

    The company plans to import raw Opium (9600) and Poppy Straw 
concentrate (9670) to manufacture other controlled substances. The 
company plans to import Tapentadol (9780) in intermediate form for the 
bulk manufacture of Tapentadol (9780) for distribution to its 
customers. The company plans to import Phenylacetone (8501) in bulk for 
the manufacture of a controlled substance.
    Comments and requests for hearings on applications to import 
narcotic raw

[[Page 17231]]

material are not appropriate. 72 FR 3417 (2007).
    DEA has considered the factors in 21 U.S.C. 823(a) and 952(a), and 
determined that the registration of Noramco 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, at this 
time. DEA has investigated Noramco, 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: March 12, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-06321 Filed 3-19-13; 8:45 am]
BILLING CODE 4410-09-P