Importer of Controlled Substances; Notice of Application, 21915-21916 [2011-9367]

Download as PDF Federal Register / Vol. 76, No. 75 / Tuesday, April 19, 2011 / Notices mstockstill on DSKH9S0YB1PROD with NOTICES 2011. This process is conducted in accordance with 5 CFR 1320.10. Written comments concerning this information collection, especially the estimated public burden and associated response time, should be sent to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attn: DOJ Desk Officer. The best way to ensure your comments are received is to e-mail them to oira_submission@omb.eop.gov or fax them to 202–395–7285. All comments should reference the 8 digit OMB number for the collection or the title of the collection. If you have questions concerning the collection, please call Cathy Poston 202–514–5430, Attorney/ Advisor, Office on Violence Against Women or the DOJ Desk Officer at 202– 395–3176. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection (1) Type of Information Collection: Extension of Currently Approved Collection. (2) Title of the Form/Collection: SemiAnnual Progress Report for Grants to Indian Tribal Governments Program. (3) Agency form number, if any, and the applicable component of the Department of Justice sponsoring the collection: Form Number: 1122–0018. U.S. Department of Justice, Office on Violence Against Women. (4) Affected public who will be asked or required to respond, as well as a brief abstract: The affected public includes the approximately 85 grantees of the VerDate Mar<15>2010 16:19 Apr 18, 2011 Jkt 223001 Grants to Indian Tribal Governments Program (Tribal Governments Program), a grant program authorized by the Violence Against Women Act of 2005. This discretionary grant program is designed to enhance the ability of tribes to respond to violent crimes against Indian women, enhance victim safety, and develop education and prevention strategies. Eligible applicants are recognized Indian tribal governments or their authorized designees. (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond/reply: It is estimated that it will take the approximately 85 respondents (Tribal Governments Program grantees) approximately one hour to complete a semi-annual progress report. The semiannual progress report is divided into sections that pertain to the different types of activities in which grantees may engage. A Tribal Governments Program grantee will only be required to complete the sections of the form that pertain to its own specific activities. (6) An estimate of the total public burden (in hours) associated with the collection: The total annual hour burden to complete the data collection forms is 170 hours, that is 85 grantees completing a form twice a year with an estimated completion time for the form being one hour. If additional information is required contact: Lynn Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N. Street, NE., Room 2E– 808, Washington, DC 20530. Dated: April 12, 2011. Lynn Murray, Department Clearance Officer, PRA, United States Department of Justice. [FR Doc. 2011–9353 Filed 4–18–11; 8:45 am] BILLING CODE 4410–FX–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this is notice that on February 25, 2011, Stepan Company, Natural Products Department, 100 W. Hunter Avenue, Maywood, New Jersey 07607, made application by renewal to the Drug Enforcement Administration (DEA) for registration as an importer of Coca Leaves (9040), a basic class of controlled substance listed in schedule II. PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 21915 The company plans to import the listed controlled substance to manufacture bulk controlled substance for distribution to its customer. As explained in the Correction to Notice of Application pertaining to Rhodes Technologies, 72 FR 3417 (2007), comments and requests for hearings on applications to import narcotic raw material are not appropriate. 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 class of any controlled substance 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: April 11, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2011–9366 Filed 4–18–11; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to issuing a registration under this Section to a bulk manufacturer of a controlled substance in schedule I or II, and prior to issuing a regulation under 21 U.S.C. 952(a) authorizing the importation of such a substance, provide manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing. Therefore, in accordance with Title 21 Code of Federal Regulations (CFR), 1301.34(a), this is notice that on January 21, 2011, Meda Pharmaceuticals Inc., 705 Eldorado Street, Decatur, Illinois 62523, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Nabilone (7379), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance as a finished drug product in dosage form for distribution to its customers. The company does not import the listed controlled substance in bulk E:\FR\FM\19APN1.SGM 19APN1 21916 Federal Register / Vol. 76, No. 75 / Tuesday, April 19, 2011 / Notices active pharmaceutical ingredient (API) form. There are no domestic sources of Nabilone in finished drug product form available in the United States. The U.S. Food and Drug Administration has approved this product for medical use 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 may 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 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 19, 2011. 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 listed 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: April 11, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. DEPARTMENT OF JUSTICE Manufacturer of Controlled Substances; Notice of Application mstockstill on DSKH9S0YB1PROD with NOTICES BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration internally within the company. It is the company’s intention that, when the manufacturing process is refined to the point that its Nabilone bulk product is available for commercial use, the company will export the controlled substance in bulk solely to customers engaged in dosage-form manufacturing outside the United States. The company is aware of the requirement to obtain a DEA registration as an exporter to conduct this activity. 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 June 20, 2011. Dated: April 11, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2011–9370 Filed 4–18–11; 8:45 am] Manufacturer of Controlled Substances; Notice of Application BILLING CODE 4410–09–P Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on December 14, 2010, Norac Inc., 405 S. Motor Avenue, P.O. Box 577, Azusa, California 91702–3232, 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: DEPARTMENT OF JUSTICE Schedule I I II II II Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration By Notice dated December 20, 2010, and published in the Federal Register on December 29, 2010, 75 FR 82073, Siegfried (USA), Inc., 33 Industrial Park Road, Pennsville, New Jersey 08070, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the basic classes of controlled substances listed in schedules I and II: Drug Drug Enforcement Administration Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on September 16, 2010, Mallinckrodt, Inc., 3600 North Second Street, St. Louis, Missouri 63147, made application by letter to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of 4-Anilino-N-Phenethyl- Jkt 223001 [FR Doc. 2011–9369 Filed 4–18–11; 8:45 am] Gamma Hydroxybutyric Acid (2010). Tetrahydrocannabinols (7370) ..... Methamphetamine (1105) ............ Pentobarbital (2270) ..................... Nabilone (7379) ............................ BILLING CODE 4410–09–P 16:19 Apr 18, 2011 Dated: April 11, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Drug [FR Doc. 2011–9367 Filed 4–18–11; 8:45 am] VerDate Mar<15>2010 4-Piperidine (ANPP)(8333), a basic class of controlled substance listed in schedule II. The company plans to use this controlled substance in the manufacture of another controlled substance. 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 June 20, 2011. With regard to Gamma Hydroxybutyric Acid (2010), Tetrahydrocannabinols (7370), and Methamphetamine (1105) only, the company manufactures these controlled substances in bulk solely for domestic distribution within the United States to customers engaged in dosage-form manufacturing. With regard to Nabilone (7379) only, the company presently manufactures a small amount of this controlled substance in bulk solely to conduct manufacturing process development PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 Gamma Hydroxybutyric Acid (2010). Dihydromorphine (9145) ............... Methylphenidate (1724) ................ Amobarbital (2125) ....................... Pentobarbital (2270) ..................... Secobarbital (2315) ...................... Codeine (9050) ............................. Oxycodone (9143) ........................ Drug Hydromorphone (9150) ................ Hydrocodone (9193) ..................... E:\FR\FM\19APN1.SGM 19APN1 Schedule I I II II II II II II Schedule II II

Agencies

[Federal Register Volume 76, Number 75 (Tuesday, April 19, 2011)]
[Notices]
[Pages 21915-21916]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9367]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Application

    Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to 
issuing a registration under this Section to a bulk manufacturer of a 
controlled substance in schedule I or II, and prior to issuing a 
regulation under 21 U.S.C. 952(a) authorizing the importation of such a 
substance, provide manufacturers holding registrations for the bulk 
manufacture of the substance an opportunity for a hearing.
    Therefore, in accordance with Title 21 Code of Federal Regulations 
(CFR), 1301.34(a), this is notice that on January 21, 2011, Meda 
Pharmaceuticals Inc., 705 Eldorado Street, Decatur, Illinois 62523, 
made application by renewal to the Drug Enforcement Administration 
(DEA) to be registered as an importer of Nabilone (7379), a basic class 
of controlled substance listed in schedule II.
    The company plans to import the listed controlled substance as a 
finished drug product in dosage form for distribution to its customers.
    The company does not import the listed controlled substance in bulk

[[Page 21916]]

active pharmaceutical ingredient (API) form. There are no domestic 
sources of Nabilone in finished drug product form available in the 
United States. The U.S. Food and Drug Administration has approved this 
product for medical use 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 may 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 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 19, 2011.
    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 
listed 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: April 11, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2011-9367 Filed 4-18-11; 8:45 am]
BILLING CODE 4410-09-P

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