Importer of Controlled Substances; Notice of Application, 46227-46228 [E9-21543]

Download as PDF 46227 Federal Register / Vol. 74, No. 172 / Tuesday, September 8, 2009 / Notices jlentini on DSKJ8SOYB1PROD with NOTICES additional information, please contact: Amy Callaghan, (202) 514–9292, Office of Audit, Assessment, and Management, Office of Justice Programs, U.S. Department of Justice, 810 Seventh Street, NW., Washington, DC 20531 or Amy.Callaghan@usdoj.gov. Written comments and suggestions from the public and affected parties concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points: —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; —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; —Enhance the quality, utility, and clarity of the information to be collected; and —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 (1) Type of information collection: Information in response to the required data elements outlined in the solicitation template for programs administered by the Office of Justice Programs. (2) The title of the form/collection: Office of Justice Programs solicitation template. (3) The agency form number, if any, and the applicable component of the Department sponsoring the collection: The Office of Audit, Assessment, and Management, Office of Justice Programs, U.S. Department of Justice. (4) Affected public who will be asked or required to respond, as well as a brief abstract: State agencies, tribal governments, local governments, colleges and universities, non-profit organizations, for-profit organizations and faith-based organizations. The purpose of the solicitation template is to provide framework to develop programspecific announcements soliciting applications for funding. A program solicitation outlines the specifics of the funding program; describes requirements for eligibility; instructs an applicant on the necessary components of an application under a specific VerDate Nov<24>2008 17:32 Sep 04, 2009 Jkt 217001 program (e.g, project activities and timeline, proposed budget); outlines program evaluation and performance measure; explains selection criteria and the review process; and provides registration dates, due dates, and instructions on how to apply within the designated application system. (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 information will be collected annually from 9,800 applicants, representing State agencies, tribal governments, local governments, colleges and universities, non-profit organizations, and for-profit organizations. Annual cost to the respondents is based on the number of hours involved in preparing and submitting a complete application package. Public reporting burden for this collection of information is estimated at up to 30 hours per application. The 30-hour estimate is based on the amount of time to prepare research and evaluation proposals, one of the most time intensive types of applications solicited by OJP. The estimate of burden hours is based on OJP’s prior experience with the research application submissions process. (6) An estimate of the total public burden (in hours) associated with the collection: The estimated public burden associated with this collection is 294,000 hours. If additional information is required contact: Mrs. Lynn Bryant, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Suite 1600, 601 D Street, NW., Washington, DC 20530. Dated: September 1, 2009. Lynn Bryant, Department Clearance Officer, PRA, U.S. Department of Justice. [FR Doc. E9–21514 Filed 9–4–09; 8:45 am] BILLING CODE 4410–18–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)(2) authorizing the importation of such a substance, provide manufacturers holding registrations for PO 00000 Frm 00148 Fmt 4703 Sfmt 4703 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 July 16, 2009, Cerilliant Corporation, 811 Paloma Drive, Suite A, Round Rock, Texas 78665–2402, 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 schedules I and II: Drug Cathinone (1235) .......................... Methcathinone (1237) .................. N–Ethylamphetamine (1475) ........ N,N–Dimethylamphetamine (1480). Fenethylline (1503) ....................... Gamma Hydroxybutyric Acid (2010). Ibogaine (7260) ............................ Lysergic acid diethylamide (7315) 2,5-Dimethoxy-4-(n)propylthiophenethylamine (7348). Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... Mescaline (7381) .......................... 3,4,5-Trimethoxyamphetamine (7390). 4-Bromo-2,5dimethoxyamphetamine (7391). 4-Bromo-2,5dimethoxyphenethylamine (7392). 4-Methyl-2,5dimethoxyamphetamine (7395). 2,5-Dimethoxyamphetamine (7396). 3,4-Methylenedioxyamphetamine (7400). 3,4-Methylenedioxy-Nethylamphetamine (7404). 3,4-Methylenedioxymethamphetamine (7405). 4-Methoxyamphetamine (7411) ... Alpha-methyltryptamine (7432) .... Diethyltryptamine (7434) .............. Dimethyltryptamine (7435) ........... Psilocybin (7437) .......................... Psilocyn (7438) ............................. N-Benzylpiperazine (7493) ........... Etorphine (except HCl) (9056) ..... Heroin (9200) ............................... Morphine-N-oxide (9307) ............. Normorphine (9313) ..................... Pholcodine (9314) ........................ Dextromoramide (9613) ............... Dipipanone (9622) ........................ Trimeperidine (9646) .................... Amphetamine (1100) .................... Methamphetamine (1105) ............ Methylphenidate (1724) ................ Amobarbital (2125) ....................... Pentobarbital (2270) ..................... Secobarbital (2315) ...................... Phencyclidine (7471) .................... Phenylacetone (8501) .................. Cocaine (9041) ............................. Codeine (9050) ............................. Dihydrocodeine (9120) ................. E:\FR\FM\08SEN1.SGM 08SEN1 Schedule I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I II II II II II II II II II II II 46228 Federal Register / Vol. 74, No. 172 / Tuesday, September 8, 2009 / Notices Schedule Drug Oxycodone (9143) ........................ Hydromorphone (9150) ................ Benzoylecgonine (9180) ............... Ethylmorphine (9190) ................... Meperidine (9230) ........................ Methadone (9250) ........................ Dextropropoxyphene, bulk (nondosage forms). (9273) ........................................... Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Levo-alphacetylmethadol (9648) .. Oxymorphone (9652) ................... Poppy Straw Concentrate (9670) Fentanyl (9801) ............................ DEPARTMENT OF JUSTICE II II II II II II Drug Enforcement Administration Importer of Controlled Substances; Notice of Application II II II II II II II II jlentini on DSKJ8SOYB1PROD with NOTICES The company plans to import small quantities of the listed controlled substances for the manufacture of analytical reference standards. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances 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 October 8, 2009. 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: August 28, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–21543 Filed 9–4–09; 8:45 am] BILLING CODE 4410–09–P VerDate Nov<24>2008 17:32 Sep 04, 2009 Jkt 217001 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)(2) 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 July 8, 2009, Clinical Supplies Management, Inc., 342 42nd Street South, Fargo, North Dakota 58103, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Sufentanil (9740), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance with the sole purpose of packaging, labeling, and distributing to customers which are qualified clinical sites conducting clinical trials under the auspices of an FDA-approved clinical study. 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, VA 22152; and must be filed no later than October 8, 2009. 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 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 PO 00000 Frm 00149 Fmt 4703 Sfmt 4703 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: August 28, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–21541 Filed 9–4–09; 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)(2) 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 July 2, 2009, GE Healthcare, 3350 North Ridge Avenue, Arlington Heights, Illinois 60004–1412, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Cocaine (9041), a basic class of controlled substance listed in schedule II. The company plans to import small quantities of ioflupane, in the form of three separate analogues of Cocaine, to validate production and quality control systems, for a reference standard, and for producing material for a future investigational new drug (IND) submission. 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, VA. 22152; and must be filed no later than October 8, 2009. E:\FR\FM\08SEN1.SGM 08SEN1

Agencies

[Federal Register Volume 74, Number 172 (Tuesday, September 8, 2009)]
[Notices]
[Pages 46227-46228]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-21543]


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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)(2) 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 July 16, 2009, Cerilliant 
Corporation, 811 Paloma Drive, Suite A, Round Rock, Texas 78665-2402, 
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 schedules I and II:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Cathinone (1235)...........................  I
Methcathinone (1237).......................  I
N-Ethylamphetamine (1475)..................  I
N,N-Dimethylamphetamine (1480).............  I
Fenethylline (1503)........................  I
Gamma Hydroxybutyric Acid (2010)...........  I
Ibogaine (7260)............................  I
Lysergic acid diethylamide (7315)..........  I
2,5-Dimethoxy-4-(n)-                         I
 propylthiophenethylamine (7348).
Marihuana (7360)...........................  I
Tetrahydrocannabinols (7370)...............  I
Mescaline (7381)...........................  I
3,4,5-Trimethoxyamphetamine (7390).........  I
4-Bromo-2,5-dimethoxyamphetamine (7391)....  I
4-Bromo-2,5-dimethoxyphenethylamine (7392).  I
4-Methyl-2,5-dimethoxyamphetamine (7395)...  I
2,5-Dimethoxyamphetamine (7396)............  I
3,4-Methylenedioxyamphetamine (7400).......  I
3,4-Methylenedioxy-N-ethylamphetamine        I
 (7404).
3,4-Methylenedioxy- methamphetamine (7405).  I
4-Methoxyamphetamine (7411)................  I
Alpha-methyltryptamine (7432)..............  I
Diethyltryptamine (7434)...................  I
Dimethyltryptamine (7435)..................  I
Psilocybin (7437)..........................  I
Psilocyn (7438)............................  I
N-Benzylpiperazine (7493)..................  I
Etorphine (except HCl) (9056)..............  I
Heroin (9200)..............................  I
Morphine-N-oxide (9307)....................  I
Normorphine (9313).........................  I
Pholcodine (9314)..........................  I
Dextromoramide (9613)......................  I
Dipipanone (9622)..........................  I
Trimeperidine (9646).......................  I
Amphetamine (1100).........................  II
Methamphetamine (1105).....................  II
Methylphenidate (1724).....................  II
Amobarbital (2125).........................  II
Pentobarbital (2270).......................  II
Secobarbital (2315)........................  II
Phencyclidine (7471).......................  II
Phenylacetone (8501).......................  II
Cocaine (9041).............................  II
Codeine (9050).............................  II
Dihydrocodeine (9120)......................  II

[[Page 46228]]

 
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Benzoylecgonine (9180).....................  II
Ethylmorphine (9190).......................  II
Meperidine (9230)..........................  II
Methadone (9250)...........................  II
Dextropropoxyphene, bulk (non-dosage forms)
(9273).....................................  II
Morphine (9300)............................  II
Oripavine (9330)...........................  II
Thebaine (9333)............................  II
Levo-alphacetylmethadol (9648).............  II
Oxymorphone (9652).........................  II
Poppy Straw Concentrate (9670).............  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to import small quantities of the listed 
controlled substances for the manufacture of analytical reference 
standards.
    Any bulk manufacturer who is presently, or is applying to be, 
registered with DEA to manufacture such basic classes of controlled 
substances 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 October 8, 2009.
    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: August 28, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. E9-21543 Filed 9-4-09; 8:45 am]
BILLING CODE 4410-09-P
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