Manufacturer of Controlled Substances; Notice of Registration; Patheon Pharmaceuticals, Inc., 39340-39341 [2013-15563]

Download as PDF 39340 Federal Register / Vol. 78, No. 126 / Monday, July 1, 2013 / Notices Drug Schedule Cocaine (9041) ............................. Codeine (9050) ............................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Diphenoxylate (9170) ................... Ecgonine (9180) ........................... Ethylmorphine (9190) ................... Hydrocodone (9193) ..................... Levorphanol (9220) ...................... Meperidine (9230) ........................ Methadone (9250) ........................ Morphine (9300) ........................... Thebaine (9333) ........................... Opium, powdered (9639) ............. Levo-alphacetylmethadol (9648) .. Oxymorphone (9652) ................... Fentanyl (9801) ............................ II II II II II II II II II II II II II II II II II Boehringer Ingelheim Chemicals, Inc., 2820 N. Normandy Drive, Petersburg, Virginia 23805–9372, 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: Amphetamine (1100) II Drug Schedule Methylphenidate (1724) ................ Methadone (9250) ........................ Methadone Intermediate (9254) ... Tapentadol (9780) ........................ The company plans to import the listed controlled substances for sale to research facilities for drug testing and analysis. 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 SA INTL GMBH C/O., Sigma Aldrich Co. 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, at this time. DEA has investigated SA INTL GMBH C/O., Sigma Aldrich Co. 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. II II II II The company plans to manufacture the listed controlled substances in bulk for sale to its customers for formulation into finished pharmaceuticals. In reference to Methadone Intermediate (9254) the company plans to produce Methadone HCL active pharmaceutical ingredients (APIs) for sale to its customers. 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 August 30, 2013. Dated: June 18, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–15604 Filed 6–28–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Dated: June 18, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Drug Enforcement Administration [FR Doc. 2013–15576 Filed 6–28–13; 8:45 am] Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on May 21, 2013, Chemtos, LLC., 14101 W. Highway 290, Building 2000B, Austin, Texas 78737– 9331, 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: Manufacturer of Controlled Substances; Notice of Application; Chemtos, LLC. BILLING CODE 4410–09–P mstockstill on DSK4VPTVN1PROD with NOTICES DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Boehringer Ingelheim Chemicals, Inc. Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on May 31, 2013, VerDate Mar<15>2010 22:39 Jun 28, 2013 Jkt 229001 Drug Schedule Amphetamine (1100) .................... PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 II Drug Methamphetamine (1105) ............ Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Nabilone (7379) ............................ Phenylacetone (8501) .................. Cocaine (9041) ............................. Codeine (9050) ............................. Etorphine HCL (9059) .................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Ecgonine (9180) ........................... Ethylmorphine (9190) ................... Hydrocodone (9193) ..................... Levomethorphan (9210) ............... Levorphanol (9220) ...................... Isomethadone (9226) ................... Meperidine (9230) ........................ Meperidine-intermediate-A (9232) Meperidine-intermediate-B (9233) Meperidine-intermediate-C (9234) Methadone (9250) ........................ Methadone intermediate (9254) ... Morphine (9300) ........................... Thebaine (9333) ........................... Dihydroetorphine (9334) ............... Levo-alphacetylmethadol (9648) .. Oxymorphone (9652) ................... Racemethorphan (9732) .............. Racemorphan (9733) ................... Schedule 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 II II The company plans to manufacture small quantities of the listed controlled substances in bulk for distribution to its customers for use as reference standards. 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 August 30, 2013. Dated: June 18, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–15572 Filed 6–28–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration; Patheon Pharmaceuticals, Inc. By Notice dated March 20, 2013, and published in the Federal Register on March 28, 2013, 78 FR 19016, Patheon E:\FR\FM\01JYN1.SGM 01JYN1 Federal Register / Vol. 78, No. 126 / Monday, July 1, 2013 / Notices Pharmaceutical, Inc., 2110 E. Galbraith Road, Cincinnati, Ohio 45237, 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 clinical trials and 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 Patheon Pharmaceuticals, Inc., to manufacture the listed basic class of controlled substance is consistent with the public interest at this time. DEA has investigated Patheon Pharmaceuticals, 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. 823(a), and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer 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. 2013–15563 Filed 6–28–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Federal Bureau of Investigation [OMB Number 1110–NEW] Agency Information Collection Activities: Proposed Collection, Comments Requested: Notice of Collection of Information Relative to Customer Service Satisfaction mstockstill on DSK4VPTVN1PROD with NOTICES ACTION: 30-day Notice. The Department of Justice, Federal Bureau of Investigation (FBI), National Center for the Analysis of Violent Crime (NCAVC), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with established review procedures of the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected VerDate Mar<15>2010 21:38 Jun 28, 2013 Jkt 229001 agencies. This proposed information collection was previously published in the Federal Register Volume 78, Number 72, page 22332, on April 15, 2013, allowing for a 60 day comment period. The purpose of this notice is to allow for an additional 30 days for public comment until July 31, 2013. This process is conducted in accordance with 5 CFR 1320.10. ADDRESSES: All comments, suggestions, or questions regarding additional information, to include obtaining a copy of the proposed information collection instrument with instructions, should be directed to Yvonne Muirhead, Federal Bureau of Investigation, NCAVC, Critical Incident Response Group, FBI Academy, 1 Range Road, Quantico, Virginia, 22135. SUPPLEMENTARY INFORMATION: Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Comments should address one or more of the following four points: (1) 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 of other forms of information technology, e.g., permitting electronic submission of responses. Overview of this information collection: (1) Type of information collection: Customer satisfaction ratings regarding the quality and value of the FBI’s NCAVC services. (2) The title of the form/collection: FBI–NCAVC Satisfaction Survey. (3) There is no agency form number applicable to this survey. (4) The survey will be distributed to state, local and tribal law enforcement agencies to which the NCAVC has provided investigative assistance. The survey is being proposed as a means to assess the effectiveness and efficiency with which the NCAVC serves these agencies in the execution of their PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 39341 missions. The survey will query respondents as to the agencies’ satisfaction with NCAVC services, and concrete achievements which were furthered via NCAVC services. (5) Time burden anticipated with this collection: It is estimated that 100 respondents per calendar year will be contacted to complete a survey consisting of 11 questions. An approximate non-response rate of 50% is anticipated. It is estimated that a burden of approximately three to five minutes, or .05 to .08 hours, will be cast upon each respondent to complete the survey, with a total estimate of five to 8.3 hours in a calendar year for all respondents combined, if all respondents complete a survey. If the expected non-response rate of 50% holds true, then the combined burden estimate drops to approximately 2.5 to 4.2 hours per calendar year. The NCAVC estimates little to no variability within this time estimate based upon on individualized data retrieval systems, availability of requested data, and other variables, because this survey is intended to assess customer satisfaction rather than generate empirical data. (6) Methodology: The survey will be distributed and collected electronically, via electronic mail communication. Contact: If additional information is required contact: Jerri Murray, Department Clearance Officer, Policy and Planning Staff, Justice Management Division, United States Department of Justice, Two Constitution Square, 145 N Street NE., Room 1407B, Washington, DC 20530. Dated: June 25, 2013. Jerri Murray, Department Clearance Officer for PRA, United States Department of Justice. [FR Doc. 2013–15566 Filed 6–28–13; 8:45 am] BILLING CODE 4410–02–P NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 13–070] NASA Advisory Council; Science Committee; Planetary Science Subcommittee; Meeting. National Aeronautics and Space Administration. ACTION: Notice of meeting. AGENCY: In accordance with the Federal Advisory Committee Act, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Planetary Science Subcommittee of the NASA Advisory Council (NAC). This SUMMARY: E:\FR\FM\01JYN1.SGM 01JYN1

Agencies

[Federal Register Volume 78, Number 126 (Monday, July 1, 2013)]
[Notices]
[Pages 39340-39341]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15563]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Registration; 
Patheon Pharmaceuticals, Inc.

    By Notice dated March 20, 2013, and published in the Federal 
Register on March 28, 2013, 78 FR 19016, Patheon

[[Page 39341]]

Pharmaceutical, Inc., 2110 E. Galbraith Road, Cincinnati, Ohio 45237, 
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 clinical trials and 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 
Patheon Pharmaceuticals, Inc., to manufacture the listed basic class of 
controlled substance is consistent with the public interest at this 
time. DEA has investigated Patheon Pharmaceuticals, 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. 823(a), and in accordance with 21 
CFR 1301.33, the above named company is granted registration as a bulk 
manufacturer 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. 2013-15563 Filed 6-28-13; 8:45 am]
BILLING CODE 4410-09-P?>