Manufacturer of Controlled Substances; Notice of Registration; Cambrex Charles City, Inc., 14299-14300 [2014-05495]

Download as PDF 14299 Federal Register / Vol. 79, No. 49 / Thursday, March 13, 2014 / Notices class of controlled substance listed in schedule II. The company plans to manufacture the listed controlled substance in support of product development. No comments or objections have been received. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Nektar Therapeutics to manufacture the listed basic class of controlled substance is consistent with the public interest at this time. The DEA has investigated Nektar Therapeutics 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, 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: Signed February 19, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Drug Schedule Thebaine (9333) ........................... II The company plans to manufacture the listed controlled substances in bulk for distribution and sale to its customers. No comments or objections have been received. The DEA has considered the factors in 21 U.S.C. 823(a), and determined that the registration of Johnson Matthey, Inc., to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. The DEA has investigated, Johnson Matthey, 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 classes of controlled substances listed. Dated: February 19, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2014–05489 Filed 3–12–14; 8:45 am] BILLING CODE 4410–09–P [FR Doc. 2014–05500 Filed 3–12–14; 8:45 am] DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration; Johnson Matthey, Inc. DEPARTMENT OF JUSTICE By Notice dated November 5, 2013, and published in the Federal Register on November 18, 2013, 78 FR 69133, Johnson Matthey, Inc., Pharmaceuticals Materials, 900 River Road, Conshohocken, Pennsylvania 19428, 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 Registration; Pharmacore, Inc. TKELLEY on DSK3SPTVN1PROD with NOTICES Drug Schedule Gamma Hydroxybutyric Acid (2010). Amphetamine (1100) .................... Methylphenidate (1724) ................ Codeine (9050) ............................. Oxycodone (9143) ........................ Diphenoxylate (9170) ................... Hydrocodone (9193) ..................... Meperidine (9230) ........................ Methadone (9250) ........................ Methadone intermediate (9254) ... Morphine (9300) ........................... VerDate Mar<15>2010 17:33 Mar 12, 2014 Drug Enforcement Administration I II II II II II II II II II II Jkt 232001 By Notice dated September 27, 2013, and published in the Federal Register on October 25, 2013, 78 FR 64017, PharmaCore, Inc., 4180 Mendenhall Oaks Parkway, High Point, North Carolina 27265, made application by letter to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of Noroxymorphone (9668), a basic class of controlled substance listed in schedule II. The company plans to manufacture the listed controlled substance as active pharmaceutical ingredients (API) for clinical trials. No comments or objections have been received. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of PharmaCore, Inc., to manufacture the PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 listed basic class of controlled substance is consistent with the public interest at this time. The DEA has investigated PharmaCore, 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, 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: February 19, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2014–05504 Filed 3–12–14; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration; Cambrex Charles City, Inc. By Notice dated September 27, 2013, and published in the Federal Register on October 25, 2013, 78 FR 64017, Cambrex Charles City, Inc., 1205 11th Street, Charles City, Iowa 50616, 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: Drug Gamma Hydroxybutyric Acid (2010). Amphetamine (1100) .................... Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ 4-Anilino-N-phenethyl-4-piperidine (8333). Phenylacetone (8501) .................. Cocaine (9041) ............................. Codeine (9050) ............................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Methadone (9250) ........................ Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Opium, raw (9600) ....................... Opium extracts (9610) .................. Opium fluid extract (9620) ............ Opium tincture (9630) .................. Opium, powdered (9639) ............. Opium, granulated (9640) ............ Oxymorphone (9652) ................... E:\FR\FM\13MRN1.SGM 13MRN1 Schedule I II II II II II II II II II II II II II II II II II II II II II 14300 Federal Register / Vol. 79, No. 49 / Thursday, March 13, 2014 / Notices Drug Schedule Noroxymorphone (9668) .............. Poppy Straw Concentrate (9670) Alfentanil (9737) ........................... Remifentanil (9739) ...................... Sufentanil (9740) .......................... Fentanyl (9801) ............................ II II II II II II The company plans to manufacture the listed controlled substances in bulk for sale to its customers, for dosage form development, for clinical trials, and for use in stability qualification studies. No comments or objections have been received. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Cambrex Charles City, Inc., to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. The DEA has investigated Cambrex Charles City, 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, and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic classes of controlled substances listed. Dated: February 19, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. BILLING CODE 4410–09–P DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket Number: OSHA–2014–0004] Occupational Safety and Health Administration (OSHA), DOL. ACTION: Request for nominations to serve on the Whistleblower Protection Advisory Committee. DEPARTMENT OF JUSTICE The Assistant Secretary of Labor for Occupational Safety and Health requests nominations for membership on the Whistleblower Protection Advisory Committee (WPAC). SUMMARY: Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration; GE Healthcare TKELLEY on DSK3SPTVN1PROD with NOTICES [FR Doc. 2014–05484 Filed 3–12–14; 8:45 am] AGENCY: BILLING CODE 4410–09–P By Notice dated October 16, 2013, and published in the Federal Register on October 25, 2013, 78 FR 64018, 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 a bulk manufacturer of Cocaine (9041), a basic class of controlled substance listed in schedule II. The company plans to manufacture a radioactive product to diagnose Parkinson’s disease for distribution to its customers. 17:33 Mar 12, 2014 Dated: February 19, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Whistleblower Protection Advisory Committee [FR Doc. 2014–05495 Filed 3–12–14; 8:45 am] VerDate Mar<15>2010 No comments or objections have been received. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of GE Healthcare to manufacture the listed basic class of controlled substance is consistent with the public interest at this time. The DEA has investigated GE Healthcare 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, 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. Jkt 232001 Nominations for WPAC must be submitted (postmarked, sent, transmitted, or received) by May 12, 2014. DATES: You may submit nominations for WPAC, identified by the OSHA Docket No., OSHA–2014– 0004, by any of the following methods: Electronically: Nominations, including attachments, may be submitted electronically at https:// www.regulations.gov, which is the Federal eRulemaking Portal. Follow the instructions online for making electronic submissions. ADDRESSES: PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 Facsimile: If your nomination and supporting materials, including attachments, do not exceed 10 pages, you may fax them to the OSHA Docket Office at (202) 693–1648. Mail, hand delivery, express mail, messenger or courier service: Submit your nominations and supporting materials to the OSHA Docket Office, Docket No. OSHA–2014–0004, U.S. Department of Labor, Room N–2625, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693–2350 (OSHA’s TTY number is (877) 889–5627). Deliveries (hand, express mail, messenger and courier service) are accepted during the Department of Labor’s and Docket Office’s normal business hours, 8:15 a.m.–4:45 p.m., e.t. Instructions: All nominations and supporting materials for WPAC must include the Agency name and docket number for this Federal Register notice (Docket No. OSHA–2014–0004). Because of security-related procedures, submitting nominations by regular mail may result in a significant delay in their receipt. Please contact the OSHA Docket Office for information about security procedures for submitting nominations by hand delivery, express delivery, and messenger or courier service. For additional information on submitting nominations see the ‘‘Public Participation—Submission of Nominations and Access to Docket’’ heading in the SUPPLEMENTARY INFORMATION section below. Submissions in response to this Federal Register notice, including personal information provided, are posted without change at https:// www.regulations.gov. Therefore, OSHA cautions interested parties about submitting personal information such as social security numbers and dates of birth. Docket: To read or download submissions or other material in the docket, go to https://www.regulations.gov or the OSHA Docket Office at the address above. All documents in the docket are listed in the https:// www.regulations.gov index; however, some information (e.g., copyrighted material) is not publicly available to read or download through that Web site. All submissions, including copyrighted material, are available for inspection and copying at the OSHA Docket Office. FOR FURTHER INFORMATION CONTACT: Meghan Smith, OSHA, Directorate of Whistleblower Protection Programs, U.S. Department of Labor, Room N– 4624, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693–2199; email address smith.meghan.p@dol.gov. E:\FR\FM\13MRN1.SGM 13MRN1

Agencies

[Federal Register Volume 79, Number 49 (Thursday, March 13, 2014)]
[Notices]
[Pages 14299-14300]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05495]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Registration; 
Cambrex Charles City, Inc.

    By Notice dated September 27, 2013, and published in the Federal 
Register on October 25, 2013, 78 FR 64017, Cambrex Charles City, Inc., 
1205 11th Street, Charles City, Iowa 50616, 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:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)...........  I
Amphetamine (1100).........................  II
Lisdexamfetamine (1205)....................  II
Methylphenidate (1724).....................  II
4-Anilino-N-phenethyl-4-piperidine (8333)..  II
Phenylacetone (8501).......................  II
Cocaine (9041).............................  II
Codeine (9050).............................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II
Methadone (9250)...........................  II
Morphine (9300)............................  II
Oripavine (9330)...........................  II
Thebaine (9333)............................  II
Opium, raw (9600)..........................  II
Opium extracts (9610)......................  II
Opium fluid extract (9620).................  II
Opium tincture (9630)......................  II
Opium, powdered (9639).....................  II
Opium, granulated (9640)...................  II
Oxymorphone (9652).........................  II

[[Page 14300]]

 
Noroxymorphone (9668)......................  II
Poppy Straw Concentrate (9670).............  II
Alfentanil (9737)..........................  II
Remifentanil (9739)........................  II
Sufentanil (9740)..........................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to manufacture the listed controlled substances 
in bulk for sale to its customers, for dosage form development, for 
clinical trials, and for use in stability qualification studies.
    No comments or objections have been received. The DEA has 
considered the factors in 21 U.S.C. 823(a) and determined that the 
registration of Cambrex Charles City, Inc., to manufacture the listed 
basic classes of controlled substances is consistent with the public 
interest at this time. The DEA has investigated Cambrex Charles City, 
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, and in accordance with 21 CFR 
1301.33, the above named company is granted registration as a bulk 
manufacturer of the basic classes of controlled substances listed.

    Dated: February 19, 2014.
 Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2014-05495 Filed 3-12-14; 8:45 am]
BILLING CODE 4410-09-P
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