Manufacturer of Controlled Substances Registration: Organix, Inc., 52764-52765 [2014-21060]

Download as PDF 52764 Federal Register / Vol. 79, No. 171 / Thursday, September 4, 2014 / Notices DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration Controlled substance [Docket No. DEA–392] [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, Inc. Importer of Controlled Substances Registration: Akorn, Inc. ACTION: ACTION: Notice of registration. Akorn, Inc., applied to be registered as an importer of a certain basic class of controlled substance. The DEA grants Akorn, Inc., registration as an importer of this controlled substance. SUMMARY: By notice dated May 28, 2014, and published in the Federal Register on June 4, 2014, 79 FR 32317, Akorn, Inc., 1222 W. Grand Avenue, Decatur, Illinois 62522, applied to be registered as an importer of a certain basic class of controlled substance. No comments or objections were reviewed for this notice. The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Akorn, Inc., to import the basic class of controlled substance is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing 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 Remifentanil (9739), a basic class of controlled substance listed in schedule II. The company plans to import Remifentanil in bulk for use in dosage form manufacturing. SUPPLEMENTARY INFORMATION: mstockstill on DSK4VPTVN1PROD with NOTICES [FR Doc. 2014–21063 Filed 9–3–14; 8:45 am] BILLING CODE 4410–09–P 18:14 Sep 03, 2014 Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before November 3, 2014. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, and dispensers of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of 28 CFR pt. 0, subpt. R, App. In accordance with 21 CFR 1301.33(a), this is notice that on June 23, 2014, Chattem Chemicals, Inc., 3801 St. Elmo Avenue, Chattanooga, Tennessee 37409, applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: DATES: Controlled substance Dated: August 27, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. VerDate Mar<15>2010 Notice of application. Jkt 232001 Gamma Hydroxybutyric Acid (2010). 4-Methoxyamphetamine (7411) ... Dihydromorphine (9145) ............... Amphetamine (1100) .................... Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Pentobarbital (2270) ..................... Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ PO 00000 Frm 00140 Fmt 4703 Sfmt 4703 Schedule I I I II II II II II II II Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Meperidine (9230) ........................ Meperidine intermediate-A (9232) Meperidine intermediate-B (9233) Meperidine intermediate-C (9234) Methadone (9250) ........................ Methadone intermediate (9254) ... Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Opium tincture (9630) .................. Opium, powdered (9639) ............. Opium, granulated (9640) ............ Oxymorphone (9652) ................... Noroxymorphone (9668) .............. Alfentanil (9737) ........................... Remifentanil (9739) ...................... Sufentanil (9740) .......................... Tapentadol (9780) ........................ Fentanyl (9801) ............................ Schedule II II 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 and sale to its customers. Regarding (9640) the company plans to manufacture another controlled substance for sale to its customers. Dated: August 27, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–21062 Filed 9–3–14; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Organix, Inc. ACTION: Notice of registration. Organix, Inc. applied to be registered as a manufacturer of certain basic classes of narcotic and nonnarcotic controlled substances. The DEA grants Organix, Inc. registration as a manufacturer of those controlled substances. SUMMARY: By notice dated April 21, 2014, and published in the Federal Register on April 28, 2014, 79 FR 23376, Organix, Inc., 240 Salem Street, Woburn, Massachusetts 01801, applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections have been received. The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Organix, Inc. to manufacture the basic classes of controlled substances is SUPPLEMENTARY INFORMATION: E:\FR\FM\04SEN1.SGM 04SEN1 Federal Register / Vol. 79, No. 171 / Thursday, September 4, 2014 / Notices consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing 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: Controlled substance Schedule Gamma Hydroxybutyric Acid (2010). Lysergic acid diethylamide (7315) Heroin (9200) ............................... Morphine (9300) ........................... I I I II Controlled substance The company plans to manufacture reference standards for distribution to its research and forensics customers. Marihuana (7360) ....................... Tetrahydrocannabinols (7370) .... Dated: August 27, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: National Center for Natural Products Research (NIDA MProject), Inc. Notice of registration. National Center for Natural Products Research (NIDA MProject), Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants National Center for Natural Products Research (NIDA MProject), Inc., registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated November 5, 2013, and published in the Federal Register on November 18, 2013, 78 FR 69132, National Center for Natural Products Research (NIDA MProject), Inc., University of Mississippi, 135 Coy Waller Complex, University, Mississippi 38677, applied to be registered as a manufacturer of certain basic classes of controlled substances. mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Mar<15>2010 18:14 Sep 03, 2014 Jkt 232001 I I Dated: August 27, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. Drug Enforcement Administration SUMMARY: Schedule The company plans to cultivate marihuana in support of the National Institute on Drug Abuse for research approved by the Department of Health and Human Services. No comments or objections have been received. [FR Doc. 2014–21060 Filed 9–3–14; 8:45 am] ACTION: The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823(a) and determined that the registration of National Center for Natural Products Research (NIDA MProject), Inc., to manufacture 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. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verified the company’s compliance with state and local laws, and reviewed 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: [FR Doc. 2014–21077 Filed 9–3–14; 8:45 am] BILLING CODE 4410–09–P NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (14–091)] NASA Federal Advisory Committees National Aeronautics and Space Administration. ACTION: Annual invitation for public nominations by U.S. citizens for service on NASA Federal advisory committees. AGENCY: NASA announces its annual invitation for public nominations for service on NASA Federal advisory committees. U.S. citizens may submit self-nominations for consideration as potential members of NASA’s Federal advisory committees. NASA’s Federal advisory committees have member vacancies from time to time throughout the year, and NASA will consider selfnominations to fill such intermittent SUMMARY: PO 00000 Frm 00141 Fmt 4703 Sfmt 4703 52765 vacancies. NASA is committed to selecting members to serve on its Federal advisory committees based on their individual expertise, knowledge, experience, and current/past contributions to the relevant subject area. DATE: The deadline for NASA receipt of all public nominations is October 1, 2014. ADDRESSES: Self-nominations from interested U.S. citizens must be sent electronically to NASA in letter form, be signed, and must include the name of specific NASA Federal advisory committee of interest for NASA consideration. Self-nomination letters are limited to specifying interest in only one (1) NASA Federal advisory committee per year. The following additional information is required to be attached to each self-nomination letter (i.e., cover letter): (1) Professional resume (one-page maximum); (2) professional biography (one-page maximum). Please submit the selfnomination package as a single package containing cover letter and both required attachments to hq-nasanoms@ mail.nasa.gov. All public selfnomination packages must be submitted electronically via email to NASA; paperbased documents sent through postal mail (hard-copies) will not be accepted. Note: Nomination letters that are noncompliant with inclusion of the three (3) mandatory documents listed above will not receive further consideration by NASA. FOR FURTHER INFORMATION CONTACT: To view charters and obtain further information on NASA’s Federal advisory committees, please visit the NASA Advisory Committee Management Division Web site noted below. For any questions, please contact Ms. Marla King, Advisory Committee Specialist, Advisory Committee Management Division, Office of International and Interagency Relations, NASA Headquarters, Washington, DC 20546, (202) 358–1148. SUPPLEMENTARY INFORMATION: NASA’s six (6) currently chartered Federal advisory committees are listed below. The individual charters may be found at the NASA Advisory Committee Management Division’s Web site at http://oiir.hq.nasa.gov/acmd.html: • Aerospace Safety Advisory Panel— The Aerospace Safety Advisory Panel provides advice and recommendations to the NASA Administrator and the Congress on matters related to safety, and performs such other duties as the NASA Administrator may request. • Applied Sciences Advisory Committee—The Applied Sciences E:\FR\FM\04SEN1.SGM 04SEN1

Agencies

[Federal Register Volume 79, Number 171 (Thursday, September 4, 2014)]
[Notices]
[Pages 52764-52765]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21060]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Organix, Inc.

ACTION: Notice of registration.

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SUMMARY: Organix, Inc. applied to be registered as a manufacturer of 
certain basic classes of narcotic and non-narcotic controlled 
substances. The DEA grants Organix, Inc. registration as a manufacturer 
of those controlled substances.

SUPPLEMENTARY INFORMATION: By notice dated April 21, 2014, and 
published in the Federal Register on April 28, 2014, 79 FR 23376, 
Organix, Inc., 240 Salem Street, Woburn, Massachusetts 01801, applied 
to be registered as a manufacturer of certain basic classes of 
controlled substances. No comments or objections have been received.
    The Drug Enforcement Administration (DEA) has considered the 
factors in 21 U.S.C. 823(a) and determined that the registration of 
Organix, Inc. to manufacture the basic classes of controlled substances 
is

[[Page 52765]]

consistent with the public interest and with United States obligations 
under international treaties, conventions, or protocols in effect on 
May 1, 1971. The DEA investigated the company's maintenance of 
effective controls against diversion by inspecting and testing the 
company's physical security systems, verifying the company's compliance 
with state and local laws, and reviewing 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:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)...........  I
Lysergic acid diethylamide (7315)..........  I
Heroin (9200)..............................  I
Morphine (9300)............................  II
------------------------------------------------------------------------

    The company plans to manufacture reference standards for 
distribution to its research and forensics customers.

    Dated: August 27, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014-21060 Filed 9-3-14; 8:45 am]
BILLING CODE 4410-09-P