Manufacturer of Controlled Substances Registration: Noramco, Inc., 38472 [2015-16455]

Download as PDF 38472 Federal Register / Vol. 80, No. 128 / Monday, July 6, 2015 / Notices of certain basic classes of controlled substances. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Mylan Pharmaceuticals, Inc. 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. 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 the basic classes of controlled substances: Controlled substance Schedule Amphetamine (1100) .................... Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Pentobarbital (2270) ..................... Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Levorphanol (9220) ...................... Morphine (9300) ........................... Oxymorphone (9652) ................... Remifentanil (9739) ...................... Fentanyl (9801) ............................ II II II II II II II II II II II II The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company’s own domestically-manufactured FDF. This analysis is required to allow the company to export domesticallymanufactured FDF to foreign markets. Dated: June 25, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–16453 Filed 7–2–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Lhorne on DSK7TPTVN1PROD with NOTICES Drug Enforcement Administration [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Noramco, Inc. ACTION: Notice of registration. VerDate Sep<11>2014 14:37 Jul 02, 2015 Jkt 235001 Noramco, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Noramco, Inc. registration as a manufacturer of those controlled substances. SUMMARY: By notice dated September 26, 2014, and published in the Federal Register on October 7, 2014, 79 FR 60498, Noramco, Inc., Olympic Drive, Athens, Georgia 30601 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted to this notice. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Noramco, 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, 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: SUPPLEMENTARY INFORMATION: Controlled substance Gamma Hydroxybutyric Acid (2010). Codeine-N-oxide (9053) ............... Dihydromorphine (9145) ............... Morphine-N-oxide (9307) ............. Amphetamine (1100) .................... Methylphenidate (1724) ................ Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Opium tincture (9630) .................. Oxymorphone (9652) ................... Noroxymorphone (9668) .............. Alfentanil (9737) ........................... Sufentanil (9740) .......................... Carfentanil (9743) ......................... Tapentadol (9780) ........................ Fentanyl (9801) ............................ Schedule I I I I 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 to its customers. PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Dated: June 25, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–16455 Filed 7–2–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE [OMB Number 1110–NEW] Agency Information Collection Activities; Proposed eCollection eComments Requested; Approval of a New Collection Request for Emergency or Term Access to National Security Information Form (FD–1116) Federal Bureau of Investigation, DOJ. ACTION: 30-day notice. AGENCY: The Department of Justice (DOJ), Federal Bureau of Investigation (FBI), Security Division (SecD) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the FR 80 23290, April 27, 2015, allowing for a 60 day comment period. DATES: Comments are encouraged and will be accepted for an additional 30 days until August 5, 2015. FOR FURTHER INFORMATION CONTACT: If you have comments, especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503. Additionally, comments may be submitted via email to OIRA_submissions@omb.eop.gov. SUPPLEMENTARY INFORMATION: 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: 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; SUMMARY: E:\FR\FM\06JYN1.SGM 06JYN1

Agencies

[Federal Register Volume 80, Number 128 (Monday, July 6, 2015)]
[Notices]
[Page 38472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16455]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Noramco, Inc.

ACTION: Notice of registration.

-----------------------------------------------------------------------

SUMMARY: Noramco, Inc. applied to be registered as a manufacturer of 
certain basic classes of controlled substances. The Drug Enforcement 
Administration (DEA) grants Noramco, Inc. registration as a 
manufacturer of those controlled substances.

SUPPLEMENTARY INFORMATION: By notice dated September 26, 2014, and 
published in the Federal Register on October 7, 2014, 79 FR 60498, 
Noramco, Inc., Olympic Drive, Athens, Georgia 30601 applied to be 
registered as a manufacturer of certain basic classes of controlled 
substances. No comments or objections were submitted to this notice.
    The DEA has considered the factors in 21 U.S.C. 823(a) and 
determined that the registration of Noramco, 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, 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
Codeine-N-oxide (9053).....................  I
Dihydromorphine (9145).....................  I
Morphine-N-oxide (9307)....................  I
Amphetamine (1100).........................  II
Methylphenidate (1724).....................  II
Codeine (9050).............................  II
Dihydrocodeine (9120)......................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II
Morphine (9300)............................  II
Oripavine (9330)...........................  II
Thebaine (9333)............................  II
Opium tincture (9630)......................  II
Oxymorphone (9652).........................  II
Noroxymorphone (9668)......................  II
Alfentanil (9737)..........................  II
Sufentanil (9740)..........................  II
Carfentanil (9743).........................  II
Tapentadol (9780)..........................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to manufacture the listed controlled substances 
in bulk for distribution to its customers.

    Dated: June 25, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-16455 Filed 7-2-15; 8:45 am]
 BILLING CODE 4410-09-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.