Manufacturer of Controlled Substances; Notice of Registration, 21916-21917 [2011-9361]

Download as PDF 21916 Federal Register / Vol. 76, No. 75 / Tuesday, April 19, 2011 / Notices active pharmaceutical ingredient (API) form. There are no domestic sources of Nabilone in finished drug product form available in the United States. The U.S. Food and Drug Administration has approved this product for medical use in the United States. 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, Virginia 22152; and must be filed no later than May 19, 2011. 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: April 11, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. DEPARTMENT OF JUSTICE Manufacturer of Controlled Substances; Notice of Application mstockstill on DSKH9S0YB1PROD with NOTICES BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration internally within the company. It is the company’s intention that, when the manufacturing process is refined to the point that its Nabilone bulk product is available for commercial use, the company will export the controlled substance in bulk solely to customers engaged in dosage-form manufacturing outside the United States. The company is aware of the requirement to obtain a DEA registration as an exporter to conduct this activity. 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 June 20, 2011. Dated: April 11, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2011–9370 Filed 4–18–11; 8:45 am] Manufacturer of Controlled Substances; Notice of Application BILLING CODE 4410–09–P Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on December 14, 2010, Norac Inc., 405 S. Motor Avenue, P.O. Box 577, Azusa, California 91702–3232, 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: DEPARTMENT OF JUSTICE Schedule I I II II II Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration By Notice dated December 20, 2010, and published in the Federal Register on December 29, 2010, 75 FR 82073, Siegfried (USA), Inc., 33 Industrial Park Road, Pennsville, New Jersey 08070, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the basic classes of controlled substances listed in schedules I and II: Drug Drug Enforcement Administration Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on September 16, 2010, Mallinckrodt, Inc., 3600 North Second Street, St. Louis, Missouri 63147, made application by letter to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of 4-Anilino-N-Phenethyl- Jkt 223001 [FR Doc. 2011–9369 Filed 4–18–11; 8:45 am] Gamma Hydroxybutyric Acid (2010). Tetrahydrocannabinols (7370) ..... Methamphetamine (1105) ............ Pentobarbital (2270) ..................... Nabilone (7379) ............................ BILLING CODE 4410–09–P 16:19 Apr 18, 2011 Dated: April 11, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Drug [FR Doc. 2011–9367 Filed 4–18–11; 8:45 am] VerDate Mar<15>2010 4-Piperidine (ANPP)(8333), a basic class of controlled substance listed in schedule II. The company plans to use this controlled substance in the manufacture of another controlled substance. 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 June 20, 2011. With regard to Gamma Hydroxybutyric Acid (2010), Tetrahydrocannabinols (7370), and Methamphetamine (1105) only, the company manufactures these controlled substances in bulk solely for domestic distribution within the United States to customers engaged in dosage-form manufacturing. With regard to Nabilone (7379) only, the company presently manufactures a small amount of this controlled substance in bulk solely to conduct manufacturing process development PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 Gamma Hydroxybutyric Acid (2010). Dihydromorphine (9145) ............... Methylphenidate (1724) ................ Amobarbital (2125) ....................... Pentobarbital (2270) ..................... Secobarbital (2315) ...................... Codeine (9050) ............................. Oxycodone (9143) ........................ Drug Hydromorphone (9150) ................ Hydrocodone (9193) ..................... E:\FR\FM\19APN1.SGM 19APN1 Schedule I I II II II II II II Schedule II II Federal Register / Vol. 76, No. 75 / Tuesday, April 19, 2011 / Notices Drug Schedule Methadone (9250) ........................ Methadone intermediate (9254) ... Dextropropoxyphene, bulk (nondosage forms) (9273). Morphine (9300) ........................... Oxymorphone (9652) ................... Oxycodone (9143) ........................ II II II Drug Schedule Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... II II II The company plans to manufacture the above listed controlled substances in bulk for distribution to its customers. Drug codes 1100 (amphetamine) and 2550 (glutethimide) have been withdrawn from the application for registration at the request of the company. 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 Siegfried (USA), Inc. to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Siegfried (USA), 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: April 11, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. I I The company plans to manufacture small quantities of marihuana derivatives for research purposes. In reference to drug code 7360 (Marihuana), the company plans to bulk manufacture cannabidiol. In reference to drug code 7370 (Tetrahydrocannabinols), the company will manufacture a synthetic THC. No other activity for this drug code is authorized for this registration. 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 Cayman Chemical Company to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Cayman Chemical Company 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: April 11, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2011–9360 Filed 4–18–11; 8:45 am] BILLING CODE 4410–09–P [FR Doc. 2011–9361 Filed 4–18–11; 8:45 am] BILLING CODE 4410–09–P NATIONAL TRANSPORTATION SAFETY BOARD DEPARTMENT OF JUSTICE Sunshine Act Meeting Drug Enforcement Administration TIME AND DATE: mstockstill on DSKH9S0YB1PROD with NOTICES Manufacturer of Controlled Substances; Notice of Registration By Notice dated October 8, 2010, and published in the Federal Register on October 20, 2010, (75 FR 64744), Cayman Chemical Company, 1180 East Ellsworth Road, Ann Arbor, Michigan 48108, 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: VerDate Mar<15>2010 16:19 Apr 18, 2011 Jkt 223001 9:30 a.m., Tuesday, April 26, 2011. PLACE: NTSB Conference Center, 429 L’Enfant Plaza, SW., Washington, DC 20594. STATUS: The ONE item is open to the public. MATTER TO BE CONSIDERED: 8093A Aviation Accident Report Crash During Unstabilized Approach, Empire Airlines Flight 8284, Avions de ´ Transport Regional Aerospatiale Alenia ATR 42 320, N902FX, Lubbock, Texas, January 27, 2009. PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 21917 Telephone: (202) 314–6100. The press and public may enter the NTSB Conference Center one hour prior to the meeting for set up and seating. Individuals requesting specific accommodations should contact Rochelle Hall at (202) 314–6305 by Friday, April 22, 2011. The public may view the meeting via a live or archived webcast by accessing a link under ‘‘News & Events’’ on the NTSB home page at https:// www.ntsb.gov. NEWS MEDIA CONTACT: FOR FURTHER INFORMATION CONTACT: Candi Bing, (202) 314–6403 or by e-mail at bingc@ntsb.gov. Dated: April 15, 2011. Candi R. Bing, Federal Register Liaison Officer. [FR Doc. 2011–9565 Filed 4–15–11; 4:15 pm] BILLING CODE 7533–01–P NUCLEAR REGULATORY COMMISSION [NRC–2011–0082] Biweekly Notice; Applications and Amendments to Facility Operating Licenses Involving No Significant Hazards Considerations I. Background Pursuant to Section 189a.(2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (the Commission or NRC) is publishing this regular biweekly notice. The Act requires the Commission publish notice of any amendments issued, or proposed to be issued and grants the Commission the authority to issue and make immediately effective any amendment to an operating license upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person. This biweekly notice includes all notices of amendments issued, or proposed to be issued from March 24, 2011, to April 6, 2011. The last biweekly notice was published on April 5, 2011 (76 FR 18801). Notice of Consideration of Issuance of Amendments to Facility Operating Licenses, Proposed No Significant Hazards Consideration Determination, and Opportunity for a Hearing The Commission has made a proposed determination that the following amendment requests involve no significant hazards consideration. E:\FR\FM\19APN1.SGM 19APN1

Agencies

[Federal Register Volume 76, Number 75 (Tuesday, April 19, 2011)]
[Notices]
[Pages 21916-21917]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9361]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Registration

    By Notice dated December 20, 2010, and published in the Federal 
Register on December 29, 2010, 75 FR 82073, Siegfried (USA), Inc., 33 
Industrial Park Road, Pennsville, New Jersey 08070, made application by 
renewal to the Drug Enforcement Administration (DEA) to be registered 
as a bulk manufacturer of the basic classes of controlled substances 
listed in schedules I and II:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)...........  I
Dihydromorphine (9145).....................  I
Methylphenidate (1724).....................  II
Amobarbital (2125).........................  II
Pentobarbital (2270).......................  II
Secobarbital (2315)........................  II
Codeine (9050).............................  II
Oxycodone (9143)...........................  II
------------------------------------------------------------------------


------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II

[[Page 21917]]

 
Methadone (9250)...........................  II
Methadone intermediate (9254)..............  II
Dextropropoxyphene, bulk (non-dosage forms)  II
 (9273).
Morphine (9300)............................  II
Oxymorphone (9652).........................  II
Oxycodone (9143)...........................  II
------------------------------------------------------------------------

    The company plans to manufacture the above listed controlled 
substances in bulk for distribution to its customers.
    Drug codes 1100 (amphetamine) and 2550 (glutethimide) have been 
withdrawn from the application for registration at the request of the 
company.
    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 
Siegfried (USA), Inc. to manufacture the listed basic classes of 
controlled substances is consistent with the public interest at this 
time. DEA has investigated Siegfried (USA), 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: April 11, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2011-9361 Filed 4-18-11; 8:45 am]
BILLING CODE 4410-09-P

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