Manufacturer of Controlled Substances; Notice of Application, 21916 [2011-9370]

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

Agencies

[Federal Register Volume 76, Number 75 (Tuesday, April 19, 2011)]
[Notices]
[Page 21916]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9370]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Application

    Pursuant to Sec.  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:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)...........  I
Tetrahydrocannabinols (7370)...............  I
Methamphetamine (1105).....................  II
Pentobarbital (2270).......................  II
Nabilone (7379)............................  II
------------------------------------------------------------------------

    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 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]
BILLING CODE 4410-09-P

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