Bulk Manufacturer of Controlled Substances Application: Siegfried USA, LLC, 7634-7635 [2015-02821]

Download as PDF 7634 Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices Dated: February 5, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. (9041), a basic class of controlled substance listed in schedule II. The company plans to import small quantities of ioflupane, in the form of three separate analogues of cocaine, to validate production and quality control systems, for a reference standard, and for producing material for a future investigational new drug (IND) submission. [FR Doc. 2015–02823 Filed 2–10–15; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: GE Healthcare Dated: February 5, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–02826 Filed 2–10–15; 8:45 am] ACTION: tkelley on DSK3SPTVN1PROD with NOTICES Controlled substance BILLING CODE 4410–09–P Notice of application. 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 1301.34(a) on or before March 13, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before March 13, 2015. 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. Comments and request for hearings on applications to import narcotic raw material are not appropriate. 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, dispenser, importers, and exporters 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 part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on September 12, 2014, GE Healthcare, 3350 North Ridge Avenue, Arlington Heights, Illinois 60004–1412 applied to be registered as an importer of cocaine DATES: VerDate Sep<11>2014 17:07 Feb 10, 2015 Jkt 235001 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Mallinckrodt LLC ACTION: Notice of application. 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 1301.34(a) on or before March 13, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before March 13, 2015. 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. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007). 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, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant DATES: PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on January 16, 2014, Mallinckrodt LLC, 3600 North Second Street, St. Louis, Missouri 63147, applied to be registered as an importer of the following basic classes of controlled substances: Phenylacetone (8501) .................. Coca Leaves (9040) ..................... Opium, raw (9600) ....................... Poppy Straw Concentrate (9670) Schedule II II II II The company plans to import the listed controlled substances for the manufacture of controlled substances in bulk for distribution to its customers. In reference to Phenylacetone (8501), the company plans to import the controlled substance for the bulk manufacture of amphetamine products for sale to its customers. Dated: February 5, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–02824 Filed 2–10–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Siegfried USA, LLC ACTION: Notice of application. 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 April 13, 2015. 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 DATES: E:\FR\FM\11FEN1.SGM 11FEN1 7635 Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters 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 part 0, appendix of subpart, R. In accordance with 21 CFR 1301.33(a), this is notice that on November 17, 2014, Siegfried USA, LLC, 33 Industrial Park Road, Pennsville, New Jersey 08070 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance Schedule Gamma Hydroxybutyric Acid (2010). Dihydromorphine (9145) ............... Hydromorphinol (9301) ................. Methylphenidate (1724) ................ Amobarbital (2125) ....................... Pentobarbital (2270) ..................... Secobarbital (2315) ...................... Codeine (9050) ............................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Methadone (9250) ........................ Methadone intermediate (9254) ... Dextropropoxyphene, bulk (nondosage forms) (9273). Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Opium tincture (9630) .................. Oxymorphone (9652) ................... I I I 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. Dated: February 5, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before April 13, 2015. 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, dispensers, importers, and exporters 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 part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on August 12, 2014, Cambridge Isotope Lab, 50 Frontage Road, Andover, Massachusetts 01810 applied to be registered as a bulk manufacturer of morphine (9300), a basic class of controlled substance listed in schedule II. The company plans to utilize small quantities of the listed controlled substance in the preparation of analytical standards. Dated: February 5, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–02820 Filed 2–10–15; 8:45 am] [FR Doc. 2015–02821 Filed 2–10–15; 8:45 am] BILLING CODE 4410–09–P BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration [Docket No. DEA–392] tkelley on DSK3SPTVN1PROD with NOTICES [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: INSYS Therapeutics, Inc. Bulk Manufacturer of Controlled Substances Application: Cambridge IsotoPE LAB ACTION: ACTION: Notice of application. issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before April 13, 2015. 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. ADDRESSES: 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 part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on October 17, 2014, Insys Therapeutics, Inc., 2700 Oakmont, Round Rock, Texas 78665 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... VerDate Sep<11>2014 17:07 Feb 10, 2015 Jkt 235001 Dated: February 5, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–02819 Filed 2–10–15; 8:45 am] BILLING CODE 4410–09–P Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the PO 00000 Frm 00072 Fmt 4703 Sfmt 9990 I I The company plans to manufacture bulk synthetic active pharmaceutical ingredients (APIs) for product development and distribution to its customers. No other activity for this drug code is authorized for this registration. DATES: Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on DATES: Schedule E:\FR\FM\11FEN1.SGM 11FEN1

Agencies

[Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)]
[Notices]
[Pages 7634-7635]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02821]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Siegfried 
USA, LLC

ACTION: Notice of application.

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

DATES: 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 April 13, 2015.

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

[[Page 7635]]

exercise all necessary functions with respect to the promulgation and 
implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers, importers, and exporters 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 part 0, appendix of subpart, R.
    In accordance with 21 CFR 1301.33(a), this is notice that on 
November 17, 2014, Siegfried USA, LLC, 33 Industrial Park Road, 
Pennsville, New Jersey 08070 applied to be registered as a bulk 
manufacturer of the following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)...........  I
Dihydromorphine (9145).....................  I
Hydromorphinol (9301)......................  I
Methylphenidate (1724).....................  II
Amobarbital (2125).........................  II
Pentobarbital (2270).......................  II
Secobarbital (2315)........................  II
Codeine (9050).............................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II
Methadone (9250)...........................  II
Methadone intermediate (9254)..............  II
Dextropropoxyphene, bulk (non-dosage forms)  II
 (9273).
Morphine (9300)............................  II
Oripavine (9330)...........................  II
Thebaine (9333)............................  II
Opium tincture (9630)......................  II
Oxymorphone (9652).........................  II
------------------------------------------------------------------------

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

    Dated: February 5, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-02821 Filed 2-10-15; 8:45 am]
BILLING CODE 4410-09-P

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