Bulk Manufacturer of Controlled Substances Application: INSYS Therapeutics, Inc., 7635 [2015-02819]

Download as PDF 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]
[Page 7635]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02819]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: INSYS 
Therapeutics, Inc.

ACTION: Notice of application.

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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 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:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Marihuana (7360)...........................  I
Tetrahydrocannabinols (7370)...............  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.

    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

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