[Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)]
[Notices]
[Page 7635]
From the Federal Register Online via the Government Publishing 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:

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