[Federal Register Volume 81, Number 36 (Wednesday, February 24, 2016)]
[Notices]
[Page 9220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03855]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Insys
Therapeutics, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: The Attorney General has delegated her authority under the
Controlled Substances Act to the Administrator of the Drug Enforcement
Administration (DEA).
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 25, 2016.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The Attorney General has delegated her
authority under the Controlled Substances Act to the 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
November 12, 2015, 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 the above-listed controlled
substances in bulk for distribution to its customers. In reference to
drug codes 7360, marihuana, and 7370, tetrahydrocannabinols, the
company plans to bulk manufacture both as synthetic substances. No
other activity for these drug codes is authorized for this
registration.
Dated: February 16, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-03855 Filed 2-23-16; 8:45 am]
BILLING CODE 4410-09-P