[Federal Register Volume 81, Number 182 (Tuesday, September 20, 2016)]
[Notices]
[Page 64509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22526]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Patheon 
API Manufacturing, 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 November 21, 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 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 
January 13, 2016, Patheon API Manufacturing, Inc., 309 Delaware Street, 
Building 1106, Greenville, South Carolina 29605 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
Noroxymorphone (9668)......................  II
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    The company plans to manufacture the above-listed controlled 
substances as Active Pharmaceutical Ingredient (API) for clinical 
trials.
    In reference to drug codes 7360 (marihuana), and 7370 (THC), the 
company plans to bulk manufacture these drugs as synthetics. No other 
activities for these drug codes are authorized for this registration.

    Dated: September 12, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-22526 Filed 9-19-16; 8:45 am]
 BILLING CODE 4410-09-P