[Federal Register Volume 81, Number 243 (Monday, December 19, 2016)]
[Notices]
[Page 91948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30368]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Research 
Triangle Institute

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 February 17, 2017.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
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 Assistant Administrator of the DEA Diversion Control Division 
(``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 March 
13, 2015, Research Triangle Institute, Kenneth S. Rehder, Hermann 
Building, East Institute Drive, P.O. Box 12194, Research Triangle Park, 
North Carolina 27709-2194 applied to be registered as a bulk 
manufacturer of the following basic classes of controlled substances:

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      Controlled substance           Drug code           Schedule
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Marihuana.......................            7360  I
Tetrahydrocannabinols...........            7370  I
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    The company will manufacture marihuana (7360) and 
tetrahydrocannabinols (7370) for use by their researchers under the 
above-listed controlled substances as Active Pharmaceutical Ingredients 
(API) for clinical trials.
    In reference to drug code (7370) the company plans to bulk 
manufacture a synthetic tetrahydrocannabinol. No other activity for 
this drug code is authorized for this registration.

    Dated: December 3, 2016.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2016-30368 Filed 12-16-16; 8:45 am]
 BILLING CODE 4410-09-P