[Federal Register Volume 80, Number 168 (Monday, August 31, 2015)]
[Notices]
[Page 52509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21464]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Catalent CTS, LLC

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic class, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration in accordance with 21 CFR 
1301.34(a) on or before September 30, 2015. Such persons may also file 
a written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before September 30, 2015.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODXL, 
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. 
Comments and requests for hearings on applications to import narcotic 
raw material are not appropriate. 72 FR 3417 (January 25, 2007).

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 1301.34(a), this is notice that on May 7, 
2015, Catalent CTS, LLC, 10245 Hickman Mills Drive, Kansas City, 
Missouri 64137 applied to be registered as an importer of Marihuana 
(7360), a basic class of controlled substance listed in schedule I.
    The company plans to import finished pharmaceutical products 
containing cannabis extracts in dosage form for clinical trial studies.
    This compound is listed under drug code 7360. No other activity for 
this drug code is authorized for this registration. Approval of permits 
applications will occur only when the registrant's business activity is 
consistent with what is authorized under to 21 U.S.C. 952(a)(2). 
Authorization will not extend to the import of FDA approved or non-
approved finished dosage forms for commercial sale.

    Dated: August 21, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-21464 Filed 8-28-15; 8:45 am]
BILLING CODE 4410-09-P