81 FR 66081 - Importer of Controlled Substances Application: Catalent CTS, LLC

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 186 (September 26, 2016)

[Federal Register Volume 81, Number 186 (Monday, September 26, 2016)]
[Notices]
[Pages 66081-66082]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-23017]


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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 classes, 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 October 26, 2016. Such persons may also file a 
written request for a hearing on the application

[[Page 66082]]

pursuant to 21 CFR 1301.43 on or before October 26, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: 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 1301.34(a), this is notice that on May 6, 
2016, Catalent CTS., LLC., 10245 Hickman Mills Drive, Kansas City, 
Missouri 64137 applied to be registered as an importer of the following 
basic classes of controlled substances:

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         Controlled substance           Drug code         Schedule
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Gamma Hydroxybutyric Acid.............       2010  I
Marihuana.............................       7360  I
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    The company plans to import finished dosage unit products 
containing gamma-hydroxybutyric acid and cannabis extracts for clinical 
trial studies.
    These cannabis extracts compounds are listed under drug code 7360. 
No other activity for this drug code is authorized for this 
registration. Approval of permit 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: September 19, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-23017 Filed 9-23-16; 8:45 am]
 BILLING CODE 4410-09-P