[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)]
[Notices]
[Pages 54613-54614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23686]


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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 on or before November 29, 2018. 
Such persons may also file a written request for a hearing on the 
application on or before November 29, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
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/OALJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: 
    The Attorney General has delegated his 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 1301.34(a), this is notice that on July 
17, 2018, Catalent CTS, LLC, 10245 Hickman Mills Drive, Kansas City,

[[Page 54614]]

Missouri 64137-1418 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 Extract.....................       7350  I
Marihuana.............................       7360  I
Tetrahydrocannabinols.................       7370  I
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    The company plans to import finished dosage unit products 
containing gamma-hydroxybutryic acid and marihuana extracts for 
clinical trial studies. These marihuana extracts compounds are listed 
under drug code 7350. No other activity for these drug codes 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 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: October 19, 2018.
 John J. Martin,
Assistant Administrator.
[FR Doc. 2018-23686 Filed 10-29-18; 8:45 am]
 BILLING CODE 4410-09-P