[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