[Federal Register Volume 83, Number 10 (Tuesday, January 16, 2018)]
[Notices]
[Page 2215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00507]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Catalent Pharma 
Solutions, 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 February 15, 2018. 
Such persons may also file a written request for a hearing on the 
application February 15, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
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/DRW, 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 
October 13, 2017, Catalent Pharma Solutions, LLC, 1100 Enterprise 
Drive, Winchester, KY 40391 applied to be registered as an importer for 
Gamma Hydroxybutyric Acid (2010) the basic class of controlled 
substances.
    The company plans to import the listed controlled substance in 
finished dosage form for analytical purposes only. 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 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: January 4, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-00507 Filed 1-12-18; 8:45 am]
 BILLING CODE 4410-09-P