[Federal Register Volume 80, Number 168 (Monday, August 31, 2015)]
[Notices]
[Page 52510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21520]


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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 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.

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 July 
27, 2015, Catalent Pharma Solutions, LLC, 10381 Decatur Road, 
Philadelphia, Pennsylvania 19114 applied to be registered as an 
importer of hydromorphone (9150), a basic class of controlled substance 
listed in schedule II.
    The company plans to import the above listed controlled substance 
for a clinical trial study. 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: August 21, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-21520 Filed 8-28-15; 8:45 am]
BILLING CODE 4410-09-P