83 FR 34874 - Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 141 (July 23, 2018)

[Federal Register Volume 83, Number 141 (Monday, July 23, 2018)]
[Notices]
[Pages 34874-34875]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-15719]


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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 August 22, 2018. 
Such persons may also file a written request for a hearing on the 
application on or before August 22, 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

[[Page 34875]]

Administration, Attn: Administrator, 8701 Morrissette Drive, 
Springfield, Virginia 22152. All request 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 delegated 
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 June 
18, 2018, Catalent Pharma Solutions, LLC, 3031 Red Lion Road, 
Philadelphia, Pennsylvania 19114, applied to be registered as an 
importer of the following basic class of controlled substance:

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                                           Drug
          Controlled substance             code          Schedule
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Gamma Hydroxybutyric Acid..............     2010  I
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    The company plans to import finished dosage unit products 
containing gamma-hydroxybutyric acid for clinical trials, research, and 
analytical activities.

    Dated: July 12, 2018
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-15719 Filed 7-20-18; 8:45 am]
 BILLING CODE 4410-09-P