83 FR 14504 - Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 65 (April 4, 2018)

[Federal Register Volume 83, Number 65 (Wednesday, April 4, 2018)]
[Notices]
[Pages 14504-14505]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06872]


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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 May 4, 2018. Such 
persons may also file a written request for a hearing on the 
application on or before May 4, 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

[[Page 14505]]

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 
January 17, 2018, Catalent Pharma Solutions, LLC, 3031 Red Lion Road, 
Philadelphia, Pennsylvania 19114 applied to be registered as an 
importer of Gamma Hydroxybutyric Acid (2010), a basic class of 
controlled substance listed in schedule I.
    The company plans to import finished dosage unit products 
containing gamma-hydroxybutyric acid for clinical trials, research, and 
analytical activities.
    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: March 27, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-06872 Filed 4-3-18; 8:45 am]
 BILLING CODE 4410-09-P