2018-15719. Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC  

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    ACTION:

    Notice of application.

    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 Start Printed Page 34875Administration, 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.

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    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:

    Controlled substanceDrug codeSchedule
    Gamma Hydroxybutyric Acid2010I

    The company plans to import finished dosage unit products containing gamma-hydroxybutyric acid for clinical trials, research, and analytical activities.

    Start Signature

    Dated: July 12, 2018

    John J. Martin,

    Assistant Administrator.

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    [FR Doc. 2018-15719 Filed 7-20-18; 8:45 am]

    BILLING CODE 4410-09-P

Document Information

Published:
07/23/2018
Department:
Drug Enforcement Administration
Entry Type:
Notice
Action:
Notice of application.
Document Number:
2018-15719
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.
Pages:
34874-34875 (2 pages)
Docket Numbers:
Docket No. DEA-392
PDF File:
2018-15719.Pdf