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Home » 2015 Issues » 80 FR (09/23/2015) » 2015-24118. Importer of Controlled Substances Application: Fresenius Kabi USA, LLC

  2015-24118. Importer of Controlled Substances Application: Fresenius Kabi USA, LLC  

  • Start Preamble

    ACTION:

    Notice of application.

    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 October 23, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before October 23, 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.

    End Preamble Start Supplemental Information

    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 June 16, 2015, Fresenius Kabi USA, LLC, 3159 Staley Road, Grand Island, New York 14072 applied to be registered as an importer of remifentanil (9739), a basic class of controlled substance listed in schedule II.

    The company plans to import the listed controlled substance for product development and preparation of stability batches.

    Start Signature

    Dated: September 16, 2015.

    Joseph T. Rannazzisi,

    Deputy Assistant Administrator.

    End Signature End Supplemental Information

    [FR Doc. 2015-24118 Filed 9-22-15; 8:45 am]

    BILLING CODE 4410-09-P

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Document Information

Published:
09/23/2015
Department:
Drug Enforcement Administration
Entry Type:
Notice
Action:
Notice of application.
Document Number:
2015-24118
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 October 23, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before October 23, 2015.
Pages:
57389-57389 (1 pages)
Docket Numbers:
Docket No. DEA-392
PDF File:
2015-24118.pdf