2014-12940. Importer of Controlled Substances Application: Akorn, Inc.

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 July 7, 2014. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before July 7, 2014.

ADDRESSES:

Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 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, and dispensers 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 sec. 7(g) of 28 CFR part 0, subpart R, App.

In accordance with 21 CFR 1301.34(a), this is notice that on April 30, 2014, Akorn, Inc., 1222 W. Grand Avenue, Decatur, Illinois 62522, applied to be registered as an importer of Remifentanil (9739), a basic class controlled substance listed in schedule II.

The company plans to import Remifentanil in bulk for use in dosage form manufacturing.

Dated: May 28, 2014.

Joseph T. Rannazzisi,

Deputy Assistant Administrator.