Importer of Controlled Substances Application: Fresenius Kabi USA, LLC

Federal Register, Volume 81 Issue 158 (Tuesday, August 16, 2016)

Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)

Notices

Pages 54601-54602

From the Federal Register Online via the Government Publishing Office www.gpo.gov

FR Doc No: 2016-19434

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

Docket No. DEA-392

Importer of Controlled Substances Application: Fresenius Kabi USA, LLC

ACTION: Notice of application.

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SUMMARY: Registered bulk manufacturers of the affected basic class, and applicants therefor, 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 September 15, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 15, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 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/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152.

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 13, 2016, 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

Page 54602

development and preparation of stability batches.

Louis J. Milione,

Deputy Assistant Administrator.

FR Doc. 2016-19434 Filed 8-15-16; 8:45 am

BILLING CODE 4410-09-P