Bulk Manufacturer of Controlled Substances Application: Alcami Wisconsin Corporation

 
CONTENT

Federal Register, Volume 83 Issue 114 (Wednesday, June 13, 2018)

Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)

Notices

Page 27628

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

FR Doc No: 2018-12684

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

Docket No. DEA-392

Bulk Manufacturer of Controlled Substances Application: Alcami Wisconsin Corporation

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 August 13, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: 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 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 1301.33(a), this is notice that on May 3rd, 2018, Alcami Wisconsin Corporation, W130 N10497 Washington Dr., Germantown, WI 53022 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

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Controlled substance Drug code Schedule

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Thebaine........................... 9333 II

Alfentanil......................... 9737 II

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The company plans to provide bulk active pharmaceutical ingredient to support clinical trials.

Dated: June 6, 2018.

John J. Martin,

Assistant Administrator.

FR Doc. 2018-12684 Filed 6-12-18; 8:45 am

BILLING CODE 4410-09-P