Manufacturers Notice of Application - 2014
[Federal Register Volume 79, Number 81 (Monday, April 28, 2014)]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09563]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals, Inc.
ACTION: Notice of application with opportunity for comment.
DATES: Registered bulk manufacturers of the affected basic classes and applicants therefore may file written comments or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before June 27, 2014.
ADDRESSES: Written comments should be sent via regular or express mail 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 1301.33(a), this is notice that on January 8, 2014, Patheon Pharmaceuticals, Inc., 2110 E. Galbraith Road, Cincinnati, Ohio 45237, made application by renewal to the DEA to be registered as a bulk manufacturer of Gamma Hydroxybutyric Acid (2010), a basic class of nonnarcotic controlled substances in schedule I.
The company plans to manufacture the listed controlled substance for distribution to its customers.
Dated: April 21, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014-09563 Filed 4-25-14; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).