2014-01781. Manufacturer of Controlled Substances; Notice of Registration; Irix Manufacturing, Inc.

By Notice dated August 5, 2013, and published in the Federal Register on August 14, 2013, 78 FR 49546, IRIX Manufacturing, Inc., 309 Delaware Street, Greenville, South Carolina 29605, made application to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of Noroxymorphone (9668), a basic class of controlled substance listed in schedule II.

The company plans to manufacture the listed controlled substance as API for clinical trials.

No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a), and determined that the registration of IRIX Manufacturing, Inc., to manufacture the listed basic class of controlled substance is consistent with the public interest at this time. DEA has investigated IRIX Manufacturing, Inc., to ensure that the company's registration is consistent with the public interest. The investigation has included inspection and testing of the company's physical security systems, verification of the company's compliance with state and local laws, and a review of the company's background and history. Therefore, pursuant to 21 U.S.C. 823, and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic class of controlled substance listed.

Dated: January 15, 2014.

Joseph T. Rannazzisi,

Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.