80 FR 28 pg. 7634 - Importer of Controlled Substances Application: GE Healthcare
Type: NOTICEVolume: 80Number: 28Page: 7634
Page: 7634Docket number: [Docket No. DEA-392]
FR document: [FR Doc. 2015-02826 Filed 2-10-15; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
[top]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: GE Healthcare
ACTION:
Notice of application.
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 in accordance with 21 CFR 1301.34(a) on or before March 13, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before March 13, 2015.
ADDRESSES:
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and request for hearings on applications to import narcotic raw material are not appropriate.
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, dispenser, 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 September 12, 2014, GE Healthcare, 3350 North Ridge Avenue, Arlington Heights, Illinois 60004-1412 applied to be registered as an importer of cocaine (9041), a basic class of controlled substance listed in schedule II.
The company plans to import small quantities of ioflupane, in the form of three separate analogues of cocaine, to validate production and quality control systems, for a reference standard, and for producing material for a future investigational new drug (IND) submission.
Dated: February 5, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-02826 Filed 2-10-15; 8:45 am]
BILLING CODE 4410-09-P