Importers of Controlled Substance; Applications:

Federal Register: December 9, 2010 (Volume 75, Number 236)

Notices

Page 76755

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr09de10-84

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

Importer of Controlled Substances; Notice of Application

Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to issuing a registration under this Section to a bulk manufacturer of a controlled substance in schedule I or II, and prior to issuing a regulation under 21 U.S.C. 952(a)(2) authorizing the importation of such a substance, provide manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing.

Therefore, in accordance with 21 CFR 1301.34(a), this is notice that on October 19, 2010, Mylan Pharmaceuticals, Inc., 781 Chestnut

Ridge Road, Morgantown, West Virginia 26505, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the basic classes of controlled substances listed in schedule II:

Drug

Schedule

Methylphenidate (1724)..................... II

Oxycodone (9143)........................... II

Hydromorphone (9150)....................... II

Fentanyl (9801)............................ II

The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company's own domestically-manufactured FDF. This analysis is required to allow the company to export domestically-manufactured FDF to foreign markets.

Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic class of controlled substance may file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43, and in such form as prescribed by 21 CFR 1316.47.

Any such comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of

Diversion Control, Federal Register Representative (ODL), 8701

Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than January 10, 2011.

This procedure is to be conducted simultaneously with, and independent of, the procedures described in 21 CFR Sec. 1301.34(b),

(c), (d), (e), and (f). As noted in a previous notice published in the

Federal Register on September 23, 1975, (40 FR 43745-46), all applicants for registration to import a basic class of any controlled substance in schedule I or II are, and will continue to be, required to demonstrate to the Deputy Assistant Administrator, Office of Diversion

Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied.

Dated: November 29, 2010.

Joseph T. Rannazzisi,

Deputy Assistant Administrator, Office of Diversion Control, Drug

Enforcement Administration.

FR Doc. 2010-30901 Filed 12-8-10; 8:45 am

BILLING CODE 4410-09-P