Importer of Controlled Substances Application: Supernus Pharmaceuticals, Inc.

Federal Register: February 20, 2009 (Volume 74, Number 33)

Notices

Page 7923-7924

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

DOCID:fr20fe09-91

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 Title 21 Code of Federal Regulations

(CFR), 1301.34(a), this is notice that on January 16, 2009, Supernus

Pharmaceuticals, Inc., 1550 East Gude Drive, Rockville, Maryland 20850, made application by renewal to the Drug Enforcement Administration

(DEA) to be registered as

Page 7924

an importer of the basic classes of controlled substances listed in schedule II:

Drug

Schedule

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

Morphine (9300)............................. II

The company plans to import controlled substances for clinical trials and analytical testing.

Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances 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 March 23, 2009.

This procedure is to be conducted simultaneously with, and independent of, the procedures described in 21 CFR 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 substances 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: February 13, 2009.

Joseph T. Rannazzisi,

Deputy Assistant Administrator, Office of Diversion Control, Drug

Enforcement Administration.

FR Doc. E9-3650 Filed 2-19-09; 8:45 am

BILLING CODE 4410-09-P