[Federal Register Volume 75, Number 1 (Monday, January 4, 2010)]
[Notices]
[Page 160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-31165]



[[Page 160]]

-----------------------------------------------------------------------

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 November 5, 2009, Mylan Technologies Inc., 110 Lake Street, 
Saint Albans, Vermont 05478, 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
Fentanyl (9801)..............................................         II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
analytical research and clinical trials.
    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 February 3, 2010.
    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 
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: December 17, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. E9-31165 Filed 12-31-09; 8:45 am]
BILLING CODE 4410-09-P