[Federal Register Volume 77, Number 41 (Thursday, March 1, 2012)]
[Notices]
[Pages 12620-12621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4992]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances, Notice of Application, Mylan 
Pharmaceuticals, Inc.

    Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to 
issuing

[[Page 12621]]

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 December 30, 2011, Mylan Pharmaceuticals, Inc., 781 Chestnut 
Ridge Road, Morgantown, West Virginia 26505, made application by letter 
to the Drug Enforcement Administration (DEA) to be registered as an 
importer of the following basic classes of controlled substances:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Amphetamine (1100).........................  II
Methadone (9250)...........................  II
Morphine (9300)............................  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 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 written 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 April 2, 2012.
    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: February 23, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2012-4992 Filed 2-29-12; 8:45 am]
BILLING CODE 4410-09-P