[Federal Register Volume 72, Number 181 (Wednesday, September 19, 2007)]
[Notices]
[Pages 53605-53606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-18497]


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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 
registration under 21 U.S.C. 952(a) authorizing the importation of such 
substances, 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 10, 2006, Lannett Company Incorporated, 9001 Torresdale 
Avenue, Philadelphia, Pennsylvania 19136, made application by letter 
and subsequent renewal on February 19, 2007 to the Drug Enforcement 
Administration (DEA) for registration as an importer of the basic 
classes of controlled substances:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols (7370)...............  I
Methylphenidate (1724).....................  II
Morphine (9300)............................  II
------------------------------------------------------------------------

    The company plans to import the basic classes of controlled 
substances for analytical testing on a formulated product for 
submission to U.S. Food and Drug Administration (FDA) for generic 
product approval.
    Any manufacturer who is presently, or is applying to be, registered 
with DEA to manufacture such basic classes of

[[Page 53606]]

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 being sent via regular mail should 
be addressed, in quintuplicate, to the Drug Enforcement Administration, 
Office of Diversion Control, Federal Register Representative (ODL), 
Washington, DC 20537, or any being sent via express mail should be sent 
to Drug Enforcement Administration, Office of Diversion Control, 
Federal Register Representative (ODL), 2401 Jefferson-Davis Highway, 
Alexandria, Virginia 22301; and must be filed no later than October 19, 
2007.
    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 43745-43746), 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: September 12, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. E7-18497 Filed 9-18-07; 8:45 am]
BILLING CODE 4410-09-P