[Federal Register Volume 64, Number 62 (Thursday, April 1, 1999)]
[Notices]
[Page 15811]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8055]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importation of Controlled Substances; Notice of Application

    Pursuant to section 1008 of the Controlled Substances Import and 
Export Act (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 Section 1002(a) 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 section 1301.34 of Title 21, Code of 
Federal Regulations (CFR), notice is hereby given that on November 30, 
1998, Taro Pharmaceuticals U.S.A., Inc., 5 Skyline Drive, Hawthorne, 
New York 10532, made application to the Drug Enforcement Administration 
to be registered as a importer of the basic classes of controlled 
substances listed below:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Pentobarbital (2270).......................  II
Codeine (9050).............................  II
Oxycodone (9143)...........................  II
Hydrocodone (9193).........................  II
------------------------------------------------------------------------

    The firm plans to import finished product sample for evaluation and 
conducting clinical/Bio-equivalence testing.
    Any manufacturer holding, or applying for, registration as a bulk 
manufacturer of these basic classes of controlled substances may file 
written comments on or objections to the application described above 
and may, at the same time, file a written request for a hearing on such 
application in accordance with 21 CFR 1301.43 in such form as 
prescribed by 21 CFR 1316.47.
    Any such comments, objections or requests for a hearing may be 
addressed, in quintuplicate, to the Deputy Assistant Administrator, 
Office of Diversion Control, Drug Enforcement Administration, United 
States Department of Justice, Washington, D.C. 20537, Attention: DEA 
Federal Register Representative (CCF), and must be filed no later than 
May 3, 1999.
    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 at 40 FR 43745-46 
(September 23, 1975), 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(a), (b), (c), 
(d), (e), and (f) are satisfied.

    Dated: January 27, 1999.
John H. King,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 99-8055 Filed 3-31-99; 8:45 am]
BILLING CODE 4410-09-M