[Federal Register Volume 78, Number 35 (Thursday, February 21, 2013)]
[Notices]
[Pages 12101-12102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-03902]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Application; Caraco 
Pharmaceutical Laboratories, LTD.

    Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this 
is notice that on November 22, 2012, Caraco Pharmaceutical 
Laboratories, Ltd., 270 Prospect Plains Road, Cranbury, New Jersey 
08512, made application to the Drug Enforcement Administration (DEA) to 
be registered as an importer of Fentanyl (9801), a basic class of 
controlled substance listed in schedule II.
    The company plans to import the listed controlled substance in 
finished dosage form for clinical trials, and research.
    The import of the above listed basic class of controlled substance 
is granted only for analytical testing and clinical trials. This 
authorization does not extend to the import of a finished FDA approved 
or non-approved dosage form

[[Page 12102]]

for commercial distribution in the United States.
    Any bulk manufacturer who is presently, or is applying to be, 
registered with DEA to manufacture such basic class of controlled 
substance listed in schedule II, which falls under the authority of 
section 1002(a)(2)(B) of the Act 21 U.S.C. 952(a)(2)(B) may, in the 
circumstances set forth in 21 U.S.C. 958(i), 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 March 25, 2013.
    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 
schedules 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 8, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-03902 Filed 2-20-13; 8:45 am]
BILLING CODE 4410-09-P