[Federal Register Volume 78, Number 76 (Friday, April 19, 2013)]
[Notices]
[Page 23594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-09293]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Application; 
Catalent CTS., Inc.

    Pursuant to Title 21, of the Code of Federal Regulations 
1301.34(a), this is notice that on August 6, 2012, Catalent Cts., Inc., 
10245 Hickman Mills Drive, Kansas City, Missouri 64137, made 
application by renewal to the Drug Enforcement Administration (DEA) for 
registration as an importer of the following basic classes of 
controlled substances:

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                    Drug                               Schedule
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Marihuana (7360)...........................  I
Poppy Straw Concentrate (9670).............  II
------------------------------------------------------------------------

    The company plans to import a finished pharmaceutical product 
containing cannabis extracts in dosage form, to package for a clinical 
trial study. In addition, the company also plans to import an ointment 
for the treatment of wounds which contain trace amounts of the 
controlled substances normally found in poppy straw concentrate for 
packaging and labeling for clinical trials.
    Comments and requests for any hearings on applications to import 
narcotic raw material are not appropriate. 72 FR 3417(2007).
    Any bulk manufacturer who is presently, or is applying to be, 
registered with DEA to manufacture such basic classes of controlled 
substances listed in schedule I or II, which fall 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, VA 22152; and must be filed no later 
than May 20, 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 
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: April 10, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-09293 Filed 4-18-13; 8:45 am]
BILLING CODE 4410-09-P