[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Notices]
[Page 1888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-00197]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Application; 
Fresenius Kabi USA, LLC.

    Pursuant to 21 CFR 1301.34(a), this is notice that on November 2, 
2012, Fresenius Kabi USA, LLC., 3159 Stanley Road, Grand Island, New 
York 14072, made application to the Drug Enforcement Administration 
(DEA) for registration as an importer of Remifentanil (9739), a basic 
class of controlled substance listed in schedule II.
    The company plans to import this controlled substance for product 
development and preparation of stability batches.
    Any bulk manufacturer who is presently, or is applying to be, 
registered with DEA to manufacture such basic class of controlled 
substance listed in schedules 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 (ODW), 8701 
Morrissette Drive, Springfield, Virginia 22152; and must be filed no 
later than February 10, 2014.
    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: December 31, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2014-00197 Filed 1-9-14; 8:45 am]
BILLING CODE 4410-09-P