[Federal Register Volume 78, Number 165 (Monday, August 26, 2013)]
[Notices]
[Page 52802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20757]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Registration: 
Navinta, LLC

    By Notice dated April 10, 2013, and published in the Federal 
Register on April 19, 2013, 78 FR 23596, Navinta, LLC., 1499 Lower 
Ferry Road, Ewing, New Jersey 08618-1414, made application to the Drug 
Enforcement Administration (DEA) to be registered as a bulk 
manufacturer of the following basic classes of controlled substances:

------------------------------------------------------------------------
                             Drug                               Schedule
------------------------------------------------------------------------
Pentobarbital (2270).........................................         II
Remifentanil (9739)..........................................         II
------------------------------------------------------------------------

    The company plans initially to manufacture API quantities of the 
listed controlled substances for validation purposes and FDA approval, 
then to produce commercial size batches for distribution to dosage form 
manufacturers upon FDA approval.
    No comments or objections have been received. DEA has considered 
the factors in 21 U.S.C. 823(a) and determined that the registration of 
Navinta, LLC., to manufacture the listed basic classes of controlled 
substances is consistent with the public interest at this time. DEA has 
investigated Navinta, LLC., to ensure that the company's registration 
is consistent with the public interest. The investigation has included 
inspection and testing of the company's physical security systems, 
verification of the company's compliance with state and local laws, and 
a review of the company's background and history. Therefore, pursuant 
to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above 
named company is granted registration as a bulk manufacturer of the 
basic classes of controlled substances listed.

     Dated: August 15, 2013.
 Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-20757 Filed 8-23-13; 8:45 am]
BILLING CODE 4410-09-P