[Federal Register Volume 80, Number 232 (Thursday, December 3, 2015)]
[Notices]
[Page 75690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30558]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Navinta, LLC

ACTION: Notice of registration.

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SUMMARY: Navinta, LLC applied to be registered as a manufacturer of 
certain basic classes of controlled substances. The Drug Enforcement 
Administration (DEA) grants Navinta, LLC registration as a manufacturer 
of those controlled substances.

SUPPLEMENTARY INFORMATION: By notice dated June 25, 2015, and published 
in the Federal Register on July 6, 2015, 80 FR 38471, Navinta, LLC, 
1499 Lower Ferry Road, Ewing, New Jersey 08618-1414 applied to be 
registered as a manufacturer of certain basic classes of controlled 
substances. No comments or objections were submitted for this notice.
    The DEA has considered the factors in 21 U.S.C. 823(a) and 
determined that the registration of Navinta, LLC to manufacture the 
basic classes of controlled substances is consistent with the public 
interest and with United States obligations under international 
treaties, conventions, or protocols in effect on May 1, 1971. The DEA 
investigated the company's maintenance of effective controls against 
diversion by inspecting and testing the company's physical security 
systems, verifying the company's compliance with state and local laws, 
and reviewing 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 following basic classes of controlled substances:

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            Controlled substance                       Schedule
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4-Anilino-N-phenethyl-4-piperidine (ANPP)    II
 (8333).
Fentanyl (9801)............................  II
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    The company plans initially to manufacture API quantities of the 
listed controlled substances for validation purposes and FDA approval, 
then eventually upon FDA approval to produce commercial size batches 
for distribution to dosage form manufacturers.

    Dated: November 23, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-30558 Filed 12-2-15; 8:45 am]
 BILLING CODE 4410-09-P