81 FR 95640 - Bulk Manufacturer of Controlled Substances Application: Navinta LLC

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 249 (December 28, 2016)

[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)]
[Notices]
[Pages 95640-95641]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31282]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Navinta 
LLC

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration in accordance with 21 CFR 
1301.33(a) on or before February 27, 2017.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 
authority under the Controlled Substances Act to the Administrator of 
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or revocation of registration) has been redelegated 
to the Deputy Assistant Administrator of the DEA Office of Diversion 
Control (``Deputy Assistant Administrator'') pursuant to section 7 of 
28 CFR part 0, appendix to subpart R.
    In accordance with 21 CFR 1301.33(a), this is notice that on 
September 19, 2016, Navinta LLC, 1499

[[Page 95641]]

Lower Ferry Road, Ewing, New Jersey 08618-1414 applied to be registered 
as a bulk manufacturer of the following basic classes controlled 
substances:

------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
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Pentobarbital......................            2270  II
4-Anilino-N-phenethyl-4-piperidine             8333  II
 (ANPP).
Remifentanil.......................            9739  II
Fentanyl...........................            9801  II
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    The company plans to initially to manufacture API quantities of the 
listed controlled substances for validation purposes and FDA approval, 
then eventually up FDA approval to produce commercial size batches for 
distribution to dosage form manufacturers.

    Dated: December 19, 2016.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2016-31282 Filed 12-27-16; 8:45 am]
BILLING CODE 4410-09-P