83 FR 13521 - Bulk Manufacturer of Controlled Substances Application: Navinta LLC

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 61 (March 29, 2018)

[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)]
[Notices]
[Page 13521]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06325]


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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 class, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration on or before May 29, 2018.

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 his 
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 Assistant Administrator of the DEA Diversion Control Division 
(``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 13, 2017, Navinta LLC, 1499 Lower Ferry Rd. Ewing, NJ 08618 
applied to be registered as a bulk manufacturer for the basic classes 
of controlled substances:

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        Controlled substance            Drug code          Schedule
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Pentobarbital......................            2270  II
4-Anilino-N-phenethyl-4-piperidine             8333  II
 (ANPP).
Levorphanol........................            9220  II
Remifentanil.......................            9739  II
Fentanyl...........................            9801  II
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    The company plans to initially manufacture API quantities of the 
listed controlled substances for validation purposes and FDA approval.

    Dated: March 15, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-06325 Filed 3-28-18; 8:45 am]
 BILLING CODE 4410-09-P