[Federal Register Volume 80, Number 128 (Monday, July 6, 2015)]
[Notices]
[Page 38471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16441]
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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 September 4, 2015.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODXL,
8701 Morrissette Drive, Springfield, Virginia 22152. Request for
hearings should be sent to: Drug Enforcement Administration, Attention:
Hearing Clerk/LJ, 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 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
February 4, 2015, Navinta, LLC, 1499 Lower Ferry Road, Ewing, New
Jersey 08618-1414 applied to be registered 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: June 25, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-16441 Filed 7-2-15; 8:45 am]
BILLING CODE 4410-09-P