Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Manufacturers Notice of Application - 2013

[Federal Register Volume 78, Number 76 (Friday, April 19, 2013)]
[Pages 23596-23597]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09318]


Drug Enforcement Administration

Manufacturer of Controlled Substances, Notice of Application, Navinta, LLC.

Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on February 13, 2013, 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 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.

Any other such applicant, and any person who is presently registered with DEA to manufacture such substance,

[[Page 23597]]

may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a).

Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than June 18, 2013.

Dated: April 10, 2013.

Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.

[FR Doc. 2013-09318 Filed 4-18-13; 8:45 am]


NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).

Emergency Disaster Relief
Search for Year Round Pharmaceutical Disposal Locations.
National Prescription Drug Take Back Day. Turn in your unused or expired medication for safe disposal here.
RX Abuse Online

Diversion Control Division  •  8701 Morrissette Drive  •  Springfield, VA 22152  •  1-800-882-9539

DOJ Legal Policies and Disclaimers    |    DOJ Privacy Policy    |    FOIA    |    Section 508 Accessibility