Manufacturers Notice of Application - 2013
[Federal Register Volume 78, Number 76 (Friday, April 19, 2013)]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09318]
DEPARTMENT OF JUSTICE
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:
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,
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]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).