2016-31282. Bulk Manufacturer of Controlled Substances Application: Navinta LLC

ACTION:

Notice of application.

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 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
Pentobarbital	2270	II
4-Anilino-N-phenethyl-4-piperidine (ANPP)	8333	II
Remifentanil	9739	II
Fentanyl	9801	II

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.