2019-27095. Importer of Controlled Substances Application: Novitium Pharma 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 on or before January 15, 2020. Such persons may also file a written request for a hearing on the application on or before January 15, 2020.

ADDRESSES:

Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION:

In accordance with 21 CFR 1301.34(a), this is notice that on July 18, 2018, Novitium Pharma, LLC., 70 Lake Drive, East Windsor, New Jersey 08520 applied to be registered as an importer of the following basic class of controlled substance:

Controlled substance	Drug code	Schedule
Levorphanol	9220	II

The company plans to import the controlled substance to develop the manufacturing process for a drug product that will in turn be used to produce a tablet equivalent to the current brand product.

Dated: December 3, 2019.

William T. McDermott,

Assistant Administrator.