2017-10242. Importer of Controlled Substances Application: Mallinckrodt 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 1301.34(a) on or before June 19, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before June 19, 2017.

ADDRESSES:

Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearing on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007).

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, dispenses, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.

In accordance with 21 CFR 1301.34(a), this is notice that on December 21, 2016, Mallinckrodt LLC, 3600 North Second Street, Saint Louis, Missouri 63147 applied to be registered as an importer of the following basic classes of controlled substances:

Controlled substance	Drug code	Schedule
Marihuana	7360	I
Phenylacetone	8501	II
Coca Leaves	9040	II
Opium, raw	9600	II
Poppy Straw Concentrate	9670	II

The company plans to import the listed controlled substances to bulk manufacture into Active Pharmaceutical Ingredients for distribution to its customers. Placement of these drug codes onto the company's registration does not translate into automatic approval of subsequent permit applications to import controlled substances.

In reference to drug code 7360 (Marihuana) the company plans to import a synthetic cannabidiol. No other activity for this drug code is authorized for this registration.

Dated: May 15, 2017.

Louis J. Milione,

Assistant Administrator.