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83 FR 224 pgs. 58598-58599 - Importer of Controlled Substances Application: Janssen Pharmaceuticals Inc.

Type: NOTICEVolume: 83Number: 224Pages: 58598 - 58599
Docket number: [Docket No. DEA-392]
FR document: [FR Doc. 2018-25226 Filed 11-19-18; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version:  PDF Version
Pages: 58598, 58599

[top] page 58598

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]

Importer of Controlled Substances Application: Janssen Pharmaceuticals Inc.

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 December 20, 2018. Such persons may also file a written request for a hearing on the application on or before December 20, 2018.

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 hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 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. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007)

SUPPLEMENTARY INFORMATION:


[top] The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of page 58599 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 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 September 13, 2018, Janssen Pharmaceuticals Inc., 1440 Olympic Drive, Bldgs. 1-5 & 7-14, Athens, Georgia 30601-1645, applied to be registered as an importer of the following basic classes of controlled substances:

Controlled substance Drug code Schedule
Thebaine 9333 II
Poppy Straw Concentrate 9670 II
Tapentadol 9780 II

The company plans to import an intermediate form of tapentadol (9780) to bulk manufacture tapentadol for distribution to its customers. The company plans to import thebaine (9333) derivatives as reference standards. The company plans to import concentrated poppy straw (9670) to bulk manufacture other controlled substances. No other activity for these drug codes is authorized for this registration.

Dated: November 6, 2018.

John J. Martin,

Assistant Administrator.

[FR Doc. 2018-25226 Filed 11-19-18; 8:45 am]

BILLING CODE 4410-09-P