2018-06321. Importer of Controlled Substances Application: Fisher Clinical Services, 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 April 30, 2018. Such persons may also file a written request for a hearing on the application on or before April 30, 2018.

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 requests 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.

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, 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 June 5, 2017, Fisher Clinical Services, Inc., 700 A-C Nestle Way, Breinigsville, Pennsylvania 18031-1522 applied to be registered as an importer of the following basic classes of controlled substances:

Controlled substance	Drug code	Schedule
Methylphenidate	1724	II
Levorphanol	9220	II
Noroxymorphone	9668	II
Tapentadol	9780	II

The company plans to import the listed controlled substances in finished dosage form for testing, and clinical trials purposes only. This authorization does not extend to the import of a finished Food and Drug Administration (FDA) approved or non-approved dosage form for commercial distribution in the United States.

Dated: March 15, 2018.

Susan A. Gibson,

Deputy Assistant Administrator.