82 FR 56994 - Importer of Controlled Substances Application: ABBVIE LTD

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 230 (December 1, 2017)

[Federal Register Volume 82, Number 230 (Friday, December 1, 2017)]
[Notices]
[Page 56994]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25921]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: ABBVIE LTD

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 2, 2018. 
Such persons may also file a written request for a hearing on the 
application on or before January 2, 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 
October 27, 2016, ABBVIE, LTD, Carr. #2, KM 58.0 Cruce Davila, C/O PO 
Box 278, Barceloneta, Puerto Rico 00617 applied to be registered as an 
importer of tapentadol (9780), a basic class of controlled substance in 
schedule II.
    The company plans to import an intermediate form of tapentadol 
(9780) to bulk manufacture tapentadol (9780) for distribution to its 
customers. Placement of this drug code onto the company's registration 
does not translate into automatic approval of subsequent permit 
applications to import controlled substances. Approval of permit 
applications will occur only when the registrant's business activity is 
consistent with what is authorized under 21 U.S.C 952(a)(2). 
Authorization will not extend to the import of FDA approved or non-
approved finished dosage forms for commercial sale.

    Dated: November 24, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-25921 Filed 11-30-17; 8:45 am]
 BILLING CODE 4410-09-P