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)

Page Range		56994-56994
FR Document		2017-25921

Federal Register, Volume 82 Issue 230 (Friday, 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]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: ABBVIE LTD

ACTION: Notice of application.

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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

56994 Federal Register / Vol. 82, No. 230 / Friday, December 1, 2017 / Notices

ACTION: Notice of application. DEPARTMENT OF JUSTICE for distribution to its customers.
Placement of this drug code onto the
DATES: Registered bulk manufacturers of Drug Enforcement Administration company’s registration does not
the affected basic classes, and [Docket No. DEA–392] translate into automatic approval of
subsequent permit applications to
applicants therefore, may file written
Importer of Controlled Substances import controlled substances. Approval
comments on or objections to the
Application: ABBVIE LTD of permit applications will occur only
issuance of the proposed registration on when the registrant’s business activity is
or before January 30, 2018. ACTION: Notice of application. consistent with what is authorized
ADDRESSES: Written comments should under 21 U.S.C 952(a)(2). Authorization
be sent to: Drug Enforcement DATES: Registered bulk manufacturers of will not extend to the import of FDA
Administration, Attention: DEA Federal the affected basic classes, and approved or non-approved finished
Register Representative/DRW, 8701 applicants therefore, may file written dosage forms for commercial sale.
Morrissette Drive, Springfield, Virginia comments on or objections to the Dated: November 24, 2017.
22152. issuance of the proposed registration on Demetra Ashley,
or before January 2, 2018. Such persons
Acting Assistant Administrator.
SUPPLEMENTARY INFORMATION: The may also file a written request for a
[FR Doc. 2017–25921 Filed 11–30–17; 8:45 am]
Attorney General has delegated his hearing on the application on or before
January 2, 2018. BILLING CODE 4410–09–P
authority under the Controlled
Substances Act to the Administrator of ADDRESSES: Written comments should
the Drug Enforcement Administration be sent to: Drug Enforcement DEPARTMENT OF JUSTICE
(DEA), 28 CFR 0.100(b). Authority to Administration, Attention: DEA Federal
Register Representative/DRW, 8701 [OMB Number 1110–XXXX]
exercise all necessary functions with
respect to the promulgation and Morrissette Drive, Springfield, Virginia
Agency Information Collection
implementation of 21 CFR part 1301, 22152. All requests for hearing must be
Activities; Proposed eCollection
incident to the registration of sent to: Drug Enforcement
eComments Requested; Approval of a
manufacturers, distributors, dispensers, Administration, Attn: Administrator,
New Collection
importers, and exporters of controlled 8701 Morrissette Drive, Springfield,
substances (other than final orders in Virginia 22152. All requests for hearing AGENCY: Laboratory Division Federal
should also be sent to: (1) Drug Bureau of Investigation Laboratory
connection with suspension, denial, or
Enforcement Administration, Attn: Division Survey of Forensic Science
revocation of registration) has been
Hearing Clerk/LJ, 8701 Morrissette Services, Federal Bureau of
redelegated to the Assistant
Drive, Springfield, Virginia 22152; and Investigation, Department of Justice.
Administrator of the DEA Diversion (2) Drug Enforcement Administration, ACTION: 60-Day Notice.
Control Division (‘‘Assistant Attn: DEA Federal Register
Administrator’’) pursuant to section 7 of Representative/DRW, 8701 Morrissette SUMMARY: The Department of Justice
28 CFR part 0, appendix to subpart R. Drive, Springfield, Virginia 22152. (DOJ), Federal Bureau of Investigation
In accordance with 21 CFR SUPPLEMENTARY INFORMATION: The
(FBI), Laboratory Division (LD) will be
1301.33(a), this is notice that on August Attorney General has delegated his submitting the following information
11, 2017, Nanosyn, Inc., Nanoscale authority under the Controlled collection request to the Office of
Combinatorial Synthesis, 3331–B Substances Act to the Administrator of Management and Budget (OMB) for
Industrial Drive, Santa Rosa, California the Drug Enforcement Administration review and approval in accordance with
95403 applied to be registered as a bulk (DEA), 28 CFR 0.100(b). Authority to the Paperwork Reduction Act of 1995.
exercise all necessary functions with The proposed information collection is
manufacturer for the basic classes of
respect to the promulgation and published to obtain comments from the
controlled substances:
implementation of 21 CFR part 1301, public and affected agencies.
Drug incident to the registration of DATES: Comments are encouraged and
Controlled substance Schedule will be accepted for 60 days until
code manufacturers, distributors, dispensers,
importers, and exporters of controlled January 30, 2018.
Oxymorphone ................. 9652 II substances (other than final orders in FOR FURTHER INFORMATION CONTACT: If
Fentanyl .......................... 9801 II connection with suspension, denial, or you have additional comments,
revocation of registration) has been especially on the estimated public
The company is a contract redelegated to the Assistant burden or associated response time,
manufacturer. At the request of the Administrator of the DEA Diversion suggestions, or need a copy of the
company’s customers, it manufactures Control Division (‘‘Assistant proposed information collection
derivatives of controlled substances in Administrator’’) pursuant to section 7 of instrument with instructions or
bulk form. 28 CFR part 0, appendix to subpart R additional information, please contact
In accordance with 21 CFR Cary Oien, United States Department of
Dated: November 24, 2017. Justice, Federal Bureau of Investigation,
1301.34(a), this is notice that on October
Demetra Ashley, 27, 2016, ABBVIE, LTD, Carr. #2, KM Laboratory Division, 2501 Investigation
Acting Assistant Administrator. 58.0 Cruce Davila, C/O PO Box 278, Parkway, Quantico, VA 22135
sradovich on DSK3GMQ082PROD with NOTICES

[FR Doc. 2017–25916 Filed 11–30–17; 8:45 am] Barceloneta, Puerto Rico 00617 applied SUPPLEMENTARY INFORMATION: This
BILLING CODE 4410–09–P to be registered as an importer of process is conducted in accordance with
tapentadol (9780), a basic class of 5 CFR. Written comments and
controlled substance in schedule II. suggestions from the public and affected
The company plans to import an agencies concerning the proposed
intermediate form of tapentadol (9780) collection of information are
to bulk manufacture tapentadol (9780) encouraged. Your comments should

VerDate Sep<11>2014 16:44 Nov 30, 2017 Jkt 244001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\01DEN1.SGM 01DEN1

Document Created: 2018-10-25 10:46:21
Document Modified: 2018-10-25 10:46:21

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
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.
FR Citation		82 FR 56994

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

DEPARTMENT OF JUSTICEDrug Enforcement Administration

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

DEPARTMENT OF JUSTICE
Drug Enforcement Administration