81 FR 68455 - Importer of Controlled Substances Application: Fisher Clinical Services, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 192 (October 4, 2016)

Page Range		68455-68456
FR Document		2016-23887

Federal Register, Volume 81 Issue 192 (Tuesday, October 4, 2016)

[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)]
[Notices]
[Pages 68455-68456]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-23887]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Fisher Clinical 
Services, Inc.

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 in accordance with 21 CFR 
1301.34(a) on or before November 3, 2016. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before November 3, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
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/ODW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 
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 Deputy Assistant Administrator of the DEA Office of Diversion 
Control (``Deputy 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 
17, 2016, 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                       Schedule
------------------------------------------------------------------------
Methylphenidate (1724).....................  II
Levorphanol (9220).........................  II
Noroxymorphone (9668)......................  II
Tapentadol (9780)..........................  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
analytical research, testing, and clinical trials. This authorization 
does not extend to the import of a finished FDA approved or non-
approved dosage form for commercial distribution in the United States.
    The company plans to import an intermediate form of tapentadol 
(9780)

[[Page 68456]]

to bulk manufacture tapentadol for distribution to its customers.

Louis J. Milione,
Assistant Administrator, Diversion Control Division.
[FR Doc. 2016-23887 Filed 10-3-16; 8:45 am]
 BILLING CODE 4410-09-P

Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices 68455

INTERNATIONAL TRADE On June 23, 2016, the Commission pursuant to 21 CFR 1301.43 on or before
COMMISSION found that a Section 337 violation November 3, 2016.
occurred as to the ‘537 patent and
[Investigation No. 337–TA–944 ADDRESSES: Written comments should
therefore issued a cease and desist order
(Enforcement Proceeding)] be sent to: Drug Enforcement
(‘‘CDO’’) against Arista and a limited
exclusion order (‘‘LEO’’). 81 FR 42375– Administration, Attention: DEA Federal
Certain Network Devices, Related Register Representative/ODW, 8701
Software and Components Thereof (I) 76 (June 29, 2016). The CDO prohibited
Arista from importing, selling, Morrissette Drive, Springfield, Virginia
Notice of Institution of Formal 22152. All requests for hearing must be
Enforcement Proceeding marketing, advertising, distributing,
transferring (except for exportation), and sent to: Drug Enforcement
AGENCY: U.S. International Trade soliciting United States agents or Administration, Attn: Administrator,
Commission. distributors for certain network devices, 8701 Morrissette Drive, Springfield,
related software, and components Virginia 22152. All requests for hearing
ACTION: Notice.
thereof that infringe the asserted claims should also be sent to: (1) Drug
SUMMARY: Notice is hereby given that of the ‘537 patent. Id. at 42376. Enforcement Administration, Attn:
the U.S. International Trade On August 26, 2016, Cisco filed a Hearing Clerk/LJ, 8701 Morrissette
Commission has instituted a formal complaint requesting that the Drive, Springfield, Virginia 22152; and
enforcement proceeding relating to June Commission institute a formal (2) Drug Enforcement Administration,
23, 2016, cease and desist order issued enforcement proceeding under Attn: DEA Federal Register
in the above-referenced investigation. Commission Rule 210.75(b) to Representative/ODW, 8701 Morrissette
FOR FURTHER INFORMATION CONTACT: investigate alleged violations of the CDO Drive, Springfield, Virginia 22152.
Ronald A. Traud, Office of the General by Arista. Having examined the SUPPLEMENTARY INFORMATION: The
Counsel, U.S. International Trade enforcement complaint and the Attorney General has delegated her
Commission, 500 E Street SW., supporting documents, the Commission authority under the Controlled
Washington, DC 20436, telephone (202) has determined to institute a formal Substances Act to the Administrator of
205–3427. Copies of non-confidential enforcement proceeding to determine the Drug Enforcement Administration
documents filed in connection with this whether Arista is in violation of the (DEA), 28 CFR 0.100(b). Authority to
investigation are or will be available for June 23, 2016 CDO issued in the original exercise all necessary functions with
inspection during official business investigation and to determine what, if respect to the promulgation and
hours (8:45 a.m. to 5:15 p.m.) in the any, enforcement measures are implementation of 21 CFR part 1301,
Office of the Secretary, U.S. appropriate. Arista is named as a incident to the registration of
International Trade Commission, 500 E respondent and OUII is named as a manufacturers, distributors, dispensers
Street SW., Washington, DC 20436, party. importers, and exporters of, controlled
telephone (202) 205–2000. General The authority for the Commission’s
substances (other than final orders in
information concerning the Commission determination is contained in Section
connection with suspension, denial, or
may also be obtained by accessing its 337 of the Tariff Act of 1930, as
revocation of registration) has been
Internet server (https://www.usitc.gov). amended (19 U.S.C. 1337), and in
redelegated to the Deputy Assistant
The public record for this investigation section 210.75 of the Commission’s
Administrator of the DEA Office of
may be viewed on the Commission’s Rules of Practice and Procedure (19 CFR
210.75). Diversion Control (‘‘Deputy Assistant
electronic docket (EDIS) at https:// Administrator’’) pursuant to section 7 of
edis.usitc.gov. Hearing-impaired By order of the Commission. 28 CFR part 0, appendix to subpart R.
persons are advised that information on Issued: September 28, 2016,
this matter can be obtained by In accordance with 21 CFR
Katherine M. Hiner,
contacting the Commission’s TDD 1301.34(a), this is notice that on June
Acting Supervisory Attorney. 17, 2016, Fisher Clinical Services, Inc.,
terminal on (202) 205–1810.
[FR Doc. 2016–23863 Filed 10–3–16; 8:45 am] 700 A–C Nestle Way, Breinigsville,
SUPPLEMENTARY INFORMATION: The
Commission instituted the original
BILLING CODE 7020–02–P Pennsylvania 18031–1522 applied to be
investigation on January 27, 2015, based registered as an importer of the
on a complaint filed by Cisco Systems, following basic classes of controlled
DEPARTMENT OF JUSTICE substances:
Inc. (‘‘Cisco’’). 80 FR 4314 (Jan. 27,
2015). Pertinent to this investigation, Drug Enforcement Administration Controlled substance Schedule
the complaint alleged violations of
Section 337 of the Tariff Act of 1930, as [Docket No. DEA–392]
Methylphenidate (1724) ................ II
amended, 19 U.S.C. 1337, in the Importer of Controlled Substances Levorphanol (9220) ...................... II
importation into the United States, the Application: Fisher Clinical Services, Noroxymorphone (9668) .............. II
sale for importation into the United Inc. Tapentadol (9780) ........................ II
States, and the sale within the United
States after importation of certain ACTION: Notice of application.
network devices, related software, and The company plans to import the
components thereof by reason of DATES: Registered bulk manufacturers of listed controlled substances for
infringement of any of claims 1–2, 8–11, the affected basic classes, and analytical research, testing, and clinical
mstockstill on DSK3G9T082PROD with NOTICES

and 17–19 of U.S. Patent No. 7,162,537 applicants therefore, may file written trials. This authorization does not
(‘‘the ‘537 patent’’). Id. The notice of comments on or objections to the extend to the import of a finished FDA
institution of the investigation named issuance of the proposed registration in approved or non-approved dosage form
Arista Networks, Inc. (‘‘Arista’’) as a accordance with 21 CFR 1301.34(a) on for commercial distribution in the
respondent and the Office of Unfair or before November 3, 2016. Such United States.
Import Investigations (‘‘OUII’’) as a persons may also file a written request The company plans to import an
party. Id. for a hearing on the application intermediate form of tapentadol (9780)

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68456 Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices

to bulk manufacture tapentadol for To submit Facsimile: If your comments,
Send them to:
distribution to its customers. comments: including attachments, are not longer
than 10 pages you may fax them to the
Louis J. Milione, By e-mail ...... pubcomment-ees.enrd@ OSHA Docket Office at (202) 693–1648.
Assistant Administrator, Diversion Control usdoj.gov. Mail, hand delivery, express mail,
Division. By mail ......... Assistant Attorney General,
U.S. DOJ—ENRD, P.O.
messenger, or courier service: When
[FR Doc. 2016–23887 Filed 10–3–16; 8:45 am]
Box 7611, Washington, DC using this method, you must submit a
BILLING CODE 4410–09–P 20044–7611. copy of your comments and attachments
to the OSHA Docket Office, Docket No.
During the public comment period, OSHA–2013–0021, Occupational Safety
DEPARTMENT OF JUSTICE the consent decree may be examined and Health Administration, U.S.
and downloaded at this Justice Department of Labor, Room N–2625,
Notice of Lodging of Proposed Department Web site: https:// 200 Constitution Avenue NW.,
Consent Decree Under the www.justice.gov/enrd/consent-decrees. Washington, DC 20210. Deliveries
Comprehensive Environmental We will provide a paper copy of the (hand, express mail, messenger, and
Response, Compensation, and Liability consent decree upon written request courier service) are accepted during the
Act and payment of reproduction costs. Department of Labor’s and Docket
Please mail your request and payment Office’s normal business hours, 8:15
On September 28, 2016, the to: Consent Decree Library, U.S. DOJ— a.m. to 4:45 p.m., e.t.
Department of Justice lodged a proposed ENRD, P.O. Box 7611, Washington, DC Instructions: All submissions must
consent decree with the United States 20044–7611. include the Agency name and the OSHA
District Court for the District of Please enclose a check or money order docket number (OSHA–2013–0021) for
Columbia in the lawsuit entitled United for $11.25 (25 cents per page the Information Collection Request
States v. Anthony Spanos, Inc., et al., reproduction cost) payable to the United (ICR). All comments, including any
Civil Action No. 1:14-cv-01625–RJL. States Treasury. personal information you provide, are
placed in the public docket without
The United States filed this lawsuit Robert Brook, change, and may be made available
under the Comprehensive Assistant Section Chief, Environmental online at http://www.regulations.gov.
Environmental Response, Enforcement Section, Environment and For further information on submitting
Compensation, and Liability Act Natural Resources Division. comments see the ‘‘Public
(‘‘CERCLA’’). The United States’ [FR Doc. 2016–23926 Filed 10–3–16; 8:45 am] Participation’’ heading in the section of
complaint names Anthony Spanos, Inc., BILLING CODE 4410–15–P this notice titled SUPPLEMENTARY
George A. Spanos, in his capacity as the INFORMATION.
trustee of the George A. Spanos Living Docket: To read or download
Trust, and Gus Dinos as defendants. The DEPARTMENT OF LABOR comments or other material in the
United States’ complaint seeks recovery docket, go to http://www.regulations.gov
of costs incurred and to be incurred by Occupational Safety and Health or the OSHA Docket Office at the
the Environmental Protection Agency in Administration address above. All documents in the
connection with the removal of [Docket No. OSHA–2013–0021] docket (including this Federal Register
hazardous substances at the Georgia notice) are listed in the http://
Avenue PCE Site, located in Northwest Cranes and Derricks in Construction; www.regulations.gov index; however,
Washington, DC. The consent decree Extension of the Office of Management some information (e.g., copyrighted
resolves the United States’ claims and Budget’s (OMB) Approval material) is not publicly available to
against George A. Spanos and does not Information Collection (Paperwork) read or download from the Web site. All
resolve the United States’ claims against Requirements submissions, including copyrighted
Anthony Spanos, Inc. and Gus Dinos. material, are available for inspection
AGENCY: Occupational Safety and Health and copying at the OSHA Docket Office.
George A. Spanos agrees to pay Administration (OSHA), Labor.
$125,000 of the United States’ response You may also contact Theda Kenney at
ACTION: Request for public comments. the address below to obtain a copy of
costs and to perform the operation and
maintenance of sub-slab the ICR.
SUMMARY: OSHA solicits public
depressurization systems at the Site. In FOR FURTHER INFORMATION CONTACT:
comments concerning its proposal to
return, the United States agrees not to extend the Office of Management and Todd Owen or Theda Kenney,
sue George A. Spanos under sections Budget’s (OMB) approval of the Directorate of Standards and Guidance,
106 and 107 of CERCLA. collections of information contained in OSHA, U.S. Department of Labor, Room
the Cranes and Derricks in Construction N–3609, 200 Constitution Avenue NW.,
The publication of this notice opens Washington, DC 20210; telephone (202)
a period for public comment on the Standard (29 CFR part 1926, subpart
CC). 693–2222.
consent decree. Comments should be SUPPLEMENTARY INFORMATION:
addressed to the Assistant Attorney DATES: Comments must be submitted
General, Environment and Natural (postmarked, sent, or received) by I. Background
Resources Division, and should refer to December 5, 2016. The Department of Labor, as part of its
mstockstill on DSK3G9T082PROD with NOTICES

United States v. Anthony Spanos, Inc., ADDRESSES: Electronically: You may continuing effort to reduce paperwork
et al., D.J. Ref. No. 90–11–3–10721. All submit comments and attachments and respondent (i.e., employer) burden,
comments must be submitted no later electronically at http:// conducts a preclearance consultation
than thirty (30) days after the www.regulations.gov, which is the program to provide the public with an
publication date of this notice. Federal eRulemaking Portal. Follow the opportunity to comment on proposed
Comments may be submitted either by instructions online for submitting and continuing information collection
email or by mail: comments. requirements in accord with the

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Document Created: 2016-10-04 03:04:17
Document Modified: 2016-10-04 03:04:17

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 in accordance with 21 CFR 1301.34(a) on or before November 3, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before November 3, 2016.
FR Citation		81 FR 68455

81 FR 68455 - Importer of Controlled Substances Application: Fisher Clinical Services, Inc.

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 81, Issue 192 (October 4, 2016)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration