83_FR_17754 83 FR 17676 - Certain Clidinium Bromide and Products Containing Same; Institution of Investigation

83 FR 17676 - Certain Clidinium Bromide and Products Containing Same; Institution of Investigation

INTERNATIONAL TRADE COMMISSION

Federal Register Volume 83, Issue 78 (April 23, 2018)

Page Range17676-17677
FR Document2018-08395

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on February 20, 2018, under section 337 of the Tariff Act of 1930, as amended, on behalf of Valeant Pharmaceuticals North America LLC of Bridgewater, New Jersey and Valeant Pharmaceuticals International, Inc. of Canada. An amended complaint was filed on March 20, 2018. The complaint, as amended, alleges violations of section 337 based upon the importation into the United States or the sale after importation of certain clidinium bromide and products containing same by reason of unfair acts or methods of competition, the threat or effect of which is to destroy or substantially injure an industry in the United States. The complainants request that the Commission institute an investigation and, after the investigation, issue a general exclusion order, in the alternative a limited exclusion order, and cease and desist orders.

Federal Register, Volume 83 Issue 78 (Monday, April 23, 2018)
[Federal Register Volume 83, Number 78 (Monday, April 23, 2018)]
[Notices]
[Pages 17676-17677]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-08395]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1109]


Certain Clidinium Bromide and Products Containing Same; 
Institution of Investigation

AGENCY: U.S. International Trade Commission

ACTION: Notice.

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

SUMMARY: Notice is hereby given that a complaint was filed with the 
U.S. International Trade Commission on February 20, 2018, under section 
337 of the Tariff Act of 1930, as amended, on behalf of Valeant 
Pharmaceuticals North America LLC of Bridgewater, New Jersey and 
Valeant Pharmaceuticals International, Inc. of Canada. An amended 
complaint was filed on March 20, 2018. The complaint, as amended, 
alleges violations of section 337 based upon the importation into the 
United States or the sale after importation of certain clidinium 
bromide and products containing same by reason of unfair acts or 
methods of competition, the threat or effect of which is to destroy or 
substantially injure an industry in the United States.
    The complainants request that the Commission institute an 
investigation and, after the investigation, issue a general exclusion 
order, in the alternative a limited exclusion order, and cease and 
desist orders.

ADDRESSES: The amended complaint, except for any confidential 
information contained therein, is available for inspection during 
official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the 
Secretary, U.S. International Trade Commission, 500 E Street SW, Room 
112, Washington, DC 20436, telephone (202) 205-2000. Hearing impaired 
individuals are advised that information on this matter can be obtained 
by contacting the Commission's TDD terminal on (202) 205-1810. Persons 
with mobility impairments who will need special assistance in gaining 
access to the Commission should contact the Office of the Secretary at 
(202) 205-2000. General information concerning the Commission may also 
be obtained by accessing its internet server at https://www.usitc.gov. 
The public record for this investigation may be viewed on the 
Commission's electronic docket (EDIS) at https://edis.usitc.gov.

FOR FURTHER INFORMATION CONTACT: Pathenia M. Proctor, The Office of 
Unfair Import Investigations, U.S. International Trade Commission, 
telephone (202) 205-2560.

SUPPLEMENTARY INFORMATION: 
    Authority: The authority for institution of this investigation is 
contained in section 337 of the Tariff Act of 1930, as amended, 19 
U.S.C. 1337 and in section 210.10 of the Commission's Rules of Practice 
and Procedure, 19 CFR 210.10 (2017).
    Scope of Investigation: Having considered the complaint, the U.S. 
International Trade Commission, on April 17, 2018, ordered that--
    (1) Pursuant to subsection (b) of section 337 of the Tariff Act of 
1930, as amended, an investigation be instituted to determine whether 
there is a violation of subsection (a)(1)(A) of section 337 in the 
importation into the United States or the sale after importation of 
certain clidinium bromide and products containing same by reason of 
false advertising and unfair competition under the Lanham Act, 15 
U.S.C. 1125(a), the threat or effect of which is to destroy or 
substantially injure an industry in the United States;
    (2) Notwithstanding any Commission Rules that would otherwise 
apply, the presiding Administrative Law Judge shall hold an early 
evidentiary hearing, find facts, and issue an early decision, as to 
whether the complainants have demonstrated an injury or threat of 
injury to an industry in the United States. Any such decision shall be 
in the form of an initial determination (ID). Petitions for review of 
such an ID shall be due five calendar days after service of the ID; any 
replies shall be due three business days after service of a petition. 
The ID will become the Commission's final determination 30 days after 
the date of service of the ID unless the Commission determines to 
review the ID. Any such review will be conducted in accordance with 
Commission Rules 210.43, 210.44, and 210.45, 19 CFR 210.43, 210.44, and 
210.45. The Commission expects the issuance of an early ID relating to 
the requirement of an injury to an industry in the United States within 
100 days of institution, except that the presiding ALJ may grant an 
extension of the ID of up to 50 days for good cause shown. The issuance 
of an early ID finding that complainants failed to demonstrate an 
injury or threat of injury to an industry in the United States shall 
stay the investigation unless the Commission orders otherwise; any 
other decision shall not stay the investigation or delay the issuance 
of a final ID covering the other issues of the investigation;
    (3) Pursuant to Commission Rule 210.50(b)(1), 19 CFR 210.50(b)(1), 
the presiding administrative law judge shall take evidence or other 
information and hear arguments from the parties and other interested 
persons with respect to the public interest in this investigation, as 
appropriate, and provide the Commission with findings of fact and a 
recommended determination on this issue, which shall be limited to the 
statutory public interest factors set forth in 19 U.S.C. 1337(d)(1), 
(f)(1), (g)(1);
    (4) For the purpose of the investigation so instituted, the 
following are hereby named as parties upon which this notice of 
investigation shall be served:
    (a) The complainants are:

Valeant Pharmaceuticals North America LLC, 400 Somerset Corporate 
Boulevard, Bridgewater, NJ 08807
Valeant Pharmaceuticals International, Inc., 2150 St Elz[eacute]ar 
Boulevard West, Laval, Quebec, Canada H7L4A8


[[Page 17677]]


    (b) The respondents are the following entities alleged to be in 
violation of section 337, and are the parties upon which the amended 
complaint is to be served:

Bi-Coastal Pharma International LLC, 1161 Broad Street, Suite 216, 
Shrewsbury, NJ 07702
Bi-Coastal Pharmaceutical Corporation, 1161 Broad Street, Suite 216, 
Shrewsbury, NJ 07702
ECI Pharmaceuticals LLC, 5311 NW 35th Terrace, Fort Lauderdale, FL 
33309
Virtus Pharmaceuticals LLC, 2649 Causeway Center Drive, Tampa, FL 33619
Virtus Pharmaceuticals OPCO II LLC, 1321 Murfreesboro Pike, Nashville, 
TN 37217-2626

    (c) The Office of Unfair Import Investigations, U.S. International 
Trade Commission, 500 E Street SW, Suite 401, Washington, DC 20436; and
    (5) For the investigation so instituted, the Chief Administrative 
Law Judge, U.S. International Trade Commission, shall designate the 
presiding Administrative Law Judge.
    Responses to the amended complaint and the notice of investigation 
must be submitted by the named respondents in accordance with section 
210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 
210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will 
be considered by the Commission if received not later than 20 days 
after the date of service by the Commission of the amended complaint 
and the notice of investigation. Extensions of time for submitting 
responses to the amended complaint and the notice of investigation will 
not be granted unless good cause therefor is shown.
    Failure of a respondent to file a timely response to each 
allegation in the amended complaint and in this notice may be deemed to 
constitute a waiver of the right to appear and contest the allegations 
of the complaint and this notice, and to authorize the administrative 
law judge and the Commission, without further notice to the respondent, 
to find the facts to be as alleged in the amended complaint and this 
notice and to enter an initial determination and a final determination 
containing such findings, and may result in the issuance of an 
exclusion order or a cease and desist order or both directed against 
the respondent.

    By order of the Commission.

    Issued: April 18, 2018.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2018-08395 Filed 4-20-18; 8:45 am]
BILLING CODE 7020-02-P



                                             17676                          Federal Register / Vol. 83, No. 78 / Monday, April 23, 2018 / Notices

                                             filed by a party to the investigations                  amended complaint was filed on March                  by reason of false advertising and unfair
                                             must be served on all other parties to                  20, 2018. The complaint, as amended,                  competition under the Lanham Act, 15
                                             the investigations (as identified by                    alleges violations of section 337 based               U.S.C. 1125(a), the threat or effect of
                                             either the public or BPI service list), and             upon the importation into the United                  which is to destroy or substantially
                                             a certificate of service must be timely                 States or the sale after importation of               injure an industry in the United States;
                                             filed. The Secretary will not accept a                  certain clidinium bromide and products                   (2) Notwithstanding any Commission
                                             document for filing without a certificate               containing same by reason of unfair acts              Rules that would otherwise apply, the
                                             of service.                                             or methods of competition, the threat or              presiding Administrative Law Judge
                                                Certification.—Pursuant to section                   effect of which is to destroy or                      shall hold an early evidentiary hearing,
                                             207.3 of the Commission’s rules, any                    substantially injure an industry in the               find facts, and issue an early decision,
                                             person submitting information to the                    United States.                                        as to whether the complainants have
                                             Commission in connection with these                        The complainants request that the                  demonstrated an injury or threat of
                                             investigations must certify that the                    Commission institute an investigation                 injury to an industry in the United
                                             information is accurate and complete to                 and, after the investigation, issue a                 States. Any such decision shall be in the
                                             the best of the submitter’s knowledge. In               general exclusion order, in the                       form of an initial determination (ID).
                                             making the certification, the submitter                 alternative a limited exclusion order,                Petitions for review of such an ID shall
                                             will acknowledge that any information                   and cease and desist orders.                          be due five calendar days after service
                                             that it submits to the Commission                       ADDRESSES: The amended complaint,                     of the ID; any replies shall be due three
                                             during these investigations may be                      except for any confidential information               business days after service of a petition.
                                             disclosed to and used: (i) By the                       contained therein, is available for                   The ID will become the Commission’s
                                             Commission, its employees and Offices,                  inspection during official business                   final determination 30 days after the
                                             and contract personnel (a) for                          hours (8:45 a.m. to 5:15 p.m.) in the                 date of service of the ID unless the
                                             developing or maintaining the records                   Office of the Secretary, U.S.                         Commission determines to review the
                                             of these or related investigations or                   International Trade Commission, 500 E                 ID. Any such review will be conducted
                                             reviews, or (b) in internal investigations,             Street SW, Room 112, Washington, DC                   in accordance with Commission Rules
                                             audits, reviews, and evaluations relating               20436, telephone (202) 205–2000.                      210.43, 210.44, and 210.45, 19 CFR
                                             to the programs, personnel, and                         Hearing impaired individuals are                      210.43, 210.44, and 210.45. The
                                             operations of the Commission including                  advised that information on this matter               Commission expects the issuance of an
                                             under 5 U.S.C. Appendix 3; or (ii) by                   can be obtained by contacting the                     early ID relating to the requirement of
                                             U.S. government employees and                           Commission’s TDD terminal on (202)                    an injury to an industry in the United
                                             contract personnel, solely for                          205–1810. Persons with mobility                       States within 100 days of institution,
                                             cybersecurity purposes. All contract                    impairments who will need special                     except that the presiding ALJ may grant
                                             personnel will sign appropriate                         assistance in gaining access to the                   an extension of the ID of up to 50 days
                                             nondisclosure agreements.                               Commission should contact the Office                  for good cause shown. The issuance of
                                                Authority: These investigations are                  of the Secretary at (202) 205–2000.                   an early ID finding that complainants
                                             being conducted under authority of title                General information concerning the                    failed to demonstrate an injury or threat
                                             VII of the Tariff Act of 1930; this notice              Commission may also be obtained by                    of injury to an industry in the United
                                             is published pursuant to section 207.12                 accessing its internet server at https://             States shall stay the investigation unless
                                             of the Commission’s rules.                              www.usitc.gov. The public record for                  the Commission orders otherwise; any
                                               By order of the Commission.                           this investigation may be viewed on the               other decision shall not stay the
                                               Issued: April 18, 2018.                               Commission’s electronic docket (EDIS)                 investigation or delay the issuance of a
                                             Lisa Barton,                                            at https://edis.usitc.gov.                            final ID covering the other issues of the
                                                                                                     FOR FURTHER INFORMATION CONTACT:                      investigation;
                                             Secretary to the Commission.
                                                                                                     Pathenia M. Proctor, The Office of                       (3) Pursuant to Commission Rule
                                             [FR Doc. 2018–08412 Filed 4–20–18; 8:45 am]
                                                                                                     Unfair Import Investigations, U.S.                    210.50(b)(1), 19 CFR 210.50(b)(1), the
                                             BILLING CODE 7020–02–P                                                                                        presiding administrative law judge shall
                                                                                                     International Trade Commission,
                                                                                                     telephone (202) 205–2560.                             take evidence or other information and
                                                                                                     SUPPLEMENTARY INFORMATION:                            hear arguments from the parties and
                                             INTERNATIONAL TRADE                                                                                           other interested persons with respect to
                                             COMMISSION                                                 Authority: The authority for
                                                                                                     institution of this investigation is                  the public interest in this investigation,
                                             [Investigation No. 337–TA–1109]                         contained in section 337 of the Tariff                as appropriate, and provide the
                                                                                                     Act of 1930, as amended, 19 U.S.C. 1337               Commission with findings of fact and a
                                             Certain Clidinium Bromide and                                                                                 recommended determination on this
                                                                                                     and in section 210.10 of the
                                             Products Containing Same; Institution                                                                         issue, which shall be limited to the
                                                                                                     Commission’s Rules of Practice and
                                             of Investigation                                                                                              statutory public interest factors set forth
                                                                                                     Procedure, 19 CFR 210.10 (2017).
                                             AGENCY: U.S. International Trade                           Scope of Investigation: Having                     in 19 U.S.C. 1337(d)(1), (f)(1), (g)(1);
                                             Commission                                              considered the complaint, the U.S.                       (4) For the purpose of the
                                                                                                     International Trade Commission, on                    investigation so instituted, the following
                                             ACTION: Notice.
                                                                                                     April 17, 2018, ordered that—                         are hereby named as parties upon which
                                             SUMMARY:   Notice is hereby given that a                   (1) Pursuant to subsection (b) of                  this notice of investigation shall be
                                             complaint was filed with the U.S.                       section 337 of the Tariff Act of 1930, as             served:
amozie on DSK30RV082PROD with NOTICES




                                             International Trade Commission on                       amended, an investigation be instituted                  (a) The complainants are:
                                             February 20, 2018, under section 337 of                 to determine whether there is a                       Valeant Pharmaceuticals North America
                                             the Tariff Act of 1930, as amended, on                  violation of subsection (a)(1)(A) of                     LLC, 400 Somerset Corporate
                                             behalf of Valeant Pharmaceuticals North                 section 337 in the importation into the                  Boulevard, Bridgewater, NJ 08807
                                             America LLC of Bridgewater, New                         United States or the sale after                       Valeant Pharmaceuticals International,
                                             Jersey and Valeant Pharmaceuticals                      importation of certain clidinium                         Inc., 2150 St Elzéar Boulevard West,
                                             International, Inc. of Canada. An                       bromide and products containing same                     Laval, Quebec, Canada H7L4A8


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                                                                            Federal Register / Vol. 83, No. 78 / Monday, April 23, 2018 / Notices                                           17677

                                               (b) The respondents are the following                   Issued: April 18, 2018.                             SUPPLEMENTARY INFORMATION:      The
                                             entities alleged to be in violation of                  Lisa Barton,                                          Commission instituted this investigation
                                             section 337, and are the parties upon                   Secretary to the Commission.                          on January 26, 2018, based on a
                                             which the amended complaint is to be                    [FR Doc. 2018–08395 Filed 4–20–18; 8:45 am]           complaint, as supplemented, filed on
                                             served:                                                 BILLING CODE 7020–02–P
                                                                                                                                                           behalf of Neptune Subsea Acquisitions
                                                                                                                                                           Ltd. of the United Kingdom; Neptune
                                             Bi-Coastal Pharma International LLC,                                                                          Subsea IP Ltd. of the United Kingdom;
                                               1161 Broad Street, Suite 216,                                                                               and Xtera, Inc. of Allen, Texas
                                                                                                     INTERNATIONAL TRADE
                                               Shrewsbury, NJ 07702                                                                                        (‘‘complainants’’). 83 FR 3370 (Jan. 26,
                                                                                                     COMMISSION
                                             Bi-Coastal Pharmaceutical Corporation,                                                                        2018). The complaint, as supplemented,
                                               1161 Broad Street, Suite 216,                                                                               alleges violations of Section 337 of the
                                                                                                     [Investigation No. 337–TA–1098]
                                               Shrewsbury, NJ 07702                                                                                        Tariff Act of 1930, as amended, 19
                                             ECI Pharmaceuticals LLC, 5311 NW                        Certain Subsea Telecommunications                     U.S.C. 1337 (‘‘section 337’’), based upon
                                               35th Terrace, Fort Lauderdale, FL                     Systems and Components Thereof;                       the importation into the United States,
                                               33309                                                 Commission Determination Not To                       the sale for importation, and the sale
                                                                                                     Review an Initial Determination                       within the United States after
                                             Virtus Pharmaceuticals LLC, 2649                                                                              importation of certain subsea
                                               Causeway Center Drive, Tampa, FL                      Granting a Motion for Leave To Amend
                                                                                                     the Complaint and Notice of                           telecommunication systems and
                                               33619                                                                                                       components thereof by reason of
                                                                                                     Investigation To Correct the Name of a
                                             Virtus Pharmaceuticals OPCO II LLC,                     Respondent and Withdrawal of the                      infringement of one or more of U.S.
                                               1321 Murfreesboro Pike, Nashville,                    Complaint as to Other Respondents                     Patent No. 8,380,068; U.S. Patent No.
                                               TN 37217–2626                                                                                               7,860,403; U.S. Patent No. 8,971,171;
                                                                                                     AGENCY: U.S. International Trade                      U.S. Patent No. 8,351,798; and U.S.
                                                (c) The Office of Unfair Import                      Commission.                                           Patent No. 8,406,637. The complaint
                                             Investigations, U.S. International Trade
                                                                                                     ACTION: Notice.                                       further alleges that an industry in the
                                             Commission, 500 E Street SW, Suite
                                                                                                                                                           United States exists as required by
                                             401, Washington, DC 20436; and                          SUMMARY:   Notice is hereby given that                section 337. The Notice of Investigation
                                                (5) For the investigation so instituted,             the U.S. International Trade                          named numerous respondents,
                                             the Chief Administrative Law Judge,                     Commission has determined not to                      including: Nokia Corporation of Espoo,
                                             U.S. International Trade Commission,                    review an initial determination (‘‘ID’’)              Finland; Nokia Solutions and Networks
                                             shall designate the presiding                           (Order No. 9) of the presiding                        B.V. of Hoofddorp, The Netherlands;
                                             Administrative Law Judge.                               administrative law judge (‘‘ALJ’’),                   Nokia Solutions and Networks Oy of
                                                Responses to the amended complaint                   granting complainant’s unopposed                      Espoo, Finland; Nokia Solutions and
                                             and the notice of investigation must be                 motion for leave to amend the                         Networks US LLC of Phoenix, Arizona;
                                             submitted by the named respondents in                   complaint and notice of investigation to              and Alcatel-Lucent Submarine
                                             accordance with section 210.13 of the                   correct the name of respondent Alcatel-               Networks SAS of Boulogne-Billancourt,
                                             Commission’s Rules of Practice and                      Lucent Submarine Networks SAS to                      France. The Office of Unfair Import
                                             Procedure, 19 CFR 210.13. Pursuant to                   Alcatel Submarine Networks and                        Investigations was named as a party in
                                             19 CFR 201.16(e) and 210.13(a), such                    withdrawal of the complaint as to                     this investigation.
                                             responses will be considered by the                     respondents Nokia Solutions and                          On March 8, 2018, complainants filed
                                             Commission if received not later than 20                Networks B.V., Nokia Solutions and                    an unopposed motion to (1) amend the
                                             days after the date of service by the                   Networks Oy, and Nokia Solutions and                  complaint and notice of investigation to
                                             Commission of the amended complaint                     Networks US LLC.                                      correct the name of Alcatel-Lucent
                                             and the notice of investigation.                        FOR FURTHER INFORMATION CONTACT:                      Submarine Networks SAS to Alcatel
                                             Extensions of time for submitting                       Amanda Pitcher Fisherow, Esq., Office                 Submarine Networks and (2) withdraw
                                             responses to the amended complaint                      of the General Counsel, U.S.                          the complaint as to Nokia Solutions and
                                             and the notice of investigation will not                International Trade Commission, 500 E                 Networks B.V., Nokia Solutions and
                                             be granted unless good cause therefor is                Street SW, Washington, DC 20436,                      Networks Oy, and Nokia Solutions and
                                             shown.                                                  telephone (202) 205–2737. Copies of                   Networks US LLC. Complainants note
                                                                                                     non-confidential documents filed in                   that complainants, Nokia Corporation,
                                                Failure of a respondent to file a timely
                                                                                                     connection with this investigation are or             Nokia Solutions and Networks B.V.,
                                             response to each allegation in the
                                                                                                     will be available for inspection during               Nokia Solutions and Networks Oy,
                                             amended complaint and in this notice
                                                                                                     official business hours (8:45 a.m. to 5:15            Nokia Solutions and Networks US LLC,
                                             may be deemed to constitute a waiver of
                                                                                                     p.m.) in the Office of the Secretary, U.S.            and Alcatel-Lucent Submarine
                                             the right to appear and contest the
                                                                                                     International Trade Commission, 500 E                 Networks SAS entered into a joint
                                             allegations of the complaint and this
                                                                                                     Street SW, Washington, DC 20436,                      stipulation concerning the subject
                                             notice, and to authorize the
                                                                                                     telephone (202) 205–2000. General                     matter of the investigation where Nokia
                                             administrative law judge and the
                                                                                                     information concerning the Commission                 Corporation, Nokia Solutions and
                                             Commission, without further notice to
                                                                                                     may also be obtained by accessing its                 Networks B.V., Nokia Solutions and
                                             the respondent, to find the facts to be as
                                                                                                     internet server at https://www.usitc.gov.             Networks Oy, Nokia Solutions and
                                             alleged in the amended complaint and                    The public record for this investigation              Networks US LLC, and Alcatel-Lucent
                                             this notice and to enter an initial
amozie on DSK30RV082PROD with NOTICES




                                                                                                     may be viewed on the Commission’s                     Submarine Networks SAS represented
                                             determination and a final determination                 electronic docket (EDIS) at https://                  that Nokia Solutions and Networks B.V.,
                                             containing such findings, and may                       edis.usitc.gov. Hearing-impaired                      Nokia Solutions and Networks Oy, and
                                             result in the issuance of an exclusion                  persons are advised that information on               Nokia Solutions and Networks US LLC
                                             order or a cease and desist order or both               this matter can be obtained by                        do not sell, design, or manufacture the
                                             directed against the respondent.                        contacting the Commission’s TDD                       accused subsea telecommunication
                                                By order of the Commission.                          terminal on (202) 205–1810.                           systems and components thereof; and


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Document Created: 2018-04-21 00:32:50
Document Modified: 2018-04-21 00:32:50
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactPathenia M. Proctor, The Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205-2560.
FR Citation83 FR 17676 

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