[Federal Register Volume 83, Number 78 (Monday, April 23, 2018)]
[Notices]
[Pages 17676-17677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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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