83 FR 8106 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest

INTERNATIONAL TRADE COMMISSION

Federal Register Volume 83, Issue 37 (February 23, 2018)

Page Range		8106-8107
FR Document		2018-03774

Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Clidinium Bromide and Products Containing Same, DN 3297; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing pursuant to the Commission's Rules of Practice and Procedure.

Federal Register, Volume 83 Issue 37 (Friday, February 23, 2018)

[Federal Register Volume 83, Number 37 (Friday, February 23, 2018)]
[Notices]
[Pages 8106-8107]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03774]


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INTERNATIONAL TRADE COMMISSION


Notice of Receipt of Complaint; Solicitation of Comments Relating 
to the Public Interest

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

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SUMMARY: Notice is hereby given that the U.S. International Trade 
Commission has received a complaint entitled Certain Clidinium Bromide 
and Products Containing Same, DN 3297; the Commission is soliciting 
comments on any public interest issues raised by the complaint or 
complainant's filing pursuant to the Commission's Rules of Practice and 
Procedure.

FOR FURTHER INFORMATION CONTACT: Lisa R. Barton, Secretary to the 
Commission, U.S. International Trade Commission, 500 E Street SW, 
Washington, DC 20436, telephone (202) 205-2000. The public version of 
the complaint can be accessed on the Commission's Electronic Document 
Information System (EDIS) at https://edis.usitc.gov, and will be 
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, Washington, DC 20436, telephone (202) 205-
2000.
    General information concerning the Commission may also be obtained 
by accessing its internet server at United States International Trade 
Commission (USITC) at https://www.usitc.gov. The public record for this 
investigation may be viewed on the Commission's Electronic Document 
Information System (EDIS) at https://edis.usitc.gov. Hearing-impaired 
persons are advised that information on this matter can be obtained by 
contacting the Commission's TDD terminal on (202) 205-1810.

SUPPLEMENTARY INFORMATION: The Commission has received a complaint and 
a submission pursuant to Sec.  210.8(b) of the Commission's Rules of 
Practice and Procedure filed on behalf of Valeant Pharmaceuticals North 
America LLC and Valeant Pharmaceuticals International, Inc. on February 
20, 2018. The complaint alleges violations of section 337 of the Tariff 
Act of 1930 (19 U.S.C. 1337) in the importation into the United States, 
the sale for importation, and the sale within the United States after 
importation of certain clidinium bromide and products containing same. 
The complaint names as respondents: Bi-Coastal Pharma International LLC 
of Shrewsbury, NJ; Bi-Coastal Pharmaceutical Corporation of Shrewsbury, 
NJ; ECI Pharmaceuticals LLC of Fort Lauderdale, FL; Virtus 
Pharmaceuticals LLC of Tampa FL; and Virtus Pharmaceuticals OPCO II LLC 
of Nashville, TN. The complainant requests that the Commission issue a 
general exclusion order, a limited exclusion order, cease and desist 
orders, and impose a bond upon respondents' alleged infringing articles 
during the 60-day Presidential review period pursuant to 19 U.S.C. 
1337(j).
    Proposed respondents, other interested parties, and members of the 
public are invited to file comments, not to exceed five (5) pages in 
length, inclusive of attachments, on any public interest issues raised 
by the complaint or Sec.  210.8(b) filing. Comments should address 
whether issuance of the relief specifically requested by the 
complainant in this investigation would affect the public health and 
welfare in the United States, competitive conditions in the United 
States economy, the production of like or directly competitive articles 
in the United States, or United States consumers.
    In particular, the Commission is interested in comments that:
    (i) Explain how the articles potentially subject to the requested 
remedial orders are used in the United States;
    (ii) identify any public health, safety, or welfare concerns in the 
United States relating to the requested remedial orders;
    (iii) identify like or directly competitive articles that 
complainant, its licensees, or third parties make in the United States 
which could replace the subject articles if they were to be excluded;
    (iv) indicate whether complainant, complainant's licensees, and/or 
third party suppliers have the capacity to replace the volume of 
articles potentially subject to the requested exclusion order and/or a 
cease and desist order within a commercially reasonable time; and
    (v) explain how the requested remedial orders would impact United 
States consumers.
    Written submissions must be filed no later than by close of 
business, eight calendar days after the date of publication of this 
notice in the Federal Register. There will be further opportunities for 
comment on the public interest after the issuance of any final initial 
determination in this investigation.
    Persons filing written submissions must file the original document 
electronically on or before the deadlines

[[Page 8107]]

stated above and submit 8 true paper copies to the Office of the 
Secretary by noon the next day pursuant to Sec.  210.4(f) of the 
Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). 
Submissions should refer to the docket number (``Docket No. 3297) in a 
prominent place on the cover page and/or the first page. (See Handbook 
for Electonic Filing Procedures, Electronic Filing Procedures.\1\) 
Persons with questions regarding filing should contact the Secretary 
(202-205-2000).
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    \1\ Handbook for Electronic Filing Procedures: https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf.
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    Any person desiring to submit a document to the Commission in 
confidence must request confidential treatment. All such requests 
should be directed to the Secretary to the Commission and must include 
a full statement of the reasons why the Commission should grant such 
treatment. See 19 CFR 201.6. Documents for which confidential treatment 
by the Commission is properly sought will be treated accordingly. All 
such requests should be directed to the Secretary to the Commission and 
must include a full statement of the reasons why the Commission should 
grant such treatment. See 19 CFR 201.6. Documents for which 
confidential treatment by the Commission is properly sought will be 
treated accordingly. All information, including confidential business 
information and documents for which confidential treatment is properly 
sought, submitted to the Commission for purposes of this Investigation 
may be disclosed to and used: (i) By the Commission, its employees and 
Offices, and contract personnel (a) for developing or maintaining the 
records of this or a related proceeding, or (b) in internal 
investigations, audits, reviews, and evaluations relating to the 
programs, personnel, and operations of the Commission including under 5 
U.S.C. Appendix 3; or (ii) by U.S. government employees and contract 
personnel,\2\ solely for cybersecurity purposes. All nonconfidential 
written submissions will be available for public inspection at the 
Office of the Secretary and on EDIS.\3\
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    \2\ All contract personnel will sign appropriate nondisclosure 
agreements.
    \3\ Electronic Document Information System (EDIS): https://edis.usitc.gov.
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    This action is taken under the authority of section 337 of the 
Tariff Act of 1930, as amended (19 U.S.C. 1337), and of Sec. Sec.  
201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure 
(19 CFR 201.10, 210.8(c)).

    By order of the Commission.

    Issued: February 20, 2018.
Katherine M. Hiner,
Supervisory Attorney.
[FR Doc. 2018-03774 Filed 2-22-18; 8:45 am]
 BILLING CODE 7020-02-P

Federal Register / Vol. 83, No. 37 / Friday, February 23, 2018 / Notices 8107

stated above and submit 8 true paper Issued: February 20, 2018. Pharmaceuticals Inc., 2898
copies to the Office of the Secretary by Katherine M. Hiner, Manufacturers Road, Greensboro, NC
noon the next day pursuant to § 210.4(f) Supervisory Attorney. 27406 applied to be registered as an
of the Commission’s Rules of Practice [FR Doc. 2018–03774 Filed 2–22–18; 8:45 am] importer of Nabilone (7379), a basic
and Procedure (19 CFR 210.4(f)). BILLING CODE 7020–02–P class of controlled substance listed in
Submissions should refer to the docket Schedule II.
number (‘‘Docket No. 3297) in a The company plans to import the
prominent place on the cover page and/ DEPARTMENT OF JUSTICE listed controlled substance in finished
or the first page. (See Handbook for dosage form for commercial distribution
Electonic Filing Procedures, Electronic Drug Enforcement Administration purposes only. No other activity for this
Filing Procedures.1) Persons with drug code is authorized for this
[Docket No. DEA–392]
questions regarding filing should registration. Approval of permit
contact the Secretary (202–205–2000). Importer of Controlled Substances applications will occur only when the
Any person desiring to submit a Application: Mylan Pharmaceuticals registrant’s business activity is
document to the Commission in Inc. consistent with what is authorized
confidence must request confidential under 21 U.S.C. 952(a)(2). Authorization
treatment. All such requests should be ACTION: Notice of application. will not extend to the import of FDA
directed to the Secretary to the approved or non-approved finished
Commission and must include a full DATES: Registered bulk manufacturers of dosage forms for commercial sale.
statement of the reasons why the the affected basic classes, and
Dated: February 14, 2018.
Commission should grant such applicants therefore, may file written
Susan A. Gibson,
treatment. See 19 CFR 201.6. Documents comments on or objections to the
issuance of the proposed registration on Deputy Assistant Administrator.
for which confidential treatment by the
or before March 26, 2018. Such persons [FR Doc. 2018–03723 Filed 2–22–18; 8:45 am]
Commission is properly sought will be
treated accordingly. All such requests may also file a written request for a BILLING CODE 4410–09–P

should be directed to the Secretary to hearing on the application March 26,
the Commission and must include a full 2018.
DEPARTMENT OF JUSTICE
statement of the reasons why the ADDRESSES: Written comments should
Commission should grant such be sent to: Drug Enforcement [OMB Number 1105—New]
treatment. See 19 CFR 201.6. Documents Administration, Attention: DEA Federal
for which confidential treatment by the Register Representative/DRW, 8701 Agency Information Collection
Commission is properly sought will be Morrissette Drive, Springfield, Virginia Activities; Proposed eCollection
treated accordingly. All information, 22152. All requests for hearing must be eComments Requested; New
including confidential business sent to: Drug Enforcement
information and documents for which AGENCY: Civil Division, Department of
Administration, Attn: Administrator,
confidential treatment is properly Justice.
8701 Morrissette Drive, Springfield,
sought, submitted to the Commission for Virginia 22152. All requests for hearing ACTION: 60-Day notice.
purposes of this Investigation may be should also be sent to: (1) Drug
disclosed to and used: (i) By the SUMMARY: The Department of Justice,
Enforcement Administration, Attn: Civil Division, is submitting the
Commission, its employees and Offices, Hearing Clerk/LJ, 8701 Morrissette
and contract personnel (a) for following information collection request
Drive, Springfield, Virginia 22152; and to the Office of Management and Budget
developing or maintaining the records (2) Drug Enforcement Administration,
of this or a related proceeding, or (b) in (OMB) for review and approval in
Attn: DEA Federal Register accordance with the Paperwork
internal investigations, audits, reviews, Representative/DRW, 8701 Morrissette
and evaluations relating to the Reduction Act of 1995.
Drive, Springfield, Virginia 22152.
programs, personnel, and operations of DATES: The Department of Justice
SUPPLEMENTARY INFORMATION: The
the Commission including under 5 encourages public comment and will
Attorney General has delegated his
U.S.C. Appendix 3; or (ii) by U.S. accept input until April 24, 2018.
authority under the Controlled
government employees and contract Substances Act to the Administrator of FOR FURTHER INFORMATION CONTACT: If
personnel,2 solely for cybersecurity the Drug Enforcement Administration you have additional comments
purposes. All nonconfidential written (DEA), 28 CFR 0.100(b). Authority to especially on the estimated public
submissions will be available for public exercise all necessary functions with burden or associated response time,
inspection at the Office of the Secretary respect to the promulgation and suggestions, or need a copy of the
and on EDIS.3 implementation of 21 CFR part 1301, proposed information collection
This action is taken under the incident to the registration of instrument with instructions or
authority of section 337 of the Tariff Act manufacturers, distributors, dispensers, additional information, please contact
of 1930, as amended (19 U.S.C. 1337), importers, and exporters of controlled Talitha Guinn-Shaver, 950 Pennsylvania
and of §§ 201.10 and 210.8(c) of the substances (other than final orders in Ave. NW, Washington, DC 20005, Attn:
Commission’s Rules of Practice and connection with suspension, denial, or Civil Communications Office (Attn:
Procedure (19 CFR 201.10, 210.8(c)). revocation of registration) has been Elder Justice Initiative) (Phone: 202–
By order of the Commission. redelegated to the Assistant 598–0292).
daltland on DSKBBV9HB2PROD with NOTICES

Administrator of the DEA Diversion SUPPLEMENTARY INFORMATION: Written
1 Handbook for Electronic Filing Procedures:
Control Division (‘‘Assistant comments and suggestions from the
https://www.usitc.gov/documents/handbook_on_ Administrator’’) pursuant to section 7 of public and affected agencies concerning
filing_procedures.pdf.
2 All contract personnel will sign appropriate
28 CFR part 0, appendix to subpart R. the proposed collection of information
nondisclosure agreements. In accordance with 21 CFR are encouraged. Your comments should
3 Electronic Document Information System 1301.34(a), this is notice that on address one or more of the following
(EDIS): https://edis.usitc.gov. December 7, 2017, Mylan four points:

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Document Created: 2018-02-23 01:32:50
Document Modified: 2018-02-23 01:32:50

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.
Contact		Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at https://edis.usitc.gov, and will be 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, Washington, DC 20436, telephone (202) 205- 2000.
FR Citation		83 FR 8106