Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest, 8106-8107 [2018-03774]

Download as PDF 8106 Federal Register / Vol. 83, No. 37 / Friday, February 23, 2018 / Notices daltland on DSKBBV9HB2PROD with NOTICES party suppliers have the capacity to replace the volume of articles potentially subject to the recommended exclusion order and/or a cease and desist order within a commercially reasonable time; and (v) explain how the limited exclusion order and a cease and desist order would impact consumers in the United States. Written submissions must be filed no later than by close of business on March 22, 2018. Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) of the Commission’s Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the investigation number (‘‘Inv. No. 337–TA–1031’’) in a prominent place on the cover page and/or the first page. (See Handbook for Electronic Filing Procedures, https://www.usitc.gov/ secretary/fed_reg_notices/rules/ handbook_on_electronic_filing.pdf. Persons with questions regarding filing should contact the Secretary ((202) 205– 2000). 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. A redacted nonconfidential version of the document must also be filed simultaneously with any confidential filing. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS. The authority for the Commission’s determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission’s Rules of Practice and Procedure (19 CFR part 210). By order of the Commission. Issued: February 16, 2018. Lisa R. Barton, Secretary to the Commission. [FR Doc. 2018–03680 Filed 2–22–18; 8:45 am] BILLING CODE 7020–02–P VerDate Sep<11>2014 18:52 Feb 22, 2018 Jkt 244001 INTERNATIONAL TRADE COMMISSION Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest U.S. International Trade Commission. ACTION: Notice. AGENCY: 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 § 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 SUMMARY: PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 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 60day 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 § 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 E:\FR\FM\23FEN1.SGM 23FEN1 Federal Register / Vol. 83, No. 37 / Friday, February 23, 2018 / Notices daltland on DSKBBV9HB2PROD with NOTICES stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to § 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). 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 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 §§ 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. 1 Handbook for Electronic Filing Procedures: https://www.usitc.gov/documents/handbook_on_ filing_procedures.pdf. 2 All contract personnel will sign appropriate nondisclosure agreements. 3 Electronic Document Information System (EDIS): https://edis.usitc.gov. VerDate Sep<11>2014 18:52 Feb 22, 2018 Jkt 244001 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 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc. ACTION: Notice of application. 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 March 26, 2018. Such persons may also file a written request for a hearing on the application March 26, 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 December 7, 2017, Mylan DATES: PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 8107 Pharmaceuticals Inc., 2898 Manufacturers Road, Greensboro, NC 27406 applied to be registered as an importer of Nabilone (7379), a basic class of controlled substance listed in Schedule II. The company plans to import the listed controlled substance in finished dosage form for commercial distribution purposes only. No other activity for this drug code is authorized for this registration. 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: February 14, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018–03723 Filed 2–22–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE [OMB Number 1105—New] Agency Information Collection Activities; Proposed eCollection eComments Requested; New Civil Division, Department of Justice. ACTION: 60-Day notice. AGENCY: The Department of Justice, Civil Division, is submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. DATES: The Department of Justice encourages public comment and will accept input until April 24, 2018. FOR FURTHER INFORMATION CONTACT: If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Talitha Guinn-Shaver, 950 Pennsylvania Ave. NW, Washington, DC 20005, Attn: Civil Communications Office (Attn: Elder Justice Initiative) (Phone: 202– 598–0292). SUPPLEMENTARY INFORMATION: Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points: SUMMARY: E:\FR\FM\23FEN1.SGM 23FEN1

Agencies

[Federal Register Volume 83, Number 37 (Friday, February 23, 2018)]
[Notices]
[Pages 8106-8107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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

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).
---------------------------------------------------------------------------

    \1\ Handbook for Electronic Filing Procedures: https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \2\ All contract personnel will sign appropriate nondisclosure 
agreements.
    \3\ Electronic Document Information System (EDIS): https://edis.usitc.gov.
---------------------------------------------------------------------------

    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