81 FR 54821 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest

INTERNATIONAL TRADE COMMISSION

Federal Register Volume 81, Issue 159 (August 17, 2016)

Page Range		54821-54822
FR Document		2016-19560

Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Athletic Footwear, DN 3166; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing under section 210.8(b) of the Commission's Rules of Practice and Procedure (19 CFR 210.8(b)).

Federal Register, Volume 81 Issue 159 (Wednesday, August 17, 2016)

[Federal Register Volume 81, Number 159 (Wednesday, August 17, 2016)]
[Notices]
[Pages 54821-54822]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-19560]



[[Page 54821]]

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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 Athletic Footwear, 
DN 3166; the Commission is soliciting comments on any public interest 
issues raised by the complaint or complainant's filing under section 
210.8(b) of the Commission's Rules of Practice and Procedure (19 CFR 
210.8(b)).

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 EDIS,\1\ 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.
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    \1\ Electronic Document Information System (EDIS): http://edis.usitc.gov.
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    General information concerning the Commission may also be obtained 
by accessing its Internet server at United States International Trade 
Commission (USITC) at USITC.\2\ The public record for this 
investigation may be viewed on the Commission's Electronic Document 
Information System (EDIS) at EDIS.\3\ Hearing-impaired persons are 
advised that information on this matter can be obtained by contacting 
the Commission's TDD terminal on (202) 205-1810.
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    \2\ United States International Trade Commission (USITC): http://edis.usitc.gov.
    \3\ Electronic Document Information System (EDIS): http://edis.usitc.gov.

SUPPLEMENTARY INFORMATION: The Commission has received a complaint and 
a submission pursuant to section 210.8(b) of the Commission's Rules of 
Practice and Procedure filed on behalf of Reebok International Ltd. and 
Reebok International Limited on August 10, 2016. 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 athletic 
footwear. The complaint names as respondents TRB Acquisitions LLC of 
New York, NY; RBX Active 01 LLC of New York, NY; RBX DIRECT LLC of New 
York, NY; RBX.COM LLC of New York, NY; and Elite Performance Footwear, 
LLC of New York, NY. The complainant requests that the Commission issue 
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 section 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 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 docket 
number (``Docket No. 3166'') in a prominent place on the cover page 
and/or the first page. (See Handbook for Electronic Filing Procedures, 
Electronic Filing Procedures \4\). Persons with questions regarding 
filing should contact the Secretary (202-205-2000).
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    \4\ Handbook for Electronic Filing Procedures: http://www.usitc.gov/secretary/fed_reg_notices/rules/handbook_on_electronic_filing.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,\5\ solely for cybersecurity purposes. All nonconfidential 
written submissions will be available for public inspection at the 
Office of the Secretary and on EDIS.\6\
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    \5\ All contract personnel will sign appropriate nondisclosure 
agreements.
    \6\ Electronic Document Information System (EDIS): http://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 sections 201.10 
and 210.8(c) of the Commission's Rules of Practice and Procedure (19 
CFR 201.10, 210.8(c)).


[[Page 54822]]


    By order of the Commission.

    Issued: August 10, 2016.
 Lisa R. Barton,
Secretary to the Commission.
[FR Doc. 2016-19560 Filed 8-16-16; 8:45 am]
 BILLING CODE 7020-02-P

54822 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices

By order of the Commission. his girlfriend, knowing that the drugs showing that ‘‘Respondent’s continued
Issued: August 10, 2016. would then be provided to his girlfriend registration would be inconsistent with
Lisa R. Barton, and that Respondent further instructed the public interest.’’ R.D. at 61. Because
Secretary to the Commission. his girlfriend as to how her purported ‘‘Respondent offered no evidence that
[FR Doc. 2016–19560 Filed 8–16–16; 8:45 am] acquaintances should present as having he accepted responsibility for his
BILLING CODE 7020–02–P
headaches so that he could document a misconduct or reformed his ways,’’ the
reason in the their charts for having ALJ found that he ‘‘failed to rebut the
issued the prescriptions. Government’s prima facie case.’’ Id. The
The ALJ also found that on multiple ALJ thus recommended that I revoke
DEPARTMENT OF JUSTICE occasions, Respondent violated Rule 1.4 Respondent’s registration and deny any
of the Mississippi State Board of application to renew or modify his
Drug Enforcement Administration
Medical Licensure’s Rules by failing to registration. Id.
[Docket No. 16–14] document in his girlfriend’s chart the Respondent filed Exceptions to the
diagnosis or justification for issuing the ALJ’s Recommended Decision.
Lawrence E. Stewart, M.D.; Decision prescription, as well as required Thereafter, the ALJ forwarded the record
and Order information including the drug’s name, to me for Final Agency Action.
On June 1, 2016, Administrative Law the dose, strength and quantity. R.D. at Having considered the record in its
Judge (ALJ) Charles Wm. Dorman issued 37–39 (citing Miss. Code R. § 30–17– entirety, including Respondent’s
the attached Recommended Decision. 2640:1.4; also citing id. § 30–17– Exceptions, I have decided to adopt the
Therein, the ALJ found that on multiple 2640:1.16; Miss. Code §§ 73–25–29(3) ALJ findings of fact, conclusions of law,
occasions, Respondent issued and (13)). The ALJ also made a similar and recommended Order. However,
prescriptions outside of the usual course finding with respect to four before I address Respondent’s
of professional practice and which hydrocodone cough syrup prescriptions Exceptions, I deem it necessary to
lacked a legitimate medical purpose for Respondent issued in the names of his address the ALJ’s ruling on the
schedule II controlled substances such girlfriend’s children. R.D. at 46–47 (Rx’s admissibility of the FDA package insert
as Norco 10/325mg (hydrocodone/ issued on 6/17/14, 7/23/14, 11/19/14); for Hycodan (GX 4).
acetaminophen) and Hycodan id. at 49 (Rx 11/3/14). On motion of Respondent’s counsel,
With respect to the phentermine the ALJ ruled inadmissible Government
(hydrocodone/homatropine cough
prescriptions Respondent issued to his Exhibit 4, which the Government
syrup),1 the schedule III controlled
girlfriend, the ALJ found that he represented was the FDA package insert
substance phentermine, and the
‘‘completely failed to comply’’ with the for Hycodan.4 Tr. 422, 427. The basis of
schedule IV controlled substance
Board’s Rule 1.5 because he did not Respondent’s objection was that the
alprazolam, in violation of 21 CFR
prescribe ‘‘adjunctively with caloric exhibit contains ‘‘little more than
1306.04(a). See R.D. at 34–60.2 restriction,’’ ‘‘never conducted and
More specifically, the evidence generalizations and medical opinions’’
recorded an initial comprehensive and that the ALJ’s prehearing statement
showed that Respondent prescribed the
evaluation’’ including ‘‘a thorough required the parties to disclose ‘‘the
controlled substances to his girlfriend patient history or physical
knowing that she was seeking the drugs names and credentials and opinions of
examination,’’ and never recorded medical experts . . . who would be
to abuse them. The evidence also required histories, nor her height,
showed that while some of the offering medical opinions in this case.’’
weight, BMI, body measurements, and Id. at 420. Respondent’s counsel further
prescriptions were issued in the name of vital signs. R.D. 43. The ALJ also found
Respondent’s girlfriend, in multiple argued that ‘‘[t]he government did not
that Respondent did not conduct a re- identify any expert capable of being
instances, Respondent issued evaluation of his girlfriend every 30
prescriptions, including multiple cross-examined on any of these
days as required by Rule 1.5. Id. Finally, opinions’’ and that ‘‘[t]here is no reason
prescriptions for Hycodan, listing his noting that Rule 1.5 generally requires
girlfriend’s two children, who were then to believe that [the Exhibit was]
that the patient have a BMI greater than
three and five years old respectively, as authored by a physician, much less do
30 in order to justify prescribing
the patients, and that Respondent did so we know whether the author had
phentermine, the ALJ observed that
knowing that his girlfriend intended to credentials to offer these opinions.’’ Id.
Respondent’s girlfriend testified that she
use the cough syrup because she After the Government argued that the
had gone from 135 to 121 pounds and
enjoyed drinking it. The evidence document was the FDA package insert,
that she presented at the hearing ‘‘with
further showed that on multiple which is included ‘‘with every drug
a slender body type.’’ Id. The ALJ thus
occasions, Respondent issued purchased or sold,’’ id. at 422,
explained that ‘‘[a]fter observing [her]
prescriptions for Norco 3 to undercover Respondent argued that the copyright of
appearance,’’ he found ‘‘it difficult to
agents who posed as acquaintances of the document was the manufacturer and
comprehend . . . how Respondent
that ‘‘we don’t know who authored it, or
could have possibly believed that [she]
1 Effective October 6, 2014, combination what their credentials were, but it’s a
has a high enough BMI to justify’’
hydrocodone products including both Norco and
prescribing weight-loss medication. Id. self-interested marketing
Hycodan were transferred from schedule III to pharmaceutical company’’ that is
schedule II of the Controlled Substances Act. See The ALJ thus found that Respondent
Schedules of Controlled Substances: Rescheduling violated 21 CFR 1306.04(a), the Board’s ‘‘trying to sell their [sic] medicine’’ and
of Hydrocodone Combination Products from Rule 1.5, and Mississippi Code sections while the company has a ‘‘self-interest[]
Schedule III to Schedule II, 79 FR 49661. Thus, at
73–25–29(3) and (13) when he to comply with a federal regulation . . .
mstockstill on DSK3G9T082PROD with NOTICES

the time Respondent issued some of the Norco and ‘‘[i]t doesn’t mean that the content is
Hycodan prescriptions, the drug was a schedule III prescribed phentermine to his
controlled substance. This, however, has no girlfriend. Id. at 44. government-sanctioned.’’ Id. at 422–23.
consequence for my decision. Based on these findings, the ALJ Respondent thus asserted that the
2 All citations to the Recommended Decision are
concluded that Respondent had engaged
to the slip opinion as issued by the ALJ. 4 There is no dispute that the Exhibit was what
3 The evidence also showed that at one of the in ‘‘an egregious level of intentional the Government represented it to be—a copy of the
undercover agent’s visits, Respondent also gave her diversion’’ and that the Government had package insert. Nor is there any dispute as to how
a prescription for Hycodan cough syrup. satisfied its prima facie burden of the document was obtained.

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Document Created: 2018-02-09 11:34:54
Document Modified: 2018-02-09 11:34:54

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 EDIS,\1\ 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		81 FR 54821