Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest, 54821-54822 [2016-19560]
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Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices
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 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.
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.
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
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
1 Electronic
Document Information System
(EDIS): https://edis.usitc.gov.
2 United States International Trade Commission
(USITC): https://edis.usitc.gov.
3 Electronic Document Information System
(EDIS): https://edis.usitc.gov.
VerDate Sep<11>2014
16:39 Aug 16, 2016
Jkt 238001
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 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 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
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
54821
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).
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
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)).
4 Handbook for Electronic Filing Procedures:
https://www.usitc.gov/secretary/fed_reg_notices/
rules/handbook_on_electronic_filing.pdf.
5 All contract personnel will sign appropriate
nondisclosure agreements.
6 Electronic Document Information System
(EDIS): https://edis.usitc.gov.
E:\FR\FM\17AUN1.SGM
17AUN1
54822
Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices
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
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 16–14]
Lawrence E. Stewart, M.D.; Decision
and Order
mstockstill on DSK3G9T082PROD with NOTICES
On June 1, 2016, Administrative Law
Judge (ALJ) Charles Wm. Dorman issued
the attached Recommended Decision.
Therein, the ALJ found that on multiple
occasions, Respondent issued
prescriptions outside of the usual course
of professional practice and which
lacked a legitimate medical purpose for
schedule II controlled substances such
as Norco 10/325mg (hydrocodone/
acetaminophen) and Hycodan
(hydrocodone/homatropine cough
syrup),1 the schedule III controlled
substance phentermine, and the
schedule IV controlled substance
alprazolam, in violation of 21 CFR
1306.04(a). See R.D. at 34–60.2
More specifically, the evidence
showed that Respondent prescribed the
controlled substances to his girlfriend
knowing that she was seeking the drugs
to abuse them. The evidence also
showed that while some of the
prescriptions were issued in the name of
Respondent’s girlfriend, in multiple
instances, Respondent issued
prescriptions, including multiple
prescriptions for Hycodan, listing his
girlfriend’s two children, who were then
three and five years old respectively, as
the patients, and that Respondent did so
knowing that his girlfriend intended to
use the cough syrup because she
enjoyed drinking it. The evidence
further showed that on multiple
occasions, Respondent issued
prescriptions for Norco 3 to undercover
agents who posed as acquaintances of
1 Effective October 6, 2014, combination
hydrocodone products including both Norco and
Hycodan were transferred from schedule III to
schedule II of the Controlled Substances Act. See
Schedules of Controlled Substances: Rescheduling
of Hydrocodone Combination Products from
Schedule III to Schedule II, 79 FR 49661. Thus, at
the time Respondent issued some of the Norco and
Hycodan prescriptions, the drug was a schedule III
controlled substance. This, however, has no
consequence for my decision.
2 All citations to the Recommended Decision are
to the slip opinion as issued by the ALJ.
3 The evidence also showed that at one of the
undercover agent’s visits, Respondent also gave her
a prescription for Hycodan cough syrup.
VerDate Sep<11>2014
16:39 Aug 16, 2016
Jkt 238001
his girlfriend, knowing that the drugs
would then be provided to his girlfriend
and that Respondent further instructed
his girlfriend as to how her purported
acquaintances should present as having
headaches so that he could document a
reason in the their charts for having
issued the prescriptions.
The ALJ also found that on multiple
occasions, Respondent violated Rule 1.4
of the Mississippi State Board of
Medical Licensure’s Rules by failing to
document in his girlfriend’s chart the
diagnosis or justification for issuing the
prescription, as well as required
information including the drug’s name,
the dose, strength and quantity. R.D. at
37–39 (citing Miss. Code R. § 30–17–
2640:1.4; also citing id. § 30–17–
2640:1.16; Miss. Code §§ 73–25–29(3)
and (13)). The ALJ also made a similar
finding with respect to four
hydrocodone cough syrup prescriptions
Respondent issued in the names of his
girlfriend’s children. R.D. at 46–47 (Rx’s
issued on 6/17/14, 7/23/14, 11/19/14);
id. at 49 (Rx 11/3/14).
With respect to the phentermine
prescriptions Respondent issued to his
girlfriend, the ALJ found that he
‘‘completely failed to comply’’ with the
Board’s Rule 1.5 because he did not
prescribe ‘‘adjunctively with caloric
restriction,’’ ‘‘never conducted and
recorded an initial comprehensive
evaluation’’ including ‘‘a thorough
patient history or physical
examination,’’ and never recorded
required histories, nor her height,
weight, BMI, body measurements, and
vital signs. R.D. 43. The ALJ also found
that Respondent did not conduct a reevaluation of his girlfriend every 30
days as required by Rule 1.5. Id. Finally,
noting that Rule 1.5 generally requires
that the patient have a BMI greater than
30 in order to justify prescribing
phentermine, the ALJ observed that
Respondent’s girlfriend testified that she
had gone from 135 to 121 pounds and
that she presented at the hearing ‘‘with
a slender body type.’’ Id. The ALJ thus
explained that ‘‘[a]fter observing [her]
appearance,’’ he found ‘‘it difficult to
comprehend . . . how Respondent
could have possibly believed that [she]
has a high enough BMI to justify’’
prescribing weight-loss medication. Id.
The ALJ thus found that Respondent
violated 21 CFR 1306.04(a), the Board’s
Rule 1.5, and Mississippi Code sections
73–25–29(3) and (13) when he
prescribed phentermine to his
girlfriend. Id. at 44.
Based on these findings, the ALJ
concluded that Respondent had engaged
in ‘‘an egregious level of intentional
diversion’’ and that the Government had
satisfied its prima facie burden of
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
showing that ‘‘Respondent’s continued
registration would be inconsistent with
the public interest.’’ R.D. at 61. Because
‘‘Respondent offered no evidence that
he accepted responsibility for his
misconduct or reformed his ways,’’ the
ALJ found that he ‘‘failed to rebut the
Government’s prima facie case.’’ Id. The
ALJ thus recommended that I revoke
Respondent’s registration and deny any
application to renew or modify his
registration. Id.
Respondent filed Exceptions to the
ALJ’s Recommended Decision.
Thereafter, the ALJ forwarded the record
to me for Final Agency Action.
Having considered the record in its
entirety, including Respondent’s
Exceptions, I have decided to adopt the
ALJ findings of fact, conclusions of law,
and recommended Order. However,
before I address Respondent’s
Exceptions, I deem it necessary to
address the ALJ’s ruling on the
admissibility of the FDA package insert
for Hycodan (GX 4).
On motion of Respondent’s counsel,
the ALJ ruled inadmissible Government
Exhibit 4, which the Government
represented was the FDA package insert
for Hycodan.4 Tr. 422, 427. The basis of
Respondent’s objection was that the
exhibit contains ‘‘little more than
generalizations and medical opinions’’
and that the ALJ’s prehearing statement
required the parties to disclose ‘‘the
names and credentials and opinions of
medical experts . . . who would be
offering medical opinions in this case.’’
Id. at 420. Respondent’s counsel further
argued that ‘‘[t]he government did not
identify any expert capable of being
cross-examined on any of these
opinions’’ and that ‘‘[t]here is no reason
to believe that [the Exhibit was]
authored by a physician, much less do
we know whether the author had
credentials to offer these opinions.’’ Id.
After the Government argued that the
document was the FDA package insert,
which is included ‘‘with every drug
purchased or sold,’’ id. at 422,
Respondent argued that the copyright of
the document was the manufacturer and
that ‘‘we don’t know who authored it, or
what their credentials were, but it’s a
self-interested marketing
pharmaceutical company’’ that is
‘‘trying to sell their [sic] medicine’’ and
while the company has a ‘‘self-interest[]
to comply with a federal regulation . . .
‘‘[i]t doesn’t mean that the content is
government-sanctioned.’’ Id. at 422–23.
Respondent thus asserted that the
4 There is no dispute that the Exhibit was what
the Government represented it to be—a copy of the
package insert. Nor is there any dispute as to how
the document was obtained.
E:\FR\FM\17AUN1.SGM
17AUN1
Agencies
[Federal Register Volume 81, Number 159 (Wednesday, August 17, 2016)]
[Notices]
[Pages 54821-54822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\1\ Electronic Document Information System (EDIS): https://edis.usitc.gov.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\2\ United States International Trade Commission (USITC): https://edis.usitc.gov.
\3\ Electronic Document Information System (EDIS): https://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).
---------------------------------------------------------------------------
\4\ Handbook for Electronic Filing Procedures: https://www.usitc.gov/secretary/fed_reg_notices/rules/handbook_on_electronic_filing.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,\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\
---------------------------------------------------------------------------
\5\ All contract personnel will sign appropriate nondisclosure
agreements.
\6\ 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 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