Findings of Research Misconduct, 38316-38317 [2018-16693]
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Federal Register / Vol. 83, No. 151 / Monday, August 6, 2018 / Notices
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IV. References
The following reference marked with
an asterisk (*) is on display at the
Dockets Management Staff (see
ADDRESSES) and is available for viewing
by interested persons between 9 a.m.
and 4 p.m., Monday through Friday; it
also is available electronically at https://
www.regulations.gov. References
without asterisks are not on display
because they have copyright restriction,
or they are available as published
articles and books. Please contact the
person identified in the FOR FURTHER
INFORMATION CONTACT section to
schedule a date to inspect references
without asterisks.
1. Madsen, L.R., N.H. Vinther Krarup, T.K.
Bergmann, et al., 2016, ‘‘A Cancer That
Went Up in Smoke: Pulmonary Reaction
to E-Cigarettes Imitating Metastatic
Cancer,’’ Chest, 149(3):e65–67.
2. Ghosh, A., R.C. Coakley, T. Mascenik, et
al., 2018, ‘‘Chronic E-Cigarette Exposure
Alters the Human Bronchial Epithelial
Proteome,’’ American Journal of
Respiratory and Critical Care Medicine,
epub ahead of print February 26, 2018,
doi: 10.1164/rccm.201710–2033OC.
* 3. Olmedo, P., W. Goessler, S. Tanda, et al.,
2018, ‘‘Metal Concentrations in ECigarette Liquid and Aerosol Samples:
The Contribution of Metallic Coils,’’
Environmental Health Perspectives,
126(2): doi: 10.1289/EHP2175.
4. Rubinstein, M.L., K. Delucchi, N.L.
Benowitz, and D.E. Ramo, 2018,
‘‘Adolescent Exposure to Toxic Volatile
Organic Chemicals From E-Cigarettes,’’
Pediatrics, epub ahead of print March 5,
2018, doi: 10.1542/peds.2017–3557.
Dated: July 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–16726 Filed 8–3–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Notice is hereby given that on
July 13, 2018, the U.S. Department of
Health and Human Services (HHS)
Debarring Official, on behalf of the
Secretary of HHS, issued a final notice
of debarment based on an
Administrative Law Judge’s findings of
research misconduct against Christian
Kreipke, Ph.D., former Research
Associate Professor, Wayne State
University. Dr. Kreipke engaged in
research misconduct in research
supported by National Institute of
SUMMARY:
PO 00000
Frm 00044
Fmt 4703
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Neurological Disorders and Stroke
(NINDS), National Institutes of Health
(NIH), grants R01 NS039860 and R01
NS064976–01A2. The administrative
actions, including five (5) years of
debarment, were implemented
beginning on July 13, 2018, and are
detailed below.
FOR FURTHER INFORMATION CONTACT:
Wanda K. Jones, Dr.P.H., Interim
Director, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8200.
SUPPLEMENTARY INFORMATION:
Christian Kreipke, Ph.D., Wayne State
University: ORI issued a charge letter
enumerating findings of research
misconduct and proposing HHS
administrative actions. Dr. Kreipke
(‘‘Respondent’’) subsequently requested
a hearing before an Administrative Law
Judge (ALJ) of the Departmental Appeals
Board to dispute these findings. A
hearing before the ALJ was held on July
10–12, 2017. On May 31, 2018, the ALJ
issued his recommended decision,
finding that Respondent recklessly
caused or permitted twenty-three (23)
instances of research misconduct in his
three (3) grant applications, two (2)
articles on which he was the first listed
author, and two (2) posters on which he
was the first listed author. The ALJ held
that appropriate administrative actions
included a five-year debarment from
any contracting or subcontracting with
any agency of the United States and
from eligibility for or involvement in
nonprocurement programs of the United
States referred to as ‘‘covered
transactions.’’ 2 CFR parts 180 and 376.
The ALJ held it was an appropriate
administrative action to also impose a
five-year prohibition from serving in
any capacity to the U.S. Public Health
Service (PHS), including but not limited
to, service on any PHS advisory
committee, board, or peer review
committee, or as a consultant. The ALJ
noted that ORI also had proposed that
the publisher of certain articles be
notified of the need to retract those
articles and that retraction had already
occurred by the time of his
recommended decision.
Under the regulation, the ALJ’s
recommended decision went to the
Assistant Secretary for Health, who did
not modify it and forwarded it to the
HHS Debarring Official, who is the
deciding official for the debarment. The
ALJ decision constituted the findings of
fact to the HHS Debarring Official in
accordance with 2 CFR 180.845(c). On
July 13, 2018, the HHS Debarring
Official issued a final notice of
debarment to begin on July 13, 2018,
and end on July 12, 2023.
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06AUN1
sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 151 / Monday, August 6, 2018 / Notices
Respondent’s grant applications,
articles, and posters in question
examined the differential effects of
endothelin receptor antagonists on
traumatic brain injury-induced
hypoperfusion of cerebral blood flow,
neuronal cell injury, and cognition in
rat animal models.
Respondent recklessly included
falsely described images in the
following grant applications:
• R01 NS064976–01A1 submitted to
NINDS, NIH (unfunded)
• R01 NS064976–01A2 submitted to
NINDS, NIH (funded)
• R01 NS065824–01 submitted to
NINDS, NIH (unfunded)
Respondent recklessly included
falsely described images in the
following publications and posters:
• ‘‘Differential effects of endothelin
receptor A and B antagonism on
cerebral hypoperfusion following
traumatic brain injury.’’ Neurological
Research 32(2):209–14, 2010 Mar
(‘‘NR2010’’). Retracted in Neurological
Research 39(5):472, 2017 May.
• ‘‘Clazosentan, a novel endothelin A
antagonist, improves cerebral blood
flow and behavior after traumatic brain
injury.’’ Neurological Research
33(2):208–13, 2011 Mar (‘‘NR2011–1’’).
Retracted in Neurological Research
39(5):472, 2017 May.
• 2009 poster for a Department of
Veterans Affairs (VA) presentation:
‘‘Using endothelin-A antagonists to
ameliorate hypoperfusion and cognitive
deficits following brain trauma: towards
a clinical trial’’ (‘‘VA2009’’).
• 2010 poster for a VA presentation:
‘‘Endothelin-1 receptor A antagonists
improve neurologic and cognitive
outcome following TBI’’ (‘‘VA2010’’).
The following findings of research
misconduct were proven by a
preponderance of the evidence.
Respondent recklessly included:
• falsely described Fluoro-Jade stained
images of rat brain cells in:
—Figure 8 (left panel) in R01
NS064976–01A1
—Figure 8B (left panel) in R01
NS064976–01A2
—Figures 4A–F in R01 NS065824–01
—Figure 3 (right and left panels) in
NR2011–1
—Figure 5C in NR2010
—Figure 3 (panel 3) and Figure 6
(right and left panels) in VA2009
—Figure 3 (panel 3) and Figure 6
(right and left panels) in VA2010
• falsely described systolic blood
pressure curves in Figures 4A and
4B in NR2010
• falsely described cerebral blood flow
graphs in:
—Figure 5 (left panel) in R01
VerDate Sep<11>2014
17:36 Aug 03, 2018
Jkt 244001
NS064976–01A1
—Figure 5 (left panel) in R01
NS064976–01A2
—Figure 3A in NR2010
—Figure 5 in VA2009
—Figure 5 in VA2010
• falsely described Western blot images
in one of the following three grant
applications (because at least one of
the three must be false): Figure 1
(me+TBI panel for VEGF) in R01
NS065824–01, Figure 2B in R01
NS064976–01A1, and Figure 2B in
R01 NS064976–01A2
• falsely described Western blot images
in:
—Figure 2A in R01 NS064976–01A1
—Figure 2A in R01 NS064976–01A2
• a falsely described image of lectin
labeled rat brain section in Figure
2C in R01 NS065824–01
Thus, the research misconduct
findings set forth above became
effective, and the following
administrative actions have been
implemented for a period of five (5)
years, beginning on July 13, 2018:
(1) Dr. Kreipke is debarred from any
contracting or subcontracting with any
agency of the United States Government
and from eligibility or involvement in
nonprocurement programs of the United
States Government referred to as
‘‘covered transactions’’ pursuant to
HHS’ Implementation (2 CFR part 376)
of Office of Management and Budget
(OMB) Guidelines to Agencies on
Governmentwide Debarment and
Suspension (2 CFR part 180); and
(2) Dr. Kreipke is prohibited from
serving in any advisory capacity to PHS
including, but not limited to, service on
any PHS advisory committee, board,
and/or peer review committee, or as a
consultant.
Wanda K. Jones,
Interim Director, Office of Research Integrity.
[FR Doc. 2018–16693 Filed 8–3–18; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket Number USCG–2018–0193]
Polar Icebreaker Program; Preparation
of Environmental Impact Statement
Coast Guard, DHS.
Notice of Availability and
request for comments.
AGENCY:
ACTION:
The U.S. Coast Guard, as lead
agency, announces the availability of a
draft Programmatic Environmental
Impact Statement (EIS) in accordance
SUMMARY:
PO 00000
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38317
with the National Environmental Policy
Act (NEPA) for the Polar Icebreaker
Program’s design and build of up to six
polar icebreakers. The U.S. Coast Guard
requests public comments on the draft
EIS.
DATES: Comments must be submitted to
the online docket via https://
www.regulations.gov on or before
September 20, 2018.
ADDRESSES: You may submit comments
identified by docket number USCG–
2018–0193 using the Federal portal at
https://www.regulations.gov. See the
‘‘Public Participation and Request for
Comments’’ portion of the
SUPPLEMENTARY INFORMATION section for
further instructions on submitting
comments.
If
you have questions about this notice of
intent, email Mr. Ahmed Majumder,
Deputy Program Manager, Polar
Icebreaker Program, U.S. Coast Guard;
email PIBEnvironment@uscg.mil.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. Table of Abbreviations
CFR Code of Federal Regulations
CGC Coast Guard Cutter
EIS Environmental Impact Statement
FR Federal Register
NEPA National Environmental Policy Act
PIBs Polar Icebreakers
U.S.C. United States Code
II. Background and Purpose
The U.S. Coast Guard’s current fleet of
polar icebreakers (PIBs) consists of two
heavy icebreakers, Coast Guard Cutter
(CGC) POLAR STAR and CGC POLAR
SEA, and one medium icebreaker, CGC
HEALY. The U.S. Coast Guard’s heavy
icebreakers have both exceeded their
designed 30 year service life. CGC
POLAR STAR was commissioned in
1976 and CGC POLAR SEA in 1978.
CGC POLAR STAR began reactivation in
2010 and completed a service life
extension in 2013 to allow CGC POLAR
STAR to operate for an additional seven
to ten years. CGC POLAR SEA has
remained out of service since 2010 and
is not expected to be reactivated. The
current PIB program acquisition strategy
is approved to construct up to three
heavy PIBs and may (at a future date)
potentially expand to include up to
three medium icebreakers, with planned
service design lives of 30 years each.
The first of these new PIBs is expected
to delivered in 2023. Because the first
new PIB would not be operational in the
Polar Regions until at least 2023, new
information may become available after
the completion of this EIS. In that case,
supplemental NEPA documentation
may, as appropriate, be prepared in
E:\FR\FM\06AUN1.SGM
06AUN1
Agencies
[Federal Register Volume 83, Number 151 (Monday, August 6, 2018)]
[Notices]
[Pages 38316-38317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16693]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Notice is hereby given that on July 13, 2018, the U.S.
Department of Health and Human Services (HHS) Debarring Official, on
behalf of the Secretary of HHS, issued a final notice of debarment
based on an Administrative Law Judge's findings of research misconduct
against Christian Kreipke, Ph.D., former Research Associate Professor,
Wayne State University. Dr. Kreipke engaged in research misconduct in
research supported by National Institute of Neurological Disorders and
Stroke (NINDS), National Institutes of Health (NIH), grants R01
NS039860 and R01 NS064976-01A2. The administrative actions, including
five (5) years of debarment, were implemented beginning on July 13,
2018, and are detailed below.
FOR FURTHER INFORMATION CONTACT:
Wanda K. Jones, Dr.P.H., Interim Director, Office of Research
Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240)
453-8200.
SUPPLEMENTARY INFORMATION:
Christian Kreipke, Ph.D., Wayne State University: ORI issued a
charge letter enumerating findings of research misconduct and proposing
HHS administrative actions. Dr. Kreipke (``Respondent'') subsequently
requested a hearing before an Administrative Law Judge (ALJ) of the
Departmental Appeals Board to dispute these findings. A hearing before
the ALJ was held on July 10-12, 2017. On May 31, 2018, the ALJ issued
his recommended decision, finding that Respondent recklessly caused or
permitted twenty-three (23) instances of research misconduct in his
three (3) grant applications, two (2) articles on which he was the
first listed author, and two (2) posters on which he was the first
listed author. The ALJ held that appropriate administrative actions
included a five-year debarment from any contracting or subcontracting
with any agency of the United States and from eligibility for or
involvement in nonprocurement programs of the United States referred to
as ``covered transactions.'' 2 CFR parts 180 and 376. The ALJ held it
was an appropriate administrative action to also impose a five-year
prohibition from serving in any capacity to the U.S. Public Health
Service (PHS), including but not limited to, service on any PHS
advisory committee, board, or peer review committee, or as a
consultant. The ALJ noted that ORI also had proposed that the publisher
of certain articles be notified of the need to retract those articles
and that retraction had already occurred by the time of his recommended
decision.
Under the regulation, the ALJ's recommended decision went to the
Assistant Secretary for Health, who did not modify it and forwarded it
to the HHS Debarring Official, who is the deciding official for the
debarment. The ALJ decision constituted the findings of fact to the HHS
Debarring Official in accordance with 2 CFR 180.845(c). On July 13,
2018, the HHS Debarring Official issued a final notice of debarment to
begin on July 13, 2018, and end on July 12, 2023.
[[Page 38317]]
Respondent's grant applications, articles, and posters in question
examined the differential effects of endothelin receptor antagonists on
traumatic brain injury-induced hypoperfusion of cerebral blood flow,
neuronal cell injury, and cognition in rat animal models.
Respondent recklessly included falsely described images in the
following grant applications:
R01 NS064976-01A1 submitted to NINDS, NIH (unfunded)
R01 NS064976-01A2 submitted to NINDS, NIH (funded)
R01 NS065824-01 submitted to NINDS, NIH (unfunded)
Respondent recklessly included falsely described images in the
following publications and posters:
``Differential effects of endothelin receptor A and B
antagonism on cerebral hypoperfusion following traumatic brain
injury.'' Neurological Research 32(2):209-14, 2010 Mar (``NR2010'').
Retracted in Neurological Research 39(5):472, 2017 May.
``Clazosentan, a novel endothelin A antagonist, improves
cerebral blood flow and behavior after traumatic brain injury.''
Neurological Research 33(2):208-13, 2011 Mar (``NR2011-1''). Retracted
in Neurological Research 39(5):472, 2017 May.
2009 poster for a Department of Veterans Affairs (VA)
presentation: ``Using endothelin-A antagonists to ameliorate
hypoperfusion and cognitive deficits following brain trauma: towards a
clinical trial'' (``VA2009'').
2010 poster for a VA presentation: ``Endothelin-1 receptor
A antagonists improve neurologic and cognitive outcome following TBI''
(``VA2010'').
The following findings of research misconduct were proven by a
preponderance of the evidence. Respondent recklessly included:
falsely described Fluoro-Jade stained images of rat brain
cells in:
--Figure 8 (left panel) in R01 NS064976-01A1
--Figure 8B (left panel) in R01 NS064976-01A2
--Figures 4A-F in R01 NS065824-01
--Figure 3 (right and left panels) in NR2011-1
--Figure 5C in NR2010
--Figure 3 (panel 3) and Figure 6 (right and left panels) in VA2009
--Figure 3 (panel 3) and Figure 6 (right and left panels) in VA2010
falsely described systolic blood pressure curves in Figures 4A
and 4B in NR2010
falsely described cerebral blood flow graphs in:
--Figure 5 (left panel) in R01 NS064976-01A1
--Figure 5 (left panel) in R01 NS064976-01A2
--Figure 3A in NR2010
--Figure 5 in VA2009
--Figure 5 in VA2010
falsely described Western blot images in one of the following
three grant applications (because at least one of the three must be
false): Figure 1 (me+TBI panel for VEGF) in R01 NS065824-01, Figure 2B
in R01 NS064976-01A1, and Figure 2B in R01 NS064976-01A2
falsely described Western blot images in:
--Figure 2A in R01 NS064976-01A1
--Figure 2A in R01 NS064976-01A2
a falsely described image of lectin labeled rat brain section
in Figure 2C in R01 NS065824-01
Thus, the research misconduct findings set forth above became
effective, and the following administrative actions have been
implemented for a period of five (5) years, beginning on July 13, 2018:
(1) Dr. Kreipke is debarred from any contracting or subcontracting
with any agency of the United States Government and from eligibility or
involvement in nonprocurement programs of the United States Government
referred to as ``covered transactions'' pursuant to HHS' Implementation
(2 CFR part 376) of Office of Management and Budget (OMB) Guidelines to
Agencies on Governmentwide Debarment and Suspension (2 CFR part 180);
and
(2) Dr. Kreipke is prohibited from serving in any advisory capacity
to PHS including, but not limited to, service on any PHS advisory
committee, board, and/or peer review committee, or as a consultant.
Wanda K. Jones,
Interim Director, Office of Research Integrity.
[FR Doc. 2018-16693 Filed 8-3-18; 8:45 am]
BILLING CODE 4150-31-P