Findings of Research Misconduct, 48426-48427 [2016-17495]
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Federal Register / Vol. 81, No. 142 / Monday, July 25, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Health Center Program
Health Resources and Services
Administration, HHS.
ACTION: Notice of class deviations from
the requirements for competition and
application period for the health center
program.
AGENCY:
The Bureau of Primary Health
Care (BPHC) is awarding funds to health
centers transitioning to value-based
models of care, improving the use of
information in decision making, and
increasing engagement in delivery
system transformation.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award:
Approximately 1,380 Health Center
Program award recipients.
Amount of Competitive Awards:
Approximately $90 million will be
awarded in FY 2016 through a one-time
supplement.
Period of Supplemental Funding:
Anticipated 12 month project period is
September 1, 2016 through August 31,
2017.
CFDA Number: 93.224.
SUMMARY:
data to achieve the quality, cost, and
patient-centered goals of delivery
system reforms. In addition, health
centers that do not currently have a
certified electronic health record (EHR)
at all sites and in use by all providers
must propose at a minimum to use
DSHII funding to initiate and/or
increase the number of sites and
providers using a certified EHR. The
investments will help health centers
improve the quality and safety of
services provided to the nation’s most
vulnerable populations.
FOR FURTHER INFORMATION CONTACT:
Olivia Shockey, Expansion Division
Director, Office of Policy and Program
Development, Bureau of Primary Health
Care, Health Resources and Services
Administration at 301–443–9282 or
oshockey@hrsa.gov.
Dated: July 18, 2016.
James Macrae,
Acting Administrator.
[FR Doc. 2016–17497 Filed 7–22–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
mstockstill on DSK3G9T082PROD with NOTICES
Authority: Section 330 of the Public
Health Service Act, as amended (42 U.S.C.
254b, as amended).
AGENCY:
Justification: Targeting the Nation’s
neediest populations and geographic
areas, the Health Center Program
supports more than 1,300 health centers
that operate over 9,000 service delivery
sites in every state, the District of
Columbia, Puerto Rico, the Virgin
Islands, and the Pacific Basin. Nearly 23
million patients received
comprehensive, culturally competent,
quality primary health care services
through the Health Center Program
award recipients in 2014.
The fiscal year (FY) 2016 Health
Center Program Delivery System Health
Information Investment (DSHII) funding
will provide formula-based, one-time
support for the purchase of health
information technology (health IT)
enhancements to accelerate health
centers’ transition to value-based
models of care, improve efforts to share
and use information to support better
decisions, and increase engagement in
delivery system transformation efforts.
Grant funds will help health centers
make strategic investments to enhance
their health IT, implement new clinical
and administrative workflows, develop
new reports, and better prepare
providers and staff to use health IT and
SUMMARY:
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ACTION:
Office of the Secretary, HHS.
Notice.
Notice is hereby given that
the Office of Research Integrity (ORI)
has taken final action in the following
case:
Zhiyu Li, Ph.D., Mount Sinai School
of Medicine: Based upon the evidence
and findings of an investigation report
by the Mount Sinai School of Medicine
(MSSM) and additional analysis
conducted by ORI in its oversight
review, ORI found that Dr. Zhiyu Li,
former Postdoctoral Fellow, MSSM,
engaged in research misconduct in
research that was supported by National
Cancer Institute (NCI), National
Institutes of Health (NIH), grant R21
CA120017. ORI found that falsified and/
or fabricated data were included in the
following published papers, submitted
manuscript, poster presentation, and
grant applications:
• Li, Z., Fallon, J., Mandeli, J., Wetmur,
J., & Woo, S.L.C. ‘‘A Genetically
Enhanced Anaerobic Bacterium for
Oncopathic Therapy of Pancreatic
Cancer.’’ JNCI 100(19):1389–1400,
October 2008 (hereafter referred to as
‘‘JNCI 2008’’) (Retracted 02/2010).
• Li, Z., Fallon, J., Mandeli, J., Wetmur,
J., & Woo, S.L.C. ‘‘The Oncopathic
Potency of Clostridium perfringens is
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Independent of its a-Toxin Gene.’’
HGT 20:751–758, July 2009 (hereafter
referred to as ‘‘HGT 2009’’) (Retracted
03/2010).
• Li, Z., Fallon, J., Mandeli, J., Wetmur,
J., & Woo, S.L.C. ‘‘Oncopathic
Bacteriotherapy with Engineered C.
perfringens Spores is Superior and
Complementary to Gemcitabine
Treatment in an Orthotopic Murine
Model of Pancreatic Cancer.’’
Submitted for publication in Can. Res.
(hereafter referred to as the ‘‘Can. Res.
Manuscript 2009’’).
• Li, Z., Fallon, J., Mandeli, J., Wetmur,
J., & Woo, S.L.C. ‘‘Oncopathic
Bacteriotherapy with Cp/plc-/sod-/
PVL is Complementary to
Gemcitabine Treatment for Pancreatic
Cancer in Mice.’’ Presented at the
12th Annual Meeting of the American
Society of Gene Therapy, May 27–30,
2009.
• R21 CA120017–02
• R21 CA120017 Final Progress Report
• R01 CA130897–01
• R01 CA130897–01 A1
• R01 CA130897–01 A2
• R01 CA130897–01 A2 Supplemental
Material
• R01 CA148697–01
The JNCI 2008 and HGT 2009 papers
were retracted, and the Can. Res.
Manuscript 2009 was withdrawn.
ORI found that the Respondent
intentionally, knowingly, and recklessly
engaged in research misconduct by
falsely claiming to have generated
recombinant Clostridium perfringens
(Cp) strains, Cp/sod-, Cp/sod-/PVL, and
Cp/plc-/sod-/PVL, to depict the effects
of recombinant Cp strains on their
ability to destroy cancer cells in a
murine model, when these bacterial
strains were not produced nor the data
derived from them, and by falsifying
histopathological data reported in fiftyseven (57) images in two (2) published
papers, one (1) submitted manuscript,
two (2) poster presentations, and seven
(7) of Respondent’s supervisor’s grant
applications and fabricating the
corresponding nineteen (19) summary
bar graphs that were based on those
false images.
Specifically, Respondent trimmed and
used portions of Figure 6 (right panel)
of a draft R21 CA120017–01 grant
application, representing an image of
liver tumor two (2) days after injection
of Cp/plc- bacteria, to represent
unrelated results from different
experiments in:
• Figures 5D and 7C (left panel), grant
R21 CA120017 Final Progress Report
• Figure 6A, grant R01 CA130897–01
• Figures 9D and 17A (top left, middle,
and right panels and bottom left
panel), grant R01 CA130897–01 A1
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Federal Register / Vol. 81, No. 142 / Monday, July 25, 2016 / Notices
• Figures 6D and 9C (left panel), grant
R01 CA130897–01 A2
• Figure 2A (left, middle, and right
panels) in R01 CA130897–01 A2
Supplemental Material
• Figures 4D and 7C (left panel), grant
R01 CA148697–01
• Figure 4D (left panel), JNCI 2008
• Figure 3A (left panel), HGT 2009
• Figure 1A (left, middle and right
panels), Can. Res. Manuscript 2009
• Figure labeled ‘‘Intratumoral Bacterial
Titers and Quantification of Tumor
Necrosis’’ (top left panel), AGST 2009
Poster presentation 2
Respondent trimmed and used
portions of Figure 6C of R21 CA120017–
02, representing pancreatic tumor five
(5) days after injection of Cp/sodbacteria, to represent results from
different experiments in:
• Figures 5E, 6E and 7C (right panel),
grant R21 CA120017 Final Progress
Report
• Figures 9E, 10E, and 13C (right panel),
grant R01 CA130897–01 A1
• Figures 6E, 7E and 9C (right panel),
grant R01 CA130897–01 A2
• Figures 4E, 5E and 7C (right panel),
grant R01 CA148697–01
• Figure 4D (right panel), JNCI 2008
• Figure 3A (middle and right panels),
HGT 2009
• Figure labeled ‘‘Intratumoral Bacterial
Titers and Quantification of Tumor
Necrosis’’ (top right and middle
panels), AGST 2009 Poster
presentation 2
Respondent trimmed and used a
portion of a figure that was reported as
mouse pancreatic tumor tissue treated
with control liposomes in four (4)
figures (Figure 6D in R21 CA120017
Final Progress Report, Figure 10D in
R01 CA130897–01 A1, Figure 7D in R01
CA130897–01 A2, and Figure 5D in R01
CA148697–01), to represent results from
mouse pancreatic tumor tissue not
treated with control liposomes in:
• Figures 7C (middle panel), grant R21
CA120017 Final Progress Report
• Figure 13C (left panel), grant R01
CA130897–01 A1
• Figures 9C (middle panel), grant R01
CA130897–01 A2
• Figure 7C (middle panel), grant R01
CA148697–01
• Figure 4D (middle panel), JNCI 2008
• Figure entitled ‘‘Oncopathic Potency
of Cp/sod-/PVL in Tumor-bearing
Mice’’ row C (left panel), AGST 2009
Poster presentation 1
Respondent falsified at least four (4)
and possibly eight (8) images by using
and relabeling Figures 4A (left panel),
4B (right panel), and 4B (left panel) in
JNCI 2008 and Figure 1B (center panel)
of Cancer Res. Manuscript 2009, to
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18:27 Jul 22, 2016
Jkt 238001
represent different experimental
conditions in Figures 3C (middle panel),
3B (left panel), 3C (right panel), and 3D
(left panel) in HGT 2009 respectively.
Respondent trimmed and used
portions of Figure 4E (right panel) in
JNCI 2008, representing pancreatic
tumor from mice injected with Cp/sod/PVL bacteria, to represent mice injected
with Cp/plc-/sod-/PVL bacteria in the
following:
• Figure 2, row B (right panel), R01
CA130897 01 A2 Supplemental
Material
• Figure 3, row D (right panel), HGT
2009
• Figure entitled ‘‘Intratumoral bacterial
Titers and Quantification of Tumor
Necrosis’’ (bottom right panel), AGST
2009 Poster presentation 2
• Figure 1, row B (right panel), Can.
Res. Manuscript 2009
The Respondent also fabricated the
resulting quantitative data in nineteen
(19) summary bar-graphs based on the
false histopathological images in:
• Figure 7C, grant R21 CA120017 Final
Progress Report
• Figures 13C and 17B, grant R01
CA130897–01 A1
• Figure 9C, grant R01 CA130897–01
A2
• Figure 2A–B, grant R01 CA130897–01
A2 Supplemental Material
• Figure 7C, grant R01 CA148697–01
• Figures 4A, B, D, and E, JNCI 2008
• Figures 3A–D, HGT 2009
• Figure 1C, Can. Res. Manuscript 2009
• Figure entitled ‘‘Oncopathic Potency
of Cp/sod-/PVL in Tumor-bearing
Mice’’ graph (C) in AGST 2009 Poster
presentation 1
• Figure entitled ‘‘Intratumoral
Bacterial Titers and Quantification of
Tumor Necrosis’’ top and bottom row
graphs in AGST 2009 Poster
presentation 2
The following administrative actions
have been implemented for a period of
five (5) years, beginning on July 3, 2016:
(1) Respondent is debarred from any
contracting or subcontracting with any
agency of the United States Government
and from eligibility for, or involvement
in, nonprocurement programs of the
United States Government referred to as
‘‘covered transactions’’ pursuant to
HHS’ Implementation (2 CFR part 376 et
seq) of Office of Management and
Budget (OMB) Guidelines to Agencies
on Governmentwide Debarment and
Suspension, 2 CFR part 180 (collectively
the ‘‘Debarment Regulations’’); and
(2) Respondent is prohibited from
serving in any advisory capacity to the
U.S. Public Health Service (PHS)
including, but not limited to, service on
any PHS advisory committee, board,
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48427
and/or peer review committee, or as a
consultant.
FOR FURTHER INFORMATION CONTACT:
Director, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8800.
Kathryn M. Partin,
Director, Office of Research Integrity.
[FR Doc. 2016–17495 Filed 7–22–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Office of Direct Service and
Contracting Tribes National Indian
Health Outreach and Education—
Health Reform Funding Opportunity
Announcement Type: New Limited
Competition.
Funding Announcement Number:
HHS–2016–IHS–NIHOE–3–Health–
Reform–0001.
Catalog of Federal Domestic
Assistance Number: 93.933.
Key Dates
Application Deadline Date: August
25, 2016.
Review Date: August 29, 2016.
Earliest Anticipated Start Date:
September 15, 2016.
Proof of Non-Profit Status Due Date:
August 25, 2016.
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS)
Office of Direct Service and Contracting
Tribes (ODSCT) and the Office of
Resource Access and Partnerships
(ORAP) is accepting cooperative
agreement applications for the National
Indian Health Outreach and Education
III (NIHOE–III)–Health Reform funding
opportunity that includes outreach and
education activities on the following:
The Patient Protection and Affordable
Care Act, Public Law 111–148, as
amended by the Health Care and
Education Reconciliation Act of 2010,
Public Law 111–152, collectively known
as the Affordable Care Act (ACA), and
the Indian Health Care Improvement
Act (IHCIA), as amended. This program
is authorized under the Snyder Act,
codified at 25 U.S.C. 13, and the
Transfer Act, codified at 42 U.S.C.
2001(a). This program is described in
the Catalog of Federal Domestic
Assistance under 93.933.
Background
The NIHOE III—Health Reform
program carries out health program
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Agencies
[Federal Register Volume 81, Number 142 (Monday, July 25, 2016)]
[Notices]
[Pages 48426-48427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17495]
-----------------------------------------------------------------------
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 the Office of Research Integrity
(ORI) has taken final action in the following case:
Zhiyu Li, Ph.D., Mount Sinai School of Medicine: Based upon the
evidence and findings of an investigation report by the Mount Sinai
School of Medicine (MSSM) and additional analysis conducted by ORI in
its oversight review, ORI found that Dr. Zhiyu Li, former Postdoctoral
Fellow, MSSM, engaged in research misconduct in research that was
supported by National Cancer Institute (NCI), National Institutes of
Health (NIH), grant R21 CA120017. ORI found that falsified and/or
fabricated data were included in the following published papers,
submitted manuscript, poster presentation, and grant applications:
Li, Z., Fallon, J., Mandeli, J., Wetmur, J., & Woo, S.L.C. ``A
Genetically Enhanced Anaerobic Bacterium for Oncopathic Therapy of
Pancreatic Cancer.'' JNCI 100(19):1389-1400, October 2008 (hereafter
referred to as ``JNCI 2008'') (Retracted 02/2010).
Li, Z., Fallon, J., Mandeli, J., Wetmur, J., & Woo, S.L.C.
``The Oncopathic Potency of Clostridium perfringens is Independent of
its [alpha]-Toxin Gene.'' HGT 20:751-758, July 2009 (hereafter referred
to as ``HGT 2009'') (Retracted 03/2010).
Li, Z., Fallon, J., Mandeli, J., Wetmur, J., & Woo, S.L.C.
``Oncopathic Bacteriotherapy with Engineered C. perfringens Spores is
Superior and Complementary to Gemcitabine Treatment in an Orthotopic
Murine Model of Pancreatic Cancer.'' Submitted for publication in Can.
Res. (hereafter referred to as the ``Can. Res. Manuscript 2009'').
Li, Z., Fallon, J., Mandeli, J., Wetmur, J., & Woo, S.L.C.
``Oncopathic Bacteriotherapy with Cp/plc-/sod-/PVL is Complementary to
Gemcitabine Treatment for Pancreatic Cancer in Mice.'' Presented at the
12th Annual Meeting of the American Society of Gene Therapy, May 27-30,
2009.
R21 CA120017-02
R21 CA120017 Final Progress Report
R01 CA130897-01
R01 CA130897-01 A1
R01 CA130897-01 A2
R01 CA130897-01 A2 Supplemental Material
R01 CA148697-01
The JNCI 2008 and HGT 2009 papers were retracted, and the Can. Res.
Manuscript 2009 was withdrawn.
ORI found that the Respondent intentionally, knowingly, and
recklessly engaged in research misconduct by falsely claiming to have
generated recombinant Clostridium perfringens (Cp) strains, Cp/sod-,
Cp/sod-/PVL, and Cp/plc-/sod-/PVL, to depict the effects of recombinant
Cp strains on their ability to destroy cancer cells in a murine model,
when these bacterial strains were not produced nor the data derived
from them, and by falsifying histopathological data reported in fifty-
seven (57) images in two (2) published papers, one (1) submitted
manuscript, two (2) poster presentations, and seven (7) of Respondent's
supervisor's grant applications and fabricating the corresponding
nineteen (19) summary bar graphs that were based on those false images.
Specifically, Respondent trimmed and used portions of Figure 6
(right panel) of a draft R21 CA120017-01 grant application,
representing an image of liver tumor two (2) days after injection of
Cp/plc- bacteria, to represent unrelated results from different
experiments in:
Figures 5D and 7C (left panel), grant R21 CA120017 Final
Progress Report
Figure 6A, grant R01 CA130897-01
Figures 9D and 17A (top left, middle, and right panels and
bottom left panel), grant R01 CA130897-01 A1
[[Page 48427]]
Figures 6D and 9C (left panel), grant R01 CA130897-01 A2
Figure 2A (left, middle, and right panels) in R01 CA130897-01
A2 Supplemental Material
Figures 4D and 7C (left panel), grant R01 CA148697-01
Figure 4D (left panel), JNCI 2008
Figure 3A (left panel), HGT 2009
Figure 1A (left, middle and right panels), Can. Res.
Manuscript 2009
Figure labeled ``Intratumoral Bacterial Titers and
Quantification of Tumor Necrosis'' (top left panel), AGST 2009 Poster
presentation 2
Respondent trimmed and used portions of Figure 6C of R21 CA120017-
02, representing pancreatic tumor five (5) days after injection of Cp/
sod- bacteria, to represent results from different experiments in:
Figures 5E, 6E and 7C (right panel), grant R21 CA120017 Final
Progress Report
Figures 9E, 10E, and 13C (right panel), grant R01 CA130897-01
A1
Figures 6E, 7E and 9C (right panel), grant R01 CA130897-01 A2
Figures 4E, 5E and 7C (right panel), grant R01 CA148697-01
Figure 4D (right panel), JNCI 2008
Figure 3A (middle and right panels), HGT 2009
Figure labeled ``Intratumoral Bacterial Titers and
Quantification of Tumor Necrosis'' (top right and middle panels), AGST
2009 Poster presentation 2
Respondent trimmed and used a portion of a figure that was reported
as mouse pancreatic tumor tissue treated with control liposomes in four
(4) figures (Figure 6D in R21 CA120017 Final Progress Report, Figure
10D in R01 CA130897-01 A1, Figure 7D in R01 CA130897-01 A2, and Figure
5D in R01 CA148697-01), to represent results from mouse pancreatic
tumor tissue not treated with control liposomes in:
Figures 7C (middle panel), grant R21 CA120017 Final Progress
Report
Figure 13C (left panel), grant R01 CA130897-01 A1
Figures 9C (middle panel), grant R01 CA130897-01 A2
Figure 7C (middle panel), grant R01 CA148697-01
Figure 4D (middle panel), JNCI 2008
Figure entitled ``Oncopathic Potency of Cp/sod-/PVL in Tumor-
bearing Mice'' row C (left panel), AGST 2009 Poster presentation 1
Respondent falsified at least four (4) and possibly eight (8)
images by using and relabeling Figures 4A (left panel), 4B (right
panel), and 4B (left panel) in JNCI 2008 and Figure 1B (center panel)
of Cancer Res. Manuscript 2009, to represent different experimental
conditions in Figures 3C (middle panel), 3B (left panel), 3C (right
panel), and 3D (left panel) in HGT 2009 respectively.
Respondent trimmed and used portions of Figure 4E (right panel) in
JNCI 2008, representing pancreatic tumor from mice injected with Cp/
sod-/PVL bacteria, to represent mice injected with Cp/plc-/sod-/PVL
bacteria in the following:
Figure 2, row B (right panel), R01 CA130897 01 A2 Supplemental
Material
Figure 3, row D (right panel), HGT 2009
Figure entitled ``Intratumoral bacterial Titers and
Quantification of Tumor Necrosis'' (bottom right panel), AGST 2009
Poster presentation 2
Figure 1, row B (right panel), Can. Res. Manuscript 2009
The Respondent also fabricated the resulting quantitative data in
nineteen (19) summary bar-graphs based on the false histopathological
images in:
Figure 7C, grant R21 CA120017 Final Progress Report
Figures 13C and 17B, grant R01 CA130897-01 A1
Figure 9C, grant R01 CA130897-01 A2
Figure 2A-B, grant R01 CA130897-01 A2 Supplemental Material
Figure 7C, grant R01 CA148697-01
Figures 4A, B, D, and E, JNCI 2008
Figures 3A-D, HGT 2009
Figure 1C, Can. Res. Manuscript 2009
Figure entitled ``Oncopathic Potency of Cp/sod-/PVL in Tumor-
bearing Mice'' graph (C) in AGST 2009 Poster presentation 1
Figure entitled ``Intratumoral Bacterial Titers and
Quantification of Tumor Necrosis'' top and bottom row graphs in AGST
2009 Poster presentation 2
The following administrative actions have been implemented for a period
of five (5) years, beginning on July 3, 2016:
(1) Respondent is debarred from any contracting or subcontracting
with any agency of the United States Government and from eligibility
for, or involvement in, nonprocurement programs of the United States
Government referred to as ``covered transactions'' pursuant to HHS'
Implementation (2 CFR part 376 et seq) of Office of Management and
Budget (OMB) Guidelines to Agencies on Governmentwide Debarment and
Suspension, 2 CFR part 180 (collectively the ``Debarment
Regulations''); and
(2) Respondent is prohibited from serving in any advisory capacity
to the U.S. Public Health Service (PHS) including, but not limited to,
service on any PHS advisory committee, board, and/or peer review
committee, or as a consultant.
FOR FURTHER INFORMATION CONTACT: Director, Office of Research
Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240)
453-8800.
Kathryn M. Partin,
Director, Office of Research Integrity.
[FR Doc. 2016-17495 Filed 7-22-16; 8:45 am]
BILLING CODE 4150-31-P