Findings of Research Misconduct, 16754-16757 [2022-06246]
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Federal Register / Vol. 87, No. 57 / Thursday, March 24, 2022 / Notices
on an ad hoc basis to advance these
goals. ASPR is changing the title of this
collection from ‘‘Hospital Preparedness
Program Data Collection’’ to ‘‘Health
Care Readiness Collections’’ to better
reflect the scope of data collected under
this approval.
ANNUALIZED BURDEN HOUR TABLE
HPP Recipient End-of-Year Performance Report Collection.
HPP Sub-Recipient End-of-Year Performance Report Collection.
Ad hoc Information Collections .........
HPP Recipients ................................
62
1
21
1,302
HPP Sub-Recipients ........................
321
1
4
1,284
ASPR Health Care Readiness Portfolio Stakeholders.
5,296
1
1
5,296
Total ...........................................
...........................................................
........................
3
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7,882
[FR Doc. 2022–06255 Filed 3–23–22; 8:45 am]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Findings of research
misconduct have been made against
Daniel Leong, Ph.D. (Respondent),
formerly a Research Technician, Albert
Einstein College of Medicine (AECM).
Respondent engaged in research
misconduct in research supported by
U.S. Public Health Service (PHS) funds,
specifically National Institute of
Arthritis and Musculoskeletal and Skin
Diseases (NIAMS), National Institutes of
Health (NIH), grant R01 AR050968 and
National Heart, Lung, and Blood
Institute (NHLBI), NIH, grant P01
HL110900. The administrative actions,
including debarment for a period of four
(4) years followed by supervision for a
period of four (4) years, were
implemented beginning on February 28,
2022, and are detailed below.
FOR FURTHER INFORMATION CONTACT:
Wanda K. Jones, Dr.P.H., Acting
Director, Office of Research Integrity,
1101 Wootton Parkway, Suite 240,
Rockville, MD 20852, (240) 453–8200.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that the Office of Research
Integrity (ORI) has taken final action in
the following case:
Daniel Leong, Ph.D., Albert Einstein
College of Medicine: Based on the report
of an investigation conducted by AECM
and analysis conducted by ORI in its
oversight review, ORI found that Dr.
SUMMARY:
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burden per
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Respondents
(If necessary)
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
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Daniel Leong, formerly a Research
Technician, AECM, engaged in research
misconduct in research supported by
PHS funds, specifically NIAMS, NIH,
grant R01 AR050968 and NHLBI, NIH,
grant P01 HL110900.
ORI found that Respondent engaged
in research misconduct by intentionally,
knowingly, or recklessly falsifying and/
or fabricating data included in sixteen
(16) grant applications submitted for
PHS funds:
• R01 AR065563–01, ‘‘CITED2 and
Chondroprotection,’’ submitted to
NIAMS, NIH, on 02/05/2013.
• R01 AR066009–01, ‘‘Remote
Loading for Osteoarthritis,’’ submitted
to NIAMS, NIH, on 06/04/2013.
• R01 AR065563–01A1, ‘‘CITED2 and
Chondroprotection,’’ submitted to
NIAMS, NIH, on 11/05/2014.
• R41 AR070695–01, ‘‘A novel
product for tendinopathy treatment,’’
submitted to NIAMS, NIH, on 01/05/
2015.
• R01 AG069693–01, ‘‘Chondrocyte
fate regulation and cartilage protection,’’
submitted to National Institute on Aging
(NIA), NIH, on 06/05/2015.
• R01 AG039561–06, ‘‘Human tendon
stem progenitor cell aging and
regeneration,’’ submitted to NIA, NIH,
on 03/15/2016 (original grant funding
from 08/15/2012–04/30/2018).
• R43 AT009414–01, ‘‘A novel
nutraceutical drug for tendinopathy
treatment,’’ submitted to National
Center for Complementary and
Alternative Medicine (NCCAM), NIH,
on 04/05/2016.
• R01 AR070431–01A1, ‘‘The role of
Panx1 in the pathogenesis and pain of
osteoarthritis,’’ submitted to NIAMS,
NIH, on 07/19/2016.
• R41 AG056246–01A1, ‘‘A novel
product for tendinopathy treatment,’’
submitted to NIA, NIH, on 09/06/2016,
funded from 09/15/2017–08/31/2019.
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• R01 AG056623–01, ‘‘Chondrocyte
fate regulation and osteoarthritis,’’
submitted to NIA, NIH, on 10/05/2016.
• R01 AR072038–01, ‘‘MSC-derived
exosomes and tendon disorders,’’
submitted to NIAMS, NIH, on 10/05/
2016.
• R43 AT009414–01A1, ‘‘A novel
nutraceutical drug for tendinopathy
treatment,’’ submitted to NCCAM, NIH,
on 04/05/2017, funded from 08/01/
2018–07/31/2020.
• R01 AR073194–01, ‘‘Chondrocyte
fate regulation and cartilage protection,’’
submitted to NIAMS, NIH, on 06/05/
2017.
• R01 AR074802–01, ‘‘The role of
Panx1 in the pathogenesis and pain of
osteoarthritis,’’ submitted to NIAMS,
NIH, on 04/02/2018.
• R01 AR074802–01A1, ‘‘The role of
Panx1 in the pathogenesis and pain of
osteoarthritis,’’ submitted to NIAMS,
NIH, on 08/01/2018.
• R44 AG065089–01, ‘‘Botanical drug
for spontaneous osteoarthritis,’’
submitted to NIA, NIH, on 01/07/2019.
ORI found that Respondent
intentionally, knowingly, or recklessly
falsified and/or fabricated Western blot
and histological image data for chronic
deep tissue conditions including
osteoarthritis (OA) and tendinopathy in
murine models by reusing image data,
with or without manipulating them to
conceal their similarities, and falsely
relabeling them as data representing
different experiments in fifty (50)
figures included in sixteen (16) PHS
grant applications. In the absence of
reliable image data, the figures,
quantitative data in associated graphs
purportedly derived from those images,
statistical analyses, and related text also
are false.
Specifically, ORI found that:
1. Respondent reused and relabeled
Western blot images from the same
source to falsely represent different
proteins and/or experimental results in:
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• Figure 4B in R01 AR065563–01 and
R01 AR065563–01A1 and Figure 11 in
R01 AR069693–01, specifically:
—‘‘b-actin’’ panel for ‘‘Cartilage’’ and
‘‘b-actin’’ panel for ‘‘Liver’’ are the
same
—‘‘b-actin’’ panel for ‘‘Bone’’ and ‘‘bactin’’ panel for ‘‘Spleen’’ are the
same
—‘‘Cited2’’ blot band for Cartilage in
‘‘WT’’ and ‘‘Sham’’ are the same
—‘‘Cited2’’ blot band for Bone in ‘‘WT’’
and ‘‘Sham’’ are the same
—‘‘Cited2’’ blot band for Liver in ‘‘WT’’
and ‘‘Sham’’ are the same
—‘‘Cited2’’ blot band for Spleen in
‘‘WT’’ and ‘‘Sham’’ are the same
• Figure 2A in R01 AG056623–01 and
R44 AG065089–01 and Figure 1A in R01
AR073194–01, specifically:
—‘‘b-actin’’ panel for ‘‘Cartilage’’ and
‘‘b-actin’’ panel for ‘‘Liver’’ are the
same
—Cited2 blot bands in ‘‘WT’’ and
‘‘Sham’’ within each of the three
panels represent Cartilage, Bone, and
Liver
2. From Figure 11C in R01
AR065563–01 and Figure 16 in R01
AR066009–01, Respondent copied blot
panels representing rAAV-vector and
rAAV–GFP in human cartilage explants,
flipped, resized, added a lane to the left,
and reused and relabeled the bands to
falsely represent ‘‘Sham’’ and ‘‘KO’’
samples in conditional knock out of
Cited2 gene in cartilage of adult mice in:
• Figure 4B in R01 AR065563–01
• Figure 4B in R01 AR065563–01A1
• Figure 11 in R01 AR069693–01
• Figure 2A in R01 AG056623–01
• Figure 1A in R01 AR073194–01
• Figure 2A in R44 AG065089–01
3. Respondent reused and relabeled
the same photomicrographs of
supraspinatus tendon tissue from
tendinopathy rats exposed to different
experimental conditions in:
• Figure 2A in R01 AR072038–01 to
falsely represent overuse
tendinopathy in rats treated with exADSC–2D (control exosomes)
• Figure 2A in R01 AG039561–06 to
falsely represent overuse
tendinopathy nude rats with placebo
treatment
• Figure 4A in R41 AR070695–01 to
falsely represent overuse
tendinopathy nude rats with placebo
treatment
• Figure 3A in R43 AT009414–01 and
R43 AT009414–01A1 to falsely
represent collagenase induced
Achilles tendinopathy in rats with
placebo treatment
4. Respondent reused and relabeled
the same photomicrographs in:
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• Figure 2A in R01 AR072038–01 to
falsely represent overuse
tendinopathy in rats injected with exADSC–3D
• Figure 1A in R01 AG039561–06 to
falsely represent collagenase-induced
tendinopathy in rats injected with
Cited2 reprogrammed tendon stem/
progenitor cells (TSPCs)
5. Respondent reused and relabeled
photomicrographs from Figure 2C in
R01 AR072038–01 representing cleaved
collagen-1 stained supraspinatus tendon
of overuse tendinopathy rats injected
with placebo + ex-ADSC–2D to falsely
represent:
• Supraspinatus tendon tissue of
overuse tendinopathy in rats after
placebo injection in:
—Figure 2C in R01 AR072038–01
—Figure 5D in R41 AG056246–01A1
—Figure 2B in R01 AG039561–06
• Achilles tendon tissue of collagenaseinduced tendinopathy rats after
placebo injection in Figure 3D in R43
AT009414–01
6. Respondent reused and relabeled
photomicrographs of human cartilage
explants presented in R01 AG069693–
01. Specifically, Respondent reused
image panels from R01 AG069693–01:
• Figure 12A representing NITEGE in
non-arthritic (non-OA) sample in:
—Figure 11A in R01 AR065563–01,
Figure 8A in R01 AG069693–01,
and Figure 1A in R01 AG056623–01
to falsely represent NITEGE stained
non-OA sample
—Figure 3 in R01 AR070431–01A1 to
falsely represent IL–1b stained OA
sample
• Figure 8A representing ADAMTS5 in
non-OA and OA samples in:
—Figure 1A in R01 AG056623–01 to
falsely represent p16 stained
samples
• Figure 8A, two images representing
matrix metalloproteinase 13 (MMP–
13) and ADAMTS5 of OA samples in:
—Figure 3 in R01 AR070431–01A1 to
falsely represent NLRP3 or cleaved
caspase 1
—Figure 1A in R01 AG056623–01 to
falsely represent p21 and p16
• Figure 8B, two images in sham or
destabilization of the medial
meniscus (DMM) operated mouse
representing:
—MMP–13 reused and relabeled in
Figure 1B in R01 AG056623–01 to
falsely represent p21
—ADAMTS5 reused and relabeled in
Figure 1B in R01 AG056623–01 to
falsely represent p16
7. Respondent reused and relabeled
photomicrographs of non-OA or OA
human cartilage explants presented in
Figure 3 in R01 AR070431–01A1
representing:
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• Cleaved caspase 3 to falsely represent
b-gal staining in Figure 1A in R01
AG056623–01
• NLRP3 or cleaved caspase-1 staining
of non-OA human cartilage to falsely
represent p21 and p16 in Figure 1A in
R01 AG056623–01
8. Respondent reused and relabeled
photomicrographs from the following
published papers to falsely represent
unrelated experimental results in NIH
grant applications:
• Green tea polyphenol treatment is
chondroprotective, anti-inflammatory
and palliative in a mouse post-traumatic
osteoarthritis model. Arthritis Res Ther.
2014 Dec 17;16(6):508; doi: 10.1186/
sl3075–014–0508–y (hereafter referred
to as ‘‘Arthritis Res Ther. 2014’’).
Erratum in: Arthritis Res Ther. 2019, Jan
3;21(1):1; doi: 10.1186/s13075–018–
1791–9.
• Curcumin slows osteoarthritis
progression and relieves osteoarthritisassociated pain symptoms in a posttraumatic osteoarthritis mouse model.
Arthritis Res Ther. 2016 Jun 3;
18(1):128; doi: 10.1186/s13075–016–
1025-y (hereafter referred to as
‘‘Arthritis Res Ther. 2016’’).
• Procyanidins Mitigate Osteoarthritis
Pathogenesis by, at Least in Part,
Suppressing Vascular Endothelial
Growth Factor Signaling. Int. J. Mol. Sci.
2016, 17:2065; doi:10.3390/
ijms17122065 (hereafter referred to as
‘‘Int. J. Mol. Sci. 2016’’).
Specifically, in:
• R01 AR070431–01A1, Respondent
reused an image panel from:
—Arthritis Res Ther. 2016:
D Figure 6A representing type II
collagen cleavage epitope (Col2–3/4
M) vehicle control and relabeled to
falsely represent aggrecan cleavage in
DMM WT in Figure 2E in R01
AR070431–01A1
D Figure 6D representing ADAMTS5
staining of a vehicle control and
relabeled twice in Figure 2F in R01
AR070431–01A1 to falsely represent
IL–1b and cleaved caspase staining
—Arthritis Res Ther. 2014:
D Figure 2C representing Col2–3/4 M in
vehicle treated sham operated mice
and relabeled twice in Figures 2E and
2F in R01 AR070431–01A1 to falsely
represent cleaved caspase and IL–1b
respectively in sham operated WT
mice
D Figure 2C representing Col2–3/4 M in
epigallocatechin3-gallate (EGCG)
treated DMM mice in Figure 2E in
R01 AR070431–01A1 and relabeled to
falsely represent Col2–3/4 M in Panx1
KO DMM mice
D Figure 3A representing cleaved
aggrecan in sham operated EGCG
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treated mice and relabeled in Figure
2E in R01 AR070431–01A1 to falsely
represent cleaved aggrecan in sham
operated untreated WT mice
D Figure 3C representing cleaved
aggrecan in DMM WT mice treated
with EGCG and relabeled in Figure 2E
in R01 AR070431–01A1 to falsely
represent cleaved aggrecan in DMM
Panx1 KO mice
D Figure 4A representing MMP–13 in
sham operated EGCG treated mice and
relabeled in Figure 4E in R01
AR070431–01A1 to falsely represent
antibody-staining control
D Figure 4C representing MMP–13 in
sham operated, vehicle-treated mice
and relabeled in:
➢ Figure 2E in R01 AR074802–01
and R01 AR074802–01A1 to falsely
represent ADAMTS5 staining in
Pax1 KO DMM mice
➢ Figure 2F in R01 AR070431–01A1
to falsely represent NLRP3 staining
of Pax1 KO DMM mice
D Figure 4C representing MMP–13 in
DMM vehicle treated mice and
relabeled in:
➢ Figure 2E in R01 AR074802–01
and R01 AR074802–01A1 to falsely
represent MMP–13 in DMM WT
mice
➢ Figure 2F in R01 AR070431–01A1
to falsely represent NLRP3 in DMM
WT mice
D Figure 5C representing ADAMTS5 in
sham operated EGCG treated mouse
and relabeled twice in Figure 2E in
R01 AR074802–01 and R01
AR074802–01A1 to falsely represent
ADAMTS5 in sham operated WT
mice
D Figure 5C representing ADAMTS5 in
vehicle treated DMM operated mouse
sample and relabeled twice in Figure
2E in R01 AR074802–01 and R01
AR074802–01A1 to falsely represent
ADAMTS5 in DMM WT mouse
sample
D R01 AG056623–01, Respondent
reused an image panel from:
—Int.J. Mol. Sci. 2016:
D Figure 1A representing cartilage from
‘‘sham’’ wildtype C57BL/6 mice
treated with oral PBS and relabeled in
Figure 2B in R01 AG056623–01 to
falsely represent knee cartilage from
‘‘sham’’ Col2a1CreERTxCited2fl/fl
mice injected with corn oil without
tamoxifen
—Arthritis Res Ther. 2014:
D Figure 4A representing MMP–13 in
vehicle-treated mice 4-weeks post
DMM surgery and relabeled in:
➢ Figure 8 in R01 AG056623–01 to
falsely represent p21 in control
mice following DMM surgery
➢ Figure 3 in R01 AG056623–01 to
falsely represent b-gal in Cited2 KO
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mice
D Figure 4A representing MMP–13 in
EGCG -treated mice 4-weeks post
DMM surgery and relabeled in Figure
8 in R01 AG056623–01 to falsely
represent p21 following DMM surgery
in mice overexpressing Cited2
D Figure 4C representing MMP–13 in
vehicle-treated mice 8-weeks post
sham surgery and relabeled in Figure
2C in R01 AG056623–01 to falsely
represent p21 staining in Cited2 KO
mice following DMM surgery
D Figure 4C representing MMP–13 in
EGCG-treated mice 8-weeks post
DMM surgery and relabeled in Figure
2C in R01 AG056623–01 to falsely
represent p21 in oil-injected control
mice with Cited2 conditional deletion
in cartilage without Tamoxifen
D Figure 5A representing ADAMTS5 in
vehicle-treated DMM-induced OA
mice and relabeled in:
➢ Figure 8 in R01 AG056623–01 to
falsely represent p16 in control
mice following DMM surgery
➢ Figure 2C in R01 AG056623–01 to
falsely represent b-gal in Cited2 KO
mice
➢ Figure 3 in R01 AG056623–01 to
falsely represent b-gal in WT
control mice with conditional
deletion of Cited2 in cartilage
D Figure 5C representing ADAMTS5 in
vehicle-treated DMM-induced OA
mice and relabeled in:
➢ Figure 8 in R01 AG056623–01 to
falsely represent Cited2 in Citedoverexpressing mice, as well as bgal in control mice following DMM
surgery
➢ Figure 2C in R01 AG056623–01 to
falsely represent p16 staining in
Cited2 KO mice
➢ Figure 8 in R01 AG056623–01 to
falsely represent p16 in control
mice following DMM surgery
Respondent neither admits nor denies
ORI’s findings of research misconduct.
The parties entered into a Voluntary
Settlement Agreement (Agreement) to
conclude this matter without further
expenditure of time, finances, or other
resources. The settlement is not an
admission of liability on the part of the
Respondent.
Respondent voluntarily agreed to the
following:
(1) Respondent will exclude himself
voluntarily for a period of four (4) years
beginning on February 28, 2022 (the
‘‘Exclusion Period’’) from any
contracting or subcontracting with any
agency of the United States Government
and from eligibility for or involvement
in nonprocurement or procurement
transactions referred to as ‘‘covered
transactions’’ in 2 CFR parts 180 and
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376 (collectively the ‘‘Debarment
Regulations’’). At the conclusion of the
Exclusion Period, Respondent agreed to
have his research supervised for a
period of four (4) years (the
‘‘Supervision Period’’). During the
Supervision Period, prior to the
submission of an application for PHS
support for a research project on which
Respondent’s participation is proposed
and prior to Respondent’s participation
in any capacity in PHS-supported
research, Respondent will submit a plan
for supervision of Respondent’s duties
to ORI for approval. The supervision
plan must be designed to ensure the
integrity of Respondent’s research.
Respondent will not participate in any
PHS-supported research until such a
supervision plan is approved by ORI.
Respondent will comply with the
agreed-upon supervision plan.
(2) During the Supervision Period, the
requirements for Respondent’s
supervision plan are as follows:
i. A committee of 2–3 senior faculty
members at the institution who are
familiar with Respondent’s field of
research, but not including
Respondent’s supervisor or
collaborators, will provide oversight and
guidance. The committee will review
primary data from Respondent’s
laboratory on a quarterly basis and
submit a report to ORI at six (6) month
intervals setting forth the committee
meeting dates and Respondent’s
compliance with appropriate research
standards and confirming the integrity
of Respondent’s research.
ii. The committee will conduct an
advance review of each application for
PHS funds, or report, manuscript, or
abstract involving PHS-supported
research in which Respondent is
involved. The review will include a
discussion with Respondent of the
primary data represented in those
documents and will include a
certification to ORI that the data
presented in the proposed application,
report, manuscript, or abstract is
supported by the research record.
(3) During the Supervision Period,
Respondent will ensure that any
institution employing him submits, in
conjunction with each application for
PHS funds, or report, manuscript, or
abstract involving PHS-supported
research in which Respondent is
involved, a certification to ORI that the
data provided by Respondent are based
on actual experiments or are otherwise
legitimately derived and that the data,
procedures, and methodology are
accurately reported in the application,
report, manuscript, or abstract.
(4) If no supervision plan is provided
to ORI, Respondent will provide
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certification to ORI at the conclusion of
the Supervision Period that his
participation was not proposed on a
research project for which an
application for PHS support was
submitted and that he has not
participated in any capacity in PHSsupported research.
(5) During the Exclusion and
Supervision Periods, Respondent will
exclude himself voluntarily from
serving in any advisory or consultant
capacity to PHS including, but not
limited to, service on any PHS advisory
committee, board, and/or peer review
committee.
Dated: March 21, 2022.
Wanda K. Jones,
Acting Director, Office of Research Integrity,
Office of the Assistant Secretary for Health.
[FR Doc. 2022–06246 Filed 3–23–22; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Peter Tung at 240–669–5483 or
peter.tung@nih.gov. Licensing
information and copies of the patent
applications listed below may be
obtained by communicating with the
indicated licensing contact at the
Technology Transfer and Intellectual
Property Office, National Institute of
Allergy and Infectious Diseases, 5601
Fishers Lane, Rockville, MD 20852; tel.
301–496–2644. A signed Confidential
Disclosure Agreement will be required
to receive copies of unpublished patent
applications.
SUPPLEMENTARY INFORMATION:
Technology description follows:
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Novel Compositions of Matter
Comprising Stabilized Coronavirus
Antigens and Their Use
• Computational method of designing
vaccine antigens.
Description of Technology
• Pre-clinical testing of the novel
immunogens in non-human primates.
Inventors: Dr. Niraj Tolia and Dr.
Thayne Dickey, both of NIAID.
Publications: ‘‘Design of the SARSCoV–2 RBD vaccine antigen improves
neutralizing antibody response’’,
https://doi.org/10.1101/2021.05.09.
443238.
Intellectual Property: HHS Reference
No. E–045–2021–0–US–01—U.S.
Provisional Application No. 63/200,194,
filed February 18, 2021; PCT/US2022/
070744, filed February 1, 2022
Licensing Contact: To license this
technology, please contact Peter Tung at
240–669–5483 or peter.tung@nih.gov.
Collaborative Research Opportunity:
The National Institute of Allergy and
Infectious Diseases is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize the invention. For
collaboration opportunities, please
contact Peter Tung at 240–669–5483;
peter.tung@nih.gov.
Using a computational design
methodology, SARS-CoV–2 spike
proteins containing engineered amino
acid changes to the receptor binding
domain (RBD) were designed. These
engineered spike proteins improved the
immune response upon immunization
of animals. An engineered RBD was also
expressed at greater yield, had increased
temperature stability, and improved the
immune response upon immunization
of animals. Specifically, the disclosed
RBD designs can be produced
approximately 7 times more efficiently
than the native sequence, facilitating
vaccine manufacturing on a global scale.
The disclosed designs also have up to
10 °C higher thermal stability than the
native sequence, suggesting enhanced
stability during storage and when in the
body. Finally, immunization of animals
with the disclosed antigens produces up
to 10-fold higher levels of blocking
antibodies than the native sequence and
30-fold higher levels of pseudoviral
neutralizing antibodies. An additional
RBD protein has been engineered to
eliminate the need for glycosylation,
facilitating production and singlecomponent nanoparticle display of the
antigen. The engineered receptor
binding domain (RBD) and spike protein
antigens produce significant
improvements in pre-clinical animal
models and may be used to develop
improved coronavirus vaccines.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404, as well as for further
development and evaluation under a
research collaboration.
Potential Commercial Applications
• Novel SARS-CoV–2 vaccine.
• Improved SARS-CoV–2 diagnostics
using stabilized antigens.
• Method of designing vaccine
candidates or stabilized antigens by
computational. optimization of amino
acid identity, followed by additional
sequence comparison and selection
(Stabilizer for Protein Expression and
Epitope Design (SPEEDesign)).
Competitive Advantages
• Novel SARS-CoV–2 spike vaccine
with improved breadth and duration of
protection.
• Novel RBD monomer and
nanoparticle designs that are more
immunogenic and stable than the
naturally occurring RBD sequence.
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Development Stage
Dated: March 17, 2022.
Surekha Vathyam,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2022–06174 Filed 3–23–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Antimicrobial Resistant Infections.
Date: April 19, 2022.
E:\FR\FM\24MRN1.SGM
24MRN1
]]>Agencies
[Federal Register Volume 87, Number 57 (Thursday, March 24, 2022)]
[Notices]
[Pages 16754-16757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06246]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Findings of research misconduct have been made against Daniel
Leong, Ph.D. (Respondent), formerly a Research Technician, Albert
Einstein College of Medicine (AECM). Respondent engaged in research
misconduct in research supported by U.S. Public Health Service (PHS)
funds, specifically National Institute of Arthritis and Musculoskeletal
and Skin Diseases (NIAMS), National Institutes of Health (NIH), grant
R01 AR050968 and National Heart, Lung, and Blood Institute (NHLBI),
NIH, grant P01 HL110900. The administrative actions, including
debarment for a period of four (4) years followed by supervision for a
period of four (4) years, were implemented beginning on February 28,
2022, and are detailed below.
FOR FURTHER INFORMATION CONTACT: Wanda K. Jones, Dr.P.H., Acting
Director, Office of Research Integrity, 1101 Wootton Parkway, Suite
240, Rockville, MD 20852, (240) 453-8200.
SUPPLEMENTARY INFORMATION: Notice is hereby given that the Office of
Research Integrity (ORI) has taken final action in the following case:
Daniel Leong, Ph.D., Albert Einstein College of Medicine: Based on
the report of an investigation conducted by AECM and analysis conducted
by ORI in its oversight review, ORI found that Dr. Daniel Leong,
formerly a Research Technician, AECM, engaged in research misconduct in
research supported by PHS funds, specifically NIAMS, NIH, grant R01
AR050968 and NHLBI, NIH, grant P01 HL110900.
ORI found that Respondent engaged in research misconduct by
intentionally, knowingly, or recklessly falsifying and/or fabricating
data included in sixteen (16) grant applications submitted for PHS
funds:
R01 AR065563-01, ``CITED2 and Chondroprotection,''
submitted to NIAMS, NIH, on 02/05/2013.
R01 AR066009-01, ``Remote Loading for Osteoarthritis,''
submitted to NIAMS, NIH, on 06/04/2013.
R01 AR065563-01A1, ``CITED2 and Chondroprotection,''
submitted to NIAMS, NIH, on 11/05/2014.
R41 AR070695-01, ``A novel product for tendinopathy
treatment,'' submitted to NIAMS, NIH, on 01/05/2015.
R01 AG069693-01, ``Chondrocyte fate regulation and
cartilage protection,'' submitted to National Institute on Aging (NIA),
NIH, on 06/05/2015.
R01 AG039561-06, ``Human tendon stem progenitor cell aging
and regeneration,'' submitted to NIA, NIH, on 03/15/2016 (original
grant funding from 08/15/2012-04/30/2018).
R43 AT009414-01, ``A novel nutraceutical drug for
tendinopathy treatment,'' submitted to National Center for
Complementary and Alternative Medicine (NCCAM), NIH, on 04/05/2016.
R01 AR070431-01A1, ``The role of Panx1 in the pathogenesis
and pain of osteoarthritis,'' submitted to NIAMS, NIH, on 07/19/2016.
R41 AG056246-01A1, ``A novel product for tendinopathy
treatment,'' submitted to NIA, NIH, on 09/06/2016, funded from 09/15/
2017-08/31/2019.
R01 AG056623-01, ``Chondrocyte fate regulation and
osteoarthritis,'' submitted to NIA, NIH, on 10/05/2016.
R01 AR072038-01, ``MSC-derived exosomes and tendon
disorders,'' submitted to NIAMS, NIH, on 10/05/2016.
R43 AT009414-01A1, ``A novel nutraceutical drug for
tendinopathy treatment,'' submitted to NCCAM, NIH, on 04/05/2017,
funded from 08/01/2018-07/31/2020.
R01 AR073194-01, ``Chondrocyte fate regulation and
cartilage protection,'' submitted to NIAMS, NIH, on 06/05/2017.
R01 AR074802-01, ``The role of Panx1 in the pathogenesis
and pain of osteoarthritis,'' submitted to NIAMS, NIH, on 04/02/2018.
R01 AR074802-01A1, ``The role of Panx1 in the pathogenesis
and pain of osteoarthritis,'' submitted to NIAMS, NIH, on 08/01/2018.
R44 AG065089-01, ``Botanical drug for spontaneous
osteoarthritis,'' submitted to NIA, NIH, on 01/07/2019.
ORI found that Respondent intentionally, knowingly, or recklessly
falsified and/or fabricated Western blot and histological image data
for chronic deep tissue conditions including osteoarthritis (OA) and
tendinopathy in murine models by reusing image data, with or without
manipulating them to conceal their similarities, and falsely relabeling
them as data representing different experiments in fifty (50) figures
included in sixteen (16) PHS grant applications. In the absence of
reliable image data, the figures, quantitative data in associated
graphs purportedly derived from those images, statistical analyses, and
related text also are false.
Specifically, ORI found that:
1. Respondent reused and relabeled Western blot images from the
same source to falsely represent different proteins and/or experimental
results in:
[[Page 16755]]
Figure 4B in R01 AR065563-01 and R01 AR065563-01A1 and
Figure 11 in R01 AR069693-01, specifically:
--``[beta]-actin'' panel for ``Cartilage'' and ``[beta]-actin'' panel
for ``Liver'' are the same
--``[beta]-actin'' panel for ``Bone'' and ``[beta]-actin'' panel for
``Spleen'' are the same
--``Cited2'' blot band for Cartilage in ``WT'' and ``Sham'' are the
same
--``Cited2'' blot band for Bone in ``WT'' and ``Sham'' are the same
--``Cited2'' blot band for Liver in ``WT'' and ``Sham'' are the same
--``Cited2'' blot band for Spleen in ``WT'' and ``Sham'' are the same
Figure 2A in R01 AG056623-01 and R44 AG065089-01 and
Figure 1A in R01 AR073194-01, specifically:
--``[beta]-actin'' panel for ``Cartilage'' and ``[beta]-actin'' panel
for ``Liver'' are the same
--Cited2 blot bands in ``WT'' and ``Sham'' within each of the three
panels represent Cartilage, Bone, and Liver
2. From Figure 11C in R01 AR065563-01 and Figure 16 in R01
AR066009-01, Respondent copied blot panels representing rAAV-vector and
rAAV-GFP in human cartilage explants, flipped, resized, added a lane to
the left, and reused and relabeled the bands to falsely represent
``Sham'' and ``KO'' samples in conditional knock out of Cited2 gene in
cartilage of adult mice in:
Figure 4B in R01 AR065563-01
Figure 4B in R01 AR065563-01A1
Figure 11 in R01 AR069693-01
Figure 2A in R01 AG056623-01
Figure 1A in R01 AR073194-01
Figure 2A in R44 AG065089-01
3. Respondent reused and relabeled the same photomicrographs of
supraspinatus tendon tissue from tendinopathy rats exposed to different
experimental conditions in:
Figure 2A in R01 AR072038-01 to falsely represent overuse
tendinopathy in rats treated with ex-ADSC-2D (control exosomes)
Figure 2A in R01 AG039561-06 to falsely represent overuse
tendinopathy nude rats with placebo treatment
Figure 4A in R41 AR070695-01 to falsely represent overuse
tendinopathy nude rats with placebo treatment
Figure 3A in R43 AT009414-01 and R43 AT009414-01A1 to falsely
represent collagenase induced Achilles tendinopathy in rats with
placebo treatment
4. Respondent reused and relabeled the same photomicrographs in:
Figure 2A in R01 AR072038-01 to falsely represent overuse
tendinopathy in rats injected with ex-ADSC-3D
Figure 1A in R01 AG039561-06 to falsely represent collagenase-
induced tendinopathy in rats injected with Cited2 reprogrammed tendon
stem/progenitor cells (TSPCs)
5. Respondent reused and relabeled photomicrographs from Figure 2C
in R01 AR072038-01 representing cleaved collagen-1 stained
supraspinatus tendon of overuse tendinopathy rats injected with placebo
+ ex-ADSC-2D to falsely represent:
Supraspinatus tendon tissue of overuse tendinopathy in rats
after placebo injection in:
--Figure 2C in R01 AR072038-01
--Figure 5D in R41 AG056246-01A1
--Figure 2B in R01 AG039561-06
Achilles tendon tissue of collagenase-induced tendinopathy
rats after placebo injection in Figure 3D in R43 AT009414-01
6. Respondent reused and relabeled photomicrographs of human
cartilage explants presented in R01 AG069693-01. Specifically,
Respondent reused image panels from R01 AG069693-01:
Figure 12A representing NITEGE in non-arthritic (non-OA)
sample in:
--Figure 11A in R01 AR065563-01, Figure 8A in R01 AG069693-01, and
Figure 1A in R01 AG056623-01 to falsely represent NITEGE stained non-OA
sample
--Figure 3 in R01 AR070431-01A1 to falsely represent IL-1[beta]
stained OA sample
Figure 8A representing ADAMTS5 in non-OA and OA samples in:
--Figure 1A in R01 AG056623-01 to falsely represent p16 stained
samples
Figure 8A, two images representing matrix metalloproteinase 13
(MMP-13) and ADAMTS5 of OA samples in:
--Figure 3 in R01 AR070431-01A1 to falsely represent NLRP3 or
cleaved caspase 1
--Figure 1A in R01 AG056623-01 to falsely represent p21 and p16
Figure 8B, two images in sham or destabilization of the medial
meniscus (DMM) operated mouse representing:
--MMP-13 reused and relabeled in Figure 1B in R01 AG056623-01 to
falsely represent p21
--ADAMTS5 reused and relabeled in Figure 1B in R01 AG056623-01 to
falsely represent p16
7. Respondent reused and relabeled photomicrographs of non-OA or OA
human cartilage explants presented in Figure 3 in R01 AR070431-01A1
representing:
Cleaved caspase 3 to falsely represent [beta]-gal staining in
Figure 1A in R01 AG056623-01
NLRP3 or cleaved caspase-1 staining of non-OA human cartilage
to falsely represent p21 and p16 in Figure 1A in R01 AG056623-01
8. Respondent reused and relabeled photomicrographs from the
following published papers to falsely represent unrelated experimental
results in NIH grant applications:
Green tea polyphenol treatment is chondroprotective, anti-
inflammatory and palliative in a mouse post-traumatic osteoarthritis
model. Arthritis Res Ther. 2014 Dec 17;16(6):508; doi: 10.1186/sl3075-
014-0508-y (hereafter referred to as ``Arthritis Res Ther. 2014'').
Erratum in: Arthritis Res Ther. 2019, Jan 3;21(1):1; doi: 10.1186/
s13075-018-1791-9.
Curcumin slows osteoarthritis progression and relieves
osteoarthritis-associated pain symptoms in a post-traumatic
osteoarthritis mouse model. Arthritis Res Ther. 2016 Jun 3; 18(1):128;
doi: 10.1186/s13075-016-1025-y (hereafter referred to as ``Arthritis
Res Ther. 2016'').
Procyanidins Mitigate Osteoarthritis Pathogenesis by, at
Least in Part, Suppressing Vascular Endothelial Growth Factor
Signaling. Int. J. Mol. Sci. 2016, 17:2065; doi:10.3390/ijms17122065
(hereafter referred to as ``Int. J. Mol. Sci. 2016'').
Specifically, in:
R01 AR070431-01A1, Respondent reused an image panel from:
--Arthritis Res Ther. 2016:
[ssquf] Figure 6A representing type II collagen cleavage epitope (Col2-
3/4 M) vehicle control and relabeled to falsely represent aggrecan
cleavage in DMM WT in Figure 2E in R01 AR070431-01A1
[ssquf] Figure 6D representing ADAMTS5 staining of a vehicle control
and relabeled twice in Figure 2F in R01 AR070431-01A1 to falsely
represent IL-1[beta] and cleaved caspase staining
--Arthritis Res Ther. 2014:
[ssquf] Figure 2C representing Col2-3/4 M in vehicle treated sham
operated mice and relabeled twice in Figures 2E and 2F in R01 AR070431-
01A1 to falsely represent cleaved caspase and IL-1[beta] respectively
in sham operated WT mice
[ssquf] Figure 2C representing Col2-3/4 M in epigallocatechin3-gallate
(EGCG) treated DMM mice in Figure 2E in R01 AR070431-01A1 and relabeled
to falsely represent Col2-3/4 M in Panx1 KO DMM mice
[ssquf] Figure 3A representing cleaved aggrecan in sham operated EGCG
[[Page 16756]]
treated mice and relabeled in Figure 2E in R01 AR070431-01A1 to falsely
represent cleaved aggrecan in sham operated untreated WT mice
[ssquf] Figure 3C representing cleaved aggrecan in DMM WT mice treated
with EGCG and relabeled in Figure 2E in R01 AR070431-01A1 to falsely
represent cleaved aggrecan in DMM Panx1 KO mice
[ssquf] Figure 4A representing MMP-13 in sham operated EGCG treated
mice and relabeled in Figure 4E in R01 AR070431-01A1 to falsely
represent antibody-staining control
[ssquf] Figure 4C representing MMP-13 in sham operated, vehicle-treated
mice and relabeled in:
[rtarr8] Figure 2E in R01 AR074802-01 and R01 AR074802-01A1 to
falsely represent ADAMTS5 staining in Pax1 KO DMM mice
[rtarr8] Figure 2F in R01 AR070431-01A1 to falsely represent NLRP3
staining of Pax1 KO DMM mice
[ssquf] Figure 4C representing MMP-13 in DMM vehicle treated mice and
relabeled in:
[rtarr8] Figure 2E in R01 AR074802-01 and R01 AR074802-01A1 to
falsely represent MMP-13 in DMM WT mice
[rtarr8] Figure 2F in R01 AR070431-01A1 to falsely represent NLRP3
in DMM WT mice
[ssquf] Figure 5C representing ADAMTS5 in sham operated EGCG treated
mouse and relabeled twice in Figure 2E in R01 AR074802-01 and R01
AR074802-01A1 to falsely represent ADAMTS5 in sham operated WT mice
[ssquf] Figure 5C representing ADAMTS5 in vehicle treated DMM operated
mouse sample and relabeled twice in Figure 2E in R01 AR074802-01 and
R01 AR074802-01A1 to falsely represent ADAMTS5 in DMM WT mouse sample
[ssquf] R01 AG056623-01, Respondent reused an image panel from:
--Int.J. Mol. Sci. 2016:
[ssquf] Figure 1A representing cartilage from ``sham'' wildtype C57BL/6
mice treated with oral PBS and relabeled in Figure 2B in R01 AG056623-
01 to falsely represent knee cartilage from ``sham''
Col2a1CreERTxCited2fl/fl mice injected with corn oil without tamoxifen
--Arthritis Res Ther. 2014:
[ssquf] Figure 4A representing MMP-13 in vehicle-treated mice 4-weeks
post DMM surgery and relabeled in:
[rtarr8] Figure 8 in R01 AG056623-01 to falsely represent p21 in
control mice following DMM surgery
[rtarr8] Figure 3 in R01 AG056623-01 to falsely represent [beta]-
gal in Cited2 KO mice
[ssquf] Figure 4A representing MMP-13 in EGCG -treated mice 4-weeks
post DMM surgery and relabeled in Figure 8 in R01 AG056623-01 to
falsely represent p21 following DMM surgery in mice overexpressing
Cited2
[ssquf] Figure 4C representing MMP-13 in vehicle-treated mice 8-weeks
post sham surgery and relabeled in Figure 2C in R01 AG056623-01 to
falsely represent p21 staining in Cited2 KO mice following DMM surgery
[ssquf] Figure 4C representing MMP-13 in EGCG-treated mice 8-weeks post
DMM surgery and relabeled in Figure 2C in R01 AG056623-01 to falsely
represent p21 in oil-injected control mice with Cited2 conditional
deletion in cartilage without Tamoxifen
[ssquf] Figure 5A representing ADAMTS5 in vehicle-treated DMM-induced
OA mice and relabeled in:
[rtarr8] Figure 8 in R01 AG056623-01 to falsely represent p16 in
control mice following DMM surgery
[rtarr8] Figure 2C in R01 AG056623-01 to falsely represent [beta]-
gal in Cited2 KO mice
[rtarr8] Figure 3 in R01 AG056623-01 to falsely represent [beta]-
gal in WT control mice with conditional deletion of Cited2 in cartilage
[ssquf] Figure 5C representing ADAMTS5 in vehicle-treated DMM-induced
OA mice and relabeled in:
[rtarr8] Figure 8 in R01 AG056623-01 to falsely represent Cited2 in
Cited-overexpressing mice, as well as [beta]-gal in control mice
following DMM surgery
[rtarr8] Figure 2C in R01 AG056623-01 to falsely represent p16
staining in Cited2 KO mice
[rtarr8] Figure 8 in R01 AG056623-01 to falsely represent p16 in
control mice following DMM surgery
Respondent neither admits nor denies ORI's findings of research
misconduct. The parties entered into a Voluntary Settlement Agreement
(Agreement) to conclude this matter without further expenditure of
time, finances, or other resources. The settlement is not an admission
of liability on the part of the Respondent.
Respondent voluntarily agreed to the following:
(1) Respondent will exclude himself voluntarily for a period of
four (4) years beginning on February 28, 2022 (the ``Exclusion
Period'') from any contracting or subcontracting with any agency of the
United States Government and from eligibility for or involvement in
nonprocurement or procurement transactions referred to as ``covered
transactions'' in 2 CFR parts 180 and 376 (collectively the ``Debarment
Regulations''). At the conclusion of the Exclusion Period, Respondent
agreed to have his research supervised for a period of four (4) years
(the ``Supervision Period''). During the Supervision Period, prior to
the submission of an application for PHS support for a research project
on which Respondent's participation is proposed and prior to
Respondent's participation in any capacity in PHS-supported research,
Respondent will submit a plan for supervision of Respondent's duties to
ORI for approval. The supervision plan must be designed to ensure the
integrity of Respondent's research. Respondent will not participate in
any PHS-supported research until such a supervision plan is approved by
ORI. Respondent will comply with the agreed-upon supervision plan.
(2) During the Supervision Period, the requirements for
Respondent's supervision plan are as follows:
i. A committee of 2-3 senior faculty members at the institution who
are familiar with Respondent's field of research, but not including
Respondent's supervisor or collaborators, will provide oversight and
guidance. The committee will review primary data from Respondent's
laboratory on a quarterly basis and submit a report to ORI at six (6)
month intervals setting forth the committee meeting dates and
Respondent's compliance with appropriate research standards and
confirming the integrity of Respondent's research.
ii. The committee will conduct an advance review of each
application for PHS funds, or report, manuscript, or abstract involving
PHS-supported research in which Respondent is involved. The review will
include a discussion with Respondent of the primary data represented in
those documents and will include a certification to ORI that the data
presented in the proposed application, report, manuscript, or abstract
is supported by the research record.
(3) During the Supervision Period, Respondent will ensure that any
institution employing him submits, in conjunction with each application
for PHS funds, or report, manuscript, or abstract involving PHS-
supported research in which Respondent is involved, a certification to
ORI that the data provided by Respondent are based on actual
experiments or are otherwise legitimately derived and that the data,
procedures, and methodology are accurately reported in the application,
report, manuscript, or abstract.
(4) If no supervision plan is provided to ORI, Respondent will
provide
[[Page 16757]]
certification to ORI at the conclusion of the Supervision Period that
his participation was not proposed on a research project for which an
application for PHS support was submitted and that he has not
participated in any capacity in PHS-supported research.
(5) During the Exclusion and Supervision Periods, Respondent will
exclude himself voluntarily from serving in any advisory or consultant
capacity to PHS including, but not limited to, service on any PHS
advisory committee, board, and/or peer review committee.
Dated: March 21, 2022.
Wanda K. Jones,
Acting Director, Office of Research Integrity, Office of the Assistant
Secretary for Health.
[FR Doc. 2022-06246 Filed 3-23-22; 8:45 am]
BILLING CODE 4150-31-P
