Findings of Research Misconduct, 46251-46252 [2017-21367]
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Federal Register / Vol. 82, No. 191 / Wednesday, October 4, 2017 / Notices
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Please call the Information Line for upto-date information on this meeting.
In the
Federal Register of July 26, 2017 (82 FR
34681), FDA announced that a meeting
of the Patient Engagement Advisory
Committee would be held on October 11
and 12, 2017. On page 34681, in the
third column, the DATES section is
changed to reflect the time of these
meetings on the announced dates.
On page 34682, in the first column, in
the Procedure section, the third
sentence is changed to reflect new times
for oral presentations on October 11 and
12.
On page 34682, in the second column,
a Webcast Information section is added
before the last paragraph of the
document. The amendments read as
follows:
SUPPLEMENTARY INFORMATION:
The meeting will be held on
October 11, 2017, from 12:30 p.m. to 6
p.m. and October 12, 2017, from 8 a.m.
to 5 p.m.
Procedure: Oral presentations from
the public will be scheduled between
approximately 2:30 p.m. to 3 p.m. on
October 11, 2017, and approximately 1
p.m. to 2:30 p.m. on October 12, 2017.
Webcast Information: This meeting
will also be made available to the public
via webcast. The links for the webcasts
are below: October 11, 2017: ‘‘Patient
Engagement Advisory Committee
Meeting, Day 1,’’ https://
event.webcasts.com/
starthere.jsp?ei=1157277&tp_
key=5580d0c7a5. October 12, 2017:
‘‘Patient Engagement Advisory
Committee Meeting, Day 2,’’ Morning
Session—https://event.webcasts.com/
starthere.jsp?ei=1157280&tp_
key=dfcde848fe; and Afternoon
Session—https://event.webcasts.com/
starthere.jsp?ei=1157282&tp_
key=6d832a247e.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
sradovich on DSK3GMQ082PROD with NOTICES
DATES:
Dated: September 29, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–21317 Filed 10–3–17; 8:45 am]
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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
the Office of Research Integrity (ORI)
has taken final action in the following
case:
Azza El-Remessy, Ph.D., University of
Georgia, College of Pharmacy: Based on
the report of an investigation conducted
by the University of Georgia, College of
Pharmacy (UGCP) and additional
analysis conducted by ORI in its
oversight review, ORI found that Dr.
Azza El-Remessy, former Associate
Professor, Department of Clinical and
Administrative Pharmacy, UGCP,
engaged in research misconduct in
research supported by National Eye
Institute (NEI), National Institutes of
Health (NIH), grants R01 EY011766, R01
EY022408, and R01 EY04618, National
Heart, Lung, and Blood Institute
(NHLBI), NIH, grant R01 HL056259, and
National Cancer Institute (NCI), NIH,
grant K01 CA89689.
ORI found that false Western blot data
were included in:
• J Cell Sci. 118(Pt. 1):243–52, 2005
(hereafter referred to as ‘‘J Cell Sci.
2005’’). Retraction in: J Cell Sci.
129(16):3203, 2016.
• FASEB J. 21(10):2528–39, 2007
(hereafter referred to as ‘‘FASEB J.
2007’’). Retraction in: FASEB J.
31(1):421, 2017.
• PLoS One 8(8):e71868, 2013
(hereafter referred to as ‘‘PLoS One
2013’’).
As a result of its investigation, UGCP
recommended that PLoS One 2013 be
corrected. As a result of the
investigation, J Cell Sci. 2005 and
FASEB J. 2007 have been retracted.
ORI found that Respondent
intentionally, knowingly, or recklessly
used the same Western blot bands to
represent different experimental results.
Specifically, Respondent reused and
relabeled bands in:
1. Figure 3B, J Cell Sci. 2005, to
represent p38 bands from retinal
cultured endothelial cells in high
glucose in the absence of exogenous
VEGF and also cells in peroxynitrite in
the presence of exogenous VEGF.
2. Figure 4A, J Cell Sci. 2005, to
represent nitrotyrosine
immunoprecipitations from retinal
endothelial cells cultured in normal
glucose in the presence or absence of
FeTTP; the Respondent also duplicated
SUMMARY:
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
46251
controls for p85 immunoprecipitation
by using three bands representing 2
normal glucose and 1 high glucose
treatments, flipping them horizontally
(mirror images) to also represent 2 high
glucose and 1 peroxynitrite treatments.
3. Figure 4B, J Cell Sci. 2005, to
represent p85 immunoprecipitations
from retinal endothelial cells stimulated
with VEGF and also cells treated with
either high glucose or peroxynitrite.
4. Figure 4A, PLoS One 2013, to
represent immunoprecipitations for
phosphorylated GSK-3 (p-GSK-3) in
cells with normal glucose or high
glucose for day 1 and to also represent
cells treated with VEGF or VEGF+VEGFI
(inhibitor); the Respondent also
duplicated GSK-3 controls by using the
same bands to represent high glucose
treatment for day 1 and day 3
treatments, flipping them horizontally,
to also represent for VEGF and VEGFRI
treatments.
5. Figure 3, FASEB J. 2007, to
represent phosphorylated VEGF2 (PVEGF2) protein expression in
microvascular endothelial cells in:
Lanes 1 and 8, lanes 2 and 5, and lanes
6 and 7, where each lane represents
different experimental conditions.
Dr. El-Remessy entered into a
Voluntary Settlement Agreement
(Agreement) to resolve this matter
without further expenditure of time or
other resources. Dr. El-Remessy accepts
ORI’s findings of research misconduct
as set forth above but neither admits nor
denies ORI’s findings of research
misconduct. The settlement is not an
admission of liability on the part of the
Respondent. Dr. El-Remessy voluntarily
agreed, beginning on September 12,
2017:
(1) To have her research supervised
for a period of three (3) years beginning
with the effective date of the Agreement;
Respondent agreed that prior to the
submission of an application for U.S.
Public Health Service (PHS) support for
a research project on which the
Respondent’s participation is proposed
and prior to Respondent’s participation
in any capacity on PHS-supported
research, Respondent shall ensure that a
plan for supervision of Respondent’s
duties is submitted to ORI for approval;
the supervision plan must be designed
to ensure the scientific integrity of
Respondent’s research contribution;
Respondent agreed that she shall not
participate in any PHS-supported
research until such a supervision plan is
submitted to and approved by ORI;
Respondent agreed to maintain
responsibility for compliance with the
agreed upon supervision plan;
(2) that for three (3) years beginning
with the effective date of the Agreement,
E:\FR\FM\04OCN1.SGM
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46252
Federal Register / Vol. 82, No. 191 / Wednesday, October 4, 2017 / Notices
any institution employing her shall
submit, in conjunction with each
application for PHS funds, or report,
manuscript, or abstract involving PHSsupported 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;
(3) to exclude herself voluntarily 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 for a period of three (3) years,
beginning with the effective date of the
Agreement; and
(4) that as a condition of the
Agreement, Respondent will request
that PLoS One 8(8):e71868, 2013 be
corrected or retracted.
FOR FURTHER INFORMATION CONTACT:
Director, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8200.
Kathryn M. Partin,
Director, Office of Research Integrity.
[FR Doc. 2017–21367 Filed 10–3–17; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Human Genome Research
Institute; Notice of Closed Meeting
sradovich on DSK3GMQ082PROD with NOTICES
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: National Human
Genome Research Institute Special Emphasis
Panel, SEP U24 Research Resource.
Date: November 30, 2017.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Human Genome Research
Institute, 5635 Fishers Lane, Suite 3146,
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20:18 Oct 03, 2017
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Rockville, MD 20852 (Telephone Conference
Call).
Contact Person: Rudy O. Pozzatti, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Human Genome Research
Institute, 5635 Fishers Lane, Suite 4076, MSC
9306, Rockville, MD 20852, (301) 402–0838,
pozzattr@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.172, Human Genome
Research, National Institutes of Health, HHS)
Dated: September 28, 2017.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–21263 Filed 10–3–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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: National Institute on
Drug Abuse Special Emphasis Panel; Multisite Clinical Trials.
Date: October 19, 2017.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Shang-Yi Anne Tsai,
Ph.D., Scientific Review Officer, Office of
Extramural Policy and Review, Division of
Extramural Research, National Institute on
Drug Abuse, NIH, DHHS, 6001 Executive
Boulevard, Room 4228, MSC 9550, Bethesda,
MD 20892, 301–827–5842, shangyi.tsai@
nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; NIDA
Mentored Clinical Scientists Development
Program Award in Drug Abuse and
Addiction (K12).
Date: October 25, 2017.
Time: 9:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
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Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852.
Contact Person: Susan O. McGuire, Ph.D.,
Scientific Review Officer, Office of
Extramural Policy and Review, National
Institute on Drug Abuse, National Institutes
of Health, DHHS, 6001 Executive Blvd.,
Room 4245, Rockville, MD 20852, (301) 827–
5817, mcguireso@mail.nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; NIH
Pathway to Independence Award (K99/R00).
Date: October 25, 2017.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852.
Contact Person: Susan O. McGuire, Ph.D.,
Scientific Review Officer, Office of
Extramural Policy and Review, National
Institute on Drug Abuse, National Institutes
of Health, DHHS, 6001 Executive Blvd.,
Room 4245, Rockville, MD 20852, (301) 827–
5817, mcguireso@mail.nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; (T32)
Ruth L. Kirschstein National Research
Service Award (NRSA) Institutional Research
Training Grants.
Date: October 26–27, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852.
Contact Person: Susan O. McGuire, Ph.D.
Scientific Review Officer, Office of
Extramural Policy and Review, National
Institute on Drug Abuse, National Institutes
of Health, DHHS, 6001 Executive Blvd.,
Room 4245, Rockville, MD 20852, (301) 827–
5817, mcguireso@mail.nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel;
Exploring Novel RNA Modifications in HIV/
AIDS and Substance Use Disorders (R01,
R21).
Date: November 1, 2017.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852,
Contact Person: Susan O. McGuire, Ph.D.,
Scientific Review Officer, Office of
Extramural Policy and Review, National
Institute on Drug Abuse, National Institutes
of Health, DHHS, 6001 Executive Blvd.,
Room 4245, Rockville, MD 20852, (301) 827–
5817, mcguireso@mail.nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; CuttingEdge Basic Research Awards (CEBRA) (R21).
Date: November 29, 2017.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
E:\FR\FM\04OCN1.SGM
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Agencies
[Federal Register Volume 82, Number 191 (Wednesday, October 4, 2017)]
[Notices]
[Pages 46251-46252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21367]
-----------------------------------------------------------------------
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:
Azza El-Remessy, Ph.D., University of Georgia, College of Pharmacy:
Based on the report of an investigation conducted by the University of
Georgia, College of Pharmacy (UGCP) and additional analysis conducted
by ORI in its oversight review, ORI found that Dr. Azza El-Remessy,
former Associate Professor, Department of Clinical and Administrative
Pharmacy, UGCP, engaged in research misconduct in research supported by
National Eye Institute (NEI), National Institutes of Health (NIH),
grants R01 EY011766, R01 EY022408, and R01 EY04618, National Heart,
Lung, and Blood Institute (NHLBI), NIH, grant R01 HL056259, and
National Cancer Institute (NCI), NIH, grant K01 CA89689.
ORI found that false Western blot data were included in:
J Cell Sci. 118(Pt. 1):243-52, 2005 (hereafter referred to
as ``J Cell Sci. 2005''). Retraction in: J Cell Sci. 129(16):3203,
2016.
FASEB J. 21(10):2528-39, 2007 (hereafter referred to as
``FASEB J. 2007''). Retraction in: FASEB J. 31(1):421, 2017.
PLoS One 8(8):e71868, 2013 (hereafter referred to as
``PLoS One 2013'').
As a result of its investigation, UGCP recommended that PLoS One
2013 be corrected. As a result of the investigation, J Cell Sci. 2005
and FASEB J. 2007 have been retracted.
ORI found that Respondent intentionally, knowingly, or recklessly
used the same Western blot bands to represent different experimental
results. Specifically, Respondent reused and relabeled bands in:
1. Figure 3B, J Cell Sci. 2005, to represent p38 bands from retinal
cultured endothelial cells in high glucose in the absence of exogenous
VEGF and also cells in peroxynitrite in the presence of exogenous VEGF.
2. Figure 4A, J Cell Sci. 2005, to represent nitrotyrosine
immunoprecipitations from retinal endothelial cells cultured in normal
glucose in the presence or absence of FeTTP; the Respondent also
duplicated controls for p85 immunoprecipitation by using three bands
representing 2 normal glucose and 1 high glucose treatments, flipping
them horizontally (mirror images) to also represent 2 high glucose and
1 peroxynitrite treatments.
3. Figure 4B, J Cell Sci. 2005, to represent p85
immunoprecipitations from retinal endothelial cells stimulated with
VEGF and also cells treated with either high glucose or peroxynitrite.
4. Figure 4A, PLoS One 2013, to represent immunoprecipitations for
phosphorylated GSK-3 (p-GSK-3) in cells with normal glucose or high
glucose for day 1 and to also represent cells treated with VEGF or
VEGF+VEGFI (inhibitor); the Respondent also duplicated GSK-3 controls
by using the same bands to represent high glucose treatment for day 1
and day 3 treatments, flipping them horizontally, to also represent for
VEGF and VEGFRI treatments.
5. Figure 3, FASEB J. 2007, to represent phosphorylated VEGF2 (P-
VEGF2) protein expression in microvascular endothelial cells in: Lanes
1 and 8, lanes 2 and 5, and lanes 6 and 7, where each lane represents
different experimental conditions.
Dr. El-Remessy entered into a Voluntary Settlement Agreement
(Agreement) to resolve this matter without further expenditure of time
or other resources. Dr. El-Remessy accepts ORI's findings of research
misconduct as set forth above but neither admits nor denies ORI's
findings of research misconduct. The settlement is not an admission of
liability on the part of the Respondent. Dr. El-Remessy voluntarily
agreed, beginning on September 12, 2017:
(1) To have her research supervised for a period of three (3) years
beginning with the effective date of the Agreement; Respondent agreed
that prior to the submission of an application for U.S. Public Health
Service (PHS) support for a research project on which the Respondent's
participation is proposed and prior to Respondent's participation in
any capacity on PHS-supported research, Respondent shall ensure that a
plan for supervision of Respondent's duties is submitted to ORI for
approval; the supervision plan must be designed to ensure the
scientific integrity of Respondent's research contribution; Respondent
agreed that she shall not participate in any PHS-supported research
until such a supervision plan is submitted to and approved by ORI;
Respondent agreed to maintain responsibility for compliance with the
agreed upon supervision plan;
(2) that for three (3) years beginning with the effective date of
the Agreement,
[[Page 46252]]
any institution employing her shall submit, 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;
(3) to exclude herself voluntarily 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 for a period of three (3) years, beginning with the
effective date of the Agreement; and
(4) that as a condition of the Agreement, Respondent will request
that PLoS One 8(8):e71868, 2013 be corrected or retracted.
FOR FURTHER INFORMATION CONTACT: Director, Office of Research
Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240)
453-8200.
Kathryn M. Partin,
Director, Office of Research Integrity.
[FR Doc. 2017-21367 Filed 10-3-17; 8:45 am]
BILLING CODE 4150-31-P