Findings of Research Misconduct, 66283-66284 [2018-27874]
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Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Notices
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SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 15,
2017 (82 FR 27487), FDA published a
notice of availability for MRTPAs
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submitted by Philip Morris Products
S.A. for its IQOS products and gave the
public 180 days to comment on the
applications. FDA issued a subsequent
notice in the Federal Register of
November 22, 2017 (82 FR 55616),
extending the period for public
comment and announcing its intent to
issue a notice in a future edition of the
Federal Register announcing when the
comment period will close. FDA
recently received amendments to the
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is announcing that the period for public
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2019.
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II. Electronic Access
Persons with access to the internet
may access the application documents
at: https://www.fda.gov/
TobaccoProducts/Labeling/
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66283
MarketingandAdvertising/ucm54
6281.htm.
Dated: December 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–27807 Filed 12–21–18; 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:
Findings of research
misconduct have been made against
Uthra Rajamani, Ph.D. (Respondent),
former project scientist in the Induced
Pluripotent Stem Cell Core Facility,
Cedars-Sinai Medical Center (CSMC).
Dr. Rajamani engaged in research
misconduct in research supported by
National Center for Advancing
Translational Science (NCATS),
National Institutes of Health (NIH),
grant UL1 TR000124. The
administrative actions, including
supervision for a period of one (1) year,
were implemented beginning on
November 27, 2018, and are detailed
below.
SUMMARY:
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: Notice is
hereby given that the Office of Research
Integrity (ORI) has taken final action in
the following case:
Uthra Rajamani, Ph.D., Cedars-Sinai
Medical Center: Based on the report of
an inquiry conducted by CSMC, the
Respondent’s admission, and additional
analysis conducted by ORI in its
oversight review, ORI found that Dr.
Uthra Rajamani, former project scientist
in the Induced Pluripotent Stem Cell
Core Facility, CSMC, engaged in
research misconduct in research
supported by NCATS, NIH, grant UL1
TR000124.
ORI found that Respondent engaged
in research misconduct by falsifying
data that were included in the following
paper: Nature Communications
8(219):1–15, 2017 (hereafter referred to
as ‘‘Nature Communications 2017’’).
ORI found that Respondent
knowingly and intentionally falsified
western blot images in Nature
Communications 2017 by using the
same western blot panel to represent the
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66284
Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Notices
expression of different proteins from
whole cell lysates exposed to different
endocrine disrupting chemical (EDC)
treatments. Specifically, Respondent:
• Digitally altered the original image
to darken the western blot panel for
COX IV expression in Figure 4b in
Nature Communications 2017 and
represented the blot as the expression
of:
—pNF-kB p65 Figure 4b in Nature
Communications 2017
—NF-kB p65 Figure 4b in Nature
Communications 2017
—p50 Figure 4b in Nature
Communications 2017
—p105 Figure 4b in Nature
Communications 2017
—p100 Figure 4b Nature
Communications 2017
• Digitally altered the original image
by superimposing a darker band over
the original bands in lanes 2 and 4 of
the western blot panel for COX IV
expression in whole cell lysates exposed
to different endocrine disrupting
chemical (EDC) treatments in Figure 4b
in Nature Communications 2017 and
represented the falsified blot in Figure
6a in Nature Communications 2017 as
expression of:
— P-p65 Figure 6a in Nature
Communications 2017
— p50 Figure 6a in Nature
Communications 2017
— p105 Figure 6a in Nature
Communications 2017
— p52 Figure 6a in Nature
Communications 2017
• Reused and relabeled the blot from
Figure 3d in Cell Stem Cell 22:698–712,
2018 to falsely represent BiP expression
under different experimental conditions
in Figure 3d in Nature Communications
2017.
As a result of its inquiry, CSMC
recommended that Nature
Communications 2017 be retracted.
Dr. Rajamani entered into a Voluntary
Settlement Agreement (Agreement) and
voluntarily agreed:
(1) To have her research supervised
for a period of one (1) year beginning on
November 27, 2018; Respondent agrees
that prior to submission of an
application for U.S. Public Health
Service (PHS) support for a research
project on which 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 agrees that she shall not
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participate in any PHS-supported
research until such a supervision plan is
submitted to and approved by ORI;
Respondent agrees to maintain
responsibility for compliance with the
agreed upon supervision plan;
(2) that for a period of one (1) year
beginning on November 27, 2018, 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) that if no supervisory plan is
provided to ORI, Respondent will
provide certification to ORI at the
conclusion of the supervision period
that she has not engaged in, applied for,
or had her name included on any
application, proposal, or other request
for PHS funds without prior notification
to ORI;
(4) to exclude herself 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 one (1) year beginning on
November 27, 2018; and
(5) that as a condition of the
Agreement, Respondent will request
that Nature Communications 8(219):1–
15, 2017 be retracted.
Wanda K. Jones,
Interim Director, Office of Research Integrity.
[FR Doc. 2018–27874 Filed 12–21–18; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Organization, Functions, and
Delegations of Authority; Part G;
Indian Health Service
Part G, of the Statement of
Organization, Functions, and
Delegations of Authority of the
Department of Health and Human
Services (HHS), as amended at 70 FR
24087, May 6, 2005, as amended at 75
FR 38112, July 1, 2010, and most
recently as amended at 79 FR 65671,
November 5, 2014, is hereby amended
to reflect a reorganization of the Indian
Health Service (IHS) Headquarters (HQ).
The IHS proposes a reorganization at
IHS HQ to strengthen operations and
oversight responsibilities to ensure
PO 00000
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quality health care by establishing an
Office of Quality.
Delete the functional statements for
the IHS HQ Office of the Director, Office
of Clinical and Preventive Services, and
Office of Management Services, and
replace with the following revised
statements, which includes a new Office
of Quality:
Chapter GA—Office of the Director
Section GA–10, Indian Health Service—
Organization
The IHS is an Operating Division
within the Department of Health and
Human Services (HHS) and is under the
leadership and direction of a Director
who is directly responsible to the
Secretary of Health and Human
Services. The IHS Headquarters is
proposing to reorganize the following
major components: Office of the
Director (GA), Office of Clinical and
Preventive Services (GAF), Office of
Management Services (GAL), and the
Office of Quality (OQ).
Section GA–20, Indian Health Service—
Functions
Office of the Director (OD) (GA)
Provides overall direction and
leadership for the IHS: (1) Establishes
goals and objectives for the IHS
consistent with the mission of the IHS
and ensures agency performance is
managed through goals/objectives,
achievements, and/or improved
outcomes; (2) provides for the full
participation of Indian tribes in the
programs and services provided by the
Federal Government; (3) develops
health care policy; (4) ensures the
delivery of quality comprehensive
health services; (5) advocates for the
health needs and concerns of American
Indians/Alaska Natives (AI/AN); (6)
promotes the IHS programs at the local,
state, national, and international levels;
(7) develops and demonstrates
alternative methods and techniques of
health services management and
delivery with maximum participation
by Indian tribes and Indian
organizations; (8) supports the
development of individual and tribal
capacities to participate in Indian health
programs through means and modalities
that they deem appropriate to their
needs and circumstances; (9) the IHS
will carry out the responsibilities of the
United States to Indian tribes and
individual Indians; (10) affords Indian
people an opportunity to enter a career
in the IHS by applying Indian
preference; (11) ensures full application
of the principles of Equal Employment
Opportunity laws and the Civil Rights
Act in managing the human resources of
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]]>Agencies
[Federal Register Volume 83, Number 246 (Wednesday, December 26, 2018)]
[Notices]
[Pages 66283-66284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27874]
-----------------------------------------------------------------------
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 Uthra
Rajamani, Ph.D. (Respondent), former project scientist in the Induced
Pluripotent Stem Cell Core Facility, Cedars-Sinai Medical Center
(CSMC). Dr. Rajamani engaged in research misconduct in research
supported by National Center for Advancing Translational Science
(NCATS), National Institutes of Health (NIH), grant UL1 TR000124. The
administrative actions, including supervision for a period of one (1)
year, were implemented beginning on November 27, 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: Notice is hereby given that the Office of
Research Integrity (ORI) has taken final action in the following case:
Uthra Rajamani, Ph.D., Cedars-Sinai Medical Center: Based on the
report of an inquiry conducted by CSMC, the Respondent's admission, and
additional analysis conducted by ORI in its oversight review, ORI found
that Dr. Uthra Rajamani, former project scientist in the Induced
Pluripotent Stem Cell Core Facility, CSMC, engaged in research
misconduct in research supported by NCATS, NIH, grant UL1 TR000124.
ORI found that Respondent engaged in research misconduct by
falsifying data that were included in the following paper: Nature
Communications 8(219):1-15, 2017 (hereafter referred to as ``Nature
Communications 2017'').
ORI found that Respondent knowingly and intentionally falsified
western blot images in Nature Communications 2017 by using the same
western blot panel to represent the
[[Page 66284]]
expression of different proteins from whole cell lysates exposed to
different endocrine disrupting chemical (EDC) treatments. Specifically,
Respondent:
Digitally altered the original image to darken the western
blot panel for COX IV expression in Figure 4b in Nature Communications
2017 and represented the blot as the expression of:
--pNF-kB p65 Figure 4b in Nature Communications 2017
--NF-kB p65 Figure 4b in Nature Communications 2017
--p50 Figure 4b in Nature Communications 2017
--p105 Figure 4b in Nature Communications 2017
--p100 Figure 4b Nature Communications 2017
Digitally altered the original image by superimposing a
darker band over the original bands in lanes 2 and 4 of the western
blot panel for COX IV expression in whole cell lysates exposed to
different endocrine disrupting chemical (EDC) treatments in Figure 4b
in Nature Communications 2017 and represented the falsified blot in
Figure 6a in Nature Communications 2017 as expression of:
-- P-p65 Figure 6a in Nature Communications 2017
-- p50 Figure 6a in Nature Communications 2017
-- p105 Figure 6a in Nature Communications 2017
-- p52 Figure 6a in Nature Communications 2017
Reused and relabeled the blot from Figure 3d in Cell Stem
Cell 22:698-712, 2018 to falsely represent BiP expression under
different experimental conditions in Figure 3d in Nature Communications
2017.
As a result of its inquiry, CSMC recommended that Nature
Communications 2017 be retracted.
Dr. Rajamani entered into a Voluntary Settlement Agreement
(Agreement) and voluntarily agreed:
(1) To have her research supervised for a period of one (1) year
beginning on November 27, 2018; Respondent agrees that prior to
submission of an application for U.S. Public Health Service (PHS)
support for a research project on which 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 agrees that
she shall not participate in any PHS-supported research until such a
supervision plan is submitted to and approved by ORI; Respondent agrees
to maintain responsibility for compliance with the agreed upon
supervision plan;
(2) that for a period of one (1) year beginning on November 27,
2018, 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) that if no supervisory plan is provided to ORI, Respondent will
provide certification to ORI at the conclusion of the supervision
period that she has not engaged in, applied for, or had her name
included on any application, proposal, or other request for PHS funds
without prior notification to ORI;
(4) to exclude herself 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
one (1) year beginning on November 27, 2018; and
(5) that as a condition of the Agreement, Respondent will request
that Nature Communications 8(219):1-15, 2017 be retracted.
Wanda K. Jones,
Interim Director, Office of Research Integrity.
[FR Doc. 2018-27874 Filed 12-21-18; 8:45 am]
BILLING CODE 4150-31-P
