Findings of Misconduct in Science/Research Misconduct, 23255-23256 [2013-09134]
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23255
Federal Register / Vol. 78, No. 75 / Thursday, April 18, 2013 / Notices
When
submitting comments or requesting
information, please include the OMB
control number 4040–0001 and
document identifier HHS–EGOV–
18380–30D for reference.
Information Collection Request Title:
SF–424 Research & Related (R&R).
OMB No.: 4040–0001.
Abstract: The SF–424 Research &
Related Information Collection is an
information collection comprised of a
set of standardized forms used for grant
applications to research-based agencies.
Need and Proposed Use of the
Information: The SF–424 R&R is used
by the public to apply for Federal
financial assistance in the forms of
grants. These forms are submitted to the
SUPPLEMENTARY INFORMATION:
data sources, to complete and review
the collection of information, and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
HHS estimates that the SF–424
Research and Related form will take 1
hour to complete.
We expect that 128,378 respondents
will use this form.
Once OMB approves the use of this
common form, federal agencies may
request OMB approval to use this
common form without having to publish
notices and request public comments for
60 and 30 days. Each agency must
account for the burden associated with
their use of the common form.
Federal grant-making research-based
agencies for evaluation and review.
Likely Respondents: Organizations
and institutions seeking research-based
grants.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions, to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information, to train
personnel and to be able to respond to
a collection of information, to search
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
responses per
respondent
Number of
respondents
Form name
Average
burden per
response
(in hours)
Total burden
hours
SF–424 Research and Related Application for Federal Assistance ...............
128,378
1
1
128,378
Total ..........................................................................................................
128,378
........................
........................
128,378
Keith A. Tucker,
Information Collection Clearance Officer.
[FR Doc. 2013–09046 Filed 4–17–13; 8:45 am]
BILLING CODE 4151–AE–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Misconduct in Science/
Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Notice is hereby given that
effective on March 14, 2013, a
Settlement Agreement was made and
entered into by and between Dr.
Philippe Bois and the United States
Department of Health and Human
Services (HHS), Kathleen Sebelius,
Howard K. Koh, Nancy Gunderson, and
Donald Wright (collectively HHS) by
and through the United States Attorney
for the District of Columbia in Bois v.
HHS, et al., Civil Action no. 11-cv-1563,
which was pending before the U.S.
District Court for the District of
Columbia.
In the Settlement Agreement, HHS
and Dr. Bois agreed to settle the
proceedings before the District Court of
the District of Columbia as well as to
resolve all administrative matters
pending at HHS.
sroberts on DSK5SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:54 Apr 17, 2013
Jkt 229001
ORI found that Philippe Bois, Ph.D.,
former postdoctoral fellow, Department
of Biochemistry, St. Jude Children’s
Research Hospital, engaged in research
misconduct in research funded by
National Institute of General Medical
Sciences (NIGMS), National Institutes of
Health (NIH), grant R01 GM071596, and
National Cancer Institute (NCI), NIH,
grants P30 CA021765, P01 CA071907,
R01 CA072996, and R01 CA100603.
In the Settlement Agreement, the
parties agreed that ORI found by a
preponderance of the evidence that the
Respondent committed misconduct in
science and research misconduct by:
1. Knowingly and intentionally falsely
reporting that FOXO1a was not
expressed in cell lysates from alveolar
rhabdomyosarcoma (ARMS) tumor
biopsies, by selecting a specific FOX01a
immunoblot to show the desired result,
in Figure 1A of the following paper:
Bois, P.R., Izeradjene, K., Houghton, P.J.,
Cleveland, J.L., Houghton, J.A., &
Grosveld, C.G. ‘‘FOXO1a acts as a
selective tumor suppressor in alveolar
rhabdomyosarcoma.’’ J. Cell. Biol.
170:903–912, September 2005 (‘‘JCB
2005’’)
2. Falsifying data showing SDS–PAGE
for papain digestion of VBS3 and aVBS,
by falsely labeling lane 1 to represent
papain only digestion, by falsely
labeling lane 5 to represent papain
digestion of the aVBS peptide, and by
falsely inserting a band in lane 3 to
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
represent the aVBS peptide, in Figure
4B of the following paper: Bois, P.R.,
Borgon, R.A., Vornhein, C., & Izard, T.
‘‘Structural dynamics of a-actininvinculin interactions.’’ Mol. Cell. Biol.
25:6112–6122, July 2005 (‘‘MCB 2005’’).
The parties further agreed that Dr.
Bois denied committing research
misconduct and, pursuant to 42 CFR
part 93, filed a timely request for a
hearing at which to contest ORI’s
findings. An HHS Administrative Law
Judge (ALJ) denied Dr. Bois’ request for
a hearing. HHS subsequently entered a
debarment order against Dr. Bois. Dr.
Bois filed the above referenced lawsuit
in the United States District Court for
the District of Columbia asking the
Court to vacate the debarment order and
remand the matter for further
proceedings before HHS, including but
not limited to granting Dr. Bois’ request
for a hearing.
On March 2, 2012, Judge Berman
Jackson of the United States District
Court for the District of Columbia issued
an order vacating HHS’ debarment
order, affirming Finding #1, and
remanding the matter to HHS for further
proceedings regarding Finding #2. On
March 30, 2012, HHS filed a Motion for
Reconsideration before Judge Berman
Jackson.
On March 14, 2013, Dr. Bois and HHS
entered into a Settlement Agreement
(Agreement) to settle and dismiss the
pending civil action. The terms of the
E:\FR\FM\18APN1.SGM
18APN1
sroberts on DSK5SPTVN1PROD with NOTICES
23256
Federal Register / Vol. 78, No. 75 / Thursday, April 18, 2013 / Notices
Settlement Agreement include that Dr.
Bois denied that he committed research
misconduct but he agreed not to further
appeal ORI’s findings of research
misconduct set-forth above. Dr. Bois and
HHS further agreed to the following
administrative actions beginning on
March 14, 2013:
(1) To have his research supervised
for a period of three (3) years beginning
on the effective date of the Agreement;
he agreed that prior to the submission
of an application for U.S. Public Health
Service (PHS) support for a research
project on which his participation is
proposed and prior to his participation
in any capacity on PHS-supported
research, he shall ensure that a plan for
supervision of his duties is submitted to
ORI for approval; the supervision plan
must be designed to ensure the
scientific integrity of his research
contribution; he agreed that he shall not
participate in any PHS-supported
research until such a supervision plan is
submitted to and approved by ORI, with
such review and approval to be
conducted promptly by ORI and not
unreasonably withheld; he 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,
any institution employing him shall
submit, in conjunction with each
application for PHS funds, or report,
manuscript, or abstract involving PHSsupported research in which Dr. Bois is
involved, a certification to ORI that the
data provided by him 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; and
(3) to exclude himself 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
years (3) beginning with the effective
date of the Agreement.
Dr. Bois further agreed to dismiss his
lawsuit with prejudice and to withdraw
further proceedings before HHS. Dr.
Bois and HHS both agreed to waive or
abandon all other claims. This notice
supercedes the notice regarding this
matter that was previously published in:
Federal Register 76:111, June 9, 2011.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Investigative
Oversight, Office of Research Integrity,
VerDate Mar<15>2010
18:54 Apr 17, 2013
Jkt 229001
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8800.
David E. Wright,
Director, Office of Research Integrity.
[FR Doc. 2013–09134 Filed 4–17–13; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities; Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project: ‘‘Pilot
Test of the Proposed Value and
Efficiency Surveys and Communicating
with Patients Checklist.’’ In accordance
with the Paperwork Reduction Act, 44
U.S.C. 3501–3521, AHRQ invites the
public to comment on this proposed
information collection.
This proposed information collection
was previously published in the Federal
Register on January 7th, 2013 and
allowed 60 days for public comment. No
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment.
DATES: Comments on this notice must be
received by May 20, 2013.
ADDRESSES: Written comments should
be submitted to: AHRQ’s OMB Desk
Officer by fax at (202) 395–6974
(attention: AHRQ’s desk officer) or by
email at
OIRA_submission@omb.eop.gov
(attention: AHRQ’s desk officer).
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Proposed Project
Pilot Test of the Proposed Value and
Efficiency Surveys and Communicating
With Patients Checklist
Maximizing value within the
American health care system is an
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Frm 00053
Fmt 4703
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important priority. Value is often
viewed as a combination of high quality,
high efficiency care, and there is general
agreement by consumers, policy makers,
payers, and providers that it is lacking
in the U.S. A recent report by the
Institute of Medicine estimated that 20
to 30 percent ($765 billion a year) of
U.S. healthcare spending was inefficient
and could be reduced without lowering
quality.
Multiple overlapping initiatives are
currently seeking to improve value
using a variety of approaches. Public
reporting efforts led by the Centers for
Medicare and Medicaid Services (CMS),
other payers and consumer groups seek
to enable consumers to make more
informed choices about the quality, and
in some cases, the costs of their care. A
variety of demonstration projects and
payment reforms initiated by CMS and
private insurers are attempting to more
closely link care quality with payments
to create incentives for higher value
care. And national improvement
initiatives led by AHRQ (comprehensive
unit-based safety programs [CUSP] for
central line-associated blood stream
infection [CLABSI], catheter-associated
urinary tract infections [CUTI], and
surgical units [SUSP]) and CMS
(hospital engagement networks, QIO
scopes of work) are seeking to raise care
quality and reduce readmissions.
Results from the CUSP–CLABSI project
have demonstrated that central line
infections can be reduced and
unnecessary costs can be avoided across
the health care system by concerted,
unit-based improvement efforts.
As a systems level example, Denver
Health, with initial funding from AHRQ,
has taken major steps towards
redesigning clinical and administrative
processes so as to reduce staff time,
patient waiting, and unnecessary costs.
These improvements occurred without
harm to quality and in some instances
actually improved quality.
In many cases, improving quality
improves efficiency naturally. Reducing
the number of hospital errors, for
example, will reduce costs associated
with longer length of stay or errortriggered readmissions. It is more costeffective to do things right the first time.
But higher value may be more likely if
organizations doing quality
improvement link efforts to improve
care quality with efforts to reduce
unnecessary costs. AHRQ understands
that many of the root causes of
inefficiencies that drive up costs are
closely linked to root causes of
inefficiencies that lead to poor quality,
uncoordinated care where redundancies
and system failures place patients at
risk. Enhancing value in healthcare
E:\FR\FM\18APN1.SGM
18APN1
]]>Agencies
[Federal Register Volume 78, Number 75 (Thursday, April 18, 2013)]
[Notices]
[Pages 23255-23256]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09134]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Findings of Misconduct in Science/Research Misconduct
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Notice is hereby given that effective on March 14, 2013, a
Settlement Agreement was made and entered into by and between Dr.
Philippe Bois and the United States Department of Health and Human
Services (HHS), Kathleen Sebelius, Howard K. Koh, Nancy Gunderson, and
Donald Wright (collectively HHS) by and through the United States
Attorney for the District of Columbia in Bois v. HHS, et al., Civil
Action no. 11-cv-1563, which was pending before the U.S. District Court
for the District of Columbia.
In the Settlement Agreement, HHS and Dr. Bois agreed to settle the
proceedings before the District Court of the District of Columbia as
well as to resolve all administrative matters pending at HHS.
ORI found that Philippe Bois, Ph.D., former postdoctoral fellow,
Department of Biochemistry, St. Jude Children's Research Hospital,
engaged in research misconduct in research funded by National Institute
of General Medical Sciences (NIGMS), National Institutes of Health
(NIH), grant R01 GM071596, and National Cancer Institute (NCI), NIH,
grants P30 CA021765, P01 CA071907, R01 CA072996, and R01 CA100603.
In the Settlement Agreement, the parties agreed that ORI found by a
preponderance of the evidence that the Respondent committed misconduct
in science and research misconduct by:
1. Knowingly and intentionally falsely reporting that FOXO1a was
not expressed in cell lysates from alveolar rhabdomyosarcoma (ARMS)
tumor biopsies, by selecting a specific FOX01a immunoblot to show the
desired result, in Figure 1A of the following paper: Bois, P.R.,
Izeradjene, K., Houghton, P.J., Cleveland, J.L., Houghton, J.A., &
Grosveld, C.G. ``FOXO1a acts as a selective tumor suppressor in
alveolar rhabdomyosarcoma.'' J. Cell. Biol. 170:903-912, September 2005
(``JCB 2005'')
2. Falsifying data showing SDS-PAGE for papain digestion of VBS3
and [alpha]VBS, by falsely labeling lane 1 to represent papain only
digestion, by falsely labeling lane 5 to represent papain digestion of
the [alpha]VBS peptide, and by falsely inserting a band in lane 3 to
represent the [alpha]VBS peptide, in Figure 4B of the following paper:
Bois, P.R., Borgon, R.A., Vornhein, C., & Izard, T. ``Structural
dynamics of [alpha]-actinin-vinculin interactions.'' Mol. Cell. Biol.
25:6112-6122, July 2005 (``MCB 2005'').
The parties further agreed that Dr. Bois denied committing research
misconduct and, pursuant to 42 CFR part 93, filed a timely request for
a hearing at which to contest ORI's findings. An HHS Administrative Law
Judge (ALJ) denied Dr. Bois' request for a hearing. HHS subsequently
entered a debarment order against Dr. Bois. Dr. Bois filed the above
referenced lawsuit in the United States District Court for the District
of Columbia asking the Court to vacate the debarment order and remand
the matter for further proceedings before HHS, including but not
limited to granting Dr. Bois' request for a hearing.
On March 2, 2012, Judge Berman Jackson of the United States
District Court for the District of Columbia issued an order vacating
HHS' debarment order, affirming Finding 1, and remanding the
matter to HHS for further proceedings regarding Finding 2. On
March 30, 2012, HHS filed a Motion for Reconsideration before Judge
Berman Jackson.
On March 14, 2013, Dr. Bois and HHS entered into a Settlement
Agreement (Agreement) to settle and dismiss the pending civil action.
The terms of the
[[Page 23256]]
Settlement Agreement include that Dr. Bois denied that he committed
research misconduct but he agreed not to further appeal ORI's findings
of research misconduct set-forth above. Dr. Bois and HHS further agreed
to the following administrative actions beginning on March 14, 2013:
(1) To have his research supervised for a period of three (3) years
beginning on the effective date of the Agreement; he agreed that prior
to the submission of an application for U.S. Public Health Service
(PHS) support for a research project on which his participation is
proposed and prior to his participation in any capacity on PHS-
supported research, he shall ensure that a plan for supervision of his
duties is submitted to ORI for approval; the supervision plan must be
designed to ensure the scientific integrity of his research
contribution; he agreed that he shall not participate in any PHS-
supported research until such a supervision plan is submitted to and
approved by ORI, with such review and approval to be conducted promptly
by ORI and not unreasonably withheld; he 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, any institution employing him shall submit, in
conjunction with each application for PHS funds, or report, manuscript,
or abstract involving PHS-supported research in which Dr. Bois is
involved, a certification to ORI that the data provided by him 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; and
(3) to exclude himself 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 years (3) beginning with the effective
date of the Agreement.
Dr. Bois further agreed to dismiss his lawsuit with prejudice and
to withdraw further proceedings before HHS. Dr. Bois and HHS both
agreed to waive or abandon all other claims. This notice supercedes the
notice regarding this matter that was previously published in: Federal
Register 76:111, June 9, 2011.
FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative
Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite
750, Rockville, MD 20852, (240) 453-8800.
David E. Wright,
Director, Office of Research Integrity.
[FR Doc. 2013-09134 Filed 4-17-13; 8:45 am]
BILLING CODE 4150-31-P
