Meeting of the National Advisory Council for Healthcare Research and Quality, 38633-38634 [2012-15795]
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Federal Register / Vol. 77, No. 125 / Thursday, June 28, 2012 / Notices
stereological data collection was never
performed for the questioned research.
The fabricated data, falsified
methodology, and false claims based on
fabricated and falsified data were
reported in two NIEHS, NIH, grant
applications, two publications, a poster,
and a manuscript in preparation:
• R01 ES016277, ‘‘Development
Pesticide Exposure: The Parkinson’s
Disease Phenotype’’ (Dr. Mona J.
Thiruchelvam, Principal Investigator
[P.I.]), submitted 1/26/2007 and funded.
• R01 ES015041, ‘‘Gender and the
Parkinson’s Disease Phenotype’’ (Dr.
Mona J. Thiruchelvam, P.I.), submitted
12/19/05.
• Rodriguez, V.M., Thiruchelvam, M.,
& Cory-Slechta, D.A. ‘‘Sustained
Exposure to the Widely Used Herbicide,
Atrazine: Altered Function and Loss of
Neurons in Brain Monamine Systems.’’
Environ Health Perspect. 113(6):708–
715, 2005 (‘‘EHP paper’’).
• Thiruchelvam, M., Prokopenko, O.,
Cory-Slechta, D.A., Richfield, E.K.,
Buckley, B., & Mirochnitchenko, O.
‘‘Overexpression of Superoxide
Dismutase or Glutathione Peroxidase
Protects against the Paraquat + Manebinduced Parkinson Disease Phenotype.’’
J. Biol. Chem. 280(23):22530–22539,
2005 (‘‘JBC paper’’).
• Harvey, K., Victor, A.I., Wang, Y.,
Kochar, Y., Cory-Slechta, D.A., &
Thiruchelvam, M. ‘‘Gene Delivery of
GDNF Impedes Progressive
Neurodegeneration in Paraquat and
Maneb Exposure Model of Parkinson’s
Disease.’’ Poster presentation,
Neuroscience 2006 (‘‘Neuroscience
poster’’).
• Thiruchelvam, M., Kochar, Y.,
Mehta, H., Prokopenko, O., CorySlechta, D.A., Richfield, E.K., &
Mirochnitchenko, O. ‘‘Mechanisms
associated with gender difference in the
paraquat and maneb animal model of
Parkinson’s disease, 2006
(‘‘manuscript’’).
Specifically, ORI finds that the
Respondent engaged in research
misconduct by knowingly and
intentionally:
• Falsifying and fabricating summary
bar graphs and methodology for
stereological cell counts in a murine
model of Parkinson’s disease, when the
stereological counts were never
performed;
• Copying and altering in multiple
ways a single stereology ‘‘.dat’’
computer file generated on August 18,
2002, and renaming it to generate 293
data files representing counts for 13 new
experiments that were never performed,
by altering the files to make them
unreadable and claiming that these files
were from valid stereological cell count
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experiments carried out at UMDNJ
between 2004 and 2006;
• Falsifying a bar graph representing
brain proteasomal activity, by
selectively altering data for relative
fluorescent unit (RFU) values to support
the hypothesis that development of
Parkinson’s disease entails proteasomal
dysfunction with a higher effect in
males compared to females;
• By failing to perform stereological
cell counts, the following figures of
summary bar graphs, reported
methodology, and related claims of the
Respondent’s JBC paper, EHP paper, a
manuscript, a poster, and two grant
applications were falsified:
—Figure 7B and the related text in R01
ES016277–01 and the Neuroscience
2006 poster
—Figure 4 and the related text in R01
ES016277–01
—Figure 9 and the related text in R01
ES016277–01 and R01 ES015041
—Figure 3 and the related text in the
JBC paper
—Figure 4 and the related text in the
EHP paper
—Figure 5 and the related text in a
manuscript in preparation
• By falsifying and selectively
altering experimental data for relative
fluorescent unit values of brain
proteasomal activity, the summary bar
graph in Figure 6 and the claim that
combined exposure of the pesticides
causes significant decreases in
proteasomal activity with a higher effect
in males than in females were falsified
in NIH grant application R01 ES016277.
Dr. Thiruchelvam has entered into a
Voluntary Exclusion Agreement
(Agreement) and has voluntarily agreed
for a period of seven (7) years, beginning
on June 13, 2012:
(1) To exclude herself from any
contracting or subcontracting with any
agency of the United States Government
and from eligibility or involvement in
nonprocurement programs of the United
States Government referred to as
‘‘covered transactions’’ pursuant to
HHS’ Implementation (2 CFR part 376 et
seq) of OMB Guidelines to Agencies on
Governmentwide Debarment and
Suspension, 2 CFR part 180 (collectively
the ‘‘Debarment Regulations’’);
(2) 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;
and
(3) to request retraction of the
following two papers:
• Environ Health Perspect.
113(6):708–715, 2005
• J. Biol. Chem. 280(23):22530–22539,
2005.
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38633
FOR FURTHER INFORMATION CONTACT:
Director, Division of Investigative
Oversight, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8800.
John Dahlberg,
Director, Division of Investigative Oversight,
Office of Research Integrity.
[FR Doc. 2012–15887 Filed 6–27–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Meeting of the National Advisory
Council for Healthcare Research and
Quality
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Notice of public meeting.
AGENCY:
In accordance with section
10(a) of the Federal Advisory Committee
Act, 5 U.S.C. App. 2, this notice
announces a meeting of the National
Advisory Council for Healthcare
Research and Quality.
DATES: The meeting will be held on
Friday, July 13, 2012, from 8:30 a.m. to
3:30 p.m.
ADDRESSES: The meeting will be held at
the Eisenberg Conference Center,
Agency for Healthcare Research and
Quality, 540 Gaither Road, Rockville,
Maryland 20850.
FOR FURTHER INFORMATION CONTACT:
Jaime Zimmerman, Coordinator of the
Advisory Council, at the Agency for
Healthcare Research and Quality, 540
Gaither Road, Rockville, Maryland,
20850, (301) 427–1456. For press-related
information, please contact Alison Hunt
at (301) 427–1244.
If sign language interpretation or other
reasonable accommodation for a
disability is needed, please contact the
Food and Drug Administration (FDA)
Office of Equal Employment
Opportunity and Diversity Management
on (301) 827–4840, no later than Friday,
March 16, 2012. The agenda, roster, and
minutes are available from Ms. Bonnie
Campbell, Committee Management
Officer, Agency for Healthcare Research
and Quality, 540 Gaither Road,
Rockville, Maryland, 20850. Ms.
Campbell’s phone number is (301) 427–
1554.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Purpose
The National Advisory Council for
Healthcare Research and Quality is
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38634
Federal Register / Vol. 77, No. 125 / Thursday, June 28, 2012 / Notices
authorized by Section 941 of the Public
Health Service Act, 42 U.S.C. 299c. In
accordance with its statutory mandate,
the Council is to advise the Secretary of
the Department of Health and Human
Services and the Director, Agency for
Healthcare Research and Quality
(AHRQ), on matters related to AHRQ’s
conduct of its mission including
providing guidance on (A) Priorities for
health care research, (B) the field of
health care research including training
needs and information dissemination on
health care quality and (C) the role of
the Agency in light of private sector
activity and opportunities for public
private partnerships.
The Council is composed of members
of the public, appointed by the
Secretary, and Federal ex-officio
members specified in the authorizing
legislation.
II. Agenda
On Friday, July 13, 2012, the Council
meeting will convene at 8:30 a.m., with
the call to order by the Council Chair
and approval of previous Council
summary notes. The AHRQ Director
will present her update on current
research, programs, and initiatives.
Following the morning session, the
Council will hold an Executive Session
between the hours of 12 p.m. and 1:30
p.m. This Executive Session will be
closed to the public in accordance with
5 U.S.C. App. 2, section 10(d) and 5
U.S.C. 552b(c)(9)(B). This portion of the
meeting is likely to disclose information
the premature disclosure of which
would be likely to significantly frustrate
implementation of a proposed agency
action. The final agenda will be
available on the AHRQ Web site at
www.AHRQ.gov no later than Friday,
June 29, 2012.
Dated: June 21, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012–15795 Filed 6–27–12; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
srobinson on DSK4SPTVN1PROD with NOTICES
[Docket Number CDC–2012–0008; NIOSH–
251]
Request for Information: Collection
and Use of Patient Work Information in
the Clinical Setting: Electronic Health
Records
The National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
AGENCY:
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Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Request for public comments.
The National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS) requests public
comments to inform its approach in
recommending the inclusion of work
information in the electronic health
record (EHR). NIOSH requests input on
these issues (including answers to the
three questions listed below). The
instructions for submitting comments
can be found at www.regulations.gov.
Written comments submitted to the
Docket will be used to inform NIOSH
with its planning and activities in
response to the 2011 letter report
‘‘Incorporating Occupational
Information in Electronic Health
Records’’ written by the Institute of
Medicine (IOM) Committee on
Occupation and Electronic Health
Records.
SUMMARY:
Public Comment Period:
Comments must be received by August
27, 2012. Comments should reference
docket number CDC–2012–0008.
ADDRESSES: Written comments: You
may submit comments by any of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: NIOSH Docket Office, Robert
A. Taft Laboratories, MS–C34, 4676
Columbia Parkway, Cincinnati, OH
45226.
Instructions: All submissions received
must include the agency name and
docket number. All relevant comments,
including any personal information
provided, will be posted without change
to https://www.regulations.gov.
• Email: nioshdocket@cdc.gov.
All information received in response
to this notice will be available for public
examination and copying at the NIOSH
Docket Office, 4676 Columbia Parkway,
Cincinnati, Ohio 45226.
NIOSH includes all comments
received without change in the docket,
including any personal information
provided. All material submitted should
reference docket number CDC–2012–
0008 and must be submitted by August
27, 2012 to be considered by the
Agency.
DATES:
I. Background
Health care in the United States is
undergoing a significant change as
providers of health care transition from
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paper-based records to electronic health
records (EHRs). EHRs represent the
potential for cost savings and other
efficiencies and improvements in the
way that information is used to inform
health care. The Office of the National
Coordinator (ONC) for Health
Information Technology promotes a
nationwide health information
technology (HIT) infrastructure that
allows for the electronic use and
exchange of health information. More
information on the ONC and on
electronic health records can be found
at https://healthint.hhs.gov.
NIOSH, along with other centers of
CDC, works to promote and protect
population health. Public health
researchers and practitioners, including
those promoting occupational public
health, are working to ensure that public
health goals are met through the use of
EHRs. NIOSH is working to ensure that
EHRs will contribute to improvements
in individual and population health by
meeting the need to support
occupational considerations during
clinical care and by enhancing public
health professionals’ understanding of
work-related conditions so they can
identify effective treatment and
prevention strategies. Currently,
systematic collection and recording of
patient work information in the clinical
setting is not widespread. Where work
information is collected and recorded in
the EHR, that information may not be
standardized or converted to structured
data (i.e., coded), thus limiting its utility
for clinical decision making and public
health surveillance. For example,
standardized patient occupation and/or
industry information could be linked to
resources that provide clinical decision
support, such as job-specific
information about exposures and
associated potential health problems, as
well as information that would facilitate
appropriate determination of return-towork recommendations.
In 2011, at the request of NIOSH, the
Institute of Medicine (IOM) of the
National Academies of Science
appointed a committee to examine the
rationale and feasibility of incorporating
occupational information in the EHR.
The committee concluded that inclusion
of occupational information in the EHR
‘‘could contribute to fully realizing the
meaningful use of EHRs in improving
individual and population health care’’.
The Committee provided NIOSH with a
set of ten recommendations, including
‘‘Recommendation 1: Conduct
Demonstration Projects to Assess the
Collection and Incorporation of
Information on Occupation, Industry
and Work-Relatedness in the EHR.’’ The
purpose of this Request for Information
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Agencies
[Federal Register Volume 77, Number 125 (Thursday, June 28, 2012)]
[Notices]
[Pages 38633-38634]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-15795]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Meeting of the National Advisory Council for Healthcare Research
and Quality
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Notice of public meeting.
-----------------------------------------------------------------------
SUMMARY: In accordance with section 10(a) of the Federal Advisory
Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the
National Advisory Council for Healthcare Research and Quality.
DATES: The meeting will be held on Friday, July 13, 2012, from 8:30
a.m. to 3:30 p.m.
ADDRESSES: The meeting will be held at the Eisenberg Conference Center,
Agency for Healthcare Research and Quality, 540 Gaither Road,
Rockville, Maryland 20850.
FOR FURTHER INFORMATION CONTACT: Jaime Zimmerman, Coordinator of the
Advisory Council, at the Agency for Healthcare Research and Quality,
540 Gaither Road, Rockville, Maryland, 20850, (301) 427-1456. For
press-related information, please contact Alison Hunt at (301) 427-
1244.
If sign language interpretation or other reasonable accommodation
for a disability is needed, please contact the Food and Drug
Administration (FDA) Office of Equal Employment Opportunity and
Diversity Management on (301) 827-4840, no later than Friday, March 16,
2012. The agenda, roster, and minutes are available from Ms. Bonnie
Campbell, Committee Management Officer, Agency for Healthcare Research
and Quality, 540 Gaither Road, Rockville, Maryland, 20850. Ms.
Campbell's phone number is (301) 427-1554.
SUPPLEMENTARY INFORMATION:
I. Purpose
The National Advisory Council for Healthcare Research and Quality
is
[[Page 38634]]
authorized by Section 941 of the Public Health Service Act, 42 U.S.C.
299c. In accordance with its statutory mandate, the Council is to
advise the Secretary of the Department of Health and Human Services and
the Director, Agency for Healthcare Research and Quality (AHRQ), on
matters related to AHRQ's conduct of its mission including providing
guidance on (A) Priorities for health care research, (B) the field of
health care research including training needs and information
dissemination on health care quality and (C) the role of the Agency in
light of private sector activity and opportunities for public private
partnerships.
The Council is composed of members of the public, appointed by the
Secretary, and Federal ex-officio members specified in the authorizing
legislation.
II. Agenda
On Friday, July 13, 2012, the Council meeting will convene at 8:30
a.m., with the call to order by the Council Chair and approval of
previous Council summary notes. The AHRQ Director will present her
update on current research, programs, and initiatives. Following the
morning session, the Council will hold an Executive Session between the
hours of 12 p.m. and 1:30 p.m. This Executive Session will be closed to
the public in accordance with 5 U.S.C. App. 2, section 10(d) and 5
U.S.C. 552b(c)(9)(B). This portion of the meeting is likely to disclose
information the premature disclosure of which would be likely to
significantly frustrate implementation of a proposed agency action. The
final agenda will be available on the AHRQ Web site at www.AHRQ.gov no
later than Friday, June 29, 2012.
Dated: June 21, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012-15795 Filed 6-27-12; 8:45 am]
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