Findings of Research Misconduct, 45661-45662 [2015-18794]
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Federal Register / Vol. 80, No. 147 / Friday, July 31, 2015 / Notices
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 514 have been approved
under OMB control number 0910–0032.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
VI. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/cvm or https://
www.regulations.gov.
Dated: July 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–18796 Filed 7–30–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1051]
Modified Risk Tobacco Product
Applications: Applications for 10
Products Submitted by Swedish Match
North America Inc.; Reopening of
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice; reopening of the
comment period.
ACTION:
The Food and Drug
Administration (FDA) is reopening the
period for public comment on modified
risk tobacco product applications
(MRTPAs) submitted by Swedish Match
North America Inc. for 10 tobacco
products and announcing the
availability for public comment of
amendments to the MRTPAs. The notice
of availability for the originally-filed
applications appeared in the Federal
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
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Register of August 27, 2014 (79 FR
51183). In that notice, FDA requested
comments on the 10 originally-filed
MRTPAs that are posted on https://
www.regulations.gov and FDA’s Web
site. The comment period on these
originally-filed applications closed on
February 23, 2015. FDA is reopening the
comment period to seek comment
specifically on amendments made to the
originally-filed MRTPAs submitted by
Swedish Match North America Inc.
DATES: Submit either electronic or
written comments on the amendments
by August 31, 2015.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with Docket Number FDA–
2014–N–1051.
FOR FURTHER INFORMATION CONTACT:
Center for Tobacco Products, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 1–877–287–1373, AskCTP@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 27,
2014 (79 FR 51183), FDA published a
notice of availability of MRTPAs
submitted by Swedish Match North
America Inc. for 10 tobacco products
and gave the public 180 days to
comment on the applications.
FDA is required by section 911(e) of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 387k(e))
to make an MRTPA available to the
public (except for matters in the
application that are trade secrets or
otherwise confidential commercial
information) and to request comments
by interested persons on the information
contained in the application and on the
label, labeling, and advertising
accompanying the application. The
determination of whether an order is
appropriate under section 911 of the
FD&C Act is based on the scientific
information submitted by the applicant
as well as the scientific evidence and
other information that is made available
to the Agency, including through public
comments.
FDA has received and accepted a
number of amendments to Swedish
Match North America Inc.’s 10
originally-filed MRTPAs and is making
these amendments available (except for
matters in the amendments that are
trade secrets or otherwise confidential
commercial information) for public
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45661
comment. FDA is reopening the period
for public comment so that the public
has the opportunity to review and
comment on these amendments.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Persons with access to the Internet
may obtain the document at either
https://www.accessdata.fda.gov/Static/
widgets/tobacco/SMNA_MRTPA_FDA2014-N-1051.html or https://
www.regulations.gov.
Dated: July 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–18782 Filed 7–30–15; 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:
Notice is hereby given that
the Office of Research Integrity (ORI)
has taken final action in the following
case:
David Anderson, University of
Oregon, Eugene: Based on an
assessment conducted by the University
of Oregon, Eugene (UOE), the
Respondent’s admission, and analysis
conducted by ORI, ORI and UOE found
that Mr. David Anderson, Graduate
Student, UOE, engaged in research
misconduct in research supported by
National Institute of Mental Health
(NIMH), National Institutes of Health
(NIH), grants R01 MH087214, R01
MH077105, and TA MH020002.
ORI found that Respondent engaged
in research misconduct by falsifying
and/or fabricating data in the following
four (4) publications:
• Journal of Neuroscience
31(3):1128–38, 2011 (hereafter referred
to as ‘‘Paper 1’’).
Journal of Experimental Psychology:
Human Perception and Performance
SUMMARY:
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45662
Federal Register / Vol. 80, No. 147 / Friday, July 31, 2015 / Notices
39(3):824–835, 2012 (hereafter referred
to as ‘‘Paper 2’’).
• Attention, Perception and
Psychophysics 74(5):891–910, 2012
(hereafter referred to as ‘‘Paper 3’’).
• Psychological Science 24(6):929–38,
2013 (hereafter referred to as ‘‘Paper 4’’).
ORI found that Respondent
knowingly falsified data by removing
outlier values or replacing outliers with
mean values to produce results that
conform to predictions. Specifically,
these falsifications appear in:
1. Figures 4 and 8 in Paper 1.
2. Figures 3C, 3D, and 3E in Paper 2.
3. Figures 3B, 7C, 7D, and 8B in Paper
3.
4. Figures 3E and 3F in Paper 4.
Mr. Anderson has entered into a
Voluntary Settlement Agreement and
has voluntarily agreed for a period of
three (3) years, beginning on June 23,
2015:
(1) To have his research supervised;
Respondent 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, Respondent
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;
Respondent agreed that he 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 any institution employing him
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 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; and
(4) to assist UOE in advising
publishers of the need to retract or
correct the following papers:
• Journal of Neuroscience
31(3):1128–38, 2011.
• Journal of Experimental
Psychology: Human Perception and
Performance 39(3):824–835, 2012.
• Attention, Perception and
Psychophysics 74(5):891–910, 2012.
• Psychological Science 24(6):929–38,
2013.
FOR FURTHER INFORMATION CONTACT:
Acting Director, Office of Research
Integrity, 1101 Wootton Parkway, Suite
750, Rockville, MD 20852, (240) 453–
8200.
Donald Wright,
Acting Director, Office of Research Integrity.
[FR Doc. 2015–18794 Filed 7–30–15; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS–OS–0990–0407–
60D]
Agency Information Collection
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
the Office of the Secretary (OS),
Department of Health and Human
Services, announces plans to submit an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB). A 60day Federal Register Notice has been
published for this system. This request
is to approve a revision to a currently
approved collection with OMB number
0990–0407, and is not a new request for
approval.
SUMMARY:
Comments on the ICR must be
received on or before September 29,
2015.
DATES:
Submit your comments to
Information.CollectionClearance@
hhs.gov or by calling (202) 690–6162.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
When
submitting comments or requesting
information, please include the
document identifier HHS–OS–0990–
0407–60D for reference.
Information Collection Request Title:
Think Cultural Health (TCH) Web site
Quality Improvement Effort—OMB No.
0990–0407 REVISION–HHS/OS/OMH
Abstract: The Office of Minority
Health (OMH), Office of the Secretary
(OS), Department of Health and Human
Services (HHS) is requesting approval
by OMB on a revised data collection.
The Think Cultural Health (TCH) Web
site is an initiative of the HHS OMH’s
Center for Linguistic and Cultural
Competence in Health Care (CLCCHC),
and is a repository of the latest
resources and tools to promote cultural
and linguistic competency in health and
health care. The TCH Web site is unlike
other government Web sites in that its
suite of e-learning programs affords
health and health care professionals the
ability to earn continuing education
credits through training in cultural and
linguistic competency. The revision to
this information collection request
includes the online Web site registration
form, course/unit evaluations specific to
the resource or e-learning program
course/unit completed, follow up
surveys, focus groups, and key
informant interviews.
Need and Proposed Use of the
Information: The data will be used to
ensure that the offerings on the TCH
Web site are relevant, useful, and
appropriate to their target audiences.
The findings from the data collection
will be of interest to HHS OMH in
supporting maintenance and revisions
of the offerings on the TCH Web site.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Type of respondent
Registration Form .............................
Health and Health Care Professionals.
Health and Health Care Professionals.
Course/unit Evaluation Form ............
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Number
responses per
respondent
Average
burden per
response
(hours)
Total burden
(hours)
9460
1.00
3/60
473
9460
1.00
5/60
788
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Agencies
[Federal Register Volume 80, Number 147 (Friday, July 31, 2015)]
[Notices]
[Pages 45661-45662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18794]
-----------------------------------------------------------------------
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:
David Anderson, University of Oregon, Eugene: Based on an
assessment conducted by the University of Oregon, Eugene (UOE), the
Respondent's admission, and analysis conducted by ORI, ORI and UOE
found that Mr. David Anderson, Graduate Student, UOE, engaged in
research misconduct in research supported by National Institute of
Mental Health (NIMH), National Institutes of Health (NIH), grants R01
MH087214, R01 MH077105, and TA MH020002.
ORI found that Respondent engaged in research misconduct by
falsifying and/or fabricating data in the following four (4)
publications:
Journal of Neuroscience 31(3):1128-38, 2011 (hereafter
referred to as ``Paper 1'').
Journal of Experimental Psychology: Human Perception and
Performance
[[Page 45662]]
39(3):824-835, 2012 (hereafter referred to as ``Paper 2'').
Attention, Perception and Psychophysics 74(5):891-910,
2012 (hereafter referred to as ``Paper 3'').
Psychological Science 24(6):929-38, 2013 (hereafter
referred to as ``Paper 4'').
ORI found that Respondent knowingly falsified data by removing
outlier values or replacing outliers with mean values to produce
results that conform to predictions. Specifically, these falsifications
appear in:
1. Figures 4 and 8 in Paper 1.
2. Figures 3C, 3D, and 3E in Paper 2.
3. Figures 3B, 7C, 7D, and 8B in Paper 3.
4. Figures 3E and 3F in Paper 4.
Mr. Anderson has entered into a Voluntary Settlement Agreement and
has voluntarily agreed for a period of three (3) years, beginning on
June 23, 2015:
(1) To have his research supervised; Respondent 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, Respondent 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; Respondent agreed that he 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 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 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 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; and
(4) to assist UOE in advising publishers of the need to retract or
correct the following papers:
Journal of Neuroscience 31(3):1128-38, 2011.
Journal of Experimental Psychology: Human Perception and
Performance 39(3):824-835, 2012.
Attention, Perception and Psychophysics 74(5):891-910,
2012.
Psychological Science 24(6):929-38, 2013.
FOR FURTHER INFORMATION CONTACT: Acting Director, Office of Research
Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240)
453-8200.
Donald Wright,
Acting Director, Office of Research Integrity.
[FR Doc. 2015-18794 Filed 7-30-15; 8:45 am]
BILLING CODE 4150-31-P