Findings of Research Misconduct, 3394-3395 [2020-00874]
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Federal Register / Vol. 85, No. 13 / Tuesday, January 21, 2020 / Notices
study will inform the first two topic
areas.
Because we recognize the strength of
data and the confidence in the robust
nature of the findings is improved
through the results of multiple
converging studies, we continue to
develop evidence to inform our
thinking. We evaluate the results from
our studies within the broader context
of research and findings from other
sources, and this larger body of
knowledge collectively informs our
policies as well as our research program.
Our research is documented on our
homepage, which can be found at:
https://www.fda.gov/aboutfda/
centersoffices/officeofmedical
productsandtobacco/cder/
ucm090276.htm. The website includes
links to the latest Federal Register
notices and peer-reviewed publications
produced by our office. The website
maintains information on studies we
have conducted, dating back to a directto-consumer (DTC) survey conducted in
1999.
During the prescription drug approval
process, sponsors propose proprietary
names for their products. These names
undergo a proprietary name review that
involves the Office of Drug Safety, the
relevant medical office, and the OPDP.
OPDP reviews names to assess for
alignment with the FD&C Act, which
provides that labeling or advertising can
misbrand a product if misleading
representations are made (see 21 U.S.C.
321(n)). A proprietary name, which
appears in labeling, could result in such
misbranding if it is false or misleading.
OPDP focuses its misbranding review on
identifying names that overstate the
efficacy or safety of the drug, expand
drug indications, suggest superiority
without substantiation, or are of a
fanciful nature that misleadingly
implies unique effectiveness or
composition. While there are several
ways proprietary names can be
misleading, this research will primarily
focus on overstatement of the efficacy of
the drug product.
The proposed study is designed to
provide systematic, empirical evidence
to answer two research questions:
• Primary research question: How, if
at all, do names that suggest the drug’s
indication affect consumers’ and/or
healthcare providers’ perceptions of the
prescription drug?
• Secondary research question: How,
if at all, do names that suggest an
overstatement of the efficacy of the drug
affect consumers’ and/or healthcare
providers’ perceptions of prescription
drugs?
The ideas generated in the
Prescription Drug User Fee
Amendments pilot project proprietary
name review concept paper of 2008 1
provided a starting point for the study.
Based on ideas from that document, a
review of the linguistics and social
sciences literature, and an
environmental scan, FDA developed
and pretested an extreme, explicitly
suggestive name (e.g., CureAll) and a
neutral name for two indications, high
cholesterol and gastroesophageal reflux
disease (OMB control number 0910–
0695). In the proposed main study,
approximately 500 consumers from the
general population and 500 HCPs
(including physicians, nurse
practitioners, and physician assistants)
will see these pretested extreme and
neutral names plus five target (to be
tested) names per indication and answer
questions about the names, before and
after they have been told what each
drug’s indication is. Target names will
vary such that some efficacy
implications are more apparent than
others and some will more clearly imply
indication or benefits than others.
Dependent variables will include
indication identification, efficacy, and
perceptions.
To our knowledge, this study is the
first to provide a systemic investigation
of a variety of proprietary prescription
drug names.
The questionnaire is available upon
request from DTCResearch@fda.hhs.gov.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average burden
per response 2
Consumer Screener ....................................................
HCP Screener .............................................................
Consumer Study ..........................................................
HCP Study ...................................................................
1,233
1,233
493
493
1
1
1
1
1,233
1,233
493
493
Total ......................................................................
........................
........................
........................
0.08
0.08
0.33
0.33
Total hours
(5 minutes) .....
(5 minutes) .....
(20 minutes) ..
(20 minutes) ...
99
99
163
163
................................
524
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.
Dated: January 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–00823 Filed 1–17–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
AGENCY:
Office of the Secretary, HHS.
ACTION:
Notice.
Findings of research
misconduct have been made against
Ozgur Tataroglu, Ph.D. (Respondent),
former postdoctoral fellow, Department
of Neurobiology, University of
Massachusetts Medical School (UMMS).
Dr. Tataroglu engaged in research
misconduct in research supported by
U.S. Public Health Service (PHS) funds,
specifically National Institute of General
Medical Sciences (NIGMS), National
Institutes of Health (NIH), grants R01
SUMMARY:
GM066777 and R01 GM079182. The
administrative actions, including
supervision for a period of three (3)
years, were implemented beginning on
December 30, 2019, and are detailed
below.
FOR FURTHER INFORMATION CONTACT:
Elisabeth A. Handley, Interim Director,
Office of Research Integrity, 1101
Wootton Parkway, Suite 240, Rockville,
MD 20852, (240) 453–8200.
Notice is
hereby given that the Office of Research
SUPPLEMENTARY INFORMATION:
1 https://www.regulations.gov/docket?D=FDA2008-N-0281.
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Federal Register / Vol. 85, No. 13 / Tuesday, January 21, 2020 / Notices
Integrity (ORI) has taken final action in
the following case:
Ozgur Tataroglu, Ph.D., University of
Massachusetts Medical School: Based
on the report of an investigation
conducted by UMMS and additional
analysis conducted by ORI in its
oversight review, ORI found that Dr.
Ozgur Tataroglu, former postdoctoral
fellow, Department of Neurobiology,
UMMS, engaged in research misconduct
in research supported by PHS funds,
specifically NIGMS, NIH, grants R01
GM066777 and R01 GM079182.
Respondent neither admits nor denies
ORI’s findings of research misconduct.
The settlement is not an admission of
liability on the part of the Respondent.
The parties entered into a Voluntary
Settlement Agreement (Agreement) to
conclude this matter without further
expenditure of time, finances, or other
resources.
ORI found that Respondent engaged
in research misconduct by knowingly,
intentionally, and/or recklessly
falsifying data included in the following
one (1) paper and two (2) grant
applications submitted to NIGMS, NIH:
• Calcium and SOL Protease Mediate
Temperature Resetting of Circadian
Clocks. Cell 2015 Nov 19;163(5):1214–
1224 (hereafter referred to as ‘‘Cell
2015’’). Retracted in: Cell 2017 Sep
21;171(1):256.
• R01 GM079182–05A1,
‘‘Synchronization of Drosophila
Circadian Rhythms by Temperature
Cycles,’’ submitted to NIGMS, NIH, on
July 18, 2014.
• R35 GM118087–01, ‘‘Molecular and
neural mechanisms generating and
synchronizing circadian rhythms,’’
submitted to NIGMS, NIH, on May 19,
2015.
Specifically, ORI found that
Respondent engaged in research
misconduct by knowingly,
intentionally, and/or recklessly
falsifying data in bar graphs
representing phase shift of circadian
clock activity between Drosophila
without and with heat pulse (HP)
treatment in: Figures 1G, 2F, 3C, and 4C
of Cell 2015; Figures 7D, 8G, and 9C in
grant application R01 GM079182–05A1;
Figures 3C and 4 in grant application
R35 GM118087–01; and two (2) figures
recorded in his unpublished data files,
by selectively altering the original
Drosophila behavior locomotor data in
his primary data files. The data
manipulations resulted in the creation
or exaggeration of phase shifts caused
by either HP treatment or overexpression of the calpain protease SOL,
to support the hypothesis that
temperature phase shifts the Drosophila
circadian clock through the regulated
VerDate Sep<11>2014
18:20 Jan 17, 2020
Jkt 250001
degradation of the pacemaker protein
TIMELESS mediated by SOL.
Dr. Tataroglu entered into an
Agreement and voluntarily agreed:
(1) To have his research supervised
for a period of three (3) years beginning
on December 30, 2019; Respondent
agreed that prior to the submission of an
application for 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 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 supervision plan;
(2) that the requirements for
Respondent’s supervision plan are as
follows:
i. A committee of 2–3 senior faculty
members at the institution who are
familiar with Respondent’s field of
research, but not including
Respondent’s supervisor or
collaborators, will provide oversight and
guidance for three (3) years beginning
on December 30, 2019; the committee
will review primary data from
Respondent’s laboratory on a quarterly
basis and submit a report to ORI at six
(6) month intervals setting forth the
committee meeting dates, Respondent’s
compliance with appropriate research
standards, and confirming the integrity
of Respondent’s research; and
ii. the committee will conduct an
advance review of any PHS grant
applications (including supplements,
resubmissions, etc.), manuscripts
reporting PHS-funded research
submitted for publication, and abstracts;
the review will include a discussion
with Respondent of the primary data
represented in those documents and
will include a certification to ORI that
the data presented in the proposed
application/publication is supported by
the research record;
(3) that for a period of three (3) years
beginning on December 30, 2019, 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,
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3395
procedures, and methodology are
accurately reported in the application,
report, manuscript, or abstract;
(4) that if no supervisory plan is
provided to ORI, Respondent shall
provide certification to ORI at the
conclusion of the supervision period
that he has not engaged in, applied for,
or had his name included on any
application, proposal, or other request
for PHS funds without prior notification
to ORI; and
(5) 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 (3)
years beginning on December 30, 2019.
Elisabeth A. Handley,
Interim Director, Office of Research Integrity.
[FR Doc. 2020–00874 Filed 1–17–20; 8:45 am]
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SUMMARY:
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]]>Agencies
[Federal Register Volume 85, Number 13 (Tuesday, January 21, 2020)]
[Notices]
[Pages 3394-3395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00874]
-----------------------------------------------------------------------
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 Ozgur
Tataroglu, Ph.D. (Respondent), former postdoctoral fellow, Department
of Neurobiology, University of Massachusetts Medical School (UMMS). Dr.
Tataroglu engaged in research misconduct in research supported by U.S.
Public Health Service (PHS) funds, specifically National Institute of
General Medical Sciences (NIGMS), National Institutes of Health (NIH),
grants R01 GM066777 and R01 GM079182. The administrative actions,
including supervision for a period of three (3) years, were implemented
beginning on December 30, 2019, and are detailed below.
FOR FURTHER INFORMATION CONTACT: Elisabeth A. Handley, Interim
Director, Office of Research Integrity, 1101 Wootton Parkway, Suite
240, Rockville, MD 20852, (240) 453-8200.
SUPPLEMENTARY INFORMATION: Notice is hereby given that the Office of
Research
[[Page 3395]]
Integrity (ORI) has taken final action in the following case:
Ozgur Tataroglu, Ph.D., University of Massachusetts Medical School:
Based on the report of an investigation conducted by UMMS and
additional analysis conducted by ORI in its oversight review, ORI found
that Dr. Ozgur Tataroglu, former postdoctoral fellow, Department of
Neurobiology, UMMS, engaged in research misconduct in research
supported by PHS funds, specifically NIGMS, NIH, grants R01 GM066777
and R01 GM079182.
Respondent neither admits nor denies ORI's findings of research
misconduct. The settlement is not an admission of liability on the part
of the Respondent. The parties entered into a Voluntary Settlement
Agreement (Agreement) to conclude this matter without further
expenditure of time, finances, or other resources.
ORI found that Respondent engaged in research misconduct by
knowingly, intentionally, and/or recklessly falsifying data included in
the following one (1) paper and two (2) grant applications submitted to
NIGMS, NIH:
Calcium and SOL Protease Mediate Temperature Resetting of
Circadian Clocks. Cell 2015 Nov 19;163(5):1214-1224 (hereafter referred
to as ``Cell 2015''). Retracted in: Cell 2017 Sep 21;171(1):256.
R01 GM079182-05A1, ``Synchronization of Drosophila
Circadian Rhythms by Temperature Cycles,'' submitted to NIGMS, NIH, on
July 18, 2014.
R35 GM118087-01, ``Molecular and neural mechanisms
generating and synchronizing circadian rhythms,'' submitted to NIGMS,
NIH, on May 19, 2015.
Specifically, ORI found that Respondent engaged in research
misconduct by knowingly, intentionally, and/or recklessly falsifying
data in bar graphs representing phase shift of circadian clock activity
between Drosophila without and with heat pulse (HP) treatment in:
Figures 1G, 2F, 3C, and 4C of Cell 2015; Figures 7D, 8G, and 9C in
grant application R01 GM079182-05A1; Figures 3C and 4 in grant
application R35 GM118087-01; and two (2) figures recorded in his
unpublished data files, by selectively altering the original Drosophila
behavior locomotor data in his primary data files. The data
manipulations resulted in the creation or exaggeration of phase shifts
caused by either HP treatment or over-expression of the calpain
protease SOL, to support the hypothesis that temperature phase shifts
the Drosophila circadian clock through the regulated degradation of the
pacemaker protein TIMELESS mediated by SOL.
Dr. Tataroglu entered into an Agreement and voluntarily agreed:
(1) To have his research supervised for a period of three (3) years
beginning on December 30, 2019; Respondent agreed that prior to the
submission of an application for 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 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 supervision plan;
(2) that the requirements for Respondent's supervision plan are as
follows:
i. A committee of 2-3 senior faculty members at the institution who
are familiar with Respondent's field of research, but not including
Respondent's supervisor or collaborators, will provide oversight and
guidance for three (3) years beginning on December 30, 2019; the
committee will review primary data from Respondent's laboratory on a
quarterly basis and submit a report to ORI at six (6) month intervals
setting forth the committee meeting dates, Respondent's compliance with
appropriate research standards, and confirming the integrity of
Respondent's research; and
ii. the committee will conduct an advance review of any PHS grant
applications (including supplements, resubmissions, etc.), manuscripts
reporting PHS-funded research submitted for publication, and abstracts;
the review will include a discussion with Respondent of the primary
data represented in those documents and will include a certification to
ORI that the data presented in the proposed application/publication is
supported by the research record;
(3) that for a period of three (3) years beginning on December 30,
2019, 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;
(4) that if no supervisory plan is provided to ORI, Respondent
shall provide certification to ORI at the conclusion of the supervision
period that he has not engaged in, applied for, or had his name
included on any application, proposal, or other request for PHS funds
without prior notification to ORI; and
(5) 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 (3) years beginning on December 30,
2019.
Elisabeth A. Handley,
Interim Director, Office of Research Integrity.
[FR Doc. 2020-00874 Filed 1-17-20; 8:45 am]
BILLING CODE 4150-31-P
