Findings of Research Misconduct, 43784 [2015-18088]
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Federal Register / Vol. 80, No. 141 / Thursday, July 23, 2015 / Notices
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Format labeling in accordance with § 201.66(c) and (d)
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Request for Drug Facts exemption or deferral
§ 201.66(e).
Total ...........................................................................
1 There
Total annual
disclosures
Average
burden per
disclosure
Total hours
20
3
60
12 .................
720
1
0.125
0.125
24 .................
3
........................
............................
........................
......................
723
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Dated:‘ July 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
titers on reporter cells, for multiple
strains of SIV based chimeric viruses
such that the results were not accurately
represented in:
• Figure 7 in JVI 2013
• Figures 6B and 8C in R01 AI114367–
01A1
• Figures 1, 2B, and 3B in R01
AI120787–01
• Figures 1A–D, 2D, 3D, 5A–C, 5I, 6C,
and S3D in the unpublished
manuscript
[FR Doc. 2015–18026 Filed 7–22–15; 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.
ACTION: Notice.
AGENCY:
Notice is hereby given that
the Office of Research Integrity (ORI)
has taken final action in the following
case:
Julia Bitzegeio, Ph.D., Aaron Diamond
AIDS Research Center: Based on the
Respondent’s admission, an assessment
conducted by the Aaron Diamond AIDS
Research Center (ADARC), and analysis
conducted by ORI in its oversight
review, ORI found that Dr. Julia
Bitzegeio, former Postdoctoral Fellow,
ADARC, engaged in research
misconduct in research supported by
National Institute of Allergy and
Infectious Diseases (NIAID), National
Institutes of Health (NIH), grants R01
AI078788, R21 AI093255, and R37
AI064003.
ORI found that Respondent engaged
in research misconduct by falsifying
and/or fabricating data that were
included in one (1) publication, two (2)
unfunded grant applications, and one
(1) unpublished manuscript:
Journal of Virology 87:3549–3560,
2013 (hereafter referred to as ‘‘JVI
2013’’).
• R01 AI114367–01A1
• R01 AI120787–01
• ‘‘A single amino acid in the CD4
binding site of HIV–1 Env is a key
determinant of species tropism.’’
Unpublished manuscript
Specifically, ORI found that:
1. Respondent falsified and/or
fabricated in vitro rates of viral
replication or infection in human and
macaque lymphocytes and infectious
SUMMARY:
mstockstill on DSK4VPTVN1PROD with NOTICES
No. of
disclosures per
respondent
No. of
respondents
Activity
VerDate Sep<11>2014
18:39 Jul 22, 2015
Jkt 235001
2. Respondent falsified and/or
fabricated in vitro binding data of SIV
based chimeric viruses to human or
macaque CD4 such that the results were
not accurately represented in:
• Figure 6 in R01 AI120787–01
• Figures 5D–F in the unpublished
manuscript
ADARC has submitted a request for
correction of JVI 2013.
Dr. Bitzegeio has entered into a
Voluntary Settlement Agreement and
has voluntarily agreed:
(1) That if within three (3) years from
the effective date of the Agreement,
Respondent receives or applies for U.S
Public Health Service (PHS) support,
Respondent agreed to have her research
supervised for a period of three (3) years
beginning on the date of her
employment in a position in which she
receives or applies for PHS support and
to notify her employer(s)/institution(s)
of the terms of this supervision;
Respondent agreed that prior to the
submission of an application for PHS
support for a research project on which
her participation is proposed and prior
to her participation in any capacity on
PHS-supported research, Respondent
shall ensure that a plan for supervision
of her duties is submitted to ORI for
approval; the supervision plan must be
designed to ensure the scientific
integrity of her research contribution;
Respondent agreed that she 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;
PO 00000
Frm 00080
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Sfmt 4703
(2) that if within three (3) years from
the effective date of the Agreement,
Respondent receives or applies for PHS
support, Respondent agreed that 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; and
(3) to exclude herself 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 June 23, 2015.
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. 2015–18088 Filed 7–22–15; 8:45 am]
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[Federal Register Volume 80, Number 141 (Thursday, July 23, 2015)]
[Notices]
[Page 43784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18088]
-----------------------------------------------------------------------
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:
Julia Bitzegeio, Ph.D., Aaron Diamond AIDS Research Center: Based
on the Respondent's admission, an assessment conducted by the Aaron
Diamond AIDS Research Center (ADARC), and analysis conducted by ORI in
its oversight review, ORI found that Dr. Julia Bitzegeio, former
Postdoctoral Fellow, ADARC, engaged in research misconduct in research
supported by National Institute of Allergy and Infectious Diseases
(NIAID), National Institutes of Health (NIH), grants R01 AI078788, R21
AI093255, and R37 AI064003.
ORI found that Respondent engaged in research misconduct by
falsifying and/or fabricating data that were included in one (1)
publication, two (2) unfunded grant applications, and one (1)
unpublished manuscript:
Journal of Virology 87:3549-3560, 2013 (hereafter referred to as
``JVI 2013'').
R01 AI114367-01A1
R01 AI120787-01
``A single amino acid in the CD4 binding site of HIV-1 Env is
a key determinant of species tropism.'' Unpublished manuscript
Specifically, ORI found that:
1. Respondent falsified and/or fabricated in vitro rates of viral
replication or infection in human and macaque lymphocytes and
infectious titers on reporter cells, for multiple strains of SIV based
chimeric viruses such that the results were not accurately represented
in:
Figure 7 in JVI 2013
Figures 6B and 8C in R01 AI114367-01A1
Figures 1, 2B, and 3B in R01 AI120787-01
Figures 1A-D, 2D, 3D, 5A-C, 5I, 6C, and S3D in the unpublished
manuscript
2. Respondent falsified and/or fabricated in vitro binding data of
SIV based chimeric viruses to human or macaque CD4 such that the
results were not accurately represented in:
Figure 6 in R01 AI120787-01
Figures 5D-F in the unpublished manuscript
ADARC has submitted a request for correction of JVI 2013.
Dr. Bitzegeio has entered into a Voluntary Settlement Agreement and
has voluntarily agreed:
(1) That if within three (3) years from the effective date of the
Agreement, Respondent receives or applies for U.S Public Health Service
(PHS) support, Respondent agreed to have her research supervised for a
period of three (3) years beginning on the date of her employment in a
position in which she receives or applies for PHS support and to notify
her employer(s)/institution(s) of the terms of this supervision;
Respondent agreed that prior to the submission of an application for
PHS support for a research project on which her participation is
proposed and prior to her participation in any capacity on PHS-
supported research, Respondent shall ensure that a plan for supervision
of her duties is submitted to ORI for approval; the supervision plan
must be designed to ensure the scientific integrity of her research
contribution; Respondent agreed that she 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 if within three (3) years from the effective date of the
Agreement, Respondent receives or applies for PHS support, Respondent
agreed that 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; and
(3) to exclude herself 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 June 23, 2015.
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. 2015-18088 Filed 7-22-15; 8:45 am]
BILLING CODE 4150-28-P
