Findings of Research Misconduct, 31334-31335 [2017-14075]
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Federal Register / Vol. 82, No. 128 / Thursday, July 6, 2017 / Notices
Collection of Qualitative Research and
Assessment.
OMB No.: 0990–0421.
Abstract: The Office of the Assistant
Secretary for Planning and Evaluation
(ASPE) is requesting an extension for
their generic clearance for purposes of
conducting qualitative research. ASPE
conducts qualitative research to gain a
better understanding of emerging health
and human services policy issues,
develop future intramural and
extramural research projects, and to
ensure HHS leadership, agencies and
offices have recent data and information
to inform program and policy decisionmaking. ASPE is requesting approval for
at least four types of qualitative research
which include, but are not limited to: (a)
Interviews, (b) focus groups, (c)
questionnaires, and (d) other qualitative
methods.
ASPE’s mission is to advise the
Secretary of the Department of Health
and Human Services on policy
development in health, disability,
human services, data, and science, and
provides advice and analysis on
economic policy. ASPE leads special
initiatives, coordinates the Department’s
evaluation, research and demonstration
activities, and manages crossDepartment planning activities such as
strategic planning, legislative planning,
and review of regulations. Integral to
this role, ASPE will use this mechanism
to conduct qualitative research,
evaluation, or assessment, conduct
analyses, and understand needs,
barriers, or facilitators for HHS-related
programs.
ASPE is requesting comment on the
burden for qualitative research aimed at
understanding emerging health and
human services policy issues. The goal
of developing these activities is to
identify emerging issues and research
gaps to ensure the successful
implementation of HHS programs. The
participants may include health and
human services experts; national, state,
and local health or human services
representatives; public health, human
services, or healthcare providers; and
representatives of other health or human
services organizations. The increase in
burden from 747 in 2014 to 1,500
respondents in 2017 reflects an increase
in the number of research projects
conducted over the estimate in 2014.
Need and Proposed Use of the
Information: The information collected
for qualitative policy research and
assessment will be used by ASPE to
develop future intramural and
extramural research projects and to
shape emerging health and human
services policy issues for HHS
leadership, agencies, and offices. The
end purpose is to obtain broad and
diverse perspectives on public health,
human service, and health care issues to
understand emerging issues, promising
practices by innovative programs or
organizations funded by HHS, or
examining health or human service
policy issues that have as yet gone
unanswered or need further
examination. Additionally, ASPE will
collect, analyze, and interpret
information gathered through this
generic clearance to identify strengths
and weaknesses of current programs,
policies, and services.
Likely Respondents: Respondents
have typically been stakeholders from
the health and human services fields
such as state health officers, human
service professionals, groups that
represent health or human services
interests or populations, individual
experts in the fields of health, human
services, science, data, or other relevant
professions, and other individuals and
groups relevant to the work conducted
by ASPE and HHS.
The total annual burden hours
estimated for this ICR are summarized
in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
Health or Human Services Stakeholder ..........................................................
2,000
1
1
2,000
Total ..........................................................................................................
2,000
1
1
2,000
Terry S. Clark,
Asst. Information Collection Clearance
Officer.
[FR Doc. 2017–14211 Filed 7–5–17; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
ACTION: Notice.
sradovich on DSK3GMQ082PROD with NOTICES
AGENCY:
Notice is hereby given that on June
22, 2017, the Department of Health and
Human Services (HHS) took final action
in the following case:
Frank Sauer, Ph.D., University of
California, Riverside: Based on evidence
and findings of an investigation
VerDate Sep<11>2014
18:13 Jul 05, 2017
Jkt 241001
conducted by the University of
California, Riverside (UCR), the Office
of Research Integrity’s (ORI’s) review of
UCR’s Research Misconduct
Investigation Report, the Report of
Investigation by the National Science
Foundation (NSF) Office of Inspector
General, additional evidence obtained
by ORI during its oversight review of
UCR’s investigation, and independent
analyses conducted as part of ORI’s
oversight review, ORI found that Dr.
Frank Sauer, former Associate Professor
of Biochemistry, UCR, committed
research misconduct in research
supported by the following National
Institute of General Medical Sciences
(NIGMS), National Institutes of Health
(NIH) grants:
• R01 GM073776
• R01 GM066204
Images that were falsified and/or
fabricated were presented in the
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
following publications and grant
applications.
• Gou, D., Rubalcava, M., Sauer, S.,
´
Mora-Bermudez, F., ErdjumentBromage, H., Tempst, P., Kremmer, E.,
& Sauer, F. ‘‘SETDB1 is involved in
postembryonic DNA methylation and
gene silencing in Drosophila.’’ PLoS
One 5(5):e10581, 2010 (hereafter
referred to as ‘‘PLoS One 2010’’).
• Sanchez-Elsner, T., Gou, D.,
Kremmer, E., & Sauer, F. ‘‘Noncoding
RNAs of trithorax response elements
recruit Drosophila Ash1 to
Ultrabithorax.’’ Science
311(5764):1118–1123, 2006 (hereafter
referred to as ‘‘Science 2006’’).
• Maile, T., Kwoczynski, S.,
Katzenberger, R.J., Wassarman, D.A., &
Sauer, F. ‘‘TAF1 activates transcription
by phosphorylation of serine 33 in
histone H2B.’’ Science 304(5673):1010–
E:\FR\FM\06JYN1.SGM
06JYN1
sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 128 / Thursday, July 6, 2017 / Notices
1014, 2004 (hereafter referred to as
‘‘Science 2004’’).
• National Institute on Drug Abuse
(NIDA), NIH, grant application R21
DA025703–01.
• National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK),
NIH, grant application R21 DK082631–
01.
• NIDDK, NIH, grant application R01
DK082675–01.
• NIGMS, NIH, grant application R01
GM073776–06A1.
• NIGMS, NIH, grant application R01
GM085229–01.
• NIGMS, NIH, grant application R01
GM085303–01.
• NIGMS, NIH, grant application R01
GM085303–01A1.
ORI found by a preponderance of the
evidence that the Respondent engaged
in research misconduct by intentionally,
knowingly, or recklessly falsifying and/
or fabricating images in seven (7)
submitted NIH grant application and
three (3) published papers by
manipulating, reusing, and falsely
labeling images. Specifically, the
Respondent falsified and/or fabricated
images representing controls or
experimental results for in vitro
interactions between RNA and proteins,
co-immunoprecipitation (‘‘co-IP’’)
assays, histone methytransferase
(‘‘HMT’’) or kinase assays and related
stained SDS–PAGE gels, and reverse
transcription-polymerase chain
reactions (‘‘RT–PCR’’) in the following
grant applications and publications.
1. The image in Figure S4, Science
2006, representing the in vitro
interactions between RNA and specific
proteins, was used in similar assays to
represent results with other sets of
protein-RNA interactions in Figure 9,
R21 DA025703–01, Figure 9, R21
DK082631–01, and Figure 9, R01
DK082675–01, and again in R01
GM085229–01, Figure 11C.
2. The image in Figure 1A, R01
GM085303–01, representing a co-IP
assay from the Drosophila cell line S2,
was manipulated and used in Figure 1B
of the same grant application to
represent a different co-IP assay from
Drosophila embryonic extracts.
3. The image in Figure 8A, R01
GM085303–01A1, representing an SDS–
PAGE gel for an in vitro HMT assay, was
used previously in Figure 1d in a
manuscript submitted to Nature in 2005
to represent an SDS–PAGE gel from an
unrelated experiment for an
ubiquitination assay.
4. The image in Figure 1E, R01
GM085303–01 and Figure 1D, R01
GM085303–01A1, representing stained
SDS–PAGE for an HMT assay, was used
in Figure 1b, Nature 419(6909):857–862,
VerDate Sep<11>2014
18:13 Jul 05, 2017
Jkt 241001
2002, to represent an HMT assay with
different experimental conditions, and
also was used in Figure 1B, Science
2004, to represent stained PAGE for an
in vitro kinase assay.
5. The image in Figure 1C, R01
GM085303–01 and Figure 1B, R01
GM085303–01A1, representing an HMT
assay, was manipulated and used to
represent an HMT assay with different
experimental conditions in Figure 1E,
R01 GM085303–01 and Figure 1D, R01
GM085303–01A1, and also was used to
represent another unrelated HMT assay
in Figure 2 (right panel) in R01
GM085303–01.
6. The image in Figure 2 (right panel)
in R01 GM085303–01 representing an
HMT assay was used in Figure 1B, PLoS
One 2010 to represent an HMT assay
with different experimental conditions.
7. The image in Figure 6B, R21
DA025703–01, Figure 11B, R01
GM085229–01, Figure 6B, R01
DK082675–01, and Figure 6B, R21
DK082631–01, all representing RT–PCR
experiments for transcribed ncRNAs,
was used in Figure 13, R21 DK082631–
01 and Figure 13, R21 DA025703–01 to
represent RT–PCR experiments for
transcription for different ncRNAs.
8. The image in Figure 10C (right half)
in R01 GM073776–06A1, representing
transcription of endodermal genes from
embroid bodies, was manipulated and
used in Figure 10C (left half) in the
same grant application to represent the
transcription of mesodermal and
ectodermal genes.
Science 311(5764):1118–1123, 2006
was retracted in: Science 344(6187):981,
2014. Science 304(5673):1010–1014,
2004 was retracted in: Science
344(6187):981, 2014. Nature
419(6909):857–862, 2002 was retracted
in Nature 521(7550):110, 2015.
ORI issued a charge letter
enumerating the above findings of
research misconduct and proposing
HHS administrative actions. Dr. Sauer
subsequently requested a hearing before
an Administrative Law Judge (ALJ) of
the Departmental Appeals Board to
dispute these findings. The parties filed
cross-motions for summary judgment.
On May 22, 2017, the ALJ recommended
to the Assistant Secretary for Health that
summary judgment be granted in favor
of ORI. On June 22, 2017, the ALJ’s
recommended decision became the final
agency decision. Thus, the research
misconduct findings set forth above
became effective, and the following
administrative actions have been
implemented, beginning on June 22,
2017:
(1) Dr. Sauer is prohibited from
serving in any advisory capacity to PHS
including, but not limited to, service on
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
31335
any PHS advisory committee, board,
and/or peer review committee, or as a
consultant, through July 27, 2020, the
end date of his government-wide
debarment, which was imposed by NSF;
and
(2) ORI will send a notice to PLoS
requesting retraction or correction of
PLoS One 5(5):e10581, 2010 (PMID:
20498723) in accordance with 42 CFR
93.411(b).
FOR FURTHER INFORMATION CONTACT:
Director, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8200.
Kathryn M. Partin,
Director, Office of Research Integrity.
[FR Doc. 2017–14075 Filed 7–5–17; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
HHS Approval of Entities That Certify
Medical Review Officers
Substance Abuse and Mental
Health Services Administration,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
The current version of the
Department of Health and Human
Services (HHS) Mandatory Guidelines
for Federal Workplace Drug Testing
Programs (Mandatory Guidelines),
effective on October 1, 2010, addresses
the role and qualifications of Medical
Review Officers (MROs) and HHS
approval of entities that certify MROs.
As required under Section 13.1(b) of the
Mandatory Guidelines, this notice
publishes a list of HHS approved MRO
certification entities.
FOR FURTHER INFORMATION CONTACT:
Sean J. Belouin, Pharm.D., CAPT,
United States Public Health Service,
Senior Pharmacology and Regulatory
Policy Advisor, Substance Abuse and
Mental Health Services Administration,
5600 Fishers Lane, Room 16N06D,
Rockville, Maryland 20857; Telephone:
(240) 276–2716; Email: sean.belouin@
samhsa.hhs.gov.
SUPPLEMENTARY INFORMATION: Subpart
M-Medical Review Officer (MRO),
Section 13.1(b) of the Mandatory
Guidelines, ‘‘Who may serve as an
MRO?’’ states as follows: ‘‘Nationally
recognized entities that certify MROs or
subspecialty boards for physicians
performing a review of Federal
employee drug testing results that seek
approval by the Secretary must submit
their qualifications and a sample
examination. Based on an annual
SUMMARY:
E:\FR\FM\06JYN1.SGM
06JYN1
Agencies
[Federal Register Volume 82, Number 128 (Thursday, July 6, 2017)]
[Notices]
[Pages 31334-31335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14075]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
Notice is hereby given that on June 22, 2017, the Department of
Health and Human Services (HHS) took final action in the following
case:
Frank Sauer, Ph.D., University of California, Riverside: Based on
evidence and findings of an investigation conducted by the University
of California, Riverside (UCR), the Office of Research Integrity's
(ORI's) review of UCR's Research Misconduct Investigation Report, the
Report of Investigation by the National Science Foundation (NSF) Office
of Inspector General, additional evidence obtained by ORI during its
oversight review of UCR's investigation, and independent analyses
conducted as part of ORI's oversight review, ORI found that Dr. Frank
Sauer, former Associate Professor of Biochemistry, UCR, committed
research misconduct in research supported by the following National
Institute of General Medical Sciences (NIGMS), National Institutes of
Health (NIH) grants:
R01 GM073776
R01 GM066204
Images that were falsified and/or fabricated were presented in the
following publications and grant applications.
Gou, D., Rubalcava, M., Sauer, S., Mora-Berm[uacute]dez,
F., Erdjument-Bromage, H., Tempst, P., Kremmer, E., & Sauer, F.
``SETDB1 is involved in postembryonic DNA methylation and gene
silencing in Drosophila.'' PLoS One 5(5):e10581, 2010 (hereafter
referred to as ``PLoS One 2010'').
Sanchez-Elsner, T., Gou, D., Kremmer, E., & Sauer, F.
``Noncoding RNAs of trithorax response elements recruit Drosophila Ash1
to Ultrabithorax.'' Science 311(5764):1118-1123, 2006 (hereafter
referred to as ``Science 2006'').
Maile, T., Kwoczynski, S., Katzenberger, R.J., Wassarman,
D.A., & Sauer, F. ``TAF1 activates transcription by phosphorylation of
serine 33 in histone H2B.'' Science 304(5673):1010-
[[Page 31335]]
1014, 2004 (hereafter referred to as ``Science 2004'').
National Institute on Drug Abuse (NIDA), NIH, grant
application R21 DA025703-01.
National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK), NIH, grant application R21 DK082631-01.
NIDDK, NIH, grant application R01 DK082675-01.
NIGMS, NIH, grant application R01 GM073776-06A1.
NIGMS, NIH, grant application R01 GM085229-01.
NIGMS, NIH, grant application R01 GM085303-01.
NIGMS, NIH, grant application R01 GM085303-01A1.
ORI found by a preponderance of the evidence that the Respondent
engaged in research misconduct by intentionally, knowingly, or
recklessly falsifying and/or fabricating images in seven (7) submitted
NIH grant application and three (3) published papers by manipulating,
reusing, and falsely labeling images. Specifically, the Respondent
falsified and/or fabricated images representing controls or
experimental results for in vitro interactions between RNA and
proteins, co-immunoprecipitation (``co-IP'') assays, histone
methytransferase (``HMT'') or kinase assays and related stained SDS-
PAGE gels, and reverse transcription-polymerase chain reactions (``RT-
PCR'') in the following grant applications and publications.
1. The image in Figure S4, Science 2006, representing the in vitro
interactions between RNA and specific proteins, was used in similar
assays to represent results with other sets of protein-RNA interactions
in Figure 9, R21 DA025703-01, Figure 9, R21 DK082631-01, and Figure 9,
R01 DK082675-01, and again in R01 GM085229-01, Figure 11C.
2. The image in Figure 1A, R01 GM085303-01, representing a co-IP
assay from the Drosophila cell line S2, was manipulated and used in
Figure 1B of the same grant application to represent a different co-IP
assay from Drosophila embryonic extracts.
3. The image in Figure 8A, R01 GM085303-01A1, representing an SDS-
PAGE gel for an in vitro HMT assay, was used previously in Figure 1d in
a manuscript submitted to Nature in 2005 to represent an SDS-PAGE gel
from an unrelated experiment for an ubiquitination assay.
4. The image in Figure 1E, R01 GM085303-01 and Figure 1D, R01
GM085303-01A1, representing stained SDS-PAGE for an HMT assay, was used
in Figure 1b, Nature 419(6909):857-862, 2002, to represent an HMT assay
with different experimental conditions, and also was used in Figure 1B,
Science 2004, to represent stained PAGE for an in vitro kinase assay.
5. The image in Figure 1C, R01 GM085303-01 and Figure 1B, R01
GM085303-01A1, representing an HMT assay, was manipulated and used to
represent an HMT assay with different experimental conditions in Figure
1E, R01 GM085303-01 and Figure 1D, R01 GM085303-01A1, and also was used
to represent another unrelated HMT assay in Figure 2 (right panel) in
R01 GM085303-01.
6. The image in Figure 2 (right panel) in R01 GM085303-01
representing an HMT assay was used in Figure 1B, PLoS One 2010 to
represent an HMT assay with different experimental conditions.
7. The image in Figure 6B, R21 DA025703-01, Figure 11B, R01
GM085229-01, Figure 6B, R01 DK082675-01, and Figure 6B, R21 DK082631-
01, all representing RT-PCR experiments for transcribed ncRNAs, was
used in Figure 13, R21 DK082631-01 and Figure 13, R21 DA025703-01 to
represent RT-PCR experiments for transcription for different ncRNAs.
8. The image in Figure 10C (right half) in R01 GM073776-06A1,
representing transcription of endodermal genes from embroid bodies, was
manipulated and used in Figure 10C (left half) in the same grant
application to represent the transcription of mesodermal and ectodermal
genes.
Science 311(5764):1118-1123, 2006 was retracted in: Science
344(6187):981, 2014. Science 304(5673):1010-1014, 2004 was retracted
in: Science 344(6187):981, 2014. Nature 419(6909):857-862, 2002 was
retracted in Nature 521(7550):110, 2015.
ORI issued a charge letter enumerating the above findings of
research misconduct and proposing HHS administrative actions. Dr. Sauer
subsequently requested a hearing before an Administrative Law Judge
(ALJ) of the Departmental Appeals Board to dispute these findings. The
parties filed cross-motions for summary judgment. On May 22, 2017, the
ALJ recommended to the Assistant Secretary for Health that summary
judgment be granted in favor of ORI. On June 22, 2017, the ALJ's
recommended decision became the final agency decision. Thus, the
research misconduct findings set forth above became effective, and the
following administrative actions have been implemented, beginning on
June 22, 2017:
(1) Dr. Sauer is prohibited 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,
through July 27, 2020, the end date of his government-wide debarment,
which was imposed by NSF; and
(2) ORI will send a notice to PLoS requesting retraction or
correction of PLoS One 5(5):e10581, 2010 (PMID: 20498723) in accordance
with 42 CFR 93.411(b).
FOR FURTHER INFORMATION CONTACT: Director, Office of Research
Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240)
453-8200.
Kathryn M. Partin,
Director, Office of Research Integrity.
[FR Doc. 2017-14075 Filed 7-5-17; 8:45 am]
BILLING CODE 4150-31-P