Findings of Research Misconduct, 28078-28079 [2017-12744]
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28078
Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices
• An indication of whether the
facility compounds from bulk drug
substances, and if so, whether it
compounds sterile or nonsterile drugs
from bulk drug substances.
Registration information should be
submitted to FDA electronically using
the Structured Product Labeling (SPL)
format and in accordance with section
IV of the FDA guidance entitled
‘‘Providing Regulatory Submissions in
Electronic Format—Drug Establishment
Registration and Drug Listing.’’ Under
the final guidance, outsourcing facilities
may request a waiver from the SPL
electronic submission process by
submitting a written request to FDA
explaining why the use of electronic
means is not reasonable.
This information collection supports
the Agency guidance discussed above.
We estimate that approximately 62
outsourcing facilities (‘‘number of
respondents’’ and ‘‘total annual
responses’’ in table 1, row 1) will
annually submit to FDA registration
information using the SPL format as
specified in the guidance, and that
preparing and submitting this
information will take approximately 4.5
hours per registrant (‘‘average burden
per response’’ in table 1, row 1). We
expect to receive no more than one
waiver request from the electronic
submission process annually (‘‘number
of respondents’’ and ‘‘total annual
responses’’ in table 1, row 2), and that
each request should take approximately
1 hour to prepare and submit to us
(‘‘average burden per response’’ in table
1, row 2).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Compounding
outsourcing
facility
Electronic Submission of Registration Information Using
SPL Format ......................................................................
Waiver Request From Electronic Submission of Registration Information .................................................................
Total ..............................................................................
1 There
[FR Doc. 2017–12838 Filed 6–19–17; 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:
Notice is hereby given that
the Office of Research Integrity (ORI)
has taken final action in the following
case:
Brandi M. Baughman, Ph.D., National
Institutes of Health (NIH): Based on
Respondent’s admission and analysis
conducted by ORI, ORI found that Dr.
Brandi M. Baughman, former Intramural
Research Training Awardee, National
Institute of Environmental and Health
Sciences (NIEHS), NIH, engaged in
research misconduct in research
supported by National Institute of
Diabetes and Digestive and Kidney
Diseases (NIDDK), NIH, grant R01
DK101645 and the NIEHS, NIH,
Postdoctoral Intramural Research
Training Award (IRTA).
ORI found that falsified and/or
fabricated data were included in eleven
SUMMARY:
sradovich on DSK3GMQ082PROD with NOTICES
Average
burden per
response
Total annual
responses
Total hours
62
1
62
4.5
279
1
1
1
1
1
........................
........................
........................
........................
280
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning
Legislation, and Analysis.
ACTION:
Number of
responses
per
respondent
Number of
respondents
VerDate Sep<11>2014
18:01 Jun 19, 2017
Jkt 241001
(11) figures in PLoS One
11(10):e0164378, 2016 (hereafter
referred to as ‘‘PLoS One 2016’’).
ORI found that Respondent falsified
and/or fabricated data and text
published in PLoS One 2016, in Figures
2, 3, 4, 5, 6, 8, S1, S2, S3, S4, and S5,
by claiming that a screening strategy of
the kinase focused libraries, PKIS and
5K, was performed, when original data
do not exist to support the claims.
Respondent also claimed that three (3)
inhibitory compounds for the inositol
phosphate kinase, PPIP5K, were
identified from the 5K library, when
these compounds, UNC10112646,
UNC10225354, and UNC10225498, were
not part of the data set for the 5K
library. Specifically, Respondent
falsified and/or fabricated the
characterization of the inhibitor
compounds in:
• Figures 2 and 3 results for Z’-factor,
%CV, signal:background ratio, and a 10point dose response titration experiment
for inhibitor UNC10225354
• claims in the text of PLoS One 2016
that eight molecules from the PKIS
library and fifteen molecules from the
5K library inhibited PPIP5K activity by
>50%
• Figure 4D results for the inhibition
by UNC10112646, UNC10225354, and
UNC10225498, in dose response assays
against the kinase domain of PPIP5K
• Figures 5A and 5B results for
isothermal titration calorimetry (ITC)
assays for quantifying intermolecular
PO 00000
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Fmt 4703
Sfmt 4703
interactions between PPIP5K and the
inhibitors, UNC1011264 and
UNC10225498, and Figure S5 for
UNC10225354
• Figure 6 results for the analysis of
the mechanisms of inhibition of PPIP5K
by UNC10112646 and UNC10225498
• Figures 8A and 8B results for high
performance liquid chromatography
(HPLC) analysis for the effects of
UNC10112646 or UNC10225498 on
PPIP5K activity and IP6K activity
• Figures S1–S4 for experimental
results further characterizing
UNC10112646, UNC10225498, and
other inhibitors, when the results were
not supported by the experimental
records.
As a result of Respondent’s
admission, NIH recommended that the
PLoS One 2016 paper be retracted.
Dr. Baughman has entered into a
Voluntary Settlement Agreement with
ORI, in which she voluntarily agreed:
(1) To have her research supervised
for a period of three (3) years beginning
on May 17, 2017; Respondent agreed to
ensure that prior to the submission of an
application for U.S. Public Health
Service (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
E:\FR\FM\20JNN1.SGM
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Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices
ensure the scientific integrity of
Respondent’s research contribution;
Respondent agreed that she will not
participate in any PHS-supported
research until a plan for supervision is
submitted to and approved by ORI;
Respondent agreed to maintain
responsibility for compliance with the
agreed upon supervision plan;
(2) that for a period of three (3) years
beginning on May 17, 2017, 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;
(3) 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 for
a period of three (3) years, beginning on
May 17, 2017; and
(4) as a condition of the Agreement,
to the retraction or correction of PLoS
One 11(10):e0164378d, 2016 (PMID:
27736936).
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. 2017–12744 Filed 6–19–17; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[CFDA Number: 93.085]
Office of Research Integrity; Awards
Unsolicited Proposal for the
Professionalism and Integrity in
Research Program
Office of Research Integrity,
Office of the Assistant Secretary for
Health, Department of Health and
Human Services.
ACTION: Notice of Award of a singlesource unsolicited grant to Washington
University in St. Louis, Missouri.
sradovich on DSK3GMQ082PROD with NOTICES
AGENCY:
Recipient: Washington University, St.
Louis, Missouri.
Purpose of the Award: Grant to
provide remediation training through
the Professionalism and Integrity in
Research Program (PI Program) to
VerDate Sep<11>2014
18:01 Jun 19, 2017
Jkt 241001
promote research integrity and prevent
research misconduct.
Amount of Award: $135,763 in
Federal Fiscal Year (FFY) 2017 funds
and estimated $135,665 in FFY 2018
funds subject to the enactment of
appropriations and availability of funds.
Project Period: July 1, 2017—June 30,
2019.
SUMMARY: The Office of Research
Integrity (ORI) announces the award of
a single-source, grant in response to an
unsolicited proposal from Washington
University, St. Louis, Missouri. The
proposal submitted was not solicited
either formally or informally by any
federal government official.
ORI performed an objective review of
the unsolicited proposal from
Washington University to expand and
evaluate the Professionalism and
Integrity in Research Program (PI
Program), the only remediation program
for researchers who violate expectations
for the responsible conduct of research.
Based on an external and internal
review of the proposal, ORI determined
that it has merit.
There is a strategic importance of
access to this type of training. Research
misconduct involving Public Health
Service (PHS) support is contrary to the
interests of PHS and the federal
government, the health and safety of the
public, the integrity of research, and the
conservation of public funds.
Participants in the PI Program will
demonstrate better research compliance
and integrity outcomes, such as
developing better, more ethical research
practices. These outcomes will promote
research integrity and help prevent
future research misconduct.
This award is being made noncompetitively because there is no
current, pending, or planned funding
opportunity announcement under
which this proposal could be competed.
ORI has identified three additional key
reasons to support rationale for
awarding this unsolicited proposal:
1. ORI’s federal regulation directs us
to focus on remediation of Respondents
who have been found to commit
research misconduct, and the PI
Program permits a pathway for that
remediation after any sanctions have
been completed.
2. Washington University is uniquely
positioned to provide this type of
training. As the only remediation
program for researchers, the grantee has
developed a comprehensive and
intensive program that will improve
research compliance and integrity
outcomes.
3. With this experience, Washington
University is well known in the research
community and is an important service
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28079
to PHS funded institutions. The
program has a robust and unique
process for assessment and data
analysis.
Legislative Authority: Sec. 301 of the
Public Health Service Act, 42 U.S.C. 241
FOR FURTHER INFORMATION CONTACT:
Kathryn Partin at kathryn.partin@
hhs.gov or by telephone at 240–453–
8200.
Dated: June 13, 2017.
Kathryn M. Partin,
Director of the Office of Research Integrity.
[FR Doc. 2017–12747 Filed 6–19–17; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR16–136:
Using the NIMH Research Domain Criteria
(RDoC) Approach to Understand Psychosis.
Date: July 5, 2017.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Julius Cinque, MS,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5186,
MSC 7846, Bethesda, MD 20892, (301) 435–
1252, cinquej@csr.nih.gov.
Name of Committee: AIDS and Related
Research Integrated Review Group;
Behavioral and Social Consequences of HIV/
AIDS Study Section.
Date: July 13–14, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Ritz-Carlton Hotel, 1700 Tysons
Boulevard, McLean, VA 22102.
Contact Person: Mark P Rubert, Ph.D.,
Scientific Review Officer, Center for
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]]>Agencies
[Federal Register Volume 82, Number 117 (Tuesday, June 20, 2017)]
[Notices]
[Pages 28078-28079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12744]
-----------------------------------------------------------------------
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:
Brandi M. Baughman, Ph.D., National Institutes of Health (NIH):
Based on Respondent's admission and analysis conducted by ORI, ORI
found that Dr. Brandi M. Baughman, former Intramural Research Training
Awardee, National Institute of Environmental and Health Sciences
(NIEHS), NIH, engaged in research misconduct in research supported by
National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK), NIH, grant R01 DK101645 and the NIEHS, NIH, Postdoctoral
Intramural Research Training Award (IRTA).
ORI found that falsified and/or fabricated data were included in
eleven (11) figures in PLoS One 11(10):e0164378, 2016 (hereafter
referred to as ``PLoS One 2016'').
ORI found that Respondent falsified and/or fabricated data and text
published in PLoS One 2016, in Figures 2, 3, 4, 5, 6, 8, S1, S2, S3,
S4, and S5, by claiming that a screening strategy of the kinase focused
libraries, PKIS and 5K, was performed, when original data do not exist
to support the claims. Respondent also claimed that three (3)
inhibitory compounds for the inositol phosphate kinase, PPIP5K, were
identified from the 5K library, when these compounds, UNC10112646,
UNC10225354, and UNC10225498, were not part of the data set for the 5K
library. Specifically, Respondent falsified and/or fabricated the
characterization of the inhibitor compounds in:
Figures 2 and 3 results for Z'-factor, %CV,
signal:background ratio, and a 10-point dose response titration
experiment for inhibitor UNC10225354
claims in the text of PLoS One 2016 that eight molecules
from the PKIS library and fifteen molecules from the 5K library
inhibited PPIP5K activity by >50%
Figure 4D results for the inhibition by UNC10112646,
UNC10225354, and UNC10225498, in dose response assays against the
kinase domain of PPIP5K
Figures 5A and 5B results for isothermal titration
calorimetry (ITC) assays for quantifying intermolecular interactions
between PPIP5K and the inhibitors, UNC1011264 and UNC10225498, and
Figure S5 for UNC10225354
Figure 6 results for the analysis of the mechanisms of
inhibition of PPIP5K by UNC10112646 and UNC10225498
Figures 8A and 8B results for high performance liquid
chromatography (HPLC) analysis for the effects of UNC10112646 or
UNC10225498 on PPIP5K activity and IP6K activity
Figures S1-S4 for experimental results further
characterizing UNC10112646, UNC10225498, and other inhibitors, when the
results were not supported by the experimental records.
As a result of Respondent's admission, NIH recommended that the
PLoS One 2016 paper be retracted.
Dr. Baughman has entered into a Voluntary Settlement Agreement with
ORI, in which she voluntarily agreed:
(1) To have her research supervised for a period of three (3) years
beginning on May 17, 2017; Respondent agreed to ensure that prior to
the submission of an application for U.S. Public Health Service (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
[[Page 28079]]
ensure the scientific integrity of Respondent's research contribution;
Respondent agreed that she will not participate in any PHS-supported
research until a plan for supervision is submitted to and approved by
ORI; Respondent agreed to maintain responsibility for compliance with
the agreed upon supervision plan;
(2) that for a period of three (3) years beginning on May 17, 2017,
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;
(3) 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 for a period of
three (3) years, beginning on May 17, 2017; and
(4) as a condition of the Agreement, to the retraction or
correction of PLoS One 11(10):e0164378d, 2016 (PMID: 27736936).
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. 2017-12744 Filed 6-19-17; 8:45 am]
BILLING CODE 4150-31-P
