Findings of Research Misconduct, 52479-52480 [2015-21421]
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Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Notices
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10401 Standards Related to
Reinsurance, Risk Corridors, and Risk
Adjustment
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party. In
compliance with the requirement of
section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, we have
submitted to the Office of Management
and Budget (OMB) the following
requirements for emergency review.
This is necessary to ensure compliance
with an initiative of the Administration.
We are requesting an emergency review
under 5 CFR 1320.13(a)(2)(i) because
public harm is reasonably likely to
result if the normal clearance
procedures are followed.
tkelley on DSK3SPTVN1PROD with NOTICES
Information Collection
1. Type of Information Collection
Request: Revision of a currently
approved information collection; Title
of Information Collection: Standards
Related to Reinsurance, Risk Corridors,
and Risk Adjustment; Use: Under
Section 1342 of the Patient Protection
and Affordable Care Act and
implementing regulation at 45 CFR part
153, issuers of qualified health plans
(QHPs) must participate in a risk
corridors program. A QHP issuer will
pay risk corridors charges or be eligible
to receive risk corridors payments or
based on the ratio of the issuer’s
allowable costs to the target amount. A
final rule (Standards Related to
Reinsurance, Risk Corridors and Risk
Adjustment) implementing the risk
corridors program was published on
March 23, 2012 (77 FR 17220), which
added part 153 to title 45 of the Code
of Federal Regulations. Final rules
(2014, 2015, and 2016 Payment Notices)
outlining the risk corridors benefit and
payment parameters for the 2014, 2015,
and 2016 benefit years were published
on March 11, 2013 (78 FR 15410),
March 11, 2014 (79 FR 13744), and
February 27, 2015 (80 FR 10750),
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16:19 Aug 28, 2015
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respectively. Additionally, on October
30, 2013, HHS published the Second
Final Program Integrity rule (78 FR
65076) to align the risk corridors
program with the requirements of the
single risk pool provision at 45 CFR
156.80. The risk corridors data
collection applies to QHP issuers the
individual and small group markets.
Each QHP issuer is required to submit
an annual report to CMS concerning the
issuer’s allowable costs, allowable
administrative costs, premium, and
proportion of market premium in QHPs.
Risk corridors premium information
that is specific to an issuer’s QHPs is
collected through a separate data
reporting form.
The risk corridors plan-level reporting
form, and instructions for completing
the form were published as part of the
information collection approved under
OMB control number 0938–1164. In
§§ 153.530 and 153.540 we set forth a
data validation process for risk corridors
data submissions. The information
collection burden associated with the
risk corridors data validation process is
accounted for in the ‘‘Supporting
Statement for Paperwork Reduction Act
Submissions: Standards Related to
Reinsurance, Risk Corridors, Risk
Adjustment, and Appeals’’ approved
under OMB control number 0938–1155.
Based on CMS’s identification of more
significant data discrepancies than
previously anticipated, we are
requesting an emergency revision to the
risk corridors data validation
information collection requirement. We
are requiring all companies with QHP
issuers to complete a checklist to attest
that their submission complied with
critical guidelines for risk corridors and
MLR data submission. For companies
with issuers whose reported claims or
premium amounts for risk corridors and
MLR differ from data collected for other
premium stabilization programs by a
greater magnitude than expected, CMS
is requiring that issuers quantify these
differences, and provide a written
explanation of the magnitude of the
discrepancy. We require these
descriptions to be approved by an
actuary. The MLR Risk Corridors
Submission Checklist and the Risk
Corridors Data Discrepancy Worksheet
will be submitted via web form at the
company level, such that a company
will submit one checklist and one
discrepancy worksheet that includes
information for all of its applicable
issuers. As a result of this new
requirement, we are updating our
annual burden hour estimates to reflect
the actual numbers of risk corridors
submissions received by QHP issuers
and the increased annual burden hours
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52479
associated with submitting additional
data validation information to CMS.
Form Number: CMS–10401 (OMB
control number: 0938–1155); Frequency:
Annual; Affected Public: Health
insurance companies that issued
qualified health plans; Number of
Respondents: 250; Total Annual
Responses: 250; Total Annual Hours:
2,040. (For policy questions regarding
this collection contact Jaya Ghildiyal at
301–492–5149).
We are requesting OMB review and
approval of this collection by September
4, 2015, with a 180-day approval period.
Written comments and
recommendations will be considered
from the public if received by the date
and address noted above.
Dated: August 26, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2015–21476 Filed 8–27–15; 4:15 pm]
BILLING CODE 4120–01–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:
Peter Littlefield, University of
California, San Francisco: Based on an
assessment conducted by the University
of California, San Francisco (UCSF), the
Respondent’s admission, and analysis
conducted by ORI, ORI and UCSF found
that Mr. Peter Littlefield, Graduate
Student on a leave of absence from the
Tetrad Graduate Program, UCSF,
engaged in research misconduct in
research supported by National Institute
of General Medical Sciences (NIGMS),
National Institutes of Health (NIH),
training grant T32 GM007810 and grant
R01 GM109176.
ORI found that the Respondent
engaged in research misconduct by
falsifying and/or fabricating data in the
following two (2) publications:
• Science Signaling 7:ra114, 2014
(hereafter referred to as ‘‘Paper 1’’)
• Chemistry & Biology 21:453–458,
2014 (hereafter referred to as ‘‘Paper
2’’)
ORI found that Respondent
knowingly falsified and/or fabricated
data and related text by altering the
SUMMARY:
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tkelley on DSK3SPTVN1PROD with NOTICES
52480
Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Notices
experimental data to support the
experimental hypothesis. Specifically:
1. ORI found falsified and/or
fabricated data in Paper 1 in:
a. Figure 5B by manipulation of the
HER3 protein concentrations in the
experiment to provide the desired
outcome
b. Figure 6C for the identification of the
kinase domain construct EGFR–
V924R by falsely claiming that both
EGFR and HER3 contained the kinase
domains and the full JM segments,
when the JM–HER3 construct
included cloning tags
c. Figure 6D by manually manipulating
the error bars to increase statistical
significance of the kinase assay
2. ORI found falsified and/or
fabricated data in Paper 2 in:
a. Figure 3C by manually altering some
of the data points by 10–20% support
the desired hypothesis
b. Figure 4A by manipulating data
points and reducing error bars and
failing to report that JM–HER3
construct had cloning tags
c. Figure 4B by reducing several data
points by ∼ 15%
Mr. Littlefield has entered into a
Voluntary Settlement Agreement and
has voluntarily agreed:
(1) To have his research supervised
for period of three (3) years beginning
on August 4, 2015; 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 will 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 for period of three (3) years
beginning on August 4, 2015, 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;
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16:19 Aug 28, 2015
Jkt 235001
(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 for period of three (3)
years beginning on August 4, 2015; and
(4) to retraction or correction of the
following papers:
• Science Signaling 7:ra114, 2014
• Chemistry & Biology 21:453–458,
2014
FOR FURTHER INFORMATION CONTACT:
Acting Director, Office of Research
Integrity, 1101 Wootton Parkway, Suite
750, Rockville, MD 20852, (240) 453–
8200.
Scientific Review Program; Division of
Extramural Activities, Room 3F52B; National
Institutes of Health/NIAID; 5601 Fishers
Lane, MSC 9823; Bethesda, MD 20892–9823;
(240) 669–5044; nv19q@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: August 26, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–21481 Filed 8–28–15; 8:45 am]
BILLING CODE 4140–01–P
Donald Wright,
Acting Director, Office of Research Integrity.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2015–21421 Filed 8–28–15; 8:45 am]
National Institutes of Health
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
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 meeting.
The meeting 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: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Investigator Initiated
Program Project Applications (P01).
Date: September 25 and 28, 2015.
Time: September 25, 2015, 12:30 p.m. to
4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health; Room
3F52B; 5601 Fishers Lane; Rockville, MD
20892; (Telephone Conference Call).
Time: September 28, 2015, 9:30 a.m. to
2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health; Room
3F52B; 5601 Fishers Lane; Rockville, MD
20892; (Telephone Conference Call).
Contact Person: Nancy VazquezMaldonado, Ph.D., Scientific Review Officer;
PO 00000
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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; PAR Panel:
Pregnancy in Women with Disabilities.
Date: September 21, 2015.
Time: 2:00 p.m. to 4:00 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: Delia Olufokunbi Sam,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158,
MSC 7770, Bethesda, MD 20892, 301–435–
0684, olufokunbisamd@csr.nih.gov.
Name of Committee: Emerging
Technologies and Training Neurosciences
Integrated Review Group, Bioengineering of
Neuroscience, Vision and Low Vision
Technologies Study Section.
Date: September 29, 2015.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: St. Gregory Luxury Hotel & Suites,
2033 M Street NW., Washington, DC 20036.
Contact Person: Robert C Elliott, Ph.D.,
Scientific Review Officer, Center for
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Agencies
[Federal Register Volume 80, Number 168 (Monday, August 31, 2015)]
[Notices]
[Pages 52479-52480]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21421]
-----------------------------------------------------------------------
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:
Peter Littlefield, University of California, San Francisco: Based
on an assessment conducted by the University of California, San
Francisco (UCSF), the Respondent's admission, and analysis conducted by
ORI, ORI and UCSF found that Mr. Peter Littlefield, Graduate Student on
a leave of absence from the Tetrad Graduate Program, UCSF, engaged in
research misconduct in research supported by National Institute of
General Medical Sciences (NIGMS), National Institutes of Health (NIH),
training grant T32 GM007810 and grant R01 GM109176.
ORI found that the Respondent engaged in research misconduct by
falsifying and/or fabricating data in the following two (2)
publications:
Science Signaling 7:ra114, 2014 (hereafter referred to as
``Paper 1'')
Chemistry & Biology 21:453-458, 2014 (hereafter referred to as
``Paper 2'')
ORI found that Respondent knowingly falsified and/or fabricated
data and related text by altering the
[[Page 52480]]
experimental data to support the experimental hypothesis. Specifically:
1. ORI found falsified and/or fabricated data in Paper 1 in:
a. Figure 5B by manipulation of the HER3 protein concentrations in the
experiment to provide the desired outcome
b. Figure 6C for the identification of the kinase domain construct
EGFR-V924R by falsely claiming that both EGFR and HER3 contained the
kinase domains and the full JM segments, when the JM-HER3 construct
included cloning tags
c. Figure 6D by manually manipulating the error bars to increase
statistical significance of the kinase assay
2. ORI found falsified and/or fabricated data in Paper 2 in:
a. Figure 3C by manually altering some of the data points by 10-20%
support the desired hypothesis
b. Figure 4A by manipulating data points and reducing error bars and
failing to report that JM-HER3 construct had cloning tags
c. Figure 4B by reducing several data points by ~ 15%
Mr. Littlefield has entered into a Voluntary Settlement Agreement
and has voluntarily agreed:
(1) To have his research supervised for period of three (3) years
beginning on August 4, 2015; 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 will 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 for period of three (3) years beginning on August 4, 2015,
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 for period of three (3) years beginning on August 4, 2015;
and
(4) to retraction or correction of the following papers:
Science Signaling 7:ra114, 2014
Chemistry & Biology 21:453-458, 2014
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. 2015-21421 Filed 8-28-15; 8:45 am]
BILLING CODE 4150-31-P