80 FR 52479 - Findings of Research Misconduct

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

Federal Register Volume 80, Issue 168 (August 31, 2015)

Page Range		52479-52480
FR Document		2015-21421

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:

Federal Register, Volume 80 Issue 168 (Monday, August 31, 2015)

[Federal Register Volume 80, Number 168 (Monday, August 31, 2015)]
[Notices]
[Pages 52479-52480]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-21421]


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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.

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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

Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Notices 52479

Contents respectively. Additionally, on October associated with submitting additional
This notice sets out a summary of the 30, 2013, HHS published the Second data validation information to CMS.
use and burden associated with the Final Program Integrity rule (78 FR Form Number: CMS–10401 (OMB
following information collections. More 65076) to align the risk corridors control number: 0938–1155); Frequency:
detailed information can be found in program with the requirements of the Annual; Affected Public: Health
single risk pool provision at 45 CFR insurance companies that issued
each collection’s supporting statement
156.80. The risk corridors data qualified health plans; Number of
and associated materials (see
collection applies to QHP issuers the Respondents: 250; Total Annual
ADDRESSES).
individual and small group markets. Responses: 250; Total Annual Hours:
CMS–10401 Standards Related to Each QHP issuer is required to submit 2,040. (For policy questions regarding
Reinsurance, Risk Corridors, and Risk an annual report to CMS concerning the this collection contact Jaya Ghildiyal at
Adjustment issuer’s allowable costs, allowable 301–492–5149).
Under the PRA (44 U.S.C. 3501– administrative costs, premium, and We are requesting OMB review and
3520), federal agencies must obtain proportion of market premium in QHPs. approval of this collection by September
approval from the Office of Management Risk corridors premium information 4, 2015, with a 180-day approval period.
that is specific to an issuer’s QHPs is Written comments and
and Budget (OMB) for each collection of
collected through a separate data recommendations will be considered
information they conduct or sponsor.
reporting form. from the public if received by the date
The term ‘‘collection of information’’ is The risk corridors plan-level reporting
defined in 44 U.S.C. 3502(3) and 5 CFR and address noted above.
form, and instructions for completing
1320.3(c) and includes agency requests Dated: August 26, 2015.
the form were published as part of the
or requirements that members of the information collection approved under William N. Parham, III,
public submit reports, keep records, or OMB control number 0938–1164. In Director, Paperwork Reduction Staff, Office
provide information to a third party. In §§ 153.530 and 153.540 we set forth a of Strategic Operations and Regulatory
compliance with the requirement of Affairs.
data validation process for risk corridors
section 3506(c)(2)(A) of the Paperwork data submissions. The information [FR Doc. 2015–21476 Filed 8–27–15; 4:15 pm]
Reduction Act of 1995, we have collection burden associated with the BILLING CODE 4120–01–P
submitted to the Office of Management risk corridors data validation process is
and Budget (OMB) the following accounted for in the ‘‘Supporting
requirements for emergency review. Statement for Paperwork Reduction Act DEPARTMENT OF HEALTH AND
This is necessary to ensure compliance Submissions: Standards Related to HUMAN SERVICES
with an initiative of the Administration. Reinsurance, Risk Corridors, Risk
We are requesting an emergency review Office of the Secretary
Adjustment, and Appeals’’ approved
under 5 CFR 1320.13(a)(2)(i) because under OMB control number 0938–1155.
public harm is reasonably likely to Findings of Research Misconduct
Based on CMS’s identification of more
result if the normal clearance significant data discrepancies than AGENCY: Office of the Secretary, HHS.
procedures are followed. previously anticipated, we are ACTION: Notice.
Information Collection requesting an emergency revision to the
risk corridors data validation SUMMARY: Notice is hereby given that
1. Type of Information Collection information collection requirement. We the Office of Research Integrity (ORI)
Request: Revision of a currently are requiring all companies with QHP has taken final action in the following
approved information collection; Title issuers to complete a checklist to attest case:
of Information Collection: Standards that their submission complied with Peter Littlefield, University of
Related to Reinsurance, Risk Corridors, critical guidelines for risk corridors and California, San Francisco: Based on an
and Risk Adjustment; Use: Under MLR data submission. For companies assessment conducted by the University
Section 1342 of the Patient Protection with issuers whose reported claims or of California, San Francisco (UCSF), the
and Affordable Care Act and premium amounts for risk corridors and Respondent’s admission, and analysis
implementing regulation at 45 CFR part MLR differ from data collected for other conducted by ORI, ORI and UCSF found
153, issuers of qualified health plans premium stabilization programs by a that Mr. Peter Littlefield, Graduate
(QHPs) must participate in a risk greater magnitude than expected, CMS Student on a leave of absence from the
corridors program. A QHP issuer will is requiring that issuers quantify these Tetrad Graduate Program, UCSF,
pay risk corridors charges or be eligible differences, and provide a written engaged in research misconduct in
to receive risk corridors payments or explanation of the magnitude of the research supported by National Institute
based on the ratio of the issuer’s discrepancy. We require these of General Medical Sciences (NIGMS),
allowable costs to the target amount. A descriptions to be approved by an National Institutes of Health (NIH),
final rule (Standards Related to actuary. The MLR Risk Corridors training grant T32 GM007810 and grant
Reinsurance, Risk Corridors and Risk Submission Checklist and the Risk R01 GM109176.
Adjustment) implementing the risk Corridors Data Discrepancy Worksheet ORI found that the Respondent
corridors program was published on will be submitted via web form at the engaged in research misconduct by
March 23, 2012 (77 FR 17220), which company level, such that a company falsifying and/or fabricating data in the
added part 153 to title 45 of the Code will submit one checklist and one following two (2) publications:
of Federal Regulations. Final rules discrepancy worksheet that includes • Science Signaling 7:ra114, 2014
tkelley on DSK3SPTVN1PROD with NOTICES

(2014, 2015, and 2016 Payment Notices) information for all of its applicable (hereafter referred to as ‘‘Paper 1’’)
outlining the risk corridors benefit and issuers. As a result of this new • Chemistry & Biology 21:453–458,
payment parameters for the 2014, 2015, requirement, we are updating our 2014 (hereafter referred to as ‘‘Paper
and 2016 benefit years were published annual burden hour estimates to reflect 2’’)
on March 11, 2013 (78 FR 15410), the actual numbers of risk corridors ORI found that Respondent
March 11, 2014 (79 FR 13744), and submissions received by QHP issuers knowingly falsified and/or fabricated
February 27, 2015 (80 FR 10750), and the increased annual burden hours data and related text by altering the

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52480 Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Notices

experimental data to support the (3) to exclude himself voluntarily Scientific Review Program; Division of
experimental hypothesis. Specifically: from serving in any advisory capacity to Extramural Activities, Room 3F52B; National
1. ORI found falsified and/or PHS including, but not limited to, Institutes of Health/NIAID; 5601 Fishers
Lane, MSC 9823; Bethesda, MD 20892–9823;
fabricated data in Paper 1 in: service on any PHS advisory committee,
(240) 669–5044; nv19q@nih.gov.
a. Figure 5B by manipulation of the board, and/or peer review committee, or
(Catalogue of Federal Domestic Assistance
HER3 protein concentrations in the as a consultant for period of three (3) Program Nos. 93.855, Allergy, Immunology,
experiment to provide the desired years beginning on August 4, 2015; and and Transplantation Research; 93.856,
outcome (4) to retraction or correction of the Microbiology and Infectious Diseases
b. Figure 6C for the identification of the following papers: Research, National Institutes of Health, HHS)
kinase domain construct EGFR– • Science Signaling 7:ra114, 2014 Dated: August 26, 2015.
V924R by falsely claiming that both • Chemistry & Biology 21:453–458,
David Clary,
EGFR and HER3 contained the kinase 2014
Program Analyst, Office of Federal Advisory
domains and the full JM segments, FOR FURTHER INFORMATION CONTACT: Committee Policy.
when the JM–HER3 construct Acting Director, Office of Research [FR Doc. 2015–21481 Filed 8–28–15; 8:45 am]
included cloning tags Integrity, 1101 Wootton Parkway, Suite BILLING CODE 4140–01–P
c. Figure 6D by manually manipulating 750, Rockville, MD 20852, (240) 453–
the error bars to increase statistical 8200.
significance of the kinase assay Donald Wright, DEPARTMENT OF HEALTH AND
2. ORI found falsified and/or Acting Director, Office of Research Integrity. HUMAN SERVICES
fabricated data in Paper 2 in: [FR Doc. 2015–21421 Filed 8–28–15; 8:45 am] National Institutes of Health
a. Figure 3C by manually altering some BILLING CODE 4150–31–P
of the data points by 10–20% support Center for Scientific Review; Notice of
the desired hypothesis Closed Meetings
b. Figure 4A by manipulating data DEPARTMENT OF HEALTH AND
points and reducing error bars and HUMAN SERVICES Pursuant to section 10(d) of the
failing to report that JM–HER3 Federal Advisory Committee Act, as
construct had cloning tags National Institutes of Health amended (5 U.S.C. App.), notice is
c. Figure 4B by reducing several data hereby given of the following meetings.
points by ∼ 15% National Institute of Allergy and The meetings will be closed to the
Infectious Diseases; Notice of Closed public in accordance with the
Mr. Littlefield has entered into a Meeting provisions set forth in sections
Voluntary Settlement Agreement and 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
has voluntarily agreed: Pursuant to section 10(d) of the
as amended. The grant applications and
(1) To have his research supervised Federal Advisory Committee Act, as
the discussions could disclose
for period of three (3) years beginning amended (5 U.S.C. App.), notice is
confidential trade secrets or commercial
on August 4, 2015; Respondent agreed hereby given of the following meeting.
The meeting will be closed to the property such as patentable material,
that prior to the submission of an and personal information concerning
application for U.S. Public Health public in accordance with the
provisions set forth in sections individuals associated with the grant
Service (PHS) support for a research applications, the disclosure of which
project on which his participation is 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and would constitute a clearly unwarranted
proposed and prior to his participation invasion of personal privacy.
in any capacity on PHS-supported the discussions could disclose
research, Respondent shall ensure that a confidential trade secrets or commercial Name of Committee: Center for Scientific
property such as patentable material, Review Special Emphasis Panel; PAR Panel:
plan for supervision of his duties is Pregnancy in Women with Disabilities.
submitted to ORI for approval; the and personal information concerning
individuals associated with the grant Date: September 21, 2015.
supervision plan must be designed to Time: 2:00 p.m. to 4:00 p.m.
ensure the scientific integrity of his applications, the disclosure of which Agenda: To review and evaluate grant
research contribution; Respondent would constitute a clearly unwarranted applications.
agreed that he will not participate in invasion of personal privacy. Place: National Institutes of Health, 6701
any PHS-supported research until such Name of Committee: National Institute of Rockledge Drive, Bethesda, MD 20892
a supervision plan is submitted to and Allergy and Infectious Diseases Special (Telephone Conference Call).
approved by ORI; Respondent agreed to Emphasis Panel; NIAID Investigator Initiated Contact Person: Delia Olufokunbi Sam,
Program Project Applications (P01). Ph.D., Scientific Review Officer, Center for
maintain responsibility for compliance Scientific Review, National Institutes of
with the agreed upon supervision plan; Date: September 25 and 28, 2015.
Time: September 25, 2015, 12:30 p.m. to Health, 6701 Rockledge Drive, Room 3158,
(2) that for period of three (3) years 4:30 p.m. MSC 7770, Bethesda, MD 20892, 301–435–
beginning on August 4, 2015, any Agenda: To review and evaluate grant 0684, olufokunbisamd@csr.nih.gov.
institution employing him shall submit applications. Name of Committee: Emerging
in conjunction with each application for Place: National Institutes of Health; Room Technologies and Training Neurosciences
PHS funds, or report, manuscript, or 3F52B; 5601 Fishers Lane; Rockville, MD Integrated Review Group, Bioengineering of
abstract involving PHS-supported 20892; (Telephone Conference Call). Neuroscience, Vision and Low Vision
research in which Respondent is Time: September 28, 2015, 9:30 a.m. to Technologies Study Section.
2:00 p.m. Date: September 29, 2015.
tkelley on DSK3SPTVN1PROD with NOTICES

involved, a certification to ORI that the
data provided by Respondent are based Agenda: To review and evaluate grant Time: 8:00 a.m. to 6:00 p.m.
applications. Agenda: To review and evaluate grant
on actual experiments or are otherwise Place: National Institutes of Health; Room applications.
legitimately derived, and that the data, 3F52B; 5601 Fishers Lane; Rockville, MD Place: St. Gregory Luxury Hotel & Suites,
procedures, and methodology are 20892; (Telephone Conference Call). 2033 M Street NW., Washington, DC 20036.
accurately reported in the application, Contact Person: Nancy Vazquez- Contact Person: Robert C Elliott, Ph.D.,
report, manuscript, or abstract; Maldonado, Ph.D., Scientific Review Officer; Scientific Review Officer, Center for

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Document Created: 2018-02-23 11:04:17
Document Modified: 2018-02-23 11:04:17

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		Acting Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453-8200.
FR Citation		80 FR 52479

80 FR 52479 - Findings of Research Misconduct

DEPARTMENT OF HEALTH AND HUMAN SERVICESOffice of the Secretary

Federal Register Volume 80, Issue 168 (August 31, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary