Findings of Research Misconduct, 52479-52480 [2015-21421]

Download as PDF 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), VerDate Sep<11>2014 16:19 Aug 28, 2015 Jkt 235001 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 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 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: E:\FR\FM\31AUN1.SGM 31AUN1 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; VerDate Sep<11>2014 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 Frm 00041 Fmt 4703 Sfmt 4703 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 E:\FR\FM\31AUN1.SGM 31AUN1

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]


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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