80 FR 45661 - Findings of Research Misconduct
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 80, Issue 147 (July 31, 2015)
Office of the Secretary
Federal Register Volume 80, Issue 147 (July 31, 2015)
| Page Range | 45661-45662 | |
| FR Document | 2015-18794 |
[Federal Register Volume 80, Number 147 (Friday, July 31, 2015)] [Notices] [Pages 45661-45662] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-18794] ----------------------------------------------------------------------- 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: David Anderson, University of Oregon, Eugene: Based on an assessment conducted by the University of Oregon, Eugene (UOE), the Respondent's admission, and analysis conducted by ORI, ORI and UOE found that Mr. David Anderson, Graduate Student, UOE, engaged in research misconduct in research supported by National Institute of Mental Health (NIMH), National Institutes of Health (NIH), grants R01 MH087214, R01 MH077105, and TA MH020002. ORI found that Respondent engaged in research misconduct by falsifying and/or fabricating data in the following four (4) publications:Journal of Neuroscience 31(3):1128-38, 2011 (hereafter referred to as ``Paper 1''). Journal of Experimental Psychology: Human Perception and Performance [[Page 45662]] 39(3):824-835, 2012 (hereafter referred to as ``Paper 2''). Attention, Perception and Psychophysics 74(5):891-910, 2012 (hereafter referred to as ``Paper 3''). Psychological Science 24(6):929-38, 2013 (hereafter referred to as ``Paper 4''). ORI found that Respondent knowingly falsified data by removing outlier values or replacing outliers with mean values to produce results that conform to predictions. Specifically, these falsifications appear in: 1. Figures 4 and 8 in Paper 1. 2. Figures 3C, 3D, and 3E in Paper 2. 3. Figures 3B, 7C, 7D, and 8B in Paper 3. 4. Figures 3E and 3F in Paper 4. Mr. Anderson has entered into a Voluntary Settlement Agreement and has voluntarily agreed for a period of three (3) years, beginning on June 23, 2015: (1) To have his research supervised; 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 shall 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 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; and (4) to assist UOE in advising publishers of the need to retract or correct the following papers: Journal of Neuroscience 31(3):1128-38, 2011. Journal of Experimental Psychology: Human Perception and Performance 39(3):824-835, 2012. Attention, Perception and Psychophysics 74(5):891-910, 2012. Psychological Science 24(6):929-38, 2013. 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. 2015-18794 Filed 7-30-15; 8:45 am] BILLING CODE 4150-31-P
![Federal Register / Vol. 80, No. 147 / Friday, July 31, 2015 / Notices 45661
IV. Paperwork Reduction Act of 1995 Register of August 27, 2014 (79 FR comment. FDA is reopening the period
This guidance refers to previously 51183). In that notice, FDA requested for public comment so that the public
approved collections of information comments on the 10 originally-filed has the opportunity to review and
found in FDA regulations. These MRTPAs that are posted on http:// comment on these amendments.
collections of information are subject to www.regulations.gov and FDA’s Web
II. Comments
review by the Office of Management and site. The comment period on these
originally-filed applications closed on Interested persons may submit either
Budget (OMB) under the Paperwork
February 23, 2015. FDA is reopening the electronic comments regarding this
Reduction Act of 1995 (44 U.S.C. 3501–
comment period to seek comment document to http://www.regulations.gov
3520). The collections of information in
specifically on amendments made to the or written comments to the Division of
21 CFR part 514 have been approved
originally-filed MRTPAs submitted by Dockets Management (see ADDRESSES). It
under OMB control number 0910–0032.
Swedish Match North America Inc. is only necessary to send one set of
V. Comments DATES: Submit either electronic or comments. Identify comments with the
Interested persons may submit either written comments on the amendments docket number found in brackets in the
electronic comments regarding this by August 31, 2015. heading of this document. Received
document to http://www.regulations.gov ADDRESSES: Submit electronic comments may be seen in the Division
or written comments to the Division of comments to http:// of Dockets Management between 9 a.m.
Dockets Management (see ADDRESSES). It www.regulations.gov. Submit written and 4 p.m., Monday through Friday, and
is only necessary to send one set of comments to the Division of Dockets will be posted to the docket at http://
comments. Identify comments with the Management (HFA–305), Food and Drug www.regulations.gov.
docket number found in brackets in the Administration, 5630 Fishers Lane, Rm. Persons with access to the Internet
heading of this document. Received 1061, Rockville, MD 20852. Identify may obtain the document at either
comments may be seen in the Division comments with Docket Number FDA– http://www.accessdata.fda.gov/Static/
of Dockets Management between 9 a.m. 2014–N–1051. widgets/tobacco/SMNA_MRTPA_FDA-
and 4 p.m., Monday through Friday, and FOR FURTHER INFORMATION CONTACT:
2014-N-1051.html or http://
will be posted to the docket at http:// Center for Tobacco Products, Food and www.regulations.gov.
www.regulations.gov. Drug Administration, 10903 New Dated: July 27, 2015.
Hampshire Ave., Silver Spring, MD Leslie Kux,
VI. Electronic Access
20993, 1–877–287–1373, AskCTP@ Associate Commissioner for Policy.
Persons with access to the Internet fda.hhs.gov. [FR Doc. 2015–18782 Filed 7–30–15; 8:45 am]
may obtain the guidance at either SUPPLEMENTARY INFORMATION: BILLING CODE 4164–01–P
http://www.fda.gov/cvm or http://
www.regulations.gov. I. Background
Dated: July 27, 2015. In the Federal Register of August 27, DEPARTMENT OF HEALTH AND
Leslie Kux, 2014 (79 FR 51183), FDA published a HUMAN SERVICES
Associate Commissioner for Policy. notice of availability of MRTPAs
submitted by Swedish Match North Office of the Secretary
[FR Doc. 2015–18796 Filed 7–30–15; 8:45 am]
America Inc. for 10 tobacco products
BILLING CODE 4164–01–P
and gave the public 180 days to Findings of Research Misconduct
comment on the applications. AGENCY: Office of the Secretary, HHS.
DEPARTMENT OF HEALTH AND FDA is required by section 911(e) of ACTION: Notice.
HUMAN SERVICES the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 387k(e)) SUMMARY: Notice is hereby given that
Food and Drug Administration to make an MRTPA available to the the Office of Research Integrity (ORI)
public (except for matters in the has taken final action in the following
[Docket No. FDA–2014–N–1051] application that are trade secrets or case:
Modified Risk Tobacco Product otherwise confidential commercial David Anderson, University of
Applications: Applications for 10 information) and to request comments Oregon, Eugene: Based on an
Products Submitted by Swedish Match by interested persons on the information assessment conducted by the University
North America Inc.; Reopening of contained in the application and on the of Oregon, Eugene (UOE), the
Comment Period label, labeling, and advertising Respondent’s admission, and analysis
accompanying the application. The conducted by ORI, ORI and UOE found
AGENCY: Food and Drug Administration, determination of whether an order is that Mr. David Anderson, Graduate
HHS. appropriate under section 911 of the Student, UOE, engaged in research
Notice; reopening of the
ACTION: FD&C Act is based on the scientific misconduct in research supported by
comment period. information submitted by the applicant National Institute of Mental Health
as well as the scientific evidence and (NIMH), National Institutes of Health
SUMMARY: The Food and Drug other information that is made available (NIH), grants R01 MH087214, R01
Administration (FDA) is reopening the to the Agency, including through public MH077105, and TA MH020002.
period for public comment on modified comments. ORI found that Respondent engaged
asabaliauskas on DSK5VPTVN1PROD with NOTICES
risk tobacco product applications FDA has received and accepted a in research misconduct by falsifying
(MRTPAs) submitted by Swedish Match number of amendments to Swedish and/or fabricating data in the following
North America Inc. for 10 tobacco Match North America Inc.’s 10 four (4) publications:
products and announcing the originally-filed MRTPAs and is making • Journal of Neuroscience
availability for public comment of these amendments available (except for 31(3):1128–38, 2011 (hereafter referred
amendments to the MRTPAs. The notice matters in the amendments that are to as ‘‘Paper 1’’).
of availability for the originally-filed trade secrets or otherwise confidential Journal of Experimental Psychology:
applications appeared in the Federal commercial information) for public Human Perception and Performance
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![45662 Federal Register / Vol. 80, No. 147 / Friday, July 31, 2015 / Notices
39(3):824–835, 2012 (hereafter referred (3) to exclude himself voluntarily DATES: Comments on the ICR must be
to as ‘‘Paper 2’’). from serving in any advisory capacity to received on or before September 29,
• Attention, Perception and PHS including, but not limited to, 2015.
Psychophysics 74(5):891–910, 2012 service on any PHS advisory committee,
(hereafter referred to as ‘‘Paper 3’’). board, and/or peer review committee, or ADDRESSES: Submit your comments to
• Psychological Science 24(6):929–38, as a consultant; and Information.CollectionClearance@
2013 (hereafter referred to as ‘‘Paper 4’’). (4) to assist UOE in advising hhs.gov or by calling (202) 690–6162.
ORI found that Respondent publishers of the need to retract or FOR FURTHER INFORMATION CONTACT:
knowingly falsified data by removing correct the following papers: Information Collection Clearance staff,
outlier values or replacing outliers with • Journal of Neuroscience Information.CollectionClearance@
mean values to produce results that 31(3):1128–38, 2011. hhs.gov or (202) 690–6162.
conform to predictions. Specifically, • Journal of Experimental
Psychology: Human Perception and SUPPLEMENTARY INFORMATION: When
these falsifications appear in: submitting comments or requesting
1. Figures 4 and 8 in Paper 1. Performance 39(3):824–835, 2012.
• Attention, Perception and information, please include the
2. Figures 3C, 3D, and 3E in Paper 2. document identifier HHS–OS–0990–
Psychophysics 74(5):891–910, 2012.
3. Figures 3B, 7C, 7D, and 8B in Paper • Psychological Science 24(6):929–38, 0407–60D for reference.
3. 2013.
4. Figures 3E and 3F in Paper 4. Information Collection Request Title:
FOR FURTHER INFORMATION CONTACT: Think Cultural Health (TCH) Web site
Mr. Anderson has entered into a
Acting Director, Office of Research Quality Improvement Effort—OMB No.
Voluntary Settlement Agreement and
Integrity, 1101 Wootton Parkway, Suite 0990–0407 REVISION–HHS/OS/OMH
has voluntarily agreed for a period of 750, Rockville, MD 20852, (240) 453–
three (3) years, beginning on June 23, Abstract: The Office of Minority
8200. Health (OMH), Office of the Secretary
2015:
(1) To have his research supervised; Donald Wright, (OS), Department of Health and Human
Respondent agreed that prior to the Acting Director, Office of Research Integrity. Services (HHS) is requesting approval
submission of an application for U.S. [FR Doc. 2015–18794 Filed 7–30–15; 8:45 am] by OMB on a revised data collection.
Public Health Service (PHS) support for BILLING CODE 4150–31–P
The Think Cultural Health (TCH) Web
a research project on which his site is an initiative of the HHS OMH’s
participation is proposed and prior to Center for Linguistic and Cultural
his participation in any capacity on DEPARTMENT OF HEALTH AND Competence in Health Care (CLCCHC),
PHS-supported research, Respondent HUMAN SERVICES and is a repository of the latest
shall ensure that a plan for supervision resources and tools to promote cultural
of his duties is submitted to ORI for Office of the Secretary and linguistic competency in health and
approval; the supervision plan must be [Document Identifier: HHS–OS–0990–0407– health care. The TCH Web site is unlike
designed to ensure the scientific 60D] other government Web sites in that its
integrity of his research contribution; suite of e-learning programs affords
Respondent agreed that he shall not Agency Information Collection health and health care professionals the
participate in any PHS-supported Request ability to earn continuing education
research until such a supervision plan is credits through training in cultural and
AGENCY: Office of the Secretary, HHS. linguistic competency. The revision to
submitted to and approved by ORI;
ACTION: Notice. this information collection request
Respondent agreed to maintain
responsibility for compliance with the SUMMARY: In compliance with the includes the online Web site registration
agreed upon supervision plan; requirement of section 3506(c)(2)(A) of form, course/unit evaluations specific to
(2) that any institution employing him the Paperwork Reduction Act of 1995, the resource or e-learning program
shall submit in conjunction with each the Office of the Secretary (OS), course/unit completed, follow up
application for PHS funds, or report, Department of Health and Human surveys, focus groups, and key
manuscript, or abstract involving PHS- Services, announces plans to submit an informant interviews.
supported research in which Information Collection Request (ICR), Need and Proposed Use of the
Respondent is involved, a certification described below, to the Office of Information: The data will be used to
to ORI that the data provided by Management and Budget (OMB). A 60- ensure that the offerings on the TCH
Respondent are based on actual day Federal Register Notice has been Web site are relevant, useful, and
experiments or are otherwise published for this system. This request appropriate to their target audiences.
legitimately derived, and that the data, is to approve a revision to a currently The findings from the data collection
procedures, and methodology are approved collection with OMB number will be of interest to HHS OMH in
accurately reported in the application, 0990–0407, and is not a new request for supporting maintenance and revisions
report, manuscript, or abstract; approval. of the offerings on the TCH Web site.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Number
Number of burden per Total burden
Form name Type of respondent responses per
respondents response (hours)
respondent (hours)
Registration Form ............................. Health and Health Care Profes- 9460 1.00 3/60 473
sionals.
Course/unit Evaluation Form ............ Health and Health Care Profes- 9460 1.00 5/60 788
sionals.
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Document Created: 2015-12-15 12:59:19
Document Modified: 2015-12-15 12:59:19
| 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 45661 |
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