Department of Health and Human Services October 4, 2011 – Federal Register Recent Federal Regulation Documents
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Medicare, Medicaid, and Children's Health Insurance Programs; Meeting of the Advisory Panel on Outreach and Education (APOE), November 17, 2011
This notice announces a meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Scott Weber, Ed.D., MSN, University of Pittsburgh: Based on the letters from the Research Integrity Officer at the University of Pittsburgh (UP), ORI's oversight review, and an admission by the Respondent, ORI found that Dr. Scott Weber, former Assistant Professor, Health and Community Systems, School of Nursing, UP, engaged in research misconduct by (1) plagiarizing text and falsifying data from two publications supported by U.S. Public Health Service (PHS) funding (P30 MH60570; HS5 SM52671; PHS employee generated article) in two unpublished manuscripts, and (2) including significant portions of that plagiarized text in two grant applications to the National Institutes of Health (NIH) (1 L30 NR010444-01; 1 R03 HD062761-01). ORI found that the Respondent engaged in research misconduct by plagiarizing text, falsifying data and references, and fabricating data from two publications (Mufson, L., Dorta, K.P., Wickramaratne, P., Nomura, Y., Olfson, M., Weissman, M.M. ``A randomized effectiveness trial of interpersonal psychotherapy for depressed adolescents.'' Arch Gen Psychiatry 61(6):577-84, 2004 June; hereafter referred to as ``Mufson et al. 2004;'' and Cho, M.J., Mo[sacute]cicki, E.K., Narrow, W.E., Rae, D.S., Locke, B.Z., Regier, D.A. ``Concordance between two measures of depression in the Hispanic Health and Nutrition Examination Survey.'' Soc Psychiatry Psychiatr Epidemiol. 28(4):156-63, 1993 August; hereafter referred to as ``Cho et al., 1993'') supported by PHS in two journal article submissions. Specifically, ORI found that the Respondent plagiarized more than 90 percent of the text from Mufson et al. 2004 in a manuscript entitled ``A randomized effectiveness trial of psychiatric-mental health nurse practitioner-administered interpersonal psychotherapy for sexual minority adolescents with depression in primary care clinics'' and submitted to the Journal of the American Academy of Nurse Practitioners (JAANP MS). Furthermore, the Respondent plagiarized approximately 66 percent of the text from Cho et al. 1993 in a manuscript entitled ``Assessing the diagnostic predictive power of a screening tool for depression: Concordance between the CES-D and DIS in the Parent Identity Survey'' and submitted to the Journal of GLBT Family Studies (JGMS MS). In both manuscripts, the Respondent falsified and fabricated tables and figures by using all or nearly all of the data in tables and graphs from the plagiarized articles while altering numbers and changing text to represent data as if from another subject population; he also copied most of the original bibliographic references but falsified 35% of the copied references from JAANP MS and 25% of the copied references from JGMS MS, by changing volume numbers and/or publication years, apparently to hinder detection of the plagiarism. The data fabrication occurred when the Respondent altered or added values to Table 2 in each manuscript describing the demographic characteristics of the study population that was never studied. ORI also finds that the Respondent engaged in research misconduct by plagiarizing text from Cho et al. 1993 in two NIH grant applications (1 L30 NR010444-01 and 1 R03 HD062761-01) by copying substantial word- for-word portions of the text describing the test instrument to be used in the proposed study without citing the Cho et al. 1993 paper. Dr. Weber has voluntarily agreed for a period of three (3) years, beginning on September 7, 2011: (1) To exclude himself from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government referred to as ``covered transactions'' pursuant to HHS' Implementation (2 CFR part 376 et seq.) of OMB Guidelines to Agencies on Governmentwide Debarment and Suspension, 2 CFR part 180 (collectively the ``Debarment Regulations''); and (2) to exclude himself 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.
Bundled Payments for Care Improvement Initiative
This notice extends the deadlines for the submission of the Bundled Payments for Care Improvement ``Model 1'' letters of intent and applications.
Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2012 Proposed Guidance Development
The Food and Drug Administration (FDA) is announcing the Web site location where the Agency will post a list of guidance documents the Center for Devices and Radiological Health (CDRH) is considering for development. In addition, FDA has established a docket where stakeholders may provide comments and/or draft language for those topics as well as suggestions for new or different guidances.
Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas; Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting of the Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas.
Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to Increase Transparency By Promoting Greater Access to the Agency's Compliance and Enforcement Data; Availability
As part of the Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report entitled ``Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to Increase Transparency By Promoting Greater Access to the Agency's Compliance and Enforcement Data.'' This report includes eight draft proposals to make FDA's publicly available compliance and enforcement data more accessible and user-friendly. FDA is seeking public comment on these draft proposals. The Transparency Task Force will ultimately recommend specific draft proposals to the Commissioner of Food and Drugs (the Commissioner) for consideration based on the comments it receives, the feasibility of the draft proposal, relative priority, and available resources.
Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, the Office of the Secretary, Office of the National Coordinator for Health Information Technology (ONC), HHS has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.).
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