Department of Health and Human Services January 3, 2006 – Federal Register Recent Federal Regulation Documents
Results 1 - 8 of 8
Findings of Scientific Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) and the Acting Assistant Secretary for Health have taken final action in the following case: Hans E. Geisler, M.D., Saint Vincent Hospital and Health Care Center: Based on the report of an inquiry and investigation conducted by Saint Vincent Hospital (SVH) in Indianapolis, Indiana, and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Hans E. Geisler, M.D., former Staff Physician and Principal Investigator for SVH's studies under the Gynecologic Oncology Group (GOG), engaged in scientific misconduct by soliciting a pathologist to falsify the originally correct tissue-type on the pathology report (omentum) as being another type (ovary) and submitting the falsified report to the GOG group member at the University of Iowa, in order to justify enrollment of a patient in GOG clinical protocol 182. The questioned research was supported by National Institutes of Health (NIH) funds to the University of Iowa through the American Society for Obstetrics and Gynecology under National Cancer Institute (NCI), National Institutes of Health (NIH), cooperative agreement U10 CA27469. Dr. Geisler has entered into a Voluntary Exclusion Agreement (Agreement ) in which he has voluntarily agreed, for a period of three (3) years, beginning on December 2, 2005: (1) 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 consultant; and (2) That any institution which uses the Respondent in any capacity on PHS-supported research, or that submits an application for PHS support for a research project on which the Respondent's participation is proposed or submits a report of PHS-funded research in which the Respondent's participation is continuing, must concurrently submit a plan for supervision of the Respondent's duties to the funding agency for approval. The supervisory plan must be designed to ensure the scientific integrity of the Respondent's research contribution. A copy of the supervisory plan must also be submitted to ORI by the institution. Respondent agrees that he will not participate in any PHS- supported research until such a supervision plan is submitted to ORI. Respondent disagrees with the ORI finding set forth herein but executes this Agreement to avoid further proceedings and bring this matter to a close. The execution of this Agreement shall not be deemed an admission to the charge of scientific misconduct by the Respondent.
Findings of Scientific Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) and the Acting Assistant Secretary for Health have taken final action in the following case: Ralph A. Highshaw, M.D., M.D. Anderson Cancer Center: Based on the report of an investigation conducted by the M.D. Anderson Cancer Center (MDACC) and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Ralph A. Highshaw, M.D., Fellow, Department of Urologic Surgery, MDACC, engaged in scientific misconduct while supported by National Cancer Institute (NCI), National Institutes of Health (NIH), postdoctoral training grant T32 CA079449-01A1. Specifically, PHS found that Dr. Highshaw engaged in scientific misconduct by plagiarizing nine pages of a twenty-one page expert review article entitled ``Chemoprevention of Urologic Cancer.'' Dr. Highshaw has entered into a Voluntary Exclusion Agreement (Agreement ) in which he has voluntarily agreed, for a period of three (3) years, beginning on December 12, 2005: (1) That he is required to certify in every PHS research application or report, and any other text, article, or manuscript, that all contributors are properly cited or otherwise acknowledged; the certification by the Respondent must be endorsed by an institutional official, and a copy of the certification is to be sent to ORI by the institution; (2) To ensure that any institution employing him submits, in conjunction with each application for PHS funds, annual reports, manuscripts, or abstracts of PHS funded research in which the Respondent is involved, a certification that the data provided by the Respondent are based on actual experiments or are otherwise legitimately derived, and that the data, procedures, and methodology are accurately reported in the application or report; the Respondent must ensure that the institution also sends a copy of the certification to ORI; and (3) 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 consultant.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and “Lookback”
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and `Lookback''' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Collection of Data Relating to the Prevention of Medical Gas Mixups at Health Care Facilities-Survey
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on measures, taken by certain health care medical facilities that use medical oxygen, to prevent mixups with other gases.
Translational Research Working Group Public Comment Period
The Translational Research Working Group (TRWG), a broad panel including advocates, researchers from academia, industry representatives, and government officials, was established in early 2005 to evaluate the status of the National Cancer Institute's (NCI) intramural and extramural investment in translational research in order to develop recommendations on ways to coordinate and optimally integrate activities. The TRWG is also charged with developing implementation strategies that will enable the scientific community and NCI leadership to appropriately prioritize its translational research opportunities. Recommendations will be made to the National Cancer Advisory Board by early 2007. To assist in its future planning efforts, TRWG is asking public stakeholders in the translational research enterprise for feedback on some of the key questions facing the panel and insights on how to proceed.
New Animal Drugs; Monensin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA revises the description of growing cattle fed monensin Type C medicated feeds for increased rate of weight gain and for prevention and control of coccidiosis.
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