Department of Health and Human Services October 9, 2007 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: Jon Sudb[oslash], D.D.S., Norwegian Radium Hospital: Based on the findings of an investigation conducted by the Investigation Commission appointed by Norwegian Radium Hospital (NRH) and the University of Oslo, the respondent's own admission, and additional analysis and information obtained by the Office of Research Integrity (ORI) during its oversight review, the U.S. Public Health Service (PHS) found that Jon Sudb[oslash], D.D.S., former doctoral student and faculty member, University of Oslo, and former physician in the Department of Medical Oncology and Radiotherapy, NRH, engaged in scientific misconduct by reporting fabricated and/or falsified research in grant application 1 P01 CA106451-01 submitted to the National Cancer Institute (NCI), National Institutes of Health (NIH), and its first-year progress report. Specifically, PHS found that Dr. Sudb[oslash] engaged in scientific misconduct by falsifying and fabricating research that served as the rationale for Project 1, ``Oral Cancer Prevention with Molecular Targeting Therapy,'' with Dr. Jon Sudb[oslash], as project leader, in the grant application, and by falsifying a progress report for the awarded grant. In particular, in Figure 1 of the Background and Significance section of the grant application, Dr. Sudb[oslash] reported fabricated/falsified results for the effects of lesion ploidy upon survival in patients with oral pre-malignant lesions. In the Preliminary Data section of the grant application, Dr. Sudb[oslash] reported several events intended to demonstrate his experience in the research field that the Investigation Commission stated ``appear as pure fiction.'' Also, in the first yearly progress report for the funded grant, Dr. Sudb[oslash] falsified the number of patients that had been screened for admission to the study. In addition to three publications for which Dr. Sudb[oslash] admitted falsifying and/or fabricating data, the Investigation Commission found at least twelve other publications that warranted retraction because they could not be considered valid. The research reported in these publications was not supported by PHS funds. However, the publications address the same general research area as that addressed in the grant application and demonstrate a pervasive pattern of falsification/fabrication in research reporting on the part of Dr. Sudb[oslash]. The falsified/fabricated data presented in the grant application purport to demonstrate the feasibility of preventing cancer in a high risk population with nontoxic oral agents. Dr. Sudb[oslash] has entered into a Voluntary Exclusion Agreement (Agreement) in which he has voluntarily agreed, beginning on August 31, 2007: (1) To exclude himself permanently 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 as delineated in the OMB Guidelines to Agencies on Governmentwide Debarment and Suspension at 2 CFR Part 376, et seq.; Dr. Sudb[oslash] agrees that he will not petition HHS to reverse or reduce the scope of the permanent voluntary exclusion or other administrative actions that are the subject of this Agreement; and (2) To exclude himself permanently 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 or contractor to PHS.

The Office of Population Affairs, OPHS, HHS published a notice in the Federal Register of Monday, June 11, 2007 announcing the anticipated availability of funds for family planning services grants. On July 13, 2007, the Notice was corrected to reflect the availability of Arizona, Navajo Nation for competition. Since that time, an additional State/population/area to be served has become available for competition. This Notice reflects the availability of Illinois, Chicago area for competition.