Department of Health and Human Services January 20, 2015 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Bin Kang, Ph.D., Oklahoma Medical Research Foundation: Based on the Respondent's admission, an assessment conducted by the Oklahoma Medical Research Foundation (OMRF), and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Bin Kang, Postdoctoral Fellow, Immunobiology and Cancer Research Program, OMRF, engaged in research misconduct in research supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), grants AI056129 and AI104057. ORI and OMRF found that Respondent engaged in research misconduct by reporting falsified data in: ``Asb2 regulates the activity of SCF E3 ubiquitin ligases by antagonizing CAND1-mediated exchange of F-box proteins,'' submitted to Molecular Cell on June 26, 2014; hereafter referred to as the ``original Molecular Cell manuscript'' the revised version of ``Asb2 regulates the activity of SCF E3 ubiquitin ligases by antagonizing CAND1-mediated exchange of F- box proteins,'' submitted to Molecular Cell on September 29, 2014; hereafter referred to as the ``revised Molecular Cell manuscript grant application CA189216-01 submitted to the National Cancer Institute (NCI), NIH; hereafter referred to as the ``original NCI grant application'' grant application CA189216-01A1 submitted to NCI, NIH; hereafter referred to as the ``revised NCI grant application'' ORI found that Respondent knowingly falsified and/or fabricated Western blot gel images by duplication, reuse and relabeling, and/or alteration through contrast, rotation, and/or scale of the images. Specifically, Respondent included falsified images in all of the figures (Figures 1-6 and S1-5) in the original Molecular Cell manuscript, all of the figures (Figures 1-6 and S1-7) in the revised Molecular Cell manuscript, Figures 2-4, 9, and 11 in the original NCI grant application, and Figures 3-5, 10, and 11 in the revised NCI grant application. Dr. Kang has entered into a Voluntary Settlement Agreement (Agreement) and has voluntarily agreed for a period of three (3) years, beginning on December 23, 2014: (1) To have his research supervised; Respondent agreed to ensure that prior to the submission of an application for U.S. Public Health Service (PHS) support for a research project on which the Respondent's participation is proposed and prior to Respondent's participation in any capacity on PHS-supported research, the institution employing him must submit a plan for supervision of his duties to ORI for approval; the plan for supervision must be designed to ensure the scientific integrity of Respondent's 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 plan for supervision; (2) that any institution employing him must 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; and (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.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes.'' FDA has received reports of blood and stool traveling through colonoscope irrigation channels and into the water bottle and tubing when the irrigation channel did not have a backflow-prevention mechanism in place. This draft guidance document, when finalized, will highlight the cross- contamination risk associated with specific types of irrigation valves and accessories when used with flexible gastrointestinal endoscopes, clarify terminology used to describe these devices, and outline strategies to mitigate the risk of cross-contamination between patients. This draft guidance is not final nor is it in effect at this time.

NIOSH gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from the Lawrence Livermore National Laboratory in Livermore, California, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: