Department of Health and Human Services December 15, 2014 – Federal Register Recent Federal Regulation Documents
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Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: James P. Warne, Ph.D., University of California San Francisco: Based on an assessment conducted by the University of California San Francisco (UCSF), the Respondent's admission, and additional analysis conducted by ORI in its oversight review, ORI found that Dr. James P. Warne, former Senior Scientist, Diabetes Center, UCSF School of Medicine, engaged in research misconduct in research supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), grants DK080427, DK007161, and DK063720. ORI found that Respondent engaged in research misconduct by falsifying data that were included in the following two (2) publications and two (2) grant applications:
National Institute of Neurological Disorders and Stroke, Interagency Pain Research Coordinating Committee Call for Committee Membership Nominations
The Department of Health and Human Services (HHS)(Department) has created the Interagency Pain Research Coordinating Committee and is seeking nominations for this committee.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: H. Rosie Xing, Ph.D., University of Chicago: Based on the report of an investigation conducted by the University of Chicago (UC) and additional analysis by ORI in its oversight review, ORI found that Dr. H. Rosie Xing, former Assistant Professor, UC, engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant R01 CA098022. ORI found that Respondent engaged in research misconduct (42 CFR 93.103-104) by using images that had been among a set of manipulated images produced while at another institution, which had been found to be false by that institution. ORI found that Respondent falsely reported these images in Figures 1D, 2A, and Supplementary Figures 1B and 1C in Molecular Cancer Therapeutics 9:2724-36, 2010. The Respondent does not agree with ORI's finding of research misconduct and asserts that there are extenuating circumstances for her actions. Specifically, ORI found that Respondent: 1. included falsely labeled immunoblots in Figures 1D and 2A as follows: a. Figure 1D (lower panel), representing the total ERK levels in extracts from cells exposed to 15 Gy of gamma radiation for 0-120 minutes, by using results from an unrelated experiment for MAPK levels in extracts from cells exposed to 2, 12, or 20 Gy of gamma irradiation for 1, 5, 20, or 60 minutes b. Figure 2A (KSR1 panel), representing a control Flag-KSR1 immunoblot for extracts of cells transfected with control (TRE), wild- type KSR (KSR-S), or dominant negative inactive KSR (DN-KSR) exposed to no radiation or 5 minutes gamma irradiation, by using results form an unrelated experiment for KSR-transfected cells (KSR-S) irradiated with 0, 2, 5, 20, 15, 20 Gy irradiation c. Figure 2A (ERK panel), representing a control ERK immunoblot for extracts of cells transfected with control (TRE), wild-type KSR (KSR- S), or dominant negative inactive KSR (DN-KSR) exposed to no radiation or 5 minutes gamma irradiation, by using results from an unrelated experiment for KSR-transfected cells (KSR-S) irradiated with 0, 2, 5, 10, 15, 20 Gy irradiation 2. included falsified images in Figures 1D, 2A, and Supplementary Figures 1B and 1C by duplicating bands within the figures as follows: a. Figure 1D (top panel) for an immunoblot for p-ERK in A431 cells, by using the same bands to represent cells treated with ionizing radiation for 5 and 10 minutes with the bands for 60 and 90 minutes b. Figure 2A (top) for an in vitro kinase assay for p-GST-Elk-1, by duplicating lanes 2 and 5 to represent the control plasmid (TRE) at 5 minutes post radiation (lane 2) and the dominant negative inactive KSR (DN-KSR) NT lane (lane 5) c. Supplementary Figure 1B (middle panel) for an in vitro kinase assay for p-GST-MEK, by using the same bands to represent cells exposed to 5 and 20 Gy ionizing radiation d. Supplementary Figure 1C (top panel) for an immunoblot for p- MEK1/2, by using the same bands to represent cells exposed to 2 and 20 Gy ionizing radiation Dr. Xing has entered into a Voluntary Settlement Agreement (Agreement) and has voluntarily agreed: (1) that if within three (3) years from the effective date of the Agreement, Respondent receives or applies for U.S. Public Health Service (PHS) support, Respondent agrees to have her PHS-supported research supervised for a period of three (3) years beginning on the date of her employment in which she receives or applies for PHS support, and to notify her employer(s)/institution(s) of the terms of this supervision; Respondent agrees that prior to the submission of an application for 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, Respondent shall ensure that a plan for supervision of her duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent's research; Respondent agrees that she shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agrees to maintain responsibility for compliance with the agreed upon supervision plan; (2) that if within three (3) years from the effective date of this Agreement, Respondent receives or applies for PHS support, for a period of three (3) years beginning on the date of her employment in which she receives or applies for PHS support, any institution employing her to work on PHS-supported projects 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; and (3) to exclude herself 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 for a period of three (3) years beginning on November 13, 2014.
Submission for OMB Review; 30-Day Comment Request Evaluation of the NIH Academic Research Enhancement Award (NIH OD)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on July 9, 2014, Vol. 79, page 38921, and allowed 60-days for public comment. No public comments were received during the 60-day period. The purpose of this notice is to allow an additional 30 days for public comment. The Office of the Director (OD), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.
Availability of Draft Toxicological Profiles
This notice announces the availability of Set 26 Toxicological Profiles for review and comment. Comments can include additional information or reports on studies about the health effects of Set 26 substances. Although ATSDR considered key studies for each of these substances during the profile development process, this Federal Register notice solicits any relevant, additional studies, particularly unpublished data. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion into the profile. ATSDR remains committed to providing a public comment period for this document as a means to best serve public health and our clients. The Set 26 Toxicological Profiles are available online at https:// www.atsdr.cdc.gov/toxprofiles/index.asp and https://www.regulations.gov/ #!home, docket ATSDR-2014-0001. The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Sec. 104(i)(3),[42 U.S.C. 9604(i)(3)], directs the ATSDR administrator to prepare Toxicological Profiles of priority hazardous substances and, as necessary, to revise and publish each updated toxicological profile.
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Withdrawal of Approval of New Animal Drug Applications
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September and October 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of six NADAs and four ANADAs, the voluntary withdrawal of approval of an ANADA, and a correcting amendment.
Oral Dosage Form New Animal Drugs; Withdrawal of Approval of New Animal Drug Application; Oxytetracycline
The Food and Drug Administration (FDA) is withdrawing approval of an abbreviated new animal drug application (ANADA) for an oxytetracycline soluble powder used to make medicated drinking water for livestock and poultry. This action is being taken at the sponsor's request because this product is no longer manufactured or marketed.
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