Energy Policy and New Uses Office, Agriculture Department July 31, 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI) #198 entitled ``Bracketing and Matrixing Designs for Stability Testing of New Veterinary Drug Substances and Medicinal Products'' (VICH GL45). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance is an annex to a VICH guidance GFI #73 entitled ``Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision)'' VICH GL3(R). This VICH guidance document is intended to provide guidance on the application of reduced designs (i.e., bracketing and matrixing) for stability studies conducted in accordance with the principles outlined in VICH GL3(R).

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Julie Mass[egrave], Pennsylvania State University (PSU): Based on an assessment conducted by the Pennsylvania State University College of Medicine (PSU-COM) and the Respondent's admission, ORI and PSU found that Ms. Julie Mass[egrave], former postdoctoral scholar, PSU-COM, engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant 4 R00 CA138498. ORI found that the Respondent knowingly engaged in research misconduct by falsifying and/or fabricating Western blot data and analyses that were including in the following manuscript: ``Cellular invasion following p120-catenin loss is mediated by AP-1, ITGA2 and MMP11,'' submitted to Molecular Cancer Research (hereafter referred to as the ``Molecular Cancer Research manuscript''). ORI found that the Respondent knowingly falsified and/or fabricated Western blot images, by manipulating the images to give the desired results, and quantitative PCR data and cell invasion and migration data, which were included in Figures 2, 3, S1, and S2 in the Molecular Cancer Research manuscript. Specifically, ORI found that the Respondent included falsified and/ or fabricated data and images in the following figures, and the corresponding text, in the Molecular Cancer Research manuscript: 1. Bands were cut and pasted from different Western blots for the following figures: a. Figures 2A, lanes 2 and 3, for P-cJun (S73) b. Figure 2D, lanes 4 and 6, bands identified as ITGA2 c. Figure 3B, bands identified as ITGA2 and MMP11 d. Figure 3D, bands identified as ITGA2 and MMP11 for lanes M2Neo- [uarr]ITGA2 control and [darr]MMP1 e. Figure 3E, bands identified as ITGA2 and MMP11 for lanes M2KO- [darr]ITGA2 control and M2KO-[darr]ITGA2-[uarr]MMP11 f. Figure S1A, bands identified as P-cJun (S73) g. Figure S2A, bands identified as P-cJun (S73) h. Figure S2C, bands identified as P-cJun (S73) i. Figure S2E, bands identified ITGA2 and MMP11 j. Figures S4B and C, identical bands were used for [beta]-actin 2. Numbers were increased or decreased in cell invasion and migration assays to give the desired results in the following figures: a. Figure 2B, for M2KO-DMSO cells and M2KO-SR11302 cells b. Figure 3F, for M2Neo-[uarr]ITGA2 [darr]MMP11 c. Figure 3G, for M2KO-[darr]ITGA2 [uarr]MMP11 d. Figure S1B, for F2KO-cJun peptide e. Figure S2B, for F2KO-cJun DMSO and F2KO-cJun SR11302 f. Figure S2D, for F2KO-cJun peptide g. Figure S2F, for F2Tom-[uarr]ITGA2 and F2KO-[darr]ITGA2 peptide h. Figures S4A, B, C, and D, for the migration for M2KO and F2KO cells 3. qPCR numbers were altered in Figure 2C, for M2KO-DMSO-PcJun ChIP and for M2KO-SR11302-PcJun ChIP, to give the desired result of PcJun binding to ITGA2 promoter. Ms. Mass[egrave] has entered into a Voluntary Settlement Agreement and has voluntarily agreed for a period of two (2) years, beginning on July 6, 2015: (1) To have her research supervised; Respondent agreed that prior to the submission of an application for U.S. Public Health Service (PHS) support for a research project on which her participation is proposed and prior to her 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 her research contribution; Respondent agreed that she 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 supervision plan; (2) that any institution employing her 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.