Department of Health and Human Services January 3, 2012 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Device Classification Product Codes.'' The purpose of the guidance document is to educate regulated industry and FDA Staff on how, when, and why to use classification product codes for medical devices regulated by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). This document describes how classification product codes are used in a variety of FDA program areas to regulate and track medical devices. This draft guidance is not final nor is it in effect at this time.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Jennifer Jamieson, State University of New York, Upstate Medical University: Based on the report of an investigation conducted by the State University of New York, Upstate Medical University (SUNY US) and additional analysis conducted by ORI in its oversight review, ORI found that Ms. Jennifer Jamieson, former graduate student, Department of Cell and Developmental Biology, SUNY US, engaged in research misconduct in research supported by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grant R01 GM047607-18A1, and National Heart, Lung, and Blood Institute (NHLBI), NIH, grants R01 HL70244-05. ORI found that Respondent engaged in research misconduct by falsifying data that were included in grant application R01 GM047607- 18A1, in a manuscript submitted for publication to the Journal of Cell Biology, and in several interdepartmental data presentations. Specifically, ORI found that: Respondent falsified Figure 1A in a manuscript submitted for publication to the Journal of Cell Biology, by altering immunoprecipitation Western blot data to make this experiment appear that no Vav2 SH2 was associated with PKL 3YF, when in fact it did. In addition, the Respondent falsified five figures depicting Western blots of similar experiments in four laboratory meeting presentations. The purpose of the falsifications was to show that the experimental results were as described when they were not, or to show that the results were of greater significance than they actually were. Respondent falsified Figure 3I in a manuscript submitted for publication to the Journal of Cell Biology by falsely labeling a Western blot to indicate levels of expression for various Vav2 mutants, when the experimental data were taken from a completely unrelated experiment. Respondent falsified Figure 6A in an interdepartmental laboratory presentation by falsifying Western blot data to falsely depict Paxillin and Hic-5 expression and phosphorylation levels after siRNA treatment. Respondent falsified Figure 5 from NIGMS, NIH, grant application GM047607-18A1, by falsifying Western blot data to support the hypothesis that co-transfection of PKL plus RhoA GEF Vav2 induces RhoA activation and signaling upon plating on fibronectin. Ms. Jamieson has entered into a Voluntary Settlement Agreement (Agreement). Ms Jamieson neither admits nor denies ORI's finding of scientific misconduct nor any particular finding of fact asserted in support of that finding. The settlement is not an admission of liability on the part of the Respondent. Ms. Jamieson has voluntarily agreed for a period of three (3) years, beginning on December 20, 2011: (1) To have her research supervised if employed by an institution that receives or applies for U.S. Public Health Service (PHS) funding; 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 contribution; 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 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 were accurately reported in the application, report, manuscript, or abstract; and (3) to exclude herself 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 revising the labeling requirements for blood and blood components intended for use in transfusion or for further manufacture by combining, simplifying, and updating specific regulations applicable to labeling and circulars of information. These requirements will facilitate the use of a labeling system using machine-readable information that would be acceptable as a replacement for the ``ABC Codabar'' system for the labeling of blood and blood components. FDA is taking this action as a part of its efforts to comprehensively review and, as necessary, revise its regulations, policies, guidances, and procedures related to the regulation of blood and blood components. This final rule is intended to help ensure the continued safety of the blood supply and facilitate consistency in labeling.