Department of Health and Human Services June 23, 2014 – 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: Melanie Cokonis, Southern Research Institute: Based on the report of an investigation conducted by Southern Research Institute (SRI) and additional analysis conducted by ORI in its oversight review, ORI found that Ms. Melanie Cokonis, former Research Technician, SRI, engaged in research misconduct in research supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), contracts N01-AI-30047 (HHSN2722011000009C) and N01-AI-70042 (HHSN272200700042C), and National Human Genome Research Institute (NHGRI), NIH, grant U54 HG005034. ORI found that the Respondent engaged in research misconduct by falsifying assay data that were submitted in reports to NIH. Specifically, ORI found that Respondent knowingly falsified data for cytoprotection assays with antiviral compounds and provided the false data for inclusion in reports submitted to NIH for contracts N01-AI- 30047 and N01-AI-70042 and grant U54 HG005034. Respondent transferred raw data from 8X12 SoftmaxPro matrix files into spreadsheets and then falsified the numbers for cell control, virus control, drug cytotoxicity, drug only, and/or cells+ virus+ drug wells to make 206 assays appear to have been successfully performed when they were not. Ms. Cokonis has voluntarily agreed for a period of three (3) years, beginning on May 29, 2014: (1) To exclude herself 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 referred to as ``covered transactions'' pursuant to HHS' Implementation (2 CFR part 376 et seq) of OMB Guidelines to Agencies on Governmentwide Debarment and Suspension, 2 CFR part 180 (collectively the ``Debarment Regulations''); and (2) 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.

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the novel influenza A (H7N9) virus (detected in China in 2013). FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Arbor Vita Corporation. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the April 19, 2013, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves the novel influenza A (H7N9) virus. On the basis of such determination, the Secretary of HHS also declared on April 19, 2013, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the novel influenza A (H7N9) virus subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.