Department of Health and Human Services August 6, 2013 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). Specifically, this publication announces the addition of a list of recognized standards that are relevant to interoperability of medical devices. This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 032'' (Recognition List Number: 032), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Pratima Karnik, Ph.D., Case Western Reserve University: Based on the admission of the Respondent, ORI found that Dr. Pratima Karnik, Assistant Professor, Department of Dermatology, Case Western Reserve University (CWRU), engaged in research misconduct in research submitted to the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), in grant application R01 AR062378. ORI found that the Respondent engaged in research misconduct by plagiarizing significant portions from research grant application R21 AR061881 that she had reviewed for NIAMS, NIH, and inserting that text into her submitted grant application R01 AR062378-01. Respondent also plagiarized significant portions of text from the following scientific articles and one U.S. patent application available on the Internet: BMC Med Genomics 4:8, 2011 J Am Col. Cardiol 52:117-123, 2008 Nature 457:910-914, 2009 J Autoimmun 29:310-318, 2007 U.S. Patent Application No. 20090047269 (published Feb. 19, 2009) Toxicol Pathol 35:952-957, 2007 BMC Med Genomics 1:10, 2008 Open Systems Biology Journal 1:1-8, 2008 Endocrinology 146:4189-4191, 2005. Dr. Karnik has entered into a Voluntary Settlement Agreement and has voluntarily agreed for a period of two (2) years, beginning on July 22, 2013: (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; she agreed that she shall 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 content is free of plagiarized material, 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.

This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2014 (for discharges occurring on or after October 1, 2013 and on or before September 30, 2014) as required by the statute. This final rule also revised the list of diagnosis codes that may be counted toward an IRF's ``60 percent rule'' compliance calculation to determine ``presumptive compliance,'' update the IRF facility-level adjustment factors using an enhanced estimation methodology, revise sections of the Inpatient Rehabilitation Facility-Patient Assessment Instrument, revise requirements for acute care hospitals that have IRF units, clarify the IRF regulation text regarding limitation of review, update references to previously changed sections in the regulations text, and revise and update quality measures and reporting requirements under the IRF quality reporting program.