Department of Health and Human Services January 25, 2013 – Federal Register Recent Federal Regulation Documents
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Solicitation of Nominations for Organizations To Serve as Non-Voting Liaison Representatives to the Chronic Fatigue Syndrome Advisory Committee (CFSAC)
The Office of the Assistant Secretary for Health (OASH), within the Department of Health and Human Services (HHS), is soliciting nominations from qualified organizations to be considered for non- voting liaison representative positions on the Chronic Fatigue Syndrome Advisory Committee (CFSAC). CFSAC provides advice and recommendations to the Secretary of HHS, through the Assistant Secretary for Health (ASH), on a broad range of issues and topics related to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The issues can include factors affecting access and care for persons with ME/CFS; the science and definition of ME/CFS; and public health, clinical, research, and educational issues related to ME/CFS. These three non-voting liaison representative positions will be occupied by individuals who are selected by their organizations to serve as representatives of organizations concerned with ME/CFS. Organizations will be designated to occupy the positions for a two-year term to commence during the 2013 calendar year. Nominations of qualified organizations are being sought for these three non-voting liaison representative positions. The organizations chosen for representation on CFSAC will be selected by the Designated Federal Officer (DFO) or designee during the 2013 calendar year. Details of nomination requirements are provided below.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Rao M. Adibhatla, Ph.D., University of Wisconsin: Based on the report of an investigation conducted by the University of Wisconsin (UW) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Rao M. Adibhatla, Assistant Professor, Department of Neurological Surgery, UW, engaged in research misconduct by falsifying results in two publications supported by National Institute of Neurological Diseases and Stroke (NINDS), National Institutes of Health (NIH), grant R01 NS042008 and in three unfunded applications that Dr. Adibhatla submitted to NINDS, NIH, as R01 NS042008-05, -05A1, and - 05A2. The questioned papers are:
Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug
The Food and Drug Administration (FDA or Agency) is proposing to classify the scleral plug into class II (special controls), and proposing to exempt the scleral plugs composed of surgical grade stainless steel (with or without coating in gold, silver, or titanium) from premarket notification (510(k)) and to continue to require premarket notification (510(k)) for all other scleral plugs in order to provide a reasonable assurance of safety and effectiveness of the device. The scleral plug is a prescription device used to provide temporary closure of a scleral incision during an ophthalmic surgical procedure.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pretesting of Tobacco Communications
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).
Announcement of Requirements and Registration for the 2013 NIBIB DEsign by Biomedical Undergraduate Teams (DEBUT) Challenge
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) DEBUT Challenge is open to teams of undergraduate students working on projects that develop innovative solutions to unmet health and clinical problems. NIBIB's mission is to improve health by leading the development and accelerating the application of biomedical technologies. The goals of the challenge are (1) to provide undergraduate students valuable experiences such as working in teams, identifying unmet clinical needs, and designing, building, and debugging solutions for such open-ended problems; (2) to generate novel, innovative tools to improve health care, consistent with NIBIB's purpose to support research, training, the dissemination of health information, and other programs with respect to biomedical imaging and engineering and associated technologies and modalities with biomedical applications; and (3) to highlight and acknowledge the contributions and accomplishments of undergraduate students.
Medicare Program; Request for Information To Aid in the Design and Development of a Survey Regarding Patient Experiences With Hospital Outpatient Surgery Departments/Ambulatory Surgery Centers and Patient-Reported Outcomes From Surgeries and Procedures Performed in These Settings
This document is a request for information regarding hospital outpatient surgery departments (HOSDs) and ambulatory surgery centers (ASCs), as well as patient-reported outcomes from surgeries or other procedures performed in these settings.
Medicare Program; Request for Information To Aid in the Design and Development of a Survey Regarding Patient and Family Member/Friend Experiences With Hospice Care
This document is a request for information regarding patient and family member or close friend experiences with hospice care.
Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules
The Department of Health and Human Services (HHS or ``the Department'') is issuing this final rule to: Modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Enforcement Rules to implement statutory amendments under the Health Information Technology for Economic and Clinical Health Act (``the HITECH Act'' or ``the Act'') to strengthen the privacy and security protection for individuals' health information; modify the rule for Breach Notification for Unsecured Protected Health Information (Breach Notification Rule) under the HITECH Act to address public comment received on the interim final rule; modify the HIPAA Privacy Rule to strengthen the privacy protections for genetic information by implementing section 105 of Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA); and make certain other modifications to the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules (the HIPAA Rules) to improve their workability and effectiveness and to increase flexibility for and decrease burden on the regulated entities.
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