Department of Health and Human Services August 24, 2009 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Determination of Regulatory Review Period for Purposes of Patent Extension; LEXISCAN
The Food and Drug Administration (FDA) has determined the regulatory review period for LEXISCAN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product.
Agency Information Collection Activities: Proposed Collection; Comment Request; Internet Survey on Barriers to Food Label Use
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Internet Survey on Barriers to Food Label Use.
Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Public Health Notification Readership Survey (formerly known as “Safety Alert/Public Health Advisory Readership Survey”)
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA Public Health Notification Readership Survey.
Breach Notification for Unsecured Protected Health Information
The Department of Health and Human Services (HHS) is issuing this interim final rule with a request for comments to require notification of breaches of unsecured protected health information. Section 13402 of the Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009 (ARRA) that was enacted on February 17, 2009, requires HHS to issue interim final regulations within 180 days to require covered entities under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and their business associates to provide notification in the case of breaches of unsecured protected health information. For purposes of determining what information is ``unsecured protected health information,'' in this document HHS is also issuing an update to its guidance specifying the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals.
Request for Information Relevant to the Regionalization of Emergency Medical Care Delivery Systems and Demonstration Model Development
This is a time-sensitive Request for Information (RFI) issued by the Emergency Care Coordination Center in the Office of the Assistant Secretary for Preparedness and Response on behalf of the Council on Emergency Medical Care (CEMC) and the Federal Interagency Committee on Emergency Medical Services (FICEMS)collectively known as the Emergency Care Enterprise (ECE). The information requested is meant to ascertain key concepts, best practices, and operational approaches to support regionalized, comprehensive and accountable emergency care and trauma systems. The information will be analyzed by the ECCC to help guide the development of demonstration programs that design and evaluate innovative models of regionalized, coordinated and accountable emergency care and trauma systems.
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