Department of Health and Human Services June 7, 2012 – Federal Register Recent Federal Regulation Documents
Results 1 - 18 of 18
Announcement of Requirements and Registration for “My Air, My Health Challenge”
Environmental and public health are closely related and complementary fieldsand their future depends on a closer understanding of those connections. New portable sensors have the potential to transform the way we measure and interpret the influence of pollution on health. These technologies can provide a picture that is more detailed and more personal, with dramatic implications for health care, air quality oversight, and individuals' control over their own environments and health. The U.S. Environmental Protection Agency (EPA) and U.S. Department of Health and Human Service (HHS) [National Institute of Environmental Health Sciences (NIEHS) and Office of the National Coordinator for Health Information Technology (ONC)] envision a future in which powerful, affordable, and portable sensors provide a rich awareness of environmental quality, moment-to-moment physiological changes, and long-term health outcomes. Health care will be connected to the whole environment, improving diagnosis, treatment, and prevention at all levels. Many of the first steps toward this future have already been taken. Prototype projects have developed portable air quality and physiologic sensors, and experimental analysis tools for handling data that is higher quantity, but often lower quality, than more traditional monitoring techniques. The ``My Air, My Health Challenge'' aims to build on this foundation. We are seeking solutions that integrate data from portable physiological and air quality monitors, producing a combined picture that is meaningful and usable. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-358) and section 103 of the Clean Air Act, 42 U.S.C. 7403. This challenge addresses the mission of the NIEHS to conduct and support programs with respect to factors in the environment that affect human health, directly or indirectly. 42 U.S.C. 285.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting
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.
Notice of a Noncompetitive Supplement and a 7-Month Extension of the Period of Support for the Frontier Extended Stay Clinic (FESC) Cooperative Agreement Recipient-SouthEast Alaska Regional Health Consortium
The Health Resources and Services Administration (HRSA) will be issuing a non-competitive supplement and a 7-month extension of the period of support to the Frontier Extended Stay Clinic (FESC) Cooperative Agreement recipient of record, SouthEast Alaska Regional Health Consortium (Grant Number U17RH23237). The FESC Cooperative Agreement helps to examine the effectiveness and appropriateness of a new type of provider, FESC, in providing health care services in remote areas. The 7-month extension with funds will align with the related three-year Centers for Medicare and Medicaid Services (CMS) demonstration, which will run until March 2013.
Announcement of Requirements and Registration for “Health Data Platform Simple Sign-On Challenge”
As part of the HHS Open Government Plan, the HealthData.gov Platform (HDP) is a flagship initiative and focal point helping to establish learning communities that collaboratively evolve and mature the utility and usability of a broad range of health and human service data. HDP will deliver greater potential for new data driven insights into complex interactions of health and health care services. To augment the HDP effort, seven complementary challenges will encourage innovation around initial platform- and domain-specific priority areas, fostering opportunities to tap the creativity of entrepreneurs and productivity of developers. The ``Health Data Platform Simple Sign-On Challenge'' will improve community engagement by providing simplified sign on (SSO) for external users interacting across multiple HDP technology components, making it easier for community collaborators to contribute, leveraging new approaches to decentralized authentication. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358).
Findings of Research Misconduct; Correction
This document corrects errors that appeared in the notice published in the May 31, Federal Register entitled ``Findings of Research Misconduct.''
Announcement of Requirements and Registration for “Health Data Platform Metadata Challenge”
As part of the HHS Open Government Plan, the HealthData.gov Platform (HDP) is a flagship initiative and focal point helping to establish learning communities that collaboratively evolve and mature the utility and usability of a broad range of health and human service data. HDP will deliver greater potential for new data driven insights into complex interactions of health and health care services. To augment the HDP effort, seven complementary challenges will encourage innovation around initial platform- and domain-specific priority areas, fostering opportunities to tap the creativity of entrepreneurs and productivity of developers. The ``Health Data Platform Metadata Challenge'' requests the application of existing voluntary consensus standards for metadata common to all open government data, and invites new designs for health domain specific metadata to classify datasets in our growing catalog, creating entities, attributes and relations that form the foundations for better discovery, integration and liquidity. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358).
Announcement of Requirements and Registration for “Blue Button Mash Up Challenge”
The Office of the National Coordinator for Health Information Technology (ONC) and the Department of Veterans Affairs are working to empower individuals to be partners in their health through health information technology (health IT). Giving patients access to information about them related to the care they receive from doctors and other healthcare providers is in itself valuable, but it is also important to enable patients to use that information to make informed decisions. Individuals should be able to access and use their basic health information together with other information to take action: To better understand their current health status, use decision support software to choose treatments, anticipate and consider the costs of different options, and target and modify the everyday behaviors that have the greatest impact on their health. Inspired by the well-known ``three- part aim'' for improvement of the health care system, this challenge requires participants to help individuals to take action based on combining their health information with additional information that puts it into a more meaningful context. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358).
International Conference on Harmonisation; Guidance on S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use'' (ICH S2(R1)). This guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH S2(R1) combines and replaces two ICH guidances, ``S2A Specific Aspects for Regulatory Genotoxicity Tests for Pharmaceuticals'' and ``S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals.'' ICH S2(R1) provides guidance to drug sponsors on which tests should be performed to assess potential genotoxicity of pharmaceuticals. It also provides guidance on testing conditions, data interpretation, and followup strategies if a positive response is seen in in vitro assays. This guidance is intended to provide drug sponsors with recommendations to ensure that drugs are appropriately tested for potential to cause genetic damage and to ensure efficient development of new drugs.
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