Department of Health and Human Services June 2012 – Federal Register Recent Federal Regulation Documents
Results 251 - 291 of 291
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601
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 Form FDA 3601, entitled ``Medical Device User Fee Cover Sheet,'' which must be submitted along with certain medical device product applications, supplements, and fee payment of those applications.
Reimbursement Rates for Calendar Year 2012
Notice is given that the Director of Indian Health Service (IHS), under the authority of sections 321(a) and 322(b) of the Public Health Service Act (42 U.S.C. 248 and 249(b)), Public Law 83-568 (42 U.S.C. 2001(a)), and the Indian Health Care Improvement Act (25 U.S.C. 1601 et seq.), has approved the following rates for inpatient and outpatient medical care provided by IHS facilities for Calendar Year 2012 for Medicare and Medicaid beneficiaries and beneficiaries of other Federal programs. The Medicare Part A inpatient rates are excluded from the table below as they are paid based on the prospective payment system. Since the inpatient rates set forth below do not include all physician services and practitioner services, additional payment may be available to the extent that those services meet applicable requirements.
New Animal Drugs; Change of Sponsor's Name
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Novopharm Ltd. to Teva Canada Ltd.
Patient Safety Organizations: Expired Listing for The American Cancer Biorepository, Inc. d/b/a American Collaborative Biorepository or “ACB”
AHRQ has delisted The American Cancer Biorepository, Inc. d/b/ a American Collaborative Biorepository or ``ACB'' as a Patient Safety Organization (PSO) due to its failure to seek continued listing. The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) authorizes the listing of PSOs, which are entities or component organizations whose mission and primary activity is to conduct activities to improve patient safety and the quality of health care delivery. HHS issued the Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) to implement the Patient Safety Act. AHRQ administers the provisions of the Patient Safety Act and Patient Safety Rule relating to the listing and operation of PSOs.
AHRQ Workgroups on ICD-10-CM/PCS Conversion of Quality Indicators (QIs)
The Agency for Healthcare Research and Quality (AHRQ) is seeking nominations for members of approximately 10 multidisciplinary workgroups, to be convened by AHRQ's contractor, on ICD-10-CM/PCS conversion of the AHRQ Quality Indicators (QIs).
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