Department of Health and Human Services January 2012 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 243
Health Information Technology Implementation
The Health Resources and Services Administration (HRSA) will be transferring the American Recovery and Reinvestment Act (ARRA) (section 330 of the Public Health Service Act) Health Information Technology Implementation for Health Center Controlled Networks (HCCN) funds originally awarded to Community Health Network, Inc. (CHN), to the Tennessee Primary Care Association (TPCA) to ensure the implementation of a Health Center Controlled Network in the State of Tennessee.
Request for Information on Youth Violence
The Centers for Disease Control and Prevention, is seeking on behalf of the Department of Health and Human Services information for an anticipated Surgeon General response to the public health problem of youth violence.
Request for Public Comment on Nominations and Call for Additional Nominations to the Report on Carcinogens
The NTP requests comments on several substances, mixtures, and exposure circumstances (collectively referred to as ``substances'') nominated for possible review for future editions of the Report on Carcinogens (RoC). The NTP also invites the nomination of additional substances.
Proposed Collection; Comment Request: Solar Cell: A Mobile UV Manager for Smart Phones (NCI)
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Solar Cell: A Mobile UV Manager for Smart Phones (NCI). Type of Information Collection Request: New. Need and Use of Information Collection: The overall goal of the study is to design a smart phone application, Solar Cell, which uses smart phone technology to aid users in protecting their skin from damaging ultraviolet radiation (UV) in sunlight, a primary cause of skin cancer. The purpose of this part of the study is to produce, deploy, and evaluate the effectiveness of a state-of-the-art software application for smart phones (i.e., mobile application), ``Solar Cell.'' This software application supports decision-making related to sun protection and exposure by Americans to reduce the risk of developing skin cancer attributable to chronic and severe UV exposure and developing other cancers attributable to vitamin D deficiency. The Solar Cell mobile smart phone application combines personal and behavior data with geo- spatial data (i.e., UV Index forecast, time, and location) and delivers actionable sun protection advice to reduce risk of skin cancer. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Adults (18 and over) from the U.S. population who own Android smart phones. The annual reporting burden is estimated at 673 (see Table below). There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
Tribal Consultation; Notice of Meeting
The Department of Health and Human Services (HHS), Administration for Children and Families (ACF) will host a Tribal Consultation to consult on ACF programs and tribal priorities.
Announcement of the Requirements and Registration for the Healthy New Year Challenge
The Office of the National Coordinator for Health Information Technology (ONC), part of the Department of Health and Human Services (HHS), is announcing the launch of the Healthy New Year Challenge. This challenge is an open call for people nationwide to create and submit short videos that capture New Year's resolutions geared towards improving their health or the health of a loved one through the use of technology. The Healthy New Year Challenge is the first in a series of video contests for the public to share their personal stories about how they use health information technology (health IT) or consumer e-health tools to impact their health or the health of a loved one. The goal of this video contest series is to generate winning videos that will be used to motivate and inspire others and their loved ones to use health information technology to be more engaged partners in improving health and health care. Each challenge will be a call to action for members of the public to create a short video clip [2 minutes or less] on a particular theme, and will award cash prizes to winners in several categories.
Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from the Pantex Plant in Amarillo, Texas, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 21, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Determination That PREZISTA (darunavir) Tablets, 300 Milligrams Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that PREZISTA (darunavir) Tablets, 300 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for darunavir tablets, 300 mg, if all other legal and regulatory requirements are met.
Guidance for Industry: Preparation of Investigational Device Exemptions and Investigational New Drug Applications for Products Intended To Repair or Replace Knee Cartilage; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage'' dated December 2011. The guidance document provides sponsors of an investigational device exemption application (IDE) or an investigational new drug application (IND) recommendations about certain information that should be included in a submission describing a product intended to repair or replace knee cartilage. The guidance does not apply to prostheses such as unicondylar or total knee implants, or meniscus replacement products. The guidance supplements recommendations regarding IDE and IND submissions contained in other FDA publications. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2007.
United States Pharmacopeial Convention; Filing of Food Additive Petition; Amendment
The Food and Drug Administration (FDA) is amending the filing notice for a food additive petition filed by the U.S. Pharmacopeial Convention requesting that the food additive regulations that incorporate by reference food-grade specifications from prior editions of the Food Chemicals Codex (FCC) be amended to incorporate by reference food-grade specifications from the FCC, 7th Edition.
Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Generally Recognized as Safe: Notification Procedure
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 the information collection provisions of the Notification Procedure for Substances Generally Recognized as Safe (GRAS) and new Form FDA 3667, which may be submitted electronically via the Electronic Submission Gateway (ESG).
Medicaid Program; Disproportionate Share Hospital Payments-Uninsured Definition
This proposed rule addresses the hospital-specific limitation on Medicaid disproportionate share hospital (DSH) payments under the Social Security Act. Under this limitation, DSH payments to a hospital cannot exceed the uncompensated costs of furnishing hospital services by the hospital to individuals who are Medicaid-eligible or ``have no health insurance (or other source of third party coverage) for the services furnished during the year.'' This rule would provide that the quoted phrase would refer in context to a lack of coverage on a service-specific basis, so that the calculation of uncompensated care for purposes of the hospital-specific DSH limit would include the cost of each service furnished to an individual who had no health insurance or other source of third party coverage for that service.
Public Meeting of the Presidential Commission for the Study of Bioethical Issues
The Presidential Commission for the Study of Bioethical Issues will conduct its eighth meeting in February. At this meeting, the Commission will discuss issues of privacy and access related to human genome sequence data. The Commission will also be discussing neuroscience and related ethical issues.
Agency Information Collection Activities; Proposed Collection; 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 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 paperwork requirements for an electronic form (e-form), to collect distribution reports for antimicrobials in food producing animals.
Agency Information Collection Activities; Proposed Collection; Comment Request; Healthcare Professional Survey of Prescription Drug Promotion
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 Healthcare Professional Survey of Prescription Drug Promotion. This survey is designed to explore the opinions and perceptions of physicians, nurse practitioners, and physician assistants with regard to the promotion of prescription drugs to consumers and healthcare providers.
Office of Child Support Enforcement; Privacy Act of 1974; Computer Matching Agreement
In accordance with the Privacy Act of 1974 (5 U.S.C. 522a), as amended, OCSE is publishing notice of a computer matching program between OCSE and state agencies administering the Supplemental Nutrition Assistance Program (SNAP).
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