Department of Health and Human Services January 2012 – Federal Register Recent Federal Regulation Documents

The Health Resources and Services Administration (HRSA) is issuing a non-competitive replacement award under the Telehealth Resource Center Grant Program (TRCGP) to the California Telehealth Network in order to continue advancement of the effective use of telehealth technology that will facilitate the provision of health care services to rural, medically-underserved California residents.

This notice is a request for information (RFI) to gain market information on entities that could administer a transitional reinsurance program. This RFI will inform one or more future Requests for Proposals (RFP). This RFI solicits information about entities that could function as a reinsurance entity for the transitional reinsurance program. CMS or one or more States may contract for services required to fulfill the statutory and regulatory requirements of the reinsurance entity.

The Centers for Disease Control and Prevention (CDC) announces the next meeting of the Community Preventive Services Task Force (CPSTF). The Task Forcean independent, nonfederal body of nationally known leaders in public health practice, policy, and research who are appointed by the CDC Directorwas convened in 1996 by the Department of Health and Human Services (HHS) to assess the effectiveness of community, environmental, population, and healthcare system interventions in public health and health promotion. During this meeting, the Task Force will consider the findings of systematic reviews and issue recommendations and findings to help inform decision making about policy, practice, and research in a wide range of U.S. settings. The Task Force's recommendations, along with the systematic reviews of the scientific evidence on which they are based, are compiled in the Guide to Community Preventive Services (Community Guide).

The ``Discharge Follow-Up Appointment Challenge'' challenges software developers to create an easy-to-use web-based tool that will make post-discharge follow-up appointment scheduling a more effective and shared process for care providers, patients and caregivers. In addition, developers will need to articulate a plan for broader adoption at the community level. Submissions can be existing applications, or applications developed specifically for this challenge. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358).

The purpose of this challenge is to highlight the role of health data during commutes and how it may play a critical role in improving the health of commuters. The ``Health Innovations in Commuting Challenge'' invites innovators to submit their best ideas and models for improving the health of American commuters through better collection, exchange, and analysis of health data. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358).

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 308 hours (see Table below). There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Nycomed US, Inc., to Fougera Pharmaceuticals, Inc.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pfizer, Inc. The supplemental NADA extends the slaughter interval for intact male swine injected with gonadotropin releasing factor analog-diphtheria toxoid conjugate injectable solution.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The NADA provides for the veterinary prescription use of milbemycin oxime, lufenuron, and praziquantel for the prevention of heartworm disease, for prevention and control of fleas, and for the treatment and control of various internal parasites in dogs.

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 a study entitled ``Experimental Study of Consumer Response to Health Claims and Disclaimers About the Relationship Between Selenium and Risk of Various Cancers.''