Department of Health and Human Services August 13, 2012 – Federal Register Recent Federal Regulation Documents

Announcement of Requirements and Registration for the Challenge To Identify Audacious Goals in Vision Research and Blindness Rehabilitation
Document Number: 2012-19801
Type: Notice
Date: 2012-08-13
Agency: Department of Health and Human Services, National Institutes of Health
The National Eye Institute (NEI) is announcing the launch of the Challenge to Identify Audacious Goals in Vision Research and Blindness Rehabilitation (Challenge) to stimulate innovation in establishing a national vision research agenda. This Challenge seeks entries from the general public, not just those typically engaged in vision research. The challenge calls for submission of audacious goals in any area relevant to NEI's mission to conduct and support research, training, health information dissemination, and other programs with respect to blinding eye diseases, visual disorders, mechanisms of visual function, preservation of sight, and the special health problems and requirements of the blind (42 U.S.C. 285i). The NEI will select up to 20 winners to receive a $3,000 cash prize and will host the winners at the NEI Audacious Goals Development Meeting to present and discuss their winning entries with a broad audience of scientists, NEI staff, and other stakeholders. This challenge will generate valuable contributions from NEI's many and varied stakeholders to inform the Institute's strategic plan, energize the Institute's research efforts, increase public awareness of vision research, and enhance the national effort to reduce the burden of ocular disorders and diseases worldwide.
Office of the National Coordinator for Health Information Technology; Announcement of Requirements and Registration for Beat Down Blood Pressure Challenge
Document Number: 2012-19775
Type: Notice
Date: 2012-08-13
Agency: Department of Health and Human Services
The Office of the National Coordinator for Health Information Technology (ONC) announces the launch of the Managing Meds Video Challenge. This challenge is an open call for the public to create short, inspiring videos sharing how you use technology to manage your medications effectively or how health care providers or caregivers support individuals to take their medications as directed, improving patient health and safety. This is the fourth in a series of Health IT video contests that will occur throughout 2012. The goal of this video contest series is to generate content that will be used to motivate and inspire others to leverage technology to better manage their health and be more engaged partners in their 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.
Division of Cardiovascular Devices 30-Day Notices and Annual Reports; Public Workshop; Request for Comments
Document Number: 2012-19747
Type: Notice
Date: 2012-08-13
Agency: Food and Drug Administration, Department of Health and Human Services
Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability
Document Number: 2012-19744
Type: Notice
Date: 2012-08-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Refuse to Accept Policy for 510(k)s.'' The purpose of this document is to explain the procedures and criteria FDA intends to use in determining whether a premarket notification (510(k)) submission is administratively complete, which determines whether it should be accepted for substantive review. This guidance is applicable to 510(k)s reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). This draft guidance is not final nor is it in effect at this time.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2012-19717
Type: Notice
Date: 2012-08-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2012-19716
Type: Notice
Date: 2012-08-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute Environmental Health Sciences; Notice of Meeting
Document Number: 2012-19715
Type: Notice
Date: 2012-08-13
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2012-19689
Type: Notice
Date: 2012-08-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Tribal Consultation Meeting
Document Number: 2012-19587
Type: Notice
Date: 2012-08-13
Agency: Department of Health and Human Services, Administration for Children and Families
Pursuant to the Improving Head Start for School Readiness Act of 2007, notice is hereby given of a one-day Tribal Consultation Session to be held between the Department of Health and Human Services, Administration for Children and Families, Office of Head Start leadership and the leadership of Tribal Governments operating Head Start (including Early Head Start) programs. The purpose of this Consultation Session is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations.
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