Department of Health and Human Services October 26, 2011 – Federal Register Recent Federal Regulation Documents

October 31, 2011 marks the national release of the Healthy People 2020 leading health indicators (LHIs). The LHIs were developed to communicate high-priority health issues to the public, and actions that can be taken to address them. The Office of Disease Prevention and Health Promotion, in partnership with Health 2.0 and the Office of the National Coordinator of Health IT, is launching an LHI App Challenge to encourage teams of developers and health professionals to build an application that addresses one or more LHI topics on a community level. The overall purpose of the Challenge is to provide public health practitioners, business, elected officials, clinicians and the public with applications to help achieve national priority health goals.

The Food and Drug Administration (FDA) is announcing a review of the ``Bar Code Final Rule,'' under Executive Order 13563, ``Improving Regulation and Regulatory Review.'' The Bar Code Final Rule, which was published in 2004, requires certain human drug products and biological products to have a bar code. Information submitted can help FDA to reassess the costs and benefits of the rule and to identify any relevant changes in technology that have occurred since it went into effect. FDA is establishing a public docket to receive information relevant to reassessing the Bar Code Rule. This is an opportunity for interested persons to share information, research, and ideas on the need, maturity, and acceptability of alternative identification technologies for the identification, including the unique identification, of drugs and biological products. FDA will use the information received to assess whether the Bar Code Final Rule is achieving its intended benefits as effectively as possible or should be modified.