Department of Health and Human Services October 21, 2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by EMD Millipore Corp., proposing that the color additive regulations be amended to expand the safe use of mica-based pearlescent pigments in alcoholic beverages to include cordials, liqueurs, cocktails, and certain other alcoholic beverages, and non-alcoholic mixers and mixes.

Developers and innovators have many great ideas and products that could improve the U.S. health care system and make life better for patients and care providers. However, effecting actual change is extremely difficult due to the high barriers to entry in the health IT space. Once an innovative new product has been developed, it needs to be tested in real-life care settings. But providers can be hesitant to host this testing for a myriad of reasonsthey may have had bad experiences in the past, be anxious about deploying new tools that may disrupt their workflows, or be wary of encountering more problems than the solution solves. Without this testing, it cannot be determined how well the product actually works, making it difficult for the developers to identify the changes that need to be made to the product to make it more effective. Furthermore, without evidence of the uses a product can provide it is that much harder to acquire the venture funding that can fuel further advancement and lead to successful entry in the marketplace. The Market R&D Pilot Challenge is intended to help bridge this gap by bringing together health care organizations (``Hosts'') and innovative companies (``Innovators'') through pilot funding awards and facilitated matchmaking. The Challenge seeks to award pilot proposals in three different domains: Clinical environments (e.g., hospitals, ambulatory care, surgical centers), public health and community environments (community-based personnel such as public health departments, community health workers, mobile medical trucks, school- and jail-based clinics), and consumer health (e.g., self-insured employers, pharmacies, laboratories). Hosts and Innovators will submit joint pilot proposals, with the winners, as determined by an expert panel, proceeding to implement their pilots. The Challenge's primary goals are to: Encourage early collaboration between entrepreneurs, medical and public health personnel, patients, and the research community to link innovation in health IT to innovation in care delivery; De-risk early stage health IT and digital health products for future clinical testing and investment; Encourage uptake of and ensure the market is aware of ONC standards and functions within certified electronic health record technologies; and Explore evidence collection methods and relevant metrics for early stage health IT products that may better match agile software development. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358).